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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Adherence to Drug Therapy in Patients With HFrEF patients with HFrEF Inability or refusal to give written informed consent
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 25.0-999.0, HPV Infection Lesion Cervix Woman over 25 years, whether or not they have been vaccinated against HPV. 2. Able to read and understand the Patient Information Sheet and the Informed Consent form and accept the participation in the study by signing the Informed Consent form. 3. Patient who comes to a visit with a routine cytological result of ASCUS or LSIL and HPV-positive test, of at most 3 months prior to the start of treatment with Papilocare®. 4. Patient who, under that situation, undergoes a colposcopy and has a concordant result with cytology. 5. Patient who has been prescribed treatment with Papilocare® by medical decision prior to their participation in the study Any situation / alteration / pathology, gynecological or not, which, in medical judgment, does not advise or contraindicate the use of Papilocare®. 2. Women of childbearing age who do not use effective contraceptive methods, pregnant women, suspected pregnancy, desire for the same within the next 6 months or during breastfeeding. 3. Participation in any one clinical trial at present or in the 4 weeks prior to in the study. 4. Any planned surgery that precludes correct compliance with the guideline. 5. Known allergies to any of the components of Papilocare®
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-75.0, Hip Osteoarthritis Surgery scheduled to undergo primary unilateral anterior total hip arthroplasty for the treatment of arthritis under the care of the Principal investigator available for follow ups postoperatively Age <18 or > 75 Preoperative BMI ≥ 40 Revision (i.e., non-primary) THA procedures Patients who have undergone THA in contralateral hip within the past 6 months Patient is scheduled for or anticipating THA on contralateral limb within 6 months Patients with an active infection (at the time of screening through surgery, as this is a surgical contraindication) Current co-morbidities such as alcohol or drug addiction, and/or mental disorders could potentially interfere with study participation Cognitive deficit or significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting History of severe osteoporosis, metabolic bone disease, radioactive bone disease, or tumor in the bone surrounding the hip joint History of significant neurological and/or musculoskeletal disorders that may adversely affect gait after THA
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Lung Non-Small Cell Carcinoma Stage I Lung Cancer AJCC v8 Stage IA1 Lung Cancer AJCC v8 Stage IA2 Lung Cancer AJCC v8 Stage IA3 Lung Cancer AJCC v8 Stage IB Lung Cancer AJCC v8 Stage IIA Lung Cancer AJCC v8 Patient must have histologically or cytologically proven stage I-IIA or limited T3N0M0 non-small cell lung cancer (NSCLC), without radiographic evidence of nodal or distant involvement (N0M0). Patient may have T3 disease with the of multifocal tumors and pericardial involvement Disease must have one or more of the following high-risk features Tumor diameter >= 2 cm as assessed by diagnostic computed tomography (CT) Tumor standard uptake value (SUV) max >= 6.2 as assessed by fludeoxyglucose F-18 (FDG) positron emission tomography (PET)/CT Moderately differentiated, poorly differentiated, or undifferentiated histology Patient must have undergone diagnostic chest CT with contrast (unless medically contraindicated) within 42 days prior to randomization. PET-CT may be used if the CT portion is of identical diagnostic quality to a stand-alone CT. All disease must be assessed within 42 days prior to randomization Patient must have undergone FDG PET/CT of chest within 90 days prior to randomization Patient must not have evidence of hilar or mediastinal nodal involvement. Any patient with radiographically suspicious hilar or mediastinal nodes (including features such as non-calcified nodes with a short axis diameter > 1 cm, abnormal morphology, and/or elevated FDG avidity) must undergo cytologic sampling of suspicious nodes to rule out involvement prior to randomization. Mediastinal nodal sampling for other patients is optional Patient must have undergone history and physical examination within 28 days prior to randomization Patient must be medically or surgically inoperable as documented by a board certified thoracic surgeon or multi-disciplinary tumor board consensus OR patient's unwillingness to undergo surgical resection must be clearly documented
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Locally Advanced or Metastatic Malignant Solid Tumors Subject is considered an adult according to local regulation at the time of signing the informed consent form (ICF) Subject has measurable disease by Version 1.1 Subject has accessible archival tumor tissue from either the primary tumor or a metastatic site, for which source and availability have been confirmed prior to study treatment. If no archival tumor tissue is available, the subject will have a biopsy to obtain tumor tissue prior to study treatment. If the subject is unable to undergo a biopsy due to safety concerns, enrollment into the study must be discussed with the medical monitor Subject has ECOG performance status of 0 or 1 Subject has the following baseline laboratory data. If a subject has received a recent blood transfusion, the hematology tests must be obtained ≥ 28 days after any blood transfusion absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L platelet count ≥ 100 × 10^9/L hemoglobin ≥ 9 g/dL serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease creatinine clearance (CrCl) ≥ 30 mL/min as estimated per institutional standards or as measured by 24-hour urine collection (glomerular filtration rate [GFR] can also be used instead of CrCl) Subject has preexisting sensory or motor neuropathy Grade ≥ 2 Subject has active central nervous system (CNS) metastases. Subjects with treated CNS metastases are permitted on study if all the following are true CNS metastases have been clinically stable for ≥ 6 weeks prior to screening If requiring steroid treatment for CNS metastases, the subject is on a stable dose ≤ 20 mg/day of prednisone or equivalent for ≥ 2 weeks Baseline imaging scans show no evidence of new or enlarged brain metastasis Subject does not have leptomeningeal disease Subject has ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery) Subjects with ongoing ≥ Grade 3 immunotherapy-related hypothyroidism or panhypopituitarism are excluded. Subjects with ongoing immunotherapy-related colitis, uveitis, myocarditis or pneumonitis, or subjects with other immunotherapy-related AEs requiring high doses of steroids (> 20 mg/day of prednisone or equivalent), are excluded. Subject with ≤ Grade 2 immunotherapy-related hypothyroidism or panhypopituitarism may be enrolled when well maintained/controlled on a stable dose of hormone replacement therapy (if indicated) Subject has a history of uncontrolled diabetes mellitus within 3 months before the first dose of study treatment. Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥ 8% or HbA1c between 7 and < 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained Subject has prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE) based antibody-drug conjugates (ADCs)
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-44.0, Diabetes, Gestational Menstrual Cycle Abnormal pregnant women with gestational diabetes Patients with hypertension and pregestational diabetes mellitus Patients with rheumatologic, nephrological, and hematological diseases Presence of active infection corticosteroid use, acetylsalicylic acid, and anticoagulant use
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Women With Suspected or Confirmed Gynecological Disease Be at least 18 years of age Have capacity to understand the study Be able to provide informed consent If the patient has a recently treated cervical abnormality, she must have had a Pap smear with normal results at least 4 months following treatment by loop electrosurgical excision procedure (LEEP) or cone biopsy Have suspected or confirmed cancer of the upper genital tract and be undergoing surgery for said tumor removal Prior hysterectomy Be pregnant or possibly pregnant Be nursing, as the device contains phthalates (plasticizers) that "have not been fully characterized and there may be concern for reproductive and developmental effects" Have an infected or inflamed cervix Have a confirmed or suspected pelvic infection Have a confirmed or suspected vaginal infection Have had recent history of uterine perforation Patients with recently treated cervical abnormalities must have a Pap smear with normal results at least 4 months following treatment by loop electrosurgical excision procedure (LEEP) or cone biopsy in order to be eligible
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cancer Neoplasms Metastatic Cancer Triple Negative Breast Cancer Gastric Cancer Cervical Cancer Ovarian Cancer Hepatocellular Carcinoma Squamous Cell Carcinoma of Head and Neck Urothelial Carcinoma Urothelial Neoplasm Non Small Cell Lung Cancer Renal Cell Carcinoma Locally Advanced Solid Tumor Locally Advanced Malignant Neoplasm Squamous Cell Carcinoma Sarcoma Merkel Cell Carcinoma Bladder Cancer Have histological or cytological evidence of a diagnosis of selected cancer types that is locally advanced and/or metastatic 1. Have the presence of evaluable disease for the Phase 1b part of the study 2. Have the presence of evaluable and measurable disease for the Phase 2a part of the study 3. The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their disease or patients who have refused standard treatments. 2. Cancer treatment and type Have received at least 1 but no more than 4 prior systemic therapies for locally advanced or metastatic disease (e.g., hormonal, cytotoxic, etc.) for the following cancer types, for Phase 1b Triple Negative Breast Cancer (TNBC): Must have recurrent/refractory TNBC, defined as any breast cancer that expresses less than (˂)1% estrogen receptor (ER), ˂ 1% progesterone receptor (PR), and is Human Epidermal Growth Factor Receptor 2 (Her2) negative. Must have failed at least one chemotherapy regimen Gastric Cancer: Must have failed a platinum-containing chemotherapy regime Cervical Cancer: Must have failed at least one chemotherapy regimen Ovarian Cancer: Must have failed a platinum-containing chemotherapy regimen but not be platinum refractory Hepatocellular Cell Carcinoma (HCC): May have failed unlimited liver local therapies Sarcoma: Must have failed at least one prior chemotherapy regimen Squamous Cell Carcinoma of Head and Neck (SCCHN): Must have failed a platinum-containing chemotherapy regiment. Must have failed a previous immune checkpoint inhibitor Bladder Cancer: Must have failed a platinum-containing chemotherapy regiment. Must have failed a previous immune checkpoint inhibitor Have symptomatic central nervous system (CNS) metastasis. Patients with treated CNS metastases are eligible for this study if they are asymptomatic and off of corticosteroids for a minimum of 7 days. Patients with primary brain tumors are not eligible 2. Have a history of major organ transplant (e.g., heart, lungs, liver, and kidney) or an autologous or allogeneic hematopoietic stem cell transplant 3. Females who are pregnant or nursing 4. Have known, symptomatic acquired immuno deficiency syndrome (AIDS) or active hepatitis A, B or C 5. Previous treatment-related, severe (≥Grade 3) Adverse Event (AE) or any neurologic or ocular AE while receiving an IO agent 6. Active or prior documented autoimmune disease within the past 2 years Patients with vitiligo, Grave's disease or psoriasis not requiring systemic treatment within the past 2 years are eligible 7. Active or prior documented inflammatory bowel disease 8. History of tuberculosis, interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required corticosteroid therapy 9. Receipt of live attenuated vaccination within 28 days prior 10. Current or prior use of immunosuppressive medication within 28 days prior 11. Are currently enrolled in another clinical study of an investigational medicinal product 12. Have a second primary malignancy that may affect the interpretation of results 13. Are unwilling or unable to participate in, or do not have tissue adequate for a tumor biopsy
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 21.0-999.0, Neoplasm Cervix HIV-uninfected and infected women (without current AIDS-defining illness) Presence of a cervix Biopsy-proven LSIL disease or recently treated HSIL disease Adherence to combined anti-retrovirals (cART) if HIV infected On continuous antiretrovirals with a cluster of differentiation 4 (CD4) count >200 cells/ml with sustained undetectable viral load for at least 3 months (only for HIV-positive participants) On reliable birth control: combined oral contraceptive pills (OCP), long-acting reversible contraception (LARC), bilateral tubal ligation (BTL) or Depo-Provera (birth control shot) Willing to conform to the study requirements Reliable follow-up and contact information No risk factors for HSIL or microinvasive disease (no colposcopic features of microinvasion, adequate colposcopy and negative endocervical curettage) For women with HSIL only, LEEP completed within 6 weeks preceding initial encounter with study staff and adequate wound healing Untreated HSIL or invasive features on colposcopy and the biopsy specimen Not adherent to anti-retroviral therapy (cART) (HIV infected participants) CD4 count =<200 cells/ml and detectable viral load within the last 3 months (only for HIV-positive participants) Lactating and pregnant people Patient with irregular cycles (more than once a month) Not on reliable birth control Previous hysterectomy Prior diagnosis of cervical cancer, treated or untreated Inability to provide informed consent Medical condition that interferes with the conduct of the study in the investigator's opinion
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 0.0-999.0, Malignant Female Reproductive System Neoplasm Stage I Cervical Cancer AJCC v8 Stage I Uterine Corpus Cancer AJCC v8 Stage I Vaginal Cancer AJCC v8 Stage I Vulvar Cancer AJCC v8 Stage IA Cervical Cancer AJCC v8 Stage IA Uterine Corpus Cancer AJCC v8 Stage IA Vaginal Cancer AJCC v8 Stage IA Vulvar Cancer AJCC v8 Stage IA1 Cervical Cancer AJCC v8 Stage IA2 Cervical Cancer AJCC v8 Stage IB Cervical Cancer AJCC v8 Stage IB Uterine Corpus Cancer AJCC v8 Stage IB Vaginal Cancer AJCC v8 Stage IB Vulvar Cancer AJCC v8 Stage IB1 Cervical Cancer AJCC v8 Stage IB2 Cervical Cancer AJCC v8 Stage II Cervical Cancer AJCC v8 Stage II Uterine Corpus Cancer AJCC v8 Stage II Vaginal Cancer AJCC v8 Stage II Vulvar Cancer AJCC v8 Stage IIA Cervical Cancer AJCC v8 Stage IIA Vaginal Cancer AJCC v8 Stage IIA1 Cervical Cancer AJCC v8 Stage IIA2 Cervical Cancer AJCC v8 Stage IIB Cervical Cancer AJCC v8 Stage IIB Vaginal Cancer AJCC v8 Stage III Cervical Cancer AJCC v8 Stage III Uterine Corpus Cancer AJCC v8 Stage III Vaginal Cancer AJCC v8 Stage III Vulvar Cancer AJCC v8 Stage IIIA Cervical Cancer AJCC v8 Stage IIIA Uterine Corpus Cancer AJCC v8 Stage IIIA Vulvar Cancer AJCC v8 Stage IIIB Cervical Cancer AJCC v8 Stage IIIB Uterine Corpus Cancer AJCC v8 Stage IIIB Vulvar Cancer AJCC v8 Stage IIIC Uterine Corpus Cancer AJCC v8 Stage IIIC Vulvar Cancer AJCC v8 Stage IIIC1 Uterine Corpus Cancer AJCC v8 Stage IIIC2 Uterine Corpus Cancer AJCC v8 Stage IVA Cervical Cancer AJCC v8 Stage IVA Uterine Corpus Cancer AJCC v8 Stage IVA Vaginal Cancer AJCC v8 Stage IVA Vulvar Cancer AJCC v8 Any patient with endometrial, cervical, vaginal, or vulvar cancer receiving adjuvant external beam radiation or definitive external beam radiation and brachytherapy will be eligible for the study Those receiving concurrent chemotherapy will be eligible Any prior gynecologic surgery is permitted Patients with metastatic or recurrent disease and patients receiving brachytherapy alone
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cervical Cancer Histologically confirmed primary adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, or other histological types carcinoma of the uterine cervix. 2. Patients with Histologically confirmed stage IA1 (with lymph vascular invasion), FIGO 2018 stage IA2 to IIA2. 3. Underwent radical hysterectomy or radiochemotherapy. 4. ECOG Performance Status of 0 or 1 Life expectancy is less than 6 months 2. No prior malignancy 3. ECOG Performance Status of 2 to 5
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-99.0, Cervix Lesion Cervical Cancer No history of previously treated cervical cancer Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee Women who are pregnant or nursing
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2
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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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
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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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
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 20.0-50.0, HIV/AIDS Women who: 1. are confirmed HIV positive based on medical records 2. are women living with HIV infection support group members 3. are ages 20-50 years 4. are no prior cervical cancer screening 5. are no history of invasive cervical cancer 6. are willingness to participate in the study are not able to speak Chichewa or English 2. self-report currently receiving treatment of a serious mental illness (e.g., schizophrenia and bipolar disorder)
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-65.0, Cervical Cancer Woman between 30 and 65 years of age Covered by a Regional Cancer Screening Coordination Centre for cervical cancer in 4 of the pilot departments for the implementation of this organised screening, and participating in the study eligible for cervical cancer screening Having not had a cervical smear test for at least three years Not having responded within 6 months to a letter inviting a cervical-uterine smear test Residing in a Block Grouped for Disadvantaged Statistical Information, quintiles 4 & 5 according to the European Deprivation Index classification Covered by health insurance or AME Ineligible for screening (e.g. hysterectomy or history of cervical cancer) Pregnant woman beyond 6 months of age Under guardianship or trusteeship
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Right-sided Colon Cancer Right-sided Colon Adenoma for track 1 and 2a Male and female patients above 18 years of age with either: right-sided colon cancer tumor with adenocarcinoma histologically verified scheduled for open or laparoscopic resection at the Department of Surgery, Herlev Hospital or Zealand University Hospital for track 1. Right-sided adenomas ≥2cm in diameter endoscopically verified scheduled for endoscopic mucosal resection at the Department of Surgery, Herlev Hospital or Zealand University Hospital for track 2a ASA I,II or III The caecum must be reached by the endoscope. for retrospective controls (track 2b): Male and female patients above 18 years of age who were operated for colon adenoma ≥2cm in diameter in the right hemicolon in 2018 at Department of Surgery, Zealand University Hospital. They will be matched 2:1 with the patients included in track 2a (cases) based on age and gender and pathology of the tumor for track 1 and track 2a 1. Patients with previous allergic reaction to fosfomycin and/or metronidazole 2. Patients under current antibiotic treatment or patient who had the last dose of antibiotics 30 days prior to inclusion. 3. Patients with a non-passable tumor or patients where a part of the tumor is not visible during endoscopy (Track 1) 4. Patients with neoadjuvant chemotherapy or radiation 12 months prior to the resection. 5. Patients with a history of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC) 6. Patients with a history of inflammatory bowel disease (IBD) 7. Patients under current treatment with warfarin (Marevan) and phenprocoumon (Marcoumar), or NOAK such as dabigatran (Pradaxa®), rivaroxiban (Xarelto®), edoxaban (Lixiana®) or apixaban (Eliquis®) 8. Patients under current treatment with Fenemal (Phenobarbital) 9. Patients who previously have received a fecal transplantation 10. Patients who have previously had colorectal cancer, and are now presenting with a secondary colon tumor. 11. Patients with a current alcohol use disorder (AUD): defined as a patient who are currently drinking 8 or more drinks/week for women and 15 or more drinks/week for men. 12. Predictable poor compliance (psychiatric disease, not speaking fluent Danish, mentally, impaired etc) 13. Patients with an American Society of Anaesthesiologists physical status 14. Classification (ASAscore) of IV. 15. Patients unable to be sedated 16. Pregnancy or lactation (fertile women must have a negative serum or urine pregnancy test to participate) 17. Fertile women who do not use safe contraception during the study period 18. Following contraceptive methods are acceptable when used consistently and in accordance, with both the product label and the instructions of the physician are Oral contraceptive, either combined or progestogen alone Injectable progestogen Implants of levonorgestrel Estrogenic vaginal ring Percutaneous contraceptive patches Intrauterine device or intrauterine system with a documented failure rate < 1% per year Male partner sterilization (vasectomy with documented azoospermia) prior to female patient ́s entry into the study, and this male is the sole partner for that patient Double barrier method: condom with spermicidal agent (foam/gel/film/cream/suppository), condom and occlusive cap (diaphragm or cervical/vault cap) with vaginal spermicidal agent (foam/gel/film/cream/suppository) for retrospective controls (track 2b)
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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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
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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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
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 25.0-56.0, Cervical Cancer HIV/AIDS Women living in Limbe town and neighborhood Confirmed to be HIV[+] or HIV[-] Have never undergone cervical cancer screening, with no history of ICC Willing and able to competently understand and provide written, informed paper-based consent Women who are having a menstrual period will be deferred for 2 weeks from participating in the study Pregnant women Women with signs of abnormalities Non-menstrual bleeding suggestive of ICC Without a cervix because they have undergone hysterectomy Based on the judgment of the clinicians not sufficiently healthy to participate in a research study
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Sepsis Septic Shock Healthy Male or female, aged ≥ 18 years. 2. Apparently healthy as determined by a subject questionnaire Current diagnosis, or history, of any underlying major medical condition determined by the investigator, including but not limited to: 1. Heart disease 2. Stroke 3. Renal disease 4. Liver disease 5. Pancreatic disease 6. Chronic obstructive pulmonary disorder 7. Bleeding disorders 8. Hypercalcitoninemia 9. HIV AIDS 10. Receiving antibiotic therapy 11. Suspected infection 12. Immunosuppression 2) Underwent procedures related to sepsis, or diagnosed with sepsis, within the last 12 months. 3) Current diagnosis of uncontrolled hypertension, hypotension, or diabetes. 4) Diagnosis of bacterial, fungal, or malaria infection within the last 3 months that required antimicrobial treatment. 5 )Experienced severe trauma, surgery, cardiac shock, or severe burn within the previous 3 months requiring medical care. 6) Current diagnosis of cancer within the last 12 months. 7) Received immunotherapy to stimulate or inhibit cytokines within the last 12 months. 8) Hospitalization for more than 24 hours within the last 3 months. 9) Reported as currently pregnant or nursing a child 10) Unable or unwilling to provide the required blood sample for testing. 11) Any other that, in the opinion of the investigator, would render the participant unsuitable for in the trial
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-64.0, Cervical Carcinoma Human Papillomavirus Infection Not within recommended cervical cancer screening guidelines for women in this age range (i.e., no Papanicolaou [Pap] test in last 3 years or no Pap test plus clinic-based HPV test in last 5 years) Resident of an Appalachian county Not currently pregnant Intact cervix No history of invasive cervical cancer Seen in a participating clinic/health system in last 2 years (i.e., active patient) Have a working telephone
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-70.0, Pain Biological female Aged 30-70 Provision of written informed consent History of pelvic or vaginal surgery, active infectious gynecologic complaint, prior intervention for abnormal cervical cytology Incapable of understanding the numeric pain scale Incapable of communicating in Chinese, English, or Taiwanese Prior cervical cancer diagnosis Prior hysterectomy Pregnant women
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-69.0, Human Papilloma Virus Cervical Cancer CIN 2/3 Female Age 30-69 Undergoing cervical cancer screening, diagnostic procedure (colposcopy), or treatment (LEEP) Pregnancy History of Cervical Cancer Prior hysterectomy Inability to provide informed consent
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 0.0-999.0, Breast Cancer Cervical Cancer women who identify as Hispanic/Latina ancestry or descent and live in the Greater Houston Area in Texas no previous diagnosis of breast or cervical cancer Pregnant women, and women who are adherent to screening guidelines prior or current cancer diagnosis
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 13.0-30.0, Obesity Malignant Neoplasm Patients with a history of HSCT of any type, at least 100 days post-transplant at initial consultation of the study, will be eligible for the study Patients must classify as obese, represented as body mass index (BMI) >= 85th percentile for age and gender Patients must also be able to read English since the app intervention is only available in English form No patients will be excluded for any specific underlying medical condition, but decisions will be made on a case by case basis if a patient's functioning is deemed to significantly interfere with intervention participation His/her child meets all >= 18 years of age Can speak English Patients who are < 100 days post-transplant at initial consultation will not be eligible for the study, but may become eligible if they are > 100 days post-transplant at their next consultation that falls within the enrollment window Patients whose BMI does not fall under the obese category will be excluded
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 21.0-64.0, Cervical Cancer Female subjects ≥ 21 of age and < 65 of age Subjects who have signed the inform consent form Pregnant subjects Subjects who have had cervical cytology samples taken in the last 12 months Subjects who have previously undergone a total hysterectomy Subjects who have previously undergone cone resection, LEEP, cervical laser surgery, cervical cryosurgery or uterine ablation within 3 years Subjects who are participating in other clinical trials of cervical disease diagnostic products
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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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
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Uterine Cervical Neoplasms Participants with histologically or cytologically confirmed carcinoma of the cervix that has not been treated, with clinical staging as follows Lead-in safety cohort: FIGO stage IIIC-IVA (2018 International FIGO Staging System) After lead-in safety cohort: FIGO stage IIB-IVA (2018 International FIGO Staging System) 2. HPV16+ tumor and HLA-A*02:01+ HLA type. Note: HLA-A*02 is also acceptable for enrollment but not for treatment. 3. Measurable disease by 1.1 or (if not eligible by 1.1). 4. Age 18 years. Because no dosing or adverse event data are currently available on the use of E7 TCR T cells in participants <18 years of age, children are excluded from this study. Note: This age range is consistent with the age of participants with the disease being studied. 5. ECOG performance status 0 or 1. 6. Women of child-bearing potential must have a negative pregnancy test because E7 TCR T cells have unknown potential for teratogenic or abortifacient effects. Women of child- bearing potential are defined as all women who are not post-menopausal or who have not had a hysterectomy. Note: Postmenopausal will be defined in this study as women over the age of 55 who have not had a menstrual period in at least 1 year. 7. The effects of E7 TCR T cells on the developing human fetus are unknown. For this reason and because the chemotherapy agents used in this trial are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (e.g., intrauterine device, hormonal or barrier method of birth control; abstinence; tubal ligation or vasectomy) prior to study entry and for four months after treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. 8. Seronegative for HIV antibody. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment. 9. Seronegative for hepatitis B antigen and hepatitis C antibody. If hepatitis C antibody test is positive, then the participant must be tested for the presence of antigen by RT-PCR and be HCV RNA negative. 10. Must be willing to participate in Gene Therapy Long Term Follow up Protocol (20C0051), which will follow participants for up to 15 years per Food and Drug Administration(FDA) requirements. 11. Participants must have organ and marrow function as defined below leukocytes >=3,000/mcL absolute neutrophil count >=1,500/mcL platelets >=100,000/mcL hemoglobin >=9.0 g/dL total bilirubin within normal institutional limits except in participants with Gilbert s Syndrome who must have a total bilirubin < 3.0 mg/dL AST(SGOT)/ALT(SGPT) Serum ALT/AST < 2.5X ULN creatinine clearance Calculated creatinine clearance (CrCl) >=50 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation) 12. Ability of subject to understand and the willingness to sign a written informed consent document Previous treatment for invasive cervical cancer including Chemotherapy or other systemic treatments Radiation therapy Hysterectomy (prior LEEP procedure or cone biopsy is allowed) 2. Participants who are receiving any other investigational agents. 3. History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study. 4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations at the time of treatment that would limit compliance with study requirements. 5. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T cells, breastfeeding should be discontinued if the mother is treated with E7 TCR T cells. These potential risks may also apply to other agents used in this study. 6. Participants with any form of systemic immunodeficiency, including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease, are ineligible. The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune competence may be less responsive to the treatment. 7. Participants on immunosuppressive drugs including corticosteroids. 8. Participants with autoimmune diseases such as Crohn s disease, ulcerative colitis, rheumatoid arthritis, autoimmune hepatitis, autoimmune pancreatitis, or systemic lupus erythematosus. Hypothyroidism, vitiligo and other minor autoimmune disorders are not exclusionary. 9. Participants with a second invasive malignancy requiring treatment within the last 2 years are not eligible with the following exceptions Ductal carcinoma in situ (DCIS) of the breast Cutaneous skin cancers requiring only local excision
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Renal Tumor •CT-confirmed renal mass > 4 to 7 cm (T1b) Multiple renal tumors Recurrence of renal tumor Intolerance to iodine-containing contrast agents Pregnancy Patients with Bosniak 4 cysts Presence of other oncological diseases Impossibility of organ-preserving treatment due to the proximity of the tumor to the vessels or the calyx-pelvic system Absence of malignant pathology based on prior biopsy
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-90.0, Gynecologic Cancer Endometrial Cancer Cervical Cancer Quality of Life Opioid Use New diagnosis of either 1) endometrial cancer undergoing surgery or 2) cervical cancer undergoing chemo-sensitizing radiation Access to a smartphone Non-English speaking No access to smartphone Current use of Headspace application
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 25.0-64.0, Human Papillomavirus (HPV)-Related Cervical Cancer HPV DNA Signature of informed consent Women with an active sex life Women 25 to 64 years old Patients without hysterectomy, conization of the cervix Patients without radiotherapy treatment, cervical chemotherapy hours before taking the sample, they should not use douches, ovules, lubricants or gels Patients who have not started a sexual life Patients with uterine surgery Patients pregnant Patients with vaginal bleeding Patients who have had sexual activity 24 hours prior to taking the sample
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-52.0, Diabetes Mellitus, Type 1 Contraception Women aged 18-52 years (reproductive age) who are not currently pregnant Previous diagnosis of Diabetes Mellitus Inability to understand and write in the English language Unable to participate due to other factors, as assessed by the Chief Investigators A history of gestational diabetes but not diabetes mellitus Pregnant women
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Sexually Transmitted Diseases Gonorrhea Chlamydia Subject Recruitment Subjects must meet both of the following 1. Urogenital CT and/or GC infection (documented in a retrievable medical record) within the 16 weeks prior to enrollment and one or more of the additional risk factors included below to 24 years of age at the screening visit New sex partner within the past 12 weeks (84 days) More than one current sex partner Knowledge that current sex partner has multiple partners Partner with known sexually transmitted infection (STI) Inconsistent condom use among persons who are not in a mutually monogamous relationship 2. After three unsuccessful documented attempts to obtain medical records, the subject has a self-reported history of infection less than 17 weeks prior to enrollment AND two or more of the following additional risk factors to 24 years of age at the screening visit New sex partner within the past 12 weeks (84 days) In the opinion of the Investigator, has a history of substance or alcohol abuse in the last 12 months or, has issues, conditions, or concerns that may compromise the safety of the subject, impact the subject's compliance with the protocol requirements, or confound the reliability of the data acquired Women who have undergone a total hysterectomy (had uterus and cervix removed). However, women with subtotal hysterectomy with an intact cervix may be enrolled Has a history or expectation of noncompliance with medications or intervention protocol Has engaged in sexual vaginal intercourse or douching, or used of any form of vaginal suppository or intravaginal device (with the exception of contraceptive vaginal ring or tampons) for 24 hours prior to enrollment (may be enrolled at a later date if all other are met) Menstruating at enrollment (may be enrolled at a later date if all other are met) Is currently being treated, or has been treated, for a period of 21 days prior to enrollment, with any prohibited antibiotics. The prohibited antibiotics azithromycin, erythromycin, doxycycline, levofloxacin, ofloxacin, ceftriaxone, and cefixime In the opinion of the Investigator, has signs/symptoms that indicate persistence of CT or GC infection diagnosed at screening, new interval infection, and/or a failure to comply with or complete the prescribed treatment regimen following a positive screening NAAT
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, HIV-1-infection Gonorrhea Male Chlamydia Partner Communication Anatomically male at birth 2. Condomless anal intercourse with an HIV serodiscordant or unknown serostatus male or transgender female partner in the previous 6 months 3. 18 years of age or older 4. Diagnosis of Gonorrhea and/or Chlamydia infection at any anatomic site at the Screening visit Inability to understand the study procedures or to provide informed consent
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Total Hip Arthroplasty • All adult patients with unilateral programmed total hip prosthesis surgery are included in the absence of criteria Obligation for all patients to be affiliated with social security Patient Informed Consent Signature chronic opiod consumption pregnancy mental disorder that prevents the usage of the numeric analog scale Contra indications of the realization of QLB Local infection Allergic to the local anesthesia Hemostasis disorder Incapacity of giving the consent : individuals under guardianship by court order, or under judicial protection
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 0.0-999.0, Chronic Pancreatitis Genetic Mutation Smoking, Tobacco Drinking, Alcohol patients with a diagnosis of chronic pancreatitis agree to join the study and provide informed consent autoimmune pancreatitis pancreatic cancer diagnosed within 2 years after the diagnosis of chronic pancreatitis the follow-up time less than 3 years
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Infiltrating Cervical Carcinoma Metastatic Cervical Carcinoma Recurrent Cervical Carcinoma Stage I Cervical Cancer FIGO 2018 Stage IA Cervical Cancer FIGO 2018 Stage IA1 Cervical Cancer FIGO 2018 Stage IA2 Cervical Cancer FIGO 2018 Stage IB Cervical Cancer FIGO 2018 Stage IB1 Cervical Cancer AJCC v8 Stage IB2 Cervical Cancer FIGO 2018 Stage IB3 Cervical Cancer FIGO 2018 Stage II Cervical Cancer FIGO 2018 Stage IIA Cervical Cancer FIGO 2018 Stage IIA1 Cervical Cancer FIGO 2018 Stage IIA2 Cervical Cancer FIGO 2018 Stage IIB Cervical Cancer FIGO 2018 Stage III Cervical Cancer FIGO 2018 Stage IIIA Cervical Cancer FIGO 2018 Stage IIIB Cervical Cancer FIGO 2018 Stage IIIC Cervical Cancer FIGO 2018 Stage IIIC1 Cervical Cancer FIGO 2018 Stage IIIC2 Cervical Cancer FIGO 2018 Stage IV Cervical Cancer FIGO 2018 Stage IVA Cervical Cancer FIGO 2018 Stage IVB Cervical Cancer FIGO 2018 Able to provide written consent Patient has given permission to give tumor/blood sample for research testing Histological confirmation of squamous cell carcinoma or adenosquamous carcinoma Known HPV status defined as positive staining for p16 on immunohistochemistry (IHC) or DNA in situ hybridization (ISH) for HPV Willingness to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study) Consent to allow blood specimens to be shared with potential external collaborators Cohort #1: Surgery alone for early stage disease (Federation of Gynecology and Obstetrics [FIGO] stage IA-IB1) FIGO 2019 stage IA1, IA2, IB1 Plan to undergo surgery including but not limited to trachelectomy, radical hysterectomy, and lymph node dissection Cohort #2: Post-operative radiation +/ Other active malignancy =< 2 years prior to registration Non-melanotic skin cancer NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for cancer Pregnancy or lactation Inability on the part of the patient to understand the informed consent to be compliant with the protocol
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2
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-65.0, HPV Penn State Health Patient Has an intact cervix Found to have abnormal findings on Pap/HPV test that requires a colposcopy Speaks, read, or writes well in English or Spanish Pregnant Cognitively impaired Incarcerated Complete hysterectomy History of cervical treatment for abnormal Pap/HPV test (i.e. cryotherapy, loop electrosurgical excision procedure (LEEP))
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-65.0, HPV Age 30-65 Years Penn State Health, Family and Community Medicine, patient attending a well-woman visit Able to collect the sample within two weeks of visit Female Intact cervix Speaks, reads, or writes in English Pregnancy Cognitively Impaired Incarcerated Complete hysterectomy History of cervical treatment for abnormal Pap/HPV test (cryotherapy, LEEP)
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 25.0-55.0, HPV Females aged ≥25 and ≤55 years of age at screening Persistent hrHPV infection defined as a documented cervical infection with hrHPV type(s) in the 6 to 18 months prior to screening and confirmed at screening (participants in the main and expansion phases only). Participants in the lead-in phase are only required to have the screening result Low-grade cervical lesion (CIN1 or HPV-related change only) confirmed by histology and/or cytology report within the 1 year prior to screening Not pregnant or breast feeding and one of the following Of non-childbearing potential (i.e. women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses for at least 12 months and without an alternative medical cause) Of childbearing potential but agrees to practice highly effective contraception for 4 weeks prior to administration of the first dose of study vaccine and throughout the study until 8 weeks after administration of the second dose. Highly effective methods of contraception one or more of the following Male partner who is sterile (medically effective vasectomy) prior to the female participant's entry into the study and is the sole sexual partner for the female participant Hormonal (oral, intravaginal, transdermal, implantable or injectable). Progestogen-only hormonal contraceptives without inhibition of ovulation are not considered to be highly effective An intrauterine hormone-releasing system An intrauterine device Presence of any significant acute or chronic, uncontrolled medical (or psychiatric) illness, including blood dyscrasias Immunosuppression as a result of underlying illness or treatment including Use of high dose corticosteroids ( >10 mg/day prednisone or equivalent) for ≥7 days (inhaled, otic and ophthalmic corticosteroids are permitted) Primary immune deficiency disease Use of synthetic or biologic disease-modifying antirheumatic drugs History of bone marrow or solid organ transplant History of any other clinically significant autoimmune or immunosuppressive disease Positive diagnostic tests (for human immunodeficiency virus, hepatitis B or hepatitis C) indicating chronic infection Evidence of high-grade cervical lesions by colposcopy or by Papanicolaou (Pap) smear test in the 1 year prior to screening Any history of anaphylaxis in reaction to vaccination or history of allergic reactions likely to be exacerbated by any component of the vaccine
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-55.0, Cervical Cancer gender: female 2. age: 30-55 3. no current diagnosis of cervical cancer, and 4. have not participated in cervical cancer screening within the past 3 years
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 0.0-999.0, Coxarthrosis All patient who underwent THA via DAA by a single surgeon who routinely documents the distance from the shoulder of the stem to the upper border of the EO tendon Distance not noted No radiographs available
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, HPV 16+ Confirmed Oropharynx Cancer and Cervical Cancer All subjects Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Confirmed HPV 16+ (human papilloma virus 16 positive) genotype testing of cancer Disease-free for ≥ 2 years from other curatively treated cancers, with protocol-defined exceptions Evaluated by cardiologist and/or neurologist if protocol-defined cardiac or neurological event within the last 6 months. HPV 16+ Oropharynx Cancer (Arm 1 Cohorts 1 and 2) Newly diagnosed, squamous cell carcinoma or undifferentiated carcinoma of the oropharynx, determined to be resectable AJCC v8.0 Tumor, Node, Metastasis (TNM) stage I-III, cT1 T3, and cervical nodes N1-N3 based on clinical or radiographic with no evidence of distant metastases No prior radiation above the clavicles Must have acceptable renal and hepatic function as defined per protocol All subjects Treatment with any systemic anticancer therapy within 3 years (unless agreed otherwise between the Sponsor and the Investigator) Treatment with any chronic immunosuppressive medication within 6 months (unless agreed otherwise between the Sponsor and Investigator) Uncontrolled diabetes, uncontrolled infection despite antibiotics or uncontrolled hypertension Live vaccine within 28 days (unless agreed otherwise between Sponsor and Investigator) Known diagnosis of acquired immunodeficiency syndrome (AIDS) Positive Hepatitis B or Hepatitis C tests indicating acute or chronic infection Intercurrent illness likely to interfere with protocol therapy Female subjects who are pregnant or breastfeeding Female subjects of childbearing potential who do not agree to the use of highly effective contraception per protocol
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-85.0, Endothelial Dysfunction We recruit individuals who were referred for a routine screening in the primary prevention outpatient clinic of Attikon University hospital History of Coronary artery disease History of Peripheral Arterial Disease History of Heart failure History of Stroke hepatic failure renal failure active neoplasia poorly controlled DM, defined as Hba1C>7%
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Breast Cancer Participant Must Have histologically confirmed invasive ER+, HER2 breast carcinoma Be willing and able to provide pre and on-treatment tumor samples Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale Have adequate organ function Be able to swallow capsules Participant Must Not Have bilateral invasive breast cancer Have metastatic breast cancer Plan to receive concurrent neoadjuvant therapy with any other non-protocol anti-cancer therapy Have had prior therapy (of any kind) for an invasive or non-invasive breast cancer Have had prior radiotherapy to the ipsilateral chest wall for any malignancy Have had prior anti-estrogen therapy with raloxifene, tamoxifen, aromatase inhibitor, or other selective estrogen receptor modulator (SERM), either for osteoporosis or prevention of breast cancer Have had prior hormone-replacement therapy within 4 weeks of the start of study treatment Have had major surgery within 28 days prior to randomization to allow for post-operative healing of the surgical wound and site(s) Be pregnant or breastfeeding
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Femur Fracture -proximal femur fracture pregnancy and lactation history of opiate addiction traumatic brain injury acute cerebrovascular accident chronic heart failure (New York Heart Association Functional Classification, NYHA, class III-IV) respiratory failure renal failure with decreased creatinine clearance less than 30 ml / min / 1.73 m2 hepatic insufficiency class C according to Child-Pugh)
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-45.0, Tubal Ligation Women aged from 30-40 year Woman subjected to tubal ligation Women 12 month postpartum Non lactating women Nomedical disorders contraindication for Levonorgestrel-releasing Intrauterine System Women with any uterine or ovarian pathology women refuse to participate
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 0.0-999.0, Pleural Effusion, Malignant Prognosis Patients presented with pleural effusion Patients who undergo thoracentesis and fluid analysis for diagnosis and management Patients who refuse to be enrolled
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 16.0-39.0, Papillomavirus Vaccines Papillomavirus Infections Japanese women who seek cervical cancer screening or gynecological consultations Women with benign conditions 39 year-old Women must be sexually experienced, as defined by sexual contact (oral-genital or genital-genital) with at least one male or female partner Women with STDs Women with premalignant lesions of the cervicovaginal tract Women suffering from any cancer Women with any severe acute or chronic disease, and/or psychological problems
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1
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cervical Cancer Head and Neck Cancer Anal Cancer Signed written informed consent obtained prior to study procedures Patients ≥18 years with an ECOG 0 or 1 Histologically confirmed diagnosis by the local laboratory of persistent, recurrent, or metastatic, unresectable cervical cancer (squamous, adeno, or adenosquamous histology), HNSCC, or squamous cell cancer of the anal canal that is not amenable to curative therapy All patients must have experienced disease progression following platinum-based or mitomycin C-based chemotherapy administered in the persistent, recurrent, or metastatic setting All patients with programmed death-ligand 1 (PD-L1) positive cervical cancer and those with HNSCC must have received or have been determined to be ineligible for immunotherapy with a PD-1 or PD-L1 inhibitor All patients with cervical cancer will have received or have been determined to be ineligible for bevacizumab Confirmation of HLA-A*02:01 positive status by central testing In patients with cervical cancer or HNSCC, confirmation of HPV 16 within the tumor either from historical pathology result (using an FDA-approved HPV testing method, patients with cervical cancer only) or based on central laboratory analysis of a tumor sample. Patients with anal cancer will not be required to have prospective determination of HPV 16 positive status prior to enrollment Disease must be measurable per Response Evaluation The shorter of 28 days or 5 half-lives must have elapsed since the completion of prior therapy, before initiation of study treatment Adequate Organ Function as Defined by the protocol Patient has central nervous system (CNS) involvement. If the patient fulfills the following 3 she/he is eligible for the trial after consultation with the Sponsor Medical Monitor Completed prior therapy for CNS metastases (radiation and/or surgery) CNS tumor(s) is clinically stable at the time of enrollment Patient does not require corticosteroid or antiepileptic therapy for management of CNS metastases Known hypersensitivity to any component of study treatment or excipients Positive antibody screen using institution's standard type and screen test Clinically significant, active and uncontrolled infection, including human immunodeficiency virus (HIV), Hepatitis B virus (HBV), or Hepatitis C virus (HCV)
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Anatomic Stage IV Breast Cancer AJCC v8 BRCA-Mutated Malignant Neoplasm BRCA-Mutated Metastatic Breast Carcinoma BRCA-Mutated Ovarian Carcinoma Metastatic Breast Carcinoma Metastatic Fallopian Tube Carcinoma Metastatic Malignant Solid Neoplasm Metastatic Ovarian Carcinoma Metastatic Pancreatic Carcinoma Metastatic Primary Peritoneal Carcinoma Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8 Prognostic Stage IV Breast Cancer AJCC v8 Stage III Fallopian Tube Cancer AJCC v8 Stage III Ovarian Cancer AJCC v8 Stage III Pancreatic Cancer AJCC v8 Stage III Primary Peritoneal Cancer AJCC v8 Stage IIIA Fallopian Tube Cancer AJCC v8 Stage IIIA Ovarian Cancer AJCC v8 Stage IIIA Primary Peritoneal Cancer AJCC v8 Stage IIIA1 Fallopian Tube Cancer AJCC v8 Stage IIIA1 Ovarian Cancer AJCC v8 Stage IIIA2 Fallopian Tube Cancer AJCC v8 Stage IIIA2 Ovarian Cancer AJCC v8 Stage IIIB Fallopian Tube Cancer AJCC v8 Stage IIIB Ovarian Cancer AJCC v8 Stage IIIB Primary Peritoneal Cancer AJCC v8 Stage IIIC Fallopian Tube Cancer AJCC v8 Stage IIIC Ovarian Cancer AJCC v8 Stage IIIC Primary Peritoneal Cancer AJCC v8 Stage IV Fallopian Tube Cancer AJCC v8 Stage IV Ovarian Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Stage IV Primary Peritoneal Cancer AJCC v8 Stage IVA Fallopian Tube Cancer AJCC v8 Stage IVA Ovarian Cancer AJCC v8 Stage IVA Primary Peritoneal Cancer AJCC v8 Stage IVB Fallopian Tube Cancer AJCC v8 Stage IVB Ovarian Cancer AJCC v8 Stage IVB Primary Peritoneal Cancer AJCC v8 Unresectable Breast Carcinoma Unresectable Fallopian Tube Carcinoma Unresectable Malignant Solid Neoplasm Unresectable Ovarian Carcinoma Unresectable Pancreatic Carcinoma Unresectable Primary Peritoneal Carcinoma Participant must have breast, pancreas, ovary, fallopian tube or primary peritoneal cancer that is unresectable or metastatic, with a pathogenic mutation in BRCA1 or BRCA2 (either germline or somatic) as confirmed by next generation gene sequencing such as University of Washington (UW) OncoPlex assay or equivalent, and who have experienced progression or been intolerant to standard therapies for their disease Breast cancer patients with or without HER2+, estrogen receptor (ER)+, and/or progesterone receptor (PR)+ disease, as determined by pathological report, are allowed Participant must be able and willing to undergo pre-treatment and on-treatment biopsy Participant must have life expectancy of 4 months or greater Tumor must be measurable according to Response Evaluation in Solid Tumors (RECIST)1.1 Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 Participant must be >= 18 years of age Patient must be able to tolerate oral medication Absolute neutrophil count >= 1,500/uL Platelets >= 100,000/uL Participant must not be simultaneously enrolled in any interventional clinical trial Participant must not have had major surgery =< 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects Prior treatment with both PARP inhibitor and immune checkpoint inhibitor blockade either sequentially or together including inhibitors of PD1, PD-L1 or CTLA4 is not allowed. Patients may have had either PARP inhibitor or Immune checkpoint inhibitor previously but not within 3 months of starting treatment Participant must not have received investigational therapy =< 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy Participant must not have had radiation therapy encompassing > 20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to day 1 of protocol therapy Participant must not have a known hypersensitivity to niraparib and dostarlimab (TSR-042) components or excipients Participant must not have received a transfusion (platelets or red blood cells) =< 4 weeks prior to initiating protocol therapy Participant must not have received colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy Participant has had any known grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-64.0, Uterine Cervical Neoplasm Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Cervical Cancer Cervical Dysplasia Human Papilloma Virus HPV-Related Cervical Carcinoma HPV Infection HPV-Related Malignancy Currently enrolled at Kaiser Permanente Washington Female sex years to 64 years of age An intact cervix Has a primary care provider at Kaiser Permanente Washington Anyone flagged by the delivery system as being on a non-routine screening schedule Previously randomized to the intervention arm of the HOME trial or invited to the PATH study (Participants from the PATH study and individuals randomized to the intervention arm in the HOME Study are excluded from STEP because their prior in a STEP-related research study could influence their screening uptake and affect the outcome of this trial.) On "do not contact list" for research studies Currently pregnant or had a pregnancy-related procedure within prior 3 months Language interpreter needed
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-85.0, Cervical Cancer Age Limits: more than 18Y Histologically confirmed squamous cell carcinoma, FIGO stage IB-IVA planned for radical radiochemotherapy Eastern Cooperative Oncology Group (ECOG) performance status 0,1,2 Patients who have received any anticancer treatment for their cervical cancer. Eastern Cooperative Oncology Group (ECOG) performance status > 2 Other cervical cancer tumor histologies (e.g. small cell, serous) Contraindications to 18FDG PET-CT Contraindication to radiochemotherapy Known pregnancy or lactating
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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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
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-99.0, Bladder Cancer Radical Cystectomy Muscle-invasive Bladder Cancer Patient undergoing radical cystectomy since September 2016 December 2020 Development of bladder cancer confirmed histologically Written informed consent • Lack of clinical and prognostic data on selected patients
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-65.0, Uterine Cervical Neoplasms Patients who have signed an approved Informed Consent 5≤BMI<28 Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix Patients with Histologically confirmed stage IA1 (with lymph vascular invasion), stage IA2, stage IB1, stage IB2, or stage IIA1 disease(FIGO 2018) Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1 Patients undergoing the Non-Fertility-Sparing surgery Patients undergoing abdominal surgery The life expectancy of the patient is less than 6 months Patients with serious medical diseases Patients with contraindications to surgery or anesthesia Preoperative imaging studies suggest metastasis to pelvic lymph nodes or para-aortic lymph nodes Patient asks to preserve fertility The patient requested direct radiation therapy Patients with adjuvant radiotherapy or chemotherapy before surgery Patients judged by the investigator to be unsuitable to participate in this trial
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Advanced Breast Carcinoma Advanced Colorectal Carcinoma Advanced Gastroesophageal Junction Adenocarcinoma Advanced Malignant Solid Neoplasm Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Anatomic Stage IV Breast Cancer AJCC v8 Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 HER2 Positive Breast Carcinoma Metastatic Breast Carcinoma Metastatic Gastroesophageal Junction Adenocarcinoma Metastatic Malignant Solid Neoplasm Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8 Prognostic Stage IV Breast Cancer AJCC v8 Stage III Colorectal Cancer AJCC v8 Stage IIIA Colorectal Cancer AJCC v8 Stage IIIB Colorectal Cancer AJCC v8 Stage IIIC Colorectal Cancer AJCC v8 Stage IV Colorectal Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8 Unresectable Colorectal Carcinoma Unresectable Gastroesophageal Junction Adenocarcinoma Unresectable Malignant Solid Neoplasm DOSE-ESCALATION PHASE: Must have histologically confirmed advanced solid tumor DOSE-EXPANSION PHASE: Must have histologically confirmed advanced/metastatic gastroesophageal cancer (cohort A) or colorectal cancer (cohort B) DOSE-EXPANSION PHASE: Patients must have a biopsiable lesion and provide consent for on treatment biopsy Age >=18 years. Because no dosing or adverse event data are currently available on the use of AZD6738 in combination with DS-8201a in patients < 18 years of age, children are excluded from this study Patients must have HER2-positive or HER2-expressing tumors determined by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory. As a rule, for HER2 immunohistochemistry (IHC) scoring system trastuzumab for gastric cancer (TOGA) used for gastric/gastroesophageal junction (GEJ) cancers will be employed (Note: in escalation phase, for breast cancer patients that are included, breast cancer can be used). Specific requirement of HER2 status is outlined below HER2 expression (1-3+) by IHC locally and confirmed centrally OR HER2 expression (1-3+) by IHC tested centrally OR HER2 amplification based on fluorescence in situ hybridization (FISH) or next generation sequencing Must have received at least one line of systemic chemotherapy for either locally advanced or metastatic disease and should have either progressed on this therapy or been intolerant to this therapy For tumors where anti-HER2 therapy is standard of care, patients must have progressed on at least 1 line of anti-HER2 therapy if eligible Patients with a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. Patient using e-cigarettes/vaping are also excluded Patients with a medical history of myocardial infarction within 6 months before enrollment (study treatment), symptomatic congestive heart failure (New York Heart Association Class II to IV, corrected QT interval (QTcF) prolongation to > 470 ms (females) or > 450 ms (males) as corrected by Framingham's formula Patients with spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms Patients with multiple primary malignancies within 2 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other curatively treated solid tumors Patients with a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product Patients with an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals Patients with substance abuse or any other medical conditions that would increase the safety risk to the subject or interfere with participation of the subject or evaluation of the clinical study in the opinion of the investigator Patients with a concomitant medical condition that would increase the risk of toxicity in the opinion of the investigator Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities grade >1) with the exception of alopecia. Subjects with chronic grade 2 toxicities may be eligible per discretion of the investigator after discussion with study principal investigator (PI) (e.g., grade 2 chemo-induced neuropathy) Any previous treatment with an ATR inhibitor
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-80.0, Hip Arthropathy Clinical diagnosis of primary hip osteoarthritis(OA), fracture of femoral neck (FFN),or secondary hip osteoarthritis due to developmental dysplasia of the hip (DDH), hip avascular necrosis (AVN), rheumatoid arthritis (RA), ankylosing spondylitis (AS), and coxa plana Severe vascular diseases of the lower extremity Neuromuscular diseases Infectious diseases Severe dysfunctions of major organs Severe neurosensory deficiencies caused by spinal diseases Unable to receive CT/MRI scans
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 50.0-65.0, Cervical Cancer Uterine Cervical Disease Human Papilloma Virus Asymptomatic women 50 to 65 years old (50 and 65 years included) With no cervical smear (or gynecologic examination) for at least 3 years (≥ 3 years) Able to understand the study and provide voluntarily a written consent to participate Able to understand and answer the questions of the study questionnaire by themselves or with the help of a self-chosen third party Beneficiary of social security insurance Women deprived of their liberty, protected adults or vulnerable persons Known cervical lesion or known HPV status History of hysterectomy History of cervix pathology (conization, laser treatment of the cervix) History of cervical cancer Known immune-depression
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Anatomic Stage IV Breast Cancer AJCC v8 Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 Locally Advanced Malignant Solid Neoplasm Locally Advanced Melanoma Locally Advanced Primary Malignant Central Nervous System Neoplasm Locally Advanced Sarcoma Metastatic Malignant Solid Neoplasm Metastatic Melanoma Metastatic Primary Malignant Central Nervous System Neoplasm Metastatic Sarcoma Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8 Prognostic Stage IV Breast Cancer AJCC v8 Stage IIIC Colorectal Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Stage IV Colorectal Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8 The patient (or legally acceptable representative if applicable) provides written informed consent for the study >= 18 years of age on the day of informed consent signing Patient has a locally advanced or metastatic solid tumor and has progressed on appropriate standard therapy, has not shown clinically meaningful benefit to appropriate standard therapy, has no available standard therapy, or has declined appropriate standard therapy NOTE: Specific solid tumor types but are not limited to melanoma, breast cancer, lung cancer, gastroesophageal cancer, colorectal cancer, sarcoma, solid tumors not otherwise specified (NOS), and primary central nervous system (CNS) tumors. Patients with any other solid tumor type with the exception of gastrointestinal stromal tumor (GIST) will be eligible for enrollment in the study Measurable disease per the v1.1 or Response Assessment in Neuro-Oncology (RANO) as appropriate (for Cohorts 1 and 2 only). NOTE: Patients in Cohort 3 can have measurable or non-measurable disease Documented pathogenic CKIT activating mutation (Cohort 1) OR pathogenic activating mutation (Cohort 2) based on tissue-based next-generation sequencing (NGS) diagnostic test (Oncomine Comprehensive Assay [OCA] or FoundationOne CDx) OR plasma cfDNA-detected (Guardant360) pathogenic CKIT or activating mutation (for patients with measurable disease) or tissue or cfDNA-detected pathogenic CKIT or activating mutation (for patients with non-measurable disease; Cohort 3). Mutation pathogenicity will be verified by the MD Anderson Cancer Center (MDACC) Precision Oncology Decision Support (PODS) team Has available archival tissue for CKIT or mutation testing Lymphocyte count >= 500/uL (within 28 days of study treatment initiation) White blood cell count > 2,500/uL and < 15,000/uL (within 28 days of study treatment initiation) Absolute neutrophil count >= 1.5 x 10^9/L (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility) (within 28 days of study treatment initiation) Patients who have GIST Patients with tyrosine kinase inhibitor (TKI)-resistant CKIT mutation V654A or T670I Patient with meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases. Note: Patients with stable brain metastases (defined as asymptomatic or no requirement for high-dose or increasing dose of systemic corticosteroids and without imminent need of radiation therapy) are eligible (including those with untreated brain metastases). If applicable, patients must have completed brain radiation therapy and recovered adequately from any associated toxicity and/or complications prior to assessment. For patients who have received prior radiation therapy, post-treatment magnetic resonance imaging (MRI) scan should show no increase in brain lesion size/volume History of documented congestive heart failure (New York Heart Association functional classification III-IV) or serious cardiac arrhythmias requiring treatment QT interval corrected using Fridericia's formula of > 470 msec Is currently participating or has participated in a study of an investigational agent or has used an investigational device within 2 weeks prior to study treatment initiation Prior anticancer chemotherapy, hormone therapy, immunotherapy, targeted therapy, radiation therapy, or surgery within 2 weeks prior to study treatment initiation NOTE: Patients must have recovered from all adverse events (AEs) due to previous therapies to =< grade 1 or baseline NOTE: If patient received major surgery, she/he must have recovered adequately from the toxicity and/or complications from the intervention prior to study treatment initiation Arterial thrombotic or embolic events within 6 months prior to study treatment initiation, or venous thrombotic events within 2 weeks prior to study treatment initiation
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 20.0-75.0, Locally Advanced Cervical Carcinoma Patients with histologically confirmed invasive squamous cell carcinoma of the uterine cervix; (ii) FIGO stage system (2018 version): stage II-III 2 No previous treatment. 3- patients with age of 20-75 years at enrollment. 4 Eastern Cooperative Oncology Group performance status (PS) of 0 or 1. 5 Preserved function of major organs (bone marrow, heart, liver and kidney) 6 Lab values within specified ranges, including a neutrophil count greater than 2000/μL, a platelet count greater than 100 000/ mm3 , a hemoglobin level greater than 9.0 g/dL (values after blood transfusion are accepted), levels of aspartate aminotransferase and alanine aminotransferase less than 100 IU/L, a total bilirubin level less than 1.5 mg/dL, a serum creatinine level less than 1.5 mg/dL, creatinine clearance greater than 60 mL/ min 1. Distinct evidence of infectious disease. 2. Serious concurrent disease (cardiac disease, uncontrolled diabetes mellitus, malignant hypertension and a bleeding tendency). 3. Pregnant women, or women who want to become pregnant. 4. History of serious drug hypersensitivity or drug allergy
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 12.0-999.0, Solid Tumors Soft Tissue Sarcoma Ewing Sarcoma Malignant Epithelial Neoplasm Rhabdomyosarcoma Wilms Tumor Hepatic Tumor Germ Cell Tumor Bone Metastases AGE: ≥ 12 years of age Histologically confirmed malignant solid tumors TUMOR Patient must have at least one tumor located in areas accessible to HIFU, which will be defined as the target lesion(s). Target lesions must be reachable within the normal safety margins of HIFU as specified in the instructions for use Radiographically measurable/evaluable solid tumor target lesion(s) Malignant Tumor: The patient's cancer must have relapsed after or failed to respond to frontline curative therapy and there must not be other potentially curative treatment options available Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering on this study No limitation on the number of prior chemotherapy regimens that the patient may have received prior to study entry Myelosuppressive chemotherapy: The last dose of all myelosuppressive anticancer drugs must be at least 3 weeks prior to study entry (6 weeks for prior nitrosoureas) Prior treatment with anthracyclines is allowed as long as total cumulative dose is ≤ 450 mg/m2 Immunotherapy: The last dose of immunotherapy (monoclonal antibody or vaccine) must be at least 3 weeks prior to study entry Biologic (anti-cancer agent): The last dose of all biologic agents for the treatment of the patient's cancer (such as retinoids or tyrosine kinase inhibitors) must be at least 7 days prior to study entry Clinically significant unrelated systemic illness, such as serious infections, hepatic, renal or other organ dysfunction, which in the judgment of the Principal or Associate Investigator would compromise the patient's ability to tolerate study interventions Patients who are pregnant or breast-feeding are not eligible for this study due to risks of fetal and teratogenic adverse events seen in animal/human studies with doxorubicin. Negative pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method beginning at the signing of informed consent and until at least 30 days after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or designated associate Implant or prosthesis within the path of the HIFU beam Target pathway <1 cm from nerve plexus, spinal canal, or bowel Target lesion in the skull Inability to undergo MRI and/or contraindication for MRI Inability to tolerate stationary position during HIFU Previous history of hypersensitivity to doxorubicin or its liposomal formulations Patients currently receiving other anticancer agents Patients currently receiving other investigational agents
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 17.0-20.0, Teen Pregnancy Prevention Be an active patient of one of the participating Planned Parenthood health centers Own a smartphone Be fluent in English Be 17 to 20 years of age Be biologically able to become pregnant (to the best of their knowledge) Score at least 10 on the PHQ-8 Have had penile-vaginal sex in the past 3 months Have had penile-vaginal sex at least once a week, on average Report having done at least one of the following during the 3 months preceding screening: 1) Not using a condom every time they have sexual intercourse; 2) Used condoms, a diaphragm, cervical cap, spermicide, sponge, fertility awareness, or withdrawal as a primary form of birth control; 3) Had sexual intercourse with more than one person; 4) Had sexual intercourse within 2 hours after using drugs and alcohol; and/or 5) Been treated for an STI/STD Trying to get pregnant or currently pregnant at the time of screening Have given birth during the 6 months preceding screening Married or engaged to be married at the time of screening
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 21.0-65.0, Cervical Carcinoma Female, aged 21 to 65 years of age Had received an abnormal Pap smear result in the past month Scheduled for an initial colposcopy in the next 1-2 months Able to communicate with ease in English or Spanish Have a cell phone with text (TXT) ability Competent to give consent Are pregnant at the time of recruitment Display current evidence of positive invasive carcinoma of the cervix
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2
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Breast Cancer Adenocarcinoma of Breast Histology-confirmed epithelial cancer of the mammary gland Pre and post menopausal patients with early breast cancer and involved axillary lymph nodes (T 1-3 N1 M0) or high-risk N0 patients. A N0 patient is considered "high-risk" if she fulfills at least one of the following criteria; T>= 2cm, Estrogen Receptor (ER)/Progesterone receptor (PgR) negative, HER-2 3+, infiltration of blood or lymphatic vessels or nerves, grade 3 White Blood Cell count (WBC) > 4 x 109 / l, platelets > 100 x 109 / l Serum creatinine, Aspartate aminotransferase (AST/SGOT),Alanine aminotransferase (ALT/SGPT), gamma-glutamyltransferase, serum bilirubin 1.3 mg/ml inside the normal range of the participating hospital Performance status (WHO) 0 or 1 Age >=18 years Previous surgical treatment: Either radical surgery or, for a partial mastectomy, a histologically confirmed safe margin of 2 cm or more and the results of the axillary node dissection available No evidence of significant cardiac disease History of myocardial infarction within the previous 12 months or heart failure (including cardiac insufficiency controlled by digitalis and diuretics) or arrhythmias requiring medication or uncontrolled arterial hypertension (BP> 200/110 mm Hg). A normal baseline Left Ventricular Ejection Fraction (LVEF) should be demonstrated by multigated acquisition (MUGA) scan or echocardiogram No previous antitumor chemotherapy or radiation Time from surgery 2 to 4 weeks
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cervical Cancer Histologically confirmed adenocarcinoma (usual/classic/NOS), squamous cell carcinoma, adenosquamous carcinoma (Including glassy cell) 2. FIGO Stage IA2, IBI, IB2 (2018 staging) without evidence of definitive parametrial, vaginal, nodal or distant metastases on exam or imaging. 3. Uterine size <12 cm AND felt to be appropriate for vaginal delivery of the specimen 4. Suitable surgical candidate 5. Age 18 years or older 6. ECOG performance status 0-1 7. Adequate bone marrow, renal and hepatic function 8. Negative urine pregnancy test within 30 days of surgery in pre-menopausal women or those <2 years after onset of menopause 9. Prior malignancy allowed if >5 years since diagnosis without evidence of disease Any tumor histology other than those listed above 2. FIGO stage 1A1, IB3, II-IV (2018 staging) 3. Inability to have an MRI 4. Tumor size ≥4cm or evidence of definitive vaginal/parametrial involvement on pelvic exam or MRI 5. Uterine size >12cm or clinical suspicion that the uterus will not be able to be removed vaginally. 6. Evidence of metastatic disease (imaging or histologically positive lymph nodes) 7. History of prior pelvic or abdominal radiotherapy 8. Prior malignancy within 5 years 9. Unable to withstand prolonged lithotomy or steep trendelenberg 10. Patient compliance and geographic proximity that do not allow adequate follow-up 11. Poorly controlled HIV defined as CD4 count <500
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-999.0, Sensory Perceptual Characteristics User Acceptability of Gel Delivery System Female hrHPV positive years of age or older Have not received the HPV vaccine Not pregnant or nursing Medicaid eligible history of skin irritation and/or allergic skin reactions
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2
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Burkitt Lymphoma Lymphoma, Large-Cell, Diffuse Lymphoma, Small Noncleaved-Cell High Risk Protocol: Patients with small non-cleaved (Burkitt or Burkitt-like) or diffuse large cell lymphomas except those with: a) Minimal extra-abdominal tumor as the sole site of disease and a serum LDH less than 1.5 times the upper limit of normal (NIH patients, less than 350 U/L) or except those with b) completely resected small, localized abdominal mass (involved segmental lymph nodes permitted) and a serum LDH level less than 1.5 times upper limit of normal (NIH patients less than 350 U/L). All patients with small non-cleaved (Burkitt or Burkitt-like) or diffuse large cell lymphomas with a serum LDH level greater than 1.5 times the upper limit of normal (NIH patients, greater than 350 U/L), regardless of the clinically documented extent of disease. All patients with small non-cleaved (Burkitt or Burkitt-like) or diffuse large cell lymphomas with testicular involvement. Low risk protocol: Patients with small non-cleaved (Burkitt or Burkitt-like) or diffuse large cell lymphomas with a) minimal extra-abdominal disease as the sole site of disease and a serum LDH less than 1.5 times the upper limit of normal (NIH patients, less than 350 U/L) or b) completely resected small, localized abdominal mass (involved segmental lymph nodes permitted for gastrointestinal disease) and a serum LDH level less than 1.5 times the upper limit of normal (NIH patients, less than 350 U/L). No patients with lymphoblastic lymphomas, low grade or follicular lymphomas. No patients with peripheral T cell lymphomas that do not fall into the category of anaplastic large cell lymphoma. No patients with a previously documented lymphoma or histological evidence of co-existing lymphoma of other histology. No patients who have been previously treated with chemotherapy or radiotherapy. No patients with HIV infection. No patients above the age of 60 years. No patients with a history of inherited or non-HIV acquired immunodeficiency syndromes
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 17.0-999.0, Squamous Neck Carcinoma of the Head and Neck Cancer (SCCHN) Biopsy proven squamous cell carcinoma of the following head and neck sites: Hypopharynx Oral cavity Larynx Oropharynx Nasal cavity Unknown primary Paranasal sinus Histologically proven poorly-differentiated carcinoma of the following head and neck sites: Hypopharynx Oral cavity Larynx Oropharynx Nasal cavity Paranasal sinus Stage III/IV (T0-4 N1-3 M0-2) disease WBC at least 3,000/mm3 Bilirubin no greater than 2.0 mg/dL AST no greater than 100 U/L Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min (patients in Group N2-N3) No second malignancy within 5 years except curatively treated nonmelanomatous skin carcinoma No prior RT or chemotherapy, except prior radiotherapy to primary tumor allowed Not pregnant or nursing. Negative pregnancy test required Effective contraception required of fertile women Subjects with unknown primary cancers who had metastatic cervical lymph nodes are eligible Signed informed consent previously approved by the Institutional Review Board
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 16.0-999.0, Kidney Cancer An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate organ function as defined by a white blood cell (WBC) count of 4,000/L; a platelet count of 100,000/L; a Hemoglobin level of 10 g/dL; a serum creatinine of 1.5 mg/dL or creatinine clearance of 60 mL/min; and a direct bilirubin level of 1.5 mg/dL Forced expiratory volume at 1 second more than 2.0 L or 75% of predicted for height and age from pre-enrollment pulmonary function testing No history or evidence of cardiac disease on ECG No prior systemic treatment for RCC, but patients may have received prior locoregional radiation therapy to solitary resectable metastases, which must have undergone surgical resection before enrollment No prior history of invasive malignancy in the past 5 years Human immunodeficiency virus (HIV) negative Female patients must not be pregnant or planning to become pregnant • Age younger than 16
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 16.0-999.0, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Small Lymphocytic Lymphoma Splenic Marginal Zone Lymphoma Waldenström Macroglobulinemia Previously treated non-Hodgkin's lymphoma (all histologies except lymphoblastic and Burkitt's lymphoma) or Hodgkin's disease Maximum of 4 previous treatment regimens Measurable disease No CNS involvement Performance status Zubrod 0-1 Performance status Karnofsky 80-100% At least 12 weeks Platelet count at least 75,000/mm^3
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 3.0-60.0, Sarcoma Histologically proven high risk Ewing's family of tumors: Ewing's sarcoma of bone Extraosseous Ewing's sarcoma Peripheral neuroepithelioma Must have one of the following characteristics: Metastatic disease at diagnosis Primary tumor of the humerus, femur, or trunk Bulky (greater than 8 cm) tumor Elevated LDH prior to biopsy (at least 900 IU/mL) Age: 3 to 60 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Granulocyte count at least 500/mm3 Platelet count at least 75,000/mm3 Hemoglobin at least 8 g/dL (transfusion allowed) Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 3 times normal Renal: BUN less than 30 mg/dL Creatinine no greater than 1.5 times normal for age OR Creatinine clearance at least 70 mL/min Cardiovascular: Ejection fraction at least 50% OR Fractional shortening at least 29% Other: Not pregnant or nursing Fertile patients must use effective contraception PRIOR Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-70.0, Breast Cancer Gestational Trophoblastic Tumor Kidney Cancer Lymphoma Neuroblastoma Ovarian Cancer Sarcoma Testicular Germ Cell Tumor Diagnosis of non-Hodgkin's lymphoma, Hodgkin's disease, breast cancer, or other solid tumors with for FHCRC/PSOC protocols involving autologous peripheral blood stem cell transplantation No evidence of bone marrow disease No pericardial effusion, pleural effusion, or ascites No CNS involvement Hormone receptor status: Not specified Age: 70 and under Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL No medically unmanageable, severe hypokalemia Cardiovascular: No history of atrial arrhythmia or congestive heart failure No history of thromboembolic disease, except successfully treated catheter related thrombosis LVEF at least 45% Other: No active infection requiring systemic antibiotics HIV negative No known allergy to murine or E. coli proteins No documented prior anaphylactic reaction to interleukin-11 or filgrastim (G-CSF) No papilledema No history of Factor V Leiden defect, factor II, antithrombin III, Protein C or Protein S deficiencies Not pregnant or nursing Fertile patients must use effective contraception PRIOR Biologic therapy: See Disease Characteristics Chemotherapy: No prior cumulative dose of doxorubicin greater than 300 mg/m2 At least 3 weeks since prior chemotherapy Endocrine therapy: No concurrent estrogen supplementation Radiotherapy: No prior radiotherapy to the pelvic area Surgery: Not specified Other: No chronic diuretic therapy At least 1 week since prior aspirin or anticoagulants except low dose anticoagulation to prevent catheter thrombosis
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.5-18.0, Hemolytic Uremic Syndrome ENTRY --Disease Characteristics-- Clinically diagnosed E. coli-associated diarrhea-associated hemolytic uremic syndrome (HUS) Diarrheal prodrome within 7 days before onset of disease No HUS associated with the following: Hereditary Post-bone marrow transplantation Streptococcus pneumoniae infection No prior catastrophic complications --Patient Characteristics-- Hematopoietic: Thrombocytopenia less than 140,000/mm3 Fragmented red blood cells Renal: Renal involvement (hematuria, proteinuria, or azotemia) No underlying glomerular disease Other: HIV negative No pre-existing structural abnormality or dysmotility syndrome of the gastrointestinal tract No inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
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2
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.25-999.0, Lactic Acidosis ENTRY --Disease Characteristics-- Diagnosis of stable, persistent lactic acidemia Venous lactate at least 3 mM under basal conditions defined as: At least 4 hours postprandial No concurrent illness OR Diagnosis of cerebral lactic acidemia with elevated lactic acid in CSF but not in the blood No organic acidemias or defective gluconeogenesis --Patient Characteristics-- Hematopoietic: Hemoglobin at least 7 mg/dL Hepatic: Bilirubin no greater than 3 times upper limit of normal (ULN) AST, ALT, or GGT no greater than 10 times ULN Renal: Creatinine no greater than 2 mg/dL Cardiovascular: Ejection fraction at least 25% Other: No hypoglycemia (blood sugar less than 50 mg/dL at no greater than 12 hours fasting) No severe peripheral neuropathy interfering with normal activities of living
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 11.0-999.0, Wegener's Granulomatosis Minimum weight of 40 kg Diagnosis of WG, excluding infections, malignancies, systemic autoimmune disorders, and other forms of vasculitis that may mimic WG At least two of the five modified American College of Rheumatology (ACR) for a diagnosis of WG. The modified ACR are: (1) nasal or oral inflammation, defined as the development of painful or painless oral ulcers or purulent or bloody nasal discharge; (2) abnormal chest radiograph, defined as the presence of nodules, fixed infiltrates, or cavities; (3) active urinary sediment, defined as microscopic hematuria (> 5 red blood cells per high-power field) or red blood cell casts; (4) granulomatous inflammation on biopsy, defined as histologic changes showing granulomatous inflammation within the wall of an artery or in the perivascular or extravascular area (artery or arteriole); and (5) positive serum ELISA for ANCAs (anti-neutrophil cytoplasmic antibodies) directed at PR-3 Birmingham Vasculitis Activity Score (BVAS) score 3 or greater within 28 days of randomization. This may either the presence of one or more major items (3 points each) or the presence of three or more minor items (1 point each) Willingness and ability, with the assistance of a caregiver if necessary, to comply with treatment and followup procedures Willingness of men and women of childbearing potential to practice an adequate method of birth control during the study and for 3 months afterwards Willingness to limit alcohol consumption to one alcoholic drink per week while taking methotrexate Willingness to refrain from breast-feeding during the study and for 3 months afterwards Collection of all baseline data within 14 days prior to randomization Signed consent statement Presence of an active systemic infection White blood cell count less than 4,000/mm cubed or a platelet count less than 120,000/mm cubed Creatinine greater than 2.0 mg/dL secondary to non-WG causes (e.g., hypertensive nephropathy) for a patient with limited disease Known acute or chronic liver disease History of multiple sclerosis or other neurological symptoms suggesting a demyelinating syndrome Current evidence of malignancy or malignancy diagnosed within 5 years of study entry. Patients with squamous or basal cell carcinomas of the skin may be enrolled if they have received curative surgical treatment Positive serum pregnancy test for women of childbearing potential Previous treatment with specific therapies directed against tumor necrosis factor, e.g., etanercept or infliximab
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 15.0-999.0, Adult Acute Promyelocytic Leukemia (M3) Blastic Phase Chronic Myelogenous Leukemia Childhood Myelodysplastic Syndromes Previously Treated Myelodysplastic Syndromes Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Myeloid Leukemia Refractory Anemia With Excess Blasts Refractory Anemia With Excess Blasts in Transformation Relapsing Chronic Myelogenous Leukemia Patients must have AML, ALL, or high-risk MDS (RAEB or RAEB-t) that has Not responded (no CR) to initial induction chemotherapy, or Recurred after an initial CR of < 1 year, or Recurred after an initial CR of > 1 year and failed to respond to an initial reinduction attempt, or Recurred more than once, or Chronic myeloid leukemia in myeloid blast phase Patients with CML blast phase may receive BMS-214662 as their first therapy for blast phase or after failing other treatments for blast phase Patients with refractory or relapsed acute promyelocytic leukemia are eligible provided they have failed an ATRA-containing regimen Performance status of =< 0-2 Pregnant and nursing females will be excluded; patients of childbearing potential should practice effective methods of contraception Patients with prolonged QTc interval on EKG are excluded
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Cushing's Syndrome Healthy WITH Patients with normal adrenal glands will be recruited from those studied under NCI protocols. They will not have taken suppressive doses of glucocorticoids for 12 months, and will not have any known adrenal pathology, either of the cortex or medulla. They will not have Von-Hippel Lindau syndrome. WITH ACTH-INDEPENDENT Will be aged 18 or older; Will have plasma ACTH levels of 10 pg/mL or less; Will have an outside physician who will follow them after surgery. Must not weigh greater than 380 pounds. These patients are unable to undergo CT scans. Must not have a CT scan showing normal or atrophic bilateral adrenal glands. Must not have a CRH test showing a response as defined above. The diagnosis of these patients will need further evaluation. Must not have any condition that would preclude surgery, including advanced heart failure, significant coronary artery disease, severe pulmonary disease. Must not have a hematocrit less than 30 or research blood withdraw greater than 450 mL in the previous six weeks. Must not be pregnant. Must not have a history of angina or known coronary artery disease, because these patients are at risk for exacerbation during the vasopressin test. The SF-36 questionnaire will only be given to individuals who speak and read English fluently. Patients may participate in the remainder of the study, however, if they do not meet this criterion
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Brain and Central Nervous System Tumors Histologically confirmed supratentorial glioblastoma multiforme by surgical biopsy or resection within 5 weeks of study Postoperative residual contrast enhancing tumor and resection tumor cavity together no greater than 60 mm in maximum diameter No well-differentiated or anaplastic astrocytomas or multifocal glioma No tumors originating in the brainstem No residual tumor within 10 mm of optic chiasm No recurrent glioblastoma multiforme Age Not specified Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Hemoglobin greater than 9 g/dL
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-999.0, Lymphoma, AIDS-related Lymphoma, Large B-Cell, Diffuse Aggressive CD20 positive Diffuse Large B-cell lymphoma confirmed by Laboratory of Pathology, NCI. Note: Participants with aggressive B-cell lymphoma of the plasmablastic lymphoma sub-type who do not have surface CD20 expression, are also eligible. HIV + serology. All stages (I-IV) of disease. ECOG Performance status 0-4 NHL previously untreated with cytotoxic chemotherapy; however, participants may be entered if they have had prior cyclophosphamide for an urgent problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome) and/or a single dose of intrathecal methotrexte (MTX) at the time of the pre-treatment diagnostic lumbar puncture Age greater than or equal to 18 years Laboratory tests (unless impairment due to respective organ involvement by tumor) Creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than or equal to 50 ml/min Bilirubin less than 2.0 mg/dl, or total bilirubin less than or equal to 4.5 mg/dl with direct fraction less than or equal to 0.3 mg/dl in participants for whom these abnormalities are felt to be due to protease inhibitor therapy AST and ALT less than or equal to 3x ULN (AST and ALT less than or equal to 6x ULN for participants on hyperalimentation for whom these abnormalities are felt to be due to the hyperalimentation) ANC greater than or equal to 1000/mm(3) Platelet greater than or equal to 75,000/mm(3) (unless impairment due to ITP) Ability of participant to provide informed consent Previous rituximab Pregnancy or nursing Doxorubicin, etoposide, vincristine and cyclophosphamide are teratogenic and may be excreted in milk. Current clinical heart failure or symptomatic ischemic heart disease. Serious underlying medical condition or infection other than HIV that would contraindicate SC-EPOCH-R Examples but are not limited to Severe AIDS-related wasting Sever intractable diarrhea Active inadequately treated opportunistic infection of the CNS Primary CNS lymphoma Primary CNS lymphoma
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-1.0, Idiopathic Pulmonary Hemorrhage infant (<12 mo old) with unexplained pulmonary hemorrhage, discharged home from newborn nursery hemorrhage occurred in hospital prior to going home prior to discharge from newborn nursery
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-999.0, Kidney Cancer Histologically confirmed renal cell carcinoma Metastatic disease Unidimensionally measurable disease No brain metastases Age Not specified Performance status Karnofsky 70-100% Life expectancy More than 3 months Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic
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0
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-999.0, Crohn's Disease All subjects must have a verifiable diagnosis of active Crohn's disease of at least 4 months' duration. The diagnosis must be supported by characteristic 1) endoscopic or radiographic findings and 2) histopathologic changes on endoscopic biopsy or resected tissue. All subjects must be over age 18. The Crohn's disease is mildly to moderately active based on a Crohn's Disease Activity Index score between 225 and 450 (with either a diarrhea rating or abdominal pain rating of greater than or equal to 25). If currently receiving any medications for Crohn's disease, subjects may only be on a stable regimen of one or a combination of the following drug doses and durations: antibiotic therapy for greater than or equal to 2 weeks; Corticosteroids (less than or equal to 25 mg Prednisone/d, or Prednisone equivalent) for greater than or equal to 4 weeks; 5-ASA/Sulfasalazine for greater than or equal to 4 weeks; azathioprine/6-MP for greater than or equal to 8 weeks (Note: patients receiving Azathioprine or 6-MP must have been receiving these medications for greater than or equal to 12 weeks before randomization.); Probiotics for greater than or equal to 4 weeks. Use of barrier or hormonal methods of birth control for male and famale subjects who are not surgically sterile or postmenopausal. Negative serum beta-hCG for women of child-bearing potential (women who are not surgically sterile or postmenopausal) to early pregnancy. Negative results on stool examination for culture of enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, Vibrio, E. coli O157/H7), Clostridia difficile toxin assay, enteric parasites and their ova (including Giardia and Cryptosporidia) If any one of the above requirements is not met. Use of any the following medications within the specified time period prior to the first dose of study drug or at any time during the study: Corticosteroid enema or 5-ASA enema or suppositories (7 days); Thalidomide (2 weeks); Corticosteroids (greater than 25 mg Prednisone/d or Prednisone equivalent) (4 weeks); Methotrexate, Cyclosporin, Tacrolimus (FK506, Prograf), Thalidomide, or Mycophenolate mofetil (CellCept) (4 weeks), or any biological therapy (cytokine, anti-cytokine, or integrin-based therapy); Monoclonal antibodies to TNF (4 months); any experimental agent (1 month); use of greater than 500 mg/d aspirin or any dose of other NSAID (24 hours). Multiple bowel resections (greater than or equal to 200 cm) AND enteral or parenteral therapy to maintain weight. Use of any other investigational agent within 30 days beginning the treatment phase of this study. Any of the following abnormalities on an electrocardiogram: QT(c) greater than 0.48 sec, Mobitz type II second or third degree atrioventricular block, left bundle branch block or right bundle branch block with any fascicular block, changes consistent with acute ischemia. A diagnosis of ulcerative colitis or indeterminate colitis; Cushing's syndrome; Coexisting Th2-type inflammatory diseases: a.) scleroderma b.) persistent asthma defined as the presence of one of the features listed below: Clinical features before treatment: daily symptoms, exacerbations that affect activity and sleep, nighttime asthma symptoms two to four times a week, peak expiratory flow (PEF) or forced expiratory volume (FEV1) greater than 60 percent to less than 80 percent of predicted, variability greater than 30 percent; Daily medication required to maintain control: Daily controller medication (especially for nighttime symptoms): inhaled corticosteroids and long acting bronchodilators persistent asthma defined as the presence of one of the features listed below: Clinical features before treatment: continuous symptoms, frequent exacerbations, frequent nighttime asthma symptoms more than 4 times a week, daily physical activities limited by asthma symptoms, PEF or FEV1 less than 60 percent predicted, variability greater than 30 percent; Daily medication required to maintain control: Multiple daily controller medications (long-term); high-dose inhaled corticosteroids or bronchodilators oral corticosteroids Current active bowel obstruction, intestinal perforation, significant GI hemorrhage, or known presence of high grade structure HIV positivity or signs and symptoms consistent with HIV infection Acute systemic or intestinal infection requiring antibiotics Active hepatitis B or C Decompensated liver disease (Childs-Pugh class B or C) Hematocrit less than 30 percent; Platelet count less than 100,000 or greater than 700,000; PT INR greater than 1.3 or PTT prolonged by greater than 3 seconds; serum creatinine or BUN greater than 1.5 times the upper limit of normal (ULN); ALT(SGPT) or AST(SGOT) greater than 2 times the ULN; total bilirubin greater than 1.25 times the ULN; alkaline phosphatase greater than 1.5 times the ULN. Pregnant or nursing women History of cancer (other than resected cutaneous basal or squamous cell carcinoma; and in situ cervical cancer) with less than 5 years documentation of a disease-free state History of myocardial infarction within the last 12 months Patients expected to require surgery for their Crohn's disease within 12 weeks of study entry. Any condition that, in the investigator's opinion, places the patient at undue risk by participating in the study. History of anaphylactic reaction or hypersensitivity to G-CSF (Filgrastim) or proteins derived from E. coli Presence of splenomegaly defined as a palpable spleen on physical exam
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-999.0, Adult Anaplastic Astrocytoma Adult Anaplastic Ependymoma Adult Anaplastic Oligodendroglioma Adult Brain Stem Glioma Adult Diffuse Astrocytoma Adult Ependymoblastoma Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Adult Mixed Glioma Adult Myxopapillary Ependymoma Adult Oligodendroglioma Adult Pilocytic Astrocytoma Adult Primary Hepatocellular Carcinoma Adult Subependymoma Advanced Adult Primary Liver Cancer Advanced Malignant Mesothelioma Male Breast Cancer Recurrent Adenoid Cystic Carcinoma of the Oral Cavity Recurrent Adult Brain Tumor Recurrent Adult Primary Liver Cancer Recurrent Anal Cancer Recurrent Basal Cell Carcinoma of the Lip Recurrent Bladder Cancer Recurrent Breast Cancer Recurrent Cervical Cancer Recurrent Colon Cancer Recurrent Esophageal Cancer Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity Recurrent Lymphoepithelioma of the Nasopharynx Recurrent Lymphoepithelioma of the Oropharynx Recurrent Malignant Mesothelioma Recurrent Metastatic Squamous Neck Cancer With Occult Primary Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity Recurrent Mucoepidermoid Carcinoma of the Oral Cavity Recurrent Non-small Cell Lung Cancer Recurrent Ovarian Epithelial Cancer Recurrent Pancreatic Cancer Recurrent Prostate Cancer Recurrent Rectal Cancer Recurrent Salivary Gland Cancer Recurrent Squamous Cell Carcinoma of the Hypopharynx Recurrent Squamous Cell Carcinoma of the Larynx Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity Recurrent Squamous Cell Carcinoma of the Nasopharynx Recurrent Squamous Cell Carcinoma of the Oropharynx Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity Recurrent Verrucous Carcinoma of the Larynx Recurrent Verrucous Carcinoma of the Oral Cavity Stage II Esophageal Cancer Stage II Pancreatic Cancer Stage III Esophageal Cancer Stage III Pancreatic Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Adenoid Cystic Carcinoma of the Oral Cavity Stage IV Anal Cancer Stage IV Basal Cell Carcinoma of the Lip Stage IV Bladder Cancer Stage IV Breast Cancer Stage IV Colon Cancer Stage IV Esophageal Cancer Stage IV Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity Stage IV Inverted Papilloma of the Paranasal Sinus and Nasal Cavity Stage IV Lymphoepithelioma of the Nasopharynx Stage IV Lymphoepithelioma of the Oropharynx Stage IV Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity Stage IV Mucoepidermoid Carcinoma of the Oral Cavity Stage IV Non-small Cell Lung Cancer Stage IV Ovarian Epithelial Cancer Stage IV Pancreatic Cancer Stage IV Prostate Cancer Stage IV Rectal Cancer Stage IV Salivary Gland Cancer Stage IV Squamous Cell Carcinoma of the Hypopharynx Stage IV Squamous Cell Carcinoma of the Larynx Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity Stage IV Squamous Cell Carcinoma of the Nasopharynx Stage IV Squamous Cell Carcinoma of the Oropharynx Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity Stage IV Verrucous Carcinoma of the Larynx Stage IV Verrucous Carcinoma of the Oral Cavity Stage IVA Cervical Cancer Stage IVB Cervical Cancer Unspecified Adult Solid Tumor, Protocol Specific Untreated Metastatic Squamous Neck Cancer With Occult Primary Histologically confirmed solid tumor, including gliomas and the following epithelial malignancies Non-small cell lung Mesothelioma Breast Head and neck Esophageal Pancreatic Bladder Prostate Ovarian
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 3.0-60.0, Ewing's Sarcoma High risk Ewing's Family of tumors (metastatic disease at diagnosis, humerus, femur or trunk primary, bulky primary (greater than 8 cm)), or LDH greater or equal to 900 IU/ml prior to biopsy No prior chemotherapy Written informed consent Normal cardiac function (ejection fraction greater or equal to 50%) Males and non pregnant females Biologic age 3-60 years old Adequate bone marrow function (defined as an absolute peripheral granulocyte count of>500/mm3, platelet count of >75,000/mm3, and hemoglobin >8g/dl with transfusion if required) Adequate renal function defined as blood urea nitrogen (BUN) <30mg% and serum creatinine <1.5 x normal for age or creatinine clearance >70 Patients of child bearing potential must agree to use an effective method of contraception Normal hepatic function (bilirubin <1.5mg/dl, serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) <3x normal) N/A
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 16.0-999.0, Breast Neoplasms Metastases, Neoplasm Patients will be eligible for this trial if Female, non-pregnant, non-lactating, and, if of child-bearing potential, have a negative serum pregnancy test, and use approved contraception Sixteen years of age or older Histologically or cytologically confirmed breast cancer (stage III or IV) with evidence of inoperable local recurrence or metastasis, with measurable disease If patient has received taxane therapy as an adjuvant he/she has not relapsed within one year of completing adjuvant taxane No other malignancy present within the past 5 years, except non-melanoma skin cancer, cervical intraepithelial neoplasia or in-situ cervical cancer Suitable candidate for paclitaxel therapy Hematology levels at baseline of: absolute neutrophil count of at least 1500 cells/mm3; platelet count of at least 100,000 cells/mm3; hemoglobin of at least 9 g/dL Chemistry levels at baseline of: AST and ALT of less than or equal to 2.5 x the upper limit of normal, if no evidence of liver metastasis; total bilirubin of less than or equal to 1.5 mg/dL; creatinine of less than or equal to 2 mg/dL; alkaline phosphatase of less than or equal to 5 x the upper limit of normal, unless there is bone metastasis but not liver metastasis Expected survival of at least 12 weeks
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 4.0-17.0, Arthritis, Juvenile Idiopathic Subjects must have a diagnosis of polyarticular juvenile idiopathic arthritis (JIA) age 4 to 17 by the American College of Rheumatology (ACR) criteria. Disease onset may have been systemic, polyarticular, or pauciarticular. If the disease was systemic onset, then the subjects must be free of any systemic JIA manifestations for at least 3 months before the time of qualification At the time of study screening, the subject must have continuing active disease defined as >= 5 swollen joints and >= 3 joints with limitation of motion (LOM). These joints are not mutually exclusive Subjects may be either naïve to MTX, inadequate responders to MTX, or intolerant to MTX. Intolerance to MTX will be defined by the subject's physician. The MTX must be maintained at a dose of at least 10 mg/m2 body surface area/week for a minimum of 3 months, prior to screening Duration of disease is not limited, but must have been long enough for a subject to have been given an adequate trial of nonsteroidal anti-inflammatory drugs (NSAIDs) Have not received other disease-modifying anti-rheumatic drugs (DMARDs) including penicillamine, hydroxychloroquine, sulfasalazine, oral or injectable gold, cyclosporin; or intravenous immunoglobulin (IV Ig); or cytotoxic agents, for at least 4 weeks prior to receiving 1st dose of study drug. Subjects currently on one or more of these DMARDs must demonstrate active disease (defined above) prior to a minimum 4 weeks (28 days) washout of all DMARDs Subjects who are refractory to MTX after 3 months of treatment must demonstrate active disease (defined above) prior to enrollment in the open-label part of the trial Have not received an intra-articular glucocorticoid injection within 4 weeks (28 days) prior to enrollment into the study Have good venous access and stable hematocrit >= 24% All sexually active male and female study participants must be practicing adequate contraception. Post-pubertal females must have a negative serum pregnancy test no greater than 10 days prior to the first dose of study drug Parent or guardian has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject's parent or legal guardian has had the opportunity to ask questions Pregnant or nursing female Functional class IV by ACR criteria Laboratory parameters outside limits established in the protocol Medical history, medical condition, or previous treatment not allowed by the protocol
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 3.0-999.0, Anthrax Bacillus Infections Subjects of any age, including pregnant women, are eligible for if they meet one of the five listed below, are hemodynamically and clinically stable, and agree to stored samples. Women of child-bearing age or potential will not be excluded from participation but pregnancy status will be determined at time of enrollment in order to optimize subsequent evaluation and care. 1. Inhalation Anthrax (acute or recovering infection) --nonspecific febrile illness followed by sepsis and/or respiratory failure AND --B anthracis isolation (via culture) from any site OR 2 supportive lab tests OR --nonspecific febrile illness followed by sepsis and/or respiratory failure with no alternative diagnosis AND --one supportive lab test OR direct epidemiological link to a confirmed environmental exposure 2. Cutaneous Anthrax (acute or recovering infection) --characteristic lesion (papule->vesicular->depressed black eschar plus or minus edema, erythema, necrosis or ulceration) AND --B anthracis isolation (culture) from any site OR 2 supportive lab tests --Characteristic lesion with no alternative diagnosis AND --one supportive lab test OR direct epidemiological link to a confirmed environmental exposure 3. Gastrointestinal Anthrax (acute or recovering infection) --Severe abdominal pain often associated with bloody vomiting/diarrhea followed by fever/septicemia AND --B anthracis isolation (culture) from any site OR 2 supportive lab tests --Severe abdominal pain often associated with bloody vomiting/diarrhea followed by fever/septicemia with no alternative diagnosis AND --1 supportive lab test OR direct epidemiological link to a confirmed environmental exposure These definitions were subsequently updated by the CDC in 2010 to accept clinically compatible symptoms plus one of the following: a positive culture, a positive immunohistochemical stain for antigen, a 4-fold increase in anti-PA IgG or a positive documented exposure with detection of DNA via PCR (26). 4. Exposed individuals who are clinically asymptomatic. 5. Past or imminent vaccination in healthy (non-anthrax exposed). 6. Hemodynamically and clinically stable at time of evaluation at NIH Hemodynamically: stable vital signs Clinically: no obvious signs of disease progression (e.g. worsening pleural effusions or increasing cutaneous edema) acute/newly recovered patients must be receiving standard antimicrobial therapy 7. Participant agrees to stored samples Inability to sign informed consent or lack of designated Health Power of Attorney
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-999.0, Lung Cancer Pulmonary Complications Radiation Fibrosis One of the following histologically or cytologically confirmed diagnoses Stage II-IIIB non-small cell lung cancer (NSCLC) Stage I central NSCLC No peripheral coin lesions Limited stage small cell lung cancer Nonmetastatic disease that is receiving radiotherapy and the target is confined to a single radiotherapy treatment area Planning to receive radiotherapy At least 45 Gy to be delivered to the target volume More than 25% of total lung volume to receive > 20 Gy if receiving radiotherapy alone Age and over Performance status
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 3.0-25.0, Brain Tumor Central Nervous System Tumor Histologically confirmed primary CNS pure germ cell tumor Diagnosed within the past 31 days Meets any 1 OR none (i.e., M0 [localized disease]) of the following staging M+ (disseminated disease) Leptomeningeal or intraventricular metastases visualized on MRI scans of the brain and spine Clumps of tumor cells on lumbar cerebrospinal fluid (CSF) cytology Visible tumor studding the walls of the lateral or third ventricles noted during endoscopy or surgery Primary tumor arising within the parenchyma of the brain, brainstem, or spinal cord Measurable multi-focal tumors arising in both the pineal and suprasellar regions (i.e., multiple midline tumors) Infiltrative, intra-axial extension on brain MRI > 1 cm beyond enhancing tumor
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-999.0, Leukemia Confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL) based on the following Peripheral blood lymphocytosis > 5,000/mm^3 Co-expression of CD5, CD19 or CD20, and CD23 surface antigens Clonal kappa or lambda light chain expression No recurrent or refractory CLL No other lymphoproliferative diseases or diseases due to transformation of CLL, such as prolymphocytic leukemia or Richter's syndrome Age and over Performance status Karnofsky 60-100% Life expectancy At least 12 weeks Hematopoietic See Disease Characteristics Hepatic
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 2.0-21.0, Brain and Central Nervous System Tumors Unspecified Childhood Solid Tumor, Protocol Specific Histologically confirmed* malignant solid tumor, including CNS tumors, at original diagnosis or relapse Recurrent or refractory disease NOTE: *Histologic confirmation not required for intrinsic brain stem or optic pathway tumors Measurable or evaluable disease, defined by 1 of the following Any unidimensionally measurable lesion ≥ 10 mm by standard MRI or CT scan for either solid or CNS tumors At least 1 nonmeasurable lesion that is evaluable by nuclear medicine, immunocytochemistry, tumor markers, cerebrospinal fluid cytology, or other reliable measures No known curative therapy exists No documented tumor involvement in the bone marrow Age to 21 Performance status* Lansky 50-100% (for patients ≤ 10 years of age) Karnofsky 50-100% (for patients > 10 years of age) Life expectancy
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.0-36.0, Hyperbilirubinemia, Neonatal Jaundice, Neonatal Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature 1000 grams birth weight 36 hours postnatal age Terminal condition (pH <6.8 for >2 hours OR persistent bradycardia, heart rate <100 bpm, associated with hypoxia for >2 hours] Prior use of phototherapy Major congenital anomaly Hydrops fetalis or severe hemolytic disease diagnosed in-utero Overt congenital nonbacterial infection Parental refusal or inability to provide consent Attending physician refusal Parents who are considered unlikely to return for follow-up evaluation
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 1.0-40.0, Cholera Healthy non-pregnant adults aged 18-40 years and children aged 1-17 years Diarrhea during the past week Antibiotic and anti-diarrheal medicine use during the past week One or more episodes of diarrhea or abdominal pain lasting for 2 weeks during the past 6 months Abdominal pain, nausea, vomiting, loss of appetite or generalized ill feeling for the past 24 hours Pregnancy
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.25-3.0, Diarrhea, Malnutrition Other Nutritional Deficiencies Children ages 3 to 36 months with a history of persistent diarrhea (3 or more unformed stools/day) for >2 weeks or height-for-age Z-score (HAZ) less than negative 1, which is the median of HAZ score in children at HIAS. 2. Be an inpatient and willing to stay for 7 nights at HIAS. 3. Child´s parent or guardian must sign informed consent Children exclusively breast-fed (Reason: The diet needs to be controlled in order to evaluate the study treatment effect) 2. Children who participated in the community study or any other study within the past two years (Reason: The children in the community study will have received glutamine.) 3. Children with suspected other illnesses as indicated by fever >102º F at time of screening off antipyretics 4. Children with suspected systemic disease at the time of screening including but not limited to shock, meningitis, sepsis, pneumonia, tuberculosis, varicella 5. Severe malnutrition defined as HAZ <-3 or WAZ <-3.5 or any child weighing <10 lbs. (4.5 kg) or any child with a weight-to-height ratio <60% of the NCHS age adjusted norm
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 18.0-50.0, Gastroenteritis Norovirus Subjects must be 18 to 50 years of age and in good health as determined by medical history and physical examination Subjects must sign informed consent prior to study initiation All screening clinical laboratory test results within the protocol-defined normal range. Subjects with a history of positive Hepatitis A antibody or vaccination and normal liver transaminases (serum) may be accepted If the subject is a woman, a negative serum pregnancy test within 3 days of inoculation and negative urine or blood pregnancy test on day of inoculation Subjects must be able to demonstrate a sufficient understanding of the study protocol and the ability to follow all required study procedures, including measures to prevent Norwalk Virus (NV) contamination of the environment and spread of NV infection and illness to the community. The prospective subjects must pass (> 75 percent correct responses, or 21 of 27 questions answered correctly) a written examination before enrollment. The exam will contain 27 multiple choice or true/false questions on all aspects of the study protocol. Subjects will be re-instructed about any question they may have answered incorrectly Subjects must be available to return for follow-up visits following discharge from the General Clinical Research Center (GCRC) and deliver specimens to the investigator promptly Agree to storage of unused, identifiable clinical specimens for an indefinite period at Baylor College of Medicine for use in future research Subject must express the H type-1 oligosaccharide (as measured by positive salivary secretor status) Must use acceptable form of birth control, if female. The only acceptable birth control methods are oral contraceptives, intrauterine devices (IUDs), contraceptive implants under the skin, or contraceptive injections, and condoms with foam Living with or having daily contact with children age 10 years or less or a woman known to be pregnant. This includes contact at home, school, day-care, or equivalent facilities Living with or having daily contact with childcare workers Living with or having daily contact with elderly persons, aged 70 years or more, or the infirmed, diapered individuals, persons with disabilities or incontinent persons. This includes work or visits to nursing homes and day-care or equivalent facilities Evidence of recent (within 3 months), or of current nonbacterial gastroenteritis suggestive of Norwalk Virus (NV) infection [vomiting or unformed or watery stools (>2 during a 24 hour period)] History of chronic functional dyspepsia, chronic gastroesophageal reflux disease, peptic ulcer disease, gastrointestinal hemorrhage, gall bladder disease, inflammatory bowel disease, irritable bowel syndrome, frequent diarrhea, or diverticulitis anytime during the subject's lifetime Positive serological tests for hepatitis viruses B (core and/or surface antigen serology) and/or C, human immunodeficiency virus (HIV)-1, or syphilis. Prior to HIV-1 testing, subjects will be counseled by a qualified clinical investigator as to the purpose and meaning of such testing. Any subject with a positive test will be referred to the local HIV-1 clinic or his/her private practitioner Pregnant or lactating woman History of drug or alcohol dependence, or significant acute or chronic medical or psychiatric illness that could limit the subject's ability to complete the study and/or compromise the objectives of the study. One positive CAGE questionnaire response is exclusionary Regular use of medication, such as, but not limited to, corticosteroids, anti-diarrhea medications, opioids, immunosuppressive agents, nonsteroidal anti-inflammatory drugs, antipyretics, and anticoagulants (e.g., warfarin or heparin or gold salts). Oral contraceptives are permitted Use of antibiotics within 14 days of inoculation
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 15.0-38.0, Malaria A pregnant woman who has either a positive blood smear for P.falciparum with at least 1000 asexual parasites/uL in an asymptomatic woman or any of the following symptoms within 2 days prior to consultation history of fever headache vomiting chills/rigors and/or any of the following signs: temperature >37.50C and <39.50C, Hb>5 and <9 g/dl together with P.falciparum parasitaemia at any density and (in both cases) the following: 1. Has no criterion (see below); 2. Is 14-34 weeks pregnant on the day of attending the ANC clinic or OPD; 3. Has a viable foetus, defined by presence of foetal heartbeat by sonicaid or pinnard (foetal heartbeat is not heard until 14 weeks); 4. Is able to take study drugs by the oral route; 5. Is able to attend stipulated days for follow up clinic and provide specimens; 6. Gives informed written or witnessed verbal consent to participate by herself, and also through her parent/guardian if aged <15 years (in conformity to Tanzania Law) Severe and complicated forms of malaria (as defined by WHO, 1996); 2. Pregnancy in the first trimester; 3. A mixed plasmodial infection; 4. Complicated pregnancy, e.g. signs/symptoms of toxaemia of pregnancy; 5. 23 or more abortions or stillbirths; 6. Presence of concomitant disease masking assessment of the response to treatment ; 7. An intake of drugs contraindicated in pregnancy, e.g. tetracycline, cotrimoxazole or a macrolide antibiotic; 8. An intake of drugs with effective antimalarial activity within the last 2 weeks. 9. Significantly abnormal baseline haematology (except anaemia) or clinical chemistry parameters, e.g. laboratory evidence of renal impairment (serum creatinine >2 mg/dl) or of hepatitis (alanine aminotransferase [ALT] >5 times upper limit of normal); 10. Previous participation in the study: Women having a second episode of malaria after completing the 28-day follow up will have details recorded and offered quinine but not be re-enrolled. 11. Multiple gestation pregnancies, eg twins 12. Mother aged 38 years or above
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 15.0-90.0, Helicobacter Infections Gastritis Gastric Ulcer Duodenal Ulcer Patients with H. pylori infection Patients without H. pylori infection
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A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
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eligible ages (years): 0.083-18.0, Kawasaki Disease Patients who fulfill the of Kawasaki disease or atypical Kawasaki disease and their household family members Not cases of Kawasaki disease
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