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A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Intrusive Memories of Traumatic Event(s) Post Traumatic Stress Disorder Aged 18 or over Clinical work during the COVID-19 pandemic in hospital care facilities (e.g. ICU, ambulance, intermediate care, ward) Experienced at least one traumatic event in relation to their clinical work as health care staff during the COVID-19 pandemic This/these event(s) at work meet(s) the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM5) criterion A for Posttraumatic Stress Disorder (PTSD): exposure to actual or threatened death, serious injury, or sexual violence by "Directly experiencing the traumatic event(s)" or "Witnessing, in person, the event(s) as it occurred to others" The traumatic event(s) occured since the start of the COVID-19 pandemic Report memory of the accident Fluent in spoken and written Swedish Alert and orientated Have sufficient physical mobility to use their smartphone Willing and able to provide informed consent and complete study procedures Loss of consciousness of > 5 minutes in relation to the traumatic event Current intoxication during the traumatic event or in relation to study | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Thyroid Carcinoma Thyroid Cancer Thyroid Cancer, Follicular Thyroid Cancer (Follicular Cell) Thyroid Cancer, Papillary BRAF V600E Mutation Positive Histologically or cytologically confirmed thyroid carcinoma of follicular origin (including papillary, follicular, and poorly differentiated subtypes and their respective variants) A tumor sample (primary, recurrent, or metastatic tumors) possessing a BRAF V600 mutation, as confirmed in a CLIA-certified laboratory or using an FDA-approved assay Measurable disease by v1.1 (tumors in previously irradiated fields may be considered measurable if there is evidence of tumor progression after radiation treatment) RAIR disease, as defined by any one of the following A metastatic lesion that is not RAI-avid on a diagnostic radioiodine scan An RAI-avid lesion that remained stable in size or progressed despite RAI treatment before entry in this study (there are no size limitations for the index lesion used to satisfy this entry criterion) The presence of at least 1 FDG-avid lesion No receipt of treatment for thyroid cancer, defined as No I-131 therapy < 6 months before initiation of the protocol (time of initiation of the protocol is defined as the first day of drug therapy with vemurafenib and copanlisib); diagnostic activities of I-131 (0-10m Ci) are allowed within 6months of initiating the protocol No external beam radiation therapy <4 weeks before initiation of the protocol Untreated metastatic brain or leptomeningeal tumors (metastatic brain or leptomeningeal tumors treated with radiation and/or surgery are allowed) Prior malignancy if diagnosed and treated within 2 years of trial drug initiation (with the exception of nonmelanoma skin cancers or Stage I cancers treated with curative intent).Patients may be included if they have completed therapy for a prior malignancy >2 years before drug initiation and currently have no evidence of disease Inability to follow a low-iodine diet or requiring a medication with a high content of iodide (amiodarone) Current congestive heart failure class >2, as defined by the New York Heart Association functional classification system Myocardial infarction < 6 months before the initiation of protocol Unstable angina (angina symptoms at rest) or new-onset angina (begun within the last 3 months) Uncontrolled hypertension (blood pressure >150/90, despite optimal medical management) Uncontrolled type I or II diabetes mellitus, as judged by the investigator, or Hgb A1C of >8.5 Arterial or venous thrombotic event or embolic event, such as a cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism, within 3 months before the start of study medication Nonhealing wound, ulcer, or bone fracture (tumor-related nonhealing wounds are allowed) | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Rectal Cancer All patients with rectal cancer with one or more lateral nodes with a short-axis of ≥7mm. MR images are reviewed by a one of the study radiologists and both the nodes in the internal iliac as the obturator compartment are assessed. The largest node in each compartment is used as the reference short-axis in the flow charts. If there are both ≥7mm internal iliac and obturator nodes, the internal iliac flowchart is used Younger than 18 years old Pelvic irradiation in the medical history Previous lateral lymph node dissection related to pelvic malignancy Synchronous distant metastases Familiar adenomatous polyposis Synchronous colon cancer with a higher stage than rectal cancer Absolute contraindication for general anaesthesia Pregnancy | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Metastatic Breast Cancer Female or Male patients. 2. Age ≥18 years. 3. Signed informed consent prior to any screening procedure. 4. Locally advanced or metastatic breast cancer of any subtype confirmed both pathologically and radiologically (stage IIIb IV disease). 5. The subjects must be about to receive, or receiving, or will have completed treatment for their metastatic disease with any line of treatment in either a clinical trial or the healthcare setting. 6. Availability of one metastatic (preferably), primary tumor sample or blood sample. 7. Measurable or non-measurable disease. 8. Quality of life score according to ECOG scale ≤ 3. 9. Minimal life expectancy of 6 months Inability to consent or conform to the processes involved in a clinical study. 2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-75.0, Traumatic Brain Injury (TBI) > 6 months post traumatic brain injury 75 years old ability to walk without physical assistance Self selected walking speed of 0.01-1.0 m/s <18 years old >75 years old self selected walking speed of > 1.0 m/s < 3 months from botulinum toxin injection Above the knee brace Currently receiving physical therapy | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, To Evaluate PACT, a Mobile Application for Improving Engagement in Advance Care Planning Patient (1) diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic cancer (e.g., pancreaticobiliary, esophagogastric, hepatocellular carcinoma, lung, or gynecological cancer) and/or disease progression following at least first line chemotherapy; (2) access to a mobile device; (3) the ability to provide informed consent; and (4) identification of a loved one/informal caregiver Caregiver (1) the person (family member or friend) whom the patient indicates being an informal caregiver; (2) English speaking; (3) 18 years of age or older; and (4) able to provide informed consent Provider (1) current clinical practice and/or research with advanced cancer patients, (2) a history of 3+ years working with advanced cancer patients; (3) 18 years of age or older. Providers across disciplines (e.g., social work, oncology) will be enrolled Patient (1) not fluent in English; (2) severely cognitively impaired (as measured by Short Portable Mental Status Questionnaire scores of < 6);23 (3) too ill or weak to complete the interviews (as judged by the interviewer); (4) currently receiving hospice at the time of enrollment; and (5) children and young adults under age 18 Caregivers and Providers None | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Thyroid Neoplasia Well-Differentiated Thyroid Cancer Medullary Thyroid Cancer Lymph Node Metastases years of age or older Patients with fine needle aspiration biopsy (FNAb)-proven metastatic cervical lymph nodes at levels I, II, III, IV, V, VI or VII from differentiated thyroid carcinoma or medullary thyroid carcinoma who underwent total thyroidectomy and subsequent radioiodine therapy, in case of differentiated thyroid carcinoma Patients considered high surgical risk candidate or patients who are informed about the ablation therapy and prefers it instead surgery Patients with metastatic cervical lymph nodes over 0.8 cm diameter and under 4.0 cm diameter; no more than 6 simultaneous cervical nodal metastases Cervical recurrences in previously lateral neck dissection patients for differentiated thyroid carcinoma or medullary thyroid carcinoma over 0.8 cm diameter Age under 18 years Uncorrectable coagulopathy Inconclusive or benign cytologic specimens Pregnancy or breast-feeding Anaplastic or poor-differentiated thyroid carcinoma Partial thyroidectomy Cervical tumors not considered to surgery (invading vessels, nerves, larynx or trachea) Serious medical illness, including any of the following: uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the baseline visit, uncontrolled congestive heart failure Participation in other studies that could affect the primary endpoint | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-90.0, Chronic Kidney Disease Requiring Chronic Dialysis Hyperphosphatemia Signed and dated informed consent form prior to any study specific procedures. 2. Males or females aged 18 to 80 years, inclusive, at Screening (Visit 1). 3. Females must be non-pregnant and non-lactating. 4. Patients on phosphate binder therapy must be on chronic maintenance hemodialysis (HD) 3 times per week for at least 3 months or chronic maintenance peritoneal dialysis (PD) for a minimum of 6 months. If modality of dialysis has changed, the patient must meet one of the two dialysis above and been on the new modality of dialysis for a minimum of one month. Phosphate binder naïve patients must be on chronic maintenance HD 3 times per week or chronic maintenance PD. 5. Kt/V ≥1.2 at most recent measurement prior to Screening (Visit 1). 6. Prescribed and taking phosphate binder medication at least 3 times per day or being phosphate binder naïve; defined as having not taken phosphate binders for at least 3 months prior to Screening. The patient must be taking a minimum of 6 pills per day for Renvela, Auryxia, or PhosLo; and/or a minimum of 3 pills per day for Fosrenol or Velphoro. 7. For patients taking phosphate binders, both the s-P level at the most recent measurement prior to Screening (Visit 1) and the s-P level at Screening (Visit 1) must be >5.5 and ≤10.0 mg/dL. 8. For phosphate binder naïve patients, the s-P level at Screening (Visit 1) must be >4.5 and ≤10.0 mg/dL. 9. Able to understand and comply with the protocol Severe hyperphosphatemia defined as having an s-P level >10.0 mg/dL at any time point during routine clinical monitoring for the 3 preceding months before Screening (Visit 1). 2. Serum/plasma PTH >1200 pg/mL. The most recent value from the patient's medical records should be used. 3. Clinical signs of hypovolemia at Screening (Visit 1) as judged by the Investigator. 4. History of inflammatory bowel disease or irritable bowel syndrome with diarrhea. 5. Scheduled for living donor kidney transplant or plans to relocate to another center during the study. 6. Use of an investigational agent within 30 days prior to Screening (Visit 1). 7. Involvement in the planning and/or conduct of the study (applies to both Ardelyx/Contract Research Organization (CRO) staff and/or staff at the study site). 8. If, in the opinion of the Investigator, the patient is unable or unwilling to fulfill the requirements of the protocol or has a condition which would render the results uninterpretable | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-65.0, Neck Pain To have neck pain for at least 3 months Turkish literate individual Operation history due to neck pain problems Individuals diagnosed with tumor, infection, ankylosing spondylitis, rheumatoid arthritis or inflammatory diseases, fracture, cauda equina syndrome Pregnancy Individuals who do not give consent | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Thyroid Nodule complicated thyroid nodule less than 18 malignant thyroid nodule | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Triple-Negative Breast Cancer Cohort A Metastatic or locally advanced unresectable, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression Only patients with metastatic TNBC tumors that are centrally tested and found to be programmed death-ligand 1 (PD-L1) positive will be enrolled No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC Eastern Cooperative Oncology Group performance status of 0 or 1 Measurable disease, as assessed by the investigator according to v1.1 Adequate hematologic and end-organ function Cohort B Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Histologically documented TNBC (negative HER2, ER, and PR status) Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen Cohort A Formalin-fixed, paraffin-embedded (FFPE) tumor tissue that is PD-L1 negative, as determined on the SP142 PD-L1 immunohistochemistry assay, with positivity defined as immune cells greater than or equal to (>/=) 1% Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >2 weeks prior to initiation of study treatment Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases Leptomeningeal disease Cohort B History of invasive breast cancer Stage IV (metastatic) breast cancer Prior systemic therapy for treatment and prevention of breast cancer Previous therapy with anthracyclines, platinum, or taxanes for any malignancy Synchronous, bilateral invasive breast cancer | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Femoral Neck Fractures years and older non-displaced femoral neck fracture community ambulator younger than 18 years displaced femoral neck fracture intertrochanteric fracture subtrochanteric fracture | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 20.0-100.0, Thyroid Cancer Thyroid Cancer, Papillary Benign Thyroid Tumor Patients with thyroid nodules who received total or subtotal thyroidectomy Patients aged 20 years and above Patients with any other type of cancer, immunocompromised disease, or autoimmune disease | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-77.0, Thyroid Cancer Atypia of Undetermined Significance FLUS Clinical cytology diagnosis of Bethesda category III (AUS/FLUS) pathological confirmation of thyroid malignancy after surgery pathological confirmation of other thyroid carcinomas, including follicular carcinoma ,medullary carcinoma ,undifferentiated Spindle cell carcinoma and lymphoma were excluded 2. female who were pregnant were excluded 3. patients with mental disorders were excluded 4. patients without the complete clinical data were excluded | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Papillary Thyroid Microcarcinoma Thyroid Thyroid Cancer Age ≥ 18 years A single, cytologically confirmed papillary thyroid microcarcinoma Maximum diameter ≤ 10 mm Declined active surveillance The thyroid lesion must be solid without coarse calcifications greater than 2 mm No US evidence of extracapsular invasion and /or lymph node metastasis Preserved contralateral vocal cord function prior to PLA Thyroid cancer that is non papillary thyroid cancer (PTC) Clinical / US evidence of multicentric papillary thyroid cancer Thyroid lesion with a cystic component Lesion with US evidence of capsular invasion Clinical or ultrasonographic evidence of lymph node metastasis Subcapsular lesions abutting the posterior thyroid capsule (to avoid recurrent laryngeal nerve or parathyroid injury) Subcapsular lesions abutting the medial thyroid capsule (to avoid recurrent laryngeal nerve or tracheal injury) Pregnancy Contraindications to thyroid surgery | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Papillary Thyroid Cancer Papillary Thyroid Carcinoma Papillary Microcarcinoma of the Thyroid Patients 18 years of age or older Newly diagnosed previously surgically untreated papillary thyroid cancer (PTC) or suspicious for PTC on fine needle aspiration biopsy of the thyroid. PTC must be < 2 cm in maximal diameter on thyroid ultrasound The absence of metastatic cervical lymphadenopathy or gross extrathyroidal extension of PTC, as confirmed on neck ultrasound imaging The absence of other current absolute indication for thyroid or parathyroid surgery (e.g. severe hyperthyroidism that cannot be controlled medically, large goitre with severe compressive symptoms, or primary hyperthyroidism meeting surgical criteria) Metastatic thyroid cancer (lymph nodes or distant) History of prior thyroid surgery for any indication The primary PTC being on the trachea or immediately adjacent to the recurrent laryngeal nerve, and with progression would be deemed to be at high risk of growth into these critical structures Clinical signs, imaging, or laryngoscopy findings suggestive of locally advanced thyroid cancer (i.e. vocal cord paralysis due to the thyroid cancer or any clinical or radiographic signs of extrathyroidal invasion into adjacent structures such as the strap muscles of the neck, trachea or esophagus) Known/suspected poorly differentiated or non-papillary thyroid cancer Medically unfit for surgery due to severe co-morbidity. Severe comorbidity may another active malignancy with limited life expectancy of < 1 year) Pregnancy at the time of study enrollment Unable/unwilling to provide informed consent for the study or comply with study follow-up procedures due to current active physical limitations/medical co-morbidity, cognitive, or psychiatric impairment substance abuse, or other reasons | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-85.0, Rectal Cancer middle to low-lying rectal adenocarcinoma patients with enlarged lateral lymph node ≥5mm for short diameter in CT and/or MRI other kind of rectal tumor including neuroendocrine and malignant high location rectal cancer recurrent rectal cancer | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 6.0-18.0, Abdominal Wall Defect All patients born with an abdominal wall defect mental disease | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-45.0, Obesity Weight Loss Eating Behavior overweight to obese (BMI 25-45 kg/m2) not currently engaged in exercise or weight loss activities free of any cardiac, pulmonary, or metabolic health conditions able to safely engage in exercise female participants must be premenopausal and not pregnant or nursing Lost or gained over 5% of their current bodyweight in the previous 12 months taking any medications or dietary supplements which may influence energy expenditure or intake have not been diagnosed with an eating disorder, clinical depression, or an anxiety disorder engage in less than 150 minutes of moderate to vigorous physical activity per week (assessed via accelerometry at baseline) | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-75.0, Thyroid Carcinoma Thyroid Nodule (Benign) Ablation; Retina Patients diagnosed with unilateral thyroid carcinoma and contralateral benign nodule confirmed by preoperative ultrasound-guided fine-needle aspiration cytology Patients with contralateral nodules ≤ 20mm and located in the thyroid gland Patients with clinical node-negative cervical compartment at palpation and neck ultrasound Previous history of neck surgery Previous history of neck radiation therapy | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-75.0, Peripheral T Cell Lymphoma Subjects fully understand and voluntarily participate in this study and sign informed consent; 2. Age ≥18, ≤75 years, no gender limitation; 3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2; 4. Histopathologically confirmed Peripheral T -cell Lymphoma (PTCL) according to World Health Organization (WHO) (version 2016), with the subtypes as follows: 1. Peripheral T-cell lymphoma, unspecified (PTCL, NOS); 2. Angioimmunoblastic T-cell lymphoma (AITL); 3. ALK+ systematic anaplastic large T-cell lymphoma (ALCL, ALK+); 4. ALK-systematic anaplastic large T-cell lymphoma (ALCL，ALK-); 5. Extranobal NK/T cell lymphoma (nasal type) (NKTCL); 6. Other subtypes of PTCL which are appropriate to be enrolled in the opinion of the investigator. 5. Patients have relapsed or are refractory to at least one line of prior systemic therapy (anthracycline-containing regimen) for PTCL. Relapse is defined as recurrence after CR or progress after PR; refractory refers to the efficacy of 2 cycles of treatment is PD, or the efficacy of 4 cycles of treatment is SD; 6. Subjects have at least one measurable lesion in accordance with the Lugano evaluation (version 2014): the long axis of the lymph node shall be>1.5 cm, the long axis of the extranodal lesions shall be>1.0 cm. 7. Subjects must provide a written pathology/histological diagnosis report during the screening period and must agree to provide a tumor tissue section or tumor/lymph node tissue specimen to be sent to the central laboratory. 8. Life expectancy ≥ 12 weeks; 9. During the screening period, the patients should meet the following requirements and have not received infusion of cell growth factor, platelet and granulocyte within 7 days of the hematology test; 1) Absolute value of neutrophils ≥ 1.5 × 109/L; absolute value of neutrophil ≥ 1.0 × 109/L in patients with involvement of bone marrow; 2) Hemoglobin ≥ 90 g/L (no red cell infusion within 14 days), hemoglobin ≥ 75 g/L in patients with involvement of bone marrow; 3) Platelet ≥ 75 × 109/L in patients without involvement of bone marrow; platelet ≥ 50 × 109/L in patients with involvement of bone marrow; 4) Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) (total bilirubin ≤ 3 × ULN if bilirubin level increase is caused by lymphoma invading the liver); 5) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; if the elevated level of AST or ALT is caused by liver involvement, both AST and ALT shall be ≤ 5 × ULN); 6) Creatinine < 1.5 × ULN. 10. Eligible fertile patients (male and female) must agree to use an effective method of contraception (hormonal or barrier or abstinence) with their partners from the study initiation until at least 7 months after the last treatment; women of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment (Limit: 15,000 characters) 1. Patients with leukemia type PTCL (adult T-cell leukemia/lymphoma, etc.), or in lymphoma leukemia stage (malignant cell proportion of > 20% in bone marrow examination); or with central nervous system (CNS) involvement, or with complicated of hemophagocytic syndrome. 2. History of allergy and contraindications to the same class and excipients of the experimental drug.; 3. Patients have one of the following conditions in the previous anti-tumor treatments:1) Patients received mitoxantrone or liposome mitoxantrone within 6 months;2) Patients who was treated with Chidamide and the efficacy was evaluated as PD; Patients who was treated with Chidamide within 6 months (if the patients have been treated with Chidamide for no more than 2 weeks, had no clear evidence of PD and no intolerable toxicity during the treatment period, and discontinued therapy for other reasons, may be considered with the investigator's consent);3) Those receiving treatment of Adriamycin or other anthracyclines previously, with the total cumulative dose of > 360 mg/m2 (other anthracycline drugs: 1 mg of epirubicin/pyramycin/daunorubicin is equivalent to 0.5 mg of doxorubicin, 1 mg of deoxydaunorubicin is equivalent to 2 mg of doxorubicin);4) Those received anti-tumor treatment, including cytotoxic chemotherapy, radiotherapy and targeted drug therapy within 4 weeks prior to the first use of the study drug, or immunomodulators (thalidomide, lenalidomide) within 3 weeks; or hormone or herbal therapy with lymphoma as indication within 2 weeks; 4. Participated in other clinical studies and received therapy within 4 weeks prior to the first administration of the study drug; 5. Those received allogeneic hematopoietic stem cell transplantation previously and autologous hematopoietic stem cell transplantation within 6 months; 6. Adverse reactions from the previous anti-tumor treatment have not yet recovered (>Grade 1 in NCI-CTCAE [Version 4.03], with the exception of hair loss and pigmentation); 7. Subjects with the impaired cardiac function or significant heart disease, including but not limited to:1) Myocardial infarction, congestive heart failure and viral myocarditis occurred 6 months before screening; heart disease with symptoms requiring treatment and intervention, such as unstable angina, arrhythmia, etc.;2) Congestive heart failure of ≥Grade 2 according to the New York Heart Association Classification;3) Cardiac ejection fraction less than 50% or less than the lower limit of the reference range of the laboratory examination used in the Research Center;4) Persistent myocardial disease;5) QTc > 450 milliseconds, or congenital long QT syndrome. 8. Patients with active infection, including hepatitis B (positive hepatitis B virus surface antigen and HBV-DNA titer higher than the upper limit of the reference range) and hepatitis C (positive hepatitis C virus RNA and HCV-RNA titer higher than the upper limit of the reference range); 9. History of severe autoimmune disease and immunodeficiency, including positive for human immunodeficiency virus (HIV); or other acquired or congenital immune deficiency diseases; or a history of organ transplantation; 10. Patients with other malignant tumors in the past five years (except the cured non-melanoma skin basal cell carcinoma and cervical carcinoma in situ); 11. Major surgery within 6 weeks prior to screening. or have a surgical schedule during the study period; 12. Patients have significant gastrointestinal disorders that may affect the ingestion, transportation, or absorption of the drug (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.) during the screening period; 13. Patients have uncontrolled hypertension (systolic pressure of 180 mmHg and/or diastolic pressure of 110 mmHg after treatment); or type 2 diabetes that cannot be controlled by oral hypoglycemic drugs or insulin therapy; 14. History of mental illness or history of drug abuse or dependence; 15. Pregnant or lactating women; 16. Not suitable for this study as determined by the investigator due to other reasons | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Anatomic Stage IV Breast Cancer AJCC v8 BRCA-Mutated Malignant Neoplasm BRCA-Mutated Metastatic Breast Carcinoma BRCA-Mutated Ovarian Carcinoma Metastatic Breast Carcinoma Metastatic Fallopian Tube Carcinoma Metastatic Malignant Solid Neoplasm Metastatic Ovarian Carcinoma Metastatic Pancreatic Carcinoma Metastatic Primary Peritoneal Carcinoma Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8 Prognostic Stage IV Breast Cancer AJCC v8 Stage III Fallopian Tube Cancer AJCC v8 Stage III Ovarian Cancer AJCC v8 Stage III Pancreatic Cancer AJCC v8 Stage III Primary Peritoneal Cancer AJCC v8 Stage IIIA Fallopian Tube Cancer AJCC v8 Stage IIIA Ovarian Cancer AJCC v8 Stage IIIA Primary Peritoneal Cancer AJCC v8 Stage IIIA1 Fallopian Tube Cancer AJCC v8 Stage IIIA1 Ovarian Cancer AJCC v8 Stage IIIA2 Fallopian Tube Cancer AJCC v8 Stage IIIA2 Ovarian Cancer AJCC v8 Stage IIIB Fallopian Tube Cancer AJCC v8 Stage IIIB Ovarian Cancer AJCC v8 Stage IIIB Primary Peritoneal Cancer AJCC v8 Stage IIIC Fallopian Tube Cancer AJCC v8 Stage IIIC Ovarian Cancer AJCC v8 Stage IIIC Primary Peritoneal Cancer AJCC v8 Stage IV Fallopian Tube Cancer AJCC v8 Stage IV Ovarian Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Stage IV Primary Peritoneal Cancer AJCC v8 Stage IVA Fallopian Tube Cancer AJCC v8 Stage IVA Ovarian Cancer AJCC v8 Stage IVA Primary Peritoneal Cancer AJCC v8 Stage IVB Fallopian Tube Cancer AJCC v8 Stage IVB Ovarian Cancer AJCC v8 Stage IVB Primary Peritoneal Cancer AJCC v8 Unresectable Breast Carcinoma Unresectable Fallopian Tube Carcinoma Unresectable Malignant Solid Neoplasm Unresectable Ovarian Carcinoma Unresectable Pancreatic Carcinoma Unresectable Primary Peritoneal Carcinoma Participant must have breast, pancreas, ovary, fallopian tube or primary peritoneal cancer that is unresectable or metastatic, with a pathogenic mutation in BRCA1 or BRCA2 (either germline or somatic) as confirmed by next generation gene sequencing such as University of Washington (UW) OncoPlex assay or equivalent, and who have experienced progression or been intolerant to standard therapies for their disease Breast cancer patients with or without HER2+, estrogen receptor (ER)+, and/or progesterone receptor (PR)+ disease, as determined by pathological report, are allowed Participant must be able and willing to undergo pre-treatment and on-treatment biopsy Participant must have life expectancy of 4 months or greater Tumor must be measurable according to Response Evaluation in Solid Tumors (RECIST)1.1 Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 Participant must be >= 18 years of age Patient must be able to tolerate oral medication Absolute neutrophil count >= 1,500/uL Platelets >= 100,000/uL Participant must not be simultaneously enrolled in any interventional clinical trial Participant must not have had major surgery =< 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects Prior treatment with both PARP inhibitor and immune checkpoint inhibitor blockade either sequentially or together including inhibitors of PD1, PD-L1 or CTLA4 is not allowed. Patients may have had either PARP inhibitor or Immune checkpoint inhibitor previously but not within 3 months of starting treatment Participant must not have received investigational therapy =< 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy Participant must not have had radiation therapy encompassing > 20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to day 1 of protocol therapy Participant must not have a known hypersensitivity to niraparib and dostarlimab (TSR-042) components or excipients Participant must not have received a transfusion (platelets or red blood cells) =< 4 weeks prior to initiating protocol therapy Participant must not have received colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy Participant has had any known grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Squamous Cell Carcinoma of Head and Neck Written informed consent given according to ICH/GCP and national/local regulations must be obtained prior to any screening procedures. 2. World Health Organization (WHO) performance status 0-1. 3. Age ≥ 18 years. 4. Patients with a pathologically proven invasive HNSCC, including oral cavity, oropharynx (independently of HPV status), larynx or hypopharynx. 5. Decision by Multidisciplinary Tumor Board of primary treatment with radical radiotherapy with or without concurrent chemotherapy (according to the local guidelines). 6. Baseline imaging of the neck a. ≤ 2.5 mm slices CT with iodine injection (independently or during the FDG-PET/CT examination IF acquired in normal diagnostic conditions, i.e. arms along the thorax with diagnostic quality) b. MRI not mandatory but allowed, performed according to centres guidelines c. FDG-PET/CT. 7. Tumor characteristics: 1. cT-classification (8th TNM staging): T1(except T1 of glottis)-T3. 2. cN-classification (8th TNM staging), as assessed by iodine contrasted CT (or MRI) and FDG-PET: i. mandatorily cN0 contralaterally to the primary tumor (or on one side of the neck for midline primary tumors): 1. smallest diameter < 5 mm in retropharyngeal level (VIIa); 2. smallest diameter of Küttner node (level IIa) < 12 mm; 3. smallest diameter < 10 mm or sum of smallest and largest diameters < 17 mm in any other level; 4. no central necrosis ; 5. maximal standardized uptake value (SUVmax) ≤ 2.2; 6. in dubious cases (typically 2.2 < SUVmax < 4.5 and inconclusive CT or MRI), US-guided FNAC may be required to positive node contralaterally. ii. ipsilaterally positive (if any of the above mentioned is met). c. No distant metastasis Patient has history of: 1. radiotherapy or surgery in the neck with potential impact on lymphatic drainage ("violated neck"); 2. cancer in the last five years (excluding skin basal cell carcinoma and in situ cervix carcinoma); 3. Absolute contra-indication to iodine contrast injection, even after proper cortisone and cetirizine pre-medication. 2. HNSCC from nose, sinuses, oesophagus, salivary glands or nasopharynx. 3. Non-HNSCC histology. 4. Positive contralateral neck by node size or positive US-FNAC in dubious nodes. 5. Synchronous second malignancy. 6. Distant metastasis. 7. Tumor crossing the midline without contralateral mapping after 99mTc-nanocolloïd injection. 8. Any psychological disorder or familial, sociological or geographical condition which, in the investigator's opinion, might jeopardise participant's safety or compliance with the protocol. 9. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatments) or vasectomised partner | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Head and Neck Cancer Head Cancer Head Cancer Neck Neck Cancer Head and Neck Squamous Cell Carcinoma HNSCC Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the head and neck that has arisen from the oral cavity, oropharynx, nasal cavity, paranasal sinuses, larynx, or hypopharynx Clinical stage T1, N2-3; T2, N1-3, T3/T4a, Any N (AJCC, 8th ed.) without evidence of distant metastasis (M0) based on PET/CT or CT chest, abdomen, and pelvis, for which standard-of-care treatment would entail surgical resection with adjuvant radiation +/- chemotherapy. ° Patients with recurrent and multiple primary head and neck cancers that are surgically resectable are eligible if the patient did not receive prior radiation or systemic therapy Disease must be amenable to surgical resection The patient must be a surgical candidate. 1. Hemoglobin > 9.0 g/dL 2. Absolute neutrophil count (ANC) >1.5 x 10^9/L 3. Platelet count >100 x 10^9/L 4. Serum creatinine <1.5 upper limit of normal (ULN) or estimated creatinine clearance (CrCl) >30 mL/min 5. Adequate hepatic function Total bilirubin <1.5 x upper limit of normal ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both < 3 x ULN Alkaline phosphatase (ALP) <2.5 x ULN Note: For patients with Gilbert syndrome, total bilirubin <3x ULN. Upper central must be documented appropriately as past medical history Men and woman >18 years old Eastern cooperative oncology group performance status < 1 Prior radiation and systemic therapy for a head and neck cancer Oral cavity cancer that is not amenable to surgical resection or the patient is not a surgical candidate Active or prior documented autoimmune or inflammatory disorders that have been treated with steroids or immunomodulator therapy in the past 5 years. Exceptions: Patients with vitiligo, type 1 diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, childhood asthma that is resolved, or psoriasis it does not require systemic treatment are permitted Conditions requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressant medications within 14 days of treatment on study Receipt of live attenuated vaccine within 30 days prior initiating treatment on study Prior allogeneic stem cell transplantation, or autologous stem cell transplantation Any infection requiring hospitalization and/or intravenous antibiotic therapy within 2 weeks of the start of treatment Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency. 1. Patients with known HIV infection who have controlled infection (undetectable viral load (HIV RNA PCR) and CD4 count above 350, either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection monitoring will be performed per local standards 2. Patients with HBV (hepatitis B surface antigen positive; HBsAg+) who have controlled infection (serum HBV DNA PCR that is below the limit of detection and receiving anti-viral therapy for HBV) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months be on the last dose of Cemiplimab. 3. Patients were HCV antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR, either spontaneously or in response to successful prior course of anti-HCV therapy) are permitted History of immune-related pneumonitis with the last 5 years History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of leuko-corticoids to assist with management | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Thyroid Gland Anaplastic Carcinoma Male or female subjects ≥ 18 years of age. 2. Willingness to participate in the study by signing an informed consent form approved by the ethics committee of the KVMT named after N.I. Pirogov St. Petersburg State University. 3. ECOG status 0 or 1 or 2. The ECOG assessment must be completed within 7 days prior to the distribution date. 4. Measurable disease according to 1.1, as defined by the investigator. 5. Patients with a histologically confirmed disease (according to the pathologist's report) that meets one of the following (according to 2010 WHO classification): BRAF positive anaplastic thyroid cancer, determined by immunohistochemistry for the presence of the BRAF V600E mutation in tumor tissue, genetic/molecular testing of the tumor, or by liquid biopsy of circulating DNA to determine the presence of the BRAF V600E mutation (if the histological examination is not possible). The primary tumor may or may not be resectable, but the risk of aerodigestive compression or bleeding should be excluded. 6. Weight over 30 kg. 7. Ability to swallow tablets/capsules or gastrostomy. 8. The absence of metastases in the brain. 9. Normal organ and bone marrow function as defined below (obtained = <30 days prior to study entry) Hemoglobin ≥ 9.0 g / dL Absolute neutrophil count (ANC)> 1500 per mm Platelet count ≥ 100,000 per mm Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN) if liver metastases are absent, in which case it should be ≤ 2X ULN. This does not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia, which is predominantly unconjugated in the absence of hemolysis or liver pathology); however, they will only be admitted after consulting their doctor Aspartate transaminase (AST) (SGOT) / alanine aminotransferase (ALT) (SGPT) ≤ 2.5x the institutional upper limit of normal, unless liver metastases are present, in which case it should be ≤ 5x ULN Measured creatinine clearance (CL)> 40 ml/min or Estimated creatinine clearance> 40 ml/min using the Cockcroft-Gault formula (Cockcroft and Gault, 1976) or 24-hour urine collection to determine creatinine clearance Albumin> = 2.5 mg / dL (received = <30 days prior to registration) International normalized ratio (INR) or prothrombin time (PT) = <1.5 X ULN if the subject is not receiving anticoagulant therapy while PT or partial thromboplastin time (PTT) is within the therapeutic range of the intended use of anticoagulants Concurrent participation in another clinical trial unless it is an observational (non-interventional) clinical trial or during the follow-up period of an interventional trial. 2. Taking any type of low molecular weight kinase inhibitor (including the investigational kinase inhibitor) for 2 weeks or 5 half-lives of the agent, whichever is greater. 3. Receiving any type of anticancer drugs (including investigational) or systemic chemotherapy within 2 weeks before starting treatment. 4. The presence of distant metastases (for example, to the brain, lungs). 5. Subject has an uncontrolled, serious underlying medical condition or recent illness, including but not limited to the following conditions: A) Cardiovascular diseases Congestive heart failure, grade 3 or 4 as defined by the New York Heart Association, unstable angina, and severe cardiac arrhythmias Uncontrolled hypertension, defined as sustained blood pressure> 150 mm Hg. Systolic or diastolic> 100 mmHg Stroke, including transient ischemic attack (TIA), myocardial infarction, other ischemic event or thromboembolic events such as deep vein thrombosis (DVT) and pulmonary embolism) within 6 months prior to inclusion. Subjects with a later diagnosis of DVT are eligible if they are stable, asymptomatic, and have received LMWH for at least 6 weeks prior to study treatment. B) Gastrointestinal disorders (eg malabsorption syndrome or gastric outlet obstruction), including those associated with a high risk of perforation or fistula formation Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreas or bile ducts, or obstruction of the gastric outlet Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months prior to inclusion. Note: Complete healing of the intra-abdominal abscess must be confirmed before starting treatment. C) Clinically significant vomiting or hemoptysis> 0.5 teaspoons (> 2.5 ml) of red blood or another significant bleeding in history within 3 months prior to treatment. D) Interstitial lung lesions or known manifestations of the endobronchial disease. F) Lesions invading the main pulmonary blood vessels. F) Other clinically significant disorders such as An active infection requiring systemic treatment, infection with human immunodeficiency virus or disease associated with acquired immunodeficiency syndrome, or chronic infection with hepatitis B or C Serious non-healing wound / ulcer / bone fracture Moderate or severe liver failure (Child-Pugh B or C) The need for hemodialysis or peritoneal dialysis | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-90.0, Lymphadenopathy Lung Cancer Sarcoidosis Tuberculosis Age >18 years at the time of the procedure Known or suspected lung cancer based on imaging (CT and/or PET/CT) Endosonography (EBUS and/or EUS) indicated for intrathoracic lymph node assessment/sampling according to national and international guidelines: 1) enlarged (> 1 cm on its short axis at CT) and/or PET positive lymph node; and/or 2) conditions at risk for occult mediastinal metastases, such as: i) central primary tumor; ii) primary tumor > 3 cm; iii) PET negative primary tumor; iv) ipsilateral hilar metastasis (cN1 status) Inability or unwillingness to consent Compromised upper airway (i.e., concomitant head and neck cancer with upper airway obstruction; critical central airway obstruction from any cause) Contraindication for temporary interruption of the use of antiplatelet (excluded aspirin) or anticoagulant drugs ASA 4 | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 12.0-999.0, Locally Advanced Thyroid Gland Carcinoma Malignant Thyroid Gland Neoplasm Poorly Differentiated Thyroid Gland Carcinoma Recurrent Thyroid Gland Carcinoma Thyroid Gland Anaplastic Carcinoma Thyroid Gland Medullary Carcinoma Thyroid Gland Papillary Carcinoma Thyroid Gland Squamous Cell Carcinoma Patients with RET-altered thyroid cancer who present with locally advanced primary tumor, defined as T3 or T4 by imaging or invasive/bulky nodal disease, or with recurrent/residual invasive/bulky nodal disease will be enrolled in this trial, regardless of whether distant metastases are present or not At least 12 years of age on the day of signing informed consent Pathologic findings supporting the clinical impression of medullary thyroid carcinoma, papillary thyroid carcinoma, poorly differentiated thyroid carcinoma, or anaplastic thyroid carcinoma. Diagnosis of anaplastic thyroid carcinoma may consistent with or suggestive of terminology associated with: anaplastic thyroid carcinoma, undifferentiated carcinoma, squamous carcinoma; carcinoma with spindled, giant cell, or epithelial features; poorly differentiated carcinoma with pleomorphism, extensive necrosis with tumor cells present Having an activating RET gene alteration (fusion or mutation). The RET alteration result should be generated from a laboratory with Clinical Laboratory Improvement Act (CLIA), ISO/EIC, College of American Pathologists (CAP), or other similar certification that clearly denotes the presence of a RET alteration in tumor, or institutional-approved cell free DNA blood test for RET alteration Prior multikinase inhibitors (MKIs) with anti-RET activity are allowed. The specific agent(s), duration of treatment, clinical benefit, and reason for discontinuation (e.g., progressive disease [PD], drug toxicity, or intolerance) should be documented for all kinase inhibitors the patient has been exposed to At least one measurable lesion as defined by 1.1 Surgical morbidity/complexity score of 1 to 4 (moderate, severe, very severe, or unresectable) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (age >=16 years) or Lansky Performance Score (LPS) >= 40% (age <16 years) with no sudden deterioration 2 weeks prior to study registration Absolute neutrophil count (ANC) >= 1500/uL Hemoglobin >= 9 g/dL (5.58 mmol/L) An additional validated oncogenic driver that could cause resistance to selpercatinib treatment (if known) Prior treatment with a selective RET inhibitor(s) (pralsetinib [BLU-667], including investigational selective RET inhibitor[s]) Investigational agent or anticancer therapy (including chemotherapy, biologic therapy, or immunotherapy) within 5 half-lives or 3 weeks (whichever is shorter) prior to planned start of selpercatinib Exception: Patients with ATC No concurrent investigational anti-cancer therapy is permitted Major surgery (excluding placement of vascular access and diagnostic procedures) within 4 weeks prior to planned start of selpercatinib Exception: Patients with ATC Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation, which must be completed at least 4 weeks prior to the first dose of study treatment Any unresolved toxicities from prior therapy greater than Common Terminology for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum therapy related neuropathy Symptomatic primary central nervous system (CNS) tumor, metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 12.0-999.0, Thyroid Cancer Must have histologically confirmed unresectable locally advanced or metastatic MTC and be a candidate for systemic therapy with SOC MKI Must have received no prior systemic anticancer treatment with MKI therapies for advanced or metastatic MTC Must have radiologically confirmed progressive disease within the last 14 months and at least one of the following: [1] A MTC-associated symptom and [2] CLN (Calcitonin) and CEA (carcinoembryonic antigen) level doubling time of less than 24 months Confirmed RET mutation Must be able to swallow an oral medication Must have an ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2 For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use appropriate contraception during the treatment period and for the respective period of time after final dose of study drug For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use appropriate contraception during the treatment period and for the respective period of time after final dose of study drug and to refrain from donating sperm Participants who are pregnant or breastfeeding, or intending to become pregnant during the study within 14 days after the final dose of pralsetinib or within 4 months after the final dose of vandetanib or cabozantinib Have disease that is suitable for surgery or radiotherapy administered with curative intent Have been previously treated with any systemic kinase inhibitor therapy regimens, including a selective RET inhibitor, given for recurrent and/or metastatic disease Have received any radiation therapy within 14 days prior to Day 1 of Cycle 1 and any related toxicity must be resolved to Grade 1 or better Participant's tumor has any additional known primary driver alterations other than RET Have known hypersensitivity to pralsetinib, vandetanib, or cabozantinib, or any of their ingredients Have a history of pneumonitis within the last 12 months Have ongoing treatment with chronic immunosuppressants or systemic steroids >10 mg/day Have any history of hereditary bleeding disorder or any evidence of hematemesis Have had major surgery or invasive dental procedure within 3 weeks prior to Day 1 of Cycle 1 | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 0.0-999.0, ICD ICD Malfunction S/P S-ICD Implantation n/a | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-80.0, Thyroid Diseases Surgery Patients needing surgery for: Benign or indeterminate nodule less than 6 cm in size or; T1 well differentiated papillary carcinoma less than 2 cm in size or; Well-controlled Grave's disease or; Parathyroid adenoma Total thyroid size is 7-8 cm (no more than 10 cm) Their age is ≥18 years and ≤80 years Able to give written consent History of neck surgery or neck radiotherapy Recurrent thyroid disease Lymph node metastases Presence of intraoral infections Presence of extrathyroidal or substernal extensions Smoking Morbid obesity Contra-indication to general anesthesia with nasotracheal intubation Previous mediastinal surgery Any anatomical anomaly that in the opinion of the investigator may render the intervention more difficult (ex. variations in the structure of the platysmas muscle) | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 20.0-70.0, Thyroid Nodule Thyroid Cancer Voice Disorders Patients undergoing open thyroidectomy for thyroid cancer Patients whose tumor size is less than 4cm Patients who are not suspected of surrounding organ involvement (T4) or metastasis to central lymph nodes in preoperative imaging Patients with no history of voice-related diseases prior to surgery Patients with normal movement of both vocal cords in the preoperative vocal cord examination Patients who consented to the study and obtained consent for the study Patients with uncontrolled high blood pressure, diabetes, chronic renal failure, coagulation disease, etc History of cardiovascular disease (angina pectoris, heart failure, myocardial infarction, cerebral infarction, cerebral hemorrhage, etc.) Medical history of drug or substance disorder (alcohol, etc.) Patients with diseases related to airways, esophagus, and vocal cords (vocal palsy, vocal cord polyps, etc.) Patients who have already had adhesions in the foreground due to radiation therapy or surgery on the foreground in the past Patients with a history of keloid or hypertrophic scars Patients planning to perform lateral cervical lymph node dissection Patients with medical thyroid disease, such as Graves' disease and thyroid inflammation in need of treatment Pregnant or lactating female patients Other patients who are in charge of clinical trials as unsuitable for participation in the study | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Aortic Valve Insufficiency Mitral Valve Insufficiency years of age. Patients with severe aortic regurgitation and patients with severe mitral regurgitation. Patients will discontinue medications 48 hours prior to the study. Women must not be pregnant. Patients must not have an associated valvular heart disease (i.e., patients with aortic regurgitation will be excluded if there is coexistent mitral valve disease; patients with mitral regurgitation will be excluded if there is coexistent aortic valve disease). Patients must not have any form of cardiomyopathy. Patients must not have coronary artery disease. Patients must not have ventricular ectopy during baseline conditions (i.e., couplets, frequent PVc's [greater than 6/min], early coupling ["R-on-T" phenomenon], ventricular bigeminy) that might potentially predispose the patient for the development of dangerous dysrhythmia during dobutamine infusion. Patients must not have a history of cardiac arrest or ventricular tachycardia. Patients must not have a history of congestive heart failure. Patients must not have hypotension (i.e., systolic blood pressure less than 100 mmHg). Patients must not have a systolic blood pressure greater than 200 mmHg. Patients must not have a left atrial size of greater than 100 mm. Patients must not have atrial fibrillation. Patients must not have sinus tachycardia greater than or equal to 100 beats/min. Patients must not have esophageal disease. Patients must not have any other medical condition that , at the discretion of the physician in charge, may increase the risk of the procedure | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Connective Tissue Disease Dissecting Aneurysm Ehlers Danlos Syndrome Marfan Syndrome Nail Patella Syndrome Individuals and their family members will be offered enrollment if they have a suspected or established diagnosis of Marfan, Stickler, Ehlers-Danlos, or a closely related syndrome. Personal or family history of one or more of the following features in a pattern suggestive of a heritable connective tissue disorder: Marfanoid body habitus; Aortic dilatation and/or dissection; Ectopia lentis, detached retina, vitreous degeneration and/or early onset high myopia; Posterior cleft palate; joint laxity and/or dislocation; Premature osteoarthritis; Skin fragility, striae, easy bruisability and/or hyperextensibility; Pectus excavatum or carinatum; Scoliosis, spondylolisthesis, and/or dural ectasia; High frequency sensorineural hearing loss Inability to provide informed consent | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 21.0-999.0, Heart Valve Diseases Patients a) 21 years old or older, with b) MR observed with color flow imaging, c) due to organic mitral valve disease demonstrated by Echocardiography (not normal valve as in functional or ischemic MR), c) isolated (no valve disease other than functional tricuspid regurgitation by Doppler-Echocardiography), d) pure (no mitral stenosis by Doppler-Echocardiography), e) quantifiable by Doppler-Echocardiography, f) of degree * moderate, defined as RVol * 30 mL/beat, g) occurring on native valves, h) with echocardiographic imaging allowing assessment of LA and LV, and i) asymptomatic (or mildly symptomatic but not considered as candidates for immediate surgery by their attending physician) | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Heart Septal Defects, Ventricular Aortic Valve Insufficiency ventricular septal defect patients receiving total repair from Jan, 1987 to Dec, 2002 follow up more than 1 year after operation complex cardiac lesions | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Valve Insufficiency Mitral Valve Regurgitation Mitral Valve Incompetence Mitral Regurgitation Mitral Insufficiency Key Inclusion/ Patients with Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR) based on American Society of Echocardiography guidelines Are 18 years or older Symptomatic If asymptomatic, must have new onset of atrial fibrillation, pulmonary hypertension, or evidence of left ventricular dysfunction Are candidates for mitral valve surgery Are candidates for transseptal catheterization Primary regurgitant jet must originate from malcoaptation of the A2 and P2 scallops of the mitral valve Appropriate valve anatomy for MitraClip Does not need other cardiac surgery or any emergency surgery Did not experience myocardial infarction in prior 12 weeks or endovascular procedure in prior 30 days | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Valve Insufficiency Mitral Valve Regurgitation Mitral Valve Incompetence Mitral Regurgitation Mitral Insufficiency Have moderate to severe mitral regurgitation, symptomatic or asymptomatic with evidence of left ventricular dysfunction Experience regurgitation origination from the central two-thirds of the valve Qualify as a candidate for mitral valve surgery including cardiopulmonary bypass Ejection fraction < 30% Endocarditis Rheumatic heart disease Renal insufficiency | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-72.0, Liver Cirrhosis Liver Transplant Disorder Male and female patients between 18 and 72 years of age Male or female patients who are primary cadaveric liver transplant recipients Cold ischemia time must be <20 hours Females capable of becoming pregnant must have a negative pregnancy test at baseline and are required to practice an approved method of birth control for the duration of the study and for a period of three months following discontinuation of study medication Patient has given written informed consent to participate in the study Patients meeting any of the following at baseline will be excluded from study participation Patients who have previously received an organ transplant Patients who are recipients of a multiple organ transplants Women of childbearing potential not using the contraception method(s) specified in this study, as well as women who are breastfeeding Known sensitivity to Simulect or class of Simulect Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study Use of any other investigational agent in the last 30 days | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Cystoid Macular Edema Adults (ages 18 years or older) with diabetes mellitus Best corrected visual acuity worse than 20/40 but no worse than 20/800 in the study eye Best corrected visual acuity better than or equal to 20/800 in the fellow eye DME in the study eye (eye scheduled to undergo cataract surgery) as documented on OCT as a center point thickness of at least 250 microns no more than 3 weeks prior to cataract surgery No prior laser photocoagulation in the study eye for at least 4 months prior to cataract surgery Women of child-bearing potential who are interested in participating in this study will use two effective forms of contraception prior to initiation of pegaptanib and then throughout the remainder of the study. For women of childbearing potential, results from a urine pregnancy test will be obtained prior to each injection with pegaptanib. Urine samples will be disposed of after the test is performed History of intravitreal steroid (triamcinolone) injection into the study eye within 4 months prior to cataract surgery Macular edema due to non-diabetic etiologies such as vein occlusion Retinal diseases that preclude evaluation of the macula for edema (e.g., macular hole) Media opacity will not be an criterion provided that the investigator can assess the presence or absence of DME on OCT | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 21.0-80.0, Postoperative Pain Age 21-80 year old ASA Physical Status ASA I and II Mentally competent Intellectually competent Body mass index <35 No severe cardiac diseases No severe pulmonary diseases Unilateral knee disease No other lower extremity joint disease No chronic narcotic therapy or illicit drug use Age <21 or >80 year old ASA Physical Status >ASA II Mentally incompetent Intellectually incompetent or cognitively impaired Non-English speaking patient Worker's compensation patient Body mass index > 35 Bilateral knee disease Has other lower extremity joint disease Severe cardiac diseases | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Polycystic Ovary Syndrome Probands who meet the following will be enrolled: Menses < 6 per year without confounding meds Not taking confounding medications at the time of hormone analysis, willing to be off confounding medications for required washout period, or able to provide documentation of hyperandrogenemia (without hyperprolactinemia or evidence of non-classical adrenal hyperplasia) with past laboratory tests during a time when not taking confounding medications Total Testosterone >58 ng/dl or bioavailable testosterone >15 ng/dl Prolactin <25 ng/ml Baseline 17-OHP <3 ng/ml (and stimulated 17-OHP <10 ng/ml if subject is studied on-site) Control women who meet the following will be enrolled: History of completely regular menstrual cycles. No history of hirsutism or alopecia. Control women will have a blood sample obtained 3-6 months after they have stopped lactating and resumed regular menses to ensure that they have normal T, uT and DHEAS levels. Any pregnant woman who develops gestational diabetes will be excluded from the analysis. To disorders associated with insulin resistance, control subjects will have no personal history of hypertension or hypertriglyceridemia and no first-degree relative with Type 2 DM history of gestational diabetes mellitus, eclampsia, pre-eclampsia or any medical disorders complicating their pregnancies | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-65.0, Systemic Lupus Erythematosus Eligible women will be those having any two of the following 1. Amenorrhea of 6 months or more. 2. Serum follicle-stimulating hormone level of 30 IU/L or more. 3. Menopausal symptoms. 4. Age 48 years or older Women older than 65 years. 2. Severe lupus activity at baseline (SLEDAI score, more than 30). 3. Use of estrogens within 3 months of the screening visit. 4. Serum creatinine of 2.0 mg/dL or more. 5. Hypertriglyceridemia 500 mg/dL or more. 6. Metabolic bone diseases. 7. Liver disease. 8. Untreated hyperthyroidism. 9. Recent thrombosis. 10. Malignancy. 11. Endometrial hyperplasia. 12. Undiagnosed uterine bleeding or cervical dysplasia | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Mitral Regurgitation Coronary Artery Disease Patients undergoing CABG. 2. Patients with moderate functional ischaemic mitral regurgitation without leaflet prolapse Patients with severe LV dysfunction (EF less than 30%). 2. Patients with associated significant aortic valve disease. 3. Patients with significant co-morbidities: renal impairment (creatinine > 160), liver impairment (INR > 2.0, bilirubin > 40), or underlying chronic obstructive lung disease (FEV1:FVC ratio < 0.6). 4. Patients with NYHA class IV symptoms, unstable angina, acute pulmonary oedema or cardiogenic shock. 5. Patients unsuitable for surgery e.g. patients with advanced malignancy, unable to give informed consent. 6. Patients with structural abnormalities of the mitral valve e.g. papillary muscle rupture, chordal rupture, etc. 7. Patients with associated conditions which would significantly increase the risk of surgery. 8. Patients who have had previous cardiac surgery. 9. Patients with a previous history of endocarditis | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Valve Regurgitation Congestive Heart Failure Cardiomyopathy Patients would be at least 18 years old They will have history of congestive heart failure and be in New York Heart Association Class III or IV Their left ventricular ejection fraction will be less or equal to 30% They will have moderate or severe mitral regurgitation as determined by echocardiogram. Echocardiogram's for severe mitral regurgitation will be regurgitant volume greater than 50 ml regurgitant fraction greater than 50% and effective regurgitant orifice greater than 40 mm2. If the quantitative are not available, severity of the MR will be graded qualitative in grades I, II, III, and IV. Patients with mitral regurgitation in grade III and IV will be eligible to be included in the study Cancer Metastatic or any cancer within five years except patients with non melanoma skin cancer Recent stroke (less than six months) Severe COPD (patients with an FEV1 less than .8 liters) Patients on inotropic infusion preoperatively Patients in atrial fibrillation Pregnant patients Patients with any other valvular disease that required surgical intervention except tricuspid valve disease Patients that will require surgical ventricular restoration | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers Subjects with diagnosed descending thoracic aortic aneurysms or penetrating atherosclerotic ulcers Subjects who are at least 18 years of age Subjects whose anatomy can accommodate the Relay device Subjects who consent to participate Subjects who agree to comply with follow-up schedule Subjects with non-aneurysm lesions Subjects with less than 1 year life expectancy Subjects who are pregnant Subjects with medical conditions that would complicate the endovascular procedure or confound the results (e.g., Marfan's Syndrome, prior repair in the thoracic aorta, severe coronary artery disease, morbid obesity, etc.) Subjects participating in another investigational study | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 40.0-75.0, Diabetes Mellitus Hypertension Men or women of any racial background Age >= 40 years and <= 75 years SBP>= 130 mmHg and < 140 mmHg or DBP >= 85 mmHg and < 90 mmHg, average of screening and randomisation visits (in absence of any antihypertensive medication) FG >=100 mg/dl (5.6 mmol/l) and < 126 mg/dl (7.0 mmol/l) between screening and randomisation (in absence of any antidiabetic medication) Waist circumference >= 102 cm in men and >= 88 cm in women SBP >= 140 mmHg or DBP >= 90 mmHg Any antihypertensive, antidiabetic or antiobesity medication at the time of or during the 6 months previous to randomisation Any current or previous cardiovascular or renal disease requiring continuous administration of Ds, ßBs, ACEIs, ARBs, CAs, and any other antihypertensive medication Any medical condition preventing adherence to lifestyle measures included in the protocol Hepatic disease as AST (SGOT) or ALT (SGPT) values equal or greater than two times the upper limit of normal Chronic renal dysfunction as serum creatinine > 2.0 mg/dl Any gastrointestinal disorder interfering with drug absorption Known allergy or contraindications to ACEIs or ARBs Pregnant or lactating women; women in reproductive age not using recognized contraceptive methods Malignancy within the last 5 years | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 21.0-80.0, Mitral Valve Insufficiency Dilated Cardiomyopathy Congestive Heart Failure Patients that fulfill surgical set by the 2006 ACC/AHA guidelines for the management of patients with valvular heart disease Symptomatic mitral regurgitation with left ventricular dysfunction (LVEF < or = 40%) on maximal medical therapy Mitral valve replacement Concomitant coronary artery bypass surgery Patient unable to give informed consent | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-40.0, Marfan Syndrome Age 18-40 Diagnosis of Marfan Syndrome, on the basis of the Ghent Age <18, >40 Women of child-bearing potential not on adequate contraception Serum creatinine of >0.11 A history of intolerance to ACEI Patients on angiotensin receptor blockers Blood pressure >140/90mmHg History of previous aortic surgery | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Regurgitation Patients with severe isolated mitral regurgitation due to valvular disease Missing written patient consent Active infective endocarditis Relative mitral regurgitation due to left ventricular disease Other moderate to severe dysfunctional valve Previous cardiac surgery Pregnancy Sepsis | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Non-union Diaphysary Tibial Fractures Diaphysary tibial non-unions will be included (9 months after first surgery) Major surgery includes exchange nailing, bone grafting, internal fixation, amputation and soft-tissue coverage procedures, such as delayed primary closure and free flaps Surgery is classified as minor for removal of external fixator pins for local infection and removal of a static locking screw from intramedullary nails, a procedure known as dynamization ASA 1 and ASA 2 Gap length/bone contact detected (1-5 cm): largest cortical gap in any radiographic incidence Subject or legal guardian is willing and able to understand, sign and date the study specific Patient Informed Consent, which has been approved by the Institutional Review Board Agrees to participate in post-operative evaluations and required rehabilitation regimen Patients with known hypersensitivity to the active substance or collagen Gap more than 5 cm Immature skeleton Known auto-immune disease, including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome and dermatomyositis/polymyositis Active infection on unhealed site or active systemic infection Non-healing resulting from pathological fractures, tumours or metabolic bone diseases Presence of tumour in vicinity of non-union Patients receiving chemotherapy, radiotherapy or immunosuppressant treatment or excessive steroids Patients with severely compromised soft tissue coverage or vascularisation at the non-union site, sufficient to impair bone healing Patients with congenital non-union | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Atrial Fibrillation Indication for open-heart surgery: Mitral valve repair or replacement, evidence of a dilated left atrium History of Atrial Fibrillation Need for emergent cardiac surgery Previous cardiac surgery Preoperative need for an intraaortic balloon pump or intravenous inotropes Current diagnosis of active endocarditis Mental impairment/or experience other conditions which may not allow subject to understand nature Significance and scope of study Pregnancy | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Valve Insufficiency Heart Failure Symptomatic chronic heart failure, New York Heart Association (NYHA) class II to IIIb Left ventricular ejection fraction of 0.35 due to non-ischemic etiology Evidence by transthoracic echocardiography (TTE) of moderate or severe MR without obvious primary mitral valve pathology Peak VO2 less than or equal to 22 ml/kg/min, as obtained at study entry Optimal heart failure therapy for at least 6 months prior to study entry Significant coronary artery disease (greater than 75% lesion in any vessel) by coronary angiography or by a history of a prior heart attack Heart failure due to active myocarditis, congenital heart disease, or obstructive hypertrophic cardiomyopathy Significant ventricular arrhythmias not treated with an implantable defibrillator Primary MR due to significant chordal or leaflet abnormalities by TTE Other hemodynamically relevant stenotic or regurgitant valvular diseases Severe tricuspid regurgitation (TR) (moderate TR is allowed) Severe pulmonic regurgitation (PR) (moderate PR is allowed) Moderate to severe aortic regurgitation Any moderate to severe stenotic lesions using American Heart Association/American College of Cardiology (AHA/ACC) 31 Dependence on chronic inotropic therapy | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Moderate Mitral Regurgitation Patients with ischemic heart disease, who fulfil the indications for CABG, and who also have a moderate ischemic MR. Ischemic MR is defined as mitral regurgitation due to coronary artery disease and not fortuitously associated with it. It is caused either by a mitral annular dilatation (Carpentier type I), or a restrictive motion of the posterior mitral leaflet (Carpentier type IIIb), or a combination of these. The mitral leaflets should be slender and without signs of intrinsic organic disease. The mitral annulus should be with no significant calcification that can be held responsible for valve insufficiency. The severity of mitral regurgitation is quantified by means of echoardiography using the Proximal Isovelocity Surface Area (PISA)-method. Moderate MR is defined as a calculated ERO of 15-30 mm2 at rest . Hence, patients referred for CABG and showing signs of mitral regurgitation on auscultation, by echocardiography, or by ventriculography will further be evaluated by a thorough echocardiography (Transthoracic (TTE) in ambiguous cases supplemented by transesophageal echocardiography (TEE) before surgery, in order to determine whether the patient fulfil the criteria. In addition, ejection fraction (visually estimated), left atrial dimension, mitral annular and tricuspid annular size, as well as estimates of pulmonary hypertension will be recorded Age ≥ 18 yrs The is independent of the left ventricular function The is independent of the left atrial size It is mandatory that the patient is able to fully understand the written information, the purpose of the study, and able to give an informed consent Patients with previous cardiac surgery Emergency surgery Malignant disease with an expected survival of less than 5 years ST-elevation myocardial infarction within 16 days Significant aortic valve disease necessitating aortic valve replacement Calcification of the ascending aorta Significant mitral annular calcification Type II MR (ruptured papillary muscle, or infracted elongated papillary muscle with prolapse) Refusal to participate in the study | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-80.0, Heart Valve Diseases Patients > 18 years with a clinical condition of mitral valve prosthesis Evidence of prosthesis valve dysfunction (dehisence, endocarditis or thrombus of prosthetic mitral valve) Concomitant aortic valve prosthesis and tricuspid valve prosthesis Presence of > +2 aortic valve regurgitation and/or mild aortic stenosis Prosthetic mitral valve replacement operation < 6 months Left ventricular ejection fraction < 50% Chronic obstructive pulmonary disease Concomitant hypertrophic cardiomyopathy, atrial septal defect Patients with poor ehocardiographic window | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 1.0-999.0, Marfan Syndrome Marfan syndrome with recognized aortic root dilation Patients must be older than one year of age Beta-blocker treatment at least three months Must sign an informed consent form Prior to aortic root surgery Aortic root dimension more than 5.5cm Aortic surgery within 6 months Diabetes mellitus or liver and renal dysfunction or asthma Pregnancy Intolerance to Losartan therapy | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 20.0-65.0, Mitral Valve Stenosis rheumatic mitral valve stenosis Degenerative mitral valve disease EF<50% atrial fibrillation inconclusive planimetric assessment moderate or severe mitral regurgitation moderate or severe aortic regurgitation history of previous mitral valve commissurotomy or balloon valvotomy | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-55.0, Cholera Age: 15 years Gender: Male (women would be excluded due to difficulties in separation of their urine from stools, particularly in those with severely dehydrated and associated mental obtundation) Duration of diarrhoea: 24 hours or less Clinical signs and symptoms of severe dehydration Demonstration of V. cholerae in dark-field microscopy of a fresh stool specimen Written informed consent for participation in the study (for patients with temporary inability to provide consent due to their severe dehydration and mental obtundation, initial consent would be obtained from their attendants; however, the consent process would be re-applied to the patients when they are fully oriented) Chronic or iatrogenic diarrhoea Dysentery (presence of visible blood in stool) History of receiving antimicrobial or antidiarrhoeal drugs prior to admission Presence of concomitant infection or underlying disease, which might complicate diagnosis and/or assessment of response to study interventions History of renal or hepatic dysfunction Failure to obtain informed consent | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 1.0-55.0, Marfan Syndrome Diagnosis of MFS: Ghent and genetically proven defect of the FBN1 gene Age: 12 months to 55 years BSA-adjusted aortic z score = or >2 measured at the level of the sinuses of Valsalva at baseline according to Roman's method, or absolute aortic root diameter >38mm for females and >40 mm for males Prior aortic surgery and/or dissection Aortic root diameter at the level of the sinuses of Valsalva 5 cm Planned aortic surgery within 6 months of enrollment for a rate of ARD progression>5 mm/year even in pts with ARD less than 5 cm Clinical or molecular diagnosis of non-MFS connective tissue diseases sharing some features with MFS (Shprintzen-Goldberg syndrome or Loeys-Dietz syndromes) Un-renounceable therapeutic (systemic hypertension, arrhythmia, ventricular dysfunction, valve regurgitation) use of drugs such as ACE inhibitors, BBs, or calcium-channel blockers Known side-effects while taking an ARB or a BB Intolerance to ARB that resulted in termination of therapy Intolerance to BB that resulted in termination of therapy Renal dysfunction (creatinine level more than upper limit of age-related normal values) Diabetes mellitus | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-42.0, Gestational Diabetes Mellitus 42 years of age at 20-30 weeks of gestation Caucasian or African-American and non-users of medications known to influence carbohydrate metabolism <18 years or >42 years of age non-Caucasian or non-African-American ethnicity use of drugs that could interfere with glucose or insulin metabolism; or health problems such as diabetes mellitus or liver, heart, lung and kidney diseases | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Cardiovascular Disease Mitral Valve Repair Cerebral Microemboli Cognitive Decline provide informed consent male or female who are 18 years of age or older elective patients to undergo mitral valve repair +/ coronary artery bypass surgery ability to read and write patients with a history of stroke, TIA, carotid vascular disease patients with a contraindication to TEE or MRI patients with an active history of drug/alcohol dependence or abuse history | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 25.0-999.0, Marfan Syndrome Age greater than 25 years Clinical Marfan Syndrome Previous aortic or cardiac surgery Pregnancy Renal Insufficiency Medication intolerance | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-50.0, Pregnancy Heart Diseases Potential subjects for the cardiac disease in pregnancy cohort: 1. At least 18 years of age 2. Cardiac disease as per Clark's Maternal Mortality Associated with Pregnancy: Group 1 (mortality less than 1%) atrial septal defect, ventricular septal defect, patent ductus arteriosus, pulmonic or tricuspid valve disease, corrected tetrology of Fallot, bioprosthetic valve, mitral stenosis with NYHA class I and II functional status Group 2 (mortality 5-15%) mitral stenosis with NYHA class III and IV functional status, aortic stenosis, coarctation of aorta without valvular involvement, uncorrected tetrology of Fallot, previous myocardial infarction, Marfan syndrome with normal aorta, mitral stenosis with atrial fibrillation, artificial valve Group 3 (mortality 25-50%) pulmonary hypertension, coarctation of aorta with valvular involvement, Marfan syndrome with aortic involvement (7) 3. Other significant cardiac disease not listed above 4. Other medical disorders, such as diabetes mellitus, chronic hypertension, asthma, other endocrine disorders, et cetera, will be acceptable 5. Diagnosis of a least a single intrauterine pregnancy, multiple gestation acceptable Potential subjects for pregnancy without cardiac disease cohort: 1. At least 18 years of age 2. Absence of significant cardiac disease, minor cardiac disorders such as mitral valve prolapse without arrythmia 3. Other medical disorders, not directly related to cardiac disease, such as diabetes mellitus, chronic hypertension, asthma, other endocrine disorders et cetera, will be acceptable 4. Diagnosis of at least a single intrauterine pregnancy, multiple gestation acceptable Less than 18 years of age 2. Non-viable pregnancy such as a threatened spontaneous miscarriage, or ectopic pregnancy 3. Planned termination of pregnancy, either elective or medically indicated based on history 4. Inability to complete informed consent process or participate in the study protocol | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 10.0-999.0, Marfan Syndrome years or older Marfan syndrome according to international Signed informed consent Previous surgery of the ascending aorta, or surgery planned Non echogenicity Contre-indication lactose Pregnancy on going or planned within 3 years Breast feeding Participation in another clinical study Non member of the social security or CMU | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 10.0-999.0, Marfan Syndrome Patients > 10 years Diagnosis of MFS, according to the Ghent and/or genetically proven FBN1 mutations or linkage Consent obtained (written) either for the patient and for his/her parents (<18y Z-score of the aorta at the level of the sinus of Valsalva ≥2 (BSA adjusted) ARB naïve patients Poor echocardiographic window,limiting the accurate measurement of the aortic root Contra-indication for ARB: Bilateral renal artery stenosis, renal function abnormalities (creatinine above normal for age), hyperkalemia Intolerance for ARB (eg angioedema) Pregnancy or breast feeding women Absence of effective contraception Liver function abnormalities Heart Failure Patients included in other clinical trial | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Valve Prolapse for MVP patients Male or female subject ≥18 years Affiliation to the French social insurance system Written informed consent Idiopathic MVP defined by the presence of 1) and 2) OR of criterion 3) : 1. Echographic MVP > 2 mm on the left ventricular parasternal long-axis view 2. Echographic myxomatous valve (thickness > 4 mm) or significant mitral regurgitation (> 2 + using color Doppler) 3. History of mitral valve surgery for pure mitral regurgitation due to MVP (myxomatous or fibroelastic deficiency) with available detailed operative report Presence of heart disease causing MVP (rheumatic, HCM…) Syndromic disease (Marfan, Ehlers-Danlos…) for healthy subject Male or female subject ≥40 years Absence of MVP or absence of mitral valve dystrophy Caucasian | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Valve Insufficiency Coronary Artery Disease Chronic severe ischemic mitral regurgitation (often with tethering as a major mechanism) in the judgment of the clinical site echocardiographer, assessed by transthoracic echocardiogram. Assessment of mitral regurgitation will be performed using an integrative method (Zoghbi W. et al. J. American Society of Echocardiography. 2003:16:777-802. see appendix). Quantitative guidelines as proposed would be: ERO ≥ 0.4 cmsq. If ERO < 0.4, then the degree of mitral regurgitation will be guided by other color Doppler quantitative methods (jet area/left atrial area ratio, vena contracta, supportive in an integrated fashion Eligible for surgical repair and replacement of mitral valve CAD with or without the need for coronary revascularization Any evidence of structural (chordal or leaflet) mitral valve disease or ruptured papillary muscle Prior mitral valve repair Severe irreversible pulmonary hypertension in the judgment of the investigator Medically unable to undergo cardiopulmonary bypass (CPB) Inability to derive ERO and end-systolic volume index (ESVI) by transthoracic echocardiography Planned concomitant intra-operative procedures (with the exception of tricuspid valve repair, closure of patent foramen ovale [PFO] or atrial septal defect [ASD] or Maze procedure) Clinical signs of cardiogenic shock at the time of surgery Treatment with long-term intravenous inotropic therapy at the time of surgery ST segment elevation myocardial infarction (MI) requiring intervention in the 7 days before surgery Congenital heart disease (except PFO or ASD) | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-40.0, Pregnancy Fetal Growth Singleton, viable pregnancy plus 0 plus 6 weeks of gestation Maternal age 18 years BMI 19.0 -29.9kg/m(2) for low risk group; BMI 30.0 0kg/m(2) for obese group Firm LMP LMP-date and ultrasound date match within 5 days for gestation estimates between 8 weeks + 0 days and 10 weeks + 6 days, 6 days for those between 11 weeks + 0 days and 12 weeks + 6 days, and 7 days for estimates between 13 weeks + 0 days and 13 weeks + 6 days No confirmed or suspected fetal congenital structural or chromosomal anomalies Smoked cigarettes or used illicit drugs in the six months Used illicit drugs in the past year Having at least 1 alcoholic drink per day Conception by ovulation stimulation drugs or assisted reproductive technology Chronic hypertension or renal disease under medical supervision Asthma requiring weekly medication Diabetes mellitus Thyroid disease under medical supervision Autoimmune disorder (rheumatoid arthritis, lupus, antiphospholipid antibody syndrome,scleroderma) Hematologic disorders (chronic anemia, sickle cell disease thrombocytopenia coagulation defects, thrombophilia) | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-75.0, Aortic Regurgitation Severe aortic regurgitation Successful valve replacement Informed consent Sinus rhythm No comorbidities No bundle branch block No pregnancy Unwillingness to undergo postop. cath diabetes mellitus arterial hypertension bleeding disorder pulmonary hypertension | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-65.0, Cartilage Lesion to the Femoral Condyle Males or females 18 and 65 years of age. 2. Not more than two treatable symptomatic lesions which are NOT posterior; patient must present with pain in the index knee of moderate or severe level (VAS score ≥5) 3. If Female: Actively practicing a contraception method, or Practicing abstinence, or Surgically sterilized, or Postmenopausal 4. Understands and voluntarily signs and dates an informed consent document. 5. Grade 3 or 4 acute (traumatic) or chronic (degenerative) lesion 6. Willingness to follow standardized rehabilitation procedures. 7. Willingness and ability to comply with the requirements of this protocol, including returning for evaluation (clinical and imaging) at periodic intervals post-treatment. 8. Study knee has intact ligaments 9. Ipsilateral knee compartment has intact menisci (or requires partial meniscectomy resulting in stable menisci) 10. Contralateral knee is asymptomatic, stable and fully functional. 11. MRI obtained preoperatively within 3 months of Surgery Intraoperative Arthroscopic Confirmation: 12. one or two symptomatic lesions of the femur rated as ICRS III, or IVA with less than 6 mm of bone loss below the subchondral plate 13. Individual defect size between 1 cm2 cm2 after arthroscopic debridement More than two symptomatic lesions 2. Untreatable Posterior lesions 3. Lesion greater than 6cm2 4. ICRS Grade larger than grade II on a surface that directly opposes the defect 5. Osteoarthritis or avascular necrosis (clinical and/or radiographic diagnosis) 6. History of autoimmune disease or inflammatory arthropathy, such as rheumatoid arthritis, systemic lupus, active gout, septic or reactive arthritis including any history of a positive ANA blood test. 7. History of chronic debilitating systemic disease and any other unstable cardiac and pulmonary disorders. 8. History of current or prior malignancy within the last 5 years. 9. Patients treated in the affected knee with microfracture in the last 12m months or had prior tendon repair, meniscus repair, ligament repair or realignment surgery in the last 6 months. 10. Patient with prior total or subtotal meniscectomy. 11. Body Mass Index (BMI) >32 Kg/m2 12. 'Patients with known HIV, Hepatitis A, B, or C infections or other immunodeficient state. 13. Patients requiring immunosuppressive medications. 14. Clinically significant organic disease including clinically significant cardiovascular, pulmonary, neurologic, hepatic or renal disease or other medical condition, serious concurrent illness or extenuating circumstance that, in the opinion of the investigator, make the subject a poor candidate for participation in the study. 15. Patients received any other investigational products within 6 months prior to study enrollment. 17.Taking specific OA drugs such as chondroitin sulfate, diacerein, n-glucosamine, piascledine, capsaicin within 2 weeks of the screening 18.Is receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee condition, chronic use of anticoagulant, or taking corticosteroids 19.Uncontrolled diabetes 20.Any concomitant painful or disabling disease of the spine, hips or lower limbs that would interfere with evaluation of the afflicted knee 21.Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities 22.Any evidence of the following diseases in the target joint : septic arthritis, inflammatory joint disease, gout, recurrent episodes of pseudogout, Paget's disease of bone, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders, collagen gene mutation 23.Current diagnosis of osteomyelitis 24.Liver enzymes (SGOT, SGPT, Alkaline Phosphatase) of more than two times the upper limit of normal or any other result that is clinically important according to the Investigator 25.CRP > 10 mg/l 26.Clinically significant abnormal finding on screening laboratory parameters. 27.Clinically relevant compartment malalignment (> 5 degrees) as measured from the mechanical axis verified by clinical assessment or radiographic imaging when required 28.Patients with a history of bleeding disorders, patients receiving anti-platelet therapy or other anticoagulant medication use within 10 days prior to the beginning of the study, or patients in whom antiplatelet or other anticoagulant medication use is anticipated during the course of the study. However, patients on low-dose aspirin may be included in the study if aspirin therapy is interrupted at least 10 days before the treatment and not resumed until at least 2 weeks after the treatment | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-45.0, Gestational Diabetes Mellitus Age > 18 yrs Gestational age between 6 and 13 weeks from last menstrual period Alcohol < 2 drinks/day Not involved in regular high intensity physical activity Singleton pregnancy Otherwise good health status Type 1 or type 2 diabetes Taking drugs interfering with glucose metabolism | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-65.0, Metabolic Syndrome Insulin Resistance Adipokines Cytokines for part A: Patients who are included in the obesity surgery program will be recruited if they fulfill the following Age between 18 and 65 years Body mass index (BMI) >40 kg/m2 or BMI > 35 kg/m2 with co-morbidity related to obesity. for part B: In the treatment response study we will patients diagnosed at the baseline polysomnography with severe OSA (AHI >= 30) who fulfill the for part A and who do not present specific for part B. General (for part A) Prior treatment with CPAP Severe or unstable cardiovascular disease (severe or surgically treated valvulopathy, myocardial infarction, unstable angina, cardiac surgery) during the 6 months prior to in the study Evidence of acute or chronic inflammatory illness different to obesity itself (connective tissue disease, active neoplasia) or associated infectious process during the 6 weeks prior to in the study Severe cognitive or psychiatric disorder that would make it difficult to complete the clinical questionnaires Severe chronic diseases that may interfere in a significant way with the results of the study Chronic obstructive pulmonary disease defined by FEV1/FVC < 0.7 Pregnancy Alcohol abuse (daily alcohol consumption >80 g) | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 20.0-65.0, Metabolic Syndrome Age between 20 and 65 years Metabolic syndrome by IDF 2005 known diabetes obesity due to endocrinologic disorders Psychological disorder or using psychological medications Abnormal liver function (three-fold upper normal limit) Abnormal renal function (1.5-fold upper normal limit) Investigator judgement for abnormal clinical data Life-threatening disease Acute infective status Alcohol or drug abuse pregnant potency without prevention | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-85.0, Mitral Valve Insufficiency Signed and dated the Patient Informed Consent (PIC) Indicated to have a surgical repair for a given degree of moderate to severe mitral valve regurgitation Willing to return to the implanting hospital for a 9 month follow-up visit Unwilling or inability to sign the PIC Already participating in another investigational device study, if this would create bias and jeopardize scientific appropriate assessment of the current study endpoints Life expectancy of less than one year Pregnant or desire to be pregnant within 12 months of the study treatment Less than 18 years and more than 85 years of age | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 3.0-999.0, Hypochondroplasia Male or female children with hypochondroplasia defined by a disproportional short limb height and a X-ray evidence of shortening of the long bones and failure of increase in the interpedicular distance between lumbar vertebrae L1 and L5 Result of genetic analysis for mutation of gene FGFR3 already known or ongoing analysis at the beginning of the study Chronological age greater than or equal to 3 years Height for chronological age less than or equal to SDS Bone age less than or equal to 11 years for girls and 13 years for boys A written informed consent at the beginning of the pre-treatment period must be obtained from the parent(s)/legal guardian(s). Children able to understand the trial should personally sign and date the written informed consent Additional for each study prolongation Bone age at Month 36 or Month 60 is compatible with treatment prolongation according to investigator opinion Subject is still under r-hGH treatment with Saizen® at Month 36 or Month 60 Height gain greater than or equal to + 1 SDS after the 2 first years of treatment for treatment prolongation at Month 36 and growth velocity greater than or equal to 5 centimeter (cm) per year, with bone age less than 14 years for females or less than 16 years for males for treatment prolongation at Month 60 Turner's Syndrome in girls Active malignant neoplastic disease Severe congenital malformations Proliferative or preproliferative diabetic retinopathy Evidence of any progression or recurrence of an underlying intra-cranial space occupying lesion Severe psychomotor retardation Diabetes mellitus or history of significant glucose intolerance as defined by a fasting blood glucose greater than 6.4 millimole per liter (mmol/L) Known renal insufficiency as defined by serum creatinine level 1.0 milligram per deciliter (mg/dL) (88 micromole per liter [mcmol/L]) Known hepatic disease as defined by elevated liver enzymes or total bilirubin (* 2 Normal) Current congestive heart failure, untreated hypertension, serious chronic edema of any cause | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 5.0-60.0, Marfan Syndrome Subjects must conform to the diagnostic Marfan syndrome according to the Ghent Criteria. 2. Outpatient subjects. 3. Male or female, aged between 5 and 60 years. 4. Women who are in a childbearing age are required a result of negative Gonadotropin pregnancy test to be included in the study. 5. Subjects must be able to take oral medication. 6. After having received information about the study, subjects must understand the nature of it and give written informed consent. 7. For Subjects under 18 years, the informed consent must be signed by their parents or guardians. 8. Subjects with a maximum diameter of the aorta, at length, <45 mm 9. Female subjects of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for four weeks prior to, during and three months after the last dose study medication. For the purposes of this study, women of childbearing potential is defined as: All female subjects after puberty unless they are post-menopausal for at least two years, or are surgically sterile. Adequate contraception is defined as two barrier methods, or one barrier method with a spermicide, or an intrauterine device or use of the oral female contraceptive (or other hormonal methods) Women who are pregnant, suspected to be pregnant or breast-feeding. 2. Ongoing participation in another clinical trial or who received the investigational drug in the month prior to the in the study. 3. Known or suspected failure to comply with the study protocol. 4. Previous surgery: cardiac or at any segment of the aorta. 5. Functional class III-IV. 6. Maximum diameter of the aorta exceeding 45 mm 7. More than moderate valvular involvement. 8. History or presence of respiratory failure, liver (ALT> 3 x ULN), renal (creatinine clearance <30 mL / min), gastrointestinal, hematological, endocrine, or any other situation that may affect the assessment of the study treatment, according to the investigator opinion. 9. History of aortic dissection. 10. History or presence of neurological disease (especially seizures, dementia ...). 11. History or presence of alcohol abuse and / or toxic substances 12. Uncontrolled depression. 13. Any need for another antihypertensive treatment (betablockers, diuretics, calcium channel blockers, ACE inhibitors, ARBs, etc.) 14. Hypersensitivity, intolerance or contraindication to any component of the study drug. 15. Patients with a history of drug abuse or toxic dependence | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 19.0-75.0, Myocardial Infarction Mitral Regurgitation Patients who have undergone PCI for first acute MI (index MI) since 7/1/09 at MMC and STJ documented moderate mitral regurgitation on follow up echocardiography six or more weeks after PCI procedure English speaking CABG after PCI for acute MI History of previous MI prior to index MI History of previous PCI or CABG prior to index PCI EF <30 % on the echocardiogram at 6 weeks after PCI for MI | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Revision Total Knee Replacement Revision knees with bone defect for which metaphyseal sleeve in femoral and/or tibial side is used 2. Cases with at least 2 year follow-up 3. Cases with regular follow-up visits completed Cemented sleeves 2. Patients with less than two year follow-up completed 3. Cases lost to follow-up | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 20.0-999.0, Stomach Ulcer patients underwent ESD for gastric adenoma or cancer subjects with previous gastric surgery subjects taking aspirin, anticoagulant, or antiplatelet agent subjects having malignancy except gastric cancer pregnant or breast-feeding women | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Mitral Valve Insufficiency Atrial Fibrillation Heart Failure Patients with severe mitral regurgitation are admitted for surgical intervention and are willing to participate in this study Presence of mitral stenosis More than mild severity of aortic valvular problem Any abnormality of atrial septum (e.g., atrial septal defect or aneurysm) Rhythm other than sinus rhythm Inadequate image quality Lack of informed consent | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Procalcitonin Coronary Artery Bypass Grafting Elective CABG + / Aortic / Mitral valve patients Off pump and on pump cases Check any box that applies: Patients with recent infection in last week and / or Antibiotics in last 1 week or pre op fever > 99.5f / 38C in 24hrs prior to surgery Patients on oral or IV corticosteroids within 1 week of being on them. Known immune dysfunction Active congestive heart failure / Recovering from cardiogenic shock\ Intra aortic balloon pump pre op No CABG patients with CRYO MAZE, or Ablation | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Aortic Valve Disease Patients > or = to 18 years of age Presenting with aortic stenosis and to undergo elective aortic valve replacement or repair with or without aortic aneurysm dilation repair Able to sign informed consent document Patients unable to provide informed consent for any reason Patients with predominant aortic regurgitation valve disease Patients with other known connective tissue disorders (such as Marfan's Syndrome, Ehlers-Danlos Syndrome) | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Pulmonary Arterial Hypertension HIV Infection Congenital Heart Defect Systemic Sclerosis Connective Tissue Disease age over 18 for PAH patients: pre-capillary PAH evidenced by right-heart catheterization no associated systemic disease for idiopathic PAH patients for HIV patients, HIV1 infection confirmed by ELISA and western blot for patients with porto pulmonary hypertension: evidence by endoscopy of esophageal varices, confirmation of hepatic venous pressure gradient over 5 mmHg by catheterization of the hepatic veins for patients with congenital heart defect: evidence by imaging of atrial or ventricular septal defect, or patent ductus arterious and confirmed by heart catheterization patients with SSc will fulfill the American College of Rheumatology (ACR) and the LEROY and patients with MCTD will fulfill the for MCTD patients with SLE will fulfill the updated and revised ACR patients with Sjögren's syndrome will fulfill the American-European consensus group age under 18 pregnant women absence of written informed consent associated malignant tumor | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Regurgitation Patient is at least 18 years of age Patients with moderate-to-severe or severe functional MR EROA > 40 mm2 and an MR/LA > 40% (severe) ≤ EROA ≤ 40 mm2 and 30 ≤ MR/LA ≤ 40% (moderate-to-severe) Baseline rates of 50-90 beats per minute (patients with sinus rhythm) or AF QRS < 120 ms LVEF < 35% Willing to sign informed consent On standard stable heart failure medical regimen (beta blockers and ACE-I or ARBs) for at least 1 month before randomization, if tolerated Patient has the ability to understand the requirements of the study, including consent for use and disclosure of research-related information candidate for CRT or has a previously implanted CRT device previously implanted implantable pulse generators (IPG) or implantable cardioverter defibrillator (ICD) with at least 10 % pacing in the right ventricle patient has life expectancy <6 months patient is pregnant significant aortic stenosis uncontrolled hypertension mitral valve stenosis severe mitral valve calcification ruptured chordae tendinae or papillary muscle mitral valve leaflet disorders (i.e. endocarditis, lupus, tumors, rheumatic heart disease) | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 21.0-67.0, Tricuspid Valve Regurgitation Significant disorders in aortic and mitral valves Moderate ～ severe tricuspid regurgitation Underwent tricuspid repair or replacement operation Isolate tricuspid valve lesion Mild tricuspid valve regurgitation Tricuspid valve regurgitation was left without surgical treatment | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Cardiac Surgery Tricuspid Valve Regurgitation All patients 18-65 + older years undergoing mitral valve surgery. 2. Presence of moderate or mild-moderate tricuspid regurgitation as read on any echocardiographic study performed within 6 months prior to operation. Assessment if tricuspid regurgitation will be performed using an integrative method. 3. All patients referred for mitral valve surgery. 4. Able to understand the consent and able to sign informal consent Patients under 18 years of age. 2. Patient with structural/ organic tricuspid valve disease. 3. Refusal/ Inability to sign informal consent form. 4. Pregnant women. 5. Tricuspid valve endocarditis. 6. Requirement for concomitant cardiac surgery (other than atrial fibrillation correction surgery, closure of PFO (Patent Foramen Ovale) or ASD (Atrial Septal Defect), or coronary artery bypass surgery). 7. Cardiogenic shock at the time of randomization. 8. ST segment elevation myocardial infarction requiring Intervention within 7 days prior to randomization. 9. Evidence of cirrhosis or hepatic synthetic failure | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-85.0, Heart Valve Disease Coronary Artery Disease Willing and able to provide written informed consent Age >17 and < 86 years Patients undergoing planned cardiopulmonary bypass (CPB) for: 1. combined coronary artery bypass grafting and valve replacement/repair surgery 2. single valve replacement surgery 3. mitral valve repair surgery 3. or double valve surgery (aortic and mitral) Presence of clinically relevant microvascular bleeding after protamine administration (hemostasis assessment score of 2-3) Patients should fulfill the following parameters prior to the study intervention Body temperature > 35.0°C Blood pH > 7.2 Hb > 7.0 mg/dL Activated clotting time (ACT) < 155 seconds CPB time > 60 minutes Replacement of aorta Planned valve replacement without median sternotomy Previous valve replacement surgery (previous coronary artery bypass graft (CABG) acceptable) History or suspicion of a congenital or acquired coagulation disorder such as hemophilia, von Willebrand disease, and liver disease Hemodialysis dependent renal failure Liver dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) increased ≥ 2-fold above the upper limit of local laboratory normal ranges) Known allergy/anaphylaxis to fibrinogen concentrate or apheresis platelet units Clopidogrel administration within 5 days of surgery Coumadin (warfarin) administration within 5 days of surgery Participation in another clinical study in the 4 weeks preceding surgery | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 16.0-60.0, Marfan Syndrome Ages 16-60 years old with no treatment or β-blocker or other monotherapy only for Marfan syndrome Previous aortic dissection or aortic surgery Severe valvular regurgitation Aortic diameter at the sinotubular junction ≥ 5.0cm Contraindications to specific drug treatment, e.g. asthma and β-blocker Those who were pregnant or at risk of pregnancy | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Gestational Diabetes Gestational Hypertension Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB Pregnant females (DoD beneficiaries) at least 18 years of age Diagnosed as being diabetic Diagnosed with chronic hypertension prior to pregnancy Personal or family history of neural tube defects or personal history of birth defects Unable to communicate Non-English speaking Patients who know they will move prior to delivery Patients who have had Gastric Bypass surgery Patients with known seizure disorder or on anti-seizure medication Patients taking a folic acid antagonist Patients who are hypohomocysteine | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 65.0-999.0, Anti-coagulation Therapy DVT Pulmonary Embolism Joint Surgery Multiple Atrial Fibrillation Prosthetic Replacement of Mitral Valve Men and women at least 65 years old 2. Beginning warfarin (0 doses of warfarin taken at the time of enrollment) for a variety of diseases or conditions that require at least 30 days oral anticoagulation with target INR ≥ 2.0 Unable to complete the study materials (questionnaires) with or without assistance (for example, those with dementia) 2. A previous genetically determined warfarin dose 3. The treating physician does not agree to use the recommended warfarin dose or feels that the patient should not be enrolled in the study | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Marfan Syndrome Turner Syndrome Ehlers-Danlos Syndrome Loeys-Dietz Syndrome FBN1, TGFBR1, TGFBR2, ACTA2 or MYH11 Genetic Mutation Bicuspid Aortic Valve Without Known Family History Bicuspid Aortic Valve With Family History Bicuspid Aortic Valve With Coarctation Familial Thoracic Aortic Aneurysm and Dissections Shprintzen-Goldberg Syndrome Other Aneur/Diss of Thoracic Aorta Not Due to Trauma, <50yo Other Congenital Heart Disease Eligible subjects must have one of the conditions listed below and be enrolled in-person at one of the participating clinical centers.Contact the study coordinator at the location nearest you for more information about participation Marfan syndrome Turner syndrome Ehlers-Danlos syndrome Loeys-Dietz syndrome FBN1, TGFBR1, TGFBR2, ACTA2 or MYH11 genetic mutation Bicuspid aortic valve without known family history Bicuspid aortic valve with family history Bicuspid aortic valve with coarctation Familial Thoracic Aortic Aneurysm and DissectionsYes Inability of the patient, parent or guardian to give consent Unwillingness to provide a blood or buccal specimen | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 21.0-999.0, Aortic Stenosis Disorder of Prosthetic Cardiac Valve Aortic Valve Insufficiency Mitral Valve Insufficiency Hypertrophic Cardiomyopathy Tricuspid Valve Insufficiency patients with mild, moderate, or severe aortic stenosis or aortic or mitral prosthesis. Patients with aortic or mitral regurgitation. patients with hypertrophic cardiomyopathy. Patients with dysfunctional heart valve replacement or repair. Patients with severe tricuspid regurgitation associated with pacemaker or defibrillator lead. Ten normal control patients who will not be required to have echocardiography referred for a clinically indicated echocardiogram; the echo must be of good quality and specifically have patient height, weight, left ventricular outflow tract diameter, subaortic velocity profile by Doppler, and aortic transvalvular continuous wave Doppler velocity profile. For mitral regurgitation and aortic regurgitation the data must be adequate to allow calculation of regurgitant volume. For hypertrophic cardiomyopathy, a recording of left ventricular outflow tract peak velocity must be recorded years or older patients with aortic stenosis, defined as peak aortic velocity greater than 2.5 m/sec with evidence of aortic valve thickening, or an aortic or mitral valve prosthesis able to provide written informed consent Missing or inadequate echocardiographic data inability to give informed consent inability to provide a research blood sample hemoglobin less than 8 severe valvular regurgitation stenosis of the mitral valve | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 20.0-75.0, Gastroesophageal Reflux Disease Heartburn Patients with age of 20-75 years old (inclusive) in Taiwan of both genders Out-patients who had been diagnosed as non-erosive gastroesophageal reflux disease (NERD) Patients with heartburn or regurgitation (either one) as main symptom at least 2 days a week and had been present for > or = 1 month before screening Patients with heartburn or regurgitation (either one) during the 7 days screening period, either with frequency for > or = 4 days of mild symptom, or for > or = 2 days of moderate to severe symptom Patients have signed the informed consent form Patients with erosive gastroesophageal reflux disease (GERD), Barrett's esophagus or esophageal stricture Patients with active or healing gastroduodenal ulcer (except scars) Patients with history of gastric, duodenal or esophageal surgery Patients with malignant disease of any kind Patients with intrahepatic stone, gallstone, gallbladder sludge, hepatic or pancreatic carcinoma as evidenced by abdominal ultrasonography Patients with ischemic heart disease as evidenced by electrocardiogram Female patients who are pregnant or nursing mother Patients with a history of allergy to any of the study drugs or their related compounds Patients with a history of alcohol or drug abuse Patients with clinically significant liver disease (aspartate aminotransferase (AST), alanine aminotransferase (ALT)>2 upper limits of normal) | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.5-24.0, Marfan Syndrome Individual with Marfan syndrome consented in to the Main Atenolol Vs. Losartan NIH study Subjects in the main PHN Marfan trial who have not achieved the maintenance drug dosing or who have stopped taking study drug | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 30.0-75.0, Mitral Valve Insufficiency Patient is a male or female between 30 to 75 years of age (inclusive) on the day of signing the informed consent Patients with a verified diagnosis of CAD, including post myocardial infarction scar Coronary artery pathology to be coronary artery bypasses grafting The presence of moderate or severe ischemic mitral regurgitation The patient did not sign the informed consent Aortic valve disease requiring prosthetic or aortic valve repair Organic lesion of valve and subvalvular structures (endocarditis and degenerative processes of the mitral valve). а) separation of the mitral valve chords; б) rupture and perforation of the mitral valve; в) myxomatous degeneration and calcification of the mitral valve Patients with acute coronary syndrome The presence of the indications for angioplasty of the coronary arteries Coronary artery bypasses grafting in history Parallel patient participation in other studies The organs diseases, which can be reason to death after surgery during the first 3 years | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.5-18.0, Nephrotic Syndrome Age > 6 months and< 18 years 2. Idiopathic nephrotic syndrome 3. Ethical committee approval Age < 6 months or > 18 years 2. Congenital nephrotic syndrome 3. Secondary nephrotic syndrome (post-infectious, SLE, Schonlein-Henoch) defined by clinical features, low C3 and C4 levels, severe hypertension and macrohematuria 4. nephrotic syndrome associated to other syndromes (Dennys Drash, Frasier syndrome, et.cet) or to Wilms'tumor | 0 |
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