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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): 40.0-999.0, Menopause Insomnia Women 40+ years old Subject must have any of the following perimenopausal or postmenopausal signs and symptoms as defined by the Stages of Reproductive Aging Workshop (STRAW) Early Menopausal Transition (Stage -2): Variable cycle length >7 days different from normal Late Menopausal Transition (Stage -1) : > 2 skipped cycles and an interval of amenorrhea > 60 days Post Menopause (Stage +1): Amenorrhea for at least 12 months Surgical Post Menopause Hysterectomized women with one or both ovaries preserved will be eligible if FSH levels > 20 IU/L If on hormonal therapy, history of menstrual-cycle abnormalities consistent with any of 2a-2e above indicating peri-/postmenopausal status prior to initiation of hormonal therapy One or both the following insomnia symptoms for ³ 3 nights per week for at least one month prior to study enrollment Difficulty initiating sleep (³ 30 minutes) According to M.I.N.I (Mini International Neuropsychiatric Interview), subject meets current or past for past 3 months Major Depression Dysthymia Panic disorder PTSD (Post-Traumatic Stress Disorder) According to M.I.N.I, subject has no evidence of current suicidal ideation, homicidal ideation, or psychotic symptoms at screening visit Suicide attempt in the past 5 years According to M.I.N.I, subject meets for substance use disorder diagnosis within the past 5 years Subject has current or recent use (in the past month and used > 25% of time) of hypnotic agents Subject is on an antidepressant or hormone therapy in past 2 months. (Unless they are taking currently and have had a stable dose for ≥ 2 months) | 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): 20.0-999.0, Dysmenorrhea Patients aged 20 years or older at obtaining informed consent Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruation before the final enrollment Patients with ovarian chocolate cysts Patients with fibroid needed to be treated Patients with estrogen-dependent tumors and patients with cervical cancer or suspected cervical cancer Patients with undiagnosed abnormal vaginal bleeding Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, or coronary artery disease or a history of those diseases Patients aged 35 years or older who smoke at least 15 cigarettes per day Patients with migraine accompanied by prodromata Patients with pulmonary hypertension or valvular heart disease Patients who are regularly taking nutritional products that contain St. John's Wort Patients who underwent surgical treatment for endometriosis within 2 months prior to screening | 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, Bipolar Disorder Ages 18-45 Bipolar Disorder (BD) I or II (DSM-IV criteria) must agrees to communication between PI and Psychiatrist Healthy Control without Past or Current Major Depression, Psychotic Disorder, premenstrual syndrome or Premenstrual Dysphoric Disorder 31day menstrual cycles Minimum 6 menstrual cycles per year Current DSM-IV Alcohol or Substance Abuse/Dependence Pregnancy Chronic Anovulation (<4 menstrual cycles/yr) Menopause (< 1menses in 1yr) Active thyroid disease Hormonal Contraception | 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): 20.0-45.0, Breast Pain Premenstrual mastalgia Age 20-45 years Reliable non-hormonal contraception Pregnancy Breast cancer or uterine corpus cancer Unexplained menstrual disorders Serious health problems Hormonal contraception, including hormonal IUD trade name Mirena Oestrogen and/or progestin treatment Hysterectomy and/or oophorectomy or radiation therapy Artificial cardiac pacemaker/metallic prostheses | 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): 6.0-18.0, ADHD Trichotillomania DSM-IV Diagnosis of trichotillomania DSM-IV diagnosis of ADHD Has not taken stimulants or alpha-adrenergic medications for more than 2 weeks prior to entering the study History of moderate or severe adverse event, related to MPH History of any psychotic disorder Current drug abuse, acute psychotic or affective disorder | 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, Metrorrhagia Women age 18 or older who are initiating Depo-Provera for contraception English or Spanish-speaking Have a negative urine pregnancy test Contraindications to either Depo-Provera or Femring (estrogen vaginal ring) Have used Depo-Provera or Mirena in the prior 6 months Have had an induced abortion, spontaneous abortion, or birth in prior 8 weeks | 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): 18.0-48.0, Premenstrual Syndrome Meets DSM-IV for PMDD by history Regular menstrual cycles that are 25 to 35 days in length during the year prior to study entry Willing to use barrier methods of birth control during the study if sexually active If engaged in psychotherapy for at least 3 months before study entry, participation will be allowed if the intensity of psychotherapy remains the same during the study Normal PAP and physical exam, including pelvic exam, within the 1 year prior to study entry Use of oral contraceptives or other exogenous hormone preparations within the 3 months prior to study entry Suicide attempt or severe suicidal ideation within the 2 years prior to study entry History of any psychotic disorder or bipolar disorder Substance abuse, except nicotine, within the 6 months prior to study entry Use of pharmacological treatment for PMDD symptoms (e.g., antidepressants, hormones, gonadotropin-releasing hormone agonists, anxiolytics, calcium, herbal preparations, diuretics) within the 3 months prior to study entry Daily use of psychotropic or anticonvulsant medications within the 3 months prior to study entry Use of sleeping pills more than once per week Consumption of more than 50 ounces of alcohol per week Pregnant or breastfeeding Hepatic, renal, autoimmune, or chronic inflammatory 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, Premenstrual Syndrome Depression Women who are non-smokers between the ages of 18-45 years (smokers 18-34 years) Regular menstrual cycles (26-34 days in length, predictable within 7 days) for the past 6 months Determination that the antidepressant medication was initiated for the treatment of unipolar major depression, minor depression (depression, not otherwise specified), or dysthymia. Major depression and dysthymia will be evaluated through administration of the Mini-International Neuropsychiatric Interview (MINI). Minor depression will be evaluated by administration of the Structured Clinical Interview for Diagnosis-IV(SCID)10 section J.3 Use of an antidepressant for at least 3 months for treatment of a depressive disorder, with stable dose for at least 2 months. It is acceptable to be on more than one psychiatric medication as long as one of them is an antidepressant Expected continued use of the same antidepressant at the same dose for the duration of the study 30% increase of the mid-follicular phase Montgomery-Åsberg Depression Rating Scale (MADRS) score to the late-luteal phase MADRS will be required for during the tracking phase of the study and will be assessed prospectively over 1 menstrual cycle Normal pelvic exam and PAP smear in the past 12 months Normal TSH at screen if on thyroid medication, must be on a stable dose for 2 months or greater, and have a normal TSH at screen Negative serum HCG at baseline, and negative urine HCG at visits 3 and 5 Amenorrhea or irregular menstrual periods (defined as unable to predict within 7 days) during past 6 months Pregnancy or breastfeeding (serum HCG test administered at baseline study visit, and urine HCG at visits 3 and 5) Current cigarette smoking in women who are older than 34 years Presence of any of the following psychiatric and substance use disorders, based on administration of the MINI at the baseline study visit Any history of mania or hypomania suggesting bipolar disorder Any lifetime history of a psychotic disorder Depression deemed by the physician investigator to be too severe to be treated in the study Use of benzodiazepines or antipsychotic to target premenstrual symptoms Luteal-phase dose adjustment of the antidepressant. Use of a hormone releasing IUD (intrauterine device) Use of an OCP or other systemic hormonal therapies (oral, transdermal or injection preparations of androgens, estrogens, or progestins) in the past 2 months Any contraindication or previous adverse event to any OCP therapy | 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, Contraception Signed and dated informed consent Age between 18 and 50 years (inclusive), smokers maximum age of 35 years (inclusive) at Visit 1 Otherwise healthy female subjects requesting contraception and currently using a LNG, NGM, or norethindrone/norethindrone acetate containing OC in a 21-day regimen and suffering from at least moderate pelvic pain, headache or both defined by an average of the highest 3 values of >/=35 mm on a VAS during cycle days 22-28 (35 mm VAS is the expected standard deviation of the population VAS reduction) Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the last 6 months before screening) Women with atypical squamous cell of undetermined significance (ASCUS) can be included if they have a negative human papilloma virus (HPV) test result. The laboratory will perform an HPV test if the Pap smear result is ASCUS Able to tolerate ibuprofen and willing to use only ibuprofen supplied by the investigator Pregnancy or lactation (less than three cycles since delivery, abortion, or lactation before start of treatment) Body mass index (BMI) >32 kg/m2 Hypersensitivity to any of the study drug ingredients Individuals not willing to consume pork and beef products. Women may be included if they are willing to take the capsules Safety relevant laboratory values, provided by the central laboratory, outside range before start of treatment Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication (such as but not limited to duodenal ulcers, gastritis, gastrectomy or gastric resection surgery, or renal compromise) Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results Any disease or condition that may worsen under hormonal treatment Undiagnosed abnormal genital bleeding Abuse of alcohol, drugs, or medicines (eg, laxatives) | 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, Contraception Bleeding Must be of reproductive age from 18 to 45 years Must be choosing LNG-IUC for contraception Must be English-speaking Be willing to avoid additional use of exogenous hormones, such as oral contraceptives, for the duration of the study Be willing to avoid additional use of nonsteroidal antiinflammatory drugs, such as ibuprofen or aspirin for the duration of the study Be willing to comply with the study protocol, keep the bleeding diary and comply with follow-up visits and telephone interviews as scheduled Be willing and able to provide informed consent Known or suspected pregnancy Contraindication to estrogen use, such as presence or history of venous thromboembolism Arterial thrombosis Thrombophilia disorders, or known family history of Hypertension Migraine headaches with aura or focal neurologic involvement, or any migraine over age 35 years Recent or planned future major surgery which will result in prolonged immobilization during the study period Presence or history of severe hepatic disease or liver tumors Known or suspected estrogen-dependent neoplasm | 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 Infertility Chronic Pelvic Pain Tubal Ligation A patient who meets all of the following is eligible for the study Premenopausal female 18 to 45 years of age Attending for her first diagnostic laparoscopy or for laparoscopy for tubal sterilisation Has no previous history of endometriosis diagnosis through surgery A patient who meets any of the following is ineligible for the study Already has a surgically-confirmed diagnosis of endometriosis Aged less than18 or greater than 45 Aged 18-45 but post-menopausal | 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): 0.0-999.0, Achalasia Alacrima early age onset primary achalasia patient less than 35 years old secondary achalasia patients | 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): 20.0-45.0, Premenstrual Syndrome Person is over the age of 20 but not older than age 45 Person is willing to participate as evidenced by signing the written informed consent form Suffers from known dominant severe symptom of breast swelling and tenderness (level 7-10 according to standard scale of PMS symptoms severity) Other severe symptoms of Premenstrual syndrome (based on WHO and ACOG criteria). This may one or more of PMS symptoms with level 7-10 according to standard scale of PMS symptoms severity At work, school, home, or in daily routine, at least one of the PMS symptoms caused reduction of productivity or inefficiency At least one of the PMS symptoms caused avoidance of or less participation in hobbies or social activities At least one of the PMS symptoms interfere with relationships with others i. Timing of PMS symptom(s): during the 14 days prior to onset of menstrual flow (rather than spotting) and up to 5 days during the menstrual flow ii. Pattern and length of PMS symptomatic period: minimum of 2 days, up to 14 days iii. For PMS diagnosis two out of last three consecutive menstrual cycles were monitored by daily monitoring of symptoms Pregnant or lactating woman Oral contraceptives during last three months, including hormonal IUD (trade name mirena) Serious health problems Unexplained menstrual disorders Treated by hormones (estrogen and progesterone) For healthy: Irregular or abnormal test results | 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, Contraception Healthy female subjects in need for contraception will be selected to participate in the trial Each subject must be >=18 to <=40 years of age at screening and in need for contraception Each subject must have given birth to at least one child (gestational age >=28 weeks) Each subject must have a uterus with a measured length between 6.0 and 9.0 cm (extremes included) from external os to fundus uteri A subject must not be pregnant or suspected to be pregnant A subject must not have had an ectopic pregnancy in the past or must not have a history or presence of predisposing factors for this condition such as salpingitis, endometritis or pelvic peritonitis A subject must not have a history or presence of any malignancy A subject must not have a history or presence of premalignant disease of the uterus or cervix, including endometrial hyperplasia, or (other) sex-steroid sensitive premalignancies A subject must not have an active venous thromboembolic disorder (e.g. deep vein thrombosis, pulmonary embolism) A subject must not have a history or presence of severe hepatic disease with AST and/or ALT levels of >=3 times the upper normal limit A subject must not have congenital or acquired malformations or distortions of the uterus or cervix A subject must not have large or multiple uterine fibromyomata, or a smaller uterine fibromyoma which may interfere with the insertion of the MIUS/IUD according to the investigator A subject must not have vaginal bleeding of undiagnosed etiology A subject must not have dysmenorrhea interfering with daily activities or menorrhagia | 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, Hypertension age 18 years or older stage I or II hypertension defined as: a mean seated cuff diastolic blood pressure >=95 and <=115 mmHg ability to provide written informed consent severe hypertension defined as: a mean seated cuff diastolic blood pressure >=116mmHg or a mean seated cuff systolic blood pressure >=200mmHg known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma) has severe heart disease(Heart failure NYHA functional class 3, 4), unstable angina or myocardial infarction, arrhythmia within the past three months has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months Type I Diabets Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) > 8% known severe or malignant retinopathy hepatic or renal dysfunction as defined by the following laboratory parameters: AST/ALT > UNL X 2, serum creatinine > UNL X 1.5 acute or chronic inflammatory status need to treatment need to additional antihypertensive drugs during the study need to concomitant medications known to affect blood pressure during the study | 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): 40.0-60.0, Hot Flushes Menopause, Premature Obesity Vitamin D Deficiency Women in late menopausal transition or early menopause Age 40-55 BMI >25 kg/m2 Suffer from menopausal symptoms Change in previously regular cycles consisting of at least ≥2 skipped cycles and an interval of amenorrhea (≥60 days) in the last year Negative pregnancy test Vitamin D insufficiency (<30 ng/ml) Weight stability (+/ ) for 3 months No period for >12 months Hormone use (i.e. menopausal hormone therapy, oral contraceptive, other hormonal medications) in last 3 months History of hysterectomy more than 11 months ago Abnormal screening blood tests (i.e. elevated serum calcium level, elevated creatinine) History of medical conditions where Vitamin D supplementation is not indicated (i.e. chronic renal insufficiency, elevated calcium, sarcoidosis or other granulomatous disease, lymphoma, or tuberculosis History of osteoporosis or osteoporosis on baseline DXA (expect less than 4% of screened population)84 Vitamin D deficiency (<10 ng/ml) as we felt it was unethical to withhold supplementation for 12 months in severe deficiency (according to our KPNW survey, this will <2% of population) Consuming more than 400 IU of Vitamin D supplementation daily (we felt such doses taken outside of the study design could confound results) Current smoker (within the last year) Taking medications that affect body weight | 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, Uterine Hemorrhage Signed and dated informed consent Healthy female subjects requesting contraception Age: 18 years inclusive Successful interval insertion of History of regular cyclic menstrual periods Normal or clinically insignificant cervical smear not requiring further follow up Pregnancy or lactation Climacteric symptoms prior to the screening visit Known or suspected clinically significant ovarian cysts, endometrial polyps, fibroids, or other genital organ pathology, that, in the opinion of the investigator, may interfere with the assessment of the bleeding profile during the study Undiagnosed abnormal genital bleeding Current or history of thrombembolic disease, or established risk factors for venous thromboembolism Current migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia, or exceptionally severe headaches Hypersensitivity to any ingredient of the investigational medicinal products or the non-investigational medicinal product Daily or frequent use of a nonsteroidal anti-inflammatory drug (NSAIDs) for any condition Not willing to use nonsteroidal anti-inflammatory drug (NSAIDs) medication as pain medication during the double blind treatment period | 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, Healthy Middle-aged Subjects Age Range Was 18 to 31 Years Caucasian Whites Males and Females healthy middle-aged subjects volunteers with systemic or ocular diseases | 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): 18.0-45.0, Cyclic Mastodynia Premenstrual Syndrome Females aged 18 to 45 who have signed an Informed Consent Form (ICF) at screening visit S-2 (screening visit -2) at the latest Subject has a history of cyclic mastodynia and premenstrual syndrome Stable cycle duration of 25 to 35 days during the past 6 months before screening visit S-2 At screening visit S-2 subject is reporting at least one physical premenstrual syndrome symptom rated moderate or severe (lead symptom requiring treatment) and one psychic symptom for the late luteal phase of the preceding cycle, using the Calendar of Pre-menstrual Experiences (COPE) symptom list At screening visit S-2 subject is reporting symptoms of a total score of at least 15 in the late luteal phase of the preceding cycle, using the Calendar of Pre-menstrual Experiences (COPE) symptom list In both run-in cycles Visual analog scale greater or equal 50 mm at least on one of the days of the late luteal phase Cyclic course of the mastodynia, i.e. visual analog scale in the mid follicular phase (maximum value of 5 daily recordings) is less than 75 % of the visual analog scale in the late luteal phase (maximum value of 5 daily recordings) Premenstrual syndrome sum score resulting from Calendar of Pre-menstrual Experiences (COPE) must be 20 or more in the late luteal phase (average of daily recordings documented on days -5 to -1) At least one physical premenstrual syndrome symptom must have been rated moderate or severe on at least one day of the late luteal phase, and one psychic symptom is present Pre Menstrual Dysphoric Disorder Intake of any of the following medications before treatment start (visit S-2 up to visit V0) and within 6 months prior to visit S-2 Any treatment for mastodynia or premenstrual complaints Sexual hormones, combinations and inhibitors Pituitary hormones and their inhibitors Hypothalamic hormones Neuroleptics, antidepressants Serotonin-re-uptake-inhibitors Prolactin-inhibitors or prolactin stimulating preparations | 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): 18.0-44.0, Infertility infertile females with preserved gonadal function ages 18 years old included first oocyte donation cycle BMI: > 28 recurrent miscarriages (3 or more) recurrent of implantation failure severe male factor important miomas > 44 years old Problems with the drugs used in the study | 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): 45.0-55.0, Perimenopausal Depression Females who are currently physically well and between 45 and 55 years of age Current DSM-IV diagnosis of depression disorder Able to give informed consent Perimenopausal as determined by symptom profile on the Stages of Reproductive Aging Workshop and gonadal hormonal profile Known abnormalities in the hypothalamic-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, active or past history of a venous thromboembolic event, breast pathology, undiagnosed vaginal bleeding or abnormal Pap smear results in the previous 2 years Patients with any significant unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; or the presence of illness causing immobilisation Patients receiving treatment for depression including antidepressant medications, electroconvulsive therapy (ECT) / Transcranial Magnetic Stimulation (TMS), formal psychotherapy or counselling, within the past 6 months Patients experiencing severe melancholia, neurovegetative symptoms or current suicidality necessitating acute hospitalisation or intensive psychiatric treatment Patients with psychotic symptoms or past history of severe mental illness including schizophrenia, and bipolar disorder Use of any form of estrogen, progestin or androgen as hormonal therapy, or antiandrogen including tibolone or use of phytoestrogen supplements as powder or tablet Pregnancy / Lactation Smoking cigarettes and other nicotine products illicit drug use and more than 3 standard drinks per day | 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, Uterine Fibroids Age>18 years Premenopausal Symptomatic fibroids Fibroids accessible for focused ultrasound treatment Desires future fertility Current pregnancy Hematocrit <30% Emergency room visit in last 3 months for fibroid symptoms History of venous thromboembolism Fibroids that are: >10cm, non-enhancing with contrast Adenomyosis Contraindications to undergoing MRI Unexplained menstrual irregularity | 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): 20.0-40.0, Endometriosis for patients with endometriosis Female patients with ovarian endometriosis, peritoneal and recto-vaginal Aged between 20 and 40 Signing of informed consent for collection and storage of biological samples Contraindications for endometrial biopsy Failure to sign informed consent for collection and storage of biological samples | 2 |
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): 0.0-21.0, Menorrhagia Menstruating females with menorrhagia or menometrorrhagia referred to hematology or gynecology clinics at Texas Childrens Hospital. Menorrhagia is defined as regular periods with heavy menstrual bleeding with a PBAC score greater than 100; menometrorrhagia is heavy vaginal bleeding occurring at irregular intervals PBAC Score greater than 100 for 2 consecutive cycles Pelvic ultrasound that excludes pelvic pathology that can cause menorrhagia within 12 months prior to study participation Normal external genitalia examination within 6 months prior to study participation Normal thyroid stimulating hormone (TSH) in the last 6 months prior to study participation Negative urine or serum pregnancy test within 4 weeks prior to study participation Presence of intra uterine device Presence of a diagnosed bleeding disorder based on the standard work-up including complete blood count (CBC), prothrombin time, partial thromboplastin time, fibrinogen, von Willebrand panel and platelet function analysis (PFA-100) or platelet aggregation Intake of medications with increased risk of bleeding Taking herbal products Sexually active status Body weight less than 40 kg | 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): 18.0-35.0, Copper Intrauterine Device Induced Bleeding Regularly menstruating women before CIUD insertion Age between 18 and 35 years Hormonal treatment has not been taken at least two months before the study Non steroidal anti-inflammatory drugs has not been taken 24 hours before the examination Pregnancy The presence of pelvic pathology as ovarian cysts, pelvic endometriosis, endometrial polyps or fibrosis Present or past history of pelvic inflammatory disease Patients on hormonal treatment in the last two months before the study Patients on non steroidal anti-inflammatory drugs last 24 hours before the examination | 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, Uterine Fibroids Women, age between 18 and 55 years Weight < 140 kg Pre or peri-menopausal Uterine size < 24 weeks Cervical cell assessment by Pap smear/Thin-prep Cytologic Test (TCT): Normal, Low Grade Squamous Intraepithelial Lesion (SIL), Low risk Human Papillomavirus (HPV) or Atypical Squamous Cells of Uncertain Significance (ASCUS) subtypes of cervical tissue Fibroids selected for treatment meeting the following Total planned ablation volume of all fibroids should not exceed 250 ml, and No more than 5 fibroids should be planned for ablation, and Dominant fibroid (diameter) is greater than or equal to 3 cm, and Other pelvic disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis) Desire for future pregnancy Significant systemic disease, even if controlled Positive pregnancy test Hematocrit < 25% Extensive scarring along anterior lower abdominal wall (> 50% of area) Surgical clips in the direct path of the HIFU beam MRI contraindicated MRI contrast agent contraindicated Fibroids not quantifiable on MRI (e.g. multi-fibroid cases where volume measurements are not feasible) | 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): 20.0-45.0, Adenomyosis Women have dysmenorrhoea and/or chronic pelvic pain secondary to adenomyosis Planning for birth spacing for at least 2 years Patient aged between 20-45 years old Ultrasonographic and Doppler examination suggestive of adenomyosis Living in a nearby area to make follow-up reasonably possible Pregnancy Evidence of defective coagulation History or evidence of malignancy Hyperplasia in the endometrial biopsy Incidental adnexal abnormality on ultrasound Contraindications to COCs Absolute contraindication of LNG-IUS insertion Previous endometrial ablation or resection Uninvestigated postcoital bleeding Untreated abnormal cervical cytology | 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): 21.0-999.0, Uterine Fibroids Premenopausal (at least 1 menstrual period in last 3 months) Age >21years Fibroids are associated with heavy bleeding, pelvic pressure or discomfort, urinary or bowel symptoms, or dyspareunia Desires surgical management of fibroids Uterus ≤16 weeks in size All fibroids ≤ 10cm in maximum diameter by ultrasound or MRI assessment within the last year Total number of fibroids ≤6 by ultrasound or MRI assessment within the last year. (For this study "Fibroids" will be leiomyomas > 2cm) Had a Pap smear within the last 3 years with appropriate follow-up and treatment for cellular abnormalities Endometrial biopsy indicates no hyperplasia or cancer (biopsy only required if age >45 years and has anovulatory heavy bleeding) Able to tolerate laparoscopic surgery Planned treatment for infertility Pedunculated fibroid with thin stalk (total stalk length is <25% maximum diameter of fibroid) Intracavitary (FIGO Type 0) fibroid Symptomatic fibroids are only FIGO Type 1 (submucosal with ≥ 50% intracavitary) Planned concomitant surgical procedure in addition to treatment of uterine fibroids Use of Essure or any other metallic, implantable device within pelvis Pregnancy Pelvic infection with the last 3 months History of pelvic malignancy and/or pelvic radiation Known or high suspicion for dense pelvic adhesions | 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): 18.0-60.0, Low Back Pain Symptom of low back pain during last 4 weeks Low back pain history for more than 3 months Have lower limbs radiating pain beyond knee joints Spinal tumorous or infectious disease, fracture, ankylosing spondylitis, cauda equina syndrome or other severe spinal diseases Spinal surgical history Severe heart, lung, liver, kidney disease or high blood pressure With cardiac pacemaker Coagulopathy or thrombosis Have ESW therapy or pharmaceutical treatment for low back pain during last 1 months Mental illnesses or none cooperation Pregnancy | 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, Uterine Leiomyomas Fibroids Uterine Fibroids Myomas Able and willing to give consent Age 18 or older Presence of known uterine leiomyoma Suspected malignancy | 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): 18.0-35.0, Endometriosis Age 18-35 years of age. Written and signed informed consent by the patient to participate in the study. Patients with regular menses, both ovaries, serum TSH within normal range, body mass index (BMI) <30 kg/m2 with normal sperm analysis of the husband Patients with previous endocrine disorders. Cases in which the cause for infertility was other than endometriosis (except for patients with tubal obstruction, in the control group) Patient with previous surgery for endometriosis | 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): 18.0-38.0, Endometriosis aged18-38 years clinically diagnosed with endometriosis (Stage I-IV) patient is seeking pain relief from symptoms of endometriosis/ pelvic pain/ dyspareunia/ dysmenorrhea pregnancy or current breastfeeding use of hormonal suppression for symptom control (OCP, progestins, GnRHa) within past 3 months surgical treatment for endometriosis within last 3 months history of renal disease, liver dysfunction, myopathies in the past baseline AST, ALT or creatinine levels that are more than 1.5 times the normal limits current use of medications that may interact with statins (erythromycin, gemfibrosil, antifungals, antiretroviral, other cholesterol lowering drug etc) | 2 |
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): 20.0-45.0, Adenomyosis Infertility Dysmenorrhea Premenopausal women aged 20-45 years having been diagnosed with adenomyosis earlier and have no other pathology of the uterus, regardless of clinical symptoms Postmenopausal women Pregnant women Gynaecological cancer GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy Endometriosis Uterine fibroids | 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): 25.0-50.0, Adenomyosis Premenopausal women aged 30 years old scheduled for vaginal, abdominal or laparoscopic total hysterectomy one or more of the following clinical symptoms: bleeding disorders (menorrhagia, irregular bleeding, hypermenorrhoea), chronic pelvic pain, dysmenorrhoea, or dyspareunia junction zone definable postmenopausal women pregnancy gynecological cancer GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy junctional zone not identifiable | 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): 38.0-52.0, Adenomyosis females complaining of pelvic congestion: dysmenorrhea, dyspareunia, chronic pelvic pain, menorrhagia, metrorrhagia refusal of the patient to get enrolled in the study | 2 |
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): 18.0-37.0, Deep Endometriosis Stage III Deep Endometriosis Stage IV female patient between 18 and 38 years endometriosis stage III or IV in the AFSr classification laparoscopy included deep endometriosis procedures (adhesiolysis, ureterolysis, cystectomy, resection of bowel, urinary or deep peritoneal endometriosis) written informed consent previous adnexectomy or adnexectomy during surgery | 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): 18.0-90.0, Constipation diagnosis of constipation according to Roma III complete bowel movements per week <3 total bowel movements per week <6 written informed consent report of loose (mushy) or watery stool in the absence of laxative use ongoing artificial nutrition lactose intolerance chronic inflammatory bowel disease previous abdominal surgery use of anti-cholinergics use of antibiotics in the 6 weeks before baseline visit Radio chemotherapy Cognitive decline (Mini Mental State Examination <27) | 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): 21.0-999.0, Leiomyoma Uterine Fibroids ≥21 years old Premenopausal (at least one menses in last 3 months) Symptomatic fibroids (fibroids visualized on ultrasound or MRI and heavy uterine bleeding, pelvic pressure or discomfort, urinary or bowel abnormalities, dyspareunia) Fibroids that are ≤4 in total number or Fibroids that are ≤7 in total number if all fibroids are less than 4cm (40 mm) each Fibroids that are ≤7cm in maximum diameter, on screening imaging, if ≤4 fibroids in total number(fibroid is defined as any mass with radiographic characteristics of fibroid >2cm) Up to date in Pap smear screening and surveillance Endometrial biopsy (required if age>45 years with irregular bleeding) does not indicate premalignant or malignant cells Agree to use non-hormonal barrier method of contraception during study period if at risk for pregnancy Has primary care provider or gynecologist Agrees not to start new medications/treatments for fibroids during the study Fibroids treated by surgery, radiologic procedure, or GnRH agonist or antagonist in the last 3 months Any submucosal fibroid ≥2cm that is >50% in uterine cavity (FIGO Type 0 or Type 1 fibroids) amenable to hysteroscopic resection Use of exogenous estrogen and/or progestin in the last month. (for 3 month long-acting depoprovera injection, no use in last 3 months) Pregnant, lactating, or planning to become pregnant in the next 6 months Hematocrit <27% or visit to emergency room or hospitalization for fibroid symptoms in the last 3 months (cannot be safely randomized to a placebo) History of osteopenia or osteoporosis History of hyperlipidemia Current liver or kidney disease Unable or unwilling to attend 4 study visits Pelvic imaging concerning for gynecologic cancer or cancer of the genitourinary or gastrointestinal system | 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): 18.0-38.0, Endometriosis Patients over 18 years Patients operated by laparoscopy for endometriosis in our department between 2006 and 2014 Patients under 18 years | 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): 18.0-999.0, Endometriosis Quality of Life Pain Sexuality Anxiety Depression Infertility female >18 years fluent German Cases: diagnosis of endometriosis Control 1: no endometriosis, no chronic pain Control 2: no endometriosis, chronic abdominal/pelvic pain male <18years not fluent in German | 2 |
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): 18.0-100.0, Uterine Fibroid Able to give informed consent A type 3 uterine fibroid Sufficient physical condition to undergo deep sedation Waist circumference that allows positioning on the HIFU table top inside the MR bore Contra-indication for MRI scanning according to the hospital guidelines Contra-indication to injection of gadolinium-based contrast agent, including known prior allergic reaction to any contrast agent, and renal failure (GFR <30 mL/min/1.73 m2) Surgical clips or considerable scar tissue in the HIFU beam path A total of more than ten fibroids Post or peri-menopausal status Fibroid size >10 cm in diameter Patient has an active pelvic infection Patient has an undiagnosed pelvic mass outside the uterus Patient who is not able to tolerate the required stationary prone position during treatment | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 0.0-17.0, Guillain-Barre Syndrome ENTRY --Disease Characteristics-- Guillain-Barre syndrome (GBS): Progressive weakness of two or more limbs; Absence or reduced tendon reflexes; No atypical symptoms of GBS (e.g., Miller-Fisher variant); No pure sensory neuropathy; No prior history of GBS Disability at least grade 3 according to Guillain-Barre Study Group grading scale (unable to walk 5 meters without assistance); Must not have improvement of one or more disability grades prior to randomization in this study No paresthesias, numbness, or weakness that began more than 14 days before randomization in this study No CNS involvement --Prior/Concurrent Therapy-- Biologic therapy: No prior treatment with plasmapheresis or infusion of human immunoglobulin (IVIg) Endocrine therapy: No concurrent corticosteroids or other immunosuppressants (except for concurrent medical conditions, e.g., asthma) Radiotherapy: Not specified | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-45.0, Bacterial Infections Group B Streptococcus This information currently is not available | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-999.0, Hypothyroidism Male or female subjects >18 years of age Primary hypothyroidism ≥6 months duration arising from autoimmune hypothyroidism, thyroidectomy or radioiodine treatment Thyroxine dose ≥100 mcg/day No change in thyroxine dose in past 2 months Serum TSH of 0.1-4.8 mU/L Adequate contraceptive measures for women of childbearing age Major systemic illness affecting quality of life or likely to affect participation in the study Treatment with T3 currently or in past 2 months History of thyroid cancer requiring suppression of TSH secretion by thyroxine Ischaemic heart disease – previous myocardial infarction, angina or coronary artery revascularisation Renal failure: serum creatinine >135 micromol/L Known liver disease with alkaline phosphatase or ALT >2x upper limit of reference range Bony fracture in past 3 months or Paget’s disease of bone Secondary (central) hypothyroidism or hypopituitarism | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 5.0-17.0, Influenza Healthy children enrolled in the target schools Written informed consent obtained from the child's parent(s) if they agree to participate History of severe hypersensitivity (anaphylactic response) to egg products or previous FluMist FluMist is licensed exclusively for use in healthy individuals age 5-49 years. Therefore children for whom annual receipt of inactivated influenza vaccine for specific medical condition(s) is recommended will not be eligible. These conditions Asthma, other chronic pulmonary diseases, kidney disease, metabolic disease, heart disease, or hemoglobinopathy Immunosuppression of child Severe immunosuppression of a household member Pregnancy Past history of Guillian-Barre Syndrome Aspirin therapy within 1 month prior to FluMist or the anticipated use of aspirin containing products for one month after FluMist administration Administration of any inactivated vaccine within 2 weeks or any live vaccine within 4 weeks prior to receipt of FluMist Received anti-influenza medication in the past 48 hours | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 8.0-17.0, Hypothyroidism Patients should have clinical and biochemical evidence of hypothyroidism, T4 less than 5.0 ng /dl , fT4 less than 1.0 mcg/dl and TSH of more than 10. Patients with prolonged hypothyroidism should have growth failure and delayed bone age of at least 2 SD from the mean. Patients with short term hypothyroidism should have normal growth velocity and bone age Females 8 to 16 years old Males 9 to 17 years old Patients without any chronic medical conditions Availability of a parent or guardian to attend study visits with the patient and to be actively involved in the patient treatment plan Give written informed consent prior to any study specific screening procedure with the understanding that the patient has the right to withdraw from the study at any time without penalty Taking medications that affect their growth. (eg. Systemic corticosteroids, anabolic steroids) Experiencing other health problems/conditions that affect their growth rate such as growth hormone deficiency, Cushing Syndrome, rickets, and chronic diseases Patients with any condition that is a contraindication for GH therapy would conditions such as an active tumor, impaired glucose tolerance, neurofibromatosis (worsening of neurofibromatosis), and hypertrophy of tonsils and adenoids with sleep apnea. Contraindications for patients for GNRHa therapy would a severe systemic reaction to GNRHa which is rare, osteopenia, and osteoporosis, because delaying puberty will worsen the condition Moving to a location that the patient will not be able to be followed by a pediatric endocrinologist Patient is not willing to continue with the study. - | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 0.0-0.192, Congenital Chylothorax Infants with congenital chylothorax requiring thorax drain | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 0.0-999.0, Hypothyroidism Defined group of women who tested positive for post partum thyroiditis in 1985 Control group randomly picked from those who tested negative | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-64.0, Influenza Healthy Adults Previous vaccination with an influenza Vaccine containing the H5N1 strain History of clinically significant medical conditions History of Guillian-Barre Syndrome or active Neurological disease | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-999.0, Advanced Cancer Patient with drowsiness/sedation caused by opiate for > 3 days and its intensity more or equal to 3/10 (0 to 10 scale; 0 = no sedation, 10=worst possible sedation) Patient receiving a regular dose of a strong opioid for the treatment of cancer pain, and no dose changes or dose change within 50% for at least 48 hours.Regular administration, defined as short acting opioids oral or parenteral every 4 hours around clock, slow release oral opioids every 12 hs or 24 hs, or transdermal opioids every 72 hours. Strong opioids morphine, hydromorphone, methadone, fentanyl, and oxycodone Patient with relatively intact cognition defined by the Mini Mental State Examination according to age and educational level. A score of 24 or above is usually considered normal Patient willing to engage in follow up visit with a nurse by phone on day 2-7 (each day), 11 and 15 of the study and to return for follow up visit on day 8 of treatment. If patient is unable to come to clinic, assessment will be performed through telephone Sexually active females at risk of being pregnant with a negative urine pregnancy test Written consent form signed Patients are 18 years or older Concurrent radiation treatment (defined as 10 or less fractions for a palliative indication) is allowed Concurrent chemotherapy is allowed, if the first two cycles have been well tolerated (defined as no grade 3 or 4 non-hematological toxicity) Major contraindication to donepezil i.e. hypersensitivity to donepezil or piperidine derivatives Patients in whom a major change in opiate dose, analgesia requirements, anesthetic procedures or general anesthetic is expected over the next seven days Treatment with anti-cholinergic agents (i.e., glycopyrrolate) Patients taking Methylphenidate Patients with tube feeding (due to difficulty of accurate assessing some of the symptoms such as appetite and anorexia) History of ongoing arrhythmia causing a rhythm other than a sinus rhythm | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-90.0, Dry Eye Syndromes Signed and dated informed consent Male or female aged from 18 to 90 years old Known treated bilateral dry eye Dry eye syndrome confirmed by ocular examination with a fluorescein and/or lissamine green staining, BUT and Schirmer, performed within the last 12 months before Visit, for both eyes Bilateral symptomatology suggestive of dry eye defined by: at least one of the following ocular symptoms suggestive of dry eye (burning, stinging, dryness feeling, sandy and/or gritty sensation, light sensitivity, reflex tearing, ocular fatigue) and Questioning on patient’s feeling (score >=3) Fulfilling the following of dry eye syndrome in both eyes defined by: Keratoconjunctivitis defined by a lissamine green score ≥ 4 (Van Bijsterveld score) and Schirmer test <= 10 mm in 5 min or BUT < 10 s severe dry eye symptom eyelid dysfunction severe progressive rosacea any relevant ocular anomaly interfering with ocular surface best corrected far visual acuity <= 1/10 history of ocular allergy traumatism, infection, inflammation within last 3 months ocular surgery and laser within the last 3 months lasik, laser, PKR within the last 12 months contact lenses | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-75.0, Secondary Hypothyroidism Hypopituitarism Hyperlipidemias hypopituitarism of at least 3 axes (TSH plus gonadotropin, somatotropin, corticotropin or ADH deficiency) termination of surgical or radiation treatment of pituitary tumors at least six month before study entry BMI of 20 9 kg/m2 non-smoking status history of cardiovascular or pulmonary diseases current thyroxin dosage > 1.6 µg/kg bw pregnancy epilepsy cerebrovascular diseases nodular goiter | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 20.0-999.0, Neoplasms, Gastrointestinal Tract Specific Information regarding warnings, precautions, contraindications, adverse events, and other pertinent information on the investigational product that may impact subject is provided in the Investigator's Brochure (IB) Pilot Part Subjects eligible for enrollment in the Pilot Part of the study must meet all of the following Signed informed consent Male or female; ≥ 20 years (at the time of giving consent) Any histologically or cytologically confirmed gastric carcinoma independent of tumor ErbB2 status Subjects who have received one prior regimen for gastric carcinoma and developed disease progression or recurrence. The regimen must have contained 5-fluoropyrimidine and/or cisplatin Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram (ECHO). Multigated acquisition (MUGA) scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive (LVEF of ≥50% required if normal range of LVEF is not provided by institution) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 Able to swallow and retain oral medication Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study Subjects meeting any of the following must not be enrolled in the study Pregnant or lactating female at anytime during the study Planned concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2) Peripheral neuropathy of Grade 2 or greater Malabsorption syndrome, disease significantly affecting gastrointestinal function. Subjects with ulcerative colitis and Crohn's disease are also excluded History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety Life threatening infection Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 0.0-999.0, Congenital Hypothyroidism Patients with congenital hypothyroidism due to thyroglobulin defective synthesis Patients with another disease | 1 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-999.0, Hypothyroidism Newly diagnosed hypothyroidism with tsh over 40 mU/L, etiology chronic autoimmune thyroiditis Healthy controls matched regarding sex, age and body mass index Pregnancy, breastfeeding | 1 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 23.0-73.0, Iron Deficiency Anemia Subclinical Hypothyroidism Clinical diagnosis and laboratory confirmation of iron deficiency anemia and subclinical hypothyroidism Must be able to swallow tablets Multifactorial anemia or anemia due to other reasons Iron deficiency anemia requiring urgent intervention cardiac ischemia, severe anemia, GI or GU losses due to malignancy and or acute/subacute big loses by respiratory, Gİ, GU, etc. system Prior thyroid disorder and/or treatment history Presence of any other co-morbid disease like renal insufficiency/ failure, coronary heart disease, hypertension, diabetes mellitus, any endocrine system disease other than subclinical hypothyroidism | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 20.0-90.0, Thyroid Nodule age between 20 to 90 years old Benign nodular goiter diagnosed with thyroid echo and fine-needle aspiration cytology Age younger than 20 or older than 90 years old Pregnancy Allergy to eltroxin Taking other drugs which will have drug interaction with eltroxin patients with cardiovascular disease, hypertension, gastrointestinal disease | 1 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 0.0-0.077, Hypothyroxinemia Birth weight: less than 1500g Gestation: 22 weeks 0 day ≤ Serum free thyroxine level lower than 0.8 ng/dl Serum thyrotropin lower than 10 μU/ml Age of between 2 and 4 weeks after birth Informed consent any known thyroid disease in mother | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 2.0-6.0, Gram Positive Infection Concurrent Antibiotic Treatment Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care Male or female between the ages of 2 and 6 years old, inclusive Able to comply with the protocol for the duration of the study Clinically stable with no evidence of hemodynamic instability (defined as a requirement for pharmacological intervention to manage blood pressure) in the 72 hour window prior to enrollment, and no history or evidence of renal or hepatic compromise Suspected or diagnosed Gram-positive infection for which the subject is receiving standard antibiotic therapy A calculated creatinine clearance rate (CLcr) ≥ 80 ml/min/1.73m2 as determined by the Schwartz equation at baseline Creatine phosphokinase (CPK) levels less than 2X ULN (upper limit of normal) at baseline Presence of two patent intravenous lines (or comparable means of venous access) prior to dosing on Study Day 1 Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry Known allergy/ hypersensitivity to daptomycin History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic, autoimmune disease or primary immune deficiency Pneumonia as sole Gram-positive infection being treated with standard antibiotics Subjects with clinically significant abnormal laboratory test results [including electrocardiograms (ECGs)], as determined by Investigator Administration of rifampin within 7 days of study drug administration Body mass index (BMI) that is outside of the 5th to 95th percentile Subjects in whom collection of the required blood volume would put them at risk of hemodynamic disturbance (at the discretion of Investigator) History of or current clinically significant (at the discretion of the Investigator) muscular disease, nervous system or seizure disorder Administration of intramuscular injection between baseline and study drug administration or expected intramuscular injection within 24 hours following dosing | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-48.0, Hypothyroidism Premenopausal women with overt primary hypothyroidism (reduced T4 concentration accompanied by increased TSH concentration at the time of initial diagnosis) who did not receive thyroid hormones Peri and postmenopause Pregnancy Major comorbidity Use of drugs that affect metabolism or bioavailability of thyroid hormones preparations | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 17.0-44.0, Hypothyroidism TSH value >98th centile in early pregnancy Women with known hypothyroidism | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-80.0, Schizophrenia Schizoaffective Disorder Weight Gain non-diabetic schizophrenic or schizoaffective currently prescribed olanzapine or ziprasidone 80 y.o <18 or >80 years of age diabetic not schizophrenic or schizoaffective not currently prescribed olanzapine or ziprasidone | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-80.0, Depression Age 18 Written informed consent Current MDD according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) Recently started to receive or about to start receiving treatment for MDD Quick Inventory of Depressive Symptomatology Clinician-Rated (QIDS-C) and QIDS-IVR scores equal or greater than 10 at baseline visit Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, other than alcohol, active within the last 12 months History or current diagnosis of dementia Diagnosis or history of hypothyroidism | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-70.0, Arthroplasty, Replacement, Knee Scheduled for total knee replacement or revision of total knee replacement Agree to have a regional technique including neuraxial analgesia for post-operative analgesia Be 18 to 70 years old Classified as ASA score I-III Allergic to morphine Allergic to local anesthetics Been on opioids for more than 4 weeks Not willing to be randomized On anticoagulation medications that prevent placement of epidural Sensitive to effects of neuraxial opioids BMI>35 Severe COPD Obstructive sleep apnea (OSA, see below). Each patient will be asked the questions below to determine their risk for OSA (STOP questionnaire). Patients who answer yes to 3 or more of the major of the STOP questionnaire and have one of the minor will be excluded from the study STOP Questionnaire for OSA | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 4.0-18.0, Chronic Constipation Less than 2 per week defecation Fecal incontinence Retentive behavior Pain at defecation and Hard stools Medication use (calcium, antacid, diuretic and hematinic) Organic causes (spina bifid, hypothyroidism, hirschusprung disease, developmental delay neuropsychomotor, kidney disease and metabolic diseases) | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 60.0-95.0, Subclinical Hypothyroidism TSH between 4 and 10 mUI/L inclusive Known and treatment of thyroideal disease Arrythmia Anticoagulant treatment Dementia Disease leading to dementia (acv, LIVER....) | 1 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-65.0, Fibromyalgia Female volunteers who have been diagnosed with fibromyalgia by a rheumatologist Overall body pain average score ≥ 4 Age range: 18 to 65 years old You must be on stable doses of anyone of these fibromyalgia-related medications for at least 4 weeks: cyclobenzaprine, tramadol, gabapentin, pregabalin, amitriptyline, nortriptyline, trazodone, sertraline, fluoxetine, paxil, remeron, venlafaxine and duloxetine Willingness to restrict any change (add or switch or change in the dose) of any fibromyalgia-related medication for 12 weeks Volunteers who have long-standing history of diabetes (> 2 years), or have been diagnosed with any type of peripheral neuropathy Have a prior history of myocardial infarction (heart attack) or unstable angina or other heart arrhythmias Have been diagnosed with multiple sclerosis or any other demyelinating disorder Have planned to undergo an elective surgery over the next 12 weeks Have other major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and other connective tissue disease) Are currently pregnant or actively trying to become pregnant | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 12.0-65.0, Vitiligo Any Vitiligo patient (age 12 years and above) with non-segmental Vitiligo Body surface area (BSA) involvement ≥ 3% Unable to consent Any topical, systemic or phototherapy for Vitiligo in the previous 2 months Pregnancy, breast feeding Liver or kidney disease Epilepsy Bleeding disorder or anticoagulant treatment | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-999.0, Anemia years or older Diagnosis of low or intermediate-1 risk Myelodysplastic (MDS) with any chromosome karyotype except del 5q[31] Anemia that requires red blood cell transfusions Resistant to erythropoiesis stimulating agents (ESAs) or blood erythropoietin level > 500 mU/mL Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2 Must agree to follow pregnancy precautions as required by the protocol Must agree to receive counseling related to teratogenic and other risks of lenalidomide Must agree not to donate blood or semen Must be willing to consent to two or more bone marrow aspirate procedures to be completed during study Subjects previously receiving immunomodulating or immunosuppressive agents, or epigenetic or deoxyribonucleic acid (DNA) modulation agents Allergic reaction to thalidomide Renal insufficiency creatinine clearance (CrC1)<40 mL/min by Cockcroft-Gault method) Prior history of cancer, other than MDS, unless the subject has been free of the disease for ≥ 5 years. (Basal cell carcinoma of the skin, carcinoma in situ of the cervix, or stage Tumor (T) 1a or T1b prostate cancer is allowed) Absolute neutrophil count (ANC) < 500/uL Platelets < 50,000/uL Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3X upper limit of normal Uncontrolled hyperthyroidism or hypothyroidism Significant neuropathy Prior stem cell transplantation | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-999.0, Neuropathy Men and women, ages of 18 or greater Documented evidence of HIV-1 infection Documented diagnosis of HIV-associated Distal Symmetrical Polyneuropathy (DSP) with subjective sensory symptom of pain Pain starts in the feet Subject has untreated vitamin B12 deficiency (serum B12 level <200 pg/ml) or if treated B12 deficiency -treatment is less than 6 months of B12 supplementation (injection or intranasal B12) prior to screening Diabetes mellitus requiring regular medical treatment (other than diet and exercise) or HbA1C >6.9 Subjects with peripheral neuropathic pain that is not associated with HIV infection; including subjects with conditions such as: Post Herpetic Neuralgia (PHN), Diabetic Peripheral Neuropathy (DPN), familial neuropathies; compression related neuropathy, radicular pain, other infection related neuropathies (eg, leprosy); neuropathy related to: metabolic abnormalities; nutritional factors; vascular insults; inflammation; autoimmune disease; and malignancy | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 21.0-85.0, Cerebral Stroke Ischemic or hemorrhagic stroke greater than 3 months prior Residual hemiparetic gait with observable asymmetry in the gait pattern Women or men aged 21 to 85 years Completed all conventional physical therapy Adequate language and neurocognitive function to participate in training, testing, and to give informed consent Minimal ankle flexion in either direction (dorsi or plantar-) MMSE score < 23 (9th grade education or more) or MMSE score < 17 (8th grade education or less) CES-D score > 16 Clinical history of orthopedic, chronic pain or severe neuromuscular disorders restricting participation in a short term ankle movement training paradigm Severe or global receptive aphasia which confounds reliable testing and training Women of child-bearing potential, if there is any self-reported chance that they may be pregnant | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 65.0-999.0, Acute Myeloid Leukemia Diagnosis of one of the following Newly diagnosed de novo acute myeloid leukemia (AML) AML secondary to myelodysplastic syndromes (MDS) AML secondary to exposure to leukemogenic therapy or agents with primary malignancy in remission for at least 2 years Bone marrow blasts >30% Age ≥ 65 years Easter Cooperative Oncology Group (ECOG) 0-2 Previous cytotoxic or biologic treatment for AML (except hydroxyurea) Previous treatment with azacitidine, decitabine or cytarabine Prior use of targeted therapy agents (e.g., FLT3 inhibitors, other kinase inhibitors) AML French American British subtype (FAB M3) AML associated with inv(16), t(8;21), t(16;16), t(15:17), or t(9;22) karyotypes Prior bone marrow or stem cell transplantation Candidate for allogeneic bone marrow or stem cell transplant Diagnosis of malignant disease within the previous 12 months (excluding base cell carcinoma, "in-situ" carcinoma of the cervix or breast or other local malignancy excised or irradiated with a high probability of cure) Malignant hepatic tumors Uncontrolled systemic infection | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 40.0-80.0, Macular Degeneration for subjects will be a clear diagnosis of Age-related Macular Degeneration (AMD) for controls will be less than five small (< 63 um) hard drusen At least a 20/40 view of the fundus The ability to provide a blood sample, and the absence of listed We will individuals with ocular diseases that might simulate Age-related Macular Dengeration (AMD) or preclude its diagnosis Those might prior laser photocoagulation, cryopexy, media opacity, and inflammatory diseases It is important for potential control subjects not to exhibit media opacity (e.g., cataract), which will prevent visualization of the macula Also, subjects will be excluded if they exhibit diseases that phenotypically overlap with Age-related Macular Degeneration (AMD) such as drusen or pigmentary disturbance of the retinal pigment epithelium (RPE), or that provided insufficient evidence to diagnose Age-related Macular Degeneration (AMD) In addition, subjects with pattern dystrophies, toxoplasmosis, histoplasmosis, degenerative myopia, central serous chorioretinopathy, or any disease or treatment that would diminish the ability to recognize drusen such as laser photocoagulation, prior retinal detachment surgery, posterior uveitis, and trauma will be excluded | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 35.0-60.0, Hypothyroidism Recently diagnosed hypothyroid subject (either during the period, or within the 6 previous months) for whom, data related to the diagnosis is available if the diagnosis was not carried out initially by the investigating doctor Subject, who has given his/her oral consent for participation Subject included in clinical trial or having participated in a clinical trial during the last 3 months Subject presenting a major and objectifiable risk of not being able to follow-up until the next TSH level (moving, problems encountered during another study, pathology affecting the vital prognosis in the short-term) All contraindications to Lévothyrox | 2 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 0.538-0.712, Nursing Care Preterm Infant were included according with the Official Mexican Norm -007-SSA2-1993 (1995) Preterm Infant were not included in case of malformations that involved lost of the cutaneous integrity or in case of severe cardiac congenital disease | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-49.0, Phase 1 Safety Study of GelVac™ Nasal Powder H5N1 Influenza Vaccine. able to read and sign Informed Consent Form (ICF) male or female > 18 and < 49 years of age at the time the ICF is signed generally healthy, as determined by medical history and clinical assessment able to attend all scheduled visits and to comply with all trial procedures if female of child-bearing potential, use of an acceptable method of contraception or abstinence for at least 4 weeks prior to the first vaccination through at least four weeks after the second vaccination. Acceptable methods are hormonal birth control or a barrier method with spermicide if female, post menopausal (no menstrual period within the last 12 months), surgically sterile (hysterectomy or tubal ligation), or have a negative urine pregnancy test within 24 hours prior to the time of vaccination has a known allergy to fruits (e.g., apples, oranges) or pectin and/or pectin by-products (including jams or jellies) has a known allergy to dairy/milk products/lactose is breast-feeding or pregnant or planning on becoming pregnant within 1 month of vaccination has a history of a chronic viral infection (i.e.; Shingles, Herpes Zoster, HIV) has a history of severe allergic reaction following influenza vaccination, systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing the same substances has a history of demyelinating disease (esp. Guillian-Barre Syndrome) history of Bell's Palsy immunosuppression as a result of underlying illness or treatment use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 µg/day of beclomethasone dipropionate or equivalent) within 1 month prior to vaccination use of other immunosuppressive or cytotoxic drugs or radiation therapy within six months prior to vaccination | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 0.0-5.0, Hypothyroxinemia Gestational age < 32 WG FT4 (5, 6 or 7 days of life) ≤ 0.8 ng/dL TSH (5, 6 or 7 days of life) < 20 mIU/L Written consent from the parents Maternal thyroid disease FT4 (5, 6 or 7 days of life) > 0.8 ng/dL TSH (5, 6 or 7 days of life) > 20 mIU/L Grade III or IV intracerebral hemorrhage | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-80.0, Dyslipidemia Patients >18 years old With Subclinical hypothyroidism defined as serum TSH concentration above 5.0 IU/mL when serum FT4 level is within the reference range With OSA defined as mild OSA: AHI 5 to 15/h; moderate OSA:AHI 15 to 30/h; and severe OSA: AHI greater than 30/h (30) will be enrolled With confirmed sustained subclinical hypothyroidism, thus excluding patients with a temporary condition such as that in recovery from a non-thyroidal illness, measurement of TSH and FT4 will be conducted within four weeks before randomization Current treatment with Levothyroxine and lipid lowering medications or within two months before randomization Conditions known to cause dyslipidemia e.g. uncontrolled diabetes mellitus (HbA1c >9), alcoholism and some medication use e.g. Estrogens. Glucocorticoids, Retinoids or Interferons Conditions indicating levothyroxine treatment (34); including TSH levels more than 10 mU/l, clear symptoms or signs associated with thyroid failure and not related to OSA . e.g. goiter State of pregnancy, Breast feeding or allergy to levothyroxine | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 3.0-17.0, Pediatric Solid Organ Transplant Patients Pediatric SOT patients (kidney, liver, heart, lungs, intestine, and/or multi-visceral) Must be at least 6 months after transplant 17 years of age, inclusive Available for duration of study Parent or guardian able to be reached by phone History of hypersensitivity to previous influenza vaccination or severe hypersensitivity to eggs/egg protein History of Guillian-Barre syndrome Receipt of rituximab within the past one year Rejection treatment with intravenous steroid bolus within 30 days Rejection treatment with monoclonal antibody or antilymphocyte preparation (e.g. Alemtuzumab, Muromonab-CD3, etc.) within 90 days Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol Have any condition that the investigator believes may interfere with successful completion of the study History of received 2011-2012 influenza vaccine Pregnant female History of proven influenza disease after September 1, 2011 | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 0.0-999.0, Hypopituitarism All patients with pituitary hypopituitarism Unavailability of data | 1 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 0.5-1.5, Down Syndrome patient with a karyotype demonstrating homogeneous, free or Robertsonian translocation trisomy 21 patient having undergone a cardiac ultrasound not demonstrating any severe heart disease patient aged 6 to 18 months at congenital hypothyroidism hypothyroidism demonstrated by laboratory tests presenting or having presented hyperthyroidism presenting or having presented leukaemia presenting or having presented West syndrome or any other form of epilepsy or unstable neurological disease presenting or having presented signs of central nervous system distress: stroke, postoperative hypoxia, meningitis) presenting severe heart disease on cardiac ultrasound, with haemodynamic effects presenting non-controlled cardiac arrhythmia Apgar < 7 to 5 min at birth Gestational age < 245 days (35 weeks) | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-45.0, Group B Streptococcal Infection pregnant women with positive GBS screening culture at 35-37 weeks of gestation singleton gestation subjects with agreement to abstain from the use of any systemic or intravaginal antibiotic, anti-fungal agents, or any other intravaginal product (i.e., contraceptive creams, gels, foams, sponges, lubricants, douches, etc) throughout the trial period multiple gestations subjects with impaired immunity , diabetes or other significant disease or acute illness that in the investigator's assessment could complicate the evaluation vaginal or systemic antibiotics or antifungal therapy within 2 weeks of the screening visit | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 80.0-999.0, Hypothyroidism Males and Females aged 80 years or older Diagnosed with hypothyroidism and treated with Levothyroxine for at least 6 months Living independently in the community All TSH results within the range 0.4 U/L in the 3 months before commencing the study Participant has provided written informed consent for participation in the study, prior to any study-specific procedures Established dementia and therefore deemed incapable of providing informed consent Other medical conditions which, inthe opinion of the Chief Investigator, would prevent them from participating in the study (for example, end stage cancer, severe chronic health conditions where the patient is housebound) Nursing Homes or Residential Care Home residents Individuals with thyroid cancer: since they require high doses of LT4 to suppress their serum TSH Individuals on 25 mcg dailty of LT4: dose reduction will mean that they stop thyroid replacement treatment Non english speaking individuals Participation in any other investigational trials within the last 3 months Participants prescribed medications that can affect thyroid function (amiodarone, lithium, carbimazole or propylthiouracil) Known or suspected lactose intolerance (this would have implications for the proposed over-encapsulated IMP) | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-65.0, Acute Mountain Sickness Healthy adults History of serious illness Current smoker or Hemoglobin >15.5gm/dL Uncontrolled hypertension | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-999.0, Neoplasms Patients must have biopsy-confirmed non-hematological malignancy Patients must be scheduled to receive cytotoxic chemotherapy (adjuvant or metastatic setting), excluding immunotherapy Patients must be of age >=18 years Patients must have an absolute lymphocyte count >= 1,000/mcL immediately prior to influenza vaccination Ability of the patient (or legally authorized representative if applicable) to understand and the willingness to sign a written informed consent document Patients who have already received the influenza vaccine during the season in which they are considered for will be excluded History of allergic reactions attributed to compounds of similar chemical or biologic composition to the influenza vaccine or egg allergies Previous history of Guillian-Barre syndrome within the previous 6 weeks to influenza vaccination Patients must not be receiving chronic steroid therapy, defined as >= 14 days, unless used as part of a chemotherapy regimen Patients must not be on any other agents that can suppress the immune system Planned concurrent therapy with radiation Uncontrolled illness at time of enrollment or influenza vaccination including, but not limited to, ongoing or active febrile illness Psychiatric illness/social situations that would limit compliance with study requirements Known immunosuppression eg. history of organ transplantation or known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because they may not be able to mount an appropriate immune response History of influenza-like illness, defined as a temperature > 37.8 degree C with cough or sore throat starting October 1, 2011 throughout the duration of the study | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-40.0, Sprain of Lateral Ligament of Ankle Joint age equal or less than 40 years-old, military subject, acute ankle injury, To have completed and signed the informed consent contraindications to cryotherapy ( cold allergy, cryoglobulinemia, Raynaud's phenomenon, cutaneous sensory abnormalities, and diabetes mellitus), paracetamol allergy, 4th grade sprains according to the Trevino Classification (with bone wrenching), to take analgesic or anti-inflammatory treatment other than paracetamol | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-999.0, Women at Risk of Neonatal Infections Colonize With GBS (Group B Streptococci). Patient having a positive vaginal swab for GBS at the end of pregnancy (PCR +) Patient aged over 18 years Patient who received information and agreeing to sign informed consent Patient affiliated or beneficiary of an insurance Patient does not speak and does not understand French | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-65.0, Primary Hypothyroidism. Patients will be between the ages of 18 to 65 and will have been on levothyroxine for primary hypothyroidism for at least 6 months Patients will be excluded if they have the following problems: pregnancy, plan for pregnancy in the next 12 months, cardiac disease, especially coronary artery disease, chronic obstructive lung disease, malabsorption disorder, gastrointestinal surgeries, significant renal or liver dysfunction, seizure disorders, thyroid and non-thyroid active cancers, uncontrolled psychosis, psychotropic medication use, steroid use, amiodarone, chemotherapy for cancer, iron supplement more than 325mg per day, carafate/ proton pump inhibitor use, cholestyramine use, and those with recent PCS orders who are expected to move out of the geographic area, age less than 18 years old or older than 65 years old Patients scheduled for deployment will be excluded | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 8.0-20.0, Down Syndrome Subclinical Hypothyroidism Males and females, ages 8 years Diagnosis of Down syndrome Subclinical hypothyroidism: TSH level between 5 mIU/L, normal T4 Parental/guardian permission (informed consent) and if appropriate, child assent Females who are at least 11 years of age or who are menarchal must have a negative urine/serum pregnancy test Committed to adherence to levothyroxine treatment and study completion Pregnancy Type 1/Type 2 diabetes Chronic medical conditions or medication use that can affect growth, nutrition, blood glucose, insulin secretion, or thyroid function (such as lithium or certain seizure medications) Current use of levothyroxine or anti-thyroid hormone Cyanotic congenital heart disease, or pulmonary hypertension (as described by last echo report in subjects with CHD), or congenital heart disease considered medically unstable by the study cardiologists | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-999.0, Thyroid Cancer Differentiated thyroid cancer treated by thyroidectomy and at least 1 ablation with 131-I > 5 months ago TSH < 4 imU/L Pregnancy Known metastasis | 1 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 40.0-75.0, Hypothyroidism Thyroid Diseases Endocrine System Diseases 75 years old Diagnosis of overt or subclinical hypothyroidism in two occasions with a minimum interval period of three months Pregnant or lactating women Severe hepatic or renal dysfunction Psychiatric disabilities, acute cardiovascular and cerebrovascular diseases, chronic respiratory diseases, familiar hypercholesterolemia, malignancy, cholelithiasis, pancreatitis, bowel diseases and other disorders influencing lipid and bile acid metabolism Taking lipid-lowering agents and other drugs influencing thyroid function, lipid and bile acid metabolism Obviously poor compliance | 1 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 65.0-999.0, Subclinical Hypothyroidism Depression Community-dwelling patients aged >= 65 years with subclinical hypothyroidism Written informed consent Subjects currently on Levothyroxine or antithyroid drugs, amiodarone or lithium Recent thyroid surgery or radio-iodine (within 12 months) Grade IV NYHA heart failure Prior clinical diagnosis of dementia Recent hospitalisation for major illness or elective surgery (within 4 weeks) Terminal illness Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption Subjects who are participating in ongoing RCTs of therapeutic interventions (including CTIMPs) Plan to move out of the region in which the trial is being conducted within the next 2 years (proposed minimum follow-up period) | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-999.0, Celiac Disease Hypothyroidism Celiac Sprue Malabsorption Patients with the diagnosis of hypothyroidism that require thyroid replacement therapy Surgical resection of thyroid tissue, neck irradiation, radioactive iodine therapy, prior medical treatment with lithium, methimazole, propylthiouracil, ethionamide, amiodarone, or sunitinib, prior serologic testing for celiac disease | 2 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 5.0-6.0, Dental Caries attending kindergarten in one of the participating schools must have parental permission children with severe stomach illness (ex. Crohn's disease, ulcerative colitis, Celiac disease, irritable bowel syndrome, etc.) children with strict dietary restriction (ex. Diabetes) | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 0.0-999.0, Congenital Hypothyroidism Patient: newborn (0-27 days) or infant (28 days 23 months), or child or adult with congenital hypothyroidism (that is to say with a TSH > 15 mU / ml at screening on filter paper and / or plasma TSH> 10 mU / ml) diagnosed in the first months of life, whatever their age, sex, weight and size Subjects with blood levels of free thyroid hormones (FT3 and FT4) in the standards will be described as having subclinical hypothyroidism If treatment with L-thyroxine could be stopped without relapse (that is to say, always with a TSH <5 mU / ml with different controls), hypothyroidism is said to be transient, whatever the age of discontinuation of treatment No pre or neonatal goitre by palpation or ultrasound thyroid negative perchlorate test (ie decreased rate of iodine captation <10% at 2h injection of perchlorate) when the thyroid gland in place No self-immunity known to thyroid in children with and / or his mother (defined by a antithyroperoxidase antibodies and / or antithyroglobulin) Signature of free and informed consent by the patient or his legal representative Affiliation or enjoying a social security system Presence of markers antithyroid autoimmunity in children and / or mother (antithyroperoxidase antibodies and / or antithyroglobulin) Pre or neonatal goiter on palpation or ultrasound thyroid Test positive perchlorate (ie salting rate of iodine> 10% at 2 injection perchlorate) Patients of foreign origin returned to their country will be excluded from the study | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-999.0, Gullian Barre Syndrome Patients aged >18 years diagnosed with GBS according to NINDS diagnostic Onset of weakness due to GBS is less than 2 weeks ago Patients who are unable to walk unaided for >10 metres (grade >3 on GBS disability scale) Patients who are being considered for or already on IVIg treatment First dose of eculizumab must be started within 2 weeks from onset of weakness and any time during the IVIg treatment period Signed informed consent Age <18 years Patients who are being considered for, or already on, plasma exchange Pregnancy or lactation Patients show clear clinical evidence of a polyneuropahty caused by e.g. diabetes mellitus (except mild sensory), alcoholism, severe vitamin deficiency, and porphyria Patients received immunosuppressive treatment (e.g. azathioprine, cyclosporine, mycofenolatemofetil, tacrolimus, sirolimus or > 20 mg prednisolone daily) during the last month Patients known to have severe concurrent disease, like malignancy, severe cardiovascular disease, AIDS, severe COPD, TB Inability to comply with study related procedures or appointments during 6 months Any condition that in the opinion of the investigator could increase the patient's risk by participating in the study or confound the outcome of the study Related to the administration of eculizumab Unresoled Neisseria meningitidisinfection of history of meningococcal infection Unsuitable for antibiotic prophylaxis (e.g due to allergy) Known hypersensitivity to eculizumab, murine proteins or to any of the excipients Known or suspected hereditary complement deficiencies Women of child-bearing potential who are unwilling to use effective contraception during treatment and for 5 months after treatment is completed | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-80.0, Constipation To be considered eligible for enrolment into the study, subjects must Be able to give written informed consent Be between 18 and 80 years of age Subject has chronic functional constipation according to the Rome III Diagnostic where (f) is mandatory i. Must two or more of the following Straining during at least 25% of defæcations Lumpy or hard stools in at least 25% of defæcations Sensation of incomplete evacuation for at least 25% of defæcations Sensation of anorectal obstruction / blockage for at least 25% of defaecations Manual manœuvers to facilitate at least 25% of defæcations (e.g., digital evacuation, support of the pelvic floor) Subjects will be excluded from the study if they meet any of the below criteria Are less than 18 and greater than 80 years of age Females are pregnant, lactating or wish to become pregnant during the study Are hypersensitive to any of the components of the test product Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigators judgement, entry to the study Subject has an obstructive or metabolic aetiology for constipation Subject has a history of laxative abuse (greater than the daily dosage recommended on the label for any laxative) Subject has used a probiotic or prebiotic product or a dietary fibre supplement in the 4 weeks prior to the baseline visit Subject has a history of drug and/or alcohol abuse at the time of enrolment Having a condition or have taken a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-40.0, Muscle Injury for control subjects [primary target being Reserve Officer Training Corps (ROTC) personnel]: 1) healthy individuals ages 18-40 years; and 2) ankle range of motion for the leg to be tested from 0 degrees of plantarflexion to 30 degrees of plantarflexion for control subjects (primary target being ROTC personnel): 1) previous history of trauma and/or surgery to the lower extremities that may limit function; 2) neurological, vascular, or cardiac problems that may limit function; 3) diabetes; 4) previous traumatic head injury or post-traumatic stress disorder; 5) a contraindication to MRI e.g.: pacemakers, metal implants which are not MRI compatible, pregnancy, and severe claustrophobia; and 6) currently performing an exercise program that specifically targets the dorsiflexor muscles for subjects with muscle atrophy: 1) individuals ages 18-40 years with an injury to the lower leg requiring immobilization but no surgical intervention; and 2) ankle range of motion for the leg to be tested from 0 degrees of plantarflexion to 30 degrees of plantarflexion for subjects with muscle atrophy: 1) previous history of trauma and/or surgery to the lower extremities, other than the injury for being immobilized, that may limit function; 2) neurological, vascular, or cardiac problems that may limit function; 3) orthopedic conditions affecting the contralateral, uninvolved lower extremity that may limit function; 4) diabetes; 5) previous traumatic head injury or post-traumatic stress disorder; and 6) a contraindication to MRI e.g.: pacemakers, metal implants which are not MRI compatible, pregnancy, and severe claustrophobia | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-60.0, Asthma years of age or older Known Asthma The exacerbation is defined as moderate or severe Not currently enrolled as an active participant in another clinical trial of a medical therapy or device The patient or first degree family relative (in cases where the patient is intubated) has authorized his/her consent to participate in this trial. The patient will be asked to give his consent only after initial bronchodilator therapy years of age or older Known thyroid disorders Subject where thyrotoxicosis is suspected Known heart disease Heart rate > 140 | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 60.0-75.0, Aging Age 18 to 35 years, or 60 to 75 years Body mass index ≤ 27 kg•m2 Ability to sign informed consent Score of ≥26 for Mini-Mental State Exam Diabetics (plasma glucose concentration >200 mg/dl at 2 hr after oral intake of 75 g glucose) Fasting plasma triacylglycerol concentration above 500 mg/dl Kidney disease Liver disease Bleeding disorders Anaemia (Hb < 13 g/dl in males or < 12 g/dl in females) Endocrine disease (with the exception of well-regulated hypothyroidism) Positive hepatitis or HIV screens Alcohol (CAGE questionnaire; abnormal liver enzyme values) or drug abuse (amphetamines, cocaine, opioids, marijuana) Lipid altering agents | 0 |
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