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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-999.0, Advanced Hepatocellular Carcinoma BCLC Stage A Hepatocellular Carcinoma BCLC Stage B Hepatocellular Carcinoma BCLC Stage C Hepatocellular Carcinoma Metastatic Hepatocellular Carcinoma PRE-REGISTRATION: Age >= 18 years PRE-REGISTRATION: Disease characteristics Radiologically confirmed hepatocellular carcinoma (HCC) that is not eligible for curative resection, transplantation, or ablative therapies Received at least one prior systemic treatment for HCC NOTE: Prior radiation, chemoembolization, radioembolization or other local ablative therapies or hepatic resection are permitted PRE-REGISTRATION: Measurable disease by any imaging modality as defined by Response Evaluation in Solid Tumors (RECIST) 1.1 in at least one site not previously treated with radiation or liver directed therapy (including bland, chemo- or radio-embolization, or ablation) NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; disease that is measurable by physical examination only is not eligible PRE-REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 PRE-REGISTRATION: Child-Pugh scores of =< 7 (Child-Pugh A or B7) PRE-REGISTRATION: Barcelona Clinic Liver Cancer Stage (BCLC) stage A, B, or C PRE-REGISTRATION: Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy PRE-REGISTRATION: Prior organ transplantation PRE-REGISTRATION: History of untreated brain metastasis PRE-REGISTRATION: History of hepatitis B (HBV) and viral load >=100 IU/mL NOTE: Patients who have received antiviral therapy and have viral load < 100 IU/mL are eligible PRE-REGISTRATION: History and/or current evidence of any of the following disorders Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator Ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the Investigator Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant in the opinion of the Investigator PRE-REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 25.0-50.0, Tooth Loss Vitamin D3 Deficiency Osteomalacia Signing of written informed consent of the patient to participate in a study 2. Age from 25 to 50 years old 3. Established diagnosis: tooth loss (K08.1 ICD 10), vitamin D3 imbalance. 4. Patients who are medically stable Refusal of the patient from further participation in the study 2. Pregnancy diagnosed after the into the trial 3. Non-compliance by the patient with postoperative recommendations. 4. Residence address change
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0
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The patient is a 33-year-old woman complained of fatigue, weight gain and abnormal spotting between menses. No hirsutism or nipple discharge was detected. Her BMI was 34. Her lab results were remarkable for high TSH level (13 mU/L) and low free T4 level (0.2 ng/dl). Her anti-TPO levels were extremely high (120 IU/ml). She was diagnosed with Hashimoto's thyroiditis. Her aunt, brother and mother have the same disease. After starting 250 mcg Levothyroxine per day, her symptoms improved significantly and her periods are normal. She is still overweight with BMI of 31. Her most recent thyroid profile revealed all results except for anti-TPO within the normal range: TSH: 2.35 mU/L Free T4: 2.7 ng/dl Anti-TPO: 75 IU/ml
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eligible ages (years): 18.0-50.0, Hypothyroidism Pregnancy Related Thyroid Dysfunction Iodine Deficiency Singleton pregnancy Twin pregnancy Free of pre-existing thyroid disease That do not use thyroid interfering medication That did not undergo IVF treatment TPOAb negative Adolescent pregnancy Patient with pre-existing thyroid disease TPOAb positive Patient using thyroid interfering medication That had IVF treatment
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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, Adrenal Gland Hyperfunction Adrenal Gland Hypofunction Cushing's Syndrome Healthy The normal volunteers are obtained through the NIH volunteer program or are NIH employees. Normal volunteers are in excellent health and are receiving no chronic medications. We now routinely test patients with hypocortisolism or hypercortisolism in our clinic and ward
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 0.0-999.0, Cervical Cancer Previously untreated, histologically proven invasive carcinoma of the cervix Eligible histologies: Squamous Adenocarcinoma Adenosquamous Eligible stages: Bulky stage IB, i.e.: Exophytic lesions 4 cm or greater in diameter OR Cervix expanded to 4 cm or greater and presumed clinically to result from cancer No extension beyond cervix clinically and by IVP or CT with contrast Age: Not specified Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal AST no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Other: No septicemia or severe infection No other concurrent malignancy within the past 5 years except curatively treated nonmelanomatous skin cancer and prior malignancy therapy does not contraindicate current protocol therapy Suitability for radical hysterectomy and lymphadenectomy required PRIOR No prior therapy for cervical cancer No prior pelvic irradiation
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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 Cancer Histologically proven stage IV or recurrent squamous cell, adenosquamous, or adenocarcinoma of the uterine cervix including: Lung, liver, lymph node, or skin metastases OR Retroperitoneal disease OR Other advanced measurable disease OR Positive paraaortic lymph nodes Measurable disease that is beyond the scope of conventional radiation therapy or surgery, or recurrent after radiation therapy or surgery Measurable, recurrent disease within a previously irradiated field must have increased in size by 100% on at least 2 successive scans, MRI, or physical examinations Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times the upper limit of normal (ULN) AST and ALT no greater than 2 times ULN Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No New York Heart Association class III/IV heart disease No uncontrolled congestive heart failure or angina Pulmonary: No chronic obstructive pulmonary disease Gastrointestinal: No evidence of active gastrointestinal bleeding No active peptic ulcer disease No inflammatory bowel disease Other: Normal diet required No known active infections HIV negative AIDS-related complex (ARC) negative No substance abuse or psychiatric problems No evidence of autoimmune disease No other prior invasive malignancy except resected basal cell or squamous cell skin cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR Biologic therapy: 1 prior biologic therapy allowed At least 4 weeks since prior biologic therapy Chemotherapy: 1 prior adjuvant chemotherapy regimen allowed 1 prior chemotherapy regimen for advanced disease allowed At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: No concurrent steroid therapy No concurrent megestrol acetate Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: See Disease Characteristics At least 2 weeks since prior 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): 18.0-999.0, Cervical Cancer Histologically proven stage IB or IIA cervical cancer Squamous cell carcinoma Adenosquamous cell carcinoma Adenocarcinoma Pelvic and/or common iliac or para-aortic lymph node involvement Undergone a radical hysterectomy, complete pelvic lymphadenectomy, and resection of any enlarged common iliac or para-aortic lymph nodes No clear cell carcinoma or small cell carcinoma with neuroendocrine differentiation Resectable disease Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 14.6 mg/dL Renal: Creatinine no greater than 1.356 mg/dL Creatinine clearance at least 60 mL/min Pulmonary: Maximum breathing capacity at least 30 L/min FEV1 at least 1.0 L No signs of respiratory insufficiency Other: No potentially active site of infection (e.g., fistula or abscesses) No prior or concurrent second malignancy except adequately treated basal cell carcinoma of the skin PRIOR Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No preoperative external radiotherapy Surgery: See Disease Characteristics
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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, Precancerous Condition Stage 0 Cervical Cancer Cytologically confirmed atypical glandular cells of undetermined significance (AGUS) Must be scheduled to undergo complete histologic examination of the cervix by cone biopsy using loop electrosurgical excision procedure with an endocervical curettage, excisional cone biopsy with or without endocervical curettage, or hysterectomy within 6 months of the initial cytologic diagnosis of AGUS No history of endometrial hyperplasia No history of cancer of the endometrium, vagina, or cervix HIV negative No pregnant patients who are at high risk for excessive bleeding or preterm labor if a cone biopsy is performed No prior cytotoxic chemotherapy for vaginal and/or cervical cancer No prior radiotherapy to the vagina or cervix No concurrent radiotherapy to the vagina or cervix No prior hysterectomy
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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 Diagnosis of abnormal Pap test, as indicated by one of the following: Atypical squamous cells of undetermined significance (ASCUS) Low grade squamous intraepithelial lesion (LGSIL) High grade squamous intraepithelial lesion (HGSIL) Visible lesion on cervix by colposcopy Age: Any age Performance status: ECOG 0-4 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Pregnant or nursing women allowed PRIOR Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior pelvic irradiation Surgery: No prior total hysterectomy
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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): 13.0-999.0, HIV Infections Papilloma Women may be eligible for this study if they Are HIV-positive Are at least 13 years of age and menstruating Are willing to enroll in another drug study Have written consent of a parent or guardian if under 18 years This study has been changed to increase enrollment. Women who are starting HAART-based therapy prescribed by a personal physician or participating in an antiretroviral trial are all eligible Intend to start antiretroviral therapy within 14 days of study entry Women will not be eligible for this study if they Have been on anti-HIV treatment for more than 14 days Are abusing drugs or alcohol Are receiving medication that affects the immune system, fights HPV, or is investigational, except for anti-HIV drugs provided by coenrolling in a Phase II or III trial with approval of a study chair within 30 days of study entry, including but not limited to systemic interferons and interleukins, thalidomide, systemic cidofovir, and HPV vaccines. This study has been changed. The following medications are no longer excluded: thymopentin, hydroxyurea, granulocyte colony-stimulating factor (G-CSF and filgrastim), and GM-CSF (sargramostim) Have cervical cancer or a history of cervical cancer Have had a hysterectomy (removal of the uterus) Participated in HPV trials at any time Use imiquimod inside the vagina Are taking corticosteroid treatment in large doses
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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, Cervical Cancer Histologically or cytologically confirmed stage IIB-IVA carcinoma of the cervix Adenocarcinoma Squamous cell carcinoma Mixed cell histology No small cell anaplastic histology No para-aortic lymph node involvement No indication for para-aortic radiotherapy No distant metastases No CNS disease Age and over Performance status
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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, Anal Cancer Cervical Cancer Esophageal Cancer Head and Neck Cancer Penile Cancer Vulvar Cancer Histologically proven stage III, IV, or recurrent carcinoma of the cervix or other tumor that carries human papilloma virus 16 (HPV16) such as other anogenital (vulvar, penile, and anal), esophageal, and head and neck cancers HLA-A2.1 positive Patients with tumors other than cervical cancer must have no other therapeutic options Fresh tissue or paraffin block available for HPV genome detection and typing (optional for cervical cancer) No history of CNS metastases Age Over 18 Performance status ECOG 0-1 Life expectancy More than 3 months Hematopoietic WBC at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic
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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, Cervical Cancer Histologically confirmed cervical cancer, including the following subtypes Squamous cell carcinoma Adenosquamous cell carcinoma Adenocarcinoma (excluding small cell, clear cell, and other rare variants of the classical adenocarcinoma) FIGO stage IB2, IIA (greater than 4 cm), or IIB Age to 75 Performance status WHO 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hepatic
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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, Cervical Cancer Histologically confirmed stage IB2 invasive carcinoma of the uterine cervix of one of the following types Squamous cell carcinoma Adenocarcinoma Adenosquamous carcinoma Primary, previously untreated disease Exophytic cervical lesions greater than 4 cm in diameter OR Cervical expansion to greater than 4 cm in diameter, presumed to be the result of principal involvement with cancer No evidence of extrauterine disease other than pelvic lymph node involvement (by clinical and radiographic examinations) No para-aortic lymph nodal disease (suspected on CT scan, MRI, positron-emission tomography, or lymphangiogram) unless nodes are confirmed to be pathologically negative (by CT-guided biopsy or extraperitoneal lymph node dissection) Eligible for radical hysterectomy and lymph node dissection 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): 0.0-999.0, Pregnancy Women of child bearing age Not pregnant Interested in delaying pregnancy using oral contraceptives or a depo-provera shot Had sex in the last month or are planning to have sex in the next month Have not used contraception during every sexual encounter within 3 months prior to study entry
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 0.0-999.0, Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma Stage I Cervical Cancer Diagnosis of carcinoma of the cervix of 1 of the following cellular types Squamous cell carcinoma Adenocarcinoma Adenosquamous cell carcinoma Stage IB1 disease (no greater than 4 cm) No unequivocal evidence of metastases Adequate surgical candidate No known allergy to triphenylmethane compounds No prior pelvic irradiation No prior retroperitoneal 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): 18.0-999.0, Cervix Neoplasms Stage Ib1-IVa cervical cancer Treatment with concurrent chemotherapy and radiation at the University of Iowa Hospitals and Clinics Immunosuppressive disorders Use of immunosuppressive medications Transplant recipient Metastatic or recurrent cervical cancer History of any other type of 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): 16.0-23.0, Cervical Cancer Genital Warts Female with an intact uterus with lifetime history of 0-4 sexual partners Prior Human Papillomavirus (HPV) vaccination Prior abnormal paps History of genital warts
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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): 18.0-40.0, Papillomavirus Infections Willing to be on acceptable method of birth control Have a Pap smear result of LSIL or ASCUS Is high risk HPV positive No evidence of high-grade disease or glandular abnormalities Complete visualization of all lesion margins and the transformation zone No uncontrolled significant medical illness or sexually transmitted infections Taking any restricted medications such as interferon, immunomodulators, cytotoxic drugs, investigational drugs, steroids
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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): 18.0-70.0, Cervix Neoplasms Women with ONLY the following results on a routine Pap smear Low grade epithelial abnormality Minor changes in squamous cell Minor changes in squamous cells with appearances consistent with Papillomavirus Women aged between 18-70 years Women who are pregnant or planning to become pregnant in the next 12 months Women with previous Pap smear abnormality for 2 years
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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): 15.0-25.0, Infections, Papillomavirus A woman whom the investigator believes that she and/or her parents/legally acceptable representative can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) A woman between, and including, 15 and 25 years of age at the time of the first vaccination Written informed consent must be obtained from the subject prior to enrollment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legal guardian of the subject and, in addition, the subject should sign and personally date a written informed assent) Subject must be free of obvious health problems as established by medical history and clinical examination before entering into the study Subject must have a negative urine pregnancy test Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using adequate contraceptive precautions for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series Has had no more than 6 lifetime sexual partners prior to enrollment. This criterion may not be applicable in subjects less than 18 years of age, according to local regulatory/ethical requirements Subject must have intact cervix Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Months 0-8) Previous administration of components of the investigational vaccine Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0-29) each dose of vaccine. Administration of some routine vaccines up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window Previous vaccination against human papillomavirus (HPV) History of vaccination against Hepatitis A or a known clinical history of Hepatitis A disease History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination
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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, Cervix Cancer Cervical cancer undergoing primary radiotherapy Stage 1B Patient refusal
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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): 18.0-25.0, Cervical Cancer Precancerous Condition •Healthy participants Deemed to be in good general health by history and physical examination •Resident of Guanacaste Province of Costa Rica and surrounding areas Must remain a resident for ≥ 6 months after the first study vaccination Age to 25 Performance status •Not specified Life expectancy •Not specified Hematopoietic •Not specified Hepatic No history of chronic hepatitis requiring treatment No acute or chronic clinically significant hepatic function abnormality by physical examination or laboratory findings No known history of hepatitis A infection Renal No history of kidney disease requiring treatment No acute or chronic clinically significant kidney function abnormality by physical examination or laboratory findings Cardiovascular No acute or chronic clinically significant cardiovascular function abnormality by physical examination or laboratory findings Pulmonary
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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): 18.0-80.0, Cancer of Cervix Using epidemiologic data drawn from a wide range of countries and population groups, investigators have found evidence of HPV in 90% to 95% of cervical cancers. The incidence of HPV in cervical cancer was 79% in our own report. Besides, 91% of high-grade CIN cases and 50% of low-grade CIN cases could be attributed to HPV infection in Taiwanese women. Because these reports for Taiwanese women were published around 10 years ago. It is important to survey and update the incidence of HPV in CIN and cervical cancer patients in Taiwanese women. We will survey the incidence of HPV infection in 500 cervical cancer patients, 100 patients of CIN and 100 normal population patients
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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): 18.0-80.0, Cervical Cancer Healthy volunteers People infected with HPV type 16 but without CIN lesions Patients with CIN lesions Patients with cervical cancer from National Taiwan University Hospital Informed consent is obtained, and the protocols are reviewed and approved by the appropriate Investigative Review Boards
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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): 18.0-75.0, Cervical Cancer recurrent cervical cancer 2. HPV 16 infection 3. Previously received cisplatin ot 5-FU based chemotherapy or refused to receive chemotherapy 4. HLA-A2 haplotype 5. Older than 20 years old 6. ECOG I or II 7. Life expectancy longer than 3 months 8. Adequate bone marrow reserve 9. pregnancy test: negative 10. Informed consent obtained CNS metastasis 2. Acute or chronic infection 3. Pregnant or lactating women 4. Asthma 5. Cardiac diseases such as heart failure, unstable angina, arrhythmia, myocardial infarction 6. Autoimmune disease 7. Previously other cancers (except basal cell cancer) 8. Without chemotherapy, biotherapy for more than 6 weeks
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-74.0, HIV Infections Sexually Transmitted Diseases for CBT or Peer Intervention Participants: 1. Female 2. Age 18-55 3. Did not inject drugs in the past 6 months 4. Self-reported sex with at least 1 male partner in the past 6 months 5. Had at least 1 of the following sexual risk factors: 1. More than 2 sex partners in the past 6 months 2. STI diagnosis in the past 6 months 3. Had a high risk sex partner in the past 90 days (i.e. a sex partner that injected drugs, smoked crack, was HIV+, or MSM) for Peer Network Participants: 1. 18 years old or older 2. One of the following: 1. Injected drugs 2. Sex partner of index 3. Social network member that the index felt comfortable talking to about HIV/STIs for All Participants Currently enrolled in another HIV prevention intervention
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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, Painful Joint Prostheses Patients selected for entry into this study will be men or women of any ethnic background who are scheduled to undergo clinical and diagnostic evaluation by a member of the Department of Orthopedic Surgery at the Hospital of the University of Pennsylvania Health System or by the collaborating physicians at the Rothman Institute or the VA Philadelphia Medical Center. Study I: FDG-PET imaging in painful partial or total joint prostheses Each patient who is a candidate will be evaluated by one of the collaborators mentioned above for a painful partial or total joint prosthesis. The patient will undergo an appropriate routine evaluation including history, physical examination, radiographic, scintigraphic, and necessary laboratory evaluation. An initial diagnosis must be made for each patient. The diagnosis of loosening will be established based on clinical examination and/or radiographic evaluation demonstrating clear evidence of this complication. Other etiologies for the joint pain, except for infection and aseptic loosening, need to be excluded. Surgical intervention (prosthesis revision) may or may not be planned for the patient who is a candidate for this study. Study II: FDG-PET imaging following uncomplicated partial or total joint arthroplasty All patients fulfilling the below will be considered potential candidates for this study. Each patient must have a diagnosis of degenerative joint disease caused by osteoarthritis (no previous hip surgery) and have undergone primary partial or total joint arthroplasty by a member of the Department of Orthopedic Surgery at the Hospital of the University of Pennsylvania or referring hospitals. Other causes of degenerative joint disease will be excluded by physical, radiographic and laboratory evaluation as clinically indicated. Osteoarthritis is the most common cause of degenerative joint disease, and in order to avoid any confounding factors in experimental results that may be caused by other types of disorders, only this group of patients will be studied. A patient will be eliminated from this group at anytime if the post-operative course is complicated by any process that is thought to influence the outcome. Variations from an uncomplicated postoperative course will be determined by the operating surgeon and clinical signs or other evidence to suggest infection, early loosening, or any other process directly involving the prosthesis Patients with other etiologies for pain, other than for infection and aseptic loosening, will be excluded from enrollment into the study
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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): 15.0-55.0, Infections, Papillomavirus for primary study A woman who the investigator believes that she and/or her parents/legally acceptable representative can and will comply with the requirements of the protocol A woman between, and including, 15 and 55 years of age at the time of the first vaccination Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative and, in addition, the subject should sign and personally date a written informed assent) Free of obvious health problems Subject must have a negative urine pregnancy test Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using adequate contraceptive precautions for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study and therefore become of childbearing potential must agree to follow the same precautions for extension studies A female who enrolled in the primary study and received three doses of vaccine Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative and, in addition, the subject must sign and personally date a written informed assent) for primary study Pregnant or breastfeeding A woman planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12) Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose, or planned administration during the study period Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of study vaccine. Planned administration/administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window Previous administration of components of the investigational vaccine Previous vaccination against HPV Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine
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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): 20.0-999.0, Malignant Tumor Patients age 20 years or older 2. Patients with malignant tumor who are to be intravenously administered cisplatin as a single dose of 70 mg/m2 or more in under 3 hours 3. Patients whose performance status is 0 to 2 4. Other as specified in the study protocol In case of patients who are previously treated with cisplatin, those having no past history of vomiting as of administration of cisplatin 2. Patients who had vomiting or dry vomiting within 24 hours before the initial administration of the moderate or severe emetic chemotherapy (including cisplatin) on Day 1 of the study 3. Pregnant women, nursing women, women of child-bearing potential, women who wish to become pregnant or women using oral contraception 4. Other as specified in the study protocol
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 0.0-999.0, Cervical Cancer biopsy-diagnosed CIN1 infection with oncogenic HPV Any other stage of cervical abnormality pregnant or planning a pregnancy diabetic taking B vitamin supplements taking anti-epileptic treatment taking methotrexate bleeding after intercourse abnormal GI function infection with chlamydia, HIV or other agent
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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): 35.0-65.0, Cervical Cancer Has a cervix Never been screened for cervical cancer Not currently pregnant Has previously had a Pap smear Has previously undergone treatment for cervical squamous intraepithelial lesion (SIL) Have lesions suspicious for cancer, have large acetowhite lesions extending over 70% of the cervix or into endocervical canal, are unsuitable for cryotherapy because of severe atrophy, polyps, cervix distorted, cervix cannot be adequately visualized Is unable to cooperate with study procedures or tolerate the insertion of a speculum
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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): 18.0-60.0, Cervical Intraepithelial Neoplasia Histological evidence of CIN I and II 2. Transformation zone and lesion margins fully visible 3. Compliant subject 4. Safe contraception 5. Negative pregnancy test Lesion related 1. CIN III, (micro)-Invasive Cancer 2. Endocervical lesion, upper margin of lesion not visible on colposcopy 3. Non-compliance of patient 4. PAP V Drug related 1. Age > 60 2. Hypersensitivity to progesterone or any component of the formulation 3. Thrombophlebitis 4. Undiagnosed vaginal bleeding 5. Carcinoma of the breast 6. Cerebral apoplexy 7. Severe liver dysfunction 8. Pregnancy 9. Depression 10. Diabetes 11. Epilepsy 12. Migraine 13. Renal dysfunction 14. Asthma 15. HIV infection 16. Hepatitis B or C 17. Concurrent use of anticoagulants 18. Uncontrolled hypertension (> 160/90 mmHg) 19. Breast cancer in personal history 20. Concurrent hormonal therapy including OC Clinical laboratory related 1. Hemoglobin < 11 g/dl 2. Leukocytes < 4,0 x 109/L 3. Platelet count < 100 x 109/L 4. Serum bilirubin > 2 x above upper cut-off value 5. Serum GOT > 2 x above upper cut-off value 6. Serum GPT > 2 x above upper cut-off value 7. Serum alkaline phosphatase > 2 x above upper cut-off value 8. Serum creatinine > 2 x above cut-off value
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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, Cervix Cancer Patients with abnormal Pap smears who are referred for colposcopy Anyone of the male sex since this study focuses on cervical cell abnormalities Any woman who has had a hysterectomy, LEEP, or chemotherapy
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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, Cervical Cancer Patients must have histologically proven stage IVB, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy 2. Age greater than or equal to 18 3. All patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be greater than or equal to 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or greater than or equal to 10 mm when measured by spiral CT. Biopsy confirmation is required if the lesion measures < 30 mm or if the treating physician determines it is clinically indicated. Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by Response Evaluation in Solid Tumors (RECIST). This lesion should be the one that was biopsied if one was performed. Patients with tumors within and outside a previously irradiated field should have the lesion outside of the irradiated area preferentially designated as the "target" lesion. 4. Patients must have adequate Hematologic function: ANC greater than or equal to 1500/mm3; Platelets greater than or equal to 100,000/mm3; Hemoglobin greater than or equal to 8.0 g/dl Renal function: Serum creatinine less than or equal to 1.2 mg/dl. Patients with a serum creatinine greater than 1.2 mg/dl but less than 1.5 mg/dl must have a 24-hour creatinine clearance determination of > 50 cc/min to be eligible Hepatic function: Total Bilirubin must be within normal limits. Transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is less than or equal to ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are less than or equal to ULN 5. Patients must have a GOG Performance Status of 0 or 1. 6. Patients must have recovered from the effects of surgery, radiation therapy, or chemoradiotherapy. At least six weeks must have elapsed from the last administration of chemoradiotherapy, and at least three weeks must have elapsed from the last administration of radiation therapy alone. 7. Patients must have signed an approved informed consent form. 8. Patients must be free of clinically active infection. 9. Women of childbearing potential must have a negative pregnancy test. Women of childbearing potential must be willing to consent to using effective contraception while on treatment until they reach menopause Patients with bilateral hydronephrosis which cannot be alleviated by ureteral stents or percutaneous drainage. Patients with a serum creatinine greater than 1.2 mg/dl but less than 1.5 mg/dl with a 24-hour creatinine clearance determination of < 50 cc/min. 2. Patients with a serum creatinine of 1.5 mg/dl or greater. 3. Patients previously treated with chemotherapy except when used concurrently with radiation therapy 4. Patients with a history of severe hypersensitivity reaction to docetaxel, drugs formulated with polysorbate 80, fluoropyrimidine therapy or 5-FU. 5. Patients who are pregnant or lactating 6. Patients with craniospinal metastases or history of craniospinal metastases. 7. Patients with a concomitant malignancy other than non-melanoma skin cancer. 8. Patients with a prior invasive malignancy (except non-melanoma skin cancer) who have had any evidence of disease within the last 5 years or whose prior malignancy treatment contraindicates the current protocol therapy
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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): 18.0-30.0, Healthy Female through 30 years of age (must not have reached the 31st birthday) Unless previously surgically sterilized, agrees to use an effective method of birth control (e.g., abstinence, intrauterine contraceptive device, oral contraceptives, diaphragm or condom in combination with contraceptive jelly, cream or foam, Norplant® or DepoProvera®) beginning 30 days before the first study injection and continuing through 60 days after the final study injection Healthy by medical history and physical examination Cervical specimen positive for HPV-16 and/or HPV-18 DNA using the Digene Hybrid Capture® II HPV test within 21 days of study entry Cervical cytology by Pap smear that is either normal or no greater than ASCUS or AGCUS, using the Cytyc ThinPrep® Pap Test, within 21 days of study entry (a normal Pap smear must also be adequate for interpretation; a Pap smear that is normal but inadequate for interpretation must be repeated). Those volunteers with ASCUS or AGCUS must have had a clinical evaluation by colposcopy within the previous month which showed no evidence of CIN or SIL No evidence of anogenital HPV lesions or no physical findings suggestive of other gynecologic pathogens on pelvic examination within 21 days of study entry Agrees to no other experimental therapy or vaccines until 30 days after the last study injection Written informed consent obtained from the volunteer Acute illness or fever (oral temperature ³99.5°F [37.5°C]) at start of the study History or clinical manifestations of significant medical or psychiatric disorder Pregnant or lactating Use of immunosuppressive medication (inhaled and topical corticosteroids are permitted) within the previous 90 days or history of immunodeficiency History of cancer History of alcohol or drug abuse within the past 2 years At screening (must be within 21 days of study entry) any of the following: hemoglobin <11 gm/dL; white blood cell count <4000/mm3; platelet count <120,000/mm3; AST, ALT, creatinine >1.5x upper limit of normal for the laboratory in question; other abnormal laboratory values in the screening panel which in the opinion of the principal investigator are judged to be clinically significant Receipt of immunoglobulin or blood products within 90 days prior to study entry History of Pap smear more severe than ASCUS or AGCUS Positive tests for hepatitis C antibody, hepatitis B surface antigen, or HIV-1 antibody
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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, Papilloma Virus, Human Abnormal pap smear ASCUS or higher Age 18-postmenopausal Less than 18 years old Prior hysterectomy Pregnancy Use of corticosteroids HIV positive
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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 Histologically confirmed adenocarcinoma of the breast Clinical manifestations of metastatic disease If patient's tumor is HER2 positive (3+ by immunohistochemistry [IHC] or amplified by fluorescent in situ hybridization [FISH]), must have received at least one prior trastuzumab (Herceptin)-containing regimen unless there is a contraindication Measurable disease defined as at least one lesion whose longest diameter can be accurately measured The only evidence of metastasis must not be bone metastases or other non-measurable disease Nonmeasurable disease is defined as all other lesions, including small lesions (longest diameter < 2 cm) and truly nonmeasurable lesions which any of the following Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion
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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): 19.0-65.0, Cervical Cancer Women who have a diagnosis of cervical cancer 2. Women who are scheduled for either a radical hysterectomy or radical trachelectomy at the British Columbia Cancer Agency Vancouver Cancer Centre 3. Proficient in English No woman who meets the will be excluded from participating
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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): 26.0-999.0, Infections, Papillomavirus Papillomavirus Vaccines A woman who the investigator believes that she can and will comply with the requirements of the protocol A women of at least 26 years of age at the time of the first vaccination Written informed consent obtained from the subject prior to enrolment Free of obvious health problems as established by medical history and clinical examination before entering into the study Subject must have intact cervix Subject must have a negative urine pregnancy test. This test is not applicable to women of non-childbearing potential Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using an effective method of birth control for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series Pregnant or breastfeeding (women must be at least three months post-pregnancy and not breastfeeding to enter the study) A women planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose (Month 0 Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 84) Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0 the first dose of study vaccine. Planned administration/administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window Previous administration of components of the investigational vaccine Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period History of HPV infection/treatment or planned treatment to evaluate an abnormal cervical cytology (Pap smear) test, e.g. colposcopy Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination
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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): 18.0-45.0, Papillomavirus Infections A female subject of childbearing potential who is sexually active using contraception Subject is willing to abstain from all sexual contact involving her genitalia for at least 24 hours prior to and 24 hours after study drug administration Subject must be neither pregnant nor lactating from Screening throughout the duration of the study Subject has 1 of the following Menstruating with a stable cycle and has at least 21 non-bleeding days Amenorrheic (due to injectable or extended-cycle contraceptives) Subject is willing to refrain from using vaginal douche products during the treatment period and through the Follow-up Month 4 visit Subject has a Pap test interpretation of either low-grade squamous intraepithelial lesions or atypical squamous cells of undetermined significance Subject has a uterine cervical sample that is high-risk human papillomavirus positive The Subject has evidence of an uncontrolled, clinically significant medical condition as determined by the investigator The Subject has a history of hemorrhagic diatheses or coagulopathy The Subject has a history of toxic shock syndrome The Subject has received any of the following medications in the timeframes listed below (in any form) or an active (non-placebo) human papillomavirus vaccine at any time prior to the screening visit In the 4 weeks prior to the screening visit the subject has received Interferon therapy or other therapies that promote a proinflammatory immune state, including immunomodulators cytotoxic drugs drugs known to have major organ toxicity
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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, Cervical Cancer Cervical Intraepithelial Neoplasia CIN All women who are referred for cervical colposcopy to the University of Oklahoma will be considered eligible for the study. These women will be categorized into four groups: (i) cancer, (ii) precancer, (iii) HPV-infected, and (iv) normal. Cancers will be limited to women diagnosed with early cancer (Stage 1-2) to minimize potential disease effects. Precancers will be defined as women diagnosed histologically with cervical intraepithelial neoplasia 3 (CIN3). This is a highly specific and well-reproduced diagnosis which effectively represents carcinoma in situ. All women testing DNA positive for any of the 13 known oncogenic HPV types (HPV-infected), but not diagnosed with CIN3 or cancer (all stages) will be placed in the HPV-positive group. This group will therefore encompass all HPV-infected women diagnosed with either cervical intraepithelial neoplasia 1 (CIN1), CIN2, low grade squamous intraepithelial lesion (LSIL), atypical squamous cells of undetermined significance (ASCUS), atypical glandular cells of underdetermined significance (AGUS), or found cytologically normal. Women referred to the colposcopy clinic but found to be negative for oncogenic HPV and normal upon histological diagnoses will be eligible as normal controls; this approach will be an ethical method for collecting biopsies from essentially "normal" women as there are many benign "look alike" conditions that are ruled out in colposcopy clinics. While this group may not be a random sample of the general population, the use of specimens from these women as controls will ensure a group of women who are truly confirmed as having no neoplasia Women attending the clinic solely for vaginal colposcopies will be excluded from the study. Women who are under 18 years of age or pregnant at the visit will also be excluded from the study. In addition, women who have had prior treatment (women coming to the clinic for a follow-up visit subsequent to treatment (women coming to the clinic for a follow-up visit subsequent to treatment or women coming for their initial clinic visit following pretreatment with chemotherapy or radiation) will be excluded. All women with known HIV or AIDS will be excluded from the study. This information will not be readily available unless the woman has previously been seen at the University of Oklahoma clinic. This event is considered rare; recent studies of HIV and AIDS by the University of Oklahoma from the same population have been terminated due to the lack of HIV/AIDS detected in the population
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 20.0-75.0, Cervical Cancer Patients undertaken radical hysterectomy with diagnosis of invasive cervical cancer Ib-IIa (non-small cell type) Patients must have at least one of the following risk factors; pelvic lymph node involvemet, involvement of vaginal resection margin,parametrial invasion Patients must have a GOG performance of 0, 1, or 2 Patients must have expected life span over 6 months Patients with peripheral neurotoxicity over grade 2 in CTC criteria Patients with history of chemotherapy or radiation treatment Patients with histologicallly proven or highly suspected metastasis to paraaortic lymph node Patients with history of hypersensitive reaction to platinum agent
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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): 18.0-100.0, Cervical Neoplasia FOR PHASE OF STUDY: Less than 35 years of age. Intact uterus (non-hysterectomized). In good general health. Non-pregnant. For women not using OCs: Having regular cycles [cycles 25-35 days in length]. HPV16 seropositive [based on data from latest visit tested]. No evidence of HSIL/cancer [based on data from latest visit within cohort]. Willing to participate [informed consent]. FOR PHASE OF STUDY: Must be between the ages of 45 to 70 years. Women who do not have a final diagnosis of HSIL
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 21.0-999.0, HPV Women age 21 and older Non-pregnant, non-hysterectomized Pregnant women and women under the age of 21 will not be included in this study
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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, Prostate Cancer Colorectal Cancer Breast Cancer Cervical Cancer Lung Cancer Enrolled in Medicare Part B Self-reported American Indian Have cancer other than study cancer Medicare Part C enrolled
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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): 18.0-50.0, Malignant Breast Cancer, Benign Breast Lesions Women carrying benign breast lesions will be further divided and analyzed according to the Fitzgibbon's risk categories for invasive cancer risk (4). The Fitzgibbon's categories are: 1. No increased risk group including adenosis (other than sclerotic), duct ectasia fibroadenoma without complex features, 2. slightly increased risk group (1.5-20 times) which includes fibroadenoma with complex features, moderate or florid hyperplasia without atypia, sclerosing adenosis, 3. moderately increased risk group (4.0-5.0 times) includes atypical ductal and lobular hyperplasia and 4. markedly increased risk group (8.0-10.0 times) which includes ductal and lobular carcinomas In Situ Following the blood collection, detailed relevant clinical information of the patient will be registered in a case record form. The data will age, country of birth, last menstrual period, lactation, number of children, age at first full-term pregnancy, age at onset of menopause, family history, medication, mammography findings, FNA results, tumor size, histological findings, biopsies, disease staging, and other relevant clinical information pregnancy, 2. experiencing menstruation, or 3. under hormonal or drug treatment
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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): 18.0-70.0, Uterine Cervical Cancer Age between 18 and 70 years old Cervical uterine cancer (epidermoid or adenocarcinoma, stage:from IB> or = 4 cm to IV, according to FIGO classification) histologically proven Measurable lesions,clinically and by MRI assessed PS-WHO < or = 2 ou Karnofsky Index >70 per cent Life expectancy > 3 months Hematologic function: leukocytes < or = 3 G/l, polynuclear neutrophil leukocytes > or = 1.5 G/l, platelets > or = 100 G/l, hemoglobin > or = 10 g/dl Hepatic function: ASAT and ALAT < 2.5 ULN Renal function: creatininemia < 1.5 ULN, clearance > 60 ml/min No prior chemotherapy or radiotherapy Contraception Stage IB < 4 cm or IVB Other histology than epidermoid or adenocarcinoma Distant metastases, including sus-clavicular adenopathy Contraindication to MRI Pregnant or lactating woman Auto-immune disease Peripheric neuropathy, autograft or homograft, psychiatric disease Prior cancer (except cutaneous basocellular carcinoma and uterine cervical carcinoma in situ) Active infection Other clinical trial with an experimental drug
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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): 21.0-100.0, Cervical Neoplasia Women in KPNC aged 25 years or older who tested positive for HPV. Will also a random sample of women who tested negative for HPV Male. Children under 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): 18.0-999.0, Hematological Malignancies Histologically or cytologically confirmation of AML, MDS, CML in blast phase, myelofibrosis, CLL, or aplastic anemia There are no limitations on additional, allowable type and amount of prior therapy as long as acute toxicities have resolved to the allowable grade Must have normal organ functions Must be willing to submit to blood sampling for the planned PK and PD analyses Must have the ability to understand and willingness to sign a written informed consent form No other agents or therapies administered for the intent to treat Uncontrolled, intercurrent illness Pregnant women and women who are breast feeding
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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): 26.0-65.0, Cervical Intraepithelial Neoplasia Five-hundred women attending colposcopy and 500 women receiving cytology screening, including 250 unscreened women, will be recruited for the study. Non-pregnant, non-hysterectomized women aged 26-65 will be recruited Women under 26 or over 65 years of age. Pregnant women or women having given birth to a child in the past 8 weeks. To insure women included in the study are not pregnant, we will ask women during the consenting process if they are pregnant. Women who answer yes for either query will be excluded. Participants will also receive a reminder call for their 2-week self-collection. At that time, women again will be asked if they are pregnant. If any woman answers yes, she will be instructed to not self-collect. Women who have had a total hysterectomy. Women who have an overt cancerous lesion visible upon exam by the clinician. Other reasons to women the inability to speak English, the appearance of mental incompetence, or refusal to participate or sign the informed consent form
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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, Cervical Cancer Precancerous Condition Underwent Pap smear, human papillomavirus (HPV) testing, and HIV testing AND meets any of the following Biopsy and colposcopy confirmed cervical intraepithelial neoplasia (CIN) or invasive cervical cancer (ICC), meeting any of the following CIN grade 2-3 or higher Repeated CIN1 (times 6) Abnormal Pap smear (atypical squamous cells of undetermined significance [ASCUS] or worse) HIV seropositive Negative cytology but positive for high-risk human papillomavirus (HPV) Negative cytology and negative HPV HIV negative (without biopsy-proven CIN 3 or worse) and high-risk HPV infection (types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 55, 56, 58, 59, 68, 82, 83, 73) >= 18 years of age < 18 years of age Pregnant at screening Cervix not intact not able to provide informed consent
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1
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 25.0-65.0, Cervical Cancer Screening Women from 25 to 65 years of age, registered with the Medical Services Plain in BC attending a collaborating healthcare provider for routine cervical screening in Metro Vancouver or Greater Victoria pregnant 2. history of invasive cervical cancer 3. no cervix 4. HIV positive or on immunosuppressive treatments 5. unable or unwilling to give informed consent 6. Treatment of moderate or greater dysplasia within last 5 years
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-999.0, Cervical Cancer Histologically confirmed carcinoma of the cervix, including any of the following subtypes Squamous cell carcinoma Adenocarcinoma Adenosquamous cell carcinoma Locally advanced disease (i.e., FIGO stage IB2-IVA disease) Stage confirmed by examination under anesthesia, cystoscopy, and sigmoidoscopy with biopsy of any suspicious lesions in the bladder, vagina, or rectum Disease suitable for treatment with radical intent using chemoradiotherapy ECOG performance status 0-1 Platelet count > 100,000/mm^3 Hemoglobin > 12.5 g/dL
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 0.0-999.0, Cervical Cancer Precancerous Condition First mildly dyskaryotic Pap smear or a second borderline Pap smear taken within the Cervical Screening Wales program Patients under surveillance following treatment for high-grade cervical intraepithelial neoplasia are not eligible No clinical suspicion of a concurrent invasive cervical cancer No invasive cancer within the past 3 years No known HIV positivity Not pregnant or nursing Not planning to become pregnant within the next 6 months PRIOR No concurrent immunosuppressive drugs, warfarin, or theophylline No concurrent proton pump inhibitor drugs for ulcer or reflux disease (i.e., rabeprazole, esomeprazole magnesium, lansoprazole, omeprazole, or pantoprazole sodium)
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 18.0-70.0, Cervical Cancer Abnormal Pap smear findings indicating the need for further treatment at the colposcopy clinic Scheduled for colposcopy at the Comprehensive Cancer Center of Wake Forest University No history of invasive cervical cancer Must be of Hispanic background, including any of the following Hispanic Latino Chicano Mexican American Puerto Rican Cuban American PRIOR
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 21.0-999.0, Ovarian Cancer Cervical cancer (stage I, II, or III) patients who have completed definitive treatment at least 2 months earlier and who were diagnosed between 9 and 20 months prior to enrollment Stage IV cervical cancer Have undergone previous treatment with biological response modifier or prior immunotherapy within 4 weeks of study enrollment Used investigational drugs within 30 days Were under immune suppression for any reason
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 0.0-999.0, Cervical Cancer Patients with stage IB2-IVA cervical cancer who are candidates for treatment with radiotherapy and concurrent chemotherapy Patients with biopsy-proven cervical carcinoma, any histology Patients must have no evidence of para aortic lymphadenopathy (< 2cm in diameter) on the preoperative computed tomography (CT) or magnetic resonance imaging (MRI) scan of the abdomen and pelvis Patients must sign an IRB approved informed consent Patients with adequate bone marrow, renal and hepatic function: White Blood Count (WBC) >/= 3,000 cells/mcl, Platelets >/= 100,000/mcl, Creatinine </= 2.0 mg%, Bilirubin </= 1.5 x the upper limit of normal and Serum glutamic pyruvic transaminase (SGPT) </= 3 x the upper limit of normal Zubrod Performance Status of 0, 1, or 2 Patients must be suitable candidates for surgery Patients who had a PET/CT scan prior to study entry are eligible if a) the study was done within 4 weeks of surgery, and b) they have no evidence of para aortic lymphadenopathy (< 2cm in diameter) on either a preoperative CT or MRI scan of the abdomen and pelvis Patients who have had prior retroperitoneal surgery Patients who have received prior pelvic or abdominal radiotherapy Patients known to have upper abdominal intraperitoneal disease or evidence of ovarian metastases Patients who are pregnant Patients with evidence of distant metastases on chest x-ray, CT or MRI scan or by physical examination Patients with contraindications to laparoscopy
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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 Neoplasia Women 18 years of age or older. 2. Women who have been referred for screening at U.T.M.D. Anderson Hospital, Houston, TX USA; U.T. Health Science Center-Houston,TX USA; Lyndon B. Johnson General Hospital, Houston, TX USA; British Columbia Cancer Agency, Vancouver, British Columbia, Canada; and the University College Hospital, Ibadan, Oyo State, Nigeria, Africa Cervical Screening Clinics, Family Planning Clinics or Gynecology Clinics. 3. Patients must sign an informed consent indicating awareness of the investigational nature of the study Patients will be considered ineligible if they are pregnant. 2. If they have a history of an abnormal Pap or a treatment to the cervix
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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 Women who are at least 18 years of age. 2. Women who speak English 3. Women presenting to the Colposcopy Clinic in the Gynecologic Oncology Clinic at M.D. Anderson Cancer Center OR women with an established diagnosis of either Stage IA2 or IB1 cervix cancer treated with radical hysterectomy 3-24 months prior to presenting to the Gynecologic Oncology Women who are not 18 years of age. 2. Women who are non-English speakers. 3. Women with a diagnosis of any type of cancer other than cervical cancer. 4. Women who are currently pregnant
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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 Cancer Women 18 and older with an abnormal Pap Pregnant individuals will be excluded from this study
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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): 23.0-999.0, Normal Uterine Cervical Cytology Uterine Cervical Dysplasia Uterine Cervical Neoplasms Women with cervical dysplasia been referred to conisation Women invited to cervical screening program and with only normal smear and normal smears in their history Women not performing the tampon self-test before conisation Women not performing the tampon self-test at least 3 month after having a normal PAP-smear taken
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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, Cervical Cancer Patients 18 years and older Non-pregnant Patients with abnormal smears with cervical intraepithelial neoplasia (both low grade squamous intraepithelial lesions and high grade squamous intraepithelial lesions equal to cervical intraepithelial neoplasia 1-3) Patients who have had cytotoxic chemotherapy within 12-months prior to enrolling in this study, since the chemotherapy often induces change in the cervix
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2
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 12.0-15.0, Infections, Papillomavirus Study participants who the investigator or delegate believes that they and/or their parents/legally acceptable representative can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study A male or female between, and including, 12 and 15 years of age at the time of the first vaccination. A written informed assent must be obtained from all study participants prior to enrolment. In addition, a written informed consent must be obtained from the study participants' parent or legally acceptable representative. Note: As according to the Finnish law legal age of consent is 15 years, a written informed consent form can be obtained from study participants aged 15 years old and their parent(s)/legally acceptable representative(s) will receive a letter informing them of their child participation to the study Healthy male and female study participants as established by medical history before entering into the study. If needed, a history-directed clinical examination will be performed by the investigator or delegate (e.g. study nurse) Study participants must not be pregnant. Absence of pregnancy should be verified (e.g. urine pregnancy test) as per investigator's or delegate's clinical judgement If the study participant is female, she must be of non-childbearing potential, i.e. be abstinent, have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal or pre-menarcheal, or if she is of childbearing potential, she must use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series Previous vaccination against HPV or Hepatitis B virus History of allergic disease or reactions likely to be exacerbated by any component of the vaccines Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F) / Rectal temperature <38°C (100.4°F).) Pregnant or lactating female
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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): 21.0-999.0, Locally Advanced Cervical Cancer stage IB2-IVA , histological proven cervical carcinoma no previous diagnosis of carcinoma no prior history of chemotherapy or radiotherapy ECOG less than or equal to 2 Above 21 years old medically fit for radical concurrent Cisplatin based chemotherapy and radiotherapy Hemoglobin >10g/dL Adequate hematological, renal and hepatic function according to all of the following laboratory values Absolute neutrophil count ≥ 1.5 ×109/l Platelets ≥ 100 ×109/l Age below 21 Presence of known HIV infection, chronic hepatitis B or hepatitis C infection Psychological, familial, sociological, or geographical condition that would preclude study participation Prior (within the last 3 years) or simultaneous malignancies (other then cutaneous basal cell carcinoma or non-invasive tumors) Patients with the following histologies are excluded: small cell, carcinoid, glassy cell, clear cell and adenoid cystic Life expectancy < 6 months Patients with insulin dependent diabetes Prior tumor-directed surgery Previous systemic chemotherapy or pelvic radiation therapy As radiation and cytotoxic agents are contraindicated in pregnancy, pregnant women are ineligible and those of childbearing potential should use contraception
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 30.0-999.0, Human Papillomavirus Clearance at 12 Months Biopsy-confirmed LSIL patients Age more than 30 years-old Baseline HPV testing is positive Be able to give their informed consent to this study Having active cervical infection Having lesion of 2 mm-larger than probe Having lesion inside cervical os Having suspected cervical cancer lesion
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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, Cervix Cancer Histological diagnosis of cervix cancer Prescription of radiation treatment to the primary cancer Prior radiation treatment to the pelvis
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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 Ovarian Cancer Families referred for genetic counseling consultation at Memorial Hospital Individuals self-referred or physician referred for genetic counseling due to a concern about increased risk for breast cancer, regardless of family history or ethnic origin Individuals enrolled in MSK protocol 97-029 "Germline BRCA1 and BRCA2 mutations in Jewish Women Affected by Breast Cancer" who wish to have full sequencing or who wish to have commercial testing in addition to testing done as part of that study Individuals who present for genetic counseling consultation at Memorial Hospital after undergoing genetic testing at an outside institution Member of a family with breast cancer who wishes to provide a DNA sample for research purposes Individuals enrolled on protocol 12-245 with germline variants in genes associated with risk for breast or ovarian cancer, or absent such variants in the presence of a family history or other phenotypic features of interest including but not limited to: triple negative breast cancer, early onset of disease, and/or synchronous or metachronous breast and ovarian cancer -Patients will be excluded from this study if: he/she has physical, cognitive or psychiatric conditions that interfere with ability to give meaningful informed consent; he/she cannot read, write or communicate in English; he/she is 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): 18.0-45.0, Cervical Cancer Patients should be suitable surgical candidates and completed the surgical consenting process with their gynecologic oncology surgeon Confirmed invasive cervical cancer: squamous, adeno, or adenosquamous FIGO Stage IA1 with lymph-vascular space involvement or stage IA2-IB2) Consented for a radical trachelectomy (vaginal/abdominal) or radical hysterectomy (laparoscopic/abdominal) Have not started or completed childbearing Strong desire to preserve fertility (trachelectomy group only) At least 18 years of age and not older than 45 years at the time of treatment Able to read/ speak the English language Able to provide informed conse Inability to participate in an informed consent process Patients with a psychiatric disorder precluding response to the survey Patients that are upstaged at the time of surgery and will require adjuvant therapy
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 0.0-999.0, Cervical Cancer Endometrial Cancer Cervical Carcinoma Patients with endometrial cancer diagnosed on endometrial biopsy or dilatation and curettage Patients with invasive cervical cancer diagnosed on cervical biopsy or cone biopsy Patients with a performance status of 0, 1, 2, or 3 by the Gynecologic Oncology Group (Appendix) Patients with stage I to ~IIA invasive cervical cancer disease according to the International Federation of Gynecology and Obstetrics (FIGO) clinical staging (Appendix) Patients with clinical stage I endometrial cancer Patients who will undergo surgery to a hysterectomy, radical hysterectomy and/or radical trachelectomy and bilateral lymphadenectomy via laparotomy or laparoscopy Patients who have signed an approved informed consent Patients with history of prior pelvic or para-aortic lymphadenectomy Patients with stage IIB-IV invasive cervical cancer by FIGO criteria Patients with recurrent endometrial or cervical cancer Patients with prior pelvic radiation Any patient with endometrial or cervical cancer treated with neoadjuvant chemotherapy and radiation therapy Patients with a performance score of 4 by the Gynecologic Oncology Group or who are not good surgical candidates (Appendix) Patients with grossly infected primary tumors Patients with known allergy to triphenyl-ethane compounds Patients with known deficiency of Glucose-G-Phosphate Dehydrogenase Patients with known Hemolytic Anemia from Pyruvate Kinase and G6PD Deficiencies
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0
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 0.0-999.0, BRCA1 Mutations For acquisition of control specimens, samples already collected under IRB approved protocol 99-030 will be used. This protocol was a tissue and blood acquisition protocol entitled "Collection of Tissue, Blood, and Cells to Be Used for Studying the Causes, Prevention, Diagnosis, and Treatment of Breast Cancer". Patients have already given consent and signed a research authorization for to use their blood specimens for this purpose. Controls will also be collected from patients who have previously undergone genetic counseling through the Clinical Genetics Service at MSKCC and tested negative for a germline mutations in BRCA1. These individuals will be approached and asked to donate a sample at the time of their results appointment. Blood samples from cases will be collected from patients who have tested positive for a germline mutation in BRCA1. These women will have been participants in MSKCC protocols such as 96-51 and 97-29, or tested at outside institutions and receiving followup care at MSKCC. Any patient with a presumed pathogenic mutation in BRCA1 will be eligible for inclusion Subjects will be eligible without regard to age, racial, or ethnic status. Subjects with any personal history of cancer will be excluded. Attending physicians authorized to obtain informed consent may exercise discretion in excluding individuals for appropriate medical or other (e.g., minors, mentally impaired) reasons. Patients with an unclassified variant in BRCA1 will be excluded as the functional significance of these variations is unknown
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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): 18.0-55.0, Healthy Men and women Aged 18 to 55 years BMI between 18 and 30 kg/m2 No prescription or over-the-counter medication for previous 14 days Negative tests for drug and alcohol abuse HIV, hepatitis B and hepatitis C and Healthy based on medical history, physical examination, 12-lead electrocardiograms, toxicology, antigen, antibody screens, and clinical laboratory evaluations Allergic reaction to quinolones clinically significant ECG or clinical laboratory abnormalities creatinine clearance <=80 mL/min acute illness within 7 days receipt of experimental drug or device within 60 days pregnant or breastfeeding
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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, Cervical Cancer Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix Patients with Histologically confirmed stage IA1 (with lymph vascular invasion), stage IA2, or stage IB1 disease Patients undergoing either a Type II or III radical hysterectomy (Piver Classification) Patients with adequate bone marrow, renal and hepatic function ECOG Performance Status of 0 or 1 Patient must be suitable candidates for surgery Patients who have signed an approved Informed Consent Patients with a prior malignancy allowed if > 5 years ago with no current evidence of disease Females, aged 18 years or older Negative serum pregnancy test within <30 days of surgery in pre-menopausal women and women < 2 years after the onset of menopause Any histology other than adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix Tumor size greater than 4 cm FIGO stage II-IV 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 studies, enlarged pelvic or aortic lymph nodes > 2cm; or histologically positive lymph nodes Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) Patients unable to withstand prolonged lithotomy and steep Trendelenburg position Patient compliance and geographic proximity that do not allow adequate follow-up
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0
|
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
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eligible ages (years): 0.0-999.0, Cervical Cancer Patients who are dispositioned to undergo radical hysterectomy or radical trachelectomy and pelvic lymphadenectomy. 2. No evidence of metastases on computed tomography, magnetic resonance imaging, or PET/CT scan. 3. Patients must be good surgical candidates. 4. Patients who have signed an approved informed consent and authorization permitting release of personal health information. 5. For patients of child-bearing age, a negative serum pregnancy test within 72 hours prior to injection of radiocolloid. Child-bearing potential is defined as not post-menopausal for 12 months or no previous surgical sterilization Patients with known allergies to triphenylmethane compounds or India ink. 2. Patients with a history of retroperitoneal surgery. 3. Patients with a history of pelvic irradiation. 4. Patients who had a cold knife or LEEP cone biopsy within 4 weeks of enrollment
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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 Precancerous Condition Referred to the Colposcopy clinic at Vancouver General Hospital, the MD Anderson Cancer Center, or the University of Texas at Austin Abnormal or normal Papanicolaou smear Hormone receptor status not specified Pre or post-menopausal Not pregnant PRIOR Not specified
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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): 18.0-64.0, Cervical Cancer Female presenting to clinic for a Pap test for any reason Pregnant Prisoners Mentally unable to provide informed consent
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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): 15.0-25.0, Infections, Papillomavirus Female between and including 15 and 25 years of age at the time of screening (must not have reached 26th birthday) Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must also be obtained from a parent or legal guardian of the subject) Free of obvious health problems, as established by medical history and a directed physical examination No more than 6 lifetime sexual partners prior to enrolment Intact uterus Subject must be of non-childbearing potential, i.e., either surgically sterilised or, if of childbearing potential, she must be abstinent or must be using an effective method of birth control for 30 days prior to vaccination, have a negative urine pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series For subjects not enrolled in the HPV epidemiology study (999910/106) and for subjects completing the study (999910/106) >90 days prior to enrolment in the present study: agreement to complete both entrance and exit study questionnaires concerning general personal information, and sexual, contraceptive, reproductive and other gynaecological medical history For subjects previously enrolled in the HPV epidemiology study (and who completed the study and an entrance questionnaire) ≤ 90 days prior to enrolment in the present study: agreement to complete the exit questionnaire only Normal cervical cytology (Pap smear) at screening, using the Cytyc ThinPrep® Pap Test. A normal Pap smear must also be adequate for interpretation, including the presence of endocervical cells; a Pap smear that is normal but inadequate for interpretation must be repeated as part of the protocol Seronegative for HPV-16 and HPV-18 antibody by ELISA at screening Pregnant or lactating female Female planning to become pregnant during the first eight months of the study (months 0-8) Abnormal vaginal discharge at the time of entry (once these subjects have received therapy to eradicate any discharge they will be eligible to participate in study) Previous administration of any components of the investigational vaccine Chronic administration (defined as more than 14 days) of immuno-suppressants or other immune-modifying drugs within six months prior to the first vaccine dose Administration of immunoglobulin and/or any blood products within the three months (90 days) preceding the first dose of study vaccine or planned administration during the study period Planned administration / administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine. Administration of routine Meningococcal, Hepatitis A, Hepatitis B, Influenza, and Diphtheria/Tetanus vaccine up to 8 days before the first dose of study vaccine is allowed Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period Receiving or expecting therapy for external or internal condylomata. Subjects with external condylomata not requiring therapy are eligible to participate in the study Genital herpes disease involving the cervix or characterized (on examination or by history) by extensive external lesions. Subjects with a history of recurrent genital herpes disease characterized by limited external lesions are eligible to participate in the study
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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): 16.0-999.0, Cancer Cholangiocarcinoma Liver The surgical protocol will initially be offered to liver transplant candidates with de novo hilar CCA or CCA arising in the setting of PSC. Diagnosis of CCA will be established by intraluminal brush cytology, intraluminal biopsy, or a carcinoma antigen (CA) 19.9 level greater than 100 ng / mL in the setting of a radiographic malignant stricture. Biliary aneuploidy demonstrated with DIA and FISH will be considered equivalent to cytology. All patients with CCA will be evaluated by the liver transplant team which includes experienced hepatobiliary and liver transplant surgeons. Patients will be presented at the weekly liver transplant selection conference to assess their candidacy as well as the weekly GI Multidisciplinary Tumor Conference at the Huntsman Cancer Institute. Clinical staging prior to neoadjuvant therapy will chest and abdominal computed tomography, liver ultrasound, and bone scan. Patients will also undergo endoscopic ultrasound with fine needle aspiration of suspicious lymph nodes. All patients will undergo staging laparoscopy to rule out the presence of peritoneal disease followed by staging laparotomy. Patients with N1 disease (metastasis to lymph nodes within hepatoduodenal ligament) will remain eligible for the protocol. Tumor size will not be included in the Patients with evidence of disease progression beyond study will not be eligible to continue on to liver transplantation. ** Patients with metastatic disease are not eligible for this trial ** will previous chemotherapy or radiotherapy uncontrolled infection a previous malignance other than non-melanoma skin cancer or in situ cervical cancer within the last five years medical conditions precluding transplantation metastatic disease (including N2 disease), and patients with hilar tumors extending below the cystic duct. Patients with extrahepatic metastases, local spread of disease to adjacent organs, and N2 nodal disease (metastasis to peripancreatic, periduodenal, periportal, celiac, superior mesenteric, and / or posterior pancreaticoduodenal nodes) will be excluded as will patients with extension of tumor into the main portal vein
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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): 21.0-999.0, Human Papilloma Virus (HPV) Females ≥ 21 years of age presenting for routine cervical cancer screening An intact cervix Willing and able to undergo colposcopy and biopsy and endocervical curettage within 8 weeks after study Visit 1 Known pregnancy at study Visit 1 Presenting for colposcopy at study Visit 1 Any condition resulting in increased risk of bleeding at biopsy Hysterectomy Known history of ablative or excisional therapy to the cervix within the preceding 12 months
|
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, Fallopian Tube Clear Cell Adenocarcinoma Fallopian Tube Endometrioid Adenocarcinoma Fallopian Tube Mucinous Adenocarcinoma Fallopian Tube Serous Adenocarcinoma Fallopian Tube Transitional Cell Carcinoma Malignant Ovarian Brenner Tumor Ovarian Clear Cell Adenocarcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Mucinous Adenocarcinoma Ovarian Seromucinous Carcinoma Ovarian Serous Adenocarcinoma Ovarian Transitional Cell Carcinoma Primary Peritoneal Serous Adenocarcinoma Stage IIA Fallopian Tube Cancer AJCC v6 and v7 Stage IIA Ovarian 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 IIIA Fallopian Tube Cancer AJCC v7 Stage IIIA Ovarian Cancer AJCC v6 and v7 Stage IIIA Primary Peritoneal Cancer AJCC v7 Stage IIIB Fallopian Tube Cancer AJCC v7 Stage IIIB Ovarian Cancer AJCC v6 and v7 Stage IIIB Primary Peritoneal 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 IV Fallopian Tube Cancer AJCC v6 and v7 Stage IV Ovarian Cancer AJCC v6 and v7 Stage IV Primary Peritoneal Cancer AJCC v7 Undifferentiated Fallopian Tube Carcinoma Undifferentiated Ovarian Carcinoma Patients with a histological diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, clinical stage II, III or IV at diagnosis Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner?s tumor or adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of the tumor must be compatible with a primary M?llerian epithelial adenocarcinoma Patients must have completed all primary chemotherapy and consolidation therapy (if administered) at least 6 weeks, and no more than 6 months and 2 weeks, prior to enrollment and must be in complete remission; consolidation therapy is defined as any chemotherapy or biological therapy used for a patient who has completed at least four courses of primary chemotherapy and had documented complete remission prior to initiation of such chemotherapy (chemo) or biological therapy Patients must have achieved a documented complete response to treatment based on normal cancer antigen (CA)-125 (per the institution?s upper limit of normal) and computed tomography (CT) scan or magnetic resonance imaging (MRI) with contrast (i.e. there must be no clinical evidence of persistent or recurrent disease based on CA-125 and CT scan or MRI with contrast) Patients must have a Gynecologic Oncology Group (GOG) performance grade of 0, 1, or 2 Patients must not be currently enrolled in an ongoing (participating for 6 months or longer) medically prescribed diet or physical activity regimen Patients must have no other chronic disease that would preclude randomization into a lifestyle intervention trial; such diseases recent myocardial infarction or unstable angina (in the previous 6 months), chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction and diabetics receiving insulin; or other clinical condition limiting ability to walk (recent leg fracture, significant osteoarthritis, related orthopedic conditions, degenerative neurological conditions, etc.) Patients must not have a serious psychiatric illness (e.g. lifetime bipolar disorder, schizophrenia or other psychosis, serious personality disorder, severe major depressive disorder or recent suicide or psychiatric hospitalization) (previous 12 months), or a history of an eating disorder (anorexia nervosa or bulimia nervosa) Patients must complete all pre-entry assessments Patients must have signed an approved informed consent and authorization permitting release of personal health information Patients with GOG performance grade of 3 or 4 Patients may not have a history of other invasive malignancies within the last five years, with the exception of non-melanoma skin cancer or stage 1A endometrioid adenocarcinoma of the uterus Patients diagnosed with chronic disease/illness precluding their participation (i.e., diabetics receiving insulin, myocardial infarction or unstable angina within previous 6 months, chronic hepatitis, rheumatoid disease, renal or hepatic disease/dysfunction) Patients with a histological diagnosis of clinical stage I epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma Patients who are currently undergoing treatment (primary or consolidation) for stage II, III or IV ovarian, fallopian tube or primary peritoneal cancer or who completed treatment less than six weeks ago Patients with a life expectancy of less than one year Patients with body mass index (BMI) < 20 kg/m^2 Vegan vegetarians Patients enrolled in a weight loss program or who are taking weight loss medications or dietary supplements and are unwilling to discontinue Patients who have participated in a marathon, triathlon, or other endurance-related physical activity within the previous 24 months
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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, Postoperative Nausea and Vomiting All of the following must be met for the potential subject to be eligible for participation: 1. The subject is a female scheduled to undergo ambulatory breast surgery performed under general anesthesia 2. The subject is expected to undergo general inhalation anesthesia. 3. The subject presents with two of the three following high-risk factors associated with PONV (must be in their medical history in order to be eligible) She is a non-smoker She has documented history of PONV and/or motion sickness She is expected to receive intra-operative and postoperative opioid. 4. The subject's American Society of Anesthesiologist physical status is ASA I-III 5. The subject is between18 to 65 years of age. 6. The subject is expected to be discharged from the hospital/surgical center on the same day as the surgery. 7. The subject has provided written informed consent to participate in the study. If any of the following are met, the potential subject is NOT eligible for participation: 1. The subject has a history of allergic reaction to, intolerances of or contraindications for any of the study medications or required anesthetic agents. 2. The subject has received or is expected to receive any excluded preoperative drug within 48 hours prior to induction; or is expected to receive any excluded intra-operative or postoperative medications. 3. The subject is pregnant or lactating. (If the potential subject is pre-menopausal, a urine pregnancy test must be performed within 24 hours/1 day of study prior to the planned surgery time and confirmed negative in order for the potential subject to be enrolled). 4. The subject is taking warfarin. 5. The subject has a history of alcohol and/or drug abuse within 1 year of study medication, or has a positive screening or pre-study test for alcohol or drugs of abuse. 6. The subject is expected to require the use of a nasogastric tube postoperatively. 7. The subject has a diagnosed latex allergy. 8. The subject has used oral aprepitant (Emend®) within the last 30 days. 9. The subject has participated in a randomized study or has been exposed to any experimental drug within 30 days prior to enrollment of this study
|
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, Cervical Cancer years and older Ability to speak and clearly understand English Female patients No previous history of Cervical Cancer Treatment(LEEP,Laser,Cone etc.) Women who have had Pap smears within the previous 10 months Women under the age of 18 Women who are pregnant Inability to give informed consent in English
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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.
|
eligible ages (years): 18.0-999.0, Warts Subject is 18 years of age or older and has anogenital warts Physician confirmed clinical diagnosis of anogenital warts Subject is capable of understanding the study and the content of the consent form and has agreed to participate in the study by signing the informed consent Subject will be available for the study follow up period Subject is unable to give informed consent Subject has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives such as other concurrent/active STI
|
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): 18.0-45.0, Healthy Males or females between 18 and 45 years of age, inclusive, at screening and in good general health based on medical history, physical examination, and laboratory evaluation If female, must be (as documented by patient reported medical history) postmenopausal (at least 1 year without spontaneous menses), or surgically sterile (tubal ligation or hysterectomy), or using acceptable contraception [e.g., sexual partner with non-reversed vasectomy (with azoospermia in 2 tests), 2 barrier methods (e.g., condom, diaphragm, or spermicide), or intra-uterine device] Body mass index (BMI) between 18 and 32 kg/m2, inclusive Able to swallow the assigned study medication tablet whole; and Able to fulfill the requirements of the protocol and provide written informed consent History or presence of any condition or gastrointestinal (GI) surgery causing malabsorption or an effect on GI motility Any uncontrolled acute disease or major surgical operation requiring hospitalization within 1 month of screening History of diabetes, syncope, cardiovascular, hepatic, or renal disease Uncontrolled chronic diseases such as hypertension, systemic lupus erythematosus, or rheumatoid arthritis History of cancer within the last 5 years (except for basal cell carcinoma with a documented 6-month remission) Any known enzyme-inducer, enzyme-inhibitor, or reported chronic exposure to enzyme-inducers such as paint solvents or pesticides within 30 days of treatment Any prescription drug or herbal remedy within 14 days prior to scheduled dosing
|
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): 0.0-999.0, Pelvic Inflammatory Disease women admitted to Emergency with pelvic-inflammatory disease or tubo-ovarian abscess from the year range: 1995-2000
|
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): 16.0-50.0, Bacterial Vaginosis Women will be included whether their complaint is symptoms of BV and have a positive whiff test/vaginal swab or if they have a positive whiff test/vaginal swab and are then asked if they have any symptoms of BV present. The following must be met for enrolment in the study: 1. ages 16-50 and premenopausal; 2. capable of giving written informed consent; 3. English speaking; 4. negative pregnancy test on enrolment day; 5. agree to follow study protocol; 6. documented BV infection by positive vaginal swab +/ positive whiff test/pH > 4.5; 7. agree to no intercourse for the 10 days of treatment (or to use non-lubricated condoms if unavoidable); 8. agree not to douche or use any intravaginal products during treatment (including tampons, medications, devices); 9. abstain from alcohol during the 10 days of treatment (from 24 hours before through 72 hours after taking study medication); 10. agree to no new medications or antibiotics during treatment; 11. no current sexually transmitted infection as determined by history, physical exam and negative swabs for chlamydia, gonorrhea, candidiasis, trichomonas; 12. patient is reliable for follow up The following women would be excluded from study participation: 1. less than 16 or post-menopausal; 2. negative vaginal swab regardless of whiff test/pH > 4.5; 3. menstruating at diagnosis; 4. symptoms so severe as to make allocation to placebo unacceptable to the patient; 5. currently pregnant or at high risk for pregnancy; 6. current sexually transmitted infection (HIV, hepatitis, chlamydia, gonorrhea, trichomonas, HPV or HSV); 7. current yeast infection as determined by history, physical and swabs; 8. history of PID; 9. allergy to latex or metronidazole; 10. presently lactating; 11. any open wound, excoriation, vaginal irritation and including bartholin's cyst/abscess as determined by physical exam; 12. presence of another vulvar, vaginal or medical condition, including cervical neoplasia treatment, that might confound treatment response; 13. using lithium, anti-coagulants or disulfiram drugs; 14. any antifungal or antibiotic use 14 days prior to enrolment 15. PAP smear done within one week of enrollment
|
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): 30.0-49.0, Human Papillomavirus 18 Cervical Intraepithelial Neoplasia Human Papillomavirus 16 Uterine Cervical Neoplasms Females who are 15 years to 99 years of age Previous hysterectomy Current pregnancy Inability to give informed consent
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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): 18.0-65.0, Cervical Cancer Patients with newly histologically confirmed cervical carcinoma Original clinical stage must be Ib~IIa （FIGO） Age between 18-65 With the presence of these four factors after radical surgery:(1)positive lymph nodes,(2)positive parametria, or positive surgical margins,(3)positive lymphatic vascular space,(4)outer one-third invasion of the cervical stroma More than 3 months survival is to expect Patients must give signed informed consent The presence of uncontrolled life-threatening illness Receiving other ways of anti-cancer therapy Residual tumor which can not be removed in the surgery Investigator consider the patients can't finish the whole study With normal liver function test (ALT、AST>2.5×ULN) With normal renal function test (Creatinine>1.5×ULN) WBC<4,000/mm3 or PLT<100,000/mm3 Receive the external pelvic irradiation before the surgery
|
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): 25.0-50.0, Pain All patients schedule for laparoscopic tubal ligation Not willing to consent Use of analgesic within 12 hours prior the surgery Known allergy or contraindications to bupivacaine, dipyrone, porphine, or sodium diclofenac
|
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): 18.0-40.0, Cervical Cancer Women with histologically confirmed, primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix 2. Patients with FIGO stage IA1 (with lymph vascular space invasion), IA2, or IB1 disease 3. Patients must be suitable candidates for surgery 4. Patients who have signed an approved Informed Consent 5. Patients with a prior malignancy allowed if > 3 years previous with no current evidence of disease 6. Females older than 18 years who are undergoing radical trachelectomy 7. Women must be able to read and write in either Spanish or English Any histological type other than adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix 2. Tumor size greater than 4 cm 3. FIGO stage II-IV disease 4. Patients with a history of pelvic or abdominal radiotherapy 5. Patients who are pregnant 6. Patients with contraindications to surgery 7. Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes > 2cm; or histologically positive lymph nodes
|
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, Human Papillomavirus Infection Female partners of HIM Study participants report no abnormal Pap smear during the past 6 months have not had a hysterectomy have never been diagnosed with genital warts are not pregnant residents of southern Florida are not and have not been enrolled in an HPV vaccine trial willing to comply with scheduled visits every 6 months for 2 years Do not meet the Criteria
|
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, Head And Neck Cancer Part 2. Patient is initiating radiation therapy for newly diagnosed head and neck cancer 2. Part 2. Patient has an Eastern Cooperative Oncology Group performance status score of 2 or less 3. Part 2. Patient has a spouse or significant other with whom he/she resides 4. Part 2. Patient is able to vocalize well enough to complete the spousal interaction task 5. Parts 1 and 2. Patient and spouse are able to read and speak English 6. Parts 1 and 2. Patient and spouse are able to provide informed consent 7. Parts 1 and 2. Patient and spouse are at least 18 years of age 8. Part 1. Individual is a patient who was diagnosed with head and neck cancer or the spouse or partner of an patient who was diagnosed with head and neck cancer and resides with the patient None
|
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, Solid Tumors Patients who were assigned to an axitinib (AG-013736) containing treatment arm in a previous clinical trial Patients who were receiving axitinib (AG-013736) tablets at the time their previous trial ended Patients who have stable (SD) or responding disease (PR or CR) documented by the appropriate radiological, clinical, or laboratory assessments within 12 weeks before enrollment (Note: response from the previous axitinib (AG-013736) protocol should be used to determine stable or responding disease) Patients who have progressive disease (PD) but have experienced "clinical benefit" as defined in the study protocol Patients may not participate in this trial if the conditions for continuing treatment in the previous axitinib (AG-013736) protocol are not met
|
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): 20.0-80.0, Cervical Cancer Healthy volunteers People infected with HPV type 16 but without CIN lesions Patients with CIN lesions Patients with cervical cancer from National Taiwan University Hospital Informed consent is obtained, and the protocols are reviewed and approved by the appropriate Investigative Review Boards None
|
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): 18.0-66.0, Anal Stenosis ALL with anal stenosis Pregnant female Malignant stenosis Associated anal pathology Anal stenosis with a anal diameter more than 20 mm
|
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): 0.0-999.0, Borderline Ovarian Clear Cell Tumor Borderline Ovarian Serous Tumor Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Small Cell Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Childhood Embryonal Rhabdomyosarcoma Childhood Malignant Ovarian Germ Cell Tumor Endometrioid Stromal Sarcoma Gestational Trophoblastic Tumor Malignant Mesothelioma Malignant Ovarian Epithelial Tumor Melanoma Neoplasm of Uncertain Malignant Potential Ovarian Brenner Tumor Ovarian Clear Cell Cystadenocarcinoma Ovarian Serous Cystadenocarcinoma Paget Disease of the Vulva Recurrent Cervical Carcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Ovarian Germ Cell Tumor Recurrent Primary Peritoneal Carcinoma Recurrent Uterine Corpus Carcinoma Recurrent Vaginal Carcinoma Recurrent Vulvar Carcinoma Stage I Ovarian Cancer Stage I Uterine Corpus Cancer Stage I Vaginal Cancer Stage I Vulvar Cancer Stage IA Cervical Cancer Stage IA Fallopian Tube Cancer Stage IA Ovarian Cancer Stage IA Ovarian Germ Cell Tumor Stage IB Cervical Cancer Stage IB Fallopian Tube Cancer Stage IB Ovarian Cancer Stage IB Ovarian Germ Cell Tumor Stage IC Fallopian Tube Cancer Stage IC Ovarian Cancer Stage IC Ovarian Germ Cell Tumor Stage II Ovarian Cancer Stage II Uterine Corpus Cancer Stage II Vaginal Cancer Stage II Vulvar Cancer Stage IIA Cervical Cancer Stage IIA Fallopian Tube Cancer Stage IIA Ovarian Cancer Stage IIA Ovarian Germ Cell Tumor Stage IIB Cervical Cancer Stage IIB Fallopian Tube Cancer Stage IIB Ovarian Cancer Stage IIB Ovarian Germ Cell Tumor Stage IIC Fallopian Tube Cancer Stage IIC Ovarian Cancer Stage IIC Ovarian Germ Cell Tumor Stage III Borderline Ovarian Surface Epithelial-Stromal Tumor Stage III Cervical Cancer Stage III Uterine Corpus Cancer Stage III Vaginal Cancer Stage III Vulvar Cancer Stage IIIA Fallopian Tube Cancer Stage IIIA Ovarian Cancer Stage IIIA Ovarian Germ Cell Tumor Stage IIIA Primary Peritoneal Cancer Stage IIIB Fallopian Tube Cancer Stage IIIB Ovarian Cancer Stage IIIB Ovarian Germ Cell Tumor Stage IIIB Primary Peritoneal Cancer Stage IIIC Fallopian Tube Cancer Stage IIIC Ovarian Cancer Stage IIIC Ovarian Germ Cell Tumor Stage IIIC Primary Peritoneal Cancer Stage IV Borderline Ovarian Surface Epithelial-Stromal Tumor Stage IV Fallopian Tube Cancer Stage IV Ovarian Cancer Stage IV Primary Peritoneal Cancer Stage IV Uterine Corpus Cancer Stage IVA Cervical Cancer Stage IVA Vaginal Cancer Stage IVB Cervical Cancer Stage IVB Vaginal Cancer Stage IVB Vulvar Cancer Uterine Corpus Cancer Uterine Corpus Leiomyosarcoma Vulvar Squamous Cell Carcinoma Any of the following Patients who have had gynecologic tissue removed during surgery to diagnosis, treat, monitor, and/or prevent primary, persistent, or recurrent gynecologic cancer of the ovary, peritoneum, fallopian tube, cervix, uterine corpus, vagina, or vulva, meeting at least one of the following Group A: Women who underwent surgery, were diagnosed with a primary gynecologic malignancy of the ovary, cervix, uterine corpus, or vulva, and have primary tumor, normal tissue, and blood available for submission for this protocol Patients with ovarian cancer including all stages, grades, and common epithelial cell types Invasive cancers and serous and mucinous borderline tumors of low malignant potential are allowed At least 1 gram of frozen primary tumor tissue must be submitted for this protocol for patients with FIGO stage III or IV epithelial ovarian cancer Patients with an invasive malignancy of the cervix or uterine corpus including all stages, grades, and common cell types Patients with squamous cell carcinoma of the vulva Group B: Women who underwent surgery and were diagnosed with a rare gynecologic malignancy of the ovary, peritoneum, fallopian tube, cervix, uterine corpus, vagina, vulva, a gestational trophoblastic tumor, or a tumor arising in endometriosis, and have tumor tissue available for submission for this protocol Patients with a rare gynecologic malignancy of the ovary including malignant germ cell tumors; sex cord-stromal tumors; malignant mixed mesodermal tumors; clear cell, mucinous, small cell, or transitional cell carcinomas; malignant Brenner tumors; or borderline tumors of low malignant potential (except serous and mucinous)
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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.
|
eligible ages (years): 18.0-80.0, brca1 Mutation Carrier brca2 Mutation Carrier Breast Cancer Known positive BRCA1/BRCA2 mutation carrier With or without a personal history of breast cancer prior to enrollment in clinical trial GOG-0199 Currently enrolled in clinical trial GOG-0199 AND meets the following Completed baseline questionnaire (BQ-199) Provided information on prior breast cancer history, including date of diagnosis Provided complete data from the DNA analysis on the genetic variants of interest Signed an approved informed consent and authorization permitting release of personal health information Hormone receptor status not specified Menopausal status not specified PRIOR See Disease Characteristics
|
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): 19.0-45.0, Tubal Ligation Bilateral Tubal Ligation American Society of Anesthesiologists (ASA) 1-3 postpartum women desiring Postpartum Bilateral Tubal Ligation (PPBTL) for infertility Functional epidural catheter placed for labor and delivery analgesia The epidural is still taped within 1cm of the original depth when it was functional for labor analgesia 45 years of age ASA 4 status History of dural puncture ("wet tap") during initial epidural catheter insertion History of marginal or inadequate epidural analgesia for labor Cesarean section for delivery Examination demonstrates that the indwelling catheter has migrated more than 1 cm from the original depth when secured The end of indwelling epidural catheter appears to have not been capped appropriately or the cap was not maintained intact Prolonged sensory or motor block, bladder or anal sphincter dysfunction, nerve damage, inability to ambulate, post-dural puncture headache (PDHD), or seizures, during or after delivery and following cessation of the epidural catheter dosing Pseudocholinesterase deficiency Allergy to Nesacaine® (chloroprocaine) or lidocaine General anesthesia provided for delivery
|
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 undergoing colposcopy for the diagnosis of cervical cancer LEEP for the treatment of cervical cancer in early stages Follow-up Pap smear in surveillance Women under the age of 18 (minors) will be excluded from this study patients will be excluded if she has had a recent episode of bleeding or preterm labor Subjects who are not competent to give consent will 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): 18.0-64.0, Cervical Cancer Screening HIV Infections Age 18-64 years HIV infected women due for cervical cytologic screening Pregnancy On chronic anticoagulation medication Life expectancy of the woman is less than 1 year If the woman has had a cervical or anal pap test in the last 6 months
|
1
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