topic
stringlengths 245
1.29k
| doc
stringlengths 52
16.9k
| label
stringclasses 3
values |
|---|---|---|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 0.0-999.0, Breast Cancer Patients who are hospitalized and treated in a collaborative network unit Agree to enroll in the study and sign the informed consent form Histological diagnosis of ductal carcinoma in situ or invasive breast cancer Accept the Surgery-based surgical treatment Willing to cooperate with follow-up work Previously Excisional biopsy (including minimally invasive resection) of the patient's breast Previously received neoadjuvant chemotherapy Imaging or histological evidence of distant metastasis
|
2
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 33.0-70.0, Breast Neoplasm all female with mean age 50 ± 17 having breast MRI Contraindications of MRI as pacemakers, aneurysmal clipping, retained metallic foreign bodies, or claustrophobic patients Pregnant women especially in the first trimester
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 45.0-999.0, Invasive Ductal Breast Carcinoma Invasive Ductal Carcinoma, Breast DCIS DCIS Grade 1 DCIS Grade 2 Breast Cancer Female Age >/= 45 years Unicentric pathological stage I (pT1 or T2 pN0_M0) invasive ductal breast cancer or DCIS measuring <3 cm in longest diameter on pathology and/or mammogram that is histologically confirmed. If T2, the tumor must be less than 3cm in longest diameter. Note: Women ≥ 70 years or older with T1 invasive ductal carcinoma who are estrogen- receptor positive (ER+) with clinically negative axillary nodes, and do not undergo surgical lymph node mapping or dissection (i.e., if tumor deposit is 0.2 mm or less, regardless of whether the deposit is detected by immunohistochemistry or hematoxylin and eosin staining) will also be eligible Histologically negative tumor margin or no tumor in a re-excision specimen on final shaved specimen ECOG Performance Status of 0 or 1 Clips must be placed in the lumpectomy cavity at the time of final excision in order to aid in the delineation of the tumor cavity at the time of simulation and radiation delivery Negative serum pregnancy test within 14 days prior to study treatment if a woman has child-bearing potential. Subjects of child bearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year Written informed consent obtained from subject and ability for subject or comply with the requirements of the study Female subjects of childbearing potential should be willing to use 2 methods or birth control or be surgically sterile or abstain from heterosexual activity for the duration of study participation. Should a woman become pregnant while participating on study, she should inform the treating physician immediately. for intermediate risk substudy Post-NAC cohort patients: clinical T1 or T2 (less than or equal to 5cm in longest diameter on available imaging) and clinical N0 (on exam and imaging) with pathological pT0 or pTis and pN0 (any regimen of neoadjuvant chemotherapy agents is allowed) OR Patients with distant metastasis Patients who are pregnant or breastfeeding Patients with diffuse (>1 quadrant or >5cm) suspicious microcalcifications or patients with known multicentric OR multifocal disease. (microscopic multifocal disease that may be unifocal and/or appear multifocal due to sectioning is allowed after review with PI) Prior radiation therapy to the ipsilateral or contralateral breast or thorax Histological evidence of extensive lymphovascular invasion (LVI) Histological evidence of extensive intraductal component (EIC), defined as the presence of intraductal carcinoma both within the primary infiltrating ductal tumor (comprising at least 25% of the tumo area) and intraductal carcinoma present clearly beyond the edges of the invasive tumor Patients are not required to undergo BRCA1 and BRCA2 or other genetic mutation tests in order to enroll on the study. Note: in the event a patient is tested and is found to be a mutation carrier, she would be excluded from the study. It would be an extremely rare/unlikely scenario for patients to be discovered BRCA positive after the completion of PBI, as all patients with risk factors for BRCA mutations (positive family history, Ashkenazi Jewish descent, ER-/PR-/her2-neu-negative receptor status) are usually tested prior to radiation. Should such a situation exist, these patients will be given the option of remaining on the breast conservation paradigm or opting for mastectomy (as is done in this rare scenario is standard of care practice). The patient will be replaced on the trial History of cosmetic or reconstructive breast surgery Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases) that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have "currently active" malignancies if they have completed therapy and are considered by their physicians to be at <5% risk of relapse within 3 years
|
1
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Breast Cancer Hepatitis C Biopsy-proven invasive breast cancer Patients with unknown viral marker status Patients who did not complete their management at OCMU Patients with multiple cancer diagnoses Patients with virus-unrelated hepatic pathology
|
2
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-75.0, HER2-Positive Breast Cancer • Histologically or cytologically confirmed HER2 positive invasive breast carcinoma Clinical stage #-#B Patients must have measurable disease as defined by palpable lesion with both diameters ≥2cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension ≥2cm. Bilateral mammogram and clip placement is required for study entry. Baseline measurements of the indicator lesions must be recorded on the Patient Registration Form. To be valid for baseline, the measurements must have been made within the 14 days if palpable. If not palpable, a mammogram or MRI must be done within 14 days. If palpable, a mammogram or MRI must be done within 2 months prior to study entry. If clinically indicated, xrays and scans must be done within 28 days of study entry Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of study entry Normal (greater than 50%) left ventricular ejection fraction (LVEF) by echocardiography Signed informed consent Adequate organ function within 2 weeks of study entry: Absolute neutrophil count >1500/mm3, Hgb >9.0 g/dl and platelet count >100,000/mm3 Total bilirubin < upper limit of normal Creatinine < 1.5 mg/dL or calculated cranial cruciate ligament (CrCL) >50mL/min using the Cockcroft Gault equation serum glutamate oxaloacetate transaminase(SGOT)(AST) or serum glutamic oxaloacetic transaminase(SGPT)(ALT) and Alkaline Phosphatase must be within the range allowing for Patients must be over 18 years old Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation • Metastatic disease Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer. Patients with history of breast cancer greater than 5 years from initial diagnosis are eligible for the study. Patients may not have received anthracycline-based chemotherapy in the past. Patients with history of ductal carcinoma in situ(DCIS) are eligible if there were treated with surgery alone History of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain disease free for greater than five years are eligible
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 40.0-999.0, Breast Cancer ≥ 45 years or 40-44 if there isn´t any other risk factor Diagnosed with infiltrating ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) and that have undergone conservative surgery without ganglionar involvement (pN0) of any histological degree except from invasive lobular carcinoma and with a size ≤ 3 cm Disease free margins (R0: > 2mm) Positive and negative estrogen receptor tumors Multicentric and multifocal tumors, except from if it´s focal and the only risk factor Patients must not have undergone a neoadjuvant QT therapy Patients with BRCA positive mutation will be excluded Those patients unable or unsuitable to understand and accept the informed consent Metastasic´s affectation evidence Extensive lymphovascular invasion, except from if the total resulting size of the focus and breast parenchyma addition is ≤ 3cm Breast implants presence in the breast that´s going to be treated Contraindicated radiotherapy treatment due to a diagnosis of cutaneous lupus, pregnancy or scleroderma Inability to fully know the dosimetric data of the APBI plan
|
1
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 0.0-999.0, Iatrogenic Bile Duct Injuries Duodenojejunostomy Access Loop • Iatrogenic bile duct injuries • Hepatobiliary malignancies
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, HER2-positive Breast Cancer ≥18 years old with histologically confirmed HER2 positive breast cancer. 2. Documented HER2 overexpression by local laboratory ,defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) positive. 3. Physician has determined that treatment with pyrotinib is indicated. 4. Traceable medical record available Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent . 2. Pregnant or breast feeding patients 3. Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. 4. Patients not suitable for this study under investigators' consideration
|
2
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-70.0, Nasopharyngeal Carcinoma Histological diagnosis of nasopharyngeal carcinoma Stage III or IVA according to UICC/AJCC 8th staging system Age ≥18 No prior anti-tumor treatment Karnofsky Performance Score (KPS)≥70 Adequate blood supply Informed consent obtained Can not take contrast-MRI imaging Pregnant Combined with other malignant tumor (except basal cell carcinoma of skin)
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Vitamin D Deficiency Women British African-Caribbean Self-reported Having African ancestral origin and migrated via the Caribbean islands, or having at least one parent with African ancestral origin that migrated via the Caribbean Living in England for >2 months Aged 18-35 or >55 years No significant health issues Pre-menopausal (regular menstrual periods) or Post-menopausal (menstrual periods stopped for longer than 12 consecutive months) BMI 18-30kg/m2 Women in perimenopause or menopause Pregnant or planning pregnancy during study period Hypercalcaemia (>2.5mmol/L) assessed and excluded at baseline Currently receiving treatment for medical conditions that are likely to affect vitamin D metabolism (osteoporosis, hormone replacement therapy, anti-estrogens treatment, antiepileptic drugs and breast cancer treatment) Regular use of sun beds Having a sun holiday one month prior to commencing study or plans for a sun holiday for more than 4 weeks within the study period Women who take vitamin D or calcium supplements (or multivitamin supplements that contain these vitamins) If potential participant agrees to stop supplement use to join the study, a wash-out period of 8 weeks prior to commencing the study is acceptable Living in England for less than 2 months
|
1
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Anatomic Stage 0 Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 HER2/Neu Negative Invasive Ductal Carcinoma, Not Otherwise Specified Progesterone Receptor Negative Prognostic Stage 0 Breast Cancer AJCC v8 Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage IA Breast Cancer AJCC v8 Prognostic Stage IB Breast Cancer AJCC v8 Prognostic Stage II Breast Cancer AJCC v8 Prognostic Stage IIA Breast Cancer AJCC v8 Prognostic Stage IIB Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Triple-Negative Breast Carcinoma Written informed consent must be obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 Localized, palpable, biopsy proven triple negative or ER positive HER2 negative infiltrating ductal breast cancer with size > 1.5 cm by palpation, excluding breast cancer where neoadjuvant chemotherapy is indicated by current guidelines (i.e. inflammatory subtype, etc.) Tumor that is palpable and injectable Hemoglobin >= 9 g/dL Absolute neutrophil count >= 1,500/mm^3 Platelet count >= 100,000/mm^3 Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal (ULN) Bilirubin =< 1.5 x ULN; for subjects with documented/suspected Gilbert?s disease, bilirubin =< 3 x ULN Albumin >= 2.5 g/dl Contraindications to tumor biopsy and injections (coagulopathy, known history of keloid formation, etc.) Women who are pregnant or breastfeeding Sexually active subjects and their partners unwilling to use male or female latex condom to avoid potential viral transmission during sexual contact while on treatment and within 30 days after treatment with talimogene laherparepvec Inability to give informed consent History of malignancies except cured basal cell carcinoma, cutaneous squamous cell carcinoma, melanoma in situ, superficial bladder cancer or carcinoma in situ of the cervix; for other malignancies, must be documented to be free of cancer for >= 2 years. All other cases can be considered on a case by case basis at the discretion of the principal investigator Any condition that might interfere with the subject?s participation in the study, safety, or in the evaluation of the study results Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study Prior exposure to any anti-PD-1 or anti-PD-L1 antibody, or any anti-CTLA 4 antibodies Patients must not have received prior treatment with talimogene laherparepvec or other oncolytic virus agents Patients must not have received any live vaccine within 30 days prior to registration. Seasonal flu vaccines that do not contain live virus are permitted
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Breast Cancer Triple Negative Breast Cancer HER2-positive Breast Cancer Sentinel Lymph Node Women, aged ≥ 18 years Invasive HER2+ (HR+/-) or TN breast cancer Primary tumor (T), clinical stage T1-3 Neoadjuvant systemic therapy (NST), at least 3 cycles Tumor stage assessed with breast MRI before start NST Clinically node-negative before start NST (no suspect ALNs on ultrasound and FGD-PET/CT, or negative cyto-/histopathology in case of suspect nodes) MRI after or during NST shows radiologic complete response Written and signed informed consent Primary tumor (T) clinical stage T4 Patients without ultrasound or FDG-PET/CT pre-NST History of breast cancer ipsilateral breast Synchronous contralateral breast cancer Synchronous M1 disease
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Invasive Breast Cancer Triple Negative Breast Cancer ER-Negative Breast Cancer PR-Negative Breast Cancer HER2-negative Breast Cancer Female or male patients ≥ 18 years of age Histologically confirmed diagnosis of invasive breast cancer, previously untreated Participants must have biopsy proven ER negative (ER-), PR negative (PR-), HER2 negative (HER2-), invasive breast cancer. ER, PR, and HER2 positivity would be determined per ASCO/CAP guidelines by institutional (local) assessment. Patients with multi-focal and multicentric disease are eligible provided all histologically examined lesions are ER-/PR-/HER2 (local assessment). The need to biopsy additional lesions is at the discretion of the treating physician. Patients with bilateral invasive breast cancer are eligible provided all histologically examined lesions are ER-/PR-/HER2- (local assessment) Primary tumor (at least one lesion) 1 cm or greater measured by radiological imaging. Regional lymph node AJCC (v7) TNM stages N0-N2. If node positive, any primary tumor size is permissible. Absence of distant metastatic disease (AJCC TNM stage M0). Staging scans are not required and are per discretion of the treating physician Pre and postmenopausal women are eligible ECOG performance status = 0, 1 (Karnofsky ≥60%, see Appendix A) Ability to understand and the willingness to sign a written informed consent form (ICF). Patient has signed the ICF prior to any screening procedures being performed and is able to comply with protocol requirements, including research biopsy Patient has adequate bone marrow and organ function as defined by the following laboratory values at screening Inflammatory breast cancer, or locally recurrent breast cancer Participants currently receiving systemic therapy for any other malignancy or having received systemic therapy for a malignancy in the preceding 3 years Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,or psychiatric illness/social situations that would limit compliance with study requirements Clinically significant, uncontrolled heart disease and/or cardiac reppolarization abnormality including any of the following History of angina pectoris, symptomatic pericarditis, coronary artery bypass graft (CABG) or myocardial infarction within 6 months prior to study entry History of cardiac failure, known cardiomyopathy (LVEF < 50%; new LVEF assessment is not specifically required for this trial), significant/symptomatic bradycardia, Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome or any of the following Known risk to prolong the QT interval or induce Torsade's de Pointes Uncorrected hypomagnesemia or hypokalemia Systolic Blood Pressure (SBP) >160 mmHg or <90 mmHg Bradycardia (heart rate <50 at rest), by ECG or pulse. On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF >470 screening ECG
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-70.0, Breast Cancer WHO performance status 0-1 Invasive Breast Cancer with cT1-3 cN1-2 at time of diagnosis Axillary nodal involvement can be detected using, clinical examination, ultrasound, CT scan or PET scan Pathologic confirmation using, FNAC, core biopsy or excisional biopsy ER, PR, Her2 neu and Ki67 status should be available for all patients All patients should have received standard preoperative chemotherapy prior to surgery At the time of surgery, all patients should have axillary clearance with at least 6 nodes harvested from the axilla Patients who have undergone mastectomy or lumpectomy with negative margins with ypN0, ypN0(+i) or ypN0(+mol) are eligible for randomization Poor performance status Definitive clinical or radiologic evidence of metastatic disease T4 tumors including inflammatory breast cancer N3 disease detected clinically or by imaging Patients with histologically positive axillary nodes after preoperative chemotherapy Positive surgical margin after definitive surgery Previous ipsilateral or contralateral breast cancer Previous chest wall or breast irradiation Second primary cancer Active connective tissue disease
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Breast Cancer Female Female Age 18 years or older Invasive ductal breast carcinoma and ductal carcinoma in situ having undergone breast conservation surgery May neo-adjuvant treated subjects (chemotherapeutic, endocrine therapy, or radiation) Ability to understand and the willingness to sign a written informed consent document Metastatic cancer (Stage IV) Lobular carcinoma as primary diagnosis
|
2
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Breast Neoplasm Female Sample selection 1. Prior information of the patient. 2. Histologically proven invasive breast cancer, 3. ER-positive breast cancer, according to the following ER ≥10 % (local assessment) 4. HER2-negative tumor by IHC (score 0 or 1+) and/or fluorescent in situ hybridization (FISH)/chromogenic in situ hybridization (CISH) negative (local assessment) 5. IHC staining slides for ER, PR, KI67 and HER2 carry out on surgical resection according to local protocol available, 6. In situ hybridization (ISH) staining for HER2 carry out on surgical resection, in case of IHC 2+ for HER2 immunostaining 7. EndoPredict test results available (EPclin), 8. Formalin-fixed and paraffin-embedded (FFPE) block from surgical resection of the primary tumor available, 9. Patient ≥18 years old
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Metastatic Breast Cancer Women with histological confirmed ER/PR positive, HER2-negative MBC Age >18 years old Patients initiating first or second line therapy for ER/PR positive, HER2-negative MBC Adequate hematologic, renal and hepatic function Signed informed consent (ICF) Active malignancy other than MBC Active infection
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-80.0, Breast Cancer HER2 Preoperative Systemic Treatment HER2 positive 2. early invasive breast cancer (cT1-3N0-1M0) 3. using one-year trastuzumab as anti-HER2 treatment metastasis and recurrent breast cancer 2. using trastuzumab less than a year
|
1
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-79.0, Blood Pressure Hypertension Cancer Cancer, Breast Cancer of Prostate Cancer Colorectal Cancer, Endometrial Cancer of Head and Neck Non Small Cell Lung Cancer CVD - Cardiovascular Disease Diabetes Mellitus Hypercholesterolemia Diabetes A total of 800 individuals who fall under the following will be enrolled Diagnosed with any of the following selected solid tumors - Stage I-III breast [female], colorectal, endometrial, head/neck [H/N], and prostate cancer Stage I-II non-small cell lung cancer [NSCLC] Treated with curative intent 79 years old Has at least one of three CVD comorbidities (hypertension, diabetes, or hypercholesterolemia) based upon whether the patient is currently on a medication for the comorbidity at time of recruitment Had a visit with their PCP in the previous 12 months Individuals with a history of the following conditions will be ineligible Myocardial infarction in the previous 24 months Stage III-IV heart failure Stage III-IV chronic kidney disease
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-75.0, Metastatic Breast Cancer Adult female patients with advanced breast cancer diagnosed by pathology (aged 18-75, including 18 and 75 years old), not suitable for surgical resection or radiation therapy for the purpose of cure Pathological examination confirmed ER and / or PR positive, HER-2 negative (Positive ER expression: immunohistochemistry >1% tumor cell staining; Positive PR expression: immunohistochemistry >1% tumor cell staining; HER-2 negative: immunohistochemistry is 0,1+, or FISH/CISH negative when immunohistochemistry is 2+) Patients with advanced breast cancer who have no disease progression after a 4-8-course first-line chemotherapy regimen (the effect is evaluated as complete response/ partial response/ stable disease). Capecitabine monotherapy as first-line chemotherapy is allowed and the courses of treatment should be limited to 6 WHO physical status 0-1 points, estimated lifetime at least 3 months Imaging examinations within 3 weeks before enrollment were required for assessing tumor lesions before maintenance treatment (Examination results from local Tertiary A hospital are available) Previous treatment-related toxicity should be relieved to ≤ Grade 1 according to NCI CTCAE (version 4.03) before randomization (Except for hair loss and other toxicities that are not at risk to the patient's safety based on the investigator's judgment) The routine blood test was normal within 1 week before enrollment: WBC ≥3.0×10^9／L, b. ANC ≥1.5×10^9／L, c. PLT ≥100×10^9／L The liver and kidney function test was normal within 1 week before enrollment (Take the normal value of the laboratory of each research center as the standard): a. TBIL≤1.5× Upper Limit of Normal (ULN)b. ALT/AST≤2.5×ULN（Liver metastasis patients ≤5xULN） c. Serum Cr ≤1.5×ULN, or Ccr ≥60 ml/min Informed consent form signed before enrollment Cannot be grouped if any of the following is true Newly developed central nervous system metastasis or symptom control of central nervous system is less than 4 weeks. (Patients with asymptomatic brian metastases which was stable more than 4 weeks by imaging assessment and do not need corticosteroid therapy are allowed to enrollment) Diagnosis of any other malignant tumor within 3 years before randomization, except for adequately treated basal cells or squamous cell skin cancer or cervical cancer in situ Endocrine therapy for advanced disease Pregnant or breast-feeding patients Patients with accompanying disease or situation that may interfere with the study, or any serious medical problems that may affect the safety of the subject (for example, uncontrolled heart disease or high blood pressure, active or uncontrolled infection, active hepatitis B virus infection) Patients who were unable to tolerate capecitabine toxicity were first identified in first-line treatment Patients with recurrent metastatic disease within 2 years of adjuvant endocrine therapy (including 2 years)
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 20.0-999.0, HER2-positive Breast Cancer Chemotherapy Effect Circulating Tumor DNA HER2+ Breast cancer Stage IIA IIIC Plan to receive neoadjuvant chemotherapy with docetaxel, carboplatin, herceptin, perjeta Sign to informed consent Double primary cancer
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Medication Administered in Error English or Spanish-speaking 2. 18 years of age and older 3. Child discharged home with a Rx for >1 daily liquid medication (other than multivitamin) 4. Primary person who will administers child's medications. 5. Willingness and ability to participate Does not have a working phone number 2. Does not have access to internet (via computer/smartphone) 3. Does not have a mobile phone that receives texts. 4. Not able to return to the hospital for their child's follow-up visit 5. Visual acuity worse than 20/50 according to the Rosenbaum Pocket Screener 6. Uncorrectable hearing impairment
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-65.0, Breast Cancer Female breast cancer patients at the age of >= 18 years and <= 65 years who received first treatment； 2. Pathologically confirmed HER2-positive invasive breast cancer（which is defined as the immunohistochemistry score of > 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification），regardless of hormone receptor status (ER and PR)； 3. According to the 2019 CSCO BC guidelines: When HER-2 positive is used as the standard for preoperative neoadjuvant therapy for breast cancer, the tumor is larger than 2 cm； 4. The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1； 5. The functional level of the main organs must meet the following requirements ： 1) blood routine test: hemoglobin (Hb) ≥ 90g/L;Neutrophils (ANC) ≥ 1.5 × 10^9/L; platelet count (PLT) ≥ 90 × 10^9/L; 2) Blood biochemistry: Total bilirubin (TBIL) ≤ 1.5 upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Heart color ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%; 6. Women of childbearing age, tested negative for serum pregnancy test 7 days before randomization，and willing to use appropriate methods during the trial and within 8 weeks after the last administration of the test drug; 7. A volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up Known history of hypersensitivity to pyrotinib or any of it components; 2. Patients have previously received antitumor treatment or radiation therapy for any malignant tumor (except for cervical carcinoma in situ and basal cell carcinoma that have been cured); 3. Patients underwent major breast cancer-free surgery within 4 weeks and have not fully recovered; 4. Subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of gastrointestinal absorption; 5. Patients with severe heart disease or discomfort who cannot be treated; 6. The patient suffers from mental illness or psychotropic substance abuse and cannot cooperate; 7. Pregnant or lactating women; 8. Less than 4 weeks from the last clinical trial; 9. Patients participating in other clinical trials at the same time 10. The researchers think inappropriate
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-70.0, Refusal of Breast Surgery in Patients With Breast Cancer With a cCR After NST and a Confirmed Pathological Complete Response (pCR) Using VAB and SLNB Triple negative breast cancer / HER2-positive breast cancer (ER / PR +/-) age> 18 years morphologically confirmed diagnosis of breast cancer, IIA-IIIA stage ECOG score 0-1 life expectancy of more than 3 months the consent of patients to use reliable methods of contraception throughout the study adequate liver and bone marrow function the absence of contraindications to surgical intervention (including anesthetic risk is taken into account) Inconsistency with criteria Conducting earlier any systemic therapy for breast cancer stage 4 cancer carrier mutations of the BRCA1 / 2 gene severe uncontrolled concomitant chronic diseases or acute diseases the presence of a second malignant tumor pregnancy or lactation acute conditions and complications, which, according to the doctor, interfere with treatment
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 19.0-999.0, Breast Cancer Sentinel Lymph Node Women ≥ 19 years Invasive unilateral breast carcinoma with histological confirmation History of invasive breast cancer Histologically or radiologically no suspicion of distant metastases Performance status corresponding to ECOG grade 0-2 Tumor size clinically and radiologically ≤ 5cm, independent of hormone receptor and HER2 status Clinically and sonographically negative axillary lymph nodes before biopsy; core needle biopsy or fine needle aspiration of suspicious lymph node required BCS candidate with postoperative whole-breast irradiation and adequate systemic therapy No psychological and geographical restriction in follow-up Written informed consent History of any cancer in the previous 5 years Bilateral breast cancer Invasive breast cancer treated with neoadjuvant therapy Tumor size clinically and radiologically > 5cm Mastectomy candidate Pregnancy and breastfeeding Male breast cancer Unable to understand and fill out questionnaires
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Right-sided Colon Cancer Right-sided Colon Adenoma for track 1 and 2a Male and female patients above 18 years of age with either: right-sided colon cancer tumor with adenocarcinoma histologically verified scheduled for open or laparoscopic resection at the Department of Surgery, Herlev Hospital or Zealand University Hospital for track 1. Right-sided adenomas ≥2cm in diameter endoscopically verified scheduled for endoscopic mucosal resection at the Department of Surgery, Herlev Hospital or Zealand University Hospital for track 2a ASA I,II or III The caecum must be reached by the endoscope. for retrospective controls (track 2b): Male and female patients above 18 years of age who were operated for colon adenoma ≥2cm in diameter in the right hemicolon in 2018 at Department of Surgery, Zealand University Hospital. They will be matched 2:1 with the patients included in track 2a (cases) based on age and gender and pathology of the tumor for track 1 and track 2a 1. Patients with previous allergic reaction to fosfomycin and/or metronidazole 2. Patients under current antibiotic treatment or patient who had the last dose of antibiotics 30 days prior to inclusion. 3. Patients with a non-passable tumor or patients where a part of the tumor is not visible during endoscopy (Track 1) 4. Patients with neoadjuvant chemotherapy or radiation 12 months prior to the resection. 5. Patients with a history of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC) 6. Patients with a history of inflammatory bowel disease (IBD) 7. Patients under current treatment with warfarin (Marevan) and phenprocoumon (Marcoumar), or NOAK such as dabigatran (Pradaxa®), rivaroxiban (Xarelto®), edoxaban (Lixiana®) or apixaban (Eliquis®) 8. Patients under current treatment with Fenemal (Phenobarbital) 9. Patients who previously have received a fecal transplantation 10. Patients who have previously had colorectal cancer, and are now presenting with a secondary colon tumor. 11. Patients with a current alcohol use disorder (AUD): defined as a patient who are currently drinking 8 or more drinks/week for women and 15 or more drinks/week for men. 12. Predictable poor compliance (psychiatric disease, not speaking fluent Danish, mentally, impaired etc) 13. Patients with an American Society of Anaesthesiologists physical status 14. Classification (ASAscore) of IV. 15. Patients unable to be sedated 16. Pregnancy or lactation (fertile women must have a negative serum or urine pregnancy test to participate) 17. Fertile women who do not use safe contraception during the study period 18. Following contraceptive methods are acceptable when used consistently and in accordance, with both the product label and the instructions of the physician are Oral contraceptive, either combined or progestogen alone Injectable progestogen Implants of levonorgestrel Estrogenic vaginal ring Percutaneous contraceptive patches Intrauterine device or intrauterine system with a documented failure rate < 1% per year Male partner sterilization (vasectomy with documented azoospermia) prior to female patient ́s entry into the study, and this male is the sole partner for that patient Double barrier method: condom with spermicidal agent (foam/gel/film/cream/suppository), condom and occlusive cap (diaphragm or cervical/vault cap) with vaginal spermicidal agent (foam/gel/film/cream/suppository) for retrospective controls (track 2b)
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Locally Advanced Solid Tumor Metastatic Cancer Solid Tumor HER2-positive Gastric Cancer HER2-positive Metastatic Breast Cancer Signed informed consent Subjects must be ≥ 18 years of age Subject with advanced or metastatic solid tumors that is not amenable to surgical resection and is not eligible or has refused other approved therapeutic options that have demonstrated clinical benefit Histologically confirmed HER2 expression Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 Measurable or non-measurable evaluable disease according to 1.1 Adequate hematologic and end-organ function at baseline Oxygen saturation via pulse oxygenation ≥ 90% at rest on room air Untreated central nervous system (CNS) metastases Multiple primary malignancies Clinically significant cardiovascular disease such as New York Heart Association (NYHA) cardiac disease (class III or greater) Pregnant or lactating female Serious, uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive study treatment History of autoimmune or immune mediated symptomatic disease Any anti-cancer chemotherapy or targeted small molecule therapy, or experimental therapy/device within 4 weeks or 5 half-lives of the drug prior to planned start of study
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Breast Cancer stage 1: 1. female 2. ≥18 years old 3. invasive ductal carcinoma proved by core needle biopsy. Other type of breast cancer should be well considered and decided by investigators. Pathological report should be complete (with the result of ER, PR , HER2, KI67 etc., and FISH report of ERBB2 gene if necessary). 4. lump can be detected by ultrasound. 5. image results (including ultrasound, mammography and MR image) prove the lump is single-center, the maximum diameter of the lump <2cm. 6. with enough breast tissue, and enough space from lump to skin. 7. patients is not pregnant and has no plan for pregnancy in 2 years. 8. ECOG level: 0-2 9. serum creatinine≤1.1 mg/dl 10. for patients with double side (left and right side) breast cancer, both side of the tumor should meet the criteria. 11. patients are accessible for the follow up and mentally healthy. stage 2: 1. female 2. ≥18 years old 3. invasive ductal carcinoma proved by core needle biopsy. Other type of breast cancer should be well considered and decided by investigators. Pathological report should be complete (with the result of ER, PR , HER2, KI67 etc., and FISH report of ERBB2 gene if necessary). 4. lump can be detected by ultrasound. 5. image results (including ultrasound, mammography and MR image) prove the lump is single-center, the maximum diameter of the lump <1.5cm. 6. with enough breast tissue, and enough space from lump to skin. 7. clinically N0 before cryo-ablation. 8. patients is not pregnant and has no plan for pregnancy in 2 years. 9. ECOG level: 0-2 10. serum creatinine≤1.1 mg/dl 11. for patients with double side (left and right side) breast cancer, both side of the tumor should meet the criteria. 12. patients are accessible for the follow up and mentally healthy stage 1: 1. < 18 years old 2. male 3. the same side breast of the lump have been treated by surgery or other physical treatment within 3months. 4. benign tumor or tumor in situ or tumor in situ with micro-invasion proved by core needle biopsy. Pathological report is not complete (with the result of ER, PR , HER2, KI67 etc., and FISH report of ERBB2 gene if necessary). 5. image results (including ultrasound, mammography and MR image) prove the lump is multi-center, the maximum diameter of the lump ≥2cm. 6. image results (including ultrasound, mammography) prove calcium region ≥ 5mm 7. lump can not be clearly detected by ultrasound. For example, the boundary of tumor is not clear, or the maximum diameter detected by MRI is more than 1.5 times larger than the maximum diameter detected by ultrasound. 8. before the endpoint, patients is treated by other local treatment. 9. ECOG Level >2 10. serum creatinine>1.1 mg/dl 11. patients are not accessible for the follow up and mentally unhealthy. 12. patients are pregnant or lactating, or have plan for pregnancy in 2 years. 13. other situations which make patients not suitable for the trail or cryo-ablation. stage 2: 1. < 18 years old 2. male 3. the same side breast of the lump have been treated by surgery or other physical treatment within 3months. 4. benign tumor or tumor in situ or tumor in situ with micro-invasion proved by core needle biopsy. Pathological report is not complete (with the result of ER, PR , HER2, KI67 etc., and FISH report of ERBB2 gene if necessary). 5. absolute contraindication for breast conserving surgery. 6. image results (including ultrasound, mammography and MR image) prove the lump is multi-center, the maximum diameter of the lump ≥1.5cm. 7. image results (including ultrasound, mammography) prove calcium region ≥ 5mm 8. lump can not be clearly detected by ultrasound. For example, the boundary of tumor is not clear, or the maximum diameter detected by MRI is more than 1.5 times larger than the maximum diameter detected by ultrasound. 9. NOT clinically N0 before cryo-ablation. 10. patients are treated after neoadjuvant chemotherapy or neoadjuvant endocrine therapy. 11. patients with advanced breast cancer or other type of cancers. 12. with BRCA1/2 mutation 13. before the endpoint, patients is treated by other local treatment. 14. ECOG Level >2 15. serum creatinine>1.1 mg/dl 16. can not finish the radiotherapy afterwards or with contraindication of radiotherapy 17. patients are not accessible for the follow up and mentally unhealthy. 18. patients are pregnant or lactating, or have plan for pregnancy in 2 years. 19. other situations which make patients not suitable for the trail or cryo-ablation
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 0.0-999.0, Burnout, Professional Physician employed by Cleveland Clinic Located in Ohio Must anticipate remaining employed for at least 6 months post-enrollment Non-MD or non-DO healthcare providers Unable to commit to intervention sessions Current diagnosis of uncontrolled hypertension, and/or uncontrolled diabetes mellitus (defined as hemoglobin A1c ≥9%) Current or previous history of Cushing's disease or pheochromocytoma/paraganglioma
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-75.0, HER2-positive Breast Cancer Patients provided written informed consent 2. Postmenopausal or premenopausal or perimenopausal women aged 18-75 years: 1. ≥60 years, or bilateral ovariectomy was previously performed, or 2. <60 years, natural postmenopausal status (defined as a continuous period of at least 12 months following spontaneous cessation without other pathological or physiological causes), estrogen (E2) and follicle-stimulating hormone (FSH) are present at postmenopausal levels 3. Premenopausal or perimenopausal women, willing to receive luteinizing hormone (LHRH) stimulation during the study 3. Histologically or cytologically confirmed HR-positive (ER/PR≥10%), HER2-positive (IHC 3+ or ISH+) breast cancer 4. At least one measurable non-visceral metastatic lesion (liver, lung, pleura, pericardium, peritoneum, kidney, adrenal, brain or leptomeningeal metastases are excluded), HR-positive (ER/PR≥10%), HER2-positive (IHC 3+ or ISH+), (≥10 mm on T1-weighted, gadolinium-enhanced MRI) (RECIST v1.1) 5. Previous treatment with HER2 inhibitors to be discontinued prior to first study treatment administration (at least 14 days for trastuzumab and other antibodies, at least 7 days for lapatinib) 6. Previous chemotherapy, biological or target therapy to recurrent or metastatic disease are not allowed; Previous radiotherapy allowed, but radiotherapy must have been discontinued at least 14 days prior to first study treatment administration. 7. Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2 8. Life expectancy > 24 weeks 9. left ventricular ejection fraction (LVEF) of 50% or higher at baseline (within 42 days before randomization) 10. Previous adjuvant chemotherapy treatment is allowed 11. Previous adjuvant trastuzumab treatment is allowed 12. Hormone therapy must have been discontinued at least 1 month prior to recruitment 13. Patients with good compliance 14. Patients must have recovered to baseline condition or to Common Terminology for Adverse Events (CTCAE) version 5.0 grade = 1 from any acute CTCAE v. 5.0 grade =2 side effects of previous treatments 15. Without infection of human immunodeficiency virus (HIV) on central laboratory assay results prior to randomization 16. Alanine aminotransferase (ALT) </= 2.5 × the upper limit of normal (ULN), Aspartate aminotransferase (AST) </= 2.5 × ULN prior to randomization 17. Total bilirubin (TBIL) </= 1.25 × ULN 18. Alkaline phosphatase (ALK) </= 2.5 × ULN 19. Gamma glutamyl transpeptidase (GGT) </= 2.5 × ULN 20. Serum total bilirubin (TBil) </= 1.5 × ULN 21. Serum creatinine (Scr) </= 1.5 × ULN 22. WBC >/= 3×109/L, Blood neutrophil count >/= 1×109/L, Platelet count >/= 100×109/L, HB >/= 9 g/dL 23. Albumin >/= 30g/L 24. Women of child-bearing age who had a negative serum pregnancy test (within 14 days before randomization) should take effective contraceptive measures Primary and metastatic lesion lack of histological or cytological confirmation of HR-positive (ER/PR≥10%), HER2-positive (IHC 3+ or ISH+) 2. Breast cancer with visceral metastases (liver, lung, pleura, pericardium, peritoneum, kidney, adrenal, brain or leptomeningeal metastases) 3. Inflammatory breast cancer 4. Having a life-threatening metastatic visceral disease, defined as extensive liver damage or brain or leptomeninges damage (past or present) or symptomatic pulmonary lymphatic diffusion. Patients with discrete pulmonary parenchyma metastasis were eligible if the investigators determined that their respiratory function was not significantly impaired by the disease. 5. Disease progression or recurrence within 12 months after neo/adjuvant endocrine therapy 6. Unable to tolerate endocrine therapy, including those who with symptoms, who have spread to the viscera, and who are at risk for short-term life-threatening complications (including uncontrolled thorax, pericardium, or abdominal cavity exudation, pulmonary lymphangitis, and more than 50% liver damage). 7. CT or MRI confirmed the presence of brain or leptomeningeal metastases. 8. Any other current malignancy or malignancy diagnosed within the past five years (other than breast cancer, carcinoma in situ of the cervix, skin basal cell carcinoma or squamous cell carcinoma), unless radical treatment is performed and there is no evidence of recurrence or metastasis within the last 5 years. 9. Non visceral metastatic lesions cannot be evaluated by v1.1 10. Active infection with human immunodeficiency virus (HIV) prior to first study treatment administration. 11. History of participating any other clinical trials within 30 days prior to randomization 12. Known hypersensitivity (Grade 3 or 4) to Pertuzumab, Trastuzumab, Fulvestrant or Capecitabine or the excipients of any of the trial drugs 13. Pregnancy or lactation 14. Uncontrolled illnesses including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia requiring therapy, myocardial infarction within the past 6 months, or active infection 15. severe pulmonary and renal disease 16. Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis) 17. Legal incompetence or limitation. 18. Considered unable to complete the study or sign the informed consent due to a medical or mental disorder by the investigator
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-85.0, Breast Cancer Female Breast Neoplasms • female and 18 years of age or older diagnosed with an early-stage (T1 or T2, and N0 or N1; according to the TNM-classification) invasive breast cancer eligible for breast conserving surgery • Pregnancy or lactation Diabetes Multifocal tumor disease Diagnosis of inflammatory breast cancer Appointment at the nuclear medicine department for 18F-FDG administration would result in a unacceptable delay of surgery Subject has had exposure to ionizing radiation of more than 1 mSv in other research studies within the last 12 months Subject has recently (<60 days) or is simultaneously participating in another clinical trial
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-90.0, Aortic Calcification Valve Aortic Valve Stenosis Patients who are candidates for aortic valve replacement. 2. Age greater than or equal to 18 years of age. 3. Both genders. 4. With any associated comorbidity 5. Any etiology 6. Hospitalized and with an echocardiographic study showing the variables to be studied 7. Informed Consent Patients who have previously undergone other aortic valve surgery 2. Patients who have received contrast medium ≤24 hours. 3. Patients on hemodialysis. 4. Patients with infection. 5. Patients with cancer. 6. Patients with autoimmune diseases. 7. Pregnant women. 8. Patients who refuse to be included
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-65.0, Breast Cancer Quality of Life Patient Satisfaction Under the age of 65, suffering from unilateral (cT< 3cm) in situ or invasive breast cancer, who are fit for breast conserving surgeries, who had no previous breast surgery, independent from axillary surgery (sentinel lymph node biopsy or axillary block dissection) In case the patient does not volunteer for the examination or the follow-ups Age above 65 years or poor general health condition, where the estimated life expectancies would be less than 2 years even without a tumor Malignant invasive tumor in the past history (except for non-melanoma skin tumors) Mastectomy performed due to positive resection margin Prior breast surgery (e.g. aesthetic surgery, breast lift) and/or radiotherapy on the breast or in the axilla Malignant tumor is not removed completely with pathological examination Severe non-surgical (e.g. radiotherapy) complication, which could influence the aesthetic and functional results Autoimmune diseases Tumor requiring mastectomy, or clinically larger than 3 cm tumor primary, or mastitis carcinomatosa, lymphangitis carcinomatosa Long-term steroid usage, which changed the skin's quality and structure
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Triple Negative Breast Cancer Locally Advanced Breast Cancer Recurrent Breast Cancer Metastatic Breast Cancer ER+ Breast Cancer HER2-positive Breast Cancer Part A: 1. Patients with recurrent inoperable locally advanced or metastatic breast cancer. 2. Previously treated with at least one prior line of chemotherapy for advanced disease, but no more than two prior lines of chemotherapy for advanced disease. Patients with ER+ breast cancer must have received at least one prior line of hormone therapy for advanced disease. Patients with HER2+ breast cancer must have received at least one prior line of HER2 directed therapy. 3. Measurable disease (RECIST 1.1) 4. Haematological and biochemical indices within the ranges stated in the study protocol. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes in the trial. 5. Women/female patients with child-bearing potential (defined as the fertile status following menarche and until becoming post-menopausal unless permanently sterile by methods that hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must have a negative urine or serum pregnancy test within 7 days prior to start of trial. Women/females of child bearing potential or their male partners must use a highly effective method of contraception for 2 weeks before starting the study treatment, throughout the treatment period and for 1 month after discontinuation of treatment with palbociclib and avelumab (women/female patients) or 14 weeks (men/male patients). Highly effective methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods, such methods Oral, intra-vaginal or transdermal combined hormonal contraception Oral, injectable or implantable progesterone-only contraception Intrauterine device Intrauterine hormone-releasing system Bilateral tubal occlusion Vasectomised partner True abstinence:* When this is in line with the preferred and usual lifestyle of the subject Key: * it is only considered highly effective if the patient is refraining from sexual intercourse during the entire period of risk associated with the study treatments 6. 18 years of age or over. 7. World Health Organisation (WHO) performance status 0 or 1 8. Estimated life expectancy of at least 3 months in the opinion of the investigator 9. Signed and dated informed consent. 10. Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests, follow up and other procedures Part B: 1. Patients with recurrent inoperable locally advanced or metastatic AR+ triple negative breast cancer with ER, PgR and HER2 status determined locally and AR determined centrally on archival metastatic tissue. 2. Previously treated with at least one prior line of chemotherapy for advanced disease, but no more than two prior lines of chemotherapy for advanced disease. 3. Measurable disease (RECIST 1.1) amenable to fresh biopsy 4. Haematological and biochemical indices within the ranges stated in the study protocol. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes in the trial. 5. Female patients with child-bearing potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial. Women/females of child bearing potential or their male partners must use a highly effective method of contraception for 2 weeks before starting the study treatment, throughout the treatment period and for 1 month after discontinuation of treatment with palbociclib and avelumab (women/female patients) or 14 weeks (men/male patients). Highly effective methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods, such methods Oral, intra-vaginal or transdermal combined hormonal contraception Oral, injectable or implantable progesterone-only contraception Parts A & B: 1. Systemic chemotherapy or investigational medicinal products during the previous four weeks, or hormonal therapy within 7 days except luteinizing hormone-releasing hormone (LHRH) analogues for ovarian suppression. Bisphosphonates or RANK ligand antagonists are permitted for the management of bone metastases. 2. Previous exposure to immune checkpoint inhibitors or immune co-stimulatory drugs. 3. Previous treatment with palbociclib or any agents which inhibit CDK4/6 4. Major surgery (excluding minor procedures, e.g. placement of vascular access) within 4 weeks or radiation therapy within 14 days prior to study entry 5. Patients with known symptomatic brain metastases requiring steroids, untreated brain metastases, leptomeningeal disease or spinal cord compression. 6. Active infection requiring systemic therapy 7. Any of the following within 12 months prior to study entry: myocardial infarction, history of myocarditis, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack. 8. Uncontrolled hypertension or cardiac dysrhythmia including atrial fibrillation 9. Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo or hyperthyroid diseases not requiring immunosuppressive treatment are eligible. 10. Current use of immunosuppressive medication, for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). 11. Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis (even if fully resolved), pulmonary fibrosis, end stage renal disease on haemodialysis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behaviour; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. 12. Patients on warfarin. Patients requiring anticoagulation for rate-controlled AF or previous venous thromboembolism should be switched to low-molecular weight heparin. 13. Known HIV or AIDS-related illness, active infection requiring systemic therapy, or positive HBV or HCV test indicating acute or chronic infection 14. Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI CTCAE v 5), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma) 15. Inability or unwillingness to swallow pills, or receive IV injections. 16. Persisting toxicity related to prior therapy >Grade 1 (except for stable peripheral neuropathy grade ≤2 or alopecia grade ≤2). 17. Pregnancy or lactation (women/females of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation) 18. Diagnosis of other malignancy within 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix, or low-grade (Gleason ≤6) prostate cancer 19. Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this study. Participation in an observational trial would be acceptable. 20. Known prior or suspected hypersensitivity to investigational products or to any of the excipients 21. Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines. Live vaccines must also be avoided for 3 months after the last dose of avelumab. 22. Any psychiatric condition that would prohibit the understanding or rendering of informed consent 23. Requirement for continued use of preparations containing St. John's Wort is specifically contraindicated. Other herbal medicinal or natural products that patient is intended to take during the trial must be explored at the beginning and during the course of the trial and discussed with the investigator. 24. Requirement for continued use of CYP3A inhibitors, inducers or substrates (listed in Appendix 4). 25. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine as this medicinal product contains lactose. 26. Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-86.0, Triple-negative Breast Cancer Age > 18 or <86 years of age, for Hispanic/Latino women we will use the National Advisory Committee on Racial, Ethnic and Other populations NAC definition which is (the ethnonyms "Hispanic" and "Latino" to refer collectively to the inhabitants of the United States of America who are of Latin American or Spanish origin-that is, Latino or Hispanic Americans). 2. Pre and Post menopausal women with histologically confirmed hormonal receptor negative (ER and/or PR <1%), Her2-neu negative (by IHC or/and FISH) invasive breast cancer stages I III or with metastatic triple-negative breast cancer (if develop metastatic disease during the chemotherapy or within 24 months after completion of all appropriate treatments). 3. Patient must be eligible for neo-adjuvant chemotherapy, and surgical lumpectomy or mastectomy. 4. All patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with Institutional and Federal guidelines Women < 18 or >86 years of age 2. ER/PR positive, Her-2 neu positive breast cancer
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Neurological Disorder All head MRI scans with compatible sequences > 18 years old No corresponding radiologist report for the retrospective analyses No consent for future use of the research images held within the historic database stored at The Centre for Neuroimaging Sciences (Kings College London) Poor image quality
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Locally Advanced Lung Non-Small Cell Carcinoma Stage III Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Histologically or cytologically documented non-small cell lung cancer (NSCLC) Stage III NSCLC according to American Joint Committee on Cancer (AJCC) staging version (v)8 At least one mediastinal site of disease that is discontiguous from all other visible sites of disease and can be excluded from primary tumor site radiation (i.e. at least 10 mm separation between tumors) A maximum of 20 patients with bulky mediastinal disease will be allowed on this trial, defined as at least one contiguous mediastinal mass with minimum diameter > 2 cm, that is not contiguous with the primary tumor (and therefore would not be irradiated during radiation to the primary tumor) No surgery for lung cancer for at least 3 years No other malignancies for at least 3 years, excluding low grade or non-invasive malignancies such as skin cancers, prostate cancers, and ductal breast carcinoma in situ (DCIS) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Life expectancy of >= at least 3 months Body weight > 30 kg Hemoglobin >= 9.0 g/dL Prior anti-CTLA-4, PD-1 or PD-L1 antibodies including durvalumab Prior chemotherapy in the past 3 years from consent Any unresolved toxicity National Cancer Institute (NCI) CTCAE grade >= 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the Patients with grade >= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the study physician Prior thoracic radiation that would preclude curative-intent radiation dose as outlined in this study Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study History of allogenic organ transplantation Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion Patients with vitiligo or alopecia
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 0.0-999.0, Live Birth Rate Nulliparous women registered in Perinatal Services BC database with live birth between April 2008 and March 2018 multiparous women women with missing data in Perinatal Services BC database including gravid, parity, age, date of birth
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Breast Cancer Female at least 18 years old Histologically or cytologically confirmed breast carcinoma Patients planned to receive a breast-conserving surgery Patients received a preoperative breast magnetic resonance imaging Informed consent form understood and signed Patient agrees to all follow-up visits Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of study entry Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the surgery Psychiatric or other condition that may interfere with the study Known allergy or contraindication to any study drug Patients received neoadjuvant therapies Patients received an excision biopsy of the tumor Breast feeding period Pregnant (female of childbearing potential only)
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-80.0, Breast Cancer Prevention Women between the ages of 18 and 80 Atypical hyperplasia or / and lobular carcinoma in situ confirmed by breast histology Women with breast cancer in first degree relatives Patients have better compliance with a series of research-related behaviors such as the upcoming comprehensive treatment and follow-up, and can understand and accept the research process of this study, and sign a written informed consent Hepatorenal dysfunction, cardiovascular and cerebrovascular diseases Patients not suitable for this study judged by researchers
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-99.0, Shoulder Osteoarthritis Arthropathy Shoulder Major patients and agreeing to participate in the study after oral and written information Care course patients for a reverse shoulder arthroplasty on a native shoulder joint Patients under the age of 18 Patients refusing to participate in the study Patients whose condition does not allow informed consent Patients who are subject to legal protection (safeguarding of Justice, curatorship, guardianship), persons deprived of their liberty Unaffiliated patients and non-beneficiaries of a health insurance plan
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Critical Illness Nurse's Role Risk Factor Prognosis Being 18 or older Being in the intensive care unit for the first time To stay in the intensive care unit for at least 24 hours Being discharged from the intensive care unit in 90 days and less All information in the Patient Information Form can be accessed from the automation system Being under the age of 18 Having previously slept in the intensive care unit Intensive care hospitalization has ended in less than 24 hours Staying in the intensive care unit for more than 90 days Failure to reach all questions in the Patient Information form from the automation system
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 19.0-999.0, Invasive Breast Cancer Mastectomy, Segmental Margins of Excision Newly diagnosed women with biopsy-verified invasive breast cancer planned for breast conserving surgery Age > 18 year Previous surgery for pre-malignant or malignant lesions in the breast Planned mastectomy
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Breast Cancer Women who are suspected or suspected of having breast cancer and who are advised to perform a detailed breast ultrasound or tissue sampling (biopsy) Classification into groups Group 1: Foreseen for BUS guided biopsy Group 2: BI-RADS classification I, II and III and foreseen for BUS only based diagnosis Lactating women Women with mastitis Vulnerable persons
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 HER2 Negative Breast Adenocarcinoma Hormone Receptor Positive Breast Adenocarcinoma Invasive Breast Carcinoma Multifocal Breast Carcinoma Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage IA Breast Cancer AJCC v8 Prognostic Stage IB Breast Cancer AJCC v8 Prognostic Stage II Breast Cancer AJCC v8 Prognostic Stage IIA Breast Cancer AJCC v8 Prognostic Stage IIB Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Unilateral Breast Carcinoma Ability to understand and the willingness to sign a written informed consent document Females (regardless of menopausal status), or males of all races and ethnic groups Biopsy proven estrogen receptor (ER) and/or progesterone receptor (PR) positive as defined as ER >= 1% and/or PR >= 1% by immunohistochemistry according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines for hormone receptor testing HER2 non-amplified per 2018 ASCO/CAP guidelines, defined as Immunohistochemistry (IHC) score 0/1+, or IHC 2+ and in situ hybridization (ISH) non-amplified with a ratio of HER2 to CEP17 < 2.0, and if reported, average HER2 gene copy number < 4 signals/cells; or ISH non-amplified with a ratio of HER2 to CEP17 < 2.0, and if reported, average HER2 gene copy number < 4 signals/cells Clinical T1-T3, any N, M0 invasive breast cancer, by American Joint Committee on Cancer (AJCC) 8th edition clinical staging with the goal being curative intent surgery to completely excise involved tumor in the breast and the draining lymph nodes Individuals with unilateral, multi-focal breast cancer (defined as more than one lesion of invasive breast cancer in the same breast separated from the dominant breast lesion by less than 5 cm of radiologically normal breast tissue) are eligible Participants must be planned for neoadjuvant chemotherapy Prior history of malignancy within 5 years except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, or non-melanoma skin cancer Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema) is not eligible Participants that have undergone surgical axillary staging procedure prior to study entry Fine needle aspiration (FNA) or core needle biopsy of axillary node is permitted Bilateral breast cancer, provided tumors exhibit similar biomarkers (grade, ER/PR, HER2) Clinical or radiographic evidence of metastatic disease Isolated ipsilateral supraclavicular node involvement is permitted A prior history of ductal breast carcinoma in situ (DCIS) treated with contralateral mastectomy and not receiving endocrine therapy is eligible Breast implants are contraindicated only if the implant precludes the required research biopsies or interferes with palpating the breast lesion Prior treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy or investigational agent prior to study entry
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-99.0, Breast Cancer Breast-conserving Surgery Axillary Lymph Node Dissection Diagnosis of breast cancer scheduled for surgical treatment including conservative surgery and ALND Signed informed consent for ALND Selective sentinel node biopsy negative Subsidiary mastectomy patients Denial of informed consent for axillary lymphadenectomy
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-85.0, Breast Cancer Early stage Breast Cancer DCIS gr III Not able to read Norwegian Not able to communicate in Norwegian Previously diagnosed with cancer Dementia
|
2
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 10.0-65.0, NK/T-Cell Lymphoma age:10-65 years;Eastern Cooperative Oncology Group (ECOG)score≤2;expected survival≥3 months 2 patients with NK/T Cell Lymphoma diagnosed by immuno-histochemistry (IHC) or fluorescence in situ hybridization (FISH); 3.Refractory or relapse after at least 2 regimen 4.Once the patient received radiotherapy, need to be more than 3 months away from this treatment, and it is a non-primary recurrence; 5.No chemotherapy contraindications: hemoglobin ≥ 100g / L, absolute neutrophil count ≥ 1.5 × 109 / L, platelets ≥ 80 × 109 / L, ALT, AST ≤ 2 times the upper limit of normal, serum total bilirubin ≤ 1.5 times normal Upper limit, serum creatinine ≥ 1.5 times normal upper limit, serum protein ≥ 30g / L; 6.At least one measurable lesion 7.There are no other serious diseases that conflict with this program, and the cardiopulmonary function is normal; 8.Women of childbearing age must have a negative urine or blood pregnancy test, and male patients should be contraceptive during medication; 9.There is no other antitumor treatment, but bisphosphonate for anti-bone metastasis treatment and other symptomatic treatment can be applied. 10.Can understand the situation of this study and sign the informed consent voluntarily rejecting providing blood preparation; 2. allergic to drug in this study or with hemophagocytic syndrome; 3. rejecting adopting reliable contraceptive method in pregnancy or lactation period; 4. uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac,lung,liver and pancreas）； 5. with severe infection; 6. with primary or secondary central nervous system tumor invasion; 7. with Chemotherap or radiotherapy contraindication; 8. ever suffered with malignant tumor; 9. Human immunodeficiency virus (HIV)-positive patients 10. Drug abuse or long-term alcohol abuse that affects the evaluation of test results; 11. Have peripheral nervous system disorder or mental disorder; 12. Those who have no legal capacity or whose research is affected by medical or ethical reasons
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 35.0-999.0, Breast Cancer Women in screening and symptomatic clinics aged >35 years with breast masses scored as M4 or M5 (mammographically suspicious or highly suspicious of malignancy) and U5 (ultrasonically highly suspicious of malignancy) and/or MRI5 (highly suspicious of malignancy on magnetic resonance imaging) and U5 and/or have histologically proven breast cancer and who have ipsilateral axillary lymph nodes which are indeterminate or suspicious for metastatic disease (A3, 4 or 5), as determined by individual breast unit have given written informed consent for the study Women who are on anticoagulants, antiplatelet drugs (inc. aspirin) or have known clotting disorders Previous ipsilateral axillary surgery Target lymph node not suitable for needle biopsy due to its close proximity to critical structures such as major blood vessels Unable to give written informed consent in English
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 22.0-999.0, Atrophic Scar In good general health as evidenced by medical history For females of reproductive potential: use of highly effective contraception and a negative urine pregnancy test at screening and all injection visits Score of 4-55 on a validated scarring grading system Subjects with allergies to hyaluronic acid filler, gram positive bacteria or lidocaine Subjects with auto-immune conditions Subjects with diabetes Subjects with a history of sever anaphylactic reactions Subjects with cancer, or other life-threatening medical condition Subjects taking anti---coagulants, chemotherapy, immunosuppressive agents, immunomodulatory agents, diuretics, anti---histamines, or anti---inflammatory medications in the 2 weeks prior to the study or who will need to take these medications at any time during the first 120 days of the study Subjects with any scheduled laser, light, or surgical procedures during the study, including dental surgery Subjects who had neuromodulators in the past 6 months or hyaluronic acid fillers in the previous year on the face Subjects who at any time had surgery or more permanent fillers in the face such as Bellafill or Radiesse Subjects with tattoos or many skin growths on the face that would obscure visualization of the scars
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 0.083-17.0, Refractory Epilepsy Age 1 month up to 17 years 2-Both male and female 3-Epileptic patient on two tolerated and appropriately chosen and used antiepilptic drugs with no response Neonate 2-Epieptic patient on monotherapy 3-Conditions mimic epilepsy 4-Pseudo refractioness 5-Absolute contraindications for the use of diet therapy carnitine deficiency (primary), carnitine palmitoyltransferase (CPT) I OR II deficiency, carnitine translocase deficiency, β-oxidation defects, pyruvate carboxylase deficiency, and porphyria 6-Contraindication for Rituximab: 1. Hypersensitivity to any component, murine proteins. b. Heart failure c. Active infection
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 1.0-30.0, Down Syndrome Recurrent B Acute Lymphoblastic Leukemia Patients must be >= 1 and < 31 years at time of enrollment Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories Isolated bone marrow relapse Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes Patients with Down syndrome (DS) are eligible in the following categories Isolated bone marrow relapse Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Patients with B-lymphoblastic lymphoma (B-LLy) Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia Patients with Philadelphia chromosome positive (Ph+) B-ALL Patients with mixed phenotype acute leukemia (MPAL) Patients with known Charcot-Marie-Tooth disease Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype Patients with active, uncontrolled infection defined as Positive bacterial blood culture within 48 hours of study enrollment Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed as long as blood cultures are negative for > 48 hours
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-65.0, Breast Cancer,Her2 Positive 18 years ≤ age ≤ 75 years, Performance Status Eastern Cooperative Oncology Group (ECOG) 0-1 2. Clinical T2-T4d, or T1c with axillary LN+ 3. HER2 + invasive breast cancer confirmed by histopathology Note: HER2 expression positive refers to the tumor cells with immunohistochemical staining intensity of 3 + or confirmed positive by fluorescence in situ hybridization [fish] at least once during the pathological detection/review of primary tumor in the Department of pathology of participating research center hospital 4. Clinically measurable lesions: measurable lesions revealed by ultrasound, molybdenum target or MR (optional) within 1 month before randomization 5. Organ and bone marrow function test within one month before chemotherapy showed no chemotherapy contraindication Absolute value of neutrophil count ≥ 2.0×10^9 / L Hemoglobin ≥ 100g / L Platelet count ≥ 100×10^9 / L Total bilirubin < 1.5 ULN (upper limit of normal value) Creatinine < 1.5 × ULN AST/ALT < 1.5×ULN 6. Echocardiography: left ventricular ejection fraction (LVEF ≥ 55%) 7. For women of childbearing age, serum pregnancy test was negative 14 days before randomization 8. KPS score ≥ 80 points 9. Signed the informed consent form prior to patient entry Metastatic disease (Stage IV) 2. Chemotherapy, endocrine therapy, targeted therapy and reflexotherapy have been used for this disease 3. The patient had a second primary malignant tumor, except for the well treated skin cancer 4. Patients who had undergone major surgery unrelated to breast cancer within 4 weeks before enrollment, or had not recovered completely from such operations 5. Serious heart disease or discomfort, including but not limited to the following diseases History of heart failure or systolic dysfunction (LVEF < 50%) high risk uncontrolled arrhythmias such as atrial tachycardia, resting heart rate > 100 BPM, significant ventricular arrhythmias (e.g., ventricular tachycardia) or higher-level atrioventricular block (i.e., mobitz II second degree atrioventricular block or third degree atrioventricular block) angina pectoris requiring anti angina drugs Heart valve disease with clinical significance ECG showed transmural myocardial infarction Poor control of hypertension (systolic blood pressure > 180 mmHg and / or diastolic blood pressure > 100 mmHg) 6. Due to serious and uncontrollable other medical diseases, the researchers believe that there are chemotherapy contraindications 7. Those who have been known to have allergic history to the drug components of this regimen; have a history of immune deficiency, including HIV positive test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Invasive Lobular Breast Carcinoma ER+ Breast Cancer HER2-negative Breast Cancer Female 2. Age ≥ 18 years 3. Histological diagnosis of invasive lobular breast adenocarcinoma that is ER+, and HER2 as per the updated American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines according to local testing. 4. Multifocal unilateral or bilateral breast adenocarcinoma tumours are allowed if all tested foci are lobular, ER+ and HER2- ER positive (ER+ is defined as having an IHC of 1% or more and/or an Allred of 3 or more and HER2-) HER2 negative (HER2 is defined as having an IHC of 0 or 1+ without ISH OR IHC 2+ and ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells OR ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells [without IHC]); 5. A primary non metastatic or locally advanced tumour of 15 mm or more, cN0 or cN1 without prior treatment candidate for preoperative treatment. 6. ECOG Performance Status (PS) 0 or 1. 7. Adequate Bone Marrow Function including Absolute Neutrophil Count (ANC) ≥1500/μL or ≥1.5x109/L Platelets ≥100000/μL or ≥100 x 109/L Haemoglobin ≥ 9 g/dL. 8. Adequate Renal Function including: o Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated creatinine clearance ≥ 60 ml/min as calculated using the method standard for the institution. 9. Adequate Liver Function, including all of the following parameters Total serum bilirubin ≤ 2.0 x ULN unless the subject has documented Gilbert syndrome Clinical T4 disease including inflammatory breast cancer and/or cN3. 2. Prior history of invasive cancer in the past 5 years except basal or squamous cell carcinoma of skin that has been definitively treated. 3. Known hypersensitivity to the study drugs or excipients. 4. Any illness or medical condition that is unstable or could jeopardize the safety of the subject or her compliance with study requirements. 5. Subjects unable to swallow oral medications. 6. Prior intake of letrozole, any ROS1 inhibitor, any TRK inhibitor or anticancer therapy (including endocrine therapy). 7. Concurrent treatment with strong or moderate CYP3A inhibitor. 8. Concurrent treatment with any of the drugs not permitted, i.e. strong CYP3A inducers and drugs known to cause QTc interval prolongation. 9. LVEF ≤ 55% measured by echo or MUGA 10. QTc exceeding 450 msec, history of prolonged QTc interval prolongation; risk factors for torsade de pointes; other concomitant medications that may prolong QTc; family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes (TdP). 11. Pregnant or lactating women. 12. Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis 13. Peripheral neuropathy ≥ Grade 2 14. Active gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably impact drug absorption. criterion applicable to France only 14. Vulnerable persons according to the article L.1121-6 of the CSP, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the CSP
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-55.0, Inflammatory Bowel Diseases patients with inflammatory bowel disease between 18 to 55 years presence of other diseases that affect the nutritional status of the patients like diabetes mellitus, liver cirrhosis, chronic kidney disease, and malignancy
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, HER2-positive Breast Cancer Invasive Carcinoma of the Breast Breast Cancer Node Negative Breast Cancer Micrometastasis Breast Cancer Hormone Receptor Positive Breast Cancer HER2-positive T1 histologically confirmed invasive carcinoma of the breast. Patients must have node-negative (N0) or micrometastases (N1mi) breast cancer according to the AJCC 8th edition anatomic staging table If the patient has had a negative sentinel node biopsy, then no further axillary dissection is required, and the patient is determined to be node-negative. Axillary nodes with single cells or tumor clusters ≤ 0.2 mm by either H&E or immunohistochemistry (IHC) will be considered node-negative Any axillary lymph node with tumor clusters between 0.02 and 0.2cm is considered a micrometastasis. Patients with a micrometastasis are eligible. An axillary dissection is not required to be performed in patients with a micrometastasis found by sentinel node evaluation. In cases where the specific pathologic size of lymph node involvement is subject to interpretation, the overall principal investigator will make the final determination as to eligibility. The investigator must document approval in the patient medical record Patients who have an area of T1aN0, ER+ (defined as ≥ 10%), HER2-negative cancer in either breast, in addition to their primary HER2 positive tumor, are eligible For unifocal disease, all invasive disease must have been tested for ER and PR (for multifocal disease, see below). Either ER or PR must be positive, defined as ER ≥10% or PR ≥10%. ER and PR-assays should be performed by immunohistochemical methods according to the local institution standard protocol HER2-positive by ASCO CAP 2018 guidelines, confirmed by central testing. See Appendix I for ASCO CAP 2018 HER2 testing guidelines NOTE: DCIS components will not be counted in the determination of HER2 status NOTE: HER-2 status must be confirmed to be positive by central review prior to patient starting protocol therapy. Patients previously having had HER2 testing by NeoGenomics do not need to undergo retesting for central confirmation of HER2 status. A pathology report documenting testing by NeoGenomics should be provided at time of patient registration Bilateral breast cancers that individually meet are allowed Neoadjuvant or adjuvant chemotherapy for this breast cancer prior to enrollment is prohibited Any of the following due to teratogenic potential of the study drugs Pregnant women Nursing women Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragms, IUDS, surgical sterilization, abstinence, etc). Hormonal birth control methods are not permitted Men who are unwilling to employ adequate contraception (condoms, surgical sterilization, abstinence, etc) Participants who are receiving any other investigational agents for treatment of breast cancer, unless specific approval is obtained from the Sponsor-Investigator Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes (diffuse brawny cutaneous induration with an erysipeloid edge) Patients with a history of previous invasive breast cancer Individuals with a history of a different malignancy are ineligible except for the following circumstances
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 25.0-69.0, Early Stage Breast Cancer Patients with early-stage breast cancer (clinical Tis, T1 T2 cancers are suspected on mammography at the time of diagnosis), without palpable nodes at physical examination (N0) Patients who schedule to undergo surgery and sentinel lymph node biopsy Patient's age between 25-69 years Patients who voluntarily agree to participate in this study A history of previously treated breast cancers Patients who undergo excision biopsy for diagnosed breast cancer Pregnant or lactating women Patients who have breast implants
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-80.0, Breast Tumor Microwave Ablation Breast Conserving Surgery women, 2. with invasive ductal carcinoma of the breast according to core-needle 3. tumor measuring 50mm or smaller, no axillary lymph node metastasis or Ipsilateral grade I and II axillary lymph node metastasis, movable(pT0-2N0-1M0 ) 4. located at least 10 mm from the skin surface and chest wall men 2. women who were pregnant or breastfeeding 3. radiologic suspicion of multifocality or extensive intraductal carcinoma 4. histologic diagnosis of lobular carcinoma 5. neoadjuvant therapy 6. previous surgery or radiation therapy of the ipsilateral breast
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Breast Cancer Inflammatory Breast Cancer Sentinel Lymph Node Stage III IBC (cT4d cN0-2). Inflammatory breast cancer is defined as the following constellation of symptoms (all of the following must be met) Rapid onset symptoms (6 months or less from time of diagnosis) Breast erythema, edema and/or peau d'orange and/or warm breast with or without an underlying palpable mass Erythema occupying at least one-third of the breast Pathologic confirmation (biopsy-proven) invasive breast carcinoma Women age ≥18 years ECOG performance status ≤2 Ability to understand and willingness to sign informed consent document and comply with study procedures, including baseline research biopsy. If the research biopsy is not felt to be reasonably safe or feasible, a waiver must be obtained from the Principal Investigator. A formal exception would not be required in this case Participants who initiated pre-operative/neoadjuvant therapy prior to registration are ineligible Participants with Stage IV (metastatic) breast cancer are excluded. The absence of any evidence of distant disease on staging studies needs to be confirmed at the time of diagnosis (within 42 days from initial presentation) using the staging studies that are standard for the participating institution Participants with positive contralateral axillary nodes identified on standard imaging studies (MMG, MRI, US) are excluded. In participants with clinically suspicious axillary nodes, US guided biopsy will be performed prior to registration. If the contralateral axillary biopsy is positive, patients will not be eligible. If standard imaging does not identify contralateral disease yet drainage to the contralateral axillary basin is identified on pre-NAC lymphoscintigraphy, contralateral axillary US (if not already performed) will be obtained and any suspicious contralateral axillary nodes will undergo US guided biopsy. If the contralateral axillary biopsy is positive, patients will not continue on study for the evaluation of the primary endpoint, but their data will be used for the descriptive analyses of lymphatic drainage patterns in IBC. Contralateral invasive breast cancer without axillary involvement or in-situ carcinoma in either breast is allowed
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-65.0, Burns Conscious patients Enterally fed >18 years old With inhalation burn In addition to existing burn trauma, those with other trauma (fracture, loss of limb, etc.) Organ dysfunctions or multiple organ failure History of chronic diseases such as diabetes, cholesterol and blood pressure
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 40.0-999.0, Ductal Carcinoma in Situ Extensive Disease Mastectomy Patient ≥ 40 years old 2. Histological diagnosis of ductal carcinoma in situ without infiltrating contingent 3. Clinical T0N0 4. Estrogen receptor positive (OR+) regardless of progesterone receptor (PR) status 5. Indication for mastectomy 6. DCIS visible on MRI performed with clip sequence 7. Effective contraceptive method for women of childbearing age who are sexually active and who have reported sexual activity. 8. Informing the patient and obtaining free, informed and written consent signed by the patient and the investigator. 9. Affiliated patient or beneficiary of the social security system Invasive breast carcinoma 2. Lobular carcinoma in situ 3. pN+ patient 4. Indication for conservative surgery 5. Contraindications to anastrozole or tamoxifen 6. Concomitant treatments that may interact and reduce the efficacy of tamoxifen by interaction with cytochrome CYP2D6. 7. Histologically proven multifocal lesion 8. Contraindication to breast MRI (pace maker, heart valve, metallic implant, neuronal or peripheral stimulator, severe claustrophobia, ...) 9. History of homolateral breast cancer 10. Ongoing contralateral breast cancer 11. Known mutation BRCA1 BRCA2 12. Other cancer in progress at 13. Pregnant woman, or breastfeeding, 14. Persons deprived of liberty or under guardianship or trusteeship, 15. Impossibility to undergo the medical follow-up of the trial for geographical, social, psychic or psychiatric reasons
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-90.0, Breast Cancer Stage IV Primary confirmed distant metastatic breast cancer (M1); A histologically proven diagnosis of the breast tumor; A known hormonal and HER2Neu status; Having TNM classification: T1-T3, resectable T4 status, and N0-N3 performance status and comorbidity should allow surgery and/or systemic therapy; Accepting the surgery by written informed consent are: No confirmed primary invasive breast cancer in the medical history Having another malignancy within the last 10 years, besides basal cell carcinoma of the skin or early-stage cervical cancer Having the history of surgical treatment and/or radiotherapy of the breast tumor before randomization Having irresectable T4 breast tumor Having synchronous bilateral breast cancer. -
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 0.0-999.0, Breast Cancer All patients diagnosed with breast cancer irrespective of age, gender and clinical stage Any patient who lost to follow up
|
2
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Obstructed Biliary and Pancreatic Duct Patient eligible for implantation of a pancreatic or billiary stent prior to participate in the study and according to current guidelines Patient has provided a signed and dated informed consent (according to the laws and regualtions of the country in which the observational study is conducted) Age < 18 y Inability to understand the purpose of the study or refusal to cooperate Not available for routine follow-up visits Pregnancy Currently participating in a confounding trial before reaching first endpoint
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 19.0-100.0, Patients With Large or Impacted Intra- or Extra-hepatic Bile Duct Stone IHD stones disease that cannot be treated with the ERCP. 2. Huge EHD stone disease that required mechanical/electrohydraulic lithotripsy, according to investigator's clinical decision Patients who disagree with the study 2. Patients who underwent total gastrectomy 3. Patients with IHD stones located in a peripheral IHD where spyglass cannot reach
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Breast Cancer Adenocarcinoma of Breast Histology-confirmed epithelial cancer of the mammary gland Pre and post menopausal patients with early breast cancer and involved axillary lymph nodes (T 1-3 N1 M0) or high-risk N0 patients. A N0 patient is considered "high-risk" if she fulfills at least one of the following criteria; T>= 2cm, Estrogen Receptor (ER)/Progesterone receptor (PgR) negative, HER-2 3+, infiltration of blood or lymphatic vessels or nerves, grade 3 White Blood Cell count (WBC) > 4 x 109 / l, platelets > 100 x 109 / l Serum creatinine, Aspartate aminotransferase (AST/SGOT),Alanine aminotransferase (ALT/SGPT), gamma-glutamyltransferase, serum bilirubin 1.3 mg/ml inside the normal range of the participating hospital Performance status (WHO) 0 or 1 Age >=18 years Previous surgical treatment: Either radical surgery or, for a partial mastectomy, a histologically confirmed safe margin of 2 cm or more and the results of the axillary node dissection available No evidence of significant cardiac disease History of myocardial infarction within the previous 12 months or heart failure (including cardiac insufficiency controlled by digitalis and diuretics) or arrhythmias requiring medication or uncontrolled arterial hypertension (BP> 200/110 mm Hg). A normal baseline Left Ventricular Ejection Fraction (LVEF) should be demonstrated by multigated acquisition (MUGA) scan or echocardiogram No previous antitumor chemotherapy or radiation Time from surgery 2 to 4 weeks
|
2
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 18.0-999.0, Child Diarrhea Eligible providers will be private providers over 18 years old in our sampled villages that treat at least one case of child diarrhea per week Providers in villages where there are no other providers will be excluded for confidentiality concerns
|
0
|
The patient is a 42 year-old postmenopausal woman who had a screening sonogram which revealed an abnormality in the right breast. She had no palpable masses on breast exam. Core biopsy was done and revealed a 1.8 cm infiltrating ductal breast carcinoma in the left upper outer quadrant. Lumpectomy was done and the surgical margins were clear. The tumor was HER2-positive and ER/PR negative. Axillary sampling revealed 1 positive lymph node out of 12 sampled. CXR was unremarkable. She is using “well women” multivitamins daily and no other medication. She smokes frequently and consumes alcohol occasionally. She is in a relation with only one partner and has a history of 3 pregnancies and live births. She breastfed all three children.
|
eligible ages (years): 50.0-999.0, Breast Carcinoma Breast Cancer Stage 0 Breast Cancer Stage I Breast Cancer AJCC 7th Edition stage 0 or I (TisN0 ≤ 2 cm or T1N0) histologically confirmed carcinoma of the breast, treated with partial mastectomy. Axillary sampling is required only for cases of invasive cancers. Tumor size is determined by the pathologist. Clinical size may be used if the pathologic size is indeterminate. Patients with invasive cancer must have no positive axillary lymph nodes with at least 6 axillary lymph nodes as assessed by axillary ultrasound, axillary sampling, or axillary sentinel node procedure Negative histologic margins of partial mastectomy or re-excision specimen. The posterior margin is always considered widely negative if the partial mastectomy extended to the pectoralis fascia and there is no tumor on ink. Margins generally are positive if there is invasive or noninvasive tumor at the inked resection margin, close but negative if the tumor is within 2 mm of the inked margin and negative if the tumor is at least 2 mm away from the inked edge.[42] Invasive ductal, lobular, medullary, papillary, colloid (mucinous), tubular histologies, or mixed histologies (lesions ≤ 2 cm) that are estrogen and/or progesterone receptor positive and do not exhibit HER2/neu gene amplification OR ductal carcinoma in situ (lesions ≤ 2 cm) that are estrogen and/or progesterone receptor positive Neoadjuvant hormone therapy, chemotherapy, or biologic therapy is not allowed prior to APBI, but adjuvant hormone therapy may have been started after surgery. Planned chemotherapy or biologic therapy must not start for at least 4 weeks after the completion of APBI Good candidate for treatment per protocol in the judgment of the PI and/or treating physician following simulation Postmenopausal status Age ≥ 50 years at diagnosis Able to understand and willing to sign IRB-approved written informed consent document All radiation therapy must be planned for delivery at BJH or a BJH/Siteman satellite location with the following stipulations: F_APBI may be delivered at any Siteman location. S_APBI treatment must occur at the main Siteman location at BJH and will be delivered on a Viewray Unit, the Varian Edge unit, or the Varian Halcyon unit. Pre and post treatment care is allowed at any Siteman center Presence of distant metastases Nonepithelial breast malignancies such as sarcoma or lymphoma Proven multicentric carcinoma (tumors in different quadrants of the breast, or tumors separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy Histologically confirmed positive axillary nodes in the ipsilateral axilla. Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor Prior non-hormonal therapy for the present breast cancer, including radiation therapy or chemotherapy Diagnosis of systemic lupus erythematosis, scleroderma, or dermatomyositis Diagnosis of a coexisting medical condition which limits life expectancy to < 2 years Paget's disease of the nipple Skin involvement, regardless of tumor size Unsatisfactory breast for APBI as determined by the treating physician. For example, if there is little breast tissue remaining between the skin and pectoralis muscle after surgery, treatment with APBI is technically problematic
|
1
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 16.0-120.0, Fatigue Lung Cancer Nausea and Vomiting Pain Pulmonary Complications Quality of Life Histologically or cytologically proven non-small cell lung cancer Squamous cell lung cancer Large cell lung cancer Adenocarcinoma lung cancer Mixture of above Locally advanced disease for which the patient declined aggressive treatment or that is unsuitable for aggressive curative treatment due to at least one of the following: Performance status of ECOG 2 or 3 Otherwise unexplained weight loss greater than 10% in the last 6 months Bulky disease that cannot be irradiated safely to high doses Inability to tolerate chemotherapy Cytologically positive pleural effusion OR Clinically or radiologically proven metastatic disease for which palliative chemotherapy is not planned in the first 38 days after radiotherapy No more than one brain metastasis allowed One of the following symptoms identified as the index symptom: Loss of appetite Nausea Vomiting Cough Coughing up blood Chest pain Shortness of breath Difficulty swallowing Fatigue Must have symptoms related to intrathoracic lung cancer that are amenable to radiation palliation Age: 16 and over Performance status: ECOG 0-3 Life expectancy: Greater than 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Fluent in English or French No loss of sight or other inability to complete questionnaires or diary Not pregnant No concurrent terminal illness No other active malignancy that is causing symptoms or is expected to progress in the next 3 months PRIOR Biologic therapy: Not specified Chemotherapy: At least 30 days since prior chemotherapy and failed No planned chemotherapy within 38 days after study treatment Endocrine therapy: Not specified Radiotherapy: No planned laser therapy within 38 days after study treatment Surgery: At least 30 days since prior surgery and failed Other: No planned photodynamic therapy or sclerotherapy within 38 days after study treatment
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 0.0-999.0, Pre-eclampsia ENTRY --Disease Characteristics-- Histologically diagnosed severe preeclampsia at risk for eclamptic convulsions with the following Blood pressure greater than 160/110 mmHg OR Mean arterial pressure of 126 mmHg Proteinuria greater than 5 g/24 hr Epigastric pain OR Right upper quadrant pain AST/ALT greater than 70 U/L Severe headache and/or scotomata Thrombocytopenia as evidenced by: Platelet count less than 100,000/mm3 Disseminated intravascular coagulation Microangiopathic hemolytic anemia Oliguria (less than 400 mL/day or 30 mL/hr) Pulmonary edema --Prior/Concurrent Therapy-- No prior/concurrent magnesium sulfate or dihydropyridine agents No other concurrent antiseizure medications --Patient Characteristics--
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 0.0-999.0, Fabry Disease The patient must provide written informed consent prior to any study-related procedures being performed. Patients must be 18 years of age or older. Patients must have signs of symptoms consistent with Fabry disease with no prior treatment with any enzyme replacement therapy for Fabry Disease. Patients of childbearing potential must have a negative pregnancy test (urine beta-hCG) in order to complete all study tests. If a patient is pregnant, they may still enter the trial but may not participate in MRI or MRA procedures. Patients who have received an investigational drug within 30 days prior to study enrollment or received prior treatment with any enzyme replacement therapy for Fabry disease will be excluded. Patients who have diabetic nephropathy or other confounding renal disorder will be excluded. Patients who have a clinically significant organic disease or an unstable condition that, in the opinion of the Investigator, would preclude participation in this protocol will be excluded
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-999.0, Adult Primary Cholangiocellular Carcinoma Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Cholangiocarcinoma of the Extrahepatic Bile Duct Cholangiocarcinoma of the Gallbladder Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer Recurrent Extrahepatic Bile Duct Cancer Recurrent Gallbladder Cancer Unresectable Extrahepatic Bile Duct Cancer Unresectable Gallbladder Cancer Histologically or cytologically confirmed hepatocellular carcinoma (HCC) or biliary carcinoma that is surgically unresectable; exception: for surgically unresectable HCC, a hypervascular mass on CT and an AFP > 100ng/mL will suffice as noninvasive diagnostic Measurable disease defined as at least one lesion whose longest diameter can be accurately measured as ≥ 2.0 cm Absolute neutrophil count (ANC) ≥ 1500/mm3 PLT ≥ 75,000/mm3 Total bilirubin ≤ 2 x upper normal limits (UNL) Serum AST ≤ 3 x UNL Serum ALT ≤ 3 x UNL Serum creatinine ≤ 2 mg/dL Serum albumin ≥ 2.5 g/dL Patients not receiving anticoagulation: INR ≤ 1.5 Ampulla of Vater tumors Any of the following as this regimen may be harmful to a developing fetus or nursing child Pregnant women Breastfeeding women Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) NOTE: The effects of OSI-774 on the developing human fetus at the recommended therapeutic dose are unknown Any of the following > 1 prior systemic anticancer therapy; Note: Chemoembolization will be considered as one prior chemotherapeutic regimen Prior EGFR targeting therapy Nitrosoureas or mitomycin C ≤6 weeks prior to study entry
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-999.0, Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer Recurrent Extrahepatic Bile Duct Cancer Recurrent Gallbladder Cancer Unresectable Extrahepatic Bile Duct Cancer Unresectable Gallbladder Cancer Patients must have histologically or cytologically confirmed, surgically unresectable biliary cancer (gallbladder, ampullary, intra or extrahepatic bile duct) OR patients must have surgically unresectable HCC and who are not candidates for percutaneous ethanol injection or radio frequency ablation (RFA); patients must have histological or cytological confirmation of HCC 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) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan; if a patient has undergone TACE, ethanol or RFA ablation then new lesions need to be present in the liver, if there are no other sites of disease Patients may have received prior therapy as follows No more than one prior chemotherapy regimen for metastatic or recurrent disease will be allowed; prior chemotherapy for earlier stage disease (neoadjuvant, adjuvant, or concurrent with radiation therapy) will be allowed in addition to prior chemotherapy for recurrent metastatic disease; TACE is considered one regimen; at least 3 weeks must have elapsed since prior therapy, and toxicities of therapy should have resolved to =< Grade 1 Patients may have received prior radiation therapy; three weeks must have elapsed since the completion of prior radiation therapy and patients must have recovered from all toxicities; measurable disease must either be outside the previous radiation field, or progressing within a radiated field, or a new lesion must be present There must be no plans for the patient to receive concurrent hormonal, biologic, or radiation therapy to measurable lesions Patients who have had prior treatment with EGFR targeting therapies are ineligible Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy Life expectancy of greater than 12 weeks ECOG performance status less than or equal to 2 (Karnofsky >= 60%)
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 6.0-999.0, Cystic Fibrosis CF as diagnosed by: 1. Documented sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test; or 2. Two well-characterized genetic mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; or 3. Abnormal nasal potential difference with accompanying symptoms characteristic of CF PA present in expectorated sputum or throat swab culture at Screening Participants must have received three or more courses of TIS within the previous 12 months Participants on chronic azithromycin must have had no change in regimen in the previous 3 months and must have had a need for TIS and/or additional antipseudomonal therapy since initiation of azithromycin Forced expiratory volume in 1 second (FEV1) between (and including) 25% and 75% predicted at Screening Ability to perform reproducible pulmonary function tests Arterial oxygen saturation (SaO2) greater than or equal to 90% on room air at Screening Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone a day or 20 mg prednisone every other day History of sputum or throat culture swab yielding Burkholderia cepacia in the past 2 years History of daily continuous oxygen supplementation or requirement for more than 2 liters/minute at night Administration of any investigational drug or device within 28 days of Screening (Visit 1) or within 6 half-lives of the investigational drug (whichever was longer) Known local or systemic hypersensitivity to monobactam antibiotics Inability to tolerate inhalation of a short acting Beta-2 agonist Changes in antimicrobial, bronchodilator, anti-inflammatory, or corticosteroid medications within 7 days before Screening or between Screening and the next visit Changes in physiotherapy technique or schedule within 7 days before Screening or between Screening and the next visit History of lung transplantation A chest X-ray indicating abnormal findings at Screening or within the previous 90 days
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-999.0, Pancreatitis All patients (men and women) more than 18 years old who are going to have an ERCP procedure performed at the different centers from September 1, 2004 to about January 31, 2005 will be included Before the study: active acute pancreatitis (defined as: acute upper abdominal pain and S-amylases x 3 upper normal limit OR upper abdominal pain + radiological findings [CAT-/MR-scan] consistent with acute pancreatitis OR pathoanatomical findings consistent with acute pancreatitis by surgery) Known previous sphincterotomy Chronic pancreatitis with known calcifications Hypotension (definition: systolic blood pressure < 100 mmHg) Anemia, men/women (hemoglobin < 6 mmol/l or <9.7 g/dl) Constrictive pericarditis Pericardial tamponade Hypertrophic obstructive cardiomyopathy, aortic stenosis Mitral stenosis sildenafil within 24 hours before the ERCP procedure and 24 hours after the procedure Hypersensibility to nitroglycerine
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-999.0, Nausea Neoplasms >18 years of age Significant nausea/vomiting Failed maxeran and domperidone Underlying treatment of causes has failed Adequate cognitive function Communicates well Partial/complete bowel obstruction Currently taking Haldol or olanzapine Has drug induced extrapyramidal symptoms Parkinson's disease Undergoing chemotherapy or radiotherapy (RT) to brain, abdomen, stomach or esophagus
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-65.0, Obesity Male and/or female subjects without clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12 lead ECG and clinical laboratory tests Body Mass Index (BMI) ³30 and <40 kg/m2, for subjects with no additional co morbidities; BMI ³27 kg/m2 and <40 kg/m2, for subjects with co morbidities [history of essential hypertension and/or dyslipidemia defined as high LDL (³160 mg/dL) or high total cholesterol (³240 mg/dL)] Subjects with resting sitting systolic blood pressure of 140 mmHg or greater or diastolic blood pressure of 90 mmHg or greater Subjects with type 2 diabetes or fasting blood glucose concentration ³126 mg/dL Subjects with a history of eating disorders like anorexia nervosa or bulimia nervosa Subjects on prescription and non-prescription appetite or weight modifying drugs
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-75.0, Cholecystolithiasis Patients between 18 and 75 years of age study are upon admission to the waiting list for elective cholecystectomy for symptomatic cholecystolithiasis defined as presence of gallbladder stones or sludge, without bile duct stones or bile duct dilatation at ultrasonography;\ at least one episode of severe right upper quadrant or midline epigastric pain of at least 30 min. duration, with radiation and/or movement urge, or at least three episodes of severe right upper quadrant or midline epigastric pain of at least 30 min. duration without such radiation or movement urge, in the previous 12 months Contra-indication for general anaesthesia or surgery Current or previous acute cholecystitis, obstructive jaundice or pancreatitis Previous papillotomy, because of preferential flow of UDCA-enriched bile to the intestine rather than to the gallbladder Pregnancy or lactation Current or previous use of UDCA Participation in another study Inability to speak Dutch or English or mental disability
|
1
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 20.0-90.0, Helicobacter Infections Gastritis Gastric Ulcer Duodenal Ulcer Patients with H. pylori infection Patients without H. pylori infection
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-999.0, Non Small Cell Lung Cancer • Histologically or cytologically confirmed NSCLC Stage IIIB unsuitable for radical radiation (eg. with cytologically proven malignant effusion) or stage IV disease as defined by the AJCC (see appendix 1) Karnofsky performance status 70% or higher (see appendix 2) Presence of at least one bidimensionally or unidimensionally measurable, non-CNS, indicator lesion defined by radiologic study or physical examination No previous chemotherapy for advanced disease. Prior neoadjuvant or adjuvant chemotherapy, or chemotherapy given concurrently with radiotherapy for non-metastatic disease, is allowed if the last dose was given 6 months or more before study entry Patients with recurrent disease after primary surgery and/or radiotherapy will be eligible For patients with previous radiotherapy, the indicator lesion(s) must not be within previous radiation field. The last dose of radiotherapy should be at least 3 weeks prior to study entry. The total radiotherapy received should not be more than 30% of the bone marrow Screening laboratory WBC count > 3500/microl Neutrophils > 2000/microl Platelet count > 100,000/microl Hemoglobin > 9 g/dl (transfusion allowed) Serum creatinine < 133 micromol/l, or Creatinine clearance > 30 ml/min, based on the Cockcroft formula (see section 5.1.1) Bilirubin < 1.5 x upper limit of normal ALT/AST < 2 x upper limit of normal if liver metastases are absent < 5 x upper limit of normal if liver metastases are present Aged 18 years and above Life expectancy > 3 months • Patients with only evaluable disease Active uncontrolled infection Pregnant or lactating women Females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study Presence of any underlying medical conditions which in the investigators opinion would make the patient unsuitable for treatment Concomitant malignancies or previous malignancies other than NSCLC within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma-in-situ of the cervix, or stage A low grade prostate cancer Patients with CNS and/or leptomeningeal metastases; unless asymptomatic and not receiving corticosteriod therapy
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-55.0, Indigestion A. Males and females of age 18-55. B. A diagnosis of epigastric pain/discomfort (located in the upper abdomen) rated by the patient as moderate to severe in intensity (on a four-point categorical scale), which has been present at least 3 times per week for 12 weeks, unrelated to exercise. C. Patients may have other symptoms of NUD including heartburn, regurgitation, bloating (abdominal distension), early satiety (feeling of fullness), belching (burping), or nausea; however, the dominant symptom must be epigastric pain/discomfort. D. Capable of and willing to give informed consent and comply with all study requirements A. H. pylori positive serology. B. Regular use of NSAIDs or more than 100 mg of aspirin. C. Patients requiring chronic treatment with any medication inducing GI symptoms (e.g., certain antibiotics, codeine, etc.). D. History or presence of endoscopic/radiological evidence of esophagitis. E. History or presence of chronic gastric or duodenal ulcer. F. History or presence of duodenal erosions. G. History or previous upper GI surgery. H. Presence of concomitant symptoms of irritable bowel syndrome (IBS) as assessed by three or more of the Manning or Rome criteria. I. History or presence of other known organic disease that might explain the dyspepsia symptoms (e.g., symptomatic gallstones). J. Pregnancy or lactation. K. Inadequate contraception. L. Regular consumption of greater than 2 fluid ounces of beverage alcohol (corresponding to 2 cocktails or 40 fluid ounces of beer or 16 fluid ounces of wine) per day. M. History of substance abuse. N. Unwillingness or expected inability to tolerate absence of antisecretory medications (antacids, H2 receptor antagonists or Proton pump inhibitors (PPIs) or other GI pharmacotherapy for a period of time of study protocol (16 weeks maximum)
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-70.0, Gastrointestinal Disease Signs and Symptoms, Digestive Dyspepsia At least 3 months of symptoms of pain or burning centered in the upper abdomen prior to enrollment Both Helicobacter pylori positive and negative patients eligible (Helicobacter pylori is a bacterial infection of the stomach) Presence of clinical significant abnormal findings at the endoscopy (examination of esophagus and stomach) prior to enrollment Patients with symptoms of other gastrointestinal diseases, such as Gastroesophageal Reflux Disease (GERD), Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD) Helicobacter pylori eradication treatment during the last 12 months prior to enrollment
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-999.0, Extrahepatic Bile Duct Cancer Gallbladder Cancer Pancreatic Cancer Biopsy confirmed diagnosis of any of the following Pancreatic carcinoma Ampullary carcinoma Biliary tract (gallbladder or bile duct) carcinoma Unresectable and/or biopsy-proven metastatic disease Suitable for bimodality therapy, as determined by a medical oncologist and radiation oncologist ECOG performance status 0-2 Life expectancy > 2 months ANC > 1,500/mm³ Platelet count > 100,000/mm³
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-999.0, Clostridium Infections Diarrhea Subject is 18 years of age or older, has acute diarrhea and at least 1 other sign of enteric infection present, such as fever, nausea/loss of appetite, vomiting, severe abdominal pain or discomfort Subject has a positive Clostridium difficile stool toxin assay at screening Subject has had a previous episode of clinically diagnosed Clostridium difficile within the past 6 months Subject has chronic diseases associated with diarrhea (e.g., inflammatory bowel disease or diarrhea predominant irritable bowel syndrome [DIBS]) Subject has had any therapy with any agent administered for the treatment of Clostridium difficile prior to randomization
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-999.0, Cyclic Breast Pain, Cyclic Mastalgia A woman is eligible for this study if she is pre-menopausal and at least 18 years of age has a history of cyclical mastalgia for each of the four months prior to study entry moderate or severe mastalgia as determined by >40 mm on the VAS for ≥7 days per cycle in the second part of the cycle, i.e. 13 days prior to menses and the first two days of the next cycle with a substantial decrease during the two weeks following the onset of menses, assessed during the two month run-in period has a history of regular menstrual cycles of 28 plus/minus 3 days
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-999.0, PAIN CHRONIC DISEASE Male and female subjects at least 18 years of age and of legal age of consent for the state in which they live Able to respond to a questionnaire written in English Report chronic pain (constant or recurring pain lasting more than 30 days and causing significant discomfort or limitation of activity) Provide informed consent to participate in the study Currently participating in another clinical trial Institutionalized person such as a prisoner or nursing home resident Questionnaire response suggests a medical or psychological condition that, in the opinion of the investigator, would compromise participation in the study, or suggests any other condition which, in the investigator's judgment, might increase the risk to the subject or decrease the chance of obtaining valid data Pain has resulted in a workman's compensation case Pain has resulted in litigation
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-75.0, Biliary Tract Cancer Cases of biliary tract cancer newly diagnosed between September 1, 1996 and August 31, 1999 among residents of urban Shanghai. Must be under the age of 75 at the time of diagnosis
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-45.0, Dengue A healthy male or female adult 18-45 years at the time of vaccination Free of obvious health problems as established by medical history and physical examination before entering into the study Written informed consent obtained from the subject Able to read the Subject Information Sheet and Consent Form Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception, e.g. progestin implantable, cutaneous hormonal patch or injectable contraceptives) for 30 days prior to vaccination, have a negative pregnancy test within 48 hours prior to vaccination and must agree to continue such precautions for 60 days after completion of the vaccination series Pregnant or lactating female Female planning to become pregnant or planning to discontinue abstinence or contraceptive precautions History of any neurological or behavioral disorder or seizures, with the exception of a single febrile seizure in childhood History of drug abuse or alcohol consumption (more than 2 drinks per day) History of allergic disease/reaction likely to be exacerbated by any component of the vaccine History of urticaria related to mosquito bites requiring medical attention Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal, hematologic or endocrine functional defect, as determined by physical examination or laboratory tests Any confirmed or suspected immunosuppressive or immunodeficient condition Subject seropositive for HBsAg, anti-HCV or anti-HIV Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever)
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-65.0, Gastroparesis Type-1 and Type-2 diabetic patients to 65 years old Glycated haemoglobin level (HbA1c) below 9% Body mass index (BMI) between 18 and 35 kg/m2 Use of medications potentially influencing upper gastrointestinal motility or appetite within one week of the study (e.g. prokinetic drugs, macrolide antibiotics) Exposure to radiation for research purposes during the previous 12 months
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-999.0, Biliary Tract Diseases Gallbladder Diseases Cholecystitis Cholecystolithiasis Cholecystectomy is considered the best available treatment. 2. The patient understands trial information and is capable of making a decision after having received information. 3. The patient wants to undergo cholecystectomy and accepts participation in the trial Age below 18 years. 2. The patient is unable to understand trial information. 3. Competence for both trial groups are lacking when a patient is randomized. 4. The cholecystectomy is part of a more extensive operation (e.g., pancreaticoduodenectomy). 5. The indication of cholecystectomy is proven or suspected cancer of the gallbladder
|
2
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 0.5-4.0, Fever Age: 6 mo years Rectal temperature > 38.5 Received 10-15 mg/kg of acetaminophen or 5-10 mg/kg of ibuprofen 1.5 5 hours before admission to the Received more than 75 mg acetaminophen in the last 24 hours Unable to take oral medications Hypersensitivity to acetaminophen or ibuprofen Varicella Renal failure Liver disease Rectal temperature can't be measured (due to anatomical or medical problem) Received both Ibuprofen and acetaminophen in the last 6 hours Informed consent could not be granted
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-75.0, Osteoarthritis Is a healthy adult 18 to 75 years of age, inclusive; healthy is defined as no clinically relevant abnormalities identified as detailed medical history, full physical examination, including blood pressure [BP] and pulse rate [PR]measurement, 12-lead electrocardiogram [ECG], and clinical safety laboratory tests If female and of childbearing potential (includes women who have been postmenopausal for < 2 years ), must be using adequate contraception, must not be lactating and must have had a negative serum pregnancy test at Screening and a negative urine pregnancy test result within 24 hours prior to receiving study drug. The site investigator must ensure that female subjects are not pregnant prior to receiving the first dose of drug Endoscopic evidence of inflammation, ulceration, erosion, petechiae, or active bleeding in the esophagus, stomach, pyloric channel, or duodenum at the baseline/ randomization (Day 1) endoscopy (Mucosal Grading Scale score >0) Active GI disease (e.g. inflammatory bowel disease), a history of gastroduodenal ulcers or bleeding, or a history of any gastric or duodenal surgery
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 1.0-30.0, T Acute Lymphoblastic Leukemia T Lymphoblastic Lymphoma T-ALL patients must be enrolled on AALL08B1 prior to treatment and enrollment on AALL0434 Patients must have newly diagnosed T-ALL or T-lineage lymphoblastic lymphoma (T-NHL) stage II-IV; B-lineage lymphoblastic lymphoma will not be eligible for this study; a diagnosis of T-ALL is established when leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation (cluster of differentiation [CD]19/CD22/CD20), and express either surface or cytoplasmic CD3 or two or more of the antigens CD8, CD7, CD5, CD4, CD2 or CD1a; if surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including transmission disequilibrium test (TdT), CD34 or CD99 will be assessed for expression; cases with uncertain expression will receive additional review within the appropriate Children's Oncology Group (COG) reference laboratory T-NHL For T-NHL patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to T-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and for immunophenotypic analysis to establish the diagnosis of T-NHL defined by the submitting institution will be accepted Prior therapy restrictions Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and/or IT cytarabine IT chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); systemic chemotherapy must begin within 72 hours of this IT therapy Patients diagnosed as having T-NHL or T-ALL with respiratory distress or hyperleukocytosis may require steroids prior to the initiation of additional systemic therapy; they are eligible for AALL0434 and will be stratified, based on the initial complete blood count (CBC); steroid pretreatment may alter the risk group assessment; if the T-ALL patient's clinical status precludes a lumbar puncture within 48 hours of the initiation of steroid therapy, T-ALL patients be classified as low risk and will be Intermediate or high risk based on the results of the day 29 marrow as above; patients with T-NHL who receive steroid pre-treatment will be classified as high risk; the dose and duration of previous steroid therapy should be carefully documented For the management of airway compromise, patients who have received emergent chest irradiation up to 600 cGy will be eligible for this study Patients with a prior seizure disorder requiring anti-convulsant therapy are not eligible to receive nelarabine; in addition, patients with pre-existing grade 2 (or greater) peripheral neurotoxicity, as determined prior to Induction treatment by the treating physician or a neurologist, are not eligible to receive nelarabine; these restrictions in are designed to prevent excessive nelarabine-induced central and peripheral neurotoxicity in at-risk patients; for the purposes of this study, this includes any patient that has received anticonvulsant therapy to prevent/treat seizures in the prior two years Pregnant or lactating females are ineligible Patients with Down syndrome are ineligible to enroll onto this study For T-NHL patients the following additional apply B-precursor lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma CNS3-positive or testicular involvement
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-999.0, Pain, Postoperative Orthopedic Procedures Analgesia Patients undergoing primary, unilateral total knee replacement surgery where use of opioid analgesics for short-term postoperative pain is required At baseline must be able to tolerate oral liquids, swallow a tablet, and have the presence of bowel sounds upon examination Patients must demonstrate stable vital signs immediately before dosing with OROS hydromorphone HCI At baseline pain intensity upon movement must be scored by the patient as 2 or 3 (moderate or severe) on the Pain Intensity Rating Scale At baseline patients receiving regional anesthetics/analgesics must demonstrate recovery from the motor and sensory effects of the nerve blockade Patients must be administered OROS hydromorphone HCI between 6 and 48 hours following completion of surgery Patients should expect to remain hospitalized for 36 hours after study drug administration Patients either intolerant of hydromorphone or who have experienced an anaphylactic IgE-mediated immune response (e.g. hives, wheezing, angioedema or bronchospasms) to any opioid agonist Patients having previously undergone the following major surgery for high tibial osteotomy, knee arthroplasty to the affected knee Patients with any gastrointestinal disorder, including pre-existing severe GI narrowing (pathologic or iatrogenic) that may affect the absorption or transit of orally administered drugs Patients who are pregnant or breast-feeding. A negative pregnancy test is required prior to administration of the study medication in females of childbearing potential Patients with significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, and disorders of cognition Patients with clinically significant impaired renal, hepatic, or hematological function adrenocortical insufficiency uncontrolled hypothyroidism or hyperthyroidism, or clinically significant urinary obstruction
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 15.0-45.0, Chronic or Recurrent Appendicitis Patients were eligible if they were between 15 and 45 years of age, and if they suffered from chronic or recurrent right lower abdominal quadrant pain for more than three months. They were to experience continuous pain, or should have endured at least one pain attack in the month prior to inclusion consisted of (a history of) chronic back pain, previous abdominal surgery (with the exception of diagnostic laparoscopies or a laparoscopic sterilization), specific gastro-intestinal entities (such as inflammatory bowel disease) and gynaecological disease (all female patients consulted a gynaecologist). Routine laboratory investigations included hemoglobin rate, serum leukocyte count and differentiation, C-Reactive Protein concentration, Erythrocyte Sedimentation Rate, faeces cultures and urine sedimentation. Barium contrast studies of the colon were done in all patients, abdominal ultrasound or enteroclysis on discretion. Finally, was possible when diagnostic laparoscopy revealed abnormalities (see below)
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-999.0, Gallbladder Cancer Cholangiocarcinoma Biliary Tract Cancer Presenting to IU for treatment of biliary tract disease; Age greater than or equal to 18 Problems other than biliary tract disease
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 10.0-999.0, Inflammatory Bowel Diseases Patient will be 10 years and older Patient suffers from abdominal pain and/or diarrhea for the last 6 weeks and/or expresses extra-intestinal manifestations of CD Patient has at least one of the following over the preceding 6 months (plus symptoms suspicious of small bowel Crohn's Disease) Positive inflammatory marker (ESR, CRP, thrombocytosis, leucocytosis, fecal lactoferrin, fecal α-1 antitrypsin) Unexplained anemia Recurrent fever Weight loss (at least 10% of normal body weight in adults) Hypoalbuminaemia (<3.5 g/dL) Gastro-intestinal bleeding Chronic perianal disease (fistula, fissure) Patients with indeterminate colitis where the purpose is only to make a definitive diagnosis and where the are not otherwise met Patient is known to suffer from intestinal obstruction (symptoms such as severe abdominal pain with accompanying nausea or vomiting) Definite stricture seen on SBFT Patient had suspected GI stricture, a Given® Patency capsule was administered and Patient did not pass the Patency capsule Patient has a pacemaker or other implanted electro-medical device Patient has known history of small bowel Crohn's disease Patient on treatment for active IBD Patient with suspected celiac disease that has not been excluded Patient on non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or higher) during the 3 months preceding enrolment Patient is pregnant
|
0
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-999.0, Acute Cholecystitis Patients of age > 18 years Patients with acute cholecystitis based on three of the following signs abdominal pain in the upper right quadrant Murphy's sign leucocytosis > 10 /ml rectal temperature > 38 °C or < 36.5 °C plus cholecystolithiasis (stones / sludge) or sonographic signs of cholecystitis (thickening and triple layer formation of the gall bladder wall) Immediate antibiotic therapy (400 mg Moxifloxacin i.v. once a day) Laparoscopic cholecystectomy possible within 24 hours after presentation of the patient Informed consent ASA IV and V (table 2) Septic shock Perforation or abscess of the gall bladder Impossibility of laparoscopic surgery (further surgery, surgeon, …) Additional need of antibiotics due to secondary disease Known intolerability of Moxifloxacin Known or possible pregnancy, breast feeding Life-threatening diseases (life-expectancy < 48 hours) End-stage liver disease (Child-Pugh C) Psychiatric or severe neurologic disease
|
2
|
A 45-year-old woman was referred to the emergency department with abdominal pain lasting about 4 days accompanied by nausea and 2 episodes of vomiting. The pain is localized to the epigastric region and radiates to the right upper quadrant. The pain is worsening after eating fatty food. The patient experienced similar pain twice in the past year. Her past medical history is remarkable for hypercholesterolemia and two C/sections. She has 2 children, and she is menopausal. She doesn't smoke, drink alcohol, or use illicit drugs. She is mildly febrile. Her BP is 150/85, HR 115, RR 15, T 38.2, SpO2 98% on RA. On palpation, she experiences epigastric tenderness and tenderness in the right upper quadrant without rebound. Bowel sounds are normal. Laboratory analysis is remarkable for elevated ESR and leukocytosis with a left shift. The ultrasound revealed several gallstones and biliary sludge. The largest gallstone is 0.7cm. Surgery consultation recommends elective cholecystectomy.
|
eligible ages (years): 18.0-75.0, Musculoskeletal Chest Pain Non-cardiac Chest Pain Undiagnosed Chest Pain To be included in the project the participant must Have chest pain as their primary complaint Have an acute episode of pain of less than 7 days duration before admission Consent to the standardized evaluation program at the chest pain clinic Have pain the in the thorax and/or neck Be able to read and understand Danish. Be between 18 and 75 year of age Be a resident of the Funen County. Patients will not be included if any of the following conditions are present ACS Have had Percutaneous Coronary Intervention (PCI) or Coronary Artery By-pass Grafting (CABG) Have a condition that is likely to results in the episode of chest pain. The condition must be verified clinically during admission (i.e. pulmonary embolism, pneumonia, dissection of the aorta, …) Participants will be excluded following baseline evaluation if any of the following conditions are present Pain not related to the joints and muscles of the neck and/or thorax (CTA negative, see below) New incidence of any of the above mentioned conditions/pathologies
|
0
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.