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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, ER-positive Her2-negative Early Breast Cancer Woman, Age ≥ 18 years; 2. Performance status 0 or 1 (according to World Health Organization criteria); 3. Patient with newly diagnosed, unilateral, localized, histologically confirmed, invasive breast cancer; Note: Multicentric/multifocal tumors are allowed provided a maximum of 3 lesions are present, and all are ER > 10% or Allred ≥ 4, Her2-negative (genomic test will be performed on the lesion considered the most pertinent by the multidisciplinary team) 4. Fully operated breast cancer including complete resection of breast tumor and adequate axillary surgery; 5. Available surgical material (formalin-fixed, paraffin-embedded) for genomic test evaluation; 6. ER-positive by immuno-histochemical (>10% cells stained or Allred Score≥4); 7. HER2-negative by IHC (score 0 or 1+) and/or fluorescence in situ hybridization/silver in situ hybridization/chemiluminescent in situ hybridization ; 8. Uncertainty regarding the toxicity/benefit of adjuvant chemotherapy, outlined in the following situations Grade 1: pT3 or 1-3 node positive Grade 2: pT1 pN0 but high proliferation (Ki67 >20%) or lympho-vascular emboli, or 1-3 node positive Grade 2 : pT2 pN0 Grade 3: pT1 pN0 9. Adequate renal, hepatic, cardiac and hematopoietic functions for a chemotherapy administration; 10. Willingness and ability to comply with scheduled visits as well as with test results and chemotherapy decision according to the latest; 11. Signed informed consent and Health insurance coverage Non operable, bilateral, locally advanced, T4 or metastatic breast cancer; 2. HER2 Overexpression, as assessed by 3+ IHC or FISH/SISH/CISH amplification; 3. Diagnosis of any previous malignancy within the last 5 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma; 4. Any previous systemic or locoregional treatment for the present breast cancer; 5. Documented inherited predisposition with BRCA1/2 or TP53 mutation; 6. Previous hormone replacement therapy (HRT) stopped less than 2 weeks before surgery; 7. Previous treatment for the present breast cancer; 8. Person unable to give informed consent
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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): 40.0-65.0, Breast Cancer Cervical Cancer self-identify as Muslim female residence in a NYC borough self-report as having received a mammogram more than two years ago and are age 40-74 years self-report having received a Pap test more than three years ago and are age 40-65 years Report a past or current diagnosis of breast or cervical cancer Report having had a hysterectomy Report having had breast reconstructive surgery
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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): 0.0-999.0, Stage 0 Bladder Urothelial Carcinoma Stage 0is Bladder Urothelial Carcinoma Stage I Bladder Urothelial Carcinoma Patients must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage urothelial cell carcinoma of the bladder within 90 days of registration Patients must have had all grossly visible papillary tumors removed within 30 days prior to registration or cystoscopy confirming no grossly visible papillary tumors within 30 days prior to registration Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis demonstrating no evidence of metastatic disease (magnetic resonance imaging [MRI] or computed tomography [CT] scan) within 90 days prior to registration; patients with T1 disease must have re-resection confirming =< T1 disease within 90 days prior to registration Patients must have high-grade bladder cancer as defined by 2004 World Health Organization (WHO)/International Society of Urological Pathology (ISUP) classification Patients must not have pure squamous cell carcinoma or adenocarcinoma Patients' disease must not have micropapillary components Patients must have no evidence of upper tract (renal pelvis or ureters) cancer confirmed by one of the following tests performed within 90 days prior to registration: CT urogram, intravenous pyelogram, magnetic resonance (MR) urogram, or retrograde pyelograms Patients must not have nodal involvement or metastatic disease No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years; patients with localized prostate cancer who are being followed by an active surveillance program are also eligible Patients must have a Zubrod performance status of 0-2
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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, Stage IA Non-Small Cell Lung Carcinoma Stage IB Non-Small Cell Lung Carcinoma Stage IIA Non-Small Cell Lung Carcinoma Stage IIB Non-Small Cell Lung Carcinoma Biopsy proven non-small cell lung cancer Minimum tumor dimension >= 1 cm (preferably >= 2 cm) No clinical evidence of nodal disease (N1-N3) as assessed by CT and/or positron emission tomography (PET)/CT Zubrod performance status 0-2 Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately A female of child-bearing potential is any woman (regardless of sexual orientation, 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) No prior radiation to the same area No concurrent chemotherapy Patients with tumors < 1 cm Patients with nodal disease or distant metastatic disease Patients may not be receiving any other investigational agents Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Patients must not be pregnant Patients with allergies to iodinated contrast not amenable to pre-medication Patients who are not able to lie supine with arms raised, and cooperate with breathholding instructions
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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, Cystic Fibrosis Male or female subjects with a confirmed diagnosis of CF defined as a sweat chloride value ≥60 mmol/L by quantitative pilocarpine iontophoresis or two CF-causing mutations,documented in the subject's medical record or confirmed at screening Age 18 and above on the date of informed consent Weight ≥40 kg Homozygous for the F508del-CFTR mutation. Genotyping to be confirmed at screening Ability to perform a valid, reproducible spirometry test with demonstration of a forced expiratory volume in 1 sec (FEV1) >40% of predicted normal for age, sex and height Screening laboratory tests with no clinically significant abnormalities that would interfere with the study assessments (as judged by the Investigator) Subjects who are sexually active must agree to follow the study's contraception requirements An acute upper or lower respiratory tract infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks prior to Day 1 Major complications of lung disease (including massive hemoptysis, pneumothorax, or pleural effusion) within 8 weeks prior to screening Impaired renal function or known portal hypertension History of prolonged QT and/or QTcF (Fridericia's correction) interval (>450 msec) or QTcF >450 msec at Screening History of solid organ or hematological transplantation History of alcohol abuse or drug addiction (including cannabis, cocaine and opiates) during the past year, (as judged by the Investigator) Use of ivacaftor or lumacaftor, within 4 weeks of Day 1 Any change (initiation, change in type of drug, dose modification, schedule modification, interruption, discontinuation, or re-initiation) in a chronic treatment/prophylaxis regimen for CF or for CF-related conditions within 4 weeks prior to Day 1 Ongoing immunosuppressive therapy (including systemic corticosteroids) Hemoglobin <10 g/dL
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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 Neoplasm of Cervix, Endometrium and Ovary Resectable (ovarian, endometrial, cervical) cancers. 2. Anaesthetically fit (ASA 1 and 2). 3. Abdominal pannus below symphysis pubis Non resectable gynecologic cancer. 2. Unfit patients. 3. Patients who refuse to share in the trial
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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): 25.0-65.0, Uterine Cervical Neoplasms Women between 25 and 65 years old Met within Doctors of the World programs History of total hysterectomy (= ablation of uterus and cervix) Never had sexual intercourse Last pap smear test made during the three last years (ou first pap smear test during the last year)
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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): 25.0-49.0, Mass Screening Early Detection of Cancer Uterine Cervical Neoplasm Text Message Reminder Systems Women aged between 25 and 49 years Medical registration at any of the primary health care units selected for this study Eligible for cervical cancer screening* *Defined as all women aged between 25 and 60 years old who do not verify any of the following hysterectomized, active cervical cancer disease, currently undergoing cervical cancer treatment or did not start sexual activity Unavailability of mobile phone number
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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, Human Papilloma Virus 65 years old Female Live in southwest VA Not pregnant-self reported History of Papanicolaou test in the last 3 years History of hysterectomy or pelvic radiation Co-testing (pap test and HPV test at the same time) in the last 5 years English speaking
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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): 20.0-70.0, Cervical Cancer Postoperative Pelvic Floor Dysfunction Criteria： ①Patients diagnosed as FIGO stage IA2、IB1、IIA1 cervical cancer ; ②Patients diagnosed as FIGO stage IB2、IIA2 cervical cancer, eligible for RH after neoadjuvant chemotherapy; ③Patients diagnosed as FIGO stage IIA endometrial carcinoma; ④Patients didn't have pelvic organ prolapse and urinary incontinence; ⑤Ability to hold Valsalva for dynamic MRI; ⑥Patients aged 20-70 years; ⑦Patients undergone RH surgery; ⑧Informed consent was signed ： ①With MRI or urodynamic examination contraindication; ②Previously undergone POP or SUI surgery; ③BMI>30 With serious postoperative complications
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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, Cancer Patients are those with a confirmed medical diagnosis of breast or thoracic cancer regardless of stage and followed at DCC for management The cancer diagnosis should have been made less than a year from the next scheduled appointment to the DCC The caregiver is defined as unpaid individuals involved in assisting the cancer patient with activities of daily living and/or medical tasks Patients and caregivers must be able to hear, read, and write in English; oriented to place, person, and time; and have an active telephone service, either cellular or landline Excluding patients and caregivers who are less than 18 years of age
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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 Malignant Solid Neoplasm Advanced Prostate Carcinoma 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 Castration-Resistant Prostate Carcinoma Metastatic Breast Carcinoma Metastatic Malignant Solid Neoplasm Metastatic Prostate 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 Prostate Cancer AJCC v8 Stage IIIA Prostate Cancer AJCC v8 Stage IIIB Prostate Cancer AJCC v8 Stage IIIC Prostate Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Triple-Negative Breast Carcinoma Unresectable Solid Neoplasm Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective Patients must be able to swallow and retain oral medications and be without gastrointestinal illnesses that would preclude absorption of AZD8186 Unlimited prior therapies allowed Docetaxel appropriate Patients who have not received prior docetaxel (or other taxane therapy) in the advanced setting are eligible for all cohorts Patients who have previously received docetaxel (or other taxane therapy) in the advanced setting are eligible for the dose escalation cohort only, if anticipated to have maintained taxane sensitivity and in the opinion of the investigator would still benefit from further docetaxel therapy Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) Leukocytes >= 3,000/mcL Absolute neutrophil count >= 1,500/mcL Hemoglobin >= 8 g/L HER2 positive breast cancer Prior treatment with PI3K/AKT inhibitors Any known concurrent RAF or PIK3CA mutation Patients who have had chemotherapy, radiotherapy, immunotherapy or anticancer agents within 4 weeks (6 weeks for nitrosoureas or mitomycin C) of the first dose of study treatment, except hormonal therapy with luteinizing hormone-releasing hormone (LHRH) analogues for medical castration in patients with prostate cancer and breast cancer, which are permitted Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) Patients who are receiving any other investigational agents Patients with known, untreated or unstable brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; patients with treated brain metastases are eligible if the metastases have been radiographically and clinically stable for at least one month; if on steroids for this indication, the patient must be on a stable dose for at least one month History of clinically significant allergic reactions attributed to compounds of similar chemical or biologic composition to AZD8186 or docetaxel or to docetaxel itself Patients receiving any medications or substances that are strong inhibitors and/or strong or moderate inducers of CYP3A4 are ineligible; because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product Existing bleeding or condition associated with increased risk of bleeding
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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): 25.0-65.0, Cervical Cancer Screening Self-identify as transgender male or as transmasculine Assigned female sex at birth English speaking ages 25-65 years report not having had a pap smear in the last three years if age 30 and over, report not having a Pap smear/HPV co-test in the past 5 years • Those who report having had a hysterectomy Those who report having history of cervical cancer Adults unable to consent Those who are pregnant Prisoners
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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): 20.0-70.0, Cervix Cancer Radiotherapy, Adjuvant Radiotherapy, Intensity-Modulated Hypofractionated Dose Chemotherapy, Concurrent histologically confirmed cervical cancer radical hysterectomy and pelvic lymph node dissection was done histologically indicated adjuvant chemoradiotherapy (more than one as below) positive pelvic lymph node metastasis positive parametrial invasion positive tumor involvement on surgical margin ECOG performance status 0 or 1 Bone marrow function: granulocyte ≥1.0 x 1000/µl, platelet ≥30 x 1000/µl, hemoglobin ≥10 g/dl Kidney function: Creatinine <2.0 mg/dL, Bilirubin 1.5 mg/dl positive distant metastasis (including retroperitoneal lymph node metastasis) previous history of pelvic radiotherapy more than 3 months after radical surgery for cervical cancer neoadjuvant chemotherapy was done previous history of other carcinoma except for thyroid cancer, skin cancer, in situ carcinoma on cervix
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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): 20.0-70.0, Cervix Cancer Radiotherapy, Adjuvant Radiotherapy, Intensity-Modulated Hypofractionated Dose histologically confirmed cervical cancer radical hysterectomy and pelvic lymph node dissection was done histologically indicated adjuvant radiotherapy ( more than one as below) 1. tumor size ≥4 cm 2. positive lymphovascular invasion 3. more than half stromal invasion depth ECOG performance status 0 or 1 Bone marrow function: granulocyte ≥1.0 x 1000/µl, platelet ≥30 x 1000/µl, hemoglobin ≥10 g/dl positive pelvic lymph node metastasis positive distant metastasis (including retroperitoneal lymph node metastasis) positive tumor involvement on resection margin positive parametrial invasion previous history of pelvic radiotherapy more than 3 months after radical surgery for cervical cancer neoadjuvant chemotherapy was done previous history of other carcinoma except for thyroid cancer, skin cancer, in situ carcinoma on cervix
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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): 25.0-70.0, Cervical Cancer Histology confirmed cervical cancer Clinical stage Ib2 or IIa2 (FIGO 2009) Patients who not suitable for surgery Personal history of pelvic radiotherapy
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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): 18.0-75.0, Hereditary Breast and Ovarian Cancer Mutation Index case Any person with an indication for a BRCA1/BRCA2 gene analysis and who has been offered panel screening. Age ≥18 years. Family member Family members will be eligible if the mutation identified in the Index Case is considered deleterious. Any family member to the first and second decree or a cousin of the Index Case. Family members from both sides of the family will be invited to take part. Age ≥18 years People deprived of their civil liberties or who are under judicial protection or guardianship. Patients unable to answer the questionnaire for social or psychological reasons. Children of the index cases, of any age
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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, Csf Leakage male/female patient candidate for an endoscopic endonasal transphenoidal surgery, who need repair of the sellar floor as part of the surgical procedure Diabetes, heart diseases, immunological diseases, infectious diseases, bone diseases
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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): 18.0-130.0, HER2-ve Metastatic Breast Cancer Germline BRCA1/2 Mutations Somatic BRCA1/2 Mutations Provision of informed consent prior to any study specific procedures. For patients aged <20 years and screened in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative. 2. Patients must be ≥18 years of age. 3. Histologically or cytologically confirmed HER2-ve breast cancer with evidence of metastatic disease. Patients can have either TNBC (defined as oestrogen receptor and progesterone receptor negative [immunohistochemistry nuclear staining <1%] and HER2-ve [immunohistochemistry 0, 1+ or 2+ and/or in situ hybridization nonamplified with ratio less than 2.0]) or oestrogen receptor / progesterone receptor positive breast cancer as long as they are HER2-ve. 4. Documented BRCA1/2 status To be regarded as BRCA1/2 (+ve), the patient must have a mutation that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental / lead to loss of function). Mutations that are not clearly pathogenic may be assessed by a committee of genetic specialists to adjudicate if the patient is eligible Patients with tBRCA mutations: must be confirmed by a validated method (e.g. results from a CLIA-certified laboratory or CE-IVD device) 5. Prior treatment with a taxane or an anthracycline in either an adjuvant (may neoadjuvant) or metastatic breast cancer treatment setting. 6. Patients should have received no more than two prior cytotoxic chemotherapy regimens in the metastatic setting. If a patient has oestrogen receptor and/or progesterone receptor positive HER2 negative metastatic breast cancer and has completed a prior line of hormonal treatment, then if the current or currently planned choice of treatment for the patient does not a hormonal treatment then they would be a suitable patient to enter the study. Previous endocrine therapy could be in either an adjuvant or a metastatic setting and endocrine therapy in combination with a targeted agent such as a CDK4/6 or mTOR inhibitor. 7. Be considered suitable, by the Investigator, for further treatment with single-agent chemotherapy for the metastatic disease 8. Patients must have normal organ and bone marrow function measured within 14 days prior to administration of study treatment as defined below Haemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless the patient has documented Gilbert's Syndrome Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase (SGOT)) / alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase (SGPT)) ≤ 2.5 x institutional ULN unless liver metastases are present in which case they must be ≤ 5x ULN Patients must have creatinine clearance (CrCl) estimated using the Cockcroft- Gault equation of ≥ 51 mL/min or 24 hour urine test may be done if standard of care: Estimated CrCl = (140-age [years]) x weight (kg) (x F)a serum creatinine (mg/dL) x 72 a where F=0.85 for females and F=1 for males 9. Patients must have a life expectancy ≥ 16 weeks 10. Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Day 1 Postmenopausal is defined as (at least one criterion met) Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 2. Previous enrolment in the present study 3. Exposure to an investigational product (IP) during the last 1 month or 5 half-lives (whichever is longer) prior to enrolment 4. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment 5. Any previous treatment with a PARP inhibitor, including olaparib 6. Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma. 7. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome. 8. Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks. 9. Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents. 10. Persistent toxicities (>Common Terminology for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia. 11. Patients with myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or with features suggestive of MDS/AML 12. Patients with symptomatic uncontrolled brain metastases Exception: Patients with adequately treated brain metastases documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids (except ≤10 mg/day prednisone or equivalent for at least 14 continuous days prior to dosing) for management of CNS symptoms are eligible, provided that a repeat CT or MRI following the identification of CNS metastases (obtained at least 2 weeks after definitive therapy) must document adequately treated brain metastases. 13. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery. 14. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent. 15. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication 16. Breastfeeding women 17. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) 18. Patients with a known hypersensitivity to olaparib or any of the excipients of the product 19. Patients with known active hepatitis (i.e., hepatitis B or C) 20. Whole blood transfusions in the last 28 days prior to entry to the study
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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): 18.0-30.0, Healthy Healthy males at 18 to 30 years old Free from antibiotics and probiotic products for at least 1 month Willing to participate in the study, consume the test product and perform all measurements Sever physical diseases Intolerance to probiotics or eggs
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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): 19.0-68.0, Cervical Intraepithelial Neoplasia Cervix Neoplasm Indication of cervical conization We excluded patients who were not treated by our department physicians or if the patient did not return for follow-up
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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, Breast Ductal Carcinoma In Situ Breast Lobular Carcinoma In Situ Stage 0 Breast Cancer AJCC v6 and v7 Stage I Breast Cancer AJCC v7 Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage II Breast Cancer AJCC v6 and v7 Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7 Stage III Breast Cancer AJCC v7 Stage IIIA Breast Cancer AJCC v7 Stage IIIB Breast Cancer AJCC v7 Stage IIIC Breast Cancer AJCC v7 Women scheduled for unilateral or bilateral mastectomy for breast cancer therapy, pathology confirmed stage 0-III (including ductal carcinoma in situ), or prophylaxis (BRCA1/2 mutation carriers, women with strong family history or lobular carcinoma in situ or other conditions where prophylactic mastectomy has been elected) Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%) Total bilirubin < 1.5 x upper limit of normal (ULN) (in women with prior documented bilirubin elevations consistent with Gilbert's syndrome, total bilirubin up to 3 x ULN will be allowed) Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) < 2.5 x ULN Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x ULN Creatinine < 2 x ULN Alkaline phosphatase < 2.5 x ULN Blood urea nitrogen < 2 x ULN Ability to understand and the willingness to sign a written informed consent document which includes a requirement to apply study agent to sensitive body parts daily Willingness and ability to schedule mastectomy 21-28 days following start of study agent; women with breast implants may participate The presence of gross skin invasion/ulceration by the breast cancer, or inflammatory changes with skin edema AND erythema; Note: Paget's disease is permitted Women receiving a "nipple delay" procedure prior to mastectomy Women with skin diseases (psoriasis, eczema) A history of thromboembolic disorder Endometrial intraepithelial neoplasia (also known as atypical hyperplasia) or a high risk of uterine cancer, defined here as known carriers of Lynch syndrome mutations (MLH1, MSH2, MSH6, PMS2) Participants may not have received any other investigational agents in the previous 3 months History of allergic reactions attributed to compounds of similar chemical or biologic composition to tamoxifen Taken tamoxifen or other selective estrogen/progesterone receptor modulators (SERMs/SPRMs) within two years prior to entering study or been required to discontinue SERM therapy due to thromboembolic or uterine toxicity Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements History of prior breast cancer-specific therapy within the previous 2 years (chemotherapy, radiation, anti-HER2 agents, endocrine agents, everolimus, CDK4-6 inhibitors); previous unilateral radiation of the contralateral side in women scheduled for mastectomy is allowed; study gel will be applied to both breasts
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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, Cervical Cancer HIV/AIDS ≥25 years of age HIV-positive Competent to understand study procedures and give informed consent Currently pregnant Currently menstruating or having persistent vaginal discharge Previous hysterectomy Previous diagnosis of cervical cancer
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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, Progression-Free-Survival Recurrence Overall Survival Participants' are as follows: 1. The primary breast cancer after surgical treatment, the pathological diagnosis of breast epithelial tumors (breast cancer), ER, PR and Her-2 immunohistochemical results were negative; 2. no recurrence of metastasis; 3. card score ≥ 60 points; 4. Female patients aged 18-75 years (including 18,75 years); 5. there is no serious organic or functional disorders, no drugs and food allergy; 6. willing to receive treatment, observation and inspection. Participants' are as follow: 1. does not meet the criteria; 2. patients expected to survive <6 months; 3. combined with cardiovascular and cerebrovascular, liver, kidney, hematopoietic system of serious primary disease and mental illness; 4. breastfeeding, pregnancy or women preparing for pregnancy; 5. allergies and allergies to a variety of drugs; 6. are participating in other drug subjects
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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, Metastatic Breast Cancer Invasive Breast Cancer Somatic Mutation Breast Cancer (BRCA1) Somatic Mutation Breast Cancer (BRCA2) CHEK2 Gene Mutation ATM Gene Mutation PALB2 Gene Mutation RAD51 Gene Mutation BRIP1 Gene Mutation NBN Gene Mutation Patients must have histologically confirmed invasive breast cancer with stage IV disease, either biopsy proven or with unequivocal evidence of metastatic disease by physical examination or radiological study Cohorts 1 and 2: Documented germline (Cohort 1) or somatic mutation or homozygous deletion (Cohort 2) in one of the DNA repair genes listed below that is deleterious or suspected to be deleterious, and no germline BRCA1 or BRCA2 mutation. The mutation may be identified through any CLIA approved NGS panel ATM, ATR, BARD1, BRIP1 (FANCJ), CHEK2 , FANCA, FANCC, FANCD2, FANCE, FANCF, FANCM, MRE11A, NBN, PALB2, RAD50, RAD51C, RAD51D, plus other HR-related genes at the discretion of Dr. Tung with the key study collaborators (see details below in italics). (Cohorts 1 or 2) -- Documented somatic mutation (deleterious or suspected deleterious) in BRCA1 or BRCA2 through any CLIA approved lab only if in addition to the lack of a germline BRCA1/2 mutation is demonstrated through a CLIA approved lab. Patients with germline mutations in BRCA1/2 are NOT eligible for this study. (Cohort 2 only) Cohort 1a: germline PALB2 mutation - The mutation must be identified through a CLIA-approved NGS panel. Mutations must be reviewed and confirmed by Dr. Tung to meet prior to registration Cohort 2a: somatic mutation of BRCA 1 or BRCA 2 - The mutation must be identified through a CLIA-approved NGS panel. Mutations must be reviewed and confirmed by Dr. Tung to meet prior to registration. Documentation of absence of germline mutation in BRCA 1/2 is required All deep (homozygous) deletions, frameshift mutations and truncating mutations in the genes listed above are eligible as well as missense variants in these genes that have previously been reported as pathogenic or likely pathogenic. If there is a discrepancy between two labs regarding the pathogenicity of a particular variant, the final decision regarding will be determined by the study steering committee At least one measurable lesion that can be accurately assessed at baseline by CT (MRI where CT is contraindicated) and is suitable for repeated assessment as per 1.1. - Any previous treatment with a PARP inhibitor, including olaparib Germline BRCA1 or BRCA2 mutation Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery Concomitant use of known strong CYP3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) and grapefruit, grapefruit juice or any product containing grapefruit,or moderate CYP3A inhibitors (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks Concomitant use of known strong (e.g., phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g., bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent Persistent toxicities (≥CTCAE grade 2) caused by previous cancer therapy, excluding alopecia Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)
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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 Carcinoma Endometrioid Adenocarcinoma Malignant Female Reproductive System Neoplasm Recurrent Cervical Carcinoma Stage I Uterine Corpus Cancer AJCC v7 Stage I Vaginal Cancer AJCC v6 and v7 Stage IA Uterine Corpus Cancer AJCC v7 Stage IB Cervical Cancer AJCC v6 and v7 Stage IB Uterine Corpus Cancer AJCC v7 Stage IB2 Cervical Cancer AJCC v6 and v7 Stage II Cervical Cancer AJCC v7 Stage II Uterine Corpus Cancer AJCC v7 Stage II Vaginal Cancer AJCC v6 and v7 Stage IIA Cervical Cancer AJCC v7 Stage IIB Cervical Cancer AJCC v6 and v7 Stage III Cervical Cancer AJCC v6 and v7 Stage III Uterine Corpus Cancer AJCC v7 Stage III Vaginal Cancer AJCC v6 and v7 Stage IIIA Cervical Cancer AJCC v6 and v7 Stage IIIA Uterine Corpus Cancer AJCC v7 Stage IIIB Cervical Cancer AJCC v6 and v7 Stage IIIB Uterine Corpus Cancer AJCC v7 Stage IIIC Uterine Corpus Cancer AJCC v7 Vaginal Carcinoma Patients must have one of the following biopsy proven gynecological cancer and a decision to treat with radiotherapy and concurrent cisplatin chemotherapy (RT-CT) Newly diagnosed epithelial carcinoma of the cervix, cT1B-3B, N0/1, M0/1 Patient may have small volume metastatic disease in para-aortic or supraclavicular lymph nodes or at other metastatic sites as long as, in the best judgment of the treatment team, a radical course of pelvic radiotherapy is warranted to assure local disease control Newly diagnosed epithelial carcinoma of the upper 1/3 vagina, T1-3, N0/1, M0/1 Patient may have small volume metastatic disease in para-aortic or supraclavicular lymph nodes or at other metastatic sites as long as, in the best judgment of the treatment team, a radical course of pelvic radiotherapy is warranted to assure local disease control Newly diagnosed endometrioid adenocarcinoma of the uterus, cT1-3, N0/1, M0 unsuitable for primary surgery because of the extent of local disease; these patients are eligible if a prior decision has been made to treat radically with neoadjuvant chemoradiation followed by surgery or further radiotherapy (including brachytherapy) depending on response Central pelvis or sidewall recurrence of epithelial carcinoma of the cervix of endometrioid adenocarcinoma of the uterus after previous surgery without previous pelvic radiotherapy Patients must be planned to receive whole pelvic radiotherapy to a total dose of 45 Gy or greater Patients must be able to receive weekly cisplatin Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Karnofsky >= 60%) Patients who have received any radiotherapy or chemotherapy for their current gynecological cancer Patients who received prior pelvic radiotherapy for any indication Patients who have a mean resting correct corrected QT (QTc) interval using the Fridericia formula (QTcF) > 470 msec (as calculated per institutional standards) obtained from 3 electrocardiograms (ECGs) 2-5 minutes apart at study entry, or congenital long QT syndrome; AZD1775 should not be given to patients who have a history of Torsades de pointes unless all risk factors contributed to Torsades have been corrected; AZD1775 has not been studied in patients with ventricular arrhythmias or recent myocardial infarction Patients requiring para-aortic radiotherapy Patients who are receiving any other investigational agents or anticancer therapy concurrently or within 4 weeks (i.e. 28 days) History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD1775 or cisplatin Uncontrolled intercurrent illness including, but not limited to, myocardial infarction within 6 months, congestive heart failure, symptomatic congestive heart failure, unstable angina pectoris, active cardiomyopathy, unstable ventricular arrhythmia, uncontrolled hypertension, uncontrolled psychotic disorders, serious infections, active peptic ulcer disease, active liver disease or cerebrovascular disease with previous stroke, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study because AZD1775 and chemoradiation are agents with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD1775 and cisplatin, breastfeeding must be discontinued if the mother is treated with AZD1775 and cisplatin; these potential risks may also apply to other agents used in this study Patients with another uncontrolled malignancy; patients with a previous malignancy, treated curatively and without evidence of disease relapse are eligible Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD1775; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
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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): 30.0-49.0, Human Papillomavirus Infection Cervical Cancer The District Health Management Team (DHMT), estimates that in 2011 there were 31,574 women 30-49 years of age on the Kweneng East catchment area, serviced by Scottish Livingstone Hospital and the 4 selected Health Clinics. Women will be clients of the health facility at one of the clinics (described below under recruitment), may come to the facility for cervical cancer screening after having been contacted by a community mobilizer, or women attending a community health campaign event (in the community). Participants under Research Question 1: 1022 women Participants under Research Question 2a: 24 providers and other stakeholders Participants under Research Question 2b: 27 women for in-depth interviews; 250 women for structured surveys. Service Delivery Model Age 30 to 49 years Not screened recently/never screened before, defined as No prior history of cervical cancer screening: Pap smear, VIA or HPV testing), or Prior screening, but result unknown and no treatment Prior screening occurred more than 5 years ago for HIV negative women or 3 years ago for HIV positive women HIV status is known (HIV positive result, or documented HIV negative result is less than 12 months ago) No history of prior abnormal screening or treatment/procedure on her cervix due to abnormal screening No history of cervical cancer Not currently pregnant; not less than 6 weeks postpartum Woman does not meet the for age 29 years or younger and age 50 years or older Screened for cervical cancer in last 3 years if HIV positive, or in the last 5 years if HIV negative Had an abnormal cervical cancer screening and/ or treatment of cervix History of cervical cancer HIV status unknown Pregnant (self-report or by pregnancy test confirmation Less than 6 weeks postpartum, prior hysterectomy Unable to participate and give informed consent Not interested in HPV self-collection Unwilling to give 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): 0.5-75.0, Human Papilloma Virus Written, informed consent obtained prior to any study-specific procedures. 2. Evidence of HPV virus activation (viral DNA) or high risk of HPV infection. 3. Not suitable for routine treatment or invalid to antiviral drugs. 4. Patients with viral disease symptoms and confirmed by biopsy, regardless of the level of virus DNA. 5. Age less than 75 years. 6. Did not use Penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics. 7. Initial hematopoietic reconstitution: neutrophils (ANC) ≥ 1,000/mm^3, platelet (PLT) ≥ 1,000/mm^3. 8. Proper renal and hepatic functions (ULN denotes "upper limit of normal range"): Creatinine ≤ 2*ULN, Bilirubin ≤ 2*ULN, SGOT/ SGPT ≤ 3*ULN. 9. If HPV-CTL is not from the patient's own, then the provider of HPV-CTL needs to meet the following did not receive chemotherapy or radiotherapy within 4 weeks prior to blood collection, and did not take any steroids for the previous week, did not use Penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics white blood cells ≥ 3,500 / μl, lymphocytes ≥ 750 / μl. 10. Human immunodeficiency virus (HIV) test was negative Subject or the donor of BMT recipient infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), HTLV (HTLV antibody positive), Treponema pallidum antibody positive or TB culture positive. 2. Subject is albumin-intolerant. 3. Subject with life expectancy less than 8 weeks. 4. Subject participated in other investigational somatic cell therapies within past 30 days. 5. Subject with positive pregnancy test result
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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, Breast Cancer Diagnosed with non-invasive (stage 0) or invasive (stage 1, 2 and 3A) breast adenocarcinoma Age 18 years or above Are planned to undergo at least 3 cycles of taxane treatment (i.e. paclitaxel or docetaxel) Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis) Signed informed consent Have a history of neuropathy before taxane treatment due to other medical conditions: diabetes, peripheral vascular disease, HIV infection, significant degenerative or familial neurologic disorder, nerve compression injuries (i.e., carpal tunnel syndrome, brachial plexopathy, spinal stenosis, or spinal nerve root compression) Taking stable doses of medication on prescription or dietary supplements for peripheral neuropathy. Related medications are: gabapentin, pregabalin, nortriptyline, amitriptyline, duloxetine, venlafaxine; lidocaine, opioid tramadol and other narcotics; NSAIDs; glutamine, glutathione, vitamin E and vitamin B12; Patients need to agree not to initiate a new therapy two weeks before and during the study period Metastatic disease Have a diagnosis of ethanol addiction or dependence within the past 10 years Concurrent chemotherapy with neurotoxic chemotherapeutic agents (i.e. platinum compounds or vinca alcaloids) Severe or unstable cardio respiratory or musculoskeletal disease
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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): 21.0-65.0, Human Papilloma Virus Abnormal cytology of atypical squamous cells of undetermined significance (ASCUS) on Pap smear OR Low-grade squamous intra epithelial lesions (LSIL) on Pap smear OR Positive hrHPV on routine screening (positive HPV will be assumed to be high grade) Patients who proceed to excisional procedures (loop electrosurgical excision procedure or cold knife conization) Pregnant patients Breastfeeding patients Immunocompromised patients
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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): 21.0-40.0, Healthy student in Parker University's Doctor of Chiropractic program and patient at the Parker University Wellness Clinic available to take part in the study for all 3 test days willing to forgo all non-normal daily activities and chiropractic treatments during the test days pregnant previous major injury involving the extremities previous surgeries to an extremity joint; and known neurological or systemic diseases
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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, Cancer Cervix women from 30 to 65 years old women living in french territorial division 37 ("Indre-et-Loire") no pap smear made in the three last years (ideally) Follow-up in progress for positive screening
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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 Uterine Cancer Female years and older Biopsy-proved cervical cancer or endometrial cancer within three months of study enrollment Standard-of-care (SOC) FDG PET/CT exam performed within 30 days of study enrollment Female < 18 years old No history of cervical cancer or endometrial cancer Primary biopsy > 3 months of study enrollment Systemic therapy or radiation therapy initiated SOC FDG PET/CT exam performed > 30 days of study enrollment Therapeutic procedures (chemotherapy, radiation therapy) have been initiated Pregnancy or lactation Claustrophobia or inability to tolerate the imaging procedure on the PET/MR scanner Individual is not willing to give 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): 18.0-999.0, Human Papilloma Virus Cervical Cancer Oropharyngeal Cancer Anal Cancer Vaginal or Penile Cancer Age greater than or equal to 18 years Ability of subject to understand and the willingness to sign a written informed consent document Subjects with cytologically or histologically confirmed locally advanced or metastatic HPV associated malignancies including Non-Neuroendocrine Cervical cancers P16+ Oropharyngeal cancers Anal cancers Vulvar, vaginal, penile, squamous cell rectal and neuroendocrine cervical cancers Other locally advanced or metastatic solid tumors (e.g. lung, esophagus) that are known HPV+ Patients must have disease that is not amenable to potentially curative resection Subjects must have measurable disease -Pregnant women are excluded from this study because this drug has not been tested in pregnant women and there is potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M7824, breastfeeding should be discontinued if the mother is treated with M7824 Patients with prior investigational drug, chemotherapy, immunotherapy or any prior radiotherapy (except for palliative bone directed therapy) within the past 28 days prior to the first drug administration except if the investigator has assessed that all residual treatment-related toxicities have resolved or are minimal and feel the patient is otherwise suitable for enrollment. Patients may continue adjuvant hormonal therapy in the setting of a definitively treated cancer (e.g. breast) Major surgery within 28 days prior to the first drug administration (minimally invasive procedures such as diagnostic biopsies are permitted) Known intolerance to or life threatening side effects resulting from prior checkpoint inhibitor therapy Known active brain or central nervous system metastasis (less than 1 month out from definitive radiotherapy or surgery), seizures requiring anticonvulsant treatment (<3 months) or clinically significant cerebrovascular accident (<3 months). In order to be eligible patients must have repeat CNS imaging at least two months after definitive treatment showing stable CNS disease. Patients with evidence of intratumoral or peritumoral hemorrhage on baseline imaging are also excluded unless the hemorrhage is grade less than or equal to 1 and has been shown to be stable on two consecutive imaging scans Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent with exception of diabetes type I, eczema, vitiligo, alopecia, psoriasis, hypo or hyperthyroid disease or other mild autoimmune disorders not requiring immunosuppressive treatment Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses less than or equal to 10 mg of prednisone or equivalent per day Administration of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) is acceptable
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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): 21.0-30.0, Alcohol Drinking Alcohol Use Disorder Alcohol Intoxication Alcohol; Harmful Use Alcoholism Binge Drinking Between the ages of 21 and 30 Currently drinks alcohol Able to provide at least 2 same-gender friend referrals Female participant is pregnant or trying to become pregnant Endorsed medical disorder caused by, or made worse by, alcohol History of severe alcohol problems Use of drugs known to interact with alcohol
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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): 0.0-999.0, Cancer, Metastatic Cancer Cancer of Pancreas Cancer of Liver Cancer of Stomach Cancer Liver Cancer of Rectum Cancer of Kidney Cancer of Esophagus Cancer of Cervix Cancer of Colon Cancer of Larynx Cancer, Lung Cancer, Breast Cancer, Advanced Cancer Prostate Cancer of Neck Cancer of Skin Neuroendocrine Tumors Carcinoma Mismatch Repair Deficiency BRCA Gene Rearrangement Non Hodgkin Lymphoma Leukemia Non Small Cell Lung Cancer Cholangiocarcinoma Glioblastoma Central Nervous System Tumor Melanoma Urothelial Carcinoma Bladder Cancer Ovarian Cancer Endometrial Cancer Testicular Cancer Breast Cancer COVID Pts with solid and hematological malignancies Pts cancer-related biomarkers, gene variants, fusion and rearrangements (by immunohistochemistry, PCR, FISH or NGS): PD-L1, MSI (MMR), Claudin18.2, Tumor mutational burden/load (TMB), ABL1, ACVR1B, AKT1, AKT2, AKT3, ALK, APC, AR, ATM, ATRX, AURKA, AURKB, BAP1, BCL2, BCL6, BRAF, BRCA1, BRCA2, BTK, CCND1, CCND2, CCND3, CDK4, CDK6, CDKN1A/B, CEBPA, CHEK1, CHEK2, CSF1R, CTNNB1, DAXX, DDR1/2, DNMT3A, EGFR, ERBB2, ERBB3, ERBB4, ERCC4, ER, ESR1, FANCA, FAS, FBXW7, FGFR1, FGFR2, FGFR3, FGFR4, FLT3, GATA3, GATA6, GNAS, HDAC1, HGF, HRAS, IDH1, IDH2, IGF1R, JAK1, JAK2, JAK3, KDR (VEGFR2), KIT, KRAS, MAP2K2 (MEK2), MAP3K1, MCL1, MDM2, MDM4, MEN1, MET, MSH2, MSH3, MSH6, MTOR, MUTYH, MYC, MYCL (MYCL1), NF1, NF2, NOTCH1, NPM1, NRAS, NTRK1, NTRK2, NTRK3, PALB2, PARP1, PARP2, PARP3, PBRM1, PDCD1 (PD1), PDCD1LG2 (PD-L2), PIK3C, PMS2, POLD1, POLE, PRDM1, PTCH1, PTEN, RAF1, RB1, RET, ROS1, RPTOR, SDHA/B/C, SMAD, SMARC, SMO, STK11, TGFBR2, TP53, TSC1, TSC2, VEGFA, VHL, WT1, ZNF217, ZNF703, among others. These biomarkers should be determined by local laboratory, external vendor, or next generation sequencing platform Decision to consider clinical trial pre-screening enrollment (CTE) by primary provider and/or patient ECOG PS > 2 Abnormal organ function Hospice enrollment
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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 Screening One previous routine screening Pap test showing ASC-US, HPV positive Two previous consecutive routine screening Pap tests showing ASC-US or LSIL previous hysterectomy pregnant or considering pregnancy in the next 18 months had a previous excisional or ablative procedure of the cervix younger than 18
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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): 21.0-29.0, Alcohol Drinking Alcohol Use Disorder Alcohol Intoxication Alcohol; Harmful Use Alcoholism Binge Drinking to 29 years of age currently drinks alcohol owns a smartphone are masked from public viewing until data collection is complete. Please contact project managers.]
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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): 0.0-999.0, Cervical Cancer Stage IIIB Treatment Outcome Follow up QUESTIONNAIRE Cervical Cancer Stage Ib2, II and III (Squamous carcinoma or adenocarcinoma) 2. Cancer of the vault 3. Cancer of the cervix which inadvertently underwent hysterectomy (inadequate surgery) 4. Treated with curative intent with radical radio(chemo)therapy or NACT followed by radical radio(chemo)therapy and completed all curative treatment. 5. Within 2 years post completion of treatment 6. Has complete clinical response at 3 months post treatment 7. Informed consent 8. Contactable by telephone Patients with Stage III disease treated with palliative intent with once monthly radiotherapy 2. Early stage cervical cancer patients who underwent Wertheims hysterectomy and who have completed adjuvant radiochemotherapy due to high-risk factors 3. Metastatic cervical cancers 4. Patients who are unable to comprehend the questions or dialogue over telephone by medical staff. 5. Patients who seem unreliable for follow up
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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, Obstetric Complication Postpartum Hemorrhage Postpartum Endometritis Female Able to give consent Gestational age > 24 weeks Postpartum Placement of an IBT within the last 2 hours with plans for it to remain in situ for at least 2 hours Primary obstetrician amenable to proceeding with either method of management during the study period Age < 18 years old IBT removed within 2 hours of placement Chorioamnionitis Insufficient documentation of demographics, delivery outcomes, or peripartum events including postpartum hemorrhage, infectious outcomes
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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): 30.0-999.0, Patient Adherence In the Randomized Controlled Trial we will recruit a minimum of 4000 women, aged 30 and older living in the province of Jujuy, Argentina. are: 1. Having performed self-collection of HPV-testing. 2. Mentally competent to understand the consent form. 3. Able to communicate with study staff. 4. Being able to provide a mobile phone telephone number Current pregnancy Women with Mental disability
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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): 9.0-26.0, Prevention of HPV Types 16- and 18-related Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN) 1/2/3, and Cervical Adenocarcinoma in Situ Not pregnant and 1) not a woman of childbearing potential (WOCBP), or 2) a WOCBP who has not had sex with males or has had sex with males and used effective contraception since the first day of participant's last menstrual period through Day 1 and understands and agrees that during the study she should not have sexual intercourse with males without effective contraception (the rhythm method, withdrawal, and emergency contraception are not acceptable methods per the protocol) Participant and participant's parent or guardian (participants aged 9-17 years only) provided written informed consent/assent Provided a primary and alternative telephone for follow-up purposes Extension Stage: participant was enrolled in the 9-19 years old group, received 3 doses of V501 in the Base Stage, and participant and participant's legally acceptable representative (if applicable) provided written informed consent/assent for the study extension History of severe allergic reaction that required medical intervention Allergic to any vaccine component, including aluminum, yeast, or Benzonase® (nuclease) Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections Currently immunocompromised or was diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition History of splenectomy Any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives History of recent or ongoing alcohol or other drug abuse History of a positive test for HPV Any history of abnormal Pap test History of external genital wart, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), vulvar cancer or vaginal cancer
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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): 0.0-999.0, Cervical Cancer For FP Clinics All FP clinics that receive County-supplied FP products will be eligible to participate Any clinic that is expected to be closed during part or all of the SAIA intervention period will be excluded. Any FP clinic that was previously included in the FP HIV SAIA trial will be excluded. FP clinic managers and staff Any FP clinic manager that is 18 years and older is eligible to be interviewed These clinic managers can be male or female
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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): 21.0-40.0, Alcohol Drinking Weight Loss Adiposity Obesity Visceral Obesity Pre-menopausal women only 40 years of age BMI 27-50 kg/m2 (+/ 5 will be accepted) Must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as double barrier methods [male condom with spermicide, with or without cervical cap or diaphragm], implants, intrauterine contraceptive devices, tubal ligation (surgically sterile), abstinence, or in an established relationship with a vasectomized or same sex partner) during the entire duration of the study Must be willing to adhere to all study procedures, including consumption of all study foods and beverages and attendance at all study visits Must be willing to eat at least one meal at PBRC 3 times per week on weekdays (excluding holidays) Must be willing to consume alcohol Must be willing to abstain from alcohol for 8-weeks if randomized to non-alcohol control group Must be a daily, or almost daily drinker, defined as typically consuming at least 8 drinks per week, but no more than 4 per day Non-drinkers of alcohol Habitual binge drinkers, as defined by the consumption of ≥ 4 standard drinks per day or ≥ 28 drinks per week Self-reported alcoholics or a history of alcoholism Have a 1st degree relative with alcoholism Any attendance or inpatient stay for alcohol or drug treatment Display any characteristics of current or future substance abuse disorders Presence of any psychiatric, behavioral, or medical disorder that, in the opinion of the PIs, Co-I, or MI, may interfere with study participation, the ability to adhere to the protocol, or has the potential for increased substance abuse Prescription medications that interact with alcohol intake Abnormal screening laboratory safety tests Smokers
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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): 9.0-26.0, Papillomavirus Infections Uterine Cervical Neoplasms Vulvar Neoplasms Vaginal Neoplasms Adenocarcinoma in Situ Condylomata Acuminata In good physical health Participants 9 to 15 years of age: has not had coitarche and do not plan on becoming sexually active during the study Participants 16 to 26 year of age: has never had Papanicolaou (Pap) testing or has had only normal Pap test results. Has a lifetime history of ≤4 male and/or female sexual partners Female participants 16 to 26 years of age: has not had sex with males or has had sex with males and used effective contraception, and understands and agrees that during the study she should not have sexual intercourse with males without effective contraception (rhythm method, withdrawal, and emergency contraception are not acceptable methods of contraception per-protocol) Known allergy to any vaccine component, including aluminum, yeast, or History of severe allergic reaction that required medical intervention Has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections Concurrently enrolled in clinical studies of investigational agents Immunocompromised or has been diagnosed with congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition Had a splenectomy User of recreational or illicit drugs or has had a recent history (within the last year) of drug abuse or dependence. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use History of a positive test for HPV Male participants 16 to 26 years of age: history of HPV-related external genital lesions (e.g., condyloma acuminata) or HPV-related anal lesions (e.g., condyloma acuminata, or anal intraepithelial neoplasia) or anal cancer Female participants 16 to 26 years of age: history of an abnormal cervical biopsy result (showing cervical intraepithelial neoplasia or worse)
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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): 18.0-120.0, Glottic Carcinoma Pathologically-proven diagnosis of squamous cell carcinoma in situ, squamous cell carcinoma or squamous cell variants (sarcomatoid, verrucous, basaloid, and papillary subtypes) involving the glottic larynx. 2. Clinical stage I-II (American Joint Committee on Cancer AJCC, 7th edition) with direct laryngoscopy showing no evidence of greater than stage II true glottic larynx cancer and PET/CT or CT neck showing no evidence of regional disease. 3. Age ≥ 18 years. 4. ECOG Performance Status 0-2 5. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 5.1 A female of child-bearing potential is any woman (regardless of sexual orientation, 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). 6. Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential. 7. Ability to understand and the willingness to sign a written informed consent. 8. Patients with cognitive impairment or other limited decision making capacity with the ability to understand and willingly sign written informed consent or have the consent signed by a designated legally authorized representative (LAR) AJCC stage III or stage IV larynx cancer 2. Involvement of the arytenoid cartilage beyond the vocal process. 3. Prior chemotherapy for treatment of the targeted larynx lesion 4. Synchronous primaries in the head and neck 5. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields. 6. Subjects smoking in excess of 1 pack of cigarettes per day. 7. Subjects may not be receiving any other investigational agents. 8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 9. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
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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): 18.0-75.0, Neoplasms Ability to understand and the willingness to sign a written informed consent. 2. 18-75 year old patients with newly-diagnosed cancer scheduled to undergo anthracycline-based chemotherapy (minimum of 200 mg/m2 of doxorubicin or equivalent) at UCSD Medical Center. 3. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. • A woman of child-bearing potential is any female (regardless of sexual orientation, 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) 4. Women of child-bearing potential must have a negative pregnancy test during the screening period Prior chemotherapy with anthracycline; 2. Persistent tachycardia (heart rate>90); 3. LVEF<53% or history of cardiomyopathy or decompensated heart failure; 4. Baseline GLS below lower limit of normal (normal range varies depending on age and gender (23)) or inability to obtain meaningful strain data due to poor quality of Echocardiographic images; 5. Known unrevascularized coronary artery disease, myocardial infarction within 30 days of enrollment; 6. Moderate or severe valvular heart disease; 7. Prior allergy or intolerance to iodinated contrast; 8. Renal failure (GFR<30, creatinine >1.5); 9. Cancer involvement of the heart
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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, Surgery--Complications Patients diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer Subjected to Radical Hysterectomy Pregnant women in which a RH was performed at the time of caesarean section Previous chemotherapy treatment Previous pelvic radiotherapy
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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, High Grade Ovarian Serous Adenocarcinoma Stage III Ovarian Cancer AJCC v8 Stage IIIA Ovarian Cancer AJCC v8 Stage IIIA1 Ovarian Cancer AJCC v8 Stage IIIA2 Ovarian Cancer AJCC v8 Stage IIIB Ovarian Cancer AJCC v8 Stage IIIC Ovarian Cancer AJCC v8 Stage IV Ovarian Cancer AJCC v8 Stage IVA Ovarian Cancer AJCC v8 Stage IVB Ovarian Cancer AJCC v8 With suspected advanced ovarian cancer Planned surgery Have a uterus and no history of tubal occlusion Unable to speak English Unable to provide informed consent Prior hysterectomy
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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 Jamaican women, aged 30 to 65 Women who report having had a hysterectomy have had a history of cervical cancer Women who are currently up-to-date on cervical cancer screening (have had a Pap in the last 3 years or have had a Pap smear/HPV co-test within the past 5 years) Adults unable to consent, children, pregnant women and prisoners
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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): 18.0-99.0, Uterine Cervical Neoplasms Cancer of the uterine cervix considered suitable for curative treatment with definitive radio-(chemo)therapy including MRI guided BT Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix Staging according to FIGO and TNM guidelines MRI of pelvis at diagnosis is performed MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed MRI with the applicator in place at the time of (first) BT will be performed Para-aortic metastatic nodes below L1-L2 are allowed Patient informed consent Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix Metastatic disease above and beyond the retroperitoneal para-aortic L1-L2 interspace Previous pelvic or abdominal radiotherapy Previous total or partial hysterectomy Combination of preoperative radiotherapy with surgery Patients receiving BT only Patients receiving EBRT only Patients receiving neo-adjuvant chemotherapy or other forms of antineoplastic treatment apart from weekly concomitant cisplatin (40 mg/2). However, adjuvant chemotherapy in the form of 4 courses of 3 weekly Carboplatin (AUC 5) and Paclitaxel (155 mg/m2) is allowed according to departmental policy Contra indications to MRI
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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, Pituitary Tumor years of age or older undergoing endoscopic endonasal transsphenoidal approach to pituitary resection for pituitary tumors of any pathology for the first time patients who do not have a working understanding of English patients with known allergy to Merocel nasal packing
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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 or adeno-squamous carcinoma of the uterine cervix Patients with histologically confirmed stage IB (IB3 excluded) and IIA1, according to the latest revision of the FIGO staging manual Patients undergoing either a Type B or C radical hysterectomy (Querleu and Morrow classification) Patients with adequate bone marrow, renal and hepatic function ECOG Performance Status of 0, 1 or 2 Patient must be suitable candidates for surgery Patients who have signed an approved Informed Consent Age 18 years or older Any histology other than adenocarcinoma, squamous cell carcinoma or adeno-squamous carcinoma of the uterine cervix Tumor size greater than 4 cm FIGO stage II-IV (except IIA1) Patients with a history of pelvic or abdominal radiotherapy Patients who are pregnant Patients with contraindications to surgery Patients with evidence of metastatic disease by conventional imaging, enlarged pelvic or aortic lymph nodes > 2cm; or histologically positive lymph nodes Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) Patients unable to withstand prolonged lithotomy and steep Trendelenburg position Patients with secondary invasive neoplasm in the last 5 years (except non-melanoma skin cancer, breast cancer T1N0M0 grade 1 or 2 without any signs of recurrence or activity)
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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): 0.0-999.0, Uterine Cervical Neoplasms Laparotomy Laparoscopy Survival Mortality Recurrence Pathological confirmed as uterine cervical cancer Having definite clinical information Having received radical hysterectomy or trachelectomy Not satisfying any of the
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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): 0.0-999.0, Cervical Adenocarcinoma Human Papillomavirus Genome-wide Association Study Whole Exome Sequencing Transcriptome Metabolome Tumorigenesis Prognosis Confirmed primary adenocarcinoma of the uterine cervix Signed an approved informed consents Feasible for biopsy Not meeting all of the
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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 Sentinel Lymph Node HPV-Related Cervical Carcinoma Woman > 18 years of age diagnosed with cervical cancer and admitted for surgery with radical hysterectomy and removal of SLNs between October 2018 and June 2022 Woman < 18 years Women with late-stage cervical cancer, who are treated with radio and chemotherapy
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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, HPV-Related Carcinoma HPV-Related Malignancy cases Diagnosed with cervical cancer ≥ stage 1B between june 2018 and june 2020 > 18 years of age at the time of diagnosis There must be available cervical tissue material from the patient to analyse for HPV healthy controls Women > 18 years with no prior history of any cervical dysplasia CIN3 controls Women > 18 years Must have a histologically verified severe cervical dysplasia (CIN3) Is admitted for cervical conisation cases < 18 years of age at time of cervical cancer diagnosis Cervical cancer < stage 1B healthy controls < 18 years of age Prior cervical dysplasia CIN3 controls < 18 years of age Women with only low grades of cervical dysplasia (CIN1 or CIN2) Women with HPV-negative cervical biopsies
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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, Malignant Hypertension Malignant hypertension according to the classic definition (Severe hypertension, above 180/110 associated with severe hypertensive retinopathy) Severe hypertension (above 180/110) associated with acute damage of 3 target organ due to high blood pressure Age < 18 years old Patients who cannot freely give their consent, or patients who refuse to participate Dialysis
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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): 25.0-53.0, Uterine Cervical Dysplasia Papillomavirus Vaccines (vaccinated group) Thai women aged 20-45 years at the time of HPV vaccination Received at least 1 dose of bivalent or quadrivalent HPV vaccine at least 5 years ago Willing to provide written informed consent and receive Pap smear & HPV genotyping (only for those who need specimen collection for cervical cytology and HPV genotyping result) (control group) Thai women without history of HPV vaccination Received Pap smear result at their ages 20-45 years at least 5 years ago Willing to provide written informed consent and receive Pap smear & HPV genotyping (only for those who need specimen collection for cervical cytology and HPV genotyping result) Known pregnancy History of hysterectomy or excisional treatment of the cervix Known increased risk of bleeding Not willing to provide written 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): 18.0-65.0, Anesthesia, Local Age 18 and older Patients undergoing elective post-partum bilateral tubal ligation after vaginal delivery Patients receiving spinal epidural anesthesia with combination of bupivacaine and fentanyl American Society of Anesthesiologists physical status score >3 Contraindications to neuraxial analgesia Patients in whom a combined spinal epidural cannot be performed Body mass index >40 kg/m2 Allergy or hypersensitivity to local anesthetics and fentanyl Severe liver, kidney or respiratory disease Inability to understand the study protocol Refusal to provide written consent
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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): 18.0-45.0, NASH - Nonalcoholic Steatohepatitis Females of childbearing potential, 18 to 45 years of age, inclusive. Follicle-stimulating hormone levels may be used to confirm premenopausal status, including females who have had a hysterectomy with ovaries still intact. Women who otherwise meet and who have had tubal ligation, tubal occlusion, or bilateral salpingectomy will be allowed Body mass index between 18.0 and 32.0 kg/m2, inclusive In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations at Screening and Day -1 of the Lead-in Period Must not be pregnant or lactating, and must agree to use contraception Subjects must have documentation of normal results of up-to-date cervical cancer screening as specified in the American College of Obstetricians and Gynecologists guidelines: 1. Women aged < 21 years: no documentation required 2. Women aged 21 to 29: normal Pap smear test result within previous 3 years 3. Women aged 30 to 45: normal Pap smear test result and negative high-risk human papilloma virus test within previous 5 years, OR normal Pap smear test result within previous 3 years If documented results are not available at Screening, the subject must provide documentation of normal results prior to Day -1 of the Lead-in Period Able to comprehend and willing to sign an ICF Willing and able to adhere to assessments, prohibitions, and restrictions as described in this protocol Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee) Are pregnant, breastfeeding, or are planning to conceive during the study Have been administered injectable contraceptives within 12 months prior to Day -1 of the Lead in Period, or had exposure to a hormonal intrauterine device or topical controlled delivery contraceptives (patch) within 3 months prior to Day -1 of the Lead-in Period
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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, Cervical Cancer Cervical Dysplasia Human Papillomavirus Infection All women aged between 30-69 years who are attending clinics in NUH Women who are pregnant 2. Previous total hysterectomy 3. Previous history of cervical cancer 4. Virgin Intacto 5. Negative Pap smear less than 3 years ago
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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, Salpingectomy Sterilization, Tubal Women seeking for surgical sterilization during their cesarean section Elective and Category 2 or more planned cesarean sections Clinical conditions that lead to planned cesarean hysterectomy such as placenta percreata History of ovarian cancer, previous chemotherapy or radiation Women who previously underwent sterilization
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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): 19.0-40.0, Healthy Healthy men and women (non-smokers), BMI 18,5-30 kg/m2, and with no known metabolic disorders or food allergies will be recruited to the studies. The test subjects should consume a normal diet in accordance with the Nordic Nutrition Recommendations Fasting blood glucose >6.1 mmol/L. Metabolic diseases or conditions. Food allergies or gastro intestinal conditions. Consumption of probiotics, antibiotics or other drugs
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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): 30.0-50.0, Human Papillomavirus Infection women aged between 30 and 50 years sexually active women women who were first diagnosed with high risk HPV positive (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 69, 82) postmenopausal women (defined as those with at least 12 consecutive months of amenorrhea with no other medical cause and a follicle stimulating hormone (FSH) level of 40) women with chronic disease patients with antidepressant usage or patients with psychiatric disorders women who did not agree to participate in the study after reading the informed consent form women who admitted for follow up due to prior HPV infection women with only low-risk HPV (HPV 6, 11) positivity women with a sexual abuse history women with sexual penetration disorder
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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, Cervical Intraepithelial Neoplasia Patients aged ≥ 18 and ecog performance status ≤ 1 2. Patients with a diagnosis of high-grade cervical intraepithelial neoplasia or initially invasive cervical cancer (histological results ≥ CIN2 + and ≤ Ia1 according to the FIGO staging of cervical cancer) 3. No fever at the time of vaccination 4. No previous HPV vaccination 5. Ability to understand and write Italian 6. Signed informed and privacy consent Patients enrolled in other clinical studies 2. History of allergic reaction or serious adverse events to previous vaccinations 3. Positive pregnancy test at the time of vaccination 4. Patient in treatment with immunosuppressive therapy 5. Subjects who received immunoglobulins or blood products in 3 months prior to vaccination. 6. Thrombocytopenia or any other clotting disorder that may lead to bleeding as a result of intramuscular administration 7. Clinical contraindicating the surgical act of conization 8. ECOG performance status ≥2
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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, Cervical Cancer Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, FIGO stage IB-IVA 1.2 Planned for radical radiotherapy and concurrent cisplatin chemotherapy 1.3 Age ≥ 18 years Evidence of distant metastases (suspicious paraaortic nodes below the renal vessels allowed if they will be encompassed within the radiation field) Patients who have received any anticancer treatment for their cervical cancer Other cervical cancer tumor histologies (e.g. small cell, serous) Contraindications to 18FDG PET-CT Contraindication to radiotherapy (e.g. severe Crohn's disease) Contraindication to chemotherapy (e.g. non-reversible renal failure) History of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for ≥ 5 years 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): 30.0-66.0, Cervical Cancer Screening Cervical Cancer women from 30 to 66 years old women living in french territorial division 37 ("Indre-et-Loire") women with a mobile phone in database women who do not perform a pap smear in the last 4 years women who do not answer to a first "invitation" letter to perform a pap smear STOP SMS HPV cervical pathology during treatment Hysterectomy including cervix
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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 Diseases age ≥18 years BMI ≤40 kg/m2 indication for hysterectomy for benign disease or prophylactic surgery due to hereditary cancer indication for radical hysterectomy and/or pelvic-/para-aortic (sentinel-node) lymphadenectomy for cervical cancer indication for modified radical hysterectomy and/or pelvic-/para-aortic (sentinel-node) lymphadenectomy for endometrial cancer size of uterus and vagina allows for retrieval by the vaginal route in cancer patients written informed consent known extensive intra-abdominal adhesions anaesthesiological contraindications to laparoscopy women with pacemaker or other implants where electrosurgery is to be avoided women with known defects of the hemostasis pregnancy other internal or anatomical that preclude a minimal invasive approach inability to understand patient information
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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): 20.0-65.0, Human Papilloma Virus Cervical Neoplasm 65 years old patients with normal smear Patients with invasive cervical cancer HIV-positive patients ASCUS and more risky premalignant lesions in cytology Over the age of 65 and Patients under 20 years of age patients with another known gynecological malignancy
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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): 30.0-65.0, Cervical Cancer Human Papillomavirus Infection no history of hysterectomy or cervical cancer no Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years patient of Harris Health System in Harris County (Houston), Texas have at least 2 visits to ambulatory care within Harris Health System in the past 5 years be currently enrolled in a healthcare coverage or financial assistance plan accepted by Harris Health System no valid telephone contact information unable to communicate in English or Spanish currently pregnant history of cervical dysplasia in the past 3.5 years
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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, Endometrial Carcinoma Stage 0 Fallopian Tube Cancer AJCC v7 Stage I Fallopian Tube Cancer AJCC v6 and v7 Stage I Ovarian Cancer AJCC v6 and v7 Stage IA Fallopian Tube Cancer AJCC v6 and v7 Stage IA Ovarian Cancer AJCC v6 and v7 Stage IB Fallopian Tube Cancer AJCC v6 and v7 Stage IB Ovarian Cancer AJCC v6 and v7 Stage IC Fallopian Tube Cancer AJCC v6 and v7 Stage IC Ovarian Cancer AJCC v6 and v7 Stage II Cervical Cancer AJCC v7 Stage II Fallopian Tube Cancer AJCC v6 and v7 Stage II Ovarian Cancer AJCC v6 and v7 Stage II Uterine Corpus Cancer AJCC v7 Stage IIA Cervical Cancer AJCC v7 Stage IIA Fallopian Tube Cancer AJCC v6 and v7 Stage IIA Ovarian Cancer AJCC V6 and v7 Stage IIA1 Cervical Cancer AJCC v7 Stage IIA2 Cervical Cancer AJCC v7 Stage IIB Cervical Cancer AJCC v6 and v7 Stage IIB Fallopian Tube Cancer AJCC v6 and v7 Stage IIB Ovarian Cancer AJCC v6 and v7 Stage IIC Fallopian Tube Cancer AJCC v6 and v7 Stage IIC Ovarian Cancer AJCC v6 and v7 Stage III Cervical Cancer AJCC v6 and v7 Stage III Fallopian Tube Cancer AJCC v7 Stage III Ovarian Cancer AJCC v6 and v7 Stage III Primary Peritoneal Cancer AJCC v7 Stage III Uterine Corpus Cancer AJCC v7 Stage IIIA Cervical Cancer AJCC v6 and v7 Stage IIIA Fallopian Tube Cancer AJCC v7 Stage IIIA Ovarian Cancer AJCC v6 and v7 Stage IIIA Primary Peritoneal Cancer AJCC v7 Stage IIIA Uterine Corpus Cancer AJCC v7 Stage IIIB Cervical Cancer AJCC v6 and v7 Stage IIIB Fallopian Tube Cancer AJCC v7 Stage IIIB Ovarian Cancer AJCC v6 and v7 Stage IIIB Primary Peritoneal Cancer AJCC v7 Stage IIIB Uterine Corpus Cancer AJCC v7 Stage IIIC Fallopian Tube Cancer AJCC v7 Stage IIIC Ovarian Cancer AJCC v6 and v7 Stage IIIC Primary Peritoneal Cancer AJCC v7 Stage IIIC Uterine Corpus Cancer AJCC v7 Stage IIIC1 Uterine Corpus Cancer AJCC v7 Stage IIIC2 Uterine Corpus Cancer AJCC v7 Stage IV Cervical Cancer AJCC v6 and v7 Stage IV Fallopian Tube Cancer AJCC v6 and v7 Stage IV Ovarian Cancer AJCC v6 and v7 Stage IV Primary Peritoneal Cancer AJCC v7 Stage IV Uterine Corpus Cancer AJCC v7 Stage IVA Cervical Cancer AJCC v6 and v7 Stage IVA Uterine Corpus Cancer AJCC v7 Stage IVB Cervical Cancer AJCC v6 and v7 Stage IVB Uterine Corpus Cancer AJCC v7 Uterine Carcinosarcoma Uterine Corpus Sarcoma Newly diagnosed with any stage of primary ovarian cancer, primary peritoneal cancer, or primary fallopian tube cancer in the past 6 months Newly diagnosed with high grade stage 2, any grade stage 3 or higher endometrial cancer in the past 6 months Newly diagnosed with stage 2 or higher cervical cancer within the past 6 months Newly diagnosed with any stage uterine cancer (both sarcoma and carcinosarcoma) in the past 6 months At the time of recruitment the patient is on active treatment defined as either currently receiving chemotherapy or radiation or less than 6 months post-cancer surgery At the time of recruitment, a Karnofsky performance status of 80 or above or an Eastern Cooperative Oncology Group (ECOG) (80) score of 0 or 1 English speaking Has internet access Must give informed consent within 6 months of 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): 9.0-45.0, Papillomavirus Infections Participant is a Chinese female judged to be in good physical health based on medical history and physical examination Not a woman of childbearing potential (WOCBP) or if of WOCBP, has not had sex with males or has had sex with males and used effective contraception as defined in Appendix 2 since the first day of participant's last menstrual period through Day 1. And the participant understands and agrees that during the Day 1 through Month 7 period, she should not have sexual intercourse with males without effective contraception, and that the use of the rhythm method, withdrawal, and emergency contraception are not acceptable methods Has a lifetime history of 0 to 4 male and/or female sexual partners at the time of enrollment. Male partner is defined as someone with whom the participant has penile penetrative sexual intercourse. Female partner is defined as someone who has contacted, either by penetrative (with fingers or other objects) or non-penetrative means, the participant's genitalia during sexual activity Known allergy to any vaccine component, including aluminum, yeast, or (nuclease, Nycomed™). An allergy to vaccine components is defined as an allergic reaction that met the for serious adverse event History of severe allergic reaction (e.g. swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections Has a fever (defined as an axillary temperature ≥37.1°C) within 24 hours prior to the Day 1 vaccination Has any history of abnormal Pap test showing squamous intraepithelial lesion (SIL) or atypical squamous cells undetermined significance (ASC-US), atypical squamous cells cannot HSIL (ASC-H), atypical glandular cells, or biopsy showing cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ or cervical cancer History of external genital wart, vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), vulvar cancer or vaginal cancer History of a positive test for HPV Currently immunocompromised or has been diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition
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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): 18.0-55.0, Bacterial Vaginosis Screening Visit(s) 1. Women with a current Bacterial Vaginosis (BV) infection and a history of at least two previous episodes of BV by documentation or self-report in the past year. Screening (V0) diagnosis is based on the presence of > / = 3 Amsel criteria* Homogeneous vaginal discharge; positive potassium hydroxide (KOH) whiff test; vaginal pH of > 4.5; and > / = 20% clue cells. 2. Willing and able to provide written informed consent; 3. Age 18-55 years of age at the time of V0; 4. General good health based on medical history, targeted physical examination, and pelvic examination; 5. For participants 21 years of age or older, Pap test performed within the past 3 years, with the most recent result being normal or Atypical Squamous Cells of Undetermined Significance (ASCUS) Human Papillomavirus (HPV) negative or Pap smear collected at V0*; *Consistent with current Pap screening guidelines, a Pap smear must be performed at V0, for women who meet the following and cannot provide documentation or self-report of a normal or ASCUS HPV negative Pap smear, conducted within the prior 3 years: (a) has not had a hysterectomy or (b) has had a hysterectomy and has a history of cervical intraepithelial neoplasia grade 2 plus (CIN2plus) in the past 20 years. Note: If a Pap smear is conducted at V0, the results are not required prior to enrollment. 6. Have a negative urine pregnancy test at V0, if of childbearing potential; 7. Must be of non-childbearing potential* or must be using an effective method of birth control** and must be willing to continue the method through the end of Investigational Product (IP) administration; *Defined as post-menopausal or status post bilateral tubal ligation, or status post bilateral oophorectomy or status post hysterectomy. **Acceptable methods are defined as: 1. Intrauterine Devices (IUDs) or hormonal contraceptives for at least 22 days prior to screening. Note: Intravaginal contraceptive rings (e.g., NuvaRing) are not acceptable forms of birth control for this study. 2. Consistent use of a barrier method, including diaphragms or condoms, for at least 13 days prior to screening. 3. Abstinence from vaginal sexual intercourse for at least 13 days prior to screening. 4. Exclusively same-sex relationship. 5. Monogamous relationship with vasectomized partner. 8. Willing and able to cooperate to the extent and degree required by this protocol at the discretion of the investigator; Enrollment Visit In addition to confirming all relevant Screening Visit women must meet all of the following to be eligible for enrollment in the study. 1. Willing and able to provide Enrollment written informed consent; 2. After completion of metronidazole induction therapy or another CDC-recommended BV treatment, no clinical evidence of BV* and absence of symptoms of BV** at Visit 1, Enrollment (V1) As defined by < / = 2 of 4 Amsel criteria. **Defined as absence of vaginal discharge and odor consistent with BV. 3. Must have a negative urine pregnancy test at V1, if of childbearing potential; 4. Willing to refrain from any intravaginal products/medications* other than the IP throughout the course of the trial; *For example: douches, antifungal or antibacterial preparations, lubricants, contraceptive creams, gels, foams, sponges, spermicides. 5. Must agree to abstain from receptive oral, anal, and vaginal sexual intercourse one hour prior to IP administration and for 24 hours after; 6. Willing to refrain from using tampons or menstrual cups for 24 hours after IP administration; 7. Must be of non-childbearing potential* OR must be using an effective method of birth control** and must be willing to continue the method through the end of IP administration; *Defined as post-menopausal or status post bilateral tubal ligation, or status post bilateral oophorectomy or status post hysterectomy Acceptable methods are defined as: 1. IUDs or hormonal contraceptives for at least 30 days prior to using IP. Note: Intravaginal contraceptive rings (e.g., NuvaRing) are not acceptable forms of birth control for this study. 2. Consistent use of a barrier method, including diaphragms or condoms, for at least 21 days prior to using IP. 3. Abstinence from vaginal sexual intercourse for at least 21 days prior to using IP. 4. Exclusively same-sex relationship. 5. Monogamous relationship with vasectomized partner Screening Visit(s) Diagnosis of another vaginal or vulvar condition that may confuse interpretation of response to Investigational product (IP)* For example: erosive lichen planus, desquamative inflammatory vaginitis, or contact dermatitis involving the vulvar epithelium. 2. Concurrent Vulvovaginal Candidiasis (VVC) infection with inability to be treated with oral fluconazole; 3. Infectious cause of cervicitis (e.g., N. gonorrhoeae, C. trachomatis, or T. vaginalis) confirmed on physical examination and/or with laboratory testing*, **; *Women may be rescreened for following successful treatment of confounding Sexually Transmitted Infection (STI). **Results of Nucleic Acid amplification Test (NAAT) testing will be reviewed prior to enrollment. 4. Active genital lesions, including ulcers or vesicles consistent with herpes or warts; 5. Planned ongoing immunosuppressive therapy or systemic antibiotic treatment during the course of the study; 6. History of hypersensitivity, allergy or other contraindication(s) to metronidazole or other CDC-recommended BV treatment used to treat subject; 7. History of hypersensitivity to any TOL-463 formulation components; 8. Current or untreated cervical intraepithelial neoplasia (CIN) or cervical carcinoma; 9. Currently pregnant or nursing; 10. Any other condition that, in the opinion of the investigator, would interfere with participation in the study; 11. Previous enrollment in the study or at the investigator's discretion; Enrollment Visit In addition to confirming all Screening Visit women who meet any of the following will not be eligible for enrollment in the study. 1. Active menses or significant vaginal bleeding as determined by the study clinician at V1*; *Note: women who are menstruating may be reevaluated for study enrollment within the enrollment window. 2. Use of vaginal or systemic antibiotic or antifungal since V0, other than oral metronidazole, CDC-recommended BV treatment, or oral fluconazole, as per protocol; 3. Evidence or suspicion of infectious cause of cervicitis or active genital lesion on pelvic examination at Visit 1, Enrollment (V1); 4. Concurrent VVC infection at V1 with inability to treat with oral fluconazole; 5. Use of any investigational drug within 30 days prior to V1 or planned/anticipated use during study participation
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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 HIV/AIDS HIV-infected women confirmed through medical records 2. Women residing within Lusaka district and plans to stay in this area for the next 6 months 3. Women between 18 and 65 years of age (age bracket as per Zambian guidelines for cervical cancer screening) 4. Able and willing to consent 5. Willing to undergo a pelvic examination and cancer screening 6. Has had sexual intercourse before 7. Agrees to have follow-up appointment in 6 months Women with a history of cervical cancer or previous hysterectomy (where the cervix was also removed) 2. Pregnant women or women who plan to get pregnant within the next 6 months 3. Women who have been vaccinated against HR-HPV
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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, Squamous Lntraepithelial Lesions of Vulva Neoplasms, Squamous Cell Vulvar HSIL Patients must have vulvar High-Grade Squamous Intraepithelial Lesions (HSIL) as confirmed by pathology report from a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory Vulvar HSIL must be human papillomavirus (HPV)-16+ by a polymerase chain reaction (PCR), Ribonucleic acid (RNA), or in situ hybridization test from a CLIA certified laboratory Patients must have measurable lesion(s) as defined in one or more of the following Failure of surgery to control disease (i.e. positive margins after surgery or recurrence of HSIL after surgery) Multifocal or extensive disease for which surgery would result in disfigurement that is not be acceptable to the patient Disease for which surgery would have a risk of functional impairment that is not be acceptable to the patient (i.e. involve partial or complete excision of the clitoris, anus, vagina, or urethra) Patients may have received any previous therapy, including surgical excision. Patients with recurrent disease must have histologically documented recurrence on new biopsy and a measurable lesion that meets the above criteria Patients must have the human leukocyte antigen (HLA)-A*02:01 allele Age greater than or equal to18 years Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Patients who are receiving any other investigational agents Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR, breastfeeding should be discontinued if the mother is treated with E7 TCR. These potential risks may also apply to other agents used in this study Uncontrolled intercurrent illness including, but not limited to, any ongoing or active infection (e.g. requiring anti-infective therapy), coagulation disorders, cardiovascular disorders, respiratory disorders, cancer, or psychiatric illness/social situations (within the last six months) that would limit compliance with study requirements Any form of systemic immunodeficiency, including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease. The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence maybe less responsive to the treatment Concurrent systemic steroid therapy if greater than the equivalent of 5 mg prednisone by mouth (PO) daily. Patients previously on steroids must be off steroids for four weeks prior to treatment Cardiac stress test and pulmonary function tests maybe required for patients with a clinical history of significat cardiopulmonary disease. Patients with active cardiac ischemia or severe chronic obstructive pulmonary disease are not eligible Patients with any active invasive cancer are not eligible Patients with vulvar HSIL that is not HPV-16+ or is associated with multiple types of high-risk HPV at the time of assessment are not eligible
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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, BRCA-Mutated Ovarian Carcinoma BRCA1 Gene Mutation BRCA2 Gene Mutation High Grade Fallopian Tube Serous Adenocarcinoma High Grade Ovarian Serous Adenocarcinoma Primary Peritoneal High Grade Serous Adenocarcinoma Stage III Fallopian Tube Cancer AJCC v8 Stage III Ovarian 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 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 Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA]) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Histology showing high-grade epithelial non-mucinous ovarian, primary peritoneal, or fallopian tube cancer Documented BRCA pathway mutations No prior treatment for primary advanced (stage III or IV) epithelial ovarian, primary peritoneal, or fallopian tube carcinoma such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy, surgery, and/or other concurrent agents or therapies A disposition to neoadjuvant chemotherapy (NACT) with planned interval tumor reductive surgery after 3 complete cycles of treatment Have measurable disease based on version 1.1 or evaluable disease. Measurable disease is defined at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each "target" lesion must be > 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or > 10 mm when measured by spiral CT. Evaluable disease includes nonmeasurable lesions, ascites, pleural effusion Peripheral neuropathy grade 0 or 1 by Common Terminology for Adverse Events (CTCAE) version (v)5.0 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Life expectancy of >= 16 weeks Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1. Postmenopausal is defined as: amenorrheic for 1 year or more following cessation of exogenous hormonal treatments, luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50, radiation-induced oophorectomy with last menses > 1 year ago, chemotherapy-induced menopause with > 1 year interval since last menses, or surgical sterilization (bilateral oophorectomy or hysterectomy). Women of childbearing potential (WoCBP) must utilize acceptable contraception for two weeks before the first dose of olaparib, for the duration of the study, and for at least 6 months after the last dose of olaparib Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) Previous enrollment in the present study Prior treatment for ovarian, fallopian tube, or primary peritoneal cancer Histology showing mucinous or low grade epithelial carcinoma Participation in another clinical study with an investigational product (IP) during the last 4 weeks History of another primary malignancy except for: malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, and/or adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ Resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, mean QT interval corrected for heart rate with Fridericia's correction (QTcF) prolongation > 500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome Any unresolved toxicity (> CTCAE grade 2) from previous anti-cancer therapy, excluding alopecia History of hypersensitivity to olaparib or its excipients Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) or otherwise immunocompromised subjects, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject 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): 18.0-999.0, Uterine Cervical Neoplasms Primary squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix Stage IB1 carcinoma, <4 CMS, (FIGO 2009) Preoperative pelvic MRI indicating tumor diameter < 4 cm (at least two dimensions,) and no parametrial invasion. Exceptionally it can be considered acceptable Vaginal Ultrasound, only if your Institution have internally validated this technique for cervical cancer. Otherwise it cannot be accepted Preoperative either (Abdominal) CT scan or MRI or PET-CT ruling out extracervical metastatic disease Performance status ECOG 0-1 Age 18 years or older Radical hysterectomy Type II-III or Type B-C by MIS (laparoscopic or robotic) or open surgery Patient was operated during the years 2013-2014 within the ESGO area Bilateral pelvic lymphadenectomy (+ sentinel LN biopsy) No past medical history of any invasive tumor No previous abdominal or pelvic radiotherapy of any type (including braquitherapy) No history of preoperative neoadjuvant chemotherapy No cervical conization previous to surgery No suspicious positive pelvic or paraaortic nodes or metastatic disease on PET CT, MRI, or CT There is none uterine diameter larger than 12cm No Conversion from MIS to laparotomy
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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): 18.0-50.0, Cervix Cancer Women in fertile age severe comorbidities
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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, Abdominal Hysterectomy To be 18 years and older No smoking No history of bleeding disorder No history of favism No history of uterus, ovary, cervical cancer Need to injection of vasopressor drugs Surgeon disagreement
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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, Uterine Cervical Neoplasm Uterine Neoplasms Patients undergoing hysteroscopy Pregnancy
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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): 18.0-45.0, Congenital Diaphragmatic Hernia Patient is a pregnant woman between 18 and 45 years of age Singleton pregnancy The fetuses will be 28+0/7 to 31+6/7 weeks of gestational age Confirmed diagnosis of severe left or right-sided CDH of the fetus: Observed/expected total lung volume equal to or less than 0.32 with more than 21% of liver herniated into the hemithorax. (Ideally calculated between 28+0/7 and 31+6/7 weeks' gestation.) Normal fetal echocardiogram or echocardiogram with a minor anomaly (such a small VSD) that in the opinion of the pediatric cardiologist will not affect postnatal outcome Normal fetal karyotype or microarray The mother must be healthy enough to have surgery Patient and father of the baby provide signed informed consent that details the maternal and fetal risks involved with the procedure Patient willing to remain in Houston for the duration following balloon placement until delivery Contraindication to abdominal surgery, fetoscopic surgery, or general anesthesia Allergy to latex Allergy or previous adverse reaction to a study medication specified in this protocol Preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) in the index pregnancy Fetal aneuploidy, known structural genomic variants, other major fetal anomalies that may impact the fetal/neonatal survival or known syndromic mutation Suspicion of major recognized syndrome (e.g. Fryns syndrome) on ultrasound or MRI Maternal BMI >40 High risk for fetal hemophilia
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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 Breast Cancer Contraceptive Usage Sexually Transmitted Diseases -Scheduled to leave jail within 3 days not actively intoxicated not show severe psychological distress
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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, Pregnancy Related Any patient scheduled for a postpartum tubal ligation at the Women and Infants Center will be eligible for the study age less than 18 years old allergy to either local anesthetic class (amide or ester) contraindication to spinal anesthesia
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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): 25.0-65.0, Cervical Cancer Pathological Screening Smear Women followed for a cervical pathology requiring endocervical curettage AGC type (glandular cell atypia) with positive HPV test Frottis ASC-H, LSIL, ASCUS HPV + with non-contributive colposcopy (ZT3) Pregnant woman Women under the age of 25 or over 65 Stenosis of the neck complete or tight not allowing the possible insertion of a curette (inadequate size cervical orifice and material) Presence of a vaginal lesion on colposcopic examination
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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): 25.0-49.0, Human Papillomavirus 16 Human Papillomavirus 18 Papillomavirus Infections Cervical Cancer Pre-Cancerous Dysplasia Women with no previous history of hysterectomy aged 25-49 years old no previous history of treatment for cervical cancer provided written informed consent Women who are under 25 or over 49 years of age who have previously had a hysterectomy or been treated for cervical cancer unable to provided 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): 18.0-999.0, Papillomavirus Infections Oropharyngeal Neoplasms Histologically or cytologically confirmed stage II or stage III (AJCC 8th edition) oropharyngeal squamous cell carcinoma that has not been treated HPV16+ tumor and HLA-A 02:01+ HLA type (HLA-A 02 is also acceptable for determination of eligibility) Measurable disease by 1.1 criteria Patient age 18 and older. Because no dosing or adverse event data are currently available on the use of E7 TCR T Cells in patients <18 years of age, children are excluded from this study. This reflects the age range of patients with the disease being studied ECOG performance status 0 or 1 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. Postmenopausal will be defined as women over the age of 55 who have not had a menstrual period in at least 1 year 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 and men must agree to use adequate contraception (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 or her partner is participating in this study, she should inform her treating physician immediately Seronegative for HIV antibody. The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment Seronegative for hepatitis B antigen and hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative Must be willing to participate in Gene Therapy Long Term Followup Protocol, which will follow patients for up to 15 years per Food and Drug Administration (FDA) requirements Patients who are receiving any other investigational agents History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study 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 There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E7 TCR T Cells. For this reason, women may not breastfeed while receiving study treatment and for one year after the study treatment ends. These potential risks may also apply to other agents used in this study Patients 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. Patients who have decreased immune competence may be less responsive to the treatment Current use of immunosuppressive medication, for the following Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection) Systemic corticosteroids at physiologic doses less than equal to 10 mg/day of prednisone or equivalent Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) Patients 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
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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): 18.0-40.0, Cervical Cancer Part 1 for Neoadjuvant Chemotherapy Patients must have histologically confirmed invasive cervical cancer with adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 IB2 measuring ≥2cm to <4cm by radiological imaging (MRI) Patients must be premenopausal and wish to preserve fertility At time of registration, patient may not have had any prior therapy to treat their cancer lesion Eastern Cooperative Group (ECOG) performance status ≤ 2 Within 7 days of the proposed start of treatment, patients must have normal organ and marrow function No evidence of active uncontrolled infection (patients on antibiotics are eligible) Patient must have disease that is measurable per the Response Evaluation in Solid Tumors (RECIST) 1.1 Ability to understand and willing to sign a written informed consent document Part 1 for Neoadjuvant Chemotherapy Patients who have had chemotherapy or radiotherapy or surgery for their cancer Patients who are receiving any other investigational agents Patients with other cancers requiring ongoing treatment Patients with known / evidence of brain metastases are excluded from participation in this clinical trial History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel, carboplatin, or cisplatin or other agents used in study Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Patients who are pregnant or breastfeeding Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues. Part 2
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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.
|
eligible ages (years): 15.0-44.0, Fetal Alcohol Spectrum Disorders Drinking pregnant women who are defined as women who Drank in the 3 months prior to pregnancy and/or Drank alcohol at least once at any time during the prenatal period Gestational age less than or equal to 16 weeks, but not more than 20 weeks at intake Non-drinking pregnant women who are defined as women who have not had any alcohol during the past 30 days Gestational age >20 weeks
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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.
|
eligible ages (years): 7.0-80.0, Neuroendocrine Tumors suspected or confirmed untreated NET patients previously performed 18F-FDG PET/CT signed written consent pregnancy breastfeeding known allergy against TATE any medical condition that in the opinion of the investigator, may significantly interfere with study compliance
|
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.
|
eligible ages (years): 6.0-80.0, Children, Adult prepubertal children (6-9y) postpubertal children (15-18y) young adults (18-24y) healthy non-falling older adults (65-80y) will be included if they 1) did not experience two or more falls during normal daily activities in the preceding year and 2) have no cognitive impairment (tested with Mini-Mental state examination) inability to speak and understand Dutch; 2. inability to maintain independent unsupported stance for 60 seconds; 3. current diagnosis of neurological or sensory disorders; 4. recurrent dizziness; 5. obesity ; 6. a history of orthopaedic disorders; 7. surgical operation of the lower extremity during last two years; 8. use of drugs affecting the CNS or known to affect balance control
|
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): 21.0-65.0, Health Knowledge, Attitudes, Practice All Women 21-65 years with diagnosis of abnormal pap smear presenting to Women's Health Colposcopy Clinic at WCMC Access to a smartphone English or Spanish Speaking Pregnant women Non-English or Spanish speakers
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2
|
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.
|
eligible ages (years): 18.0-999.0, Cervical Cancer Cervical cancer histopathological diagnosis Clinical stage IB1 or IIA1 CC Treated with radical hysterectomy (RH) with bilateral pelvic lymphadenectomy (BPL) Double primary tumors Treatment regimens other than standard treatment Poor quality formalin-fixed paraffin-embedded tissue blocks
|
2
|
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.
|
eligible ages (years): 19.0-57.0, Diet, Healthy adults aged 19-57 years male to female ratio (1:1 ratio) BMI 19-35 kg/m2 Currently living in Amman without significant apparent diseases Able to drink the tested herbal tea twice a day Have chronic diseases such as diabetes, hypertension, cardiovascular or endocrine diseases or disabilities Using medical drugs and/or supplements Below 19 or above 57 years participation in clinical trials within the last 2 months use of lipid-lowering drugs, or diabetic medication Lactating and pregnant women will be also excluded
|
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.
|
eligible ages (years): 21.0-65.0, Cervical Cancer Female of at least 21 years of age and not over 65 presenting who need routine cervical cancer screening per national guidelines prior history of cervical cancer or a positive Pap smear, have had a total hysterectomy (removal of uterus and cervix), or currently enrolled in any other cancer prevention study
|
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.
|
eligible ages (years): 18.0-999.0, Thyroid Neoplasms Genetic Susceptibility Radiation Exposure Diganosis of thyroid cancer during the followup or selected as a control matched on gender, date of birth and age at skin hemangioma diagnosis No available adress Refusal
|
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.
|
eligible ages (years): 18.0-999.0, Advanced Solid Tumor Malignant Solid Tumor Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Has at least 1 measurable lesion according to Response Evaluation in Solid Tumors (RECIST) Version 1.1 Has adequate cardiac, hematopoietic, renal and hepatic functions Has an adequate treatment washout period prior to start of study treatment Additional for Part 1 (Dose Escalation) Has a pathologically documented advanced/unresectable or metastatic head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, squamous and adenocarcinoma non-small cell lung cancer (NSCLC), bladder cancer, sarcoma, endometrial cancer, melanoma, prostate cancer, breast cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. Additional for Part 2 (Dose Expansion) Has a pathologically documented advanced/unresectable or metastatic head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, squamous-NSCLC that is refractory to or intolerable with standard treatment, or for which no standard treatment is available. Additional or alternative indications may be added to expansion cohorts based on preliminary signals of activity in dose escalation via a protocol amendment Has prior treatment with B7-H3 targeted agent Has prior treatment with an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan) Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (New York Heart Association classes II-IV), unstable angina or serious cardiac arrhythmia Has an uncontrolled infection requiring systemic therapy Has clinically significant pulmonary compromise or requirement for supplemental oxygen Has 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
|
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.
|
eligible ages (years): 18.0-999.0, Cervical Cancer Healthy Diet Latina immigrant Resident of selected randomization unit (place of residence) At least one HPV unvaccinated daughter between the ages of 9 and 12
|
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.
|
eligible ages (years): 25.0-64.0, Cervical Cancer HPV Infection HIV Infections Women aged 25-64 HIV diagnosis ≥ 6 months No previous diagnosis of CIN 2/3 and/or treatment for cervical dysplasia Last smear test done ≥1 year before baseline Able to speak and understand English Willing and able to provide informed consent Suspected or known invasive cervical malignancy Currently pregnant or breast-feeding Any other condition, which, in the opinion of the Investigator, would make participation in the study unsafe or interfere with interpretation of the study outcomes
|
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.
|
eligible ages (years): 18.0-999.0, Bladder Cancer Patients with a known history of Ta HG with recurrent disease Patients referred to short-term, intensive chemoresection Patients older than 18 years Known allergy or intolerance to Mitomycin Incontinence or small bladder capacity (< 100 mL) Previous pelvic radiation therapy
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0
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