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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): 13.0-17.0, Human Papillomavirus Rural African American girls aged 13-17 Female parent or primary caregiver of participating daughter Girls can not be younger than age 13, or older than 17 The target's female parent or primary caregiver must also live in the same household and agree to participate
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): 0.0-999.0, Cervical Cancer paraffin blocks of 329 patients with histologic diagnosis of CIN 2, CIN 3 or Stage I cervical cancer. -
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): 16.0-999.0, HIV Sexually Transmitted Diseases HIV Infections Evidence of sexual risk behavior, defined as either signs, symptoms, or diagnosis indicative of an STD during the past 3 months; or unprotected vaginal or anal intercourse with two or more sexual partners, a partner with two or more partners, an anonymous partner, an injection drug using partner, or a partner with an STD Impaired mental status that would prevent participant from providing informed consent or participating meaningfully Inability to understand English
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): 0.0-999.0, Cervical Neoplasms cervical cancer underwent radical hysterectomy non-small cell type FIGO stage 1B have one or more risk factors (lymph node involvement, resection margin involvement, parametrial involvement) GOG performance status 0 Previous history of chemotherapy or radiation History of other cancer Hypersensitivity to platinum agents Pregnancy Serious medical disease
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, Mixed Mesodermal (Mullerian) Tumor Ovarian Carcinosarcoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma Stage I Ovarian Cancer AJCC v6 and v7 Stage IA Fallopian Tube Cancer AJCC v6 and v7 Stage IA Ovarian Cancer AJCC v6 and v7 Stage IA Uterine Sarcoma AJCC v7 Stage IB Fallopian Tube Cancer AJCC v6 and v7 Stage IB Ovarian Cancer AJCC v6 and v7 Stage IB Uterine Sarcoma AJCC v7 Stage IC Fallopian Tube Cancer AJCC v6 and v7 Stage IC Ovarian Cancer AJCC v6 and v7 Stage IC Uterine Sarcoma AJCC v7 Stage II Ovarian Cancer AJCC v6 and v7 Stage IIA Fallopian Tube Cancer AJCC v6 and v7 Stage IIA Ovarian Cancer AJCC V6 and v7 Stage IIA Uterine Sarcoma AJCC v7 Stage IIB Fallopian Tube Cancer AJCC v6 and v7 Stage IIB Ovarian Cancer AJCC v6 and v7 Stage IIB Uterine Sarcoma AJCC 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 IIIA Uterine Sarcoma 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 IIIB Uterine Sarcoma AJCC v7 Stage IIIC Fallopian Tube Cancer AJCC v7 Stage IIIC Ovarian Cancer AJCC v6 and v7 Stage IIIC Primary Peritoneal Cancer AJCC v7 Stage IIIC Uterine Sarcoma 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 Stage IVA Uterine Sarcoma AJCC v7 Stage IVB Uterine Sarcoma AJCC v7 Uterine Carcinosarcoma Patients must have newly diagnosed stage I-IV, persistent or recurrent (including unstaged) uterine carcinosarcoma (malignant mixed mullerian tumor-MMMT or with ovarian, fallopian tube or peritoneal carcinosarcoma and an enrollment date prior to 10/21/2013; pathology confirmed by site/institutional pathologist prior to enrollment) and be chemotherapy naïve as directed against their carcinosarcoma; unstaged patients (patients who have not had hysterectomy or ovarian surgery) are eligible and should be included as "unstaged" if the only histologic (pathology) documentation of the disease is a biopsy or curettage of the uterus; if these patients have documented metastatic disease, it should be assigned the appropriate stage (III/IV) Patients may have received prior adjuvant external beam radiation therapy and/or vaginal brachytherapy; patients should be at least 4 weeks from the completion of external beam radiotherapy prior to beginning protocol chemotherapy; patients do not need to be delayed if receiving vaginal brachytherapy only Gynecologic Oncology Group (GOG) performance status 0, 1, or 2 Patients must have recovered from the effects of recent surgery, radiotherapy, or other therapy Patients must be free of active infection requiring antibiotics Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to beginning protocol chemotherapy; continuation of hormone replacement therapy is permitted Platelet count greater than or equal to 100,000/mcL Absolute neutrophil count (ANC) greater than or equal to 1,500/mcL equivalent to Common Terminology for Adverse Events (CTCAE) version (v)3.0 grade 1 Creatinine less than or equal to 1.5 times upper limit of normal (ULN), CTCAE v3.0 grade 1 Bilirubin less than or equal to 1.5 times ULN (CTCAE v3.0 grade 1) Patients who have received prior cytotoxic chemotherapy for management of uterine or ovarian carcinosarcoma Patients with a history of other invasive malignancies or with a concomitant invasive malignancy, with the exception of non-melanoma skin cancer, if there is any evidence of other malignancy being present within the last five years; patients are also ineligible if their previous cancer treatment contraindicates this protocol therapy Patients for whom radiotherapy is planned after or during chemotherapy prior to progression of cancer Patients with known hypersensitivity to Escherichia (E.) coli-derived drug preparations (pegfilgrastim and filgrastim [G-CSF]) Patients with a known hypersensitivity to mesna or other thiol compounds For enrollment prior to 10/21/2013, patients who are not biopsy proven to have carcinosarcoma of the uterus, fallopian tube, peritoneum or ovary; for enrollment after 10/21/2013, patients who are not biopsy proven to have carcinosarcoma of the uterus
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): 12.0-26.0, Cervical Cancer Females aged 12-26 years Have been diagnosed by a specialist with one of the six chronic medical conditions described: 1. Paediatric Rheumatological Disease 2. Inflammatory Bowel Disease 3. Acute Lymphoblastic Leukaemia 4. Solid Organ Transplant Recipients (kidney and liver) 5. Chronic Renal Disease 6. Bone Marrow Transplant Previous immunisation with HPV vaccine Recognised contraindication to the receipt of the vaccine e.g. anaphylaxis
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-64.0, Fetal Sex Determination Subject is 18-64 years of age Subject is female Subject is pregnant and between 6 and 16 weeks of gestation Subject provides a signed and dated informed consent If subject undergoes a routine ultrasound between weeks 16 and 28, she agrees to provide the fetal sex results If subject undergoes an invasive procedure, she agrees to provide the fetal sex results None
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): 25.0-999.0, Health Status Unknown Precancerous Condition Women in Westminster Primary Care Trust (PCT) area eligible for routine cervical screening who have not responded to two invitations to attend for smears No women who have written to the PCT to document their refusal to take part in the National Health Service Cervical Screening Program (NHSCSP) No women who are not due for routine screening as part of the Not pregnant Have been sexually active PRIOR No prior total abdominal hysterectomy
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-999.0, Cervical Cancer Histologically confirmed squamous, adenosquamous, or adenocarcinoma of the cervix with any/all of the following high-risk features after surgery Positive pelvic nodes Positive parametrium Positive para-aortic nodes that have been completely resected and are PET/CT scan-negative PET only required if positive para-aortic nodes during surgery Clinical stage IA2, IB, or IIA disease (this corresponds to surgical tumor node metastasis (TNM) staging of T1-T2, N1, M0) Must have undergone radical hysterectomy (open, laparoscopically, or robotic) and staging within the past 70 days Para-aortic and pelvic node sampling required If the patient did not have a para-aortic lymph node sampling/dissection, but had common iliac node dissection that was negative, a PET-CT is recommended, but not required A negative pre
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, Cervix Cancer last 60 patients treated definitively for cervical cancer at Sunnybrook Odette Cancer Centre no imaging and no anatomical description of disease
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 Carcinoma Fallopian Tube Carcinosarcoma Fallopian Tube Clear Cell Adenocarcinoma Fallopian Tube Endometrioid Adenocarcinoma Fallopian Tube Mucinous Adenocarcinoma Fallopian Tube Serous Neoplasm Fallopian Tube Transitional Cell Carcinoma Fallopian Tube Undifferentiated Carcinoma Ovarian Brenner Tumor Ovarian Carcinoma Ovarian Carcinosarcoma Ovarian Clear Cell Adenocarcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Mucinous Adenocarcinoma Ovarian Seromucinous Tumor Ovarian Serous Adenocarcinoma Ovarian Transitional Cell Carcinoma Ovarian Undifferentiated Carcinoma Primary Peritoneal 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 Patients with a histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, or carcinosarcoma stage II, III, or IV with either optimal (=< 1 cm residual disease) or suboptimal residual disease All patients must have a procedure for determining diagnosis of epithelial ovarian, fallopian tube, primary peritoneal, or carcinosarcoma with appropriate tissue for histologic evaluation Patients with the following histologic cell types are eligible Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial adenocarcinoma, transitional cell carcinoma, malignant Brenner's tumor, adenocarcinoma not otherwise specified (N.O.S.) or carcinosarcoma Absolute neutrophil count (ANC) greater than or equal to 1,500/mm^3, equivalent to CTEP Common Terminology for Adverse Events (CTCAE) version 4.0, grade 1; this ANC cannot have been induced or supported by granulocyte colony stimulating factors Platelets greater than or equal to 100,000/mm^3 Regimens I and II: Creatinine =< 1.5 x institutional upper limit normal (ULN), CTCAE grade 1 Regimen III: Creatinine no greater than the institutional upper limits of normal Bilirubin less than or equal to 1.5 x ULN (CTEP CTCAE version 4.0, grade 1) Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) less than or equal to 3 x ULN (CTEP CTCAE version 4.0, grade 1) Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly "tumors of low malignant potential") or recurrent invasive epithelial ovarian, primary peritoneal or fallopian tube cancer treated with surgery only (such as patients with stage IA or IB low-grade epithelial ovarian or fallopian tube cancers) are not eligible NOTE: Patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian, peritoneal primary or fallopian tube cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor Patients with synchronous primary endometrial cancer or a past history of endometrial cancer, unless all of the following conditions are met Stage not greater than IB No more than superficial myometrial invasion No vascular or lymphatic invasion No poorly differentiated subtypes, including papillary serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease Patients who have received prior chemotherapy for any abdominal or pelvic tumor within the last five years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
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): 20.0-65.0, Uterine Cervical Neoplasms Uterine Cervical Dysplasia Women between 20 and 65 Menstruation pregnant Inability to give informed consent Vaccinated against HPV 16 and 18 Total Hysterectomy treatment of CIN 1, 2 or 3 Abnormal smear in the past year Smear in the past 2 years Virgin
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin
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): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination
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): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded
0
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy
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): 29.0-63.0, Cervical Intraepithelial Neoplasia No record of PAP smear in the regional screening register for more than two screening rounds (6 years depending on age) Evidence in the regional population register that women have been living in the west region of Sweden during this time Total hysterectomy
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, High Grade Cervical Intra-epithelial Neoplasia Woman ≥ 18 years old 19 in British Columbia, Nova Scotia and Newfoundland) Understands English or French (for sites where French speaking coordinator is available) Is treated for biopsy proven CIN II, III or AIS Understands study procedures, available alternatives treatment, risks related to study, and accepts voluntarily to participate by signing the ICF has been treated for cervical cancer or pre-cancer in the past Participant has known immunosuppression or immunodeficiency Planned hysterectomy Participant is receiving or has received one of the following treatment Immunosuppressive therapy in the three months prior to enrollment Corticosteroid therapy in the two weeks prior to enrollment Two or more courses of corticosteroids (orally or parenterally) lasting at least one week in duration in the year prior to enrollment (inhalation, nasal or topical corticosteroids are permitted) There is a strong probability that the participant will not follow the procedures of study, will not come to its appointment, or plans a delocalization throughout study
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): 21.0-52.0, Pain Female, age 21-52,having a laparoscopic tubal ligation by the fallopia ring method at Oklahoma State University Medical Center between January 1, 2005 and December 31, 2009 We will women with the following comorbid conditions, since they may alter the patient's pain level or her perception of pain after the tubal ligation: history of chronic pelvic pain, history of pelvic inflammatory disease, opiate abuse, conversion to open procedure, unsuccessful tubal ligation, laceration of tube, more than one ring placed on single tube, admittance to the hospital, additional procedures performed, endometriosis, allergy to marcaine, lidocaine, or bupivicaine
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-80.0, Cervical Cancer Patients (who have been adequately clinically staged) with primary, untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, FIGO stage IB1 with pelvic lymph node metastasis, IB2, IIA(≥4cm in tumor size, or pelvic LN metastasis), IIB, IIIA, IIIB? with only unilateral pelvic wall extension Patients with negative, para-aortic lymphadenopathy determined by pelvic MRI and/or PET/CT scan Patients with adequate bone marrow function: ANC greater than or equal to 1,500/ul, platelets greater than or equal to 100,000/ul at the beginning Patients with adequate renal function: creatinine equal to or less than 2.0 mg/dL Patients who have signed an approved informed consent and authorization Patients with ECOG Performance Status of 0, 1, 2 and Karnofsky Performance Scale of 100, 90, 80, 70, 60, 50 Age: 18≤age≤80 Stage IIIb with bilateral pelvic wall extension and stage IVB lesions are not eligible Patients with histology other than squamous, adeno, adenosquamous cell carcinoma Patients who have received prior radiotherapy of pelvis or total hysterectomy Patients who have diagnosis of other malignant tumors other than non-malignant melanoma skin cancer or stage I. II papillary, follicular thyroid cancer
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, Human Papillomavirus Infections Registry Data: * Female residents of participating Nordic countries who were alive on January 1st in the year the data will be used for analysis Survey Data: --Female residents alive in the participating countries on July 1, 2011 --Women must provide consent to use questionnaire data and to link data to other registry databases - Cervical Sample Collection: --For HPV data in the general population: cervical samples from residents of the participating countries who are 45 years and under collected between 2006 and 2007, or in 2011-2012 --For HPV data in lesional samples: cervical samples from women with a diagnosis of CIN or cervical cancer between 2004-2006 and 2011-2012 Registry Data: * Women who participated in Protocol V501-015 (NCT00092534) and are included in the Long-Term Follow-Up study Survey Data: --Women under 18 or above age 45 on July 1, 2011 --Women who participated in Protocol V501-015 and are included in the Long-Term Follow-Up study Cervical Sample Collection: --Samples from women who participated in Protocol V501-015 and are included in the Long-Term Follow-Up study --Samples with inadequate integrity for HPV testing
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, Cancer Solid Tumors Lymphoma Malignancy Histologically confirmed solid tumor or lymphoma Locally advanced or metastatic disease for which no life prolonging therapy is available and no standard therapy is judged appropriate by the investigator Eastern Cooperative Oncology Group Performance Status ≤ 1 Adequate hematologic function as indicated by, ANC ≥ 1,500/mm3, Hgb >9.0 g/dL, platelet count ≥ 100,000/mm3 Adequate renal and liver function as indicated by serum creatinine ≤ 1.0 x ULN or creatinine clearance of > 60 cc/min, serum albumin ≥ 3.0 gm/dL, total bilirubin < 1.0 x ULN, AST and ALT ≤ 2.5 x ULN ; Alkaline phosphatase ≤2.5 x ULN Negative Hepatitis B and Hepatitis C testing QTc interval ≤450ms Radiation within 14 days of study entry, thoracic radiation within 28 days of study entry. Patients who have received prior radiotherapy must have discontinued steroids for 14 days prior to study entry and be clinically stable Not recovered to ≤ Grade 1 toxicity from prior radiotherapy or chemotherapy agents Use or requirement for use of aspirin or aspirin containing products with >81 mg of aspirin per day History of gastrointestinal bleeding within 1 year History of diabetes mellitus requiring treatment with oral agents or insulin Active rheumatoid arthritis, active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation Known or suspected Wilson's Disease, or other conditions that affect copper accumulation or regulation Prior treatment with IAP inhibitors
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, Borderline Ovarian Mucinous Tumor Ovarian Mucinous Cystadenocarcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Stage IA Fallopian Tube Cancer AJCC v6 and v7 Stage IA Ovarian Cancer AJCC v6 and v7 Stage IB Fallopian Tube Cancer AJCC v6 and v7 Stage IB Ovarian Cancer AJCC v6 and v7 Stage IC Fallopian Tube Cancer AJCC v6 and v7 Stage IC Ovarian Cancer AJCC v6 and v7 Stage 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 IIIB Fallopian Tube Cancer AJCC v7 Stage IIIB Ovarian Cancer AJCC v6 and v7 Stage IIIC Fallopian Tube Cancer AJCC v7 Stage IIIC Ovarian Cancer AJCC v6 and v7 Stage IV Fallopian Tube Cancer AJCC v6 and v7 Stage IV Ovarian Cancer AJCC v6 and v7 Patients with a histologic diagnosis of mucinous adenocarcinoma of the ovary or fallopian tube with either optimal (=< 1 cm residual disease) or suboptimal residual disease following initial surgery; patients may have measurable disease as defined by Response Evaluation in Solid Tumors (RECIST) 1.1 or no measurable disease All patients must have had appropriate surgery including appendectomy (unless patient has history of prior appendectomy) for ovarian or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage Patients must have stage II-IV disease (new or recurrent-chemonaïve; no brain metastasis) or recurrent stage I disease (chemonaïve) Newly diagnosed patients must begin protocol therapy within 10 weeks of primary debulking; for stage I recurrent patients (chemonaïve), they should begin protocol therapy within 14 days of randomization Patients must have a negative colonoscopy within 1 year of enrolling in the study Absolute neutrophil count (ANC) >= 1,500/mcl White blood cell (WBC) count >= 3,000/mcl Platelets >= 100,000/mcl Hemoglobin (Hgb) >= 10 g/dl (can be post transfusion) Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN) OR creatinine clearance > 50 cc/min Patients with known colon cancer or history of colon cancer Patients with primary peritoneal carcinoma Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last 5 years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy Patients who have received chemotherapy, radiotherapy or any investigational treatment for a gynecologic cancer (does breast cancer) or colorectal cancer prior to enrollment Patients with a major surgical procedure anticipated during the course of the study; this includes but is not limited to: abdominal surgery (laparotomy or laparoscopy) such as colostomy or enterostomy reversal, interval or secondary cytoreductive surgery, or second look surgery; please consult with the study chair prior to patient entry for any questions related to the classification of surgical procedures Patients may have minor surgical procedures (i.e., mediport insertion) fine needle aspiration or core biopsies as long as it is performed > 7 days prior to the first date of bevacizumab therapy and there is no evidence of wound disruption or impaired healing Patients with surgery (including open biopsy) within 4 weeks prior to anticipated first dose of bevacizumab (allowing for fact that bevacizumab can be omitted from first cycle of chemotherapy) Patients with a history of abdominal fistula or perforation within the past 12 months Patients with a current, serious, non-healing wound, ulcer, or bone fracture; patients with granulating incisions healing by secondary intention with no evidence of fascial dehiscence or infection are eligible but require weekly wound examinations Patients with known hypersensitivity to Chinese hamster cell products or other recombinant human or humanized antibodies
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): 18.0-75.0, Myelodysplastic Syndromes age > ou = 18 years and < 75 years. 2. must understand and voluntarily sign an informed consent form. 3. patient considered ineligible for intensive chemotherapy due to age, cardiac contraindication to anthracyclines, comorbidities, previous failure of intensive chemotherapy, or patient willing to avoid intensive chemotherapy. 4. must be able to adhere to the study visit schedule and other protocol requirements. 5. prior thalidomide allowed. 6. documented diagnosis of MDS (according to FAB definition, ie. with marrow blasts up to 30%, or CMML with WBC < 13000/mm3 that meets IPSS for intermediate-2 or high-risk disease. 7. with an associated del 5q[31](the deleted chromosomal region must 5q[31]), with or without additional cytogenetic abnormalities. 8. female subjects of childbearing potential must understand the study drug is expected to have a teratogenic risk agree to have a medically supervised pregnancy test with a minimum sensitivity of 25mIU/ml on the day of the study visit or in the 3 days prior to the study visit once the subject has been on effective contraception for at least weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence. the test should ensure the subject is not pregnant when she starts treatment agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. these pregnancy tests should be performed on the day of the study visit or in the 3 days prior to the study visit. this requirement also applies to women of childbearing potential who practice complete and continued abstinence. * agree to use, and to be able to comply with effective contraception without interruption, 4 weeks before starting study drug throughout the entire duration study drug therapy(including doses interruptions)and for 3 months after the end of the study drug therapy even if she has amenorrhea this applies unless the subject commits to absolute and continuous abstinence confirmed on a monthly basis, to avoid pregnancy for the duration of study. the following are effective methods of contraception implant levonorgestrel-releasing intrauterine system(IUS) Medroxyprogesterone acetate depot, tubal sterilization sexual intercourse with a vasectomised male partner only(vasectomised must be confirmed by two negative semen analyses), ovulation inhibitory progesterone-only pills(i.e.desogestrel). if not established on effective contraception, the female subject must be referred to an appropriately trained health care professional for contraceptive advice in order that contraception can be initiated. Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking lenalidomide and dexamethasone, combined oral contraceptive pills are not recommended. If a female subject is currently using combined oral contraception, the patient should switch to one of the effective methods listed above. The risk of venous thromboembolism continues for 4 to 6 weeks after discontinuing combined oral contraception. The efficacy of contraceptive steroids may be reduced during co-treatment with dexamethasone. Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of infection at the time of insertion and irregular vaginal bleeding. Prophylactic antibiotics should be considered particularly in patients with neutropenia . Copper-releasing intrauterine devices are generally not recommended due to the potential risks of infection at the time of insertion and menstrual blood loss which may compromise patients with neutropenia or thrombocytopenia Understand that even if she has amenorrhea, she must follow all the advice on effective contraception She understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy 9. Male patients must
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): 18.0-85.0, Malignant Tumors Consenting adults aged ≥ 18 years. 2. Recurrent or progressive high grade glioma after failure of at least one line of standard oncological treatment. 3. Gliomatosis cerebri, including patients declining radiation treatment Patients with malignant tumors who are receiving treatment at the time of the recruitment. 2. Early termination patients who will wish to stop their participation in the trial will discontinue the ketogenic diet and return to their usual diet
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): 35.0-69.0, Human Papillomavirus Infection Cervical Intraepithelial Neoplasia members of consenting family physicians identified through OSCAR EMR overdue for Pap smear testing have not presented for Pap smear screening after 1 reminder letter currently attending colposcopy clinic institutionalized without a cervix
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): 18.0-65.0, HPV-related Cytological Abnormalities on PAP Smear (LSIL) women with a new LSIL diagnosis an HPV positivity on PAP smear women over 65 immunocompromised patients (because of disease or drugs)
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-999.0, Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Stage I Cervical Cancer AJCC v6 and v7 Stage IA Cervical Cancer AJCC v6 and v7 Stage IB Cervical Cancer AJCC v6 and v7 Stage IIA Cervical Cancer AJCC v7 Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomy Patients with the following characteristics (depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed) Positive capillary-lymphovascular space involvement and one of the following Deep third penetration Middle third penetration, clinical tumor >= 2 cm Superficial third penetration, clinical tumor >= 5 cm Negative capillary-lymphatic space involvement Middle or deep third penetration, clinical tumor >= 4 cm Absolute neutrophil count (ANC) >= 1,500/mcl Platelets >= 100,000/mcl Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins Patients with septicemia or severe infection Patients with intestinal obstruction or gastrointestinal bleeding Patients with postoperative fistula Patients with cervix cancer who have received any previous radiation or chemotherapy Patients whose circumstances do not permit completion of the study or the required follow-up Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc.) Patients with GOG performance status of 3 or 4 Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-999.0, Solid Tumors, Glioblastoma, Recurrent Malignant Gliomas (Treatment Arm A) 1. Patients must have histologically-confirmed solid tumors that are advanced or metastatic, and refractory after standard therapy, or for which there is no standard therapy. 2. Patients must have measurable disease as defined by version 1.1. 3. Patients must have received prior anticancer therapy or not be eligible for any established conventional therapy whether surgical or pharmacologic. 4. Patients must have recovered from all acute adverse effects (excluding alopecia) of prior therapies to baseline or <=grade 1 prior to study entry. 5. Patients must have a performance status of 0, 1, or 2. 6. Patients must be men and women >=18 years of age. 7. Patients must have adequate bone marrow function, defined as an absolute neutrophil count >=1.5 x 10^9/L and a platelet count >= 100 x 10^9/L. 8. Patients must have adequate renal function, defined as serum creatinine <= 1.2 mg/dL (if > 1.2 mg/dL, a calculated creatinine clearance [by the Cockcroft-Gault method] must be >=60 mL/min/1.73 m^2). 9. Patients must have adequate hepatic function, defined as plasma total bilirubin <=1.5 mg, alanine transaminase (ALT) and aspartate transaminase (AST) <=2.5 X ULN. Patients with Gilbert's disease outside these limits are judged to be ineligible. 10. Female patients of childbearing potential must have a negative serum or urine pregnancy test result at time of pre-treatment screening. 11. Patients with reproductive potential must agree to use at least one form of barrier contraception prior to study entry and for up to 30 days beyond the last administration of study drug. 12. Patients must be judged to be capable by the Investigator of providing informed consent and must be willing to provide written informed consent prior to the start of any study specific procedures. 13. Patients should have a life expectancy of at least 12 weeks (Treatment Arm A) 1. Patients may not have had prior chemotherapy, hormonal therapy, radiation therapy, or biologic therapy in the 4 weeks prior to study entry with the exception of mitomycin C or nitrosoureas, for which patients must be 6 weeks from prior treatment. For patients who have been treated with targeted therapy, 5 half-lives of that therapy (or 28 days, whichever is shorter) must have passed prior to enrollment in the study. 2. Patients may not have any concomitant condition that could compromise the objectives of this study and the patients' compliance and ability to tolerate this therapy and complete at least 2 cycles of therapy, including, but not limited to the following Congestive heart failure or uncontrolled angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension, or dysrhythmias Active infection Unstable diabetes mellitus Psychiatric disorder that may interfere with consent and/or protocol compliance. 3. Pregnant or breastfeeding women. 4. Patients with another malignancy in the past 3 years except: curatively treated non-melanoma skin cancer; or carcinoma in situ, of either cervix or breast, that does not require further treatment. 5. Patients with known HIV, HBV, or HCV infection. 6. Patients with an underlying diagnosis or disease state associated with an increased risk of bleeding. 7. Patients with central nervous system metastases. Baseline CT or MRI scan of brain is required only in the case of clinical suspicion of central nervous system metastases. Patients with evidence of brain involvement, leptomeningeal disease, or seizure disorder are also excluded. 8. Patients may not be treated with known CYP3A4 inhibitors or inducers. and for Combination CTO Plus Temodar® (Treatment Arm B): (Treatment Arm B) In addition to the for adequate organ function as defined for the patients with advanced or metastatic solid tumors, patients enrolled in Arm B (Combination Therapy CTO Plus Temodar-R) must meet the following 1. Patients must have histologically proven malignant glioblastoma or other recurrent malignant gliomas. 2. Measurable tumor must be present on gadolinium-enhanced MRI. 3. Patients must have a life expectancy of at least 8 weeks. 4. Patients must have a Performance Status of 0, 1, or 2 (ECOG scale). 5. Patients must be men and women >=18 years of age. 6. Patients must have recovered from all acute adverse effects (excluding alopecia) of prior therapies to baseline or <=grade 1 prior to study entry. 7. Patients must have shown unequivocal radiographic evidence for tumor progression by MRI scan to be performed within 14 days prior to registration and must be on a steroid dose that has been stable for at least 5 days. If the steroid dose is increased between the date of imaging and registration, a new baseline MRI scan is required. 8. Patients who have undergone recent resection for recurrent or progressive malignant tumor will be eligible as long as all of the following conditions apply: 1. They have recovered from the effects of surgery 2. The extent of residual disease is assessed post-operatively, with an MRI scan done no later than 96 hours in the immediate post-operative period or at least 4 weeks post-operatively, within 14 days prior to registration. If the 96-hour scan is more than 14 days before registration, the scan needs to be repeated. 9. Patients must have had prior radiation therapy with or without chemotherapy and must have progressed following radiation therapy and must have an interval of >=12 weeks from the completion of radiation therapy to registration date to minimize the possibility of pseudo-progression. 10. Patients under treatment with anti-epileptic drugs which are not known CYP3A4 inhibitors or inducers must have been receiving a stable dose for at least 2 weeks with no evidence of seizures at the time of registration (Treatment Arm B) 1. Patients may not have had prior chemotherapy, hormonal therapy, or biologic therapy in the 4 weeks prior to study entry with the exception of mitomycin C or nitrosoureas, for which patients must be 6 weeks from prior treatment. For patients who have been treated with targeted therapy, 5 half-lives of that therapy (or 28 days, whichever is shorter) must have passed prior to enrollment in the study. Additional exceptions: The following specific drugs are permitted shorter recovery times: 14 days for vincristine, 21 days for procarbazine, and 7 days for non-cytotoxic agents such as interferon, tamoxifen, thalidomide, and cis-retinoic acid. 2. Patients may not have any concomitant condition that could compromise the objectives of this study and the patients' compliance and ability to tolerate this therapy and complete at least 2 cycles of therapy, including, but not limited to the following Congestive heart failure or uncontrolled angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension, or dysrhythmias Active infection Unstable diabetes mellitus
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): 21.0-999.0, Healthy Pregnancy healthy years of age or older second pregnancy, singleton conceived without fertility treatments Preexisting medical conditions Sexually transmitted diseases Medical complications during pregnancy Medications during pregnancy known to influence fetal growth Smoking, alcohol drinking Excessive physical activity level which could affect the outcome of interest
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, Adult Anaplastic Astrocytoma Adult Anaplastic Ependymoma Adult Anaplastic Oligodendroglioma Adult Brain Stem Glioma Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Adult Mixed Glioma Adult Solid Neoplasm Male Breast Carcinoma Recurrent Adult Brain Neoplasm Recurrent Breast Carcinoma Recurrent Colon Carcinoma Recurrent Melanoma Recurrent Non-Small Cell Lung Carcinoma Recurrent Ovarian Carcinoma Recurrent Ovarian Germ Cell Tumor Recurrent Pancreatic Carcinoma Recurrent Rectal Carcinoma Recurrent Renal Cell Carcinoma Stage III Pancreatic Cancer Stage III Renal Cell Cancer Stage IIIA Colon Cancer Stage IIIA Non-Small Cell Lung Cancer Stage IIIA Ovarian Cancer Stage IIIA Ovarian Germ Cell Tumor Stage IIIA Rectal Cancer Stage IIIA Skin Melanoma Stage IIIB Breast Cancer Stage IIIB Colon Cancer Stage IIIB Non-Small Cell Lung Cancer Stage IIIB Ovarian Cancer Stage IIIB Ovarian Germ Cell Tumor Stage IIIB Rectal Cancer Stage IIIB Skin Melanoma Stage IIIC Breast Cancer Stage IIIC Colon Cancer Stage IIIC Ovarian Cancer Stage IIIC Ovarian Germ Cell Tumor Stage IIIC Rectal Cancer Stage IIIC Skin Melanoma Stage IV Breast Cancer Stage IV Non-Small Cell Lung Cancer Stage IV Ovarian Cancer Stage IV Ovarian Germ Cell Tumor Stage IV Pancreatic Cancer Stage IV Renal Cell Cancer Stage IV Skin Melanoma Stage IVA Colon Cancer Stage IVA Rectal Cancer Stage IVB Colon Cancer Stage IVB Rectal Cancer Dose-escalation cohorts: Patients must have histologically and/or cytologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; expansion cohort: patients must have histologically and/or cytologically confirmed breast cancer, malignant melanoma, colorectal cancer, pancreatic cancer, kidney cancer, high grade glioma, non-small-cell lung cancer, or ovarian cancer Patients must have measurable or non-measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan; measurable disease is not required to participate in this trial No limitation on prior therapy; however, there must be at least a 4 week interval between initiation of study treatment and any prior radiotherapy or systemic therapy, 6 weeks if the last regimen included carmustine (BCNU) or mitomycin C; exceptions may be made however, for low dose, non-myelosuppressive radiotherapy for symptomatic palliation; please contact the Princess Margaret Hospital (PMH) Phase I Consortium Central Office coordinator or the Principal Investigator if any questions arise about interpretation of this criterion Life expectancy of greater than 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%) Leukocytes >= 3.0 x 10^9/L Absolute neutrophil count >= 1.5 x 10^9/L Platelets >= 100 x 10^9/L Hemoglobin >= 90 g/L (or >= 9 g/dL) International normalized ratio (INR) =< 1.3 Patients who have had systemic therapy or radiotherapy or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier Patients may not be receiving any other investigational agents within the past 30 days or have been previously treated with a gamma-secretase inhibitor and/or cediranib; exposure to other angiogenesis inhibitors (e.g. sorafenib, bevacizumab) is acceptable Patients with any meningeal metastases or untreated known brain metastases should be excluded from this clinical trial; patients with treated brain metastasis with radiologic and clinical evidence of stability, with no evidence of cavitation or hemorrhage in the brain lesions, are eligible providing that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to randomization) History of allergic reactions attributed to compounds of similar chemical or biologic composition to RO4929097 and/or cediranib used in the study Patients taking medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin®) are ineligible (except low dose warfarin for prophylaxis for central catheters) Patients who are taking concurrent medications that are strong inducers/inhibitors or substrates of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) should be switched to alternative medications to minimize any potential risk; if such patients cannot be switched to alternative medications, they will be ineligible to participate in this study Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, active peptic ulcer disease, short gut syndrome, malabsorption syndrome of any type, total or partial bowel obstruction or inability to tolerate oral medications) that potentially impairs their ability to swallow or absorb are excluded Patients who are serologically positive for hepatitis A, B or C, or have a history of liver disease, other forms of hepatitis or cirrhosis are ineligible Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia or hypokalemia defined as less than the lower limit of normal for the institution, despite adequate electrolyte supplementation are excluded from this study Note: it is acceptable to use corrected calcium when interpreting calcium levels
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): 15.0-65.0, Acute Myeloid Leukemia Patients with CBF positive AML in CR1. CBF AML includes t(8;21)(q22;q22) [AML1(RUNX1)/ETO(CBFα2T1)], inv(16)(q13q22) (CBFβ/MYH11),t(16;16)(p13;q22) (CBFβ/MYH11) Using RT-PCR, FISH, or standard karyotype analysis technique Patients who plan to receive the second cycle of HDAC consolidation chemotherapy years old or older and 65 years or younger Adequate performance status (Karnofsky score of 70 or more) Adequate hepatic and renal function (AST, ALT, and bilirubin < 3.0 x upper normal limit, and creatinine < 2.0 mg/dL) Adequate cardiac function (left ventricular ejection fraction over 40% on heart scan or echocardiography) Signed and dated informed consent must be obtained from patient Presence of significant active infection Presence of uncontrolled bleeding Any coexisting major illness or organ failure Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
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, Cervical Cancer Histologically confirmed cervical cancer, including the following subtypes Squamous small-cell or large-cell carcinoma Adenosquamous cell carcinoma Adenocarcinoma Keratinizing or non-keratinizing carcinoma Stage IB-IIIB disease No para-aortic lymph node metastases or clinical indication for para-aortic field irradiation No predominant and clinically effective neuroendocrine tumor cell differentiation WH0 performance status 0-2 Serum creatinine clearance > 50 mL/min
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): 30.0-64.0, Breast Neoplasms Uterine Cervical Neoplasms Ovarian Neoplasms Endometrial Neoplasms Breast Cancer: women age 35-64 Cervical Cancer: women age 30-59 Ovarian Cancer: symptomatic post menopausal women age 50-64 Endometrial Cancer: symptomatic post menopausal women age 50-64 women under the age of 30
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): 0.5-75.0, Hematologic Malignancies Patient Patient age 0.5-75 years Absence of a suitable related or unrelated bone marrow donor who is molecularly matched at HLA-A, B, Cw, DRB1, and DQB1 Absence of a suitable partially HLA-mismatched (haploidentical), first-degree related donor Eligible diagnoses Relapsed or refractory acute leukemia in second or subsequent remission, with remission defined as <5% bone marrow blasts morphologically Poor-risk acute leukemia in first remission, with remission defined as <5% bone marrow blasts morphologically AML with at least one of the following AML arising from MDS or a myeloproliferative disorder, or secondary AML Presence of Flt3 internal tandem duplications Not pregnant or breast-feeding No uncontrolled bacterial, viral, or fungal infection Note: HIV-infected patients are potentially eligible. of HIV-infected patients will be determined on a case-by-case basis No previous allogeneic BMT (syngeneic BMT permissible) Active extramedullary leukemia or known active CNS involvement by malignancy. Such disease treated into remission is permitted. Donor Potential donors consist of Unrelated donors Second-degree relatives First cousins The donor and recipient must be identical at at least 5 HLA alleles based on high resolution typing of HLA-A, -B, -Cw, -DRB1, and -DQB1, with at least one allele matched for a HLA class I gene (HLA-A, -B, or -Cw) and at least one allele matched for a class II gene (HLA-DRB1 or -DQB1)
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): 15.0-999.0, Infections, Papillomavirus Cervical Cancer Subjects/Subjects' parents or guardians, who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study Women >=15 years of age attending a clinic for routine cervical screening Written informed consent obtained from the subject and/or subject's parent/guardian Referral for abnormal cervical sample at the current visit Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed No cervical sample provided History of hysterectomy Known diagnosis of immunosuppression, or patient on immunosuppressives Pregnant female >=25 years of age
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 Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB All women at least 18 yrs of presenting for Pap Smear who have not previously participated in this protocol. SoloPap can be performed any day that a woman is not having vaginal bleeding Age <18 years (not recommended for Pap Smear) Known pregnancy Women who have had a total hysterectomy (cervix removed) Women with vaginal bleeding Persons who report a history of severe neuropathy or arthritis of the hands or those having other major problems with dexterity of the hands
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, 1- Women 2- HIV Infection 3- Followed in West Indies and French Guiana for His Infection 4- Acceptance of the Use of Nadis® Medical Files Women aged 18 years old or beyond Infected with HIV1 or HIV2 Follow up for HIV infection in one of the center participating in the study and acceptance of the use of Nadis® medical files in one of the center participating in the study and acceptance of the use of Nadis® medical files within the context of follow up that should be realized according to the recommandation of undertaking: systematic Pap smear for asymptomatic patient s (expert's report, Pr.P.Yéni) or Pap smear for classical searching of any pathology of the uterine-cervix Acceptance of involvement into the study and collection of non opposition to the realization of HPV search from the sample realized for the Pap smear Women under age History of total hysterectomy Patient not followed for HIV infection in one of the center involved in the study Patient that did not accept the use of Nadis® medical files Impossibility to realize a Pap smear Refusal of study's participation
0
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 25.0-65.0, DNA Probes E6 Protein Uterine Cervical Neoplasms HPV have not been previously diagnosed with cervical cancer 2. have a cervix 3. are not pregnant 4. are physically able to undergo routine cervical cancer screening 5) are able to provide informed consent We will not women if they have had previous cervical cancer screening because we assume that even if a few women have been screened for cervical cancer, the quality of cytology screening was very poor are not married AND report never having had sexual intercourse 2) have had a total hysterectomy 3) have a history of cervical cancer 4) are physically or mentally unable to undergo routine cervical cancer screening or unable to provide informed consent. 5) are pregnant or have been pregnant in the last month -Women who are currently menstruating at the time of enrollment will be deferred from participating, and will become eligible to participate 7-14 days after menstruation has ended. The menstruating women will be advised to return for the screening 7 to 14 days after their menstrual period has concluded
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-999.0, Malignant Neoplasm Eligible adult patients currently meeting and will be treated with an investigational or recently approved therapeutic agent at HCI; the patients must have measurable disease based on Response Evaluation in Solid Tumors (RECIST) 1.1 criteria; imaging must be current and have been obtained within 30 days prior to the baseline imaging session Patients must document their willingness to be followed for a period of time; for the purposes of imaging data analysis this will ideally be for at least 12 months after completing the investigational or recently approved therapy, however this may not always be possible; by signing informed consent, the patients are documenting their agreement to have clinical and radiographic endpoints and the results of histopathologic tissue analysis and other laboratory information entered into a research database All patients must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to baseline and the subsequent set of multi-tracer PET scans; the serum pregnancy test must be performed within 48 hours prior to research PET imaging; a negative test will be necessary for such patients to undergo research PET imaging Serum glutamic oxaloacetic transaminase (SGOT) less than 4.0 times below or above the upper or lower limit range Serum glutamate pyruvate transaminase (SGPT) less than 4.0 times below or above the upper or lower limit range Alkaline phosphatase (ALK phos) less than 4.0 times below or above the upper or lower limit range Lactate dehydrogenase (LDH) less than 4.0 times below or above the upper or lower limit range Total bilirubin less than 4.0 times below or above the upper or lower limit range Serum electrolytes less than 4.0 times below or above the upper or lower limit range Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals; patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion Patients who are pregnant or lactating or who suspect they might be pregnant; serum pregnancy tests will be obtained prior to the baseline and subsequent multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile Adult patients who require monitored anesthesia for PET scanning Patients known to be human immunodeficiency virus (HIV) positive
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 Postoperative Pain Women of 18 years or older referred to our service with histologically confirmed primary squamous, adenocarcinoma or adenosquamous cervical cancer diagnosed by biopsy or cervical conization, clinically FIGO (International Federation of Gynecologic and Obstetrics) staged IA2 with lymph vascular invasion, IB and II A Patients with clinically advanced disease (IIB-IV), previous pelvic or abdominal radiotherapy, pregnancy, clinical diseases that would preclude one or both surgical approaches
2
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-999.0, Cervical Cancer Advanced cervical cancer Previously treated for cancer of the cervix Karnofsky Performance Score less than 50 Renal dysfunction ( Serum creatinine > 2.0mg/dl) Hepatic dysfunction (Serum bilirubin> 2.0 mg/dl, transaminases > 1.5 times normal) Pregnant or lactating women: Women will be tested by pregnancy test for possibility of existing pregnancy. Those that meet of trial will be asked to promise that they don't become pregnant; barrier contraception will be recommended
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-26.0, Uterine Cervical Cancer Female 26 years of age Resident of an Appalachian county Intact cervix Able to read and understand English Cognitively able to provide informed consent Willing to come for four clinic visits Prior history of cervical cancer Prior history of a cervical lesion treated with cryotherapy or any form of surgical removal of a portion of the cervix to treat CIN No cervix Pregnant or planning to become pregnant in the next year History of immune disorder: auto-immune, primary immune or acquired Any contra-indications for the vaccine series Taking immune suppressive medications Any prior exposure to an HPV vaccine of any type Planning to move out of the immediate area in the next year
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-65.0, HIV Infections women > 18 years old attending outpatient gynecology consultation HIV positive with written informed consent on social security unaffiliated to the social healthy security french system
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 A female aged 18 years and above at the time of cervical specimen collection, and currently residing in New Zealand Histological diagnoses of invasive cervical cancer stage IB or greater, within at least the last 3 years Written informed consent obtained from the subject/ next of kin/ Legally acceptable representative Availability of cervical specimen on which the diagnosis was made prior to any chemotherapy or radiotherapy The cervical specimen should be of appropriate size and with regular tissue specimens The cervical specimen should be adequately preserved All links to the subject's identity should be removed from the paraffin block Not Applicable
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, Human Papillomavirus Infection • the subject attended a colposcopy visit, and the referral Pap sample had a valid HPV Assay result, and the sample had an HPV Assay positive result, or the sample had an HPV Assay negative result and the subject had a consensus histology result of cervical intraepithelial neoplasia (CIN) grade 2 [CIN2] or more severe (eg, CIN2, CIN grade 3 [CIN3], or cervical cancer; "CIN2+"), or the sample had an HPV Assay negative result and the subject had a consensus histology result of normal or CIN grade 1 (<CIN2) and was randomly selected for inclusion. the referral Pap sample had a valid HPV Assay result, and the sample had an HPV Assay positive result, or the sample had an HPV Assay negative result and the subject had a consensus histology result of CIN2+, or the sample had an HPV Assay negative result and the subject had a consensus histology result of <CIN2 and was randomly selected for inclusion Samples from evaluable subjects meeting the sample will not be tested with the AHPV-GT Assay if there is insufficient volume for AHPV-GT Assay testing or the sample was deemed unsuitable for testing (eg, stored under unacceptable conditions)
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): 18.0-65.0, Cervical Cancer Women aged 18-65 with a cytological diagnosis of CIN2+cervical lesions from all over Croatia that are referred to National Reference Center because of HSIL or malignant cytology findings Women younger than 18 or older than 65 Pregnant women
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): 35.0-90.0, Deep Vein Thrombosis Primary total hip arthroplasty Revision hip replacement, total knee replacement, revision knee replacement, semi-hip replacement and cemented THR were excluded Coagulation related disease and cancer were excluded either
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, Malignant Tumor patients with malignant tumor receiving or planning to receive chemotherapy with fresh frozen tumor tissue with informed consent
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-80.0, Malignant Tumor Females 18 to 80 years of age Tumor is well visualized through x-ray mammography or ultrasound imaging and amenable to image guidance therapy (a tumor which is well visualized through imaging can be identified from surrounding breast tissue and does not have margins obscured by other structures or artifacts on the images) Tumor must be well visualized (as defined above) on MRI Definitive pathologic diagnosis by needle core biopsy Unifocal malignant tumor that does not exceed 20mm in diameter and measures at least 5mm away from the skin and chest wall Cluster of microcalcifications that do not exceed 10 mm in diameter and measures at least 5mm away from the skin and chest wall Subjects with or without palpable lymph nodes Subjects with mammographic appearance of overall dense parenchymal tissue may be included, as long as a clearly evident marker is present at tumor site Subjects with less than 25% intraductal component Subjects younger than 18 years of age Pregnant or breast-feeding women Tumors poorly visualized by x-ray mammography or ultrasound imaging Women who are morbidly obese (>300 lbs) Acute or chronic severe renal insufficiency (Glomerular filtration rate (GFR) <30ml/min/1.73 sq.meters) Moderate to end-stage kidney disease and a history of severe asthma or allergies Tumors measuring greater than 20mm in diameter Subjects with advanced stage breast cancer Subjects with prior history of cancer in the ILT treated breast Subjects with recurrent breast cancer
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): 16.0-24.0, Sexual Transmission of Infection Women ages 16-24 years of age residing in a region of South Africa with a high HIV incidence and prevalence HIV negative has ever had vaginal intercourse has never had Papanicolaou smear (Pap) testing or has only had normal Pap test results fully understands study procedures, risks involved in the study, and voluntarily agrees to participate by giving written informed consent agrees to refrain from douching/vaginal cleansing and using vaginal medications or preparations for 2 calendar days prior to the Day 1 visit as well as other future visits that collection of cervical specimens agrees to refrain from sexual intercourse for 2 calendar days prior to the Day 1 visit as well as other future visits that collection of cervical specimens agrees to utilize effective contraception during sexual intercourse (excluding the rhythm method, withdrawal alone, and emergency contraception) during the vaccination period Informed consent procedures for females <18 years of age: Informed consent and informed assent will be obtained from parents/legal guardians and adolescents respectively, prior to participation. The consent form will information about the study and individual request for consent of participants to participate in the study. It will be emphasized that participation is voluntary and that participants are free to withdraw from the study at any stage without any disadvantage to them. An assessment of understanding will be conducted at screening to ensure that consent is informed have a history of severe allergic reaction have a known allergy to any vaccine component (e.g., aluminum, yeast, or are currently immuno-compromised have received a marketed HPV vaccine, or are pregnant and lactating
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-999.0, Fallopian Tube Clear Cell Adenocarcinoma Fallopian Tube Endometrioid Adenocarcinoma Fallopian Tube Mucinous Adenocarcinoma Fallopian Tube Serous Adenocarcinoma Fallopian Tube Undifferentiated Carcinoma Ovarian Clear Cell Adenocarcinoma Ovarian Endometrioid Adenocarcinoma Ovarian Mucinous Adenocarcinoma Ovarian Seromucinous Carcinoma Ovarian Serous Adenocarcinoma Ovarian Undifferentiated Carcinoma Primary Peritoneal Serous Adenocarcinoma Stage II Fallopian Tube Cancer AJCC v6 and v7 Stage II Ovarian Cancer AJCC v6 and v7 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 III Fallopian Tube Cancer AJCC v7 Stage III Ovarian Cancer AJCC v6 and v7 Stage III Primary Peritoneal Cancer AJCC 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 Suspected preoperative diagnosis of invasive epithelial ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer based on imaging and cancer antigen (Ca) 125; histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell carcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified; patients with primarily carcinoma histology but mixed features can be included; the surgically confirmed histologic features must be compatible with primary Mullerian epithelial adenocarcinoma Stages II-IV of the above cancer Patients to be scheduled for a planned tumor debulking Intention for chemotherapy administration at MD Anderson Cancer Center Zubrod performance status 0-2 Absolute neutrophil count (ANC) >= 1500/ml Platelets > 100,000/mL Creatinine clearance (CrCl) > 50 mL/min Bilirubin =< 1.5 x institutional upper limit normal Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x institutional upper limit normal Patients with non-epithelial ovarian tumors that do not require adjuvant chemotherapy, borderline epithelial ovarian tumor, or recurrent invasive epithelial ovarian, low grade ovarian cancer, primary peritoneal, or fallopian tube cancer treated with surgery only (such as patients with stage IA or IB); patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated new invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer are eligible, provided that they have not received chemotherapy for any tumor; no stromal cancers or germ cell cancers or low malignant potential; patients found post operatively to have ineligible histology will be removed from the study Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded; prior radiation therapy for localized cancer of the breast, head and neck, or skin is permitted provided that it was completed more than 3 years prior to registration, and the patient remains free of recurrent or metastatic disease Patients with a synchronous primary endometrial cancer, or a past history of primary endometrial cancer are excluded unless all of the following conditions are met: stage not greater than stage IA; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions Patients who have received targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their primary peritoneal, ovarian, or fallopian tube cancer With the exception of non-melanoma skin cancer and other specific malignancies as noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this protocol therapy are excluded Metastases to the ovaries from other organs except fallopian tube or primary peritoneal carcinoma Use of systemic glucocorticoids such as prednisone or Decadron in the last month Inability to accurately answer questions (e.g. dementia, brain metastases) or speak English or Spanish Cirrhosis of the liver Patients with a Zubrod performance status 3 or 4
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): 20.0-99.0, Cervical Cancer cases with cervical cancer
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, Human Papillomavirus Premenopausal women with HSIL at Pap test or high-risk HPV Suspicious cancer
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-999.0, Malignant Tumors Informed consent Clinical diagnosis of advanced tumor stages of glioblastoma IV, metastasized sarcoma, as well as non small-cell lung carcinoma (NSCLC) IV Pregnant patients
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, Hallux Valgus Patients who are undergoing primary unilateral first metatarsal bunionectomy that includes a distal Chevron osteotomy only with or without the Akin procedure Healthy or medically stable on the basis of clinical laboratory tests performed at screening. If results are outside the normal reference ranges, the patient may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study Women must be postmenopausal, surgically sterile, abstinent, or practicing or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study. Women of childbearing potential must have a negative serum β human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test before surgery If a male and sexually active, agrees to use an approved method of birth control to prevent pregnancy in his female partner and not to donate sperm from the day of first study drug intake until 3 months after the day of last study drug intake. To qualify for entry into the double-blind treatment period, the following must be met Qualifying baseline pain intensity (PI) must be rated as greater than or equal to 4 on an 11-point (0 to10) PI numerical rating scale (NRS), recorded within 30 minutes before randomization Qualifying PI must occur no earlier than 10 hours after the first surgical incision Qualifying baseline PI must occur within 9 hours after termination of the systemic analgesia during the postoperative surgical period History of seizure disorder or epilepsy suggested by the presence of mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening, and/or severe traumatic brain injury, episode(s) of unconsciousness of more than 24 hours duration, or posttraumatic amnesia of more than 24 hours duration within 15 years of screening History of malignancy within the past 2 years before the start of the study Evidence of active infections that may spread to other areas of the body or a history of human immunodeficiency virus 1 or 2 Clinical laboratory values reflecting severe renal insufficiency Moderately or severely impaired hepatic function, or patients with abnormal alanine aminotransaminase or aspartate aminotransferase Clinical laboratory values outside acceptable limits for surgery in the opinion of the investigator A clinically significant disease that in the investigator's opinion may affect efficacy or safety assessments Treated with anticonvulsants, monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or serotonin norepinephrine reuptake inhibitor within 2 weeks before randomization Systemic steroid therapy, excluding inhalers or topical steroids, within the 4 weeks before screening Women who plan to become pregnant during the study, or who are breast feeding
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, Conditions or Focus of Study: *FDAAA (Enter 1 to 5 Items) Male or Female > 18 years, 2. Newly diagnosed stage I-IV breast cancer which is defined to meets any one of the following clinical or pathological staging (version 6.0 AJCC classification17) in Appendix B. 3. No prior therapy (other than surgery) for current disease, 4. Written informed consent (if required by local regulations) Unable to receive definitive treatment 2. Unable to attend regular follow-up visit
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): 16.0-26.0, Cervical Cancer Cervical Intraepithelial Neoplasia Adenocarcinoma in Situ Healthy Japanese females Not pregnant at Screening and agree to use effective contraception through Month 7 of the study Lifetime history of 0 to 4 male or female sexual partners No oral temperature ≥37.5 centigrade within 24 hours prior to injection Received a marketed HPV vaccine Prior abnormal Papanicolaou smear (PAP) or biopsy showing CIN Known history of positive test for HPV Known history of genital warts Received immune globulin or blood products within 6 months prior to first injection or plan to receive any through Month 7 of the study History of splenectomy, known immune disorders, or receiving immunosuppressives Immunocompromised or diagnosed as having human immunodeficiency virus (HIV)
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-999.0, Cervical Cancer Patients must have a known or suspected cervical cancer Age >=18 years Patients must have no other active cancer at the time of diagnosis Patients must have no history of a hysterectomy Patients must be able to give informed consent Patients must be willing to undergo a biopsy of the cervical tumor to provide tissue for the study Patients must have completed a standard-of-care FDG-PET/CT prior to initiation of therapy, for assessment of lymph nodes Pregnant women
2
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-999.0, Uterine Cervical Neoplasms women 18 years old or older have recently received an abnormal Pap smear indicative of oncogenic HPV have been referred for initial colposcopic evaluation at the Women's Care Center at Temple University Hospital able to communicate with ease in English unable to communicate readily in English do not have access to a telephone have a history of any malignancy display current evidence of positive invasive carcinoma of the cervix display presence of another life-threatening medical condition show evidence of dementia prior participation in research study HIV
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-999.0, Uterine Neoplasms Sentinel Lymph Node Biopsy Women older than 18 years old 2. Endometrial cancer 3. Histologies: Grade 2 and 3 endometrioid adenocarcinoma, clear cell and papillary serous carcinoma 4. Suitable candidates for surgery 5. Clinically stage 1 or confined to the uterus Grade 1 endometrioid adenocarcinoma 2. Metastatic disease
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): 30.0-45.0, HPV Infection pathologic Pap smear positive "high risk" HPV DNA test positive colposcopy examination patients who had undergone wart therapy in the previous six months pregnancy invasive disease immunosuppression previous HPV vaccination
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): 25.0-70.0, Cervical Cancer Somali female age 25-70 years have lived in the U.S. 10 years or less have not had a Pap test (by self report) in the last 3 years Women with a self reported past history of any of the following will not be eligible total hysterectomy cervical cancer active history of cervical dysplasia
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): 30.0-65.0, Cervical Cancer Human Papillomavirus Infection Women from 30 to 65 years Living in Indre-et-Loire (french territorial division 37) Women who attend organized cervical cancer screening or who answer to the invitation Cervical smear made in the three last years HPV linked cervical condition undergoing treatment Hysterectomy (including cervix)
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-64.0, HIV Dementia Men and women 18 years of age or older and less than 65 years of age. Able to read and understand English. HIV infected on stable ART regimen for 5 months or greater, and not likely to change regimen for the duration of the study. Significant dementia but able to give consent (International HIV Dementia Scale score <10). Significant cognitive slowing on screening, defined as 1 SD below normal (t-score >60) on the Conner's CPT-II reaction time test. Beck Depression Inventory score <16. Documented HIV-1 RNA PCR <50 copies/mL and documented CD4 count >200 within 3 months of entry visit. Baseline CBC and chemistry panel Grade 1 or normal. For females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within 24 months prior to study entry), or women who have not undergone surgical sterilization, specifically hysterectomy or bilateral oophorectomy or tubal ligation) will require a negative serum or urine pregnancy test within 48 hours prior to entry. NOTE: Subject reported history is considered acceptable documentation of hysterectomy, bilateral oophorectomy, tubal ligation, tubal micro-inserts, menopause, and vasectomy/azoospermia. All subjects must agree not to participate in the conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject/partner must use at least two reliable methods of contraception, (condoms, without a spermicidal agent; a diaphragm or cervical cap without spermicide; an IUD; or hormone-based contraceptive), for 2 weeks before study treatment, while receiving study treatment, and for 6 weeks after receiving study treatment. Ability and willingness of subject to provide informed consent Inability to give informed consent. No proxy consent allowed. Uncontrolled hypertension (SBP >140 and DBP >90 at screening and baseline). Untreated hypogonadism, hypothyroidism or hyperthyroidism. Initiation of antidepressants, thyroid medication or anabolic steroids within 6 weeks of screening visit. Pregnancy or breast feeding. Clinically significant EKG abnormalities at screening. History of coronary artery disease, atherosclerotic disease, left ventricular hypertrophy, cardiomegaly, syncope, congestive heart failure, myocardial infarction, pacemaker, clinically significant arrhythmia, angina, history of treatment for arrhythmia. Brain related opportunistic infections, stroke, intracranial lesions/disease, or meningitis. History of epilepsy. Untreated depression. Uncontrolled diabetes (glucose <70 or >200 at screening). Use of interferon or ribavirin during study and for 1 month prior to screening. History of bipolar disorder, Alzheimer's dementia, ALS, Parkinson's disease or other medical dementias other than HIV-related. History of schizophrenia, mania or other serious mental illness. History of methylphenidate allergy. Other serious concurrent medical illness other than HIV. History of radiation therapy to the brain or brain injury. History of crystal methamphetamine, cocaine, LSD use or other recreational substance use other than marijuana within the 12 months prior to screening and for the duration of the study. Plan to use marijuana or marinol during the entire study duration and one month prior to screening visit. Plan to drink 7 or more alcoholic drinks per week during the 4 weeks prior to screen visit and for the duration of the study. History of alcohol dependence, alcohol abuse, cocaine addiction, crystal methamphetamine addiction or other recreational drug addiction or treatment for addiction or dependence within 5 years of screening visit. If subject is using prescription narcotics, should be on a stable dose for at least 1 month prior to screening and throughout the study. Previous use of Concerta™, Ritalin™, atomexitine or Adderall™ or other psychostimulants (e.g. modafinil, armodafinil) for 3 months prior to screening visit and for duration of the study. History of tic disorders in the past 3 months or any history of Tourette's syndrome. Greater than 10% below ideal body weight (IBW for men = 50 kg + 2.3 kg per inch over 5 feet of height, and IBW for women = 45.5 kg + 2.3 kg per inch over 5 feet of height) Uncontrolled migraine headaches. History of short gut syndrome, Meckel's diverticulum, or cystic fibrosis. Family history of sudden cardiac death in a young relative. History of fainting with exercise. History of attention deficit disorder will be excluded, defined as a score greater than 6 on the Childhood ADHD Symptoms Scale. -
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): 18.0-65.0, IBD i. Women and men between the ages of 18-65 with a history of inflammatory bowel disease confirmed histologically and on immunosuppression defined as at least three months of azathioprine/6MP, eight consecutive weeks of prednisone greater than 15mg per day, a cumulative dose of greater than 100mg of methotrexate, or at least one infusion of infliximab within 8 weeks of the date of the anal Pap smear. ii. Women and men between the ages of 18-65 with a history of inflammatory bowel disease confirmed histologically and not on immunosuppression (defined as above) i. Patients with HIV, transplant recipients, men who have sex with men as they already represent high risk groups ii. Women with a history of an abnormal cervical Pap test within the past 2 years. iii. Patients with active proctitis as defined by an abnormal sigmoidoscopy or colonoscopy, rectal bleeding or tenesmus
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): 18.0-50.0, Human Papillomavirus Aged 18-50 years Had recent Pap smear result consistent with HSIL or "cannot rule out HSIL" or HSIL on biopsy Untreated for HSIL or "Cannot rule out HSIL" Able to provide informed consent Certain physical exam and blood component parameters within acceptable ranges Willingness and able to comply with the requirements of the protocol with a good command of the English language History of disease or treatment causing immunosuppression (e.g., cancer, HIV, organ transplant, autoimmune disease) Being pregnant or attempting to be pregnant within the period of enrollment Breast feeding or planning to breast feed within the period of enrollment Allergy to Candida antigen History of severe asthma requiring emergency room visit or hospitalization Current use of beta-blocker medication (may not respond to epinephrine in case of anaphylaxis) If in the opinion of the Principal Investigator or other Investigators, it is not in the best interest of the patient to enter this study
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-999.0, Cervical Cancer Histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix. Diagnosis has been made by LEEP, cone or cervical biopsy and has been reviewed and confirmed by the local reference gynecological pathologist Patient has been classified as low-risk early-stage cervical cancer. These patients • FIGO Stage IA2 [FIGO Annual Report, 2009], defined as: o evidence of disease by microscopy for patients who underwent a LEEP or cone histologic evidence of depth of stromal invasion > 3.0 and ≤ 5.0 mm based on the local reference pathologist's measurement of the LEEP or cone specimen histologic evidence of lateral extension that is ≤ 7.0 mm based on the local reference pathologist's measurement of the LEEP or cone specimen; and negative margins (patients with positive margins are considered IB1, see below) for patients who underwent a cervical biopsy only radiologic evidence of less than 50% stromal invasion based on pelvic MRI • FIGO Stage IB1 [FIGO Annual Report, 2009] with favorable (low risk) features, defined as measured stromal invasion and lateral extension that meet the for IA2 (see above) but with positive margins evidence of disease by clinical exam; lesion must clinically measure ≤ 20 mm Patients with FIGO 1A1 disease [FIGO Annual Report, 2009] History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours, Hodgkin's lymphoma or non-Hodgkin's lymphoma curatively treated with no evidence of disease for > 5 years Patients with evidence of lymph node metastasis on preoperative imaging or histology Patients who have had or will receive neoadjuvant chemotherapy Patients who are pregnant
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): 18.0-70.0, Uterine Cervical Cancer Cervical cancer, advanced or recurrent metastasis Measurable and assessible tumor lesions Used ordinary paclitaxel or platinum drugs, more than 28 days Aged 18-70 KPS score> 60 points, expected to survive more than 3 months Normal bone marrow function The function of liver and kidney had no obvious damage Normal function of vital organs No brain metastases Patients or their agents to sign informed consent Brain metastases Serious complications Acute inflammatory response Combined with other tumor Pregnancy or breast-feeding women Vertebral metastasis with nerve compression symptoms Large volume of pleural effusion, pericardial effusion Other malignancy within five years Drug allergy Other chemotherapy contraindications
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, Uterine Cervical Neoplasms Referred to follow up due to one or more abnormal Pap or an HPV infection Subjects who have provided informed consent Subjects who meet the minimum age set forth by the ethics committee (EC) and/or national screening guidelines Known to be pregnant With prior complete or partial hysterectomy involving removal of cervix Subjects with an application of chemical compounds to the cervical area 24 hour prior to study entry this includes acetic acid, iodine, spermicide, douche, anti-fungal meds Subjects on who conization, Loop electrosurgical excision procedure (LEEP), laser surgery or cryosurgery has been performed
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-999.0, Malignant Tumors Male or female subjects aged 18 years and older. 2. Signed and dated informed consent form. 3. Subjects with malignancies with histological or pathologic confirmation and who are clinically stable. 4. History of treatment with at least 1 cytotoxic chemotherapy regimen for the current malignancy. 5. If the subject has received cytotoxic chemotherapy within the past 14 days, the subject is beyond the nadir of white blood cell and platelet counts. 6. At least 28 days have elapsed since the subject's prior radiotherapy or any major surgery (excluding diagnostic biopsy or venous access device placement). 7. World Health Organization (WHO) performance status 0 to 2 8. Subject has an ANC ≥1500 cells/mm³, platelet count ≥ 100,000 cells/mm³, and hemoglobin ≥ 9 g/dL. 9. Subject has adequate liver function demonstrated by transaminases within normal limits (aspartate transaminase and alanine transaminase), total bilirubin ≤ 1.5 mg/dL (unless due to Gilbert's syndrome), albumin ≥ 2.5 g/dL, international normalized ratio [INR] < 1.5). 10. Subject has adequate renal function: serum creatinine ≤ 1.5 x upper limit of normal. 11. Subject has a life expectancy >24 weeks. 12. If a women of child-bearing potential, subject has a negative pregnancy test and is not breast-feeding. 13. If a women of child-bearing potential, subject is using a medically acceptable form of birth control prior to screening and for the duration of their study participation and for 1 month after the end of the study. 14. Subject is willing to comply with protocol-required visit schedule and visit requirements and provide written informed consent Subject has rapidly progressive disease or rapid clinical deterioration as assessed by the Investigator. 2. Subject is receiving full-dose (therapeutic) anticoagulation therapy. 3. Subject is receiving concomitant radiotherapy. 4. Subject is intolerant or allergic or has a known hypersensitivity to gemcitabine. 5. Subject has clinically significant cardiovascular disease (for example: uncontrolled hypertension, unstable angina, congestive heart failure, or New York Heart Association Grade 2 or greater). 6. Subject has uncontrolled serious cardiac arrhythmia. 7. Subject has known active brain metastases, or any leptomeningeal metastases. 8. Subject has a history of drug or alcohol abuse within last year. 9. Subject has documented cerebrovascular disease. 10. Subject has a seizure disorder not controlled on medication. 11. Subject received an investigational agent within 30 days of screening. 12. Subject received systemic treatment for infection within 14 days of screening. 13. Subject has known human immunodeficiency virus infection or viral hepatitis. 14. Subject has any other serious medical condition that, in the investigator's medical opinion, would preclude safe participation in a clinical trial. 15. Subject has gastrointestinal disease or prior gastrointestinal surgery that may interfere with adequate oral therapy absorption
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): 20.0-75.0, Cervical Cancer Previously untreated, histologically confirmed cervical cancer FIGO stage IB2 and IIA2 disease One of following histologic types 1. Squamous cell carcinoma 2. Adenocarcinoma 3. Adenosquamous carcinoma Gynecologic Oncology Group performance status: 0-2 Adequate organ function 1. Bone marrow: WBC > 3000/mm3, ANC ≥ 1,000/mm3, Platelet ≥ 100*103/mm3, Hemoglobin ≥ 10g/dL 2. Kidney: Creatine < 1.25 * upper normal limit 3. Liver: AST, ANT < 3 * upper normal limit, Total bilirubin < 1.5 mg/mm3 Patient who have Singed an approved informed consent Patients with cervical cancer who have received any previous radiation or chemotherapy Neuroendocrine carcinoma of uterine cervix Occult cervical cancer which was found after simple hysterectomy Para-aortic nodal involvement (> 10 mm short axis diameter on pretreatment imaging study) History of other invasive malignancies, with the exception of non-melanoma skin cancer, in situ melanoma and thyroid cancer, who had (or have) no evidence of the other cancer present within the last 5 years Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Prior diagnosis of Crohn's disease or ulcerative colitis Neurologic or psychiatric disease Patients who are pregnant or lactating
0
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 21.0-999.0, Human Papillomavirus Infection Subjects who were previously enrolled into the prospective, multicenter US clinical study for the HPV Assay on the System (protocol 2007HPVASCUS30) will be eligible for in the study of the AHPV-GT Assay using the System described in this protocol. All evaluable ASC-US Study subjects ≥21 years of age will be eligible for inclusion. Evaluable Adjunct Study subjects ≥30 years of age will be eligible if the following are met the subject attended the colposcopy visit, or the subject did not attend the colposcopy visit but the referral Pap sample had a positive HPV Assay result in the HPV Assay System study (protocol 2007HPVASCUS30) or in the HPV Assay System study (protocol Eligible subjects will be excluded if they do not have an evaluable sample. This may be due to insufficient volume or because the sample was deemed unsuitable for testing (eg, stored under unacceptable conditions)
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, Human Papillomavirus Infection Female subjects vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan (hypothetical group) Not applicable
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-999.0, BRCA1 and BRCA2 Mutation Carrier and BRCAness Phenotype Patients with partially platinum sensitive ovarian cancer (platinum-free interval 6-12 months) who have previously received at least two platinum based chemotherapy lines, BRCA mutated or with BRCAness phenotype Definition of BRCAness phenotype: high-grade serous cancers, great initial sensitivity to platinum drugs and retention of platinum-sensitivity through multiple relapses, long history of disease, long survival, long TFIs between relapses (patients with high personal risk factors will be included after doing the analysis for BRCA 1-2 mutation before knowing the results) BRCA 1 and/or BRCA 2 mutation carriers (patients with established mutation will be included, patients with high personal risk factors will be included after doing the analysis before knowing the results) 2. Patients with platinum resistant ovarian cancer, BRCA mutated or with BRCAness phenotype who have previously received at least two previous chemotherapy lines (including platinum rechallenge). Definition of platinum resistant: Tumor progression within 6 months of completion of platinum-based therapy (after platinum re-challenge for platinum sensitive recurrence). 3. Patient's written informed consent before any clinical trial-specific procedure. 4. 18 years-of-age or older. 5. Measurable disease as defined in the Response Evaluation in Solid Tumors (RECIST) Guidelines 6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. 7. Hematologic variables: 1. Hemoglobin ≥9 g/dL 2. Absolute neutrophil count (ANC) ≥1,500/μL, and 3. Platelet count ≥100,000/μL. 8. Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 30 mL/min 9. Creatinine phosphokinase (CPK) ≤ 2.5 ULN. 10. Hepatic function variables 1. Total bilirubin ≤ ULN. 2. Total alkaline phosphatase ≤ 2.5 ULN 3. AST (serum aspartate transaminase [SGOT]) and ALT (serum alanine transaminase [SGPT]) must be ≤2.5 x ULN. 11. Albumin ≥ 25 g/l. 12. Adequately recovered from the acute toxicity of any prior treatment. - Prior exposure to trabectedin. 2. Known hypersensitivity to any of the components of the trabectedin i.v. formulation or dexamethasone. 3. Less than 2 prior chemotherapy lines given in patients with partially platinum sensitive, BRCA mutated or BRCAness phenotype, ovarian cancer recurrences (including platinum rechallenge). 4. Patients with platinum refractory, BRCA mutated or with BRCAness phenotype, ovarian cancer. 5. Less than 4 weeks from last dose of therapy with any investigational agent, or chemotherapy. 6. History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for 3 years or longer. 7. Known clinically relevant CNS metastases. 8. Other serious illnesses, such as: • Congestive heart failure or angina pectoris; myocardial infarction within 1 year before enrollment; uncontrolled arterial hypertension or arrhythmias Psychiatric disorder that prevents compliance with protocol Active viral hepatitis; or chronic liver disease Active infection Any other unstable medical conditions
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, Intimate Partner Violence She is 18 or older She is currently court supervision at Bronx Community Solutions or a drug treatment court or she is currently on probation She reports using any illicit drug or drinking 4 or more alcoholic drinks in a 6-hour period in the past 90 days or she has been in alcohol or drug treatment in the past 6 months OR if she report attending any drug or alcohol treatment in the past 6 months She reports having had an ongoing intimate, dating or sexual relationship with a male or female partner that lasted 3 or more months in the past year She lives within a 90-minute commute of 125th and Broadway Ability to speak and understand English is not sufficient to participate in assessments or intervention sessions Inability to complete informed consent process due to a psychiatric or cognitive impairment The participant is unwilling or unable to commit to completing all the activities in the study
0
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-999.0, Cervical Cancer HIV infected women, older than 18 years of age, followed in the PHPT cohort Virginity, total hysterectomy, pregnancy after 3rd month, in a HPV vaccination trial
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 Histologically proven cervical cancer: squamous cell carcinoma or adenocarcinoma; FIGO stages IB IIA (preoperatively); Karnofsky-Index ≥ 70; unrestricted operability; BMI <35; age >=18 years Individual decision for treatment of TMMR and therapeutic LNE without adjuvant radiotherapy by the responsible clinic (clinician) on a clinical routine basis Informed consent of the patient Neuroendocrine differentiation and all preoperative FIGO stage IA or >IIA Distant metastases except in para-aortic lymph nodes; sclerodermia, lupus erythematodes, mixed connective tissue disease; secondary malignancy; previous radiotherapy of the pelvis Patients with diseases of the connective tissue will be excluded because of unforeseeable (e.g. neurological) symptoms and disorders after surgery. Patients with a BMI ≥ 35 will be excluded because of very high risks regarding wound healing, infections and thrombosis independent on the type of 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.
eligible ages (years): 18.0-45.0, Human Papillomavirus Infection Couple must have been in a new relationship that started no more than six months prior to study entry Both partners plan on remaining in Montreal for at least 1 year Plan on having continued sexual contact with partner Be willing to comply with study procedures Volunteers must not have been vaccinated against HPV-Gardasil-9 (both partners) Any history of cervical, penile, oral or anal cancers Being pregnant or plan on immediately becoming pregnant
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): 18.0-99.0, Sinusitis Diagnosis of chronic rhinosinusitis years of age or older English speaking Pregnant or breastfeeding women vasculitis cystic fibrosis primary ciliary dyskinesia allergic fungal sinusitis gross immunodeficiency current use of chemotherapy insulin-dependent diabetes mellitus recent trial of maximal medical therapy
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 Dysplasia Cervical Cancer Female ages 18 years or older English speaking Presenting for pap smear examination Pregnancy
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): 18.0-55.0, Smoking Healthy generally healthy between the ages of 18 and 55 smoking an average of 5 cigarettes per day for at least one year breath CO (carbon monoxide) level > 8 ppm (if ≤ 8 ppm, then NicAlert Strip > 2) no interest in quitting smoking for the duration of time required for the experiment right-handed as measured by a three-item scale used in our laboratory ability to identify 4 personal smoking and 4 personal non-smoking places inability to attend all required experimental sessions significant health problems use of psychoactive medications use of smokeless tobacco current alcohol or drug abuse use of illegal drugs as measured by urine drug screen current use of nicotine replacement therapy or other smoking cessation treatment presence of conditions that would make MRI unsafe (e.g., pacemaker)
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-999.0, HIV Infection HIV infection 18 months or more since Pap test Speak & read English Eligible for cervical cancer screening Plans to have Pap testing at Johns Hopkins Hospital History of hysterectomy Currently pregnant
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): 20.0-80.0, Uterine Cervical Neoplasms be able to give informed consent female patients between 20 and 80 years of age biopsy proven newly diagnosed cervical cancer clinical stage International Federation of Gynecology and Obstetrics (FIGO) Ib and above patients must be willing to undergo standard treatment such as surgery or chemo-radiation therapy patients who are judged to be noncompliant to treatment or not accessible for follow up patients with contraindications to magnetic resonance imaging (MRI) scanning, such as claustrophobia, cardiac pacemaker, metal implants in field of view, or unable to cooperate for MRI study due to mental status
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, Malignant Tumor Histologically confirmed with malignant tumor and malignant cavity effusion. 2. An Eastern Cooperative Oncology Group(ECOG)performance status of 0-2. 3. Normal cardiac, hepatic, renal and bone marrow functions. 4. Life expectancy >3 months. 5. Not receive other anti-tumor treatment. 6. Not receive chemotherapy in pleural and abdominal cavity Previous history of other malignancies. 2. Serious or uncontrolled concurrent medical illness
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): 17.0-60.0, Cervical Cancer FIGO(2009) stage Ia2, Ib1, and IIa1 Untreated cervical cancer OR FIGO(2009) stage Ib2 and IIa2 cervical cancer that possible to surgery after neoadjuvant chemotherapy 2. Possible to radical hysterectomy or nerve-spring radical hysterectomy 3. Age: 17 to 60 years 4. No complication during operation 5. Written informed consent patients who underwent radiotherapy 2. Pathologically diagnosed Pathologically diagnosed squamous carcinoma, Small Cell Carcinoma, Small Cell Carcinoma 3. Patients who have uncontrolled diabetes or uncontrolled hypertension 4. patients with neurogenic bladder dysfunction 5. patients with uterine prolapse 6. Patients with psychiatric illness 7. Patients who have active infection 8. Patients who have had heart failure, unstable angina, or myocardial infarction within the past 6 months 9. Patients who are unable to undergo radical hysterectomy for complication of excessive obesity, liver cirrhosis, or bleeding tendency
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, Obstetric Fistula Presentation to the Fistula Care Centre in Lilongwe for medical evaluation 2. Ability to consent for study participation in Chichewa 3. Female aged 18-45 years 4. Willingness to undergo pelvic ultrasound for assessment of pelvic organs No history of pregnancy 2. History of hysterectomy 3. Current pregnancy or pregnancy within the past six weeks 4. Seriously or terminally ill
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): 18.0-60.0, Smoking Woman 18-60 Years Old smoking woman 18-60 years old not smoking Not want to participate in the study
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): 25.0-50.0, BRCA1 Gene Mutation BRCA2 Gene Mutation healthy premenopausal women BRCA1 mutations BRCA2 mutations women with breast or ovarian cancer
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, FIGO Stage IVA Ovarian Cancer FIGO Stage IVB Ovarian Cancer Platinum-Resistant Ovarian Carcinoma Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma Recurrent Uterine Corpus Carcinoma Stage III Fallopian Tube Cancer AJCC v7 Stage III Ovarian Cancer AJCC v6 and v7 Stage III Primary Peritoneal Cancer AJCC v7 Stage III Uterine Corpus Cancer AJCC v7 Stage IIIA Fallopian Tube Cancer AJCC v7 Stage IIIA Ovarian Cancer AJCC v6 and v7 Stage IIIA Primary Peritoneal Cancer AJCC v7 Stage IIIA Uterine Corpus Cancer AJCC v7 Stage IIIB Fallopian Tube Cancer AJCC v7 Stage IIIB Ovarian Cancer AJCC v6 and v7 Stage IIIB Primary Peritoneal Cancer AJCC v7 Stage IIIB Uterine Corpus Cancer AJCC v7 Stage IIIC Fallopian Tube Cancer AJCC v7 Stage IIIC Ovarian Cancer AJCC v6 and v7 Stage IIIC Primary Peritoneal Cancer AJCC v7 Stage IIIC Uterine Corpus Cancer AJCC v7 Stage IV Fallopian Tube Cancer AJCC v6 and v7 Stage IV Ovarian Cancer AJCC v6 and v7 Stage IV Primary Peritoneal Cancer AJCC v7 Stage IV Uterine Corpus Cancer AJCC v7 Stage IVA Uterine Corpus Cancer AJCC v7 Stage IVB Uterine Corpus Cancer AJCC v7 Provided informed consent Patient with primary or recurrent International Federation of Gynecology and Obstetrics (FIGO) stage III or IV, or recurrent ovarian, fallopian tube, peritoneal carcinoma, or uterine cancer, confined to abdominal cavity, including those who have completed neoadjuvant chemotherapy and primary surgery Gynecologic Oncology Group (GOG) or Eastern Cooperative Oncology Group (ECOG) performance status =< 1 or Karnofsky scale (KPS) >= 70% Patients who are platinum-sensitive or platinum resistant Candidate for potentially radical, maximal effort cytoreductive surgery at the discretion and expertise of the treating physician For patients with newly diagnosed-ovarian/tubal/peritoneal cancer who have received pre-operative neoadjuvant chemotherapy, evidence of response must be documented by at least one of the following Decline in serum cancer antigen (CA) 125 level At least a 30% decrease in the sum of the longest diameter of target lesions on radiographic imaging Improvement of ascites volume Neoadjuvant chemotherapy must be held for at least 3 weeks prior to surgery Patients with active extra-abdominal disease including active malignant pleural effusion; patients who have been successfully treated with neoadjuvant chemotherapy and no longer have (malignant) pleural effusions may be included Patients whose disease has progressed following at least 3 cycles of neoadjuvant chemotherapy as defined by at least one of the following Doubling of serum CA-125 level At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions Clinical deterioration (worsening ascites, carcinomatous ileus, malignant bowel obstruction, severe hypoalbuminemia, declining performance status) Cardiac or pulmonary conditions that preclude aggressive cytoreductive surgery Patients whose circumstances do not permit completion of the study or the required follow-up Pregnant, nursing, or of childbearing potential and refuse hysterectomy or bilateral salpingo-oophorectomy Other active invasive malignancies, with the exception of non-melanoma skin cancer and breast cancer (if without evidence of disease 1 year after completion of treatment) Metastatic non-gynecologic or breast primaries
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): 20.0-99.0, Cervical Cancer All women who had received radiotherapy for cervical cancer in our outpatient clinics. 2. Prior to joining test subjects for 90 days or more earlier had received a complete pelvic radiation therapy, including treatment of the cervix or vagina. 3. Subjects with radiation therapy (including combined chemical and radiation therapy or postoperative adjuvant [chemical] radiation therapy) for their first treatment recurrence of cervical cancer 2. hormone treatment within 90 days 3. vaginal vault or cervix topical treatment within 90 days. 4. Subjects had or now have other malignancies
1
The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-999.0, Malignant Solid Neoplasm Metastatic Melanoma Stage III Cutaneous Melanoma AJCC v7 Stage IIIA Cutaneous Melanoma AJCC v7 Stage IIIB Cutaneous Melanoma AJCC v7 Stage IIIC Cutaneous Melanoma AJCC v7 Stage IV Cutaneous Melanoma AJCC v6 and v7 Unresectable Melanoma PHASE I ONLY: Prior therapy is allowed; for patients enrolled in the Phase I portion of the study, patients may have received any number of prior lines of therapy including treatment with a BRAF and/or MEK inhibitor; prior navitoclax use will not be allowed, unless the patient received < 7 days of navitoclax lead-in on this or another study and had to stop for reasons other than toxicity or disease progression Patients must have histologically confirmed, BRAF-mutant (V600E/K) melanoma (molecularly confirmed using validated, commercially available assay performed in a Clinical Laboratory Improvement Act [CLIA]-approved laboratory) that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective If test at CLIA-certified lab used a non-Food and Drug Administration (FDA) approved method, information about the assay must be provided; (FDA approved tests for BRAF V600 mutations in melanoma THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam Prior therapy is allowed; for patients enrolled in the Phase II portion of the study, patients may have received prior immunotherapy (including high-dose IL-2, ipilimumab, nivolumab, and other anti-PD1/PDL1 antibodies) or chemotherapy; however prior navitoclax, BRAF inhibitor and/or MEK inhibitor therapy will not be allowed Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%) Life expectancy of greater than 3 months Leukocytes >= 3,000/mcL Absolute neutrophil count >= 1 x 10^9/L Hemoglobin >= 9 g/dl (patients may be transfused to this level) PHASE I ONLY: Patients must not have received prior navitoclax, unless the patient received < 7 days of navitoclax lead-in on this or another study and had to stop for reasons other than toxicity or disease progression Patients who have had immunotherapy, chemotherapy or radiotherapy within 14 days prior to the first dose of navitoclax, or prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or vaccine therapy) within the last 3 weeks prior to first dose of dabrafenib and/or trametinib; chemotherapy regimens without delayed toxicity within the last 2 weeks preceding the first dose of study treatment; biologics will not be allowed within 30 days prior to, or during, navitoclax administration Prior navitoclax, BRAF inhibitor, and MEK inhibitor is prohibited; (exceptions for Phase I are described above) Patients who are receiving any other investigational agents have received any other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study treatment and during the study Patients must have no clinical evidence of leptomeningeal or brain metastasis causing spinal cord compression that are symptomatic or untreated or not stable for >= 3 months (must be documented by imaging) or requiring corticosteroids; subjects on a stable dose of corticosteroids > 1 month or who have been off of corticosteroids for at least 2 weeks can be enrolled with approval of the Cancer Therapy Evaluation Program (CTEP) medical monitor; subjects must also be off of enzyme-inducing anticonvulsants for > 4 weeks History of allergic reactions attributed to compounds of similar chemical or biologic composition to navitoclax, dabrafenib, or trametinib, or excipients or to dimethyl sulfoxide (DMSO) Uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study because navitoclax, dabrafenib, and trametinib may have teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drugs, breastfeeding should be discontinued if the mother is treated with the study drugs Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy that predict to interact with any of the study drugs are ineligible because of the potential for pharmacokinetic interactions with the study drugs; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated; it is not necessary to conduct HIV testing at screening; patients who are HIV-positive with undetectable viral loads, not on interacting antiretroviral therapy, and have CD4 counts above 300/mm^3 may be eligible after discussion with the principal investigator History of another malignancy; exception: patients who have been disease-free for 3 years (depending upon tumor type studied or clinical setting, 3 or 5 years can be used; e.g., for advanced melanoma and pancreatic studies 3 years is more appropriate due to aggressiveness of the disease, while 5 years can be more appropriate for prostate or ovarian cancer or adjuvant setting when life expectancy is longer), or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent secondary malignancies, are eligible; consult the CTEP medical monitor if unsure whether second malignancies meet the requirements specified above; exception: patients with history of RAS mutation-positive tumors are not eligible regardless of interval from the current study; prospective RAS testing is not required; however, if the results of previous RAS testing are known, they must be used in assessing
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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 Dysplasia Female Smokers (defined as those who have smoked at least daily for the last year and who have smoked greater than or equal to 10 or more combustible cigarettes per day during the last year Patients with diagnoses of Cervical Dysplasia, Cervical Cancer and Lower Genital Tract Dysplasia and Cancer Ages 18-65 years Patients unwilling to commit to a 6-week intervention that may either NRT or ENDS Patients with previous diagnoses of or treatment for cancer with the exception of non-melanoma skin cancer Presence of any known stroke, heart disease, heart attack, or irregular heart beat Pregnancy and lactation Plan to continue to use other nicotine in addition to the products supplied by the study. These would chewing tobacco, snuff, an additional nicotine patch or other nicotine containing products High blood pressure, not well controlled with medication Patients using a non-nicotine "smoking cessation medication." Patients taking a prescription medicine for depression or asthma
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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): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed
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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, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship)
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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, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment
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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, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months
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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, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL
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The patient is a 37-year-old woman who came to the clinic for a routine Pap smear. The test revealed stage 1B of cervical cancer. The patient tested positive for HPV 16. She has three sexual partners and four children. She underwent tubal ligation. She smokes 30 packs/year and drinks alcohol frequently. She is otherwise healthy. She was offered a radical hysterectomy.
eligible ages (years): 18.0-54.0, Placenta Previa Participant age 18 years or older Gestational age between 22w0d and 32w0d, inclusive, at time of enrollment Singleton pregnancy Complete Placenta Previa Intact Membranes No allergies to material in pessary Plan to deliver at PI's hospital Informed consent obtained, signed/dated Active preterm labor Nonreassuring fetal heart rate tracing Intrauterine fetal death Active bleeding (may be enrolled if hemostatic >48 hours) Ruptured membranes Any fetal condition likely to cause serious neonatal morbidity independent of gestational age: Fetal malformation likely to require surgery, Fetal malformation involving vital organs, Fetal viral infection, Hydrops fetalis Known Uterine Anomaly Cervical Cerclage present at time of enrollment Maternal condition that warrant continued hospitalization (example severe preeclampsia, Diabetes out of control, maternal heart disease)
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