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A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented. | eligible ages (years): 18.0-45.0, Postprandial Glycemia Age 18-45 Male No regular medication No participation in a drug trial or blood donation within 2 months Non-smoker Signs informed consent Body mass index 18.5-27 kg/m2 Fasting plasma cholesterol < 5.5 mmol/l Fasting plasma triacylglycerols < 2.6 mmol/l Fasting plasma glucose 4-6 mmol/l Regular smoking Alcohol abuse Regular medication | 0 |
A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented. | eligible ages (years): 18.0-999.0, Foreign Object Accidentally Left in Body During Surgical and Medical Care Healthy men and women Ages 18 or older - Under 18 years of age Pregnant female or if female has not had a negative pregnancy test prior to the research scans | 2 |
A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented. | eligible ages (years): 10.0-999.0, Keloid Cicatrix Hypertrophic Keloids, defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion Hypertrophic scars1 older than 12 months and insensitive to other treatments. Keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (>1yr) A period between previous treatment and IL cryotherapy covered a minimum of 12 weeks Patients with all Fitzpatrick17 skin types Patients older than 10 years of age pregnancy diabetes mellitus | 0 |
A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented. | eligible ages (years): 35.0-70.0, Skin Aging female gender age > 35 years old good general state of health woman who had already undergone Hyaluronic acid injections woman who have not applied any retinoid product in the last 3 months woman who are not in a recovery period after laser/peeling/acne treatment accepting to return to the centre for the planned visits accepting to follow the investigator's instructions during the entire study period agreeing to present at each study visit without make-up accepting to not change their habits regarding: food, physical activity, face cleansing and make-up use Pregnancy (only for subjects not in menopause) lactation (only for subjects not in menopause) subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study subjects not in menopause who do not accept to perform the pregnancy test during the basal visit (T0), 6 and 12 weeks after the intradermal implant execution subjects participating to a similar test less than 3 months ago sensitivity to the test products or theirs ingredients subjects whose insufficient adhesion to the study protocol is foreseeable dermatitis presence of cutaneous disease on the tested area as lesions, scars, malformations clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.) | 0 |
A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented. | eligible ages (years): 18.0-999.0, External Genital Warts Adults at least 18 years old with at least two visible EGWs Subject must be in good general health as confirmed by the medical history Subject must be able to read, sign, and understand the informed consent Subject must be willing to forego any other treatments for his/her EGW lesions Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods and to comply with all study requirements including concomitant medication and other treatment restrictions If subject is a female of childbearing potential she must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study Subject with any evidence of herpes genitalis or any other current and/or recurrent genital or uncontrolled infection, including Human Immunodeficiency Virus, Hepatitis B or Hepatitis C Subject with an unstable medical condition as deemed by the clinical investigator Subject with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of EGW lesions Subject who has previously been treated in an EGW clinical trial, had treatment of anogenital warts or had systemic intake of virostatics or immunosuppressive medication within 30 days prior to Baseline Visit Women who are pregnant, lactating, or planning to become pregnant during the study period Subject who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc) Subject who have active chemical dependency or alcoholism as assessed by the investigator Subject who have known allergies to any component of the study ointment Subject who have organ allograft, skin conditions that may interfere with study ointment, or having internal (vaginal or rectal) warts that have required treatment Subject who has received any of the following within 90 days prior to study treatment initiation | 0 |
A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented. | eligible ages (years): 18.0-80.0, Bleeding Patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included bleeding tendency, poor preparation, sessile polyp | 0 |
A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented. | eligible ages (years): 18.0-999.0, Seborrheic Keratosis Subject is at least 18 years of age Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis Subject has 4 appropriate seborrheic keratosis target lesions, as defined below (Section 5.4), on the trunk/extremities Have a clinically typical appearance Be treatment naïve Have a PLA of ≥2 (Section 6.1.2) Have a longest axis that is ≥7mm and ≤15mm (Section 6.1.3) Have a longest dimension perpendicular to the longest axis that is ≥7mm and ≤15mm (Section 6.1.3) Have a thickness that is ≤3mm Be a discrete lesion Subject has clinically atypical and/or rapidly growing seborrheic keratosis lesions Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Lesser-Trelat) Subject has a current systemic malignancy Subject has a history of keloid formation or hypertrophic scarring Subject has used any of the following systemic therapies within the specified period prior to Visit 1 Retinoids; 180 days Glucocorticosteroids; 28 days Anti-metabolites (e.g., methotrexate); 28 days Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, or in a proximity to the target lesion, that in the investigator's opinion, interferes with the application of the study medication or the study assessments LASER, light (e.g., intense pulsed light [IPL], photo-dynamic therapy [PDT]) or other energy based therapy; 180 days | 0 |
A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented. | eligible ages (years): 0.0-999.0, Melanoma All patients referred to the Dermatology Department, Lanarkshire Hospitals during a period to be defined for assessment of suspicious skin lesions (cutaneous moles) will be eligible for in the study. There are no age limits but patients under the age of 18 years will also have their subject to parental/guardian consent There is no exclsion | 1 |
A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented. | eligible ages (years): 18.0-999.0, Brain Micrometastases Adult patients with brain metastasis from any primary tumour receiving GKR All intracranial micro-metastases including lesions located in the cerebral hemispheres, thalamus, basal ganglia and cerebellum and excluding lesions located in the brain stem below the level of the superior colliculi Target volume < 0.14 cc3 and maximum diameter < 7 mm The subject consents to participate in the study Inability to consent Younger than 18 years of age Lesions in the brainstem (below the level of the superior colliculi) are better treated with the 4 mm collimator and they will be excluded from the study Patients with more than 25 brain lesions suitable for randomisation will be excluded from the study Co-morbidity or previous treatment such as surgery, chemotherapy or WBRT is not to be considered as Pregnancy in the context of brain metastases is not a contraindication for GKR, and therefore it will not be considered as for this trial | 0 |
A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented. | eligible ages (years): 18.0-75.0, Seborrheic Keratosis Subject is at least 18 years of age Subject has a Fitzpatrick skin type of 1-4 Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis Subject has 1 appropriate seborrheic keratosis target lesion, as defined below (Section 5.4), on the face Have a clinically typical appearance Be treatment naïve Have a PLA of ≥2 (Section 6.1.2) Have a longest axis that is ≥7mm and ≤15mm (Section 5.4) Have a longest dimension perpendicular to the longest axis that is ≥7mm and ≤15mm (Section 5.4) Have a thickness that is ≤2mm Subject has clinically atypical and/or rapidly growing seborrheic keratosis lesions Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Lesser-Trelat) Subject has a current systemic malignancy Subject has a history of keloid formation or hypertrophic scarring Subject has used any of the following systemic therapies within the specified period prior to Visit 1 Retinoids; 180 days Glucocortico-steroids; 28 days Anti-metabolites (e.g., methotrexate); 28 days Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, or in a proximity to the target lesion, which in the investigator's opinion, interferes with the application of the study medication or the study assessments LASER, light (e.g., intense pulsed light [IPL], photo-dynamic therapy [PDT]) or other energy based therapy; 180 days | 0 |
A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented. | eligible ages (years): 18.0-65.0, Keratosis, Seborrheic Subjects are Caucasian or Asian Subjects who are between 18-65 year olds Subjects have flat or macular seborrheic keratosis on dorsum of the hands and wrists, extensor surfaces of the forearms. The diagnosis of flat seborrheic keratosis is confirmed by two clinical dermatologists using routine clinical examination and dermoscopy Subjects have Fitzpatrick skin type I-III Subjects are in good health Subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator History of keloids or hypertrophic scars Pregnant or lactating or intends to become pregnant in the next 3 months Active skin disease or skin infection in the treatment area Previous history of lidocaine allergy History of methemoglobinemia Unable to understand the protocol or to give informed consent Any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical study or would pose as an unacceptable risk to subject | 0 |
A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented. | eligible ages (years): 18.0-999.0, Breast Neoplasm Have had stereotactic or ultrasound-guided biopsy with marker placement Have a lesion or biopsy marker that is visible under ultrasound Have a surgical target =< 6 cm from the skin when lying supine Have a discreet surgical target Have a lesion in which the center/focal area is defined Have the ability to understand and the willingness to sign a written informed consent document Eastern Cooperative Oncology Group (ECOG)/Karnofsky performance status will not be used as an criterion Ability to understand and the willingness to sign a written informed consent document Require more than one localization needle for localization of the surgical target (bracket localization) Have undergone previous open surgical biopsy, lumpectomy, or mastectomy in the operative breast Have a prosthesis/implant in the operative breast Have a cardiac pacemaker or defibrillator device Be contraindicated for surgery Be pregnant | 0 |
A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented. | eligible ages (years): 20.0-999.0, Colonic Polyp All those over the age of 20 years who agree informed consent and who have at least one polyp of eligible size (6-10 mm) (1) patients taking anticoagulant therapy during the past 1 week of the procedure, (2) known coagulopathy, (3) history of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel diseases or significant infectious disease, (4) American Society of Anesthesiology class III or more, and (5) pedunculated polyps and polyps with malignant feature | 0 |
A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented. | eligible ages (years): 12.0-999.0, Acne Vulgaris Male or female at least 12 years of age and older Written and verbal informed consent must be obtained Subject must have a score of moderate or severe on the Evaluator's Global Severity assessment Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at the screening and baseline visits Subjects must be willing to comply with study instructions and return to the clinic for required visits Any dermatological conditions on the face that could interfere with clinical evaluations Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive Subjects with a facial beard or mustache that could interfere with the study assessments Subjects who are unable to communicate or cooperate with the Investigator Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subjects safety while participating in the study | 0 |
A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented. | eligible ages (years): 9.0-999.0, Acne Vulgaris Male or female at least 9 years of age and older Written and verbal informed consent must be obtained Subject must have a score of moderate or severe on the Evaluator's Global Severity assessment at the screening and baseline visit Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening and baseline visits Subjects must be willing to comply with study instructions and return to the clinic for required visits Any dermatological conditions on the face that could interfere with clinical evaluations Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive Subjects with a facial beard or mustache that could interfere with the study assessments Subjects who are unable to communicate or cooperate with the Investigator Subjects with any underlying disease that the Investigator deems uncontrolled and poses a concern for the subject's safety while participating in the study | 0 |
A 43-year-old woman visits her dermatologist for lesions on her neck. On examination, multiple lesions are seen. Each lesion is small soft, and pedunculated. The largest lesion is about 4 mm in diameter. The color of different lesions varies from flesh colored to slightly hyperpigmented. | eligible ages (years): 18.0-60.0, Dermatitis Healthy Subjects with Fitzpatrick Skin Types I, II or III Subjects with visible skin disease, tattoos, skin condition, or abnormal skin color | 1 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, HIV Infections for Step 1 HIV infected Triple-class antiretroviral treatment, as determined by the site investigator and as defined by all of the following: a) exposure to 2 or more nucleotide reverse transcriptase inhibitors (NRTIs) for at least 3 months each; b) exposure to 2 or more non-boosted protease inhibitors (PIs) for at least 3 months each, or exposure to a dual PI regimen for at least 3 months; and c) exposure to at least 1 non-nucleotide reverse transcriptase inhibitor (NNRTI) for at least 3 months CD4 cell count of at least 50 cells/mm3 within 45 days prior to study entry Viral load of 2000 copies/ml or more within 45 days prior to study entry On current antiretroviral treatment regimen for at least 30 days prior to study entry. If current treatment includes abacavir, abacavir must be discontinued at least 30 days prior to study entry Willing to use acceptable methods of contraception for Step 1 Pregnant or breastfeeding Allergy or sensitivity to the study drugs and their formulations Diabetes mellitus Cataracts or any measurable loss of vision due to lens opacity Best-corrected visual acuity worse than 20/200 Certain drugs or vaccines within 30 days prior to study entry History of any of the following: kidney disease; serious illness within 14 days prior to study entry; end organ cytomegalovirus infection; Kaposi's sarcoma; cataracts; active herpetic infection or peptic ulcer disease within 12 months; or malabsorption, severe chronic diarrhea, or inability to eat 1 or more meals a day because of chronic nausea, emesis, or abdominal/mouth and throat discomfort Current alcohol or drug abuse that would interfere with adherence to study requirements | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Peptic Ulcer Hemorrhage Patients must be men or non-pregnant women at least 18 years of age Patients who present with a gastric or duodenal ulcer Patients with ulcer appearance of clean base (non-oozing, non-spurting) or flat pigmented spot; adherent clots not removed by irrigation Patients presenting with active bleeding and/or NBVV at 2 or more separate sites Patients with any severe concomitant diseases, eg, end stage liver or renal disease, or unstable cardiovascular, pulmonary, renal, hepatic, or gastrointestinal diseases | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 0.0-6.0, Asphyxia Neonatorum Hypoxia Encephalopathy Seizures The infant will be assessed sequentially by A, B and C listed below A. Infants =>36 completed weeks gestation admitted to the NICU with at least one of the following Apgar score of =<5 at 10 minutes after birth Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth Acidosis within 60 minutes of birth (defined as any occurrence of umbilical cord, arterial or capillary pH <7.00) Base Deficit =>16 mmol/L in umbilical cord or any blood sample (arterial, venous or capillary) within 60 minutes of birth Infants that meet A will be assessed for whether they meet the neurological abnormality entry (B) by trained personnel B. Moderate to severe encephalopathy, consisting of altered state of consciousness (lethargy, stupor or coma) AND at least one of the following hypotonia abnormal reflexes including oculomotor or pupillary abnormalities Infants expected to be > 6 hours of age at the time of randomisation Major congenital abnormalities, such as diaphragmatic hernia requiring ventilation, or congenital abnormalities suggestive of chromosomal anomaly or other syndromes that brain dysgenesis | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Peptic Ulcer Male or female non-cirrhotic patients at least 18 years old suspected to bleed from PU Patients with haematemesis and/or hematochezia and/or melena which have been observed by a member of a clinical team (GP, hospital physician, nurse, ...) Either, documented signs of hypovolemia related to the current bleeding episode Or, occurrence of symptoms of hypovolemia Treatment of the present bleeding episode with somatostatin or its analogues, vasoactive drugs, or endoscopic therapy Any treatment with PPIs (IV or per os) within the last 48 hours preceding randomisation Treatment (endotherapy or pharmacotherapy) for upper gastrointestinal ulcer bleeding in the last 30 days Deficient haemostasis (platelets < 40 x 109/l, international normalised ratio of the prothrombin time > 1.5 (or prothrombin time < 70%), or activated partial thromboplastin time > 40 seconds (or according to the normal ranges validated, from local lab)) Anticoagulant therapy (vitamin K antagonists or heparin including LMW heparins) Terminal stage illness in which endoscopy is contraindicated | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Peptic Ulcer Patient has non-NSAID (non-steroidal anti-inflammatory drugs), non-Helicobacter pylori bleeding peptic ulcer Age > 18 years old Informed consent Concommitant use of high dose steroid or warfarin New start on non-steroidal anti-inflammatory drugs or aspirin or COX2 inhibitors Renal failure (serum creatinine > 200umol/l) Previous gastric surgery Oesophagitis, esophageal varices Terminal illness or malignancy | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Peptic Ulcer Hemorrhage Clean base ulcer with severe upper GIB (defined as melaena, hematochezia, hematemesis, and/or gross blood in NG lavage), and any one of the following SBP ≤ 90mmHg; P of ≥110 bpm; or orthostatic changes with SBP drops 20mmHg or P increases 20 bpm; or Transfusion of 2 or more units of packed red blood cells within 12 hrs of admission; or A documented HCT drop of at lest 6% from baseline Endoscopically confirmed bleeding from GU, DU, pyloric ulcer, or anastomotic ulcer Pt can either have primary or secondary acute UGI haemorrhage Bleeding site from lesion other than GU, DU, pyloric or anastomotic ulcer there is more than one type of significant bleeding lesion Documented hx of cirrhosis / portal HT ESRF requiring any form of dialysis Expected or persistent (>24hrs) coagulopathy with INR> 1.5 Platelet count is under 50000/mm3 Aspirin User / Plavix [Clopidogrel] User If the ulcer is neoplastic Cannot obtained consent Age < 18 or is pregnant | 1 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-90.0, Peptic Ulcer Hemorrhage all consecutive patients admitted for peptic ulcer bleeding (including bleeding anastomotic ulcers) with emergency endoscopy done in 24 hours after admission with Forrest type Ia, Ib, and IIa, IIb age 15 years Written consent available ulcer bleeding not controlled in first endoscopy Bleeding from malignant ulcer or tumor Bleeding from Dieulafoy lesion/ angiodysplasia Bleeding from injection sclerotherapy ulcer Patient with ASA category 5 | 1 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 16.0-999.0, Peptic Ulcer Hemorrhage Age >16 , can obtain written consent Ulcers that require endoscopic therapy with SRH: Forrest I a, Ib, II a and II b Moribund patients with terminal malignancy Pregnancy Intercurrent ulcer complication that prevents treatment and surgery becomes mandatory such as bulbar stenosis and ulcer perforation | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Cardiac Arrest Male or female patients ≥ 18 years Witnessed out-of-hospital cardiac arrest of presumed cardiac origin in which the initial rhythm is ventricular fibrillation, ventricular tachycardia, pulseless electrical activity (PEA) or asystole First attempt at resuscitation (ACLS or CPR) by emergency medical personnel initiated within 15 minutes of collapse Restoration of spontaneous circulation (ROSC) within 60 minutes of collapse Time from restoration of spontaneous circulation to initiation of cooling is ≤ 6 hours Informed consent provided by authorized representative/family member Temperature of less than 35C on admission Comatose or vegetative state prior to cardiac arrest Positive pregnancy test Purposeful response to verbal commands after ROSC and prior to initiation of hypothermia Evidence of hypotension (MAP<60) for more than 30 minutes after ROSC and prior to initiation of hypothermia Evidence of hypoxia (oxygen saturation<85% despite supplemental oxygen) for more than 15 minutes after ROSC and prior to initiation of hypothermia Terminal illness that preceded the arrest (life expenctancy < 1 year) Patients experiencing cardiogenic shock Patients continuing to experience refractory ventricular arrhythmias at the time of enrollment Patients receiving 2 or more high dose vasopressors | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Shock Mean arterial pressure less than 70 mmHg or systolic pressure less than 100 mmHg persisting despite adequate fluid loading (in example with at least 1000 mL crystalloid or 500 ml colloid) unless central venous pressure (CVP) or pulmonary artery occluded pressure (PAOP) are elevated (e.g. CVP> 12 mmHg or PAOP > 14 mmHg) Serious arrhythmia such as rapid atrial fibrillation (> 160/min) or ventricular tachycardia Brain death Open label administration of dopamine, norepinephrine, epinephrine or phenylephrine for more than 4hours | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 15.0-999.0, Shock, Traumatic Blunt or penetrating trauma Prehospital Systolic Blood Pressure (SBP) <= 70;OR Prehospital SBP 71-90 AND Hear Rate (HR) ≥108 years of age or older, or 50kg or more if age unknown Known or suspected pregnancy Age younger than 15 or less than 50kg if age unknown Ongoing prehospital cardiopulmonary resuscitation (CPR) Administration of more than 2000cc crystalloid or any colloid or blood products Severe hypothermia (suspected Temperature less than 28 degrees celsius) Drowning or asphyxia due to hanging Burns Total Body Surface Area (TBSA) more than 20% Isolated penetrating injury to the head Inability to obtain prehospital intravenous access Time of call received at dispatch to study intervention greater than four hours | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-90.0, Peptic Ulcers Upper Gastrointestinal Bleeding Consecutive patients admitted for upper gastrointestinal bleeding secondary to peptic ulcers that have been successfully treated with endoscopic therapy Variceal esophageal bleeding Concurrent PPI use Moribund patients | 1 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-79.0, Hypothermia Heart Arrest Age between 18 and 79 years old Out-of-hospital cardiac arrest (OH-CA) due to a presumed cardiac etiology Delay between OH-CA and return of spontaneous circulation (ROSC) < 60 minutes Delay between ROSC and starting cooling < 240 minutes Patient not obeying verbal command after ROSC and prior to starting cooling Availability of the "CoolGard" device (ALSIUS product) Do not reanimate order or terminal disease before Known pregnancy Clinical hemorrhagic syndrome or known coagulopathy Contra-indication to device usage (such as femoral venous access impossible) Hypothermia at admission < 30°C Etiology of OH-CA thought to be extra-cardiac (trauma, bleeding or anoxia) In hospital cardiac arrest Refractory shock (need for extra-corporeal life support) | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-40.0, Nausea Vomiting Cesarean Section Must be pregnant with a single baby Must be at term in their pregnancy (estimated gestational age of at least 38 weeks) Must be scheduled for an elective Cesarean section Must be between 60-70" tall Must be free of severe systemic disease (ASA class I or II) Contraindication to spinal anesthesia Any allergy to any of the medications included in the study History of pregnancy-induced hypertension or preeclampsia History of preexisting hypertension Diabetes mellitus Hyperemesis gravidum Previous perioperative nausea and vomiting History of motion sickness Women carrying a fetus with a known abnormality will also be excluded from the study | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Gastric Ulcer Duodenal Ulcer Daily intake of low-dose Aspirin (ASA) The subject must fulfill at least one of the following (a-e) Aged ≥65 years Aged ≥18 years and with a documented history of uncomplicated peptic ulcer(s) Aged ≥60 years and naïve to low-dose ASA (ie, treatment started within 1 month prior to randomization) Aged ≥60 years and with stable coronary artery disease Aged ≥60 years and with complaints of upper gastrointestinal (GI) symptoms that, as judged by the investigator, requires an Esophagogastroduodenoscopy (EGD) and with the finding of ≥5 gastric and/or duodenal erosions at the baseline endoscopy Peptic ulcer(s) at baseline esophagogastroduodenoscopy (EGD) Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline History of peptic ulcer complications such as clinically significant bleeding and/or perforation | 1 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-75.0, Healthy Males 18 to 45 (Groups 1-9) or 55 to 75 (Group 10) years of age No clinically important abnormal physical, laboratory, ECG findings Normal (or abnormal but ncs) supine blood pressure (BP) and heart rate (HR) Self or family history of cardiovascular or pulmonary disorder, coagulation or bleeding disorders or reasonable suspicion of vascular malformations eg cerebral haemorrhage, aneurysm or premature stroke Any autoimmune disease Previous allergic reaction to immunoglobulin Present, or history of, severe allergy, for example asthma or anaphylactic reactions or allergy requiring treatment Consumption of aspirin, other non-steroidal anti-inflammatory drugs or other drugs known to affect platelet function or any other aspect of coagulation within 14 days before drug administration Abnormal platelet function or clinically significant out of range values for any coagulation tests History of important bleeding episodes eg haematemesis, rectal bleeding, severe or recurrent epistaxis, haemoptysis, haematuria or intracranial haemorrhage Screening FVIII:C < 50% | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Peptic Ulcer Perforation Patients surgically treated for benign peptic ulcer perforation Age < 18 years Pregnant and breastfeeding women Malign ulcer perforation | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Peptic Ulcer Hemorrhage Patients older than 18 Informed Consent signed Diagnosis of no variceal upper gastrointestinal bleeding secondary to a duodenal ulcer, erosive duodenitis or gastric ulcer Life expectancy longer than 6 months Able to attend further clinical controls Absence of the following Previous eradication treatment Use of antibiotics 2 weeks prior to inclusion Need for Antisecretor treatment that cannot be stopped to perform the breath test Pregnancy or breastfeeding | 1 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 0.0-21.0, Vomiting Syndrome Migraines Subjects age 0-21 years old with CVS (different phenotypes). Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent Subjects age > 22 years old Vomiting is not due to CVS or other related condition | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-80.0, Peptic Ulcer Hemorrhage Patients were accepted for endoscopic therapy if a peptic ulcer with active bleeding, a non-bleeding visible vessel (NBVV) or an adherent blood clot at the ulcer base was observed within 24 hours of hospital admission If patients were pregnant Did not obtain initial hemostasis with endoscopic injection of epinephrine Did not give written informed consent Had bleeding tendency (platelet count < 50×109/L, serum prothrombin < 30% of normal, or were taking anticoagulants), uremia | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-85.0, Fever Brain Hemorrhage Two or more days with core temperature ≥ 100.4F Approval of the patient's primary attending physician Need for core temperature measurement independent of the study Admission to the Neuro-ICU [intensive care unit] for an underlying condition Evidence for an infectious cause of fever, such as pneumonia, bacteremia, CNS [central nervous system] infection or urinary tract infection Expected death from any cause Known sensitivity to the device History of pre-admission hypothalamic dysfunction or known temperature dysregulation Use of 2 or more vasopressor medications, since this may make a local skin reaction to the device more likely Hemodynamic instability | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 12.0-65.0, Scorpion Envenomation (All of the following) Patients of both sexes, in the age range of 12-65 years reporting to the PHC/ hospital within 48 hours of scorpion sting and associated with s/s of scorpion envenomation having composite score between 5 and 21 (as computed based on the below:) Grade Symptoms Sweating 0 Limited to the extremity of the sting site Minimal sweating all over the body, slight nasal secretions Generalized sweating with rigors and cold extremities Gen.profuse sweating,wetting of clothes and cold clammy skin Pulse rate 0 70 (Any of the following) Composite score less than 5 and greater than 21 Grade of 5 in any of the criterion Severe Pulmonary edema with oxygen saturation below 80% Severe scorpion envenomation with reporting time more than 2 days Any other serious medical disease which/treatment of which may confound the results e.g. cardiac diseases, diabetes, renal diseases etc Severe anaphylactic reaction to any of the study drugs Patient (or relative in case of child) not willing to participate | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Non-Small Cell Lung Cancer Locally advanced or metastatic NSCLC (stage IIIB or IV) Patients who are not candidates for radical combined modality treatments or high-dose radiation therapy At least one measurable lesion according to Good performance status Adequate haematological, renal and liver function Written informed consent Previous chemotherapy for NSCLC Brain metastasis History of cerebral haemorrhage, neurosurgery within 3 previous months or surgery within the past 6 months Indication for anticoagulant therapy, thrombolytic therapy or antiplatelet therapy for cardiovascular disease Concomitant therapy with an anti-angiogenesis agent Contra-indication for LMWH Life expectancy of < 3 months Serious concomitant systemic disease, uncontrolled arterial hypertension, active peptic ulcer or other condition which does not permit study treatment or follow-up required to comply with the study protocol | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Non-variceal Upper Gastrointestinal Bleeding Gastrointestinal Ulcer Gastrointestinal Hemorrhage Patients admitted to the hospital or inpatients with an overt non-variceal upper GI bleed manifesting as hematemesis/coffee ground vomiting, melena, hematochezia, as well as other clinical/laboratory evidences of acute blood loss from the upper GI tract Evidence that an upper GI endoscopy was performed The complete medical record is available for study related hospitalization | 1 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-65.0, Pain Male or female, more than 18 and less than 65 years of age Women using a method of contraception and with a negative pregnancy test before entering the study, or women who have been menopausal for at least 1 year Patients meeting one of the following Closed benign trauma of the motor system occurring within the last 24 hours Contusion of the motor system occurring within the last 24 hours Acute rheumatologic conditions (acute lower back pain, lumbar sciatica, cervicobrachial neuralgia) Abarticular rheumatism Requiring treatment with Bi-Profenid for 5 days With resting pain intensity measured on a numeric scale at baseline >or= 3 (before administration of any treatment) Receiving a prior medical examination suited to the study Need for surgery Need for hospitalization Need for an analgesic other than step I at the baseline visit Need for treatment with another selective or non-selective NSAID (per os and/or topical), including aspirin, selective cyclo-oxygenase 2 inhibitors, corticosteroids or muscle relaxants at baseline and throughout the study Serious trauma: knee luxation, any fracture, ruptures such as Achilles tendon rupture Sprain treated with a cast Bursitis Local and/or general severe infection Pregnant or nursing women Hypersensitivity to ketoprofen or to any of the excipients of the product | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 16.0-999.0, Peptic Ulcer Hemorrhage Bleeding peptic ulcer: Among patients suspected to have upper GI bleeding based on hematemesis or melena, those with peptic ulcers(Forrest I, IIa and IIb) in whom active bleeding, non-bleeding visible vessels and fresh blood clots are observed on upper GI endoscopy performed within 24 hours after the hospitalization patients who achieved primary hemostasis with endoscopic hemostasis procedure via upper GI endoscopy Patients who refuse endoscopic procedure Patients with complications from gastric ulcer that require operative treatment prior to upper GI endoscopic treatment(e.g., gastric outlet obstruction, peptic ulcer perforation) Pregnancy Patients with serious concurrent diseases such as malignant tumors or end-stage diseases History of previous gastrectomy or vagotomy Known hypersensitivity to proton pump inhibitors Elderly patients Epilepsy | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Peptic Ulcer/Erosions upper GIB or dyspepsia due to peptic ulcers / erosions while receiving low-dose aspirin with a daily dose ranging from 80 mg to 320 mg endoscopy revealed a gastric or duodenal ulcers of 3 mm or more in diameter with unequivocal depth, or more than 5 erosions in the stomach or duodenum they required continuous low-dose aspirin for the secondary prevention of coronary heart disease, peripheral vascular disease and ischemic stroke or transient ischemic attacks years old or older concurrent erosive or ulcerative esophagitis pyloric stenosis previous gastric or duodenal surgery other than oversewing of a perforation thrombocytopenia renal failure with estimated creatinine clearance less than 10 ml / min active cancer known allergic to aspirin, famotidine or pantoprazole pregnancy, lactation, child-bearing potential in the absence of contraception psychosomatic disorder planned co-prescription of nonsteriodal anti-inflammatory drugs corticosteriod, or anticoagulant | 1 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 40.0-90.0, Peptic Ulcer Ulcer Complications Patients are eligible if they have received PCI for their stenotic coronary arteries and taken both aspirin and clopidogrel Patients who had a past history of PUD without complication, who have taken aspirin or clopidogrel before enrolling for their CV disease will be allowed to enroll Patients are excluded if they have New York Heart Association class IV heart failure, if they had contraindications to antithrombotic or antiplatelet therapy, if they have clinical severe thrombocytopenia (platelet count< 80000/mm3), if they have previous disabling, or hemorrhagic stroke or intracranial hemorrhage, if they have severe and unstable conditions in hepatic, renal, and pulmonary disease, if they have unstable and progressive malignancy, if they have epigastralgia or have a positive occult blood in stool, if they have current or recent PUD and take PPI or histamine receptor-2 antagonist without proving healed ulcer by scopy, if they have received a surgical intervention due to PUD complication (bleeding, perforation, obstruction) in the past, if they have received a GP IIb/IIIa inhibitor fewer than 3 days before randomization | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Peptic Ulcer aged more than 18 years undergo emergent endoscopy within 24 hours of presentation have peptic ulcers in the gastroesophageal junction, stomach, or duodenum high-risk stigmata of peptic ulcers: Forrest classification IA~IIB endoscopic hemostasis by thermocoagulation or clip placement pregnant or lactating written informed consent not obtained initial endoscopic hemostasis fail bleeding tendency (platelet count < 50×109/L, prolonged prothrombin time for more than 3 seconds, or were taking anticoagulants) PPI use within 14 days of enrollment comorbid with severe hepatic or renal insufficiency (serum total bilirubin more than 5 mg/dL, serum creatinine more than 5 mg/dL, or under dialysis) bleeding gastric cancers | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-75.0, Advanced Esophageal Informed consent form signed before performing any of the study's specific procedures ECOG performance status 0-2 Age > 18 and < 75 Measurable disease by Response Evaluation in Solid Tumors (RECIST) greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan and MRI or greater than or equal to 2 cm by other ordinary radiographic technique Histologically confirmed diagnosis of locally advanced esophageal Life expectancy of more than 3 months Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy No serious blood producing,abnormal function of heart,lung, liver, or kidney or immuno-deficiency Neutrophils ≥3×109/L, platelet count≥100×109/L and haemoglobin≥9g/dL ,Creatinine ≤ 1.5 x NUL Previous radiotherapy or chemotherapy Pregnant or breast-feeding women Drug abuse, unhealthy drug/alcohol addiction,or virus (HIV) infection Evidence of distant metastasis Participation in other clinical trials Patients with aphthosis, complete obstruction, fistula or deep peptic ulcer in the esophagus, or haematemesis Uncontrolled psychiatric disease or seizure Patients not fit for the clinical trial judged by the investigators | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-65.0, Bleeding Marginal Ulcer patients status post laparoscopic RYGB surgery with active gastrointestinal hemorrhage secondary to marginal ulcer bleeding marginal ulcers after other bariatric procedures staple-line bleeding after RYGB iron-deficiency anemia (chronic) secondary to non-actively bleeding marginal ulcer after RYGB other sources of GI bleeding different from marginal ulcer such as from staple-lines, complicated PUD, and other surgical and medical causes of GI hemorrhage missing records and/or unreachable patients with scant information for analysis | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-65.0, Ulcer Disease After Gastric Bypass Marginal Ulcer Perforated Marginal Ulcer Acutely Perforated Marginal Ulcer Laparoscopic repair of perforated marginal ulcer after RYGB Perforated marginal ulcers after other bariatric procedures Repair by open approach Missing records and/or unreachable patients with scant information for analysis | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Peptic Ulcer Patients presenting with clinical diagnosis of a perforated viscus who are scheduled to undergo surgical intervention Surgical candidate for endoscopic, laparoscopic, or open procedure Age > 21 Informed written consent Prior gastric or duodenal surgery Prior total abdominal colectomy or transverse colectomy Prior omentectomy or omental flaps Known perforation site other than stomach or duodenum Patients with contra-indications for laparoscopy Patients with contraindications for endoscopy Upper gastrointestinal anatomy that would preclude endoscopic therapy Coagulopathy or thrombocytopenia Pregnant patients Patients <21 years of age | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-65.0, Postoperative Nausea and Vomiting ASA I or II female urologic, gynecologic and breast surgery patients undergoing scheduled same day procedures at LLUMC Heart and Surgical Hospital age <18 or >65 severe hypertension,diabetes mellitus, significant hepatic or renal disease excessive blood loss sustained (>10 min)>20% from baseline drop in BP after treatment inability to follow protocol refusal to sign consent | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 0.0-999.0, Peptic Ulcer We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months serious disease 2.refuse informed consent | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Bleeding Peptic Ulcer Arterial Embolization Actively bleeding peptic ulcers (Forrest I), NBVV or Forrest IIa ulcer Successful endoscopic hemostasis by combination treatment of injected epinephrine followed by either 3.2mm heat probe 30J (4 continuous pulses) or hemo-clipping (at least 2 clips) And one of the followings Spurting hemorrhage during endoscopy Ulcer >= 2 cm is determined by an opened biopsy forceps Hb on admission of < 9 g/dl; or Hypotension prior to endoscopy defined by SBP of <90 mmHg AND HR of >110 bmp | 1 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Peptic Ulcer Bleeding Age ≥ 18 Confirmed ulcer bleeding with Forrest Ia, Ib, IIa, IIb Endoscopic hemostasis achieved Informed consent obtained No consent Forrest II c, III (clear ulcer base/flat spot and no active bleeding, i.e., minimal risk for rebleeding) Unsuccessful endoscopic treatment (i.e., injection and/or thermal coagulation for the initial bleeding) or severe bleeding that immediate surgery is indicated Moribund patients in whom active treatment of any form is not considered Polytrauma, severe injury, unconsciousness, burns, or need for continuous artificial ventilation Upper GI malignancy or disseminated malignant disease Esophageal varices A Mallory-Weiss lesion Phenytoin or theophylline treatment Uses of PPI or H2RAs within 3 days of admission, including uses at Emergency Department N.B. Usage of aspirin or NSAID is not an | 1 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Upper Gastrointestinal Bleeding Established diagnosis of acute upper gastrointestinal bleeding, confirmed by presence of hematemesis/ coffee ground vomiting, melena, as well as other clinical or laboratory evidence of acute blood loss from the upper gastrointestinal tract Written informed consent provided prior the start of participation in the study Subjects who are unwilling or unable to provide informed consent | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 1.0-14.0, Gastroenteritis All acute gastroenteritis patient between 1-14 years presenting to PEC Al Saad with diarrhea, persistent vomiting , fail oral rehydration and admitted to the observation unit for intravenous hydration will be eligible for the study Previous abdominal surgery Suspicion of surgical abdominal Bile stained vomitus History of hepatic and renal illnesses In-born error of metabolism Children with shock or impending shock Sever dehydration Previous hypersensitivity or abnormal reaction to metoclopramide or ondansetron Antiemetic treatment within 48 hours prior to presentation Seizure disorder | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Peptic Ulcer A history of H. pylori-negative idiopathic peptic ulcers, defined as No exposure to aspirin, NSAIDs or drugs of unknown nature including traditional Chinese medicine within the 4 weeks before hospitalization Biopsies taken during endoscopy must be negative for both the urease test and histology for H. pylori in the absence of acid suppressive therapy; and No other causes of ulceration identified Endoscopically confirmed ulcer healing Age >18 years old Informed consent Concomitant steroid or anticoagulant Concomitant use of NSAIDs, aspirin or COX2 inhibitors Previous gastric surgery Requirement of maintenance PPI (e.g. reflux oesophagitis) Advanced comorbidity (defined as ASA 4 or above) or active malignancy Subjects who are pregnant or lactating, or is intending to become pregnant before, during, or within 1 month after participating in this study Subjects who have known hypersensitivity or allergies to any component of lansoprazole or famotidine Subject who has current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition | 1 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Peptic Ulcers Age ≥ 18 Confirmed ulcer bleeding with Forrest Ia, Ib, IIa Endoscopic hemostasis achieved by combined endoscopic hemostasis Informed consent obtained No consent Unsuccessful endoscopic treatment Upper GI malignancy History of subtotal gastrectomy Bleeding tendency, platelet count < 80x109/L, prothrombin time INR >1.5 Myocardial infarction or cerebrovascular accident within one week Ulcer bleeding because of mechanical factors (such as, induction of NG tube) Malignancy or other advanced disease with a life expectancy of < 6 months IV PPI > 40mg within 24hrs before enrollment Decompensated liver cirrhosis | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Re-bleeding in NVUGIB Adult patients (>=18yrs) admitted to the hospital, or inpatients admitted for another reason, presenting with overt non-variceal upper GI bleed manifesting as hematemesis/coffee ground vomiting, melena, hematochezia Evidence that an upper GI endoscopy was performed GI bleeding not from | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Peptic Ulcer aspirin users who have a peptic ulcer confirmed by endoscopy serious medical illness (including cardiovascular events within 6 months before endoscopy) acute gastrointestinal bleeding a history of gastric or duodenal surgery allergic to the study drugs require long-term treatment with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, or anticoagulant agents pregnancy | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Melena Hematemesis Peptic Ulcer Hemorrhage Variceal Hemorrhage Patients greater than 18 Patients presenting with actual or reported hematemesis or coffee ground emesis or melena Refusal to participate Patient is hemodynamically unstable People with dysphagia or another swallowing disorder Pacemaker Known or suspected gastrointestinal obstruction, stricture or fistula Prisoners Patient lacks the ability to give informed consent High suspicion of pregnancy | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Peptic Ulcer Bleeding A history of documented peptic ulcer bleeding (self-reported history without confirmation by the clinician is not acceptable) Negative tests for H. pylori or successful eradication of H. pylori based on urease test and histology Expected regular use of ASA for the duration of the trial Age ≥ 18 Written informed consent obtained A history of gastric or duodenal surgery other than patch repair Severe erosive esophagitis (LA grade C or D) Gastric outlet obstruction Terminal illness Active malignancies | 1 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 15.0-999.0, Blunt Trauma Penetrating Wound Hemorrhagic Shock Included will be those with Blunt or penetrating injury Age ≥15yrs or weight ≥50kg if age is unknown Prehospital SBP ≤ 90 mmHg Excluded will be those with Ground level falls Evidence of severe blunt or penetrating head injury with a Glasgow Coma Scale (GCS) ≤ 8 Bilateral paralysis secondary to suspected spinal cord injury Fluid greater than 250ml was given prior to randomization Cardiopulmonary resuscitation (CPR) by Emergency Medicine Service (EMS) prior to randomization Known prisoners Known or suspected pregnancy Drowning or asphyxia due to hanging Burns over a Total Body Surface Area (TBSA) > 20% | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-85.0, Postoperative Nausea and Vomiting (PONV) Nausea Adult patients to 85 years of age Scheduled for neurosurgery requiring opening of the cranium and dura at Ohio State University Medical Center and who consent in writing to participate in this study are eligible Patients will be excluded from this study if they are prisoners pregnant women mentally ill under the age of 18 or over the age of 85 American Society of Anesthesiologist (ASA) classification V alcohol or drug abusers have a cerebral perfusion pressure (CPP) greater than 150 mmHg or less than 50 mmHg | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 20.0-80.0, Esophageal Cancer cytologically or histologically confirmed esophageal carcinoma age of 20 -80 Karnofsky performance status ≥ 70 no treatments prior to enrollment at least one measurable lesion on CT, MRI or esophageal barium exam normal functions of heart, lung, liver, kidney and bone marrow blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL informed consent signed prior treatments of chemotherapy or irradiation poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis participating in other clinical trials pregnancy, breast feeding, or not adopting birth control drug or alcohol addiction, uncontrolled epileptic seizure, or psychotic with no ability of self control coexisted morbidities that investigators believed not suitable for chemoradiation | 1 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 16.0-60.0, Blood, Injection, Injury Type Phobia Gastrointestinal Ulcer Haemorrhage Adverse Reaction to Epinephrine all adult patients with gastroduodenal ulcer Patients with non ulcer bleeding Patients with malignancy Patients with bleeding disorders or under coagulation therapy Patients with known allergy to epinephrine | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 39.0-83.0, Peptic Ulcer Bleeding Hypoalbuminemia Clinical presentations of melena, hematochezia, or hematemesis Gastroscopy confirmed peptic ulcers and major stigmata of recent hemorrhage A Rockall score ≥ 6 Gastric or esophageal, or duodenal tumor bleeding Ulcer due to mechanical factors Warfarin use Failure to establish hemostasis under gastroscopy Hypersensitivity to omeprazole, esomeprazole, albumin or any component of the formulation | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Trauma Hemorrhagic Shock Age>=18 years Acutely injured SBP<70 mmHg or SBP 71-90 mmHg with heart rate (HR)>108 beats per minute Visibly or verbally reported pregnant women known prisoners unsalvageable injuries (defined as asystolic or cardiopulmonary resuscitation prior to randomization) known objection to blood products the patient has an opt-out bracelet or, necklace or wallet card a family member present at the scene objects to the patient's enrollment in research | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 0.0-999.0, Bleeding Peptic Ulcer General practitioners in the Region of Southern Denmark which are linked to Danish General Medical Database for minimum 6 months | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 40.0-84.0, Peptic Ulcer [Iowa Type (107680.0010)] Patients aged 40-84 years in 1997-2005 ( see study population description) Patients aged below age 40 and 85 years and above ( see study population description) | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Acute Abdomen All patients with acute abdomen undergoing abdominal surgery under emergency and presenting on arrival in ICU at least a sign of bad perfusion Patients with chronic renal failure already receiving dialysis treatment Acute Coronary Syndrome (ACS) <12 months and New York Hearth Classification (NHYA ) class > 3 Patients judged at the admission not subject to resuscitative measures for severity and comorbidity Patients with massive hemorrhage in operative room or in the immediate perioperative with the need for blood transfusions and abundant blood products > 5 units of Erytrocyte Concentrates (EC) Patients scheduled for Orthotopic Liver Transplantation (OLT) Patients younger than 18 years old | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-80.0, Gastric Varices Portal Hypertension Patients presented to our hospital with acute gastric variceal bleeding, with or without liver cirrhosis The age of the patients range from 18 to 80 years old Patients who have contraindications for cyanoacrylate, lipiodol or lauromacrogol therapy Patients who have abnormal portosystemic shunt according to the imaging results Patients who have no previous upper gastrointestinal bleeding history Patients who have multiple endoscopic treatments for esophagogastric varices before | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 20.0-75.0, Gastric or Duodenal Ulcer Patients with peptic ulcer disease Age: 20-75 years old Patients who submitted informed consent Peptic ulcer disease with spurting and oozing Shock, hypotension, pregnancy Gastrointestinal malignancy | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 19.0-85.0, This Study Will Provide Data Comparing Safety of LMWH Versus UFH in the Treatment of Acute PE Cases Who Require Thrombolytic Treatment. Adults, age ≥ 18 years Patients who have signed the study informed consent form prior to initiation of any study-related procedure Acute massive PE patients who require thrombolytic treatment Patients who have a contraindication to use of anticoagulation and thrombolysis, such as active bleeding, stroke, cranial trauma, or neurologic surgery within the preceding 6 months, current pregnancy, major surgery, or biopsy within the preceding 7 days, major trauma within the preceding 10 days, gastrointestinal bleeding within the preceding 1 months during their admission Patients who received any anticoagulation medication prior to admission to the hospital | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Chemotherapy-induced Nausea and Vomiting Minimum age of 18 years Histologically proven solid organ cancer Eastern Cooperative Oncology Group Performance status 0-2 More than 3 months for life expectancy Patients scheduled to receive the first line, first cycle (5-FU, Oxaliplatin, Leucovorin) or (5-FU, Irinotecan, Leucovorin) chemotherapy Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital Patients who have nausea and vomiting caused by other reasons such as CNS metastases or gastrointestinal obstruction Patients who were exposed previously to any chemotherapy except adjuvant FL (5-FU and leucovorin) Patients who take anti-emetic drugs or dopamine antagonist within 72 hours prior to administration of chemotherapy Patients who take other drugs that may affect serum level of biomarkers (ex. steroid, megesterol, hormone replacement therapy, parenteral nutrition) | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-80.0, Upper Gastrointestinal Bleeding Adult patients (18-80) who are admitted to the ICU for hematemesis, or coffee ground emesis Patients younger than 18 yrs old or older than 80 yrs Patients who refuse to consent to be in our study Pregnant patients Prior use of prokinetics in the last 48 hours History of cardiac arrhythmia Allergy to erythromycin or metoclopromide Patients with QT prolongation (query 7) | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-50.0, Nausea Vomiting undergoing elective orthognathic surgery age 18-50 year olds signed informed consent pregnant women past history of oesophageal surgery, oesophageal varices or stricture patients who have received antiemetic medication in the 24 hours before surgery emergency surgery prior history of motion sickness and/or PONV, vertigo or migraine headaches | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 21.0-999.0, Bleeding Peptic Ulcers Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB) Patients younger than 21 years of age Refusal to participate in study Contraindicated for endoscopy Pregnant or lactating patients Bleeding secondary to non-peptic ulcer source Patients requiring mechanical ventilation Patients with acute coronary syndrome | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Gastrointestinal Hemorrhage Adults aged 18 or over years presenting with AUGIB, defined by haematemesis or melaena Patients with whom the responsible clinician considers there is a need for immediate RBC transfusion prior to obtaining or regardless of the initial Hb result due to severity of bleeding Existing hospital in-patients who develop AUGIB | 1 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Gastrointestinal Hemorrhage Patients presenting with fresh blood hematemesis, coffee ground emesis, or melena Patients with hematochezia and hypotension (systolic blood pressure < 90 mm Hg) or tachycardia (heart rate > 110 beats per minute) Identification of a bleeding source within the first 5 minutes of the upper endoscopy or no blood seen in the upper GI tract as these patients do not require additional suctioning Age < 18 No endoscopy was performed Endoscopy previously performed for current episode of UGIB Patients unable to consent and who do not have a substitute decision maker | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-70.0, Gastric Ulcer Induced by Anti-platelet Agent Duodenal Ulcer Induced by Anti-platelet Agent Age 18-70 year-old Had cardiovascular disease which needed clopidogrel and aspirin Stable enough for gastroscopy Gastroscopy revealed peptic ulcer Had contraindication for gastroscopy Not allowed for gastroscopy by cardiologist | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 20.0-95.0, Peptic Ulcer Hemorrhage Bleeding peptic ulcers with major stigmata of recent hemorrhage All of these major SRH are treated by local injection of diluted epinephrine 1:10000 with or without combined therapy with a heater probe, argon plasma coagulation, band ligation, or hemoclip therapy Bleeding due to tumor or cancer Bleeding due to the presence of a Dieulafoy lesion Ulcer bleeding due to mechanical factors (i.e., gastrostomy tube induction) Proton pump inhibitors use within one week before enrollment Failure to establish hemostasis under gastroscopy Hypersensitivity to esomeprazole, pantoprazole, or any component of the formulation Previously participated in the study | 1 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 20.0-999.0, Bleeding Ulcers (i) over 20 years of age and (ii) patients with high-risk peptic ulcer bleeding (i) the presence of another possible bleeding site (eg, gastroesophageal varix, gastric cancer, reflux esophagitis); (ii) coexistence of actively severe ill diseases (eg, septic shock, stroke, myocardial infarction, surgical abdomen); (iii) treatment with an anticoagulant (eg, warfarin); (iv) pregnancy; (v) the presence of operated stomach or; (vi) refusal to participate in the study | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Bleeding Peptic Ulcer Patients presented with bleeding peptic ulcers Age > 18 year old Informed consent for the study and OGD Unable or refuse to give consent Onset more than 7 days Pregnancy | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 0.0-999.0, Stress Ulcers Stress-related Mucosal Disease (SRMD) The subject population that will be included in the NIS are the consecutive discharged patients ≥18 years old who were hospitalized to Neurosurgical departments. Those whose Glasgow Coma Scale (GCS) ≤10[4] within 24 hours of lesion/admission will be defined as critically ill patients. Three kinds of cases will be included: brain trauma critically ill patients, cerebral haemorrhage critically ill patients or postoperative brain tumour critically ill patients If participating in any clinical trial, the subject cannot take part in this study. Subjects are ineligible if they have below conditions Those who were likely to swallow blood (for example, those with severe facial trauma or epistaxis Patients with previous total gastrectomy Known upper GI lesions that might bleed (e.g., varices, polyps, tumours, etc) Evidence of active GI bleeding including oesophageal and gastric variceal bleeding, Peptic Ulcer Disease (PUD) | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 19.0-999.0, Peptic Ulcer Male or female over 19 years of age Accompanied by hypertension, diabetes, ischemic heart disease, arrhythmia, dyslipidemia patients who are required to continuous administration of low-dose aspirin(100mg) Patients who get Modified Lanza Score (MLS) 0 in screening period according to endoscopic findings Patients who have stomach or duodenal ulcer scar in screening period according to endoscopic findings. But, the cases that scars caused by other disorders or endoscopic treatment are excluded Patients who have no digestive symptoms(except for mild physconia, abdominal pain, diarrhea and vomit, nausea-vomiting) in screening period Signature of the written informed consent Within 4 weeks prior to screening period, patients who continuously take aspirin or NSAIDs Patient who has hypersensitivity to PMK-S005 and aspirin components or is banned to use them Patients who had a abdominal surgery that affect gastrointestinal motility (Except appendectomy and hysterectomy), But, patients who had enterectomy is excluded regardless of the time period Patients who are judged by investigator that they have other upper gastroesophageal disease, active/healing-stage peptic ulcer, digestive malignant tumor or Barrett's esophagus Patients with Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), Ulcerative Colitis, Crohn's disease, Zolinger-Ellison syndrome History of esophagus, liver, pancreas, stomach, colorectal cancer or malignant tumors within 5 years History of malabsorption within 3 months prior to screening period Patients who have been taken drug that affect the validity within 2 weeks before beginning of the clinical test Patient who is needed continuously to take antithrombotic agents , anti coagulant , anti | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Ulcer Bleeding Age >=18 Informed consent obtained Successful endosopic hemostasis Risk Score >= 5 Age < 18 Pregnancy Incomplete endoscopic haemostasis - | 2 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Pain, Postoperative Postoperative Nausea and Vomiting Postoperative Hemorrhage Body Weight Changes years and older Surgical indications: Chronic tonsillitis, Snoring, Sleep apnea Surgical procedure: Tonsillectomy with monopolar cautery, hemostasis with monopolar cautery and/or suction cautery. The surgical procedure can also Adenoidectomy with suction cautery Additional surgical procedures (i.e. UPPP (uvulopalatopharyngoplasty), septoplasty, inferior turbinate reduction) during same surgery Pregnant females Indications: Suspected malignancy History of chronic pain or daily pain medication used for another medical problem History of liver disease Contraindications to preoperative Decadron Contraindications to pain regimen medications (Tylenol, Norco, Percocet, Dilaudid) | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-65.0, Oral Glucose Tolerance Body mass index (BMI) of 18.0-30.0 kg/m2 and with no known diseases systemic infections, psychiatric or metabolic disorders, known food allergies or intolerances related to the products used in the study (e.g. dairy or gluten), ongoing or former drug abuse, high intake of alcohol (defined as a weekly intake of >7 units for women and > 14 units for men), pregnancy or ongoing planning of pregnancy, vegetarianism or veganism, participation in other scientific studies during the study period, and blood donation during or in the month leading up to the study period | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-999.0, Overt Upper Gastrointestinal Bleeding Individual aged ≥ 18 years presenting to the emergency department with acute, overt UGIB defined as coffee ground vomiting and/or melena UGIB with hemodynamic shock (BP<90mmHg and pulse>120 per minutes) requiring urgent endoscopy UGIB with fresh hematemesis requiring urgent endoscopy dysphagia, odynophagia, swallowing disorder, Zencker's diverticulum, suspected bowel obstruction or bowel perforation prior bowel obstruction, gastroparesis or known gastric outlet obstruction, Crohn's disease, past GI tract surgery presence of an electromedical device (pacemaker or internal cardiac defibrillator) altered mental status (e.g., hepatic encephalopathy) that would limit patient ability in swallowing the capsule, pregnancy and/or lactating, allergy to conscious sedation medications, allergy to Maxolon, unwillingness to swallow the capsule, patient expected to undergo Magnetic Resonance Imaging examination within 7 days of ingesting the capsule, patient on medications that may coat the upper GI tract such as antacids or sucralfate, or inability to provide written informed consent Allergy to Maxolon Patients with known Esophageal Varices or Gastric Varices with or without prior bleeding episodes Known upper/ lower GI cancer (eg, cancer of esophagus, stomach, small bowel, colon) or hepatocellular carcinoma or pancreatic cancer | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 20.0-95.0, Peptic Ulcer Hemorrhage Eligible participants included patients ≥20 years who had undergone gastroscopy for melena, haematochezia, or haematemesis due to bleeding peptic ulcers with major stigmata of recent hemorrhage. The major stigmata of recent haemorrhage were classified as Forrest class Ia, Ib, IIa, and IIb. All of the stigmata are given one or a combination of endoscopic therapies, including local injection of diluted epinephrine 1:10000, bipolar heated probe, argon plasma coagulation, band ligation, or hemoclip therapy. Patients will undergo a follow-up endoscopy about 12 to 16 weeks later to confirm that the ulcer has healed to be less than 0.5 cm; otherwise, patients are not enrolled Patients are excluded if they had tumor bleeding or ulcer bleeding due to the presence of a Dieulafoy lesion or mechanical factors (e.g, gastrostomy tube induction), comorbid with reflux esophagitis grade C or D, Barrett's esophagus, or marginal ulcer bleeding, hypersensitivity to esomeprazole or any component of the formulation, or had previously participated in the study. Because of concern for patient safety with certain drug-drug interactions, patients who receive anti-platelet therapy, e.g., aspirin, clopidogrel, or others for prophylaxis of established cardiovascular or cerebrovascular diseases will be excluded | 1 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 19.0-85.0, Hemorrhage, Surgical Hip Replacement, Total Thrombocytopathy patient scheduled for elective hip replacement surgery age between 19-85 years signed informed consent informed consent not signed traumatic hip fracture anemia (hemoglobin level < 100 g/l) allergy to study drug and/or multiple allergies chronic heart failure with LVEF < 30% shock states coagulopathy thrombocytopenia thrombocytopathy chronic kidney disease with oliguria | 1 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-45.0, Anesthesia; Adverse Effect, Spinal and Epidural Hypotension Complications; Cesarean Section The American Society of Anesthesiologists (ASA) Physical Status classification 1 and 2 Pregnant women with singleton pregnancy Gestational age greater than 36 weeks Cesarean delivery under spinal anesthesia Use of cardiac medication or medication for blood pressure control Cardiovascular disease Multiple gestation Gestation diabetes requiring insulin Refusal to be in study History of chronic opioid use (chronic pain syndrome) Emergent caesarean delivery for maternal and/or fetal distress Preeclampsia Eclampsia Progressive neurologic disease | 0 |
A 44 yo male is brought to the emergency room after multiple bouts of vomiting that has a "coffee ground" appearance. His heart rate is 135 bpm and blood pressure is 70/40 mmHg. Physical exam findings include decreased mental status and cool extremities. He receives a rapid infusion of crystalloid solution followed by packed red blood cell transfusion and is admitted to the ICU for further care. | eligible ages (years): 18.0-65.0, Shock, Hemorrhagic Fractures, Bone Multiple Trauma multitrauma defined as Injury Severity Score (ISS) > 17 dislocated pelvic fracture type B or C according to Tile[10] on emergency department pelvic radiograph hemodynamic instability defined as systolic blood pressure (SBP) <90 mmHg after administration of 4 units of packed red blood cells (PRBC) monotrauma, or ISS ≤ 17 age > 65 years age < 18 years | 0 |
A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26. | eligible ages (years): 18.0-50.0, PMDD PMS Depression The subjects of this study will be women who meet the for MRMD as described in Protocol No. 81-M-0126, 'The Phenomenology and Biophysiology of Menstrually-related Mood and Behavioral Disorders.' In brief, these history within the last two years of at least six months with menstrually-related mood or behavioral disturbances of at least moderate severity--i.e., disturbances that are distinct in appearance and associated with a notable degree of subjective distress symptoms should have a sudden onset and offset age 18-50 not pregnant and in good medical health medication free All patients participating in this protocol will have already participated in Protocol No. 81-M-0126 and will have a prospectively confirmed and predictable relationship between their mood disorder and the premenstrual phase of the menstrual cycle, i.e., a 30% change in severity of symptom self rating scales, relative to the range of the scale employed, during the seven days premenstrually compared with the seven days post-menstrually in two out of three months of study The Schedule for Affective Disorders and Schizophrenia will be administered to all patients prior to study entry. Any patient with a current axis I psychiatric diagnosis will be excluded from participating in this protocol Prior to treatment, a complete physical and neurological examination will have been performed and the following routine laboratory data obtained A. Blood The following conditions will constitute contraindications to treatment with hormonal therapy and will preclude a subject's participation in this protocol current Axis I psychiatric diagnosis history consistent with endometriosis diagnosis of ill-defined, obscure pelvic lesions, particularly, undiagnosed ovarian enlargement hepatic disease as manifested by abnormal liver function tests history of mammary carcinoma history of pulmonary embolism or phlebothrombosis undiagnosed vaginal bleeding porphyria diabetes mellitus | 0 |
A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26. | eligible ages (years): 18.0-55.0, Porphyria ENTRY --Disease Characteristics- Acute porphyria, i.e.: Acute intermittent porphyria Hereditary coproporphyria Variegate porphyria Definite cyclic attacks with severe abdominal pain and other porphyria symptoms during luteal phase of menstrual cycle only Attacks resolve completely within 5 days of onset of menses, i.e., no symptoms between attacks At least 4 to 6 attacks during the 6 months prior to entry More than half of these attacks must meet the following Readily distinguishable from menstrual cramps and premenstrual syndrome Required hospitalization for narcotic analgesics, phenothiazines, hematin, intravenous fluids, or other treatment Luteal attacks not requiring hospitalization must be similar in symptoms and differ only in severity No life-threatening porphyria attacks No cyclic abdominal pain unless caused by porphyria --Prior/Concurrent Therapy- At least 6 months since ovulation suppression --Patient Characteristics- Reproductive: Menstrual cycle 25-35 days for at least 6 months prior to entry Pelvic exam normal within 60 days prior to entry Pap smear normal, i.e., no dysplasia No amenorrhea No other menstrual abnormality No other gynecologic abnormality Negative pregnancy test Medically approved contraception required for 2 months prior to entry and throughout study OR at least 1 menstrual cycle following tubal ligation Other: No allergy to gonadotropin-releasing hormone analogues No clinically significant abnormal laboratory test results No medical contraindication to protocol treatment | 0 |
A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26. | eligible ages (years): 18.0-999.0, Amphetamine-Related Disorders years of age. Treatment seeking for meth dependence Please contact site director for more details | 0 |
A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26. | eligible ages (years): 18.0-40.0, Endometrial Bleeding Periodontal Disease Regular menstrual periods for the last 2 cycles Currently not using hormonal contraceptives, including oral contraceptives, patch, ring, or Norplant in 2 months prior to study entry, or Depo-Provera in 12 months prior to study entry Currently not using tetracycline-class antibiotics Normal Pap smear Pregnancy or breastfeeding within 2 months of study entry Chronic migraine headaches Uncontrolled high blood pressure Untreated sexually transmitted diseases Alcoholism or drug abuse within 12 months of study entry Insulin dependent diabetes Liver, kidney, or gallbladder disease Participation in another clinical trial within 30 days of study entry History of cancer History of blood clots, strokes, or heart disease | 0 |
A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26. | eligible ages (years): 18.0-45.0, Endometriosis Female patients with endometriosis-associated pelvic pain Pregnant or lactating women history or suspicion of hormone dependent tumor therapy resistant endometriosis need for primary surgical treatment any other conditions which forbid the participation | 1 |
A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26. | eligible ages (years): 21.0-40.0, Infertility Female partner age 21 up to 40th birthday, at the time of recruitment. Infertility is defined as failure to conceive a recognized pregnancy after one year (or 12 menstrual cycles) of unprotected intercourse Male partner has a normal semen analysis with a sperm concentration of >15 million total motile sperm, >1% normal forms by strict or >5 million total motile sperm on IUI prep Female patient has at least one ovary and at least one ipsilateral patent fallopian tube confirmed by HSG or laparoscopy; pelvic pathology amenable to operative laparoscopy (pelvis restored to functional). The open tube cannot have had a previous ectopic (tubal) pregnancy and the closed tube cannot be a hydrosalpinx (a tube that is blocked at the end and filled with fluid), unless a tubal ligation has been performed at the junction of the uterus and fallopian tube Patients with surgically corrected stages I and II endometriosis will be included Normal uterine cavity demonstrated by HSG, Sonohysterogram (SHG), or hysteroscopy; pathologies of uterine cavity amenable to operative hysteroscopy (cavity restored to normal and demonstrated by post operative study) Anovulatory patients who did not conceive after a minimum of three ovulatory cycles with any medications, not including gonadotropin therapy. Anovulatory patients unable to achieve ovulation at dosages up to 150 mg of clomiphene or standard dosages of other ovulation inducing medications (i.e. bromocriptine). Hypoestrogenic hypothalamic amenorrhea patients will qualify immediately for prior to any gonadotropin therapy Normal ovarian reserve demonstrated in all patients i.e., cycle day 3 FSH/E2 values of <15 mIU/mL and <100 pg/mL, respectively. Normal TSH and prolactin Female body mass index ≤ 38 Previous tubal reconstructive surgery in which the pelvis was not restored to functional Unilateral or bilateral hydrosalpinx (a tube that is blocked at the end and filled with fluid) that has not had a tubal ligation performed at the junction of the uterus and fallopian tubes A laparoscopy that demonstrated pelvic adhesions or endometriosis for which the pelvis could not be restored to normal by surgery or endometriosis was not ablated or excised. All patients with stages III and IV endometriosis One or more prior ectopic pregnancies in which one or both tubes were rendered nonfunctional; two or more ectopic pregnancies, even if tubes are patent Severe male factor (i.e.; semen analysis with a sperm concentration of <15 million total motile sperm, <1% normal forms by strict or <5 million total motile sperm on IUI prep). Couples using donor semen will be excluded Previous treatment with IUI or IVF. Previous treatment of normal ovulation patients with gonadotropins Inadequate ovarian reserve demonstrating FSH >15 mIU/mL or estradiol > 100 pg/mL Patients requiring gamete intrafallopian tube transfer (GIFT), zygote intrafallopian tube transfer (ZIFT), or tubal embryo transfer (TET) Female body mass index > 38 | 1 |
A 38 year old woman complains of severe premenstrual and menstrual pelvic pain, heavy, irregular periods and occasional spotting between periods. Past medical history remarkable for two years of infertility treatment and an ectopic pregnancy at age 26. | eligible ages (years): 25.0-50.0, Leiomyoma Female gender-to evaluate effects in the target population for clinical trials History of uterine leiomyoma causing symptoms of bleeding, pressure, or pain, as defined by the American College of Obstetrics and Gynecology (ACOG) practice bulletin Excessive uterine bleeding will be evidenced by either of the following-profuse bleeding with flooding or clots or repetitive periods lasting for more than 8 days; or anemia due to acute or chronic blood loss Pelvic discomfort caused by leiomyomata, either acute and severe or chronic lower abdominal or low back pressure or bladder pressure with urinary frequency not due to urinary tract infection Uterine leiomyoma(ta) of at least 2 cm size In good health. Chronic medication use is acceptable except for glucocorticoid use. Other chronic medication use may be acceptable at the discretion of the research team. Interval use of over-the-counter drugs is acceptable but must be recorded Menstrual cycles of 24 days Hemoglobin greater than 10 g/dL (for those wishing surgery); iron may be administered to improve red blood cell counts Willing and able to comply with study requirements Significant abnormalities in the history, physical or laboratory examination Pregnancy Lactation Use of oral, injectable or inhaled glucocorticoids or megestrol within the last year Unexplained vaginal bleeding History of malignancy within the past 5 years Use of estrogen or progesterone-containing compounds, such as oral contraceptives and hormone replacement therapy, within 8 weeks of study entry, including transdermal, injectable, vaginal and oral preparations Use of agents known to induce hepatic P450 enzymes; use of imidazoles Current use of Gonadotropin-releasing hormone (GnRH) analogs or other compounds that affect menstrual cyclicity Follicle stimulating hormone (FSH) greater than 20 IU/mL | 1 |
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