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A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-999.0, Cardiovascular Diseases HIV Simultaneous co-enrollment in the START study Signed informed consent Inability to ascertain waveform measurements that can be analyzed, i.e. atrial fibrillation | 0 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-999.0, Hematologic Neoplasm Acute Leukemia Myelodysplastic Syndrome Lymphoma, Multiple Myeloma Potential subjects must satisfy all of the following to be enrolled in the study diagnosis of hematologic neoplasm (acute leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma, chronic myeloid leukemia, Ph-negative chronic myeloproliferative neoplasms) independently of the stage of disease or treatment (including transplant procedures) platelet count <50 x109/L at the time of starting antithrombotic prophylaxis or platelet count <50 x109/L at the time of diagnosis of arterial or venous thromboembolism objectively proven or platelet count >50 x109/L at time of thrombosis but subsequent thrombocytopenia <50 x109/L while receiving antithrombotic treatment diagnosis of arterial thrombosis acute coronary syndrome, ischemic stroke (including major and minor stroke), peripheral arterial thrombosis, retinal arterial thrombosis diagnosis of venous thrombosis thrombosis of deep veins of the limbs and the abdomen, superficial veins of limbs, cerebral and splanchnic veins, retinal vein, and pulmonary embolism. Splanchnic venous thrombosis occlusion of hepatic, portal, mesenteric, and splenic veins The following situations will not be of neither outcomes of interest transient ischemic attack without CT and/or NMR signs superficial vein thrombosis without Doppler ultrasound examination showing evidence of thrombosis antithrombotic prophylaxis only local for central venous lines (i.e. CVC flushing with heparin) occlusion of the central venous catheter (notice that CVC-related deep venous thrombosis, i.e. thrombosis of the deep veins where the central line is placed, will be a criterion of or an outcome of antithrombotic prophylaxis) | 0 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 40.0-90.0, Diabetes Peripheral Arterial Disease Women Diagnosis of diabetes Diagnosis of peripheral arterial disease Regular physical activity Smokers Thrombosis active Severe peripheral arterial disease | 0 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-80.0, Heart Failure Patients over 18 years of age with chronic heart failure, ischemic and non-ischemic etiology NYHA (New York Heart Association) class II-IV LVEF (Left Ventricular Ejection Fraction) ≤ 35% Patients treated with maximum tolerated doses of standard pharmacotherapy for heart failure, who were stable for at least four weeks without acute decompensated heart failure Prior to enrollment, patients must give informed consent Patients with history of acute coronary syndrome or stroke within the last 6 months Significant valvular defects and/or planned cardiac surgery Systolic blood pressure <110 mmHg Advanced renal insufficiency (estimated GFR (Glomerular Filtration Rate) according to MDRD <30 ml/min/1.73 square meters) Unsuitable anatomy of renal arteries (presence of significant renal stenosis, renal artery narrower than 4 mm) Patients who underwent renal angioplasty or stent placement into the renal artery in the past Severe coagulation disorders Pregnancy or lactation Refusal of the patient Other diseases limiting prognosis of the patient to less than 2 years | 0 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-999.0, Percutaneous Closure of Arteriotomy in Common Femoral Artery Over 18 years of age Each patient, or his or her guardian or legal representative, is willing to give informed consent Clinically indicated for an endovascular procedure involving access through the femoral artery, with an access puncture of 18 Females who are not pregnant or lactating, and not planning to become pregnant ≤ 12 months. A pregnancy test may be performed to confirm this There will be no of patients from this trial in respect of race, co-existent disease or concomitant therapy, with the exception of those listed below Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year Evidence of systemic bacterial or cutaneous infection, including groin infection Evidence of MRSA (Methicillin-resistant Staphylococcus aureus) and/or VRE (vancomycin-resistant Enterococci) colonisation With arterial access other than the common femoral artery.* Patients suffering with definitive or potential coagulopathy or platelet count less than 100,000/µl Patient with a haematocrit of less than 32 % A measured activated clotting time (ACT) of greater than 350 seconds immediately prior to sheath removal.* If patients are expected to be continuously treated with anticoagulation therapy post-procedure such that their ACT reading is expected to be elevated above 350 seconds for more than 24 hours after the procedure Evidence of arterial diameter stenosis greater than 20 % within 20 mm of the arteriotomy.* | 1 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-90.0, Postcardiac Arrest Pulseless Electrical Activity Asystole Admission to adult ICU (age ≥18 years) at London Health Sciences Centre Primary reason for ICU admission: postcardiac arrest Both in-hospital and out-of-hospital cardiac arrest will be included ICU admission between Jan 2008 and Dec 2012 ICU admissions primarily for reasons other than cardiac arrest | 0 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-999.0, Vascular Access Complication Comfort CAG or PCI performed via the femoral artery No hematoma in the groin (> 5 cm in diameter) Heparin reversed with protamine after PCI Oozing, bleeding or hematoma Treatment with Integrilin, ReoPro, or Marevan Heparin can not be reversed The patient does not want to participate Systolic blood pressure > 180 mm Hg after the procedure BMI> 35 (can be modified if the groin can be assessed in an upright position) Demented, unconscious patients who do not understand the information for participants | 0 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-999.0, Coronary Artery Disease patients of both sexes older than 18 years submitted to CABG with CPB, presence of coronary disease confirmed by coronary angiography, use of the left internal thoracic artery and/or saphena, patients who remained in spontaneous ventilation on the first postoperative day, absence of chronic or acute pulmonary disease, and giving written informed consent to participate in the study intraoperative change of the surgical technique, surgical complications or complications occurring in the ICU, emergency reoperation, renal failure, failure to agree to continue in the study, presence of other types of heart disease, and presence of pulmonary diseases | 0 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-999.0, Abdominal Aortic Aneurysm Carotid Atherosclerosis Critical Lower Limb Ischaemia Age greater than 18 years Patient willing to give full informed consent for participation Patients undergoing elective carotid endarterectomy or Patients undergoing open abdominal aortic aneurysm repair or Patients undergoing endovascular abdominal aneurysm repair or Patients undergoing surgical lower limb revascularisation (suprainguinal or infrainguinal) Pregnancy Significant upper limb peripheral arterial disease Previous history of upper limb deep vein thrombosis Patients on glibenclamide or nicorandil (these medications may interfere with RIPC) Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2 Patients with a known history of myocarditis, pericarditis or amyloidosis Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2 Patients with severe hepatic disease defined as an international normalised ratio >2 in the absence of systemic anticoagulation Patients with severe respiratory disease (for the trial, defined as patients requiring home oxygen therapy) Patients previously enrolled in the trial representing for a further procedure Patients with previous axillary surgery | 2 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-999.0, Cardiovascular Disease eligible transplanted patients scheduled for a routine coronary angiography with age >18 years old chronic renal insufficiency (creatinine >2.0 mg/dl) with the potential necessity of using the radial artery as a native fistula will be considered one of the criteria in case of an abnormal or doubtful bilateral Allen's test, a pletysmography will be done. The presence of a type A or B curve will be considered a marker of adequate hand collaterals and the procedure will be able by this access. Only the presence of bilateral type C or D curves will be considered a contraindication to trans radial approach | 0 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-999.0, Acute Coronary Syndromes Angioplasty, Transluminal, Percutaneous Coronary Unstable angina with an indication for invasive stratification Acute coronary syndrome without ST-segment elevation Acute coronary syndrome with ST-segment elevation Patient informed of the nature of the study and have signed the Informed Consent Patient suitable for coronary angiography and / or percutaneous coronary intervention either by radial access as the femoral Below 18 years of age Pregnancy Chronic use of vitamin K antagonists, or direct thrombin inhibitors or antagonists of factor Xa Active bleeding or high risk of bleeding (severe hepatic insufficiency, active peptic ulcer disease, creatinine clearance <30 mL / min, platelet count <100,000 mm3) Uncontrolled hypertension Cardiogenic shock Previous coronary artery bypass graft surgery with the use of ≥ 1 graft Patients not candidates for the use of any of the specified vascular access Concomitant severe disease with life expectancy less than 12 months life Medical, geographical, or social conditions that impede study participation | 1 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-80.0, Hemorrhoids Pain, Postoperative Patients with symptomatic grade III or IV hemorrhoids (bleeding, pain, itching, soiling or prolapse) that are elegible for surgical treatment with both methods Associated recto-anal pathology such as acute thrombosed hemorrhoid, anal fissure, perianal fistula, perianal abscess, rectal prolapse, fecal incontinence or anal stenosis Prior anorectal surgery Systemic pathology that could alter the outcome of the surgery as coagulopathies, chronic pain with continued consumption of analgesics Age younger than 18 or older than 80 years, socio-pathology or inability to understand the study objectives | 0 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-999.0, Coronary Disease >18 year Should be able to provide valid informed signed consent CAG, possibly including intracoronary measurement (FFR) or intracoronary imaging (IVUS, optical coherence tomography (OCT), NIRS) Percutaneous coronary intervention (PCI) procedure and/or implantation of stents ST-Elevations Myocardial Infarction (STEMI) Multiple punctures Active infection Groin haematoma before the closure procedure Known pseudoaneurysm or arteriovenous (AV) fistula in the ipsilateral groin Cardiogenic shock Prior peripheral arterial surgery in abdomen or lower extremities Sheat size >7 F Life expectancy less than one year | 0 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-999.0, Endovascular Procedure Requiring an Arteriotomy in the Range of 18 to 24 F, Via the Common Femoral Artery. Over 18 years of age Each patient, or his or her guardian or legal representative, is willing to give informed consent Clinically indicated for an endovascular procedure involving access through the femoral artery, with an access puncture of 18 French (F) Females who are not pregnant or lactating, and not planning to become pregnant in ≤ 12 months Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year Evidence of systemic bacterial or cutaneous infection Evidence of MRSA (Methicillin-resistant Staphylococcus aureus) and/or VRE (vancomycin-resistant Enterococci) colonisation Arterial access other than the common femoral artery Patients suffering with definitive or potential coagulopathy or platelet count less than 100,000/μl Patient with a haematocrit of less than 32 % A measured activated clotting time (ACT) of greater than 350 seconds immediately prior to sheath removal If patients are expected to be continuously treated with anticoagulation therapy post-procedure such that their ACT reading is expected to be elevated above 350 seconds for more than 24 hours after the procedure Evidence of arterial diameter stenosis greater than 20 % within 20 mm of the arteriotomy Circumferential calcification within 20 mm of the arteriotomy | 1 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-999.0, Renal Failure Chronic Requiring Hemodialysis Central Venous Catheterization Inadequate Hemodialysis Blood Flow Venous Stenosis Venous Thrombosis Infection Due to Central Venous Catheter Central Venous Catheter Thrombosis Chronic renal failure requiring hemodialysis No medical history of central vena catheterization Maintenance hemodialysis after central vena catheterization Signed informed consent Had been performed central venous puncture or catheterization before Can not use heparin Refused to sign the informed consent Advanced cancer patients With or will take arteriovenous fistula surgery in right arm Other inappropriate situation | 1 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 25.0-90.0, Carotid Artery Thrombosis Carotid Artery Stenosis Stroke Carotid stenosis > 60% Redo carotid surgery Radiation induced carotid stenosis Extensive carotid lesion > 5 cm in length with involvement of the common carotid artery best treated by a carotid bypass | 0 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-999.0, Peripheral Artery Disease Critical Limb Ischemia Claudication Age ≥ 18 Patient undergoing vascular surgery that would a groin incision as a standard part of the operation. Infrainguinal bypass including femoral popliteal/tibial/pedal artery bypass with autogenous or prosthetic conduit Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent Any groin incision on index leg within 12 weeks prior to treatment initiation Infrainguinal bypass without a groin incision including popliteal-tibial or pedal bypass Supra inguinal procedures such as open or endovascular abdominal aortic aneurysm repair or aorto-femoral/bi-femoral bypass for occlusive disease Undergoing current chemotherapy or radiation therapy Pregnancy or lactation Inability or refusal to provide informed consent Patients who received an investigational drug for peripheral arterial disease within 4 weeks of screening or who participated in another non-observational clinical trial in the prior 30 days Surgical incision in the groin without primary closure including previously open or infected wounds Sensitivity or allergy to silver Prior enrollment in this randomized controlled trial | 1 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 0.0-17.0, Intraoperative Complications Postoperative Complications Surgical admission, with a noncardiac surgical interventions Aged between >28 days and <18years on the day of the surgical intervention Non-surgical admission Surgical interventions with <10 per group Cardio-thoracic and interventional cardiology procedures | 0 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-999.0, ATRIAL FLUTTER indication for atrial flutter ablation history of recent femoral vein thrombosis (within last 6 months) | 0 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-75.0, Pain, Postoperative Total Knee Arthroplasty Able to consent to regional anesthesia and having primary total knee arthroplasty/replacement Body-Mass Index >40 Iliac to Patella Distance (IPD) <40cm Pre-existing quadriceps weakness of involved surgical side Chronic opioid use (if using opioids within 4 weeks of surgery: excluded) | 0 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-75.0, Vascular Fistula Age from 18 to 75 years Radial artery diameter <2.0 mm or cephalic vein diameter in the forearm <2.5 mm Brachial artery diameter ≥ 2 mm Stenosis or thrombosis present in the draining vein A history of peripheral ischemia in upper extremities Active local or systemic infections Inability to consent for the procedure Patients with previous dysfunctional forearm fistula | 0 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-999.0, Pulmonary Arterial Hypertension Patients with pulmonary artery hypertension (group 1 of the Nice classification of pulmonary hypertension) Aged over 18 years old NYHA class III or IV Not controlled by optimal medical management as defined by dual therapy including a prostacyclin or dual therapy including an endothelin receptor antagonist and a phosphodiesterase inhibitors, in patients with contra-indication of prostacyclin, poor tolerance to this treatment, prostacyclin derivative treatment failure or patient refusal Valid status in the social security system Signed informed consent Patient eligible for pulmonary transplantation Pregnancy or breastfeeding Adults of the age of majority subject to guardianship court order or deprived of liberty Patient with history of radio frequency procedure Known heparin allergy | 0 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-999.0, Sleep-Disordered Breathing Pulmonary Arterial Hypertension Chronic Thromboembolic Pulmonary Hypertension minimum 18 years old diagnosed with PAH or non-operable CTEPH or operated CTEPH with peristent pulmonary hypertension diagnosis of PAH based on cardiac catherisation diagnosis of CTEPH confirmed by contrast-enhanced spiral chest CT, pulmonary angiography and V/Q scintigraphy recent diagnosis of sleep disordered breathing (polysomnography realized within 3 months before showing AHI above 15) stable clinical condition for at least 3 months before as defined by NYHA and a walking distance difference within 10% of the previous 3 months and no change in medical therapy during this 3 months congenital heart disease moderate and severe restrictive or obstructive pulmonary disease with a TLC and a FEV1<60% of the predicted value BMI 35kg/m2 or more patients already treated with CPAP patients with severe sleepiness (epworth sleepiness scale from 18 to 24/24) | 0 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 50.0-999.0, Venous Hypertension Ulcers Venous Stasis Ulcer Venous Ulcer Venous Insufficiency Leg Ulcer Foot Ulcer Varicose Ulcer Diabetic Foot Newly healed leg or diabetic foot ulcer within past 7 days Ankle brachial index 0.8 3mmHg (rule out absence of arterial disease) Willing to wear compression stockings and appropriate footwear Working freezer Open leg or foot ulcers Cognitive impairment: unable to recall 2 or more words or draw clock Mini-Cog™ for cognitive impairment Chronic inflammatory or vascular conditions where blood flow of skin may be impaired such as Lupus erythematosus, Raynaud's, scleroderma, end stage renal disease, chronic regional pain syndrome, multiple sclerosis, hypersensitivity to cold, on chemotherapy Unable to preform required protocol activities without assistance (return demonstration to study staff) | 0 |
A physician is called to see a 67-year-old woman who underwent cardiac catheterization via the right femoral artery earlier in the morning. She is now complaining of a cool right foot. Upon examination she has a pulsatile mass in her right groin with loss of distal pulses, and auscultation reveals a bruit over the point at which the right femoral artery was entered. | eligible ages (years): 18.0-999.0, Peripheral Arterial Disease Critical Limb Ischaemia Willing, able, and committed to participate in the procedures for the full length of the study All ethnic groups, male or female above the age of 18 years Diagnosis of non-reconstructable arterial disease and critical limb ischaemia (with a minimum of duplex ultrasound and an MDT discussion to have reached this diagnosis) Be of non-childbearing potential; OR using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the study device Blood pressure currently under moderate control (< 160/100mmHg) History of uncomplicated cardiovascular events beyond 3 months No current foot ulceration Patients meeting any of the following are to be excluded Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) or otherwise thought to be unreliable or incapable of complying with the study protocol Has any metal implants Pregnant Has peripheral neuropathy Has a cardiac pacemaker or defibrillator device Has recent lower limb injury or lower back pain Has current foot ulceration or other skin ulcers Has foot deformities Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study | 2 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-60.0, Facial Neuropathy 60 years of age Right-handed non-smokers Diagnosed with facial pain Continuous pain for more than 3 months Spontaneous pain greater than 3 of 10 Allodynia to brush greater than 5 of 10 Medications Depression Significant medical problems Claustrophobia Abnormal EKG Significant drug or alcohol history Positive drug screen Weight greater than 285 lbs History of allergy to anticonvulsants Tattoos with metallic ink on upper body | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-999.0, Diabetic Neuropathies Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item History of substance abuse or dependence within the past year, excluding nicotine and caffeine Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis),kidney, respiratory, or blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or be likely to lead to hospitalization during the course of the study Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study Treatment with fluoxetine within 30 days of starting the study Unstable blood sugar control and uncontrolled or poorly controlled hypertension | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 40.0-999.0, Myocardial Ischemia Documented silent myocardial ischemia type I At least one cardiovascular risk factor History of cardiovascular disease | 1 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 15.0-45.0, Chronic or Recurrent Appendicitis Patients were eligible if they were between 15 and 45 years of age, and if they suffered from chronic or recurrent right lower abdominal quadrant pain for more than three months. They were to experience continuous pain, or should have endured at least one pain attack in the month prior to inclusion consisted of (a history of) chronic back pain, previous abdominal surgery (with the exception of diagnostic laparoscopies or a laparoscopic sterilization), specific gastro-intestinal entities (such as inflammatory bowel disease) and gynaecological disease (all female patients consulted a gynaecologist). Routine laboratory investigations included hemoglobin rate, serum leukocyte count and differentiation, C-Reactive Protein concentration, Erythrocyte Sedimentation Rate, faeces cultures and urine sedimentation. Barium contrast studies of the colon were done in all patients, abdominal ultrasound or enteroclysis on discretion. Finally, was possible when diagnostic laparoscopy revealed abnormalities (see below) | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 0.0-999.0, Brain Trauma Patients of acute moderate brain trauma Patients who are medically unstable or have CT findings that may interfere with the study such as a large hemorrhage or edema encephalomalacia prior neurosurgeries hardware placed in the head or neck prior head trauma history of neurological conditions | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 50.0-75.0, Type 2 Diabetes Mellitus Age 50-75 years Type 2 diabetes mellitus Angina or anginal equivalent Abnormal rest ECG (Q or ST depression) Known CAD Stress testing within the last 3 years | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-65.0, Chronic Pain Muscular-skeletal pain in the neck/shoulder region Acute and chronic pain in the neck/shoulder region Restricted range of motion in the neck/shoulder region Fibrosis or scar tissue in the neck/shoulder region Inflammation in the neck/shoulder region Altered function in the neck/shoulder region Muscle strains in the neck/shoulder region Rating of 30 or greater on the 0-100 Visual Analog Scale (VAS) pain scale 65 years of age Severely herniated disks Pregnancy Taken pain medication within the past 12 hours | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-999.0, Angina Pectoris Silent Ischemia Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I,II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia, all treated with a second generation drug eluting stent Presence of one or more de novo stenosis equal or greater than 70% in a native coronary artery, treated with a Resolute drug eluting stent Patient is > 18 years of age (or minimum age as required by local regulations) The patient has consented to participate by signing the "Patient Informed Consent Form"" The patient is willing and able to cooperate with study procedures and required follow up visits Any type of lesion or number of lesion can be included in this trial unless specifically detailed in the At least one second generation DES implanted in the target lesion in the last 24 hours No other DES implanted before the target procedure No BMS implanted in the 12 months before the target procedure Patients treated for lesions in venous or arterial grafts Patients treated for in-stent restenosis Patients treated for Unprotected Left Main lesions ST elevation myocardial infarction in the 48 hours prior to the procedure Non ST elevation myocardial infarction Patients with LVEF≤30% Women with known pregnancy or who are lactating | 1 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-999.0, Chronic Inflammatory Demyelinating Polyneuropathy IVIG-untreated subjects Either subjects with newly diagnosed CIDP (developing over at least 2 months) or subjects with an IVIG treatment interruption for at least 1 year with a progressive disease (deteriorating in the last 2 months) prior to enrolment Actual diagnosis (including electrophysiology) of CIDP with progressive or relapsing dysfunction from motor and sensory or symmetric motor nerve only in at least 1 limb resulting from neuropathy. for definite or probable CIDP according to EFNS/PNS guideline Age ≥18 years Male or female Written informed consent for study participation obtained before undergoing any study specific procedures IVIG-pretreated subjects Being treated regularly with IVIG on a fixed cycle length of 2 to 6 weeks ± 5 days in the last 6 months, on a fixed dosage of ± 20 % in the last 6 months and deteriorating by at least 1 INCAT score point during the Washout Period of up to 10 weeks (except for an increase from 0 to 1 solely due to upper limb score) Historic diagnosis of CIDP with progressive or relapsing dysfunction from motor and sensory or symmetric motor nerve only in at least 1 limb resulting from neuropathy. for definite or probable CIDP according to EFNS/PNS guideline Age ≥18 years A motor syndrome that fulfils for multifocal motor neuropathy (MMN) with conduction block (i.e., upper limb motor weakness without sensory deficit and with a 50% decrease in action potential amplitude or area on proximal compared with distal stimulation in motor nerves) CIDP with monoclonal gammopathy of uncertain significance (CIDP-MGUS) with anti-MGUS antibodies and patients with distal acquired demyelinating symmetric (DADS)neuropathy Any disease (mainly neurological or chronic orthopedic) that may cause symptoms or may interfere with treatment or outcome assessments with the INCAT (e.g., diphtheria, drug or toxin exposure and diabetes mellitus likely to have caused the neuropathy, IgM paraproteinemia, familial neuropathy, borreliosis with radiculopathy, post-polio-syndrome,M. Parkinson, stroke) Current malignancy History of cardiac insufficiency (New York Heart Association [NYHA] III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease, congestive heart failure or severe hypertension History of thrombotic episodes (deep vein thrombosis, myocardial infarction, cerebrovascular accident) Migraine associated with IVIG infusion in the last 3 months prior to enrolment Known allergic or other severe reactions to blood products including intolerability to previous IVIG (i.e. severe headache, hypersensitivity, intravascular hemolysis) Subjects with serum IgA level less than 50% of the lower normal limit Known hyperprolinemia | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-999.0, Septic Shock ventilated patient in sinus rhythm with septic shock requiring a hemodynamic assessment < 18 yr-old pregnancy contra-indication for TEE, non sinus rhythm, aplasia, prior participation to the study, hemodynamic assessment using any other technique than those tested in the study | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-999.0, Stress Disorders, Post-Traumatic Stress Disorders, Traumatic, Acute Road traffic accident victims hospitalized in surgical department less than 2 weeks Can be called by phone Patient with a coma for more than 15 minutes Patient with a crania traumatism and with loss of consciousness over 15 minutes Homeless | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-90.0, Hand Foot Syndrome Palmar Plantar Erythrodysesthesia Subjects must meet the following to be eligible for the study Receiving capecitabine or sunitinib as part of routine standard care CTCAE version 4.0, grade 1-3 PPE Adults age ≥ 18 Karnofsky (KPS) performance status of ≥70% Adequate organ and marrow function as defined below ANC > 1000/mL Platelets > 75,000/mL Total bilirubin < 1.5 x UNL AST(SGOT)/ALT(SGPT) < 5 x UNL Subjects meeting any of the following are ineligible for study entry Currently participating in a clinical trial History of hypersensitivity or intolerance to sildenafil or other related products tadalafil (Cialis™), vardenafil (Levitra™) or poloxamer vehicle Currently taking oral sildenafil or other related products tadalafil (Cialis™), vardenafil (Levitra™) Currently taking other treatment for PPE other than standard emollients Using organic nitrates, either regularly and/or intermittently, in any form History of myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months Resting hypotension (BP <90/50 mmHg) or hypertension (BP >170/110 mmHg). Those subjects on alpha-blocker or anti-hypertensive therapy must be hemodynamically stable for at least two weeks before day 1 of study drug Cardiac failure or coronary artery disease causing unstable angina Known retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases) | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-999.0, Septic Shock or more SIRS according to ACCP/SCCM definition Documented infection or strong suspicion of infection with adequate antibiotic treatment Shock according to ACCP/SCCM definition with the necessity of vasopressor treatment Patients admitted with central nervous diseases ST elevation myocardial infarction Pulmonary embolism Out of hospital cardiac arrest patients Patients with therapy limitations Known pregnancy in other interventional trials | 1 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-999.0, Coronary Artery Disease The patient is male or female ≥ 18 years of age The patient presents with stable angina pectoris, or silent ischemia (positive stress test without chest pain) The patient is scheduled for coronary angiography, with possible angioplasty The patient is able to tolerate dual anti-platelet therapy with aspirin and clopidogrel for a minimum of 30 days and is on those medications at the time of the PCI (clopidogrel may be administered during PCI or within 30 minutes post PCI) The patient is able and willing to conform to the requirements of the study and voluntarily signs an Informed Consent The patient does not present with any form of illness or condition that in the investigator's opinion would impair the results of the study Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment Patients in cardiogenic shock Patients with acute coronary syndrome, which includes unstable angina, non-ST-elevation MI or STEMI Known history of heparin-induced thrombocytopenia Contraindication to unfractionated heparin, bivalirudin, or any anticoagulant or antithrombotic pharmacological agent Any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal participation in the study Pregnant women or nursing mothers | 1 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-80.0, Septic Shock Acute Respiratory Distress Syndrome Patients were included if they were diagnosed with Shock, Acute respiratory distress syndrome (ARDS), or both Shock was defined by the presence 4 Heart rate of at least 90/min A respiratory rate of at least 20/min or a PaCO2 of 32mmHg or lower or the use of mechanical ventilation The use of vasopressors to maintain a systolic blood pressure of at least 90mmHg despite fluid resuscitation, low dose of dopamine (≤ 5 μg/kg per minute), or dobutamine at least 1 of 3 signs of hypoperfusion (urine output < 0.5mL/kg of body weight per hour for 1 hour or more; neurologic dysfunction defined by confusion, psychosis, or a Glasgow coma scale score of ≤ 6; plasma lactate higher than the upper limit of the normal value) Acute respiratory distress syndrome： the presence of acute decrease in PaO2/FIO2 to 200mmHg or lower bilateral pulmonary infiltrates or a chest radiograph consistent with edema no clinical evidence of left atrial hypertension; and requirement for positive pressure ventilation Patients were moribund signed do-not-resuscitation odor | 1 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-60.0, Posttraumatic Stress Disorder Men and women, age 18-60 Participants must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign a written informed consent document. We determine whether they have a sufficient understanding of the study procedures and risks by asking them to explain what's involved in the study and to give examples of study risks and benefits Participants must fulfill DSM-IV for current PTSD, based on the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) and on the Clinician-Administered PTSD Scale (CAPS) CAPS score must be at least 40 (moderate PTSD severity) at screening Current, primary Axis I disorders other than PTSD History or current bipolar disorder or primary psychotic disorders (e.g. schizophrenia, schizoaffective disorder) Current diagnosis of anorexia nervosa or bulimia nervosa Women who are pregnant or are breast-feeding Drug or alcohol abuse or dependence within the preceding 3 months poorly controlled hypertension (manifest by SBP > 140 and/or DBP > 90); HR < 60 or > 100 at rest at the time of screening and confirmed immediately prior to randomization Evidence of coronary artery disease as evidenced by history, abnormal ECG, typical symptoms History of arrhythmia, cardiac surgery, or family history of sudden death Hepatic dysfunction as defined by AST and ALT > 2x URL, or alkaline phosphatase and bilirubin > 1.5 x URL within X days prior to randomization Chronic renal disease as defined by serum creatinine > 1.9 | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 21.0-999.0, Chagas Disease Heart Diseases Have Chagas disease, confirmed by two serological tests Provide evidence through any of the following diagnosis methods: Rest ECG, 24 hour Holter monitoring, electrophysiological study, stress test or loop monitoring, at least one electrical disorder consistent with sinus bradycardia greater than 45 and lower than 60 bpm, sinus arrest not greater than 2.0 seconds, second degree atrial sinus block, intraventricular conduction disorders such as right branch, left branch or a bifascicular blockage type, first degree A-V blockage, or of type I second degree AV Block without associated bradycardia, atrial and/or ventricular arrhythmias that do NOT constitute an indication for pacemaker implant, ICD or mapping and radio frequency ablation Be asymptomatic or having minimal isolated unspecific symptoms not consistent with cardiac arrest, aborted sudden death, syncope, frequent and recurrent palpitations, cardiac failure, and lower extremity edema Have ejection fraction of left ventricle >35% Be able to give his/her written informed consent Subject should be > 21 years old Be able to return for follow-up visits as required Class I or II (according to AHA/HRS/ESC guidelines) indication for final implantation of pacemaker, ICD, or cardiac resynchronizer Exhibit extrinsic causes of sinus dysfunction or A-V blockage Exhibit infiltrative myocardial diseases such as tumors or associated valvular defects Suffer any concurrent disease that may limit the follow up or evaluation Suffer aftereffects of cerebral embolism Suffer ablation or isolation of pulmonary veins previous to their in the study Not being able or willing to comply with the follow-up schedule Have previous lesions of the spinal cord or aftereffects of skull trauma Have a record of epilepsy Receive pharmacological treatment for other diseases that may modify the autonomic function | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 0.0-999.0, Pulmonary Thromboembolism Patients with signs or symptoms in favor of PTE who come to Emergency department of Alzahra General Hospital previous history of Allergy to IV contrast Serum creatinin more than 1.8 patients that will not agree to participate in the study pregnancy Body weight more than 120 kg | 2 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 21.0-999.0, Acute Coronary Syndrome Chest Pain Age greater than or equal to 21 years Chest discomfort or other symptoms consistent with possible ACS The treating physician feels the patient could be discharged home if cardiac disease was excluded New ST-segment elevation in contiguous leads on any electrocardiogram (>/= 1 mV) Unstable vitals signs: symptomatic hypotension at the time of enrollment (systolic < 90 mm Hg), tachycardia (HR>120), bradycardia (HR<40), and hypoxemia (<90% pulse-oximetry on room air or normal home oxygen flow rate) Terminal diagnosis with life expectancy less than 1 year A non-cardiac medical, surgical, or psychiatric illness determined by the provider to require admission, increase risk of objective cardiac testing, or prevent immediate discharge following negative testing Prior enrollment Incapacity or unwillingness to provide consent and comply with study procedures Non-English speaking Sub-study I & II ED attending physicians ED attending physicians who decline to participate | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-999.0, Anal Incontinence Obstetric Trauma Primiparous women aged 18 years of older Vaginal delivery, vacuum-assisted-vaginal-delivery (VAVD), or forceps-assisted-vaginal-delivery (FAVD) of a neonate of gestational age completed weeks Singleton or vaginal delivery of multiple gestation Able to read and speak the English language Unable to comply with physical therapy or office visits Unreliable transportation Preexisting neurologic, musculoskeletal or neuromuscular disorder rendering them unable to perform physical therapy requirements Cesarean delivery History of prior surgery for anorectal incontinence (i.e. sphincteroplasty | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-999.0, Acute Pain Reported pain greater than or equal to 3 out of 10 Less than 18 years of age Decreased level of consciousness Inability to answer questions Prisoner | 2 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-70.0, Dystonia Confirmed diagnosis of focal hand dystonia (patients only) Between age 18 and 70 years Able to give informed consent Right handed Agrees to not drink caffeine or alcohol for 48 hours before study session No open scalp wounds or scalp infections Has used illegal drugs within the past 6 months based on history. The intent is to those with drug use that may affect study results. Participants who appear to be intoxicated at the time of testing will be rescheduled Has more than 7 alcoholic drinks a week in the case of a woman and 14 alcoholic drinks a week in the case of a man Abnormal findings on neurologic exam (other than dystonia in patient group) Has had a brain tumor, a stroke, head trauma, epilepsy or a history of seizures Has major depression or any major mental disorders (axis I disorders) Has a neurologic disorder other than dystonia Has had a head injury where there was a loss of consciousness for more than a few seconds Has a pacemaker, intracardiac lines, implanted pumps or stimulators, or has metal objects inside the eye or skull. Dental fillings and dental braces are allowed Has known hearing loss Pregnancy | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-75.0, Septic Shock Criteria:• Written informed consent by patient or relative Time in ICU < 48 hours Septic shock Pulmonary artery catheter and radial arterial catheter Age 18 years Sinus rhythm Need for norepinephrine over 0.1 ug/kg/min but otherwise hemodynamically stable i.e no need to change the dose over the last 15min period before the study Mechanical ventilation with sedation Pwcp <18 mmHg Contraindication to elevation of PEEP ( elevated intracranial pressure, pulmonary hypertension or other contraindication ) Contraindication to fluid challenge Contraindication to TEE Previous heart failure, heart valve stenosis of insufficiency | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-999.0, Pulmonary Hypertension Prospective arm Man or woman aged over 18 With suspicion or diagnosis of pulmonary hypertension Scheduled to undergo right heart catheterization Able and willing to give informed consent Retrospective arm Man or woman aged over 18 With diagnosis of pulmonary hypertension confirmed by right heart catheterization in the past Able and willing to give informed consent Both arms Minor (aged < 18) People unable or unwilling to give informed consent Hemodynamically unstable patients Pregnant women Prospective arm only Patients with contra-indication to right heart catheterization Patients incapable of performing a Valsalva maneuver Patients with recent myocardial infarction, high degree AV block, severe aortic stenosis or glaucoma | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-999.0, Venous Thromboembolism Pulmonary Embolus Deep Vein Thrombosis Admitted to the hospital for care of injuries Have a greater than minimal (moderate to highest) level of VTE risk Discharged prior to 24 hours in hospital Minimal VTE risk | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 0.0-17.0, Septic Shock for 1 and 3 must be answered YES to be eligible for study Age 29 days to less than 18 years of age ) Patient has Persistent Signs of Shock including one or more of the following: i) Vasoactive Medication Dependence ii) Hypotension (Systolic Blood Pressure and/or Mean Blood Pressure less than the 5th percentile for age) iii) Abnormal Perfusion (2 or more of: abnormal capillary refill, tachycardia, decreased level of consciousness, decreased urine output) ) Suspected or Confirmed Septic Shock (Shock due to Suspected or Confirmed Infectious Cause) ) Patient has received initial fluid resuscitation of: Minimum of 40 mL/kg of isotonic crystalloid (0.9% Normal Saline and/or Ringer's Lactate) and/or colloid (5% albumin) as fluid boluses within the previous 2 hours for patients weighing less than 50 kg, OR Minimum of 2 litres (2000 mL) of isotonic crystalloid (0.9% Normal Saline and/or Ringer's Lactate) and/or colloid (5% albumin) as fluid boluses within the previous 2 hours for patients weighing 50 kg or more Patient has Fluid Refractory Septic Shock as defined by the Presence of all of 2a, 2b, and 2c Patient located in the Neonatal Intensive Care Unit (NICU) Patient located in the Operating Room (OR) or Post-Anesthetic Care Unit (PACU) Full Active Resuscitative Treatment Not Within the Goals of Care Shock Secondary to Cause other than Sepsis (i.e. obvious signs of cardiogenic shock, anaphylactic shock, hemorrhagic shock, spinal shock) | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 0.0-5.0, Pneumonia Bronchiolitis Asthma All children below 5 exceeding WHO age-dependent tachypnea criteria | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-30.0, Hyperalgesia Asymptomatic subjects who met the criterion of being between 18 and 30 years old rheumatologic diseases or any type of cancer, cervical surgery in the past, whiplash trauma and undergoing any type of treatment like physical therapy, manual therapy, osteopathy, chiropraxis, acupuncture during the last three months. All patients recruited for the study complained of pain localized in the neck and/or head region. Initial screening was accomplished by telephone and eligible persons attended a evaluation appointment development of systemic or degenerative diseases subjects with symptoms of depression according Beck's questionnaire pain in any area between the lower back and head in the last 9 months traumatic event in the past 12 months history of neck or face pain in the last 6 months | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-999.0, Major Adverse Cardiovascular Events Troponin T GRACE Score patients presenting to the emergency department ("chest pain unit") typical angina pectoris absence of symptoms since presentation at least 18 years low GRACE risk score (<140 points) informed consent, signed agreement conditions with need for immediate workup mental disorders dementia pregnancy, breast feeding | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-45.0, Safety Tolerability Pharmacokinetics Pharmacodynamics Food Interaction Signed informed consent prior to any study-mandated procedure Healthy Caucasian male subjects aged between 18 and 45 years (inclusive) at screening Subjects must agree to use reliable methods of contraception No clinically significant findings on physical examination at screening Body mass index (BMI) between 18.0 and 30.0 kg/m^2 (inclusive) at screening Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate (PR) 45-90 bpm (inclusive) measured at screening lead ECG without clinically relevant abnormalities, measured at screening Body temperature (T°) 35.5-37.5°C at screening and prior to (first) dosing Total and differential white blood cell (WBC) count strictly within the normal ranges at screening and on Day −1 C-reactive protein (CRP) levels below 5 mg/L Known allergic reactions or hypersensitivity to any excipient of the drug formulation History or clinical evidence of any disease, and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug Previous history of recurrent fainting, collapses, syncope, orthostatic hypotension, or vasovagal reactions Veins unsuitable for intravenous (i.v.) puncture on either arm Treatment with another investigational drug within 3 months prior to screening or having participated in more than four investigational drug studies within 1 year prior to screening History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening Excessive caffeine consumption Treatment with any prescribed or over-the-counter (OTC) medications within 2 weeks prior to (first) study drug administration or five half-lives of the medication, whichever is longer Any history of immunosuppressive treatment Chronic diseases including those with recurring periods of flare-ups and remission | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 45.0-80.0, Osteoarthritis Pain Age 45 to 80 years old, inclusive Clinical diagnosis of osteoarthritis in one target knee based on the following American College of Rheumatology (ACR) Knee Pain At least 1 of 3 Age > 50 years Morning stiffness lasting < 30 minutes Crepitus on motion Osteophytes on radiograph Symptoms associated with osteoarthritis of the knee (including pain) for ≥ 6 months prior to Screening Knee pain associated with osteoarthritis, which required NSAID or other therapy for ≥ 15 days during the preceding month General Women of childbearing potential, or men whose sexual partner(s) is a woman of childbearing potential may not be entered into the study if They are or intend to become pregnant (including use of fertility drugs) during the study They are nursing They are not using an acceptable, highly effective method of contraception until all follow-up procedures are complete. (Acceptable, highly effective forms of contraception are defined as: oral contraception, intrauterine device, systemic [injectable or patch] contraception, double barrier methods, naturally or surgically sterile, strict abstinence or partner has been sterilized. If hormonal-based birth control is being used, subject or subject's sexual partner(s) must be on a stable-dose for ≥ 3 months prior to the Baseline visit and maintained at the same dosing level throughout the 9-week clinical trial.) Body Mass Index (BMI) over 40 A history of osteoarthritis symptoms that are completely non-responsive to non-steroidal anti-inflammatory drugs (NSAIDs) at the discretion of the Investigator Planned change (increase or decrease) in subject's level of physical activity (e.g., aerobic or anaerobic exercise) during the 6-week Treatment Period following randomization Enrollment in any trial and/or use of any Investigational Drug or device within the immediate 30-day period prior to the Baseline visit Enrollment in any study previously sponsored by Olatec Industries LLC, specifically Study OLT1177-01 or OLT1177-02 | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 1.0-10.0, Stress, Physiological Patients needing venous blood sampling or insertion of an intravenous canula Normal development according to parents Critically ill children (e.g. shock, respiratory distress or failure) Children whose blood work or intravenous canula must be obtained rapidly for therapeutic reasons (e.g. antibiotic administration in a patient with severe bacterial infections) Known adrenal or pituitary disease Children who have received glucocorticoids during the preceeding six weeks | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-999.0, Shock healthy volunteers with no assumption of coffee or any other substance with possible action on the autonomic nervous system age < 18 yrs pregnancy assumption of any drugs and existence of any disease intake of any drug/substance with action on the autonomic nervous system during the previous 24 hours | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-85.0, Common Femoral Artery Injury Other Vascular Adverse Event Patients between 18 and 85 years of age Scheduled to undergo an elective PCI via arterial puncture of common femoral artery were eligible for enrollment in the study Elective PCI was defined as any coronary revascularization in a low-risk patient who presents to the facility for a planned PCI or for a coronary angiogram followed by ad hoc PCI Patients were excluded from the study if the patient has Any procedural complication included prolonged chest pain transient coronary artery closure, no-flow or slow-flow phenomenon hemodynamic instability persistent electrocardiographic changes side-branch occlusion of >1.5 mm, or an angiographically suboptimal result Arterial access other than the right or left femoral artery Vascular perforation, thrombosis during procedure | 1 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 0.0-999.0, Basal Cell Carcinoma of the Skin Nevoid Basal Cell Carcinoma Syndrome A diagnosis of basal cell nevus syndrome (BCNS) as defined in the Consensus Statement (Bree et al, American Journal of Medical Genetics [Am J Med Genet] Part A 155:2091-2097) Major are BCC prior to age 20 years, or excessive number of BCCs out of proportion to prior sun exposure and skin type Keratocyst of the jaw prior to age 20 Palmar or plantar pitting Lamellar calcification of the falx cerebri Medulloblastoma First degree relative with BCNS Minor are Rib anomalies, or other specific skeletal malformations including kyphoscoliosis and short 4th metacarpals Pregnant or nursing Currently participating in another clinical trial Using any systemic treatment for BCC (e.g. vismodegib), or any topical treatment for their BCC tumors, unless discontinued at least one month prior Currently being treated for other cancers with medical or radiation therapy Patients with a known hypersensitivity to 5-aminolevulinic acid or any component of the study material Patients with history of a photosensitivity disease, such as porphyria cutanea tarda Patients with a coexisting skin condition such as scleroderma, psoriasis, or eczema in the skin areas to be treated with PDT, that might interfere with response assessment | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 14.0-16.0, Adolescent Idiopathic Scoliosis female between 14 and 16 years old normal neurological examination right handed informed consent informed consent form signed by a parent or a holder of parental authority affiliated to medical insurance negative urine pregnancy test For patients (A-STD) : right thoracic scoliosis with a Cobb angle between 20 and 40° For healthy volunteers (A-N) : no clinical scoliosis pregnant or lactating woman antecedents of cranial trauma or cranial intervention, of migraine, of spinal trauma, of scoliosis intervention no idiopathic scoliosis contraindications to MRI patient with a legal protection measure | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-65.0, Tuberculosis of TB (tuberculosis ) subjects Diagnosis TB to 65 years Consent and signed informed consent forms(ICF) Comply with follow-up of TB (tuberculosis ) subjects advanced cancer, diabetes,copd in acute episodes, acute/ progressive liver disease or kidney disease, congestive heart failure, etc Taking part in other clinical or within 3 months involved in any other clinical histories of allergy in pregnancy or lactation In a mental illness Any conditions affect the trial evaluation of Non-tuberculosis subjects with lung disease Diagnosis non-tuberculosis subjects with lung disease to 65 years | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-999.0, Hypothermia Trauma Trauma patients ≥ 18 years of all severity stages including poly traumatized patients admissioned through the emergency room Patients < 18 years Patients after pre-hospital cardiac arrest or ongoing CPR at time of admission | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-999.0, Ankle Fractures All patients operated on Nordsjællands Hospital, department of Orthopaedic surgery, during the period, for mono-, bi and trimalleolar fracture, according to the AO-principles Age over 18 years Sub study 1 Age under 18 Dementia Need for external fixation Known or suspected DVT or pulmonary embolism Patients without Danish CPR-number, or address in Denmark Patients who doesn´t want to participate or who are not able to give written or oral consent No palpable pulse in the foot in the affected leg (the posterior tibial or dorsal artery) Multi-traumatized patients and patients with fractures of more than one extremity | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-999.0, Posttraumatic Stress Disorder Acute Stress Disorder Female, aged 18+ years Had emergency caesarean section within the past 6 hours Have given birth to a live baby at ≥ 37 weeks gestation Do not speak French sufficiently well to participate in assessments Have established intellectual disability or psychotic illness Baby was transferred to intensive care unit after the birth | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 40.0-60.0, Familial Hypercholesterolemia - Heterozygous For patients with heterozygous form of familial hypercholesterolemia Aged between 40 and 60 years With an identified genetic mutation (LDL-R, ApoB, PCSK9) Asymptomatic With no EKG sign of ischemia No personal history of coronary heart disease Treated or untreated by lipid lowering treatment High cardiovascular risk identified by 1 of the following Current smoking (1 cigarette a day) 2 Family history of very premature onset CHD: first or second-degree male relative onset before age 45, first Non-affiliation to a healthcare system Consent refusal Contra-indication to MRI or to gadolinium injection Claustrophobia, metallic devices, pacemaker, mechanical valve implanted before 1985, pregnancy, nursing Renal failure Technical contra-indication: patient diameter > 70 cm weight > 250 kg Personal history of cardiovascular disease and myocardial infarction Diabetes mellitus Uncontrolled hypertension TG < 4 g/L | 0 |
A 40-year-old woman with no past medical history presents to the ER with excruciating pain in her right arm that had started 1 hour prior to her admission. She denies trauma. On examination she is pale and in moderate discomfort, as well as tachypneic and tachycardic. Her body temperature is normal and her blood pressure is 80/60. Her right arm has no discoloration or movement limitation. | eligible ages (years): 18.0-65.0, Tuberculosis of TB (tuberculosis:include pulmonary tuberculosis and extra pulmonary tuberculosis) subjects judge the pulmonary tuberculosis patient according to Health industry standard of the People's Republic of China WS288-2008:Diagnostic for pulmonary tuberculosis to 65 years old ,no gender limited Consent and signed informed consent forms (ICF) Comply with follow-up of extra pulmonary tuberculosis subjects Diagnosed extra pulmonary tuberculosis by epidemiology, imaging, clinical symptoms, pathological examination and so on Lesions outside the lungs be in unfinished reinforced phase by chemotherapy of TB (tuberculosis) subjects Accompanied by the following severe illness:advanced cancer, diabetes, copd in acute episodes, acute/progressive liver disease or kidney disease, congestive heart failure, ect Taking part in other clinical or within three months involved in any other clinical Severe allergic constitution:allergic to two or more drugs in pregnancy or lactation in a mental illness Any conditions affect the trial evaluation by investigator's judgement of non-TB participants with lung disease A clear lung disease but can pulmonary tuberculosis by clinical symptoms, imaging, laboratory examination to 65 years old, no gender limited | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 25.0-44.0, Obesity Body Weight Changes Body mass index of 21 through 30 Presence of chronic disease that precludes regular physical activity or changes in dietary intake Currently receiving treatment for psychological disorder Currently pregnant or having given birth within last 12 months Use in last 3 months of weight loss medications or other drugs that affect body weight Participation in a weight loss program in last 12 months Planning to relocate outside the study area in the next 3 years | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 18.0-999.0, Hypothyroidism Male or female subjects >18 years of age Primary hypothyroidism ≥6 months duration arising from autoimmune hypothyroidism, thyroidectomy or radioiodine treatment Thyroxine dose ≥100 mcg/day No change in thyroxine dose in past 2 months Serum TSH of 0.1-4.8 mU/L Adequate contraceptive measures for women of childbearing age Major systemic illness affecting quality of life or likely to affect participation in the study Treatment with T3 currently or in past 2 months History of thyroid cancer requiring suppression of TSH secretion by thyroxine Ischaemic heart disease – previous myocardial infarction, angina or coronary artery revascularisation Renal failure: serum creatinine >135 micromol/L Known liver disease with alkaline phosphatase or ALT >2x upper limit of reference range Bony fracture in past 3 months or Paget’s disease of bone Secondary (central) hypothyroidism or hypopituitarism | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 25.0-80.0, Primary Insomnia patients aged 25 with insomnia, will be recruited over a 3-6 month interval All subjects will have a stable sleep/wake schedule with a preferred sleep phase between 10:00 PM and 8:00 AM Must live in the Greater Rochester NY area All subjects will meet diagnostic for Psychophysiological Insomnia according to the International Classification of Sleep Disorders (ICSD). are: the complaint of insomnia and impaired daytime function; an indication of learned sleep-preventing associations and somatized tension; active help seeking. The complaint of disturbed sleep will have one or more of the following characteristics: >30 minutes to fall asleep and/or >2 awakenings per night of >15 minutes duration and/or wake after sleep onset time of > 30 minutes, problem frequency >4 nights/ week, and problem duration >6 months. In addition, all subjects will complain of fatigue and/or sleepiness at intake As above | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 45.0-75.0, Obstructive Sleep Apnea Type 2 Diabetes Enrollment in LookAhead Type II Diabetes and Sleep Apnea Determined by parent study, LookAhead | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 18.0-50.0, Obesity Chronic Sleep Deprivation to 50 year old obese men and premenopausal women BMI between 29-55 Chronically (for more than 6 months) sleep-deprived, defined as sleeping on a regular basis less than or equal to approximately 6-1/2 hours/night by history and objective devices (wrist activity monitors and sleep logs) External comparison subjects for extension of Effectiveness Study must meet the above Diagnosed sleep disorders including Chronic insomnia Untreated sleep disordered breathing (sleep apnea at a level of severity [using standardized for measurement], or diagnosed UARS [upper airway resistance syndrome] that would impair the ability to increase sleep duration [Intervention Group] or maintain sleep duration [Comparison Group]. CPAP treatment that has been in place for 3 months or more and improves sleep is acceptable) Restless leg syndrome or periodic limb movement disorder Parasomnias (including REM sleep behavior disorders, confusional arousals, sleep terrors, sleepwalking, sleep violence) Primary bruxism is allowed as long as it does not interfere with the ability to sleep an additional 90 minutes a night Narcolepsy Central apnea Unstable weight (voluntary losses in BMI greater than 5% over the past 6 months); currently being enrolled in a weight loss program Untreated or uncontrolled diabetes | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 18.0-999.0, Diabetes Diabetes Mellitus, Type 2 Diagnosis of type 2 diabetes HbA1C <= 12.0% within the past 12 months BMI <= 45.0 kg/m2 Initiation, addition of, change to, or continuation of basal insulin therapy with insulin detemir as deemed necessary by Investigator Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors Proliferative retinopathy or maculopathy that has required acute treatment within the last 6 months Any glucose lowering medication that is not indicated in combination with insulin, such as GLP-1 Analogues Known hypoglycemia unawareness or recurrent major hypoglycemia, as judged by the Investigator | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 15.0-70.0, Autoimmune Thyroiditis Hashimotos Thyroiditis Clinically approved AIT patients who do not use any medication other than LT4 to keep TSH in the lower half of normal range Any kind of drug use other than LT4 or any kind of known pathology which may effect GIS absorption | 2 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 18.0-75.0, Secondary Hypothyroidism Hypopituitarism Hyperlipidemias hypopituitarism of at least 3 axes (TSH plus gonadotropin, somatotropin, corticotropin or ADH deficiency) termination of surgical or radiation treatment of pituitary tumors at least six month before study entry BMI of 20 9 kg/m2 non-smoking status history of cardiovascular or pulmonary diseases current thyroxin dosage > 1.6 µg/kg bw pregnancy epilepsy cerebrovascular diseases nodular goiter | 1 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 0.0-5.0, Congenital Hypothyroidism L-Thyroxine Follow-Up The diagnostic standard for manifest hypothyroidism and subclinical hypothyroidism was defined as follows Hypothyroidism TSH > 40 mU/L and T3 and T4 below the reference range or TSH > 40 mU/L, T3 normal and T4 below the reference range [2] Subclinical hypothyroidism TSH ≥ 20 mU/L, T3 and T4 normal or low-normal or TSH > 5.6 mU/L and < 20 mU/L on initial determination and on follow-up or TSH levels increase on follow-up and/or gradually declining T4 levels | 2 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 0.0-0.077, Hypothyroxinemia Birth weight: less than 1500g Gestation: 22 weeks 0 day ≤ Serum free thyroxine level lower than 0.8 ng/dl Serum thyrotropin lower than 10 μU/ml Age of between 2 and 4 weeks after birth Informed consent any known thyroid disease in mother | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 18.0-999.0, Sleep Disorders, Circadian Rhythm Females of childbearing potential who is sexually active must agree to use adequate contraception from screening throughout the duration of the study Must have a diagnosis of Delayed Sleep Phase Syndrome according to International Classification of Sleep Disorders for at least 3 months Based on sleep history, subject's habitual sleep time is more than 3 hours later than the desired sleep time Must have had self reported insomnia which is defined per the sleep history as his or her sleep latency of at least 45 minutes when attempting to sleep at desired sleep time required by his or her work or school schedule The subjective sleep latency via Post sleep questionnaire during outpatient screening period must be greater than or equal to 45 minutes during every working night or school night provided the subject went to bed at their desired sleep time During single blind placebo run-in Polysomnography screening nights, subject is instructed to go to bed at their desired bed time and must demonstrate difficulty in falling asleep based on the following During Polysomnography screening nights when the subject goes to bed at their desired sleep time or The average of total wake time Is in good health as determined by a medical and psychiatric history, physical examination, Electrocardiogram, and serum chemistry and hematology Is able to complete self-rating scales via interactive voice response system, and has a touch tone phone Has a known hypersensitivity to ramelteon or related compounds, including melatonin and melatonin-related compounds or 5-hydroxytryptophan Has participated in any other investigational study and/or taken any investigational drug within 30 days or 5 half-lives prior to the first dose of study medication, whichever is longer Has flown across greater than 3 time zones within the past 3 months prior to administration of study medication Has sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the administration of study medication Has participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the administration of study medication Has a history of alcohol abuse within the past 12 months, as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, or regularly consumes more than 14 alcoholic drinks per week or consumes any alcoholic drinks within 24 hours of Screening Visit Has a history of drug abuse within the past 12 months Has a current, clinically significant neurological (including cognitive), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, as determined by the investigator Has a probable current diagnosis of another circadian rhythm disorder or a sleep disorder other than Delayed Sleep Phase Syndrome that is the primary cause of insomnia Had an apnea hypopnea index greater than 10 on the first night of Polysomnography Screening | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 18.0-35.0, Weight Gain Age 18-35 Body mass index between 23 and 30 Interested in preventing weight gain BMI outside of range specified Age outside of range specified History of or current eating disorder or substance abuse Recent weight loss greater than 5% of weight Currently in another research study that would interfere | 2 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 18.0-80.0, Essential Tremor Subjects must be between the ages of 18 and 80 inclusive Each subject must have current manifestations of ET symptoms based on the Tremor Investigational Group (TRIG) for definite or probable ET Moderate or severe tremor in head or arms for at least 3 years duration No present causes of enhanced physiologic tremor No recent exposure to tremorogenic drugs or drug withdrawal states No direct or indirect trauma to the nervous system within 3 months preceding the onset of tremor No historic or clinical evidence of psychogenic tremor origin Subjects with a history of seizures are eligible Subjects must be in generally good health as evidenced by previous medical history and clinical examination Patients will be allowed to take Beta-blockers but will not be allowed to take any other medication for tremor (primidone, topiramate, benzodiazepines, etc.) An evening dose of a benzodiazepine to improve sleep is acceptable. They must have been on a stable dose of any existing beta-blocker for 4 weeks prior to entry into the study and will not be allowed to change the dose of that medication throughout the controlled portion of the study. Any medication discontinued during screening in order to comply with these must be stopped for 5 half-lives prior to study initiation Patients do not meet TRIG for probable ET Subjects who are not able to abstain from alcohol for 24 hours prior to each evaluation Patients who can not maintain an identical dose of any medicine that may affect tremor during their entire study involvement Subjects who have exhibited any psychotic symptomatology Subjects who have known renal deficiencies Subjects who have been intolerant of pregabalin in the past Prior surgical treatment for tremor Patients currently taking more than a single drug for ET Patients taking anti-seizure medications Breast feeding or pregnant females | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 25.0-50.0, Obesity Weight Gain Body mass index (BMI) 30-39.9 kg/m2 Age 25-50 years No more than 3 kg weight loss during past three months Negative pregnancy test at entry; women of childbearing potential may be enrolled if they have had a tubal ligation or use one of the following means of contraception: condom, diaphragm, oral or implanted contraceptives, or intrauterine device. Women in exclusive relationships with male partners who have had a successful vasectomy will not be required to use any additional means of birth control BMI < 30 or >40 Type II diabetes requiring the use of any oral antidiabetic agent and/or insulin (because of confounding effects on body weight regulation) Adverse response to study foods (lactose intolerance, dairy intolerance, dairy allergy); this will be determined by self-report History or presence of significant metabolic disease which could impact on the results of the study (i.e. endocrine, hepatic, renal disease) History of eating disorder Presence of active gastrointestinal disorders such as malabsorption syndromes Pregnancy or lactation Use of obesity pharmacotherapeutic agents within the last 6 months Use of over-the-counter anti-obesity agents (e.g. those containing phenylpropanalamine, ephedrine and/or caffeine) within the last 6 months Recent (past 12 weeks) use of tobacco | 2 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 18.0-48.0, Hypothyroidism Premenopausal women with overt primary hypothyroidism (reduced T4 concentration accompanied by increased TSH concentration at the time of initial diagnosis) who did not receive thyroid hormones Peri and postmenopause Pregnancy Major comorbidity Use of drugs that affect metabolism or bioavailability of thyroid hormones preparations | 2 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 18.0-65.0, Weight Gain Obesity Written informed consent is obtained The subject is English-speaking and 18 through 64 years of age inclusive The subject is currently receiving a serotonergic agent or is scheduled to receive a new or change in serotonergic psychotropic agents for their a psychiatric condition or can document that they have been on a stable regimen without any weight gain in last 3 months as a result The subject must have capacity to obtain and give informed consent The subject must express concern about weight gain as a potential serotonin side effect The patient is in good health as determined by a medical and psychiatric history, medical examination, and cannot have major medical illness that would jeopardize patient health during the study Women must be of nonchildbearing potential [i.e., postmenopausal, be surgically sterile (hysterectomy or tubal ligation)] or must meet all of the following conditions: using a reliable, medically accepted form of contraception for at least 60 days before the baseline visit, and agree to continue such use throughout the duration of the study and for 30 days after the final dose of study drug. Reliable forms of contraception oral, implanted, or injected contraceptives; intrauterine devices in place for at least 3 months; and adequate double-barrier methods in conjunction with spermicide (abstinence is considered an acceptable contraceptive regimen) Women must be given a urine pregnancy test (ßHCG), unless they are at least 2 years postmenopausal or surgically sterile, and the results of the test must be negative The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol The patient must be a voluntary admission inpatient at SUNY Upstate Medical University's Psychiatric department in order to enroll in the study The patient lacks capacity to make medical decisions and ability to receive and utilize the informed consent process due to their mental illness The patient is incapacitated by mental illness The patient is a significant risk of suicide as determined by the study team in this acute setting The patient has recently started a weight loss or exercise program or is taking an insulin resistance improving drug OR plans to start one upon discharge The patient has a co-morbid medical problem thought to induce weight gain or make it difficult to lose weight (ie hypothyroid, hypercortisol, diabetes…) The patient has previously ( in the last 2 months) lost or gained a significant amount of weight from any weight loss program, weight loss agent, or dietary medication The patient has used an investigational drug within 1 month before the screening visit or is participating in a concurrent clinical trial The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery) The patient is highly unlikely to comply with the study protocol, be unreliable in providing ratings, or is unsuitable for any reason, as judged by the investigator The patient has a clinically significant deviation from normal in the physical examination or medical history (renal or hepatic problems) which makes subject medically unstable at time of screening | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 21.0-999.0, Weight Loss Age range: 21 years and older Body mass index between 25.0-39.9 kg/m2 Weight stable (< 4.5 kg (~10 lbs) weight gain or loss within last 6 months) Body fat >25% (assessed by skinfold and plethysmography (if needed)) Non-smoking (within the last 6 months) Constant habitual activity patterns (within last 3 months) Clinically normal blood profiles (specifically, normal liver and kidney function; fasting blood glucose <110 mg/dl) Not taking medications known to influence appetite or metabolism Non-diabetic Age: <21 years Body mass index: outside of the 25.0-39.9 kg/m2 range Gained or lost > 4.5 kg (10 lbs) within the last 6 months Body fat <25% as assessed by plethysmography Smoker (currently or within the last 6 months) Intermittently been involved in a diet and/or exercise program within the last 3 months Clinically abnormal blood profiles as identified by our study physician, Arthur Rosen, MD Taking medications (currently or within the last 3 months) known to influence appetite or metabolism Clinically diagnosed as diabetic Allergies to eggs | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 18.0-999.0, Fibromyalgia Fibromyalgia using ACR diagnosis Other confounding disease including other inflammatory disease, pain and depression | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 21.0-35.0, Obesity Healthy normal and obese volunteers serious medical or neurological condition | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 18.0-85.0, Rheumatoid Arthritis Rheumatoid arthritis patients will meet American College of Rheumatology revised (Arnett, Edworthy et al. 1988). This requires at least four of the following seven 1) morning joint stiffness; 2) arthritis in 3 or more joint areas; 3) arthritis of hand joints; 4) symmetric arthritis; 5) rheumatoid nodules; 6) presence of serum rheumatoid factor and 7) changes on posteroanterior hand and wrist radiographs. In addition, 1-4 must be present for at least four weeks. Subjects must be between 18 and 85 years of age If rheumatoid arthritis patients are receiving treatment with traditional disease modifying antirheumatic drugs (DMARD), such as methotrexate, sulfasalazine or hydroxychloroquine, they must be on a stable regime for one month before study and stable throughout study If rheumatoid arthritis patients have received treatment with a TNF antagonist or other biologic medication, they must be drug free for greater than 3 months Steroids Individuals currently taking greater than an equivalent of 10 mg of prednisone will be excluded given the potent anti-inflammatory effects of such medications Opioids Individuals using multiple daily dosage schedule of opioid agents such as oxycodone (Percocet), hydrocodone (Vicodin), morphine, Dilaudid will be excluded Co-morbid medical disorders the presence of active unstable and uncontrolled co-morbid medical conditions such as diabetes, cardiovascular diseases, and cancer will be exclusionary criteria. In particular, individuals with co-morbid inflammatory disorders such as Crohn's disease and ulcerative colitis and other autoimmune disorders will be excluded. Any uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or put the study participant at undue risk will also be considered exclusionary criteria Chronic infections individuals with chronic infections will also be excluded because of effects on immune markers measured in study Co-morbid pain disorders individuals with co-morbid pain disorders such as fibromyalgia will also be excluded. Individuals with fibromyalgia have been found to have sleep abnormalities as well as daytime fatigue and pain (Drewes 1999) and thus could confound findings | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 25.0-999.0, Obesity Morbid Obesity Obese and morbidly obese women (BMI 30 years and older undergoing laparoscopic gastric bypass surgery Present with at least either metabolic syndrome or diabetes Have smoked in the past 4 weeks Pregnant Allergic or intolerant to ingredients used in the study (e.g. soy and THIAA) There is a sound medical, psychiatric and/or social reason as determined by the Principal Investigator (PI) that makes the subject unsuitable for the study | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 18.0-999.0, Neoplasms, Lung Carcinoma, Non-Small Cell Lung Drug Therapy Genes, EGFR Male and female patients aged over 18 years Histologically proven lung adenocarcinoma clinical stage IIIB/IV ECOG performance status 0-2 Had no prior anticancer agent, radiation or surgical therapy for lung adenocarcinoma At least one measurable lesion (according to Provision of written informed consent Life expectancy of at least 12 weeks History of malignant disease Evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded) Expected life expectancy less than 2 months As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x ULN if no demonstrable liver metastases (or >5 x in presence of liver metastases) Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 35.0-60.0, Hypothyroidism Recently diagnosed hypothyroid subject (either during the period, or within the 6 previous months) for whom, data related to the diagnosis is available if the diagnosis was not carried out initially by the investigating doctor Subject, who has given his/her oral consent for participation Subject included in clinical trial or having participated in a clinical trial during the last 3 months Subject presenting a major and objectifiable risk of not being able to follow-up until the next TSH level (moving, problems encountered during another study, pathology affecting the vital prognosis in the short-term) All contraindications to Lévothyrox | 2 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 18.0-999.0, Major Depressive Disorder Patients must be adult, diagnosed with major depressive disorder and treated with pharmacotherapy Physicians must be either a psychiatrist or a primary care physician, a prescriber of Pristiq, have at least 3 charts representing the 4 identified patient types, have been in clinical practice between 4 and 35 years, primarily office based (50%+), not participated in a research study relating to antidepressants or antidepressant therapy within the past month, not a consultant or have a professional relationship with a pharmaceutical company other than for clinical trials or speaking engagements, and not be employed by of affiliated with an advertising agency, market research company, or pharmaceutical company Patients who have not been treated for depression | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 20.0-999.0, AITd Patients With Different Polymorphisms Autoimmune thyroid patients patients who cut Nodular Goiter in Wanfang Hospital | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 18.0-90.0, Central Hypothyroidism Clinical evidence of central hypothyroidism: status post pituitary surgery and/or radiotherapy plus laboratory documentation of central hypothyroidism, with or without concurrent hormonal deficiencies in other axes, such as ACTH, LH, FSH Primary hypothyroidism | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 18.0-999.0, Recurrent Melanoma Stage IV Skin Melanoma Patients must have histologically confirmed melanoma with evidence of metastatic disease either by radiologic or physical examination In-transit metastases are allowed Biopsy should be performed to reconfirm the diagnosis in cases of doubt Patients must have measurable disease For computed tomography (CT) imaging, this is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral CT scan For cutaneous lesions, these must be measurable with a ruler and documented photographically with a ruler in place There are no limits on the number of prior therapies; patients must not have received a vaccine containing any of the melanoma antigen peptides, nor previously received daclizumab; at least 4 weeks must have passed since prior chemotherapy or radiation therapy (6 weeks for BCNU [carmustine] or mitomycin C) Life expectancy greater than or equal to 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky ≥ 80%) Leukocytes ≥ 3,000/mcL Patients who have had chemotherapy, biological or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier Patients may not be receiving any other investigational agents Presence of untreated brain metastases; all patients must undergo brain imaging as part of the pre-study evaluation; only patients with no brain metastases, or with brain lesions successfully treated by stereotactic radiation or surgical removal without progression at 28-day follow-up and off corticosteroids for 4 weeks, will be eligible History of allergic reactions attributed to compounds of similar chemical or biologic composition IL-12 or other agents used in the study Concurrent systemic corticosteroids (except physiologic replacement doses) or other immunosuppressive drugs (eg. cyclosporin A) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with IL-12; women of child-bearing age must be tested for urinary or serum beta-human chorionic gonadotropin (HCG) Patients with intrinsic immunosuppression, including seropositivity for human immunodeficiency virus (HIV) antibody; patients should be tested for HIV; HIV-positive patients are ineligible Psychiatric illness that may make compliance to the clinical protocol unmanageable or may compromise the ability of the patient to give informed consent; patients with clinical evidence of dementia should have a competent designee participate in decision making Serious concurrent infection, including active tuberculosis, hepatitis B, or hepatitis C; patients should be tested for hepatitis B surface antigen and hepatitis C antibody; patients who are hepatitis C antibody (Ab) positive can be eligible if they are polymerase chain reaction (PCR)-negative | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 18.0-70.0, Androgenetic Alopecia Male, age 18 to 70 year old, in general good health Exhibits male AGA based on a discernable hair loss in temple and vertex region rating Hamilton-Norwood Scale III vertex to VI (See Appendix 1) Subjects who give their consent to the study after thorough explanation and who personally signed and dated the informed consent document indicating that the subject, has been informed of all pertinent aspects of the trial Willing to maintain the same hairstyle, hair length and hair color throughout the study Subjects who are willing and able to comply with scheduled visits, treatment plan, mini-tattoo and other trial procedures Accepting the Information form plus accepting and signing the Informed Consent form Known to be hypersensitive to minoxidil, hair dye (p-phenylenediamine), tattoo ink, fragrances, hair gel or any vehicle components Current or 4 weeks dated back use of medical shampoos or solutions which Ketoconazole or the like (e. g. Terzolin®) in the target region interfering with the CTM or examination method Current or 3 months dated back use of topical treatment in the target regions taken for more then 2 consecutive weeks interfering with the CTM (topical corticosteroids, aminexil, minoxidil, estrogens) Current or 3 months dated back use of systemic treatment (drugs or dietary supplement) taken for more than 2 consecutive weeks interfering with the CTM or examination method (beta blocker, cimetidine, diazoxide, isotretionin, corticosteroids, vitamin A intake above 10000 IU per day) Current or 12 months dated back use of Finasteride (Propecia®, FinaHair®, etc.), Dutasteride or a similar product Within past 12 months undergoing chemotherapy or receiving cytotoxic agents as well as radiation and/or laser/surgical therapy of the scalp Current or prior enrollment in any other investigational medication (drug) study within the 4 weeks prior to study initiation Presence of hair transplants, hair weaves or non-breathable wigs and hair bonding Current or 2 months dated back severe diet or presenting a history of eating disorder Any dermatological disorders of the scalp in the target region with the possibility of interfering with the CTM or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars or scalp atrophy | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 18.0-70.0, Thyroiditis, Autoimmune adults 18-70 years of age having positive antibodies against thyroid peroxidase having sonographic evidence consistent with a diagnosis of Hashimoto's thyroiditis having evidence of end-stage thyroiditis being a current smoker or smokeless tobacco user be taking systemic glucocorticoids, interferon-alpha, anti-CD20 antibody, or anti-CTLA-4 antibody be taking any medication for treatment of autoimmune thyroiditis other than L-thyroxine or equivalent | 1 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 0.0-999.0, Hypopituitarism All patients with pituitary hypopituitarism Unavailability of data | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 0.5-1.5, Down Syndrome patient with a karyotype demonstrating homogeneous, free or Robertsonian translocation trisomy 21 patient having undergone a cardiac ultrasound not demonstrating any severe heart disease patient aged 6 to 18 months at congenital hypothyroidism hypothyroidism demonstrated by laboratory tests presenting or having presented hyperthyroidism presenting or having presented leukaemia presenting or having presented West syndrome or any other form of epilepsy or unstable neurological disease presenting or having presented signs of central nervous system distress: stroke, postoperative hypoxia, meningitis) presenting severe heart disease on cardiac ultrasound, with haemodynamic effects presenting non-controlled cardiac arrhythmia Apgar < 7 to 5 min at birth Gestational age < 245 days (35 weeks) | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 18.0-65.0, Primary Hypothyroidism. Patients will be between the ages of 18 to 65 and will have been on levothyroxine for primary hypothyroidism for at least 6 months Patients will be excluded if they have the following problems: pregnancy, plan for pregnancy in the next 12 months, cardiac disease, especially coronary artery disease, chronic obstructive lung disease, malabsorption disorder, gastrointestinal surgeries, significant renal or liver dysfunction, seizure disorders, thyroid and non-thyroid active cancers, uncontrolled psychosis, psychotropic medication use, steroid use, amiodarone, chemotherapy for cancer, iron supplement more than 325mg per day, carafate/ proton pump inhibitor use, cholestyramine use, and those with recent PCS orders who are expected to move out of the geographic area, age less than 18 years old or older than 65 years old Patients scheduled for deployment will be excluded | 0 |
A 25-year-old woman presents to the clinic complaining of prolonged fatigue. She denies difficulty sleeping and sleeps an average of 8 hours a night. She also notes hair loss, a change in her voice and weight gain during the previous 6 months. She complains of cold intolerance. On examination she has a prominent, soft, uniform anterior cervical mass at the midline. | eligible ages (years): 18.0-999.0, Metastatic Breast Cancer OF (MOST for first-line therapy • Histologically confirmed breast cancer with distant metastases Note A biopsy from the primary tumor or a metastasis can be used for diagnosis Patients with non-measurable lesions are eligible Patients with inoperable, locally advanced breast cancer with lymph node metastases other than ipsilateral locoregional (axillary, infraclavicular, parasternal) or other distant metastases are eligible Patients with bone metastases with or without bone targeted therapy (bisphosphonates, denosumab) are eligible Patients with de-novo Stage IV disease are eligible HER2-positive tumor according to central pathology testing for HER2 for first-line therapy • Prior chemotherapy for inoperable locally advanced or metastatic breast cancer Note Prior neoadjuvant/adjuvant chemotherapy is allowed if doses for anthracyclines have not exceeded 720mg/m2 and 240mg/m2 for epirubicin and doxorubicin, respectively Re-exposure to paclitaxel is permitted, if the last dose of taxane was given at least 1 year before randomization Re-exposure to vinorelbine is permitted, if the last dose of vinorelbine was given at least 1 year before randomization Prior anti-HER2 treatment for metastatic or inoperable breast cancer Note Prior neoadjuvant/adjuvant anti-HER2 treatment with trastuzumab and/or lapatinib is allowed • More than one endocrine treatment line for metastatic or inoperable breast cancer exceeding a duration of 1 month | 0 |
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