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A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 10.0-55.0, Involutional Depression Anxiety Disorders Age: 10-30 Can give consent/assent. Parents will provide consent for all minors All subjects will have IQ greater than 80 High risk Psychopathology: Offspring of adults with a history of MDD Low risk Psychopathology: Offspring of adults with no history of MDD and low developmental levels of emotion dysregulation. Subjects born to parents with only anxiety disorders will be included in this group Any medical condition that increases risk for MRI (e.g. pacemaker, metallic foreign body in eye) Pregnancy Both groups: All subjects will be free of current impairing affective disorders, separation anxiety disorder, social anxiety disorder, panic disorder, generalized anxiety disorder, PTSD, ADHD, as well as lifetime history of substance dependence, psychosis, pervasive developmental disorder, major affective disorder, obsessive compulsive disorder, conduct disorder, anorexia. All subjects will be born to parents with no history of schizophrenia or bipolar disorder Age: 18-55 Can give consent/assent Offspring: All subjects will have offspring participating in this same protocol Have an IQ greater than 80 Past history of MDD No lifetime history of MDD ADULT
2
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Depression Palliative Care Cancer Mental Disorder Either enrolled in the OHSU radiology/oncology clinic or VA palliative care, and living within 120 miles of the Portland VAMC Life-limiting disease is any type of solid or blood cancer Eighteen years of age or older Life expectancy of 1 year or less as reflected by hospice admission or palliative care status. Although exact life expectancy can not be predicted, actively dying patients with estimated life expectancy of < 10 days are unlikely to be enrolled Diagnosis of major depression disorder as determined by the Structured Clinical Interview for Diagnosis (SCID) Significant depressive cognitive symptomatology as determined by a MADRS greater than 19 Currently taking an SSRI but still depressed enough to meet or not taking SSRI but depressed enough to start on SSRI Willing and able to give informed consent to participate in this study as demonstrated by the MacArthur Competence Assessment Tool for clinical research Speaks/understands English For patients at home who cannot self-administer medications, has a caregiver who can assist with administering medication Dementia or Delirium as determined by the Short Portable Mental Status Questionnaire (SPMSQ) score of less than 7 Diagnosis of delirium as determined by the Confusional Assessment Method (CAM) Any of the following Brief Psychiatric Rating Scale (BPRS) items rated 4 -, elated mood, suspiciousness, hallucinations, excitement, distractibility or motor hyperactivity Severe insomnia Severe anxiety Significant suicidal ideation History of current mental disorder in which depressive symptoms occur, but for which psychostimulants are contraindicated (schizophrenia and bipolar disorder will be based on history; active psychotic symptoms on selected BPRS items) History of stimulant abuse or other active, severe substance abuse Contraindications to methylphenidate or an SSRI including significant cardiac arrhythmias; uncontrolled, severe hypertension; moderate-severe angina; seizure disorder; severe COPD; use of medications such as Levodopa, monoamine oxidase inhibitors, and lithium; diagnosis of narrow-angle glaucoma; or history of SSRI-induced hyponatremia Physical symptoms including increased blood pressure (DBP greater than 115, SBP greater than 180), pulse greater than 120, irregular pulse, or chest pain consistent with angina
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 14.0-75.0, Depression (1) age 14-18 years and (2) one risk factor for developing depression in the next two years: sub-clinical depressed mood (not meeting of major depression) a family history of depression in a parent or sibling, or past personal history of depression or personal perception of risk depression and desire to participate meeting or undergoing active treatment for major depression (5 or more symptoms nearly every day with functional impairment, minor depression) bipolar disorder panic disorder conduct disorder substance abuse or having suicidal ideation Active treatment for depression is defined as receiving anti-depressant medication or counseling within one year of remission of symptoms from the most recent episode Those who meet DSM-IV for minor depression (3-4 symptoms) or who report significant functional impairment (very difficult or above on the Prime MD functional impairment scale) will be notified and offered a referral for an evaluation by a mental health specialist (and will be strongly encouraged to attend) Those with 1-2 symptoms of depression will also be offered evaluation and treatment from a mental health specialist. In each case, the primary care physician will be notified and the parents (if under the age of 19)
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 14.0-25.0, Depressive Disorder, Major Cannabis Abuse DSM-IV diagnosis of current marijuana abuse or dependence, confirmed by SCID-SUD DSM-IV diagnosis of current major depressive disorder, confirmed by the K-SADS Marijuana use of at least two days within the week prior to enrollment Demonstrated adequate levels of depressive symptoms within the week prior to enrollment DSM-IV diagnosis of bipolar disorder, schizoaffective disorder, or schizophrenia Hypo or hyperthyroidism Significant cardiac, neurological, or kidney impairment Liver disease (SGOT, SGPT, or gamma-GTP greater than 3 times the normal level) Use of antipsychotic or antidepressant medication in the month prior to enrollment DSM-IV dependence on any substance except marijuana or nicotine; alcohol dependence, or history of drug use History of significant medication side effects from any SSRI antidepressant Pregnant Unable to use adequate contraceptive methods for the duration of the study Inability to read or understand English
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-65.0, Major Depressive Disorder. Hepatitis C, Chronic Patients with chronic hepatitis C who are going to initiate treatment with peginterferon alfa2a + ribavirin Age 18-65 years Signed informed consent If female, they are not in fertile period or they use barrier contraceptives Patients able to understand and fill written questionnaires Hepatic cirrhosis or carcinoma Less than 4000/mm3 leucocytes, or less than 70000/mm3 platelets Hemoglobin less than 11 g/dL (females) or 12 (males) Any risk factor for hemolysis Comorbid severe medical conditions (kidney, immune system, lung, heart, thyroid, etc) Baseline mental disorders that require antidepressants (depressive disorders and anxiety disorders) Other baseline mental disorders (delirium, substance use disorders) Mental disorders at any time (dementia, psychotic disorders, bipolar disorders Contraindications of escitalopram (hypersensibility, diabetes, patients using serotoninergic agents, drugs that enhance the risk of bleeding, or monoamineoxidase inhibitors -MAOIs-)
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Unipolar Depression Male or female 18 years or older DSM-IV diagnosis of major depressive disorder of at least moderate severity, but without psychotic features Ham-D 17 score of 18 or above Have a documentable history of 2 prior adequate trials of antidepressants including an SSRI without sufficient response. A clinically adequate trial is defined as having taken a minimum effective dose of an antidepressant for at least 3 weeks without a significant change in depressive symptoms Must be currently on an serotonin uptake inhibitor (to venlafaxine or duloxetine) at an adequate dose for at least 3 weeks Ability and willingness to provide consent for participation in the study Any medical condition that would preclude treatment with an SSRI, risperidone, or bupropion ER Any clinically significant unstable medical condition Diagnosis of bipolar disorder or a primary diagnosis of any psychotic disorder Current psychotic symptoms (hallucination or delusions) Alcohol or drug abuse or dependence in the last 3 months (excluding nicotine and caffeine dependence/abuse) or abuse within the last month Documented non-response to the combination of a novel antipsychotic or bupropion ER and a SSRI Concomitant use of any psychotropic other than an SSRI or zolpidem (PRN for sleep) Score of 4 on the suicide item of the Ham-D scale and determination by the investigator of significant suicide risk Known sensitivity to risperidone or bupropion ER
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-55.0, Major Depressive Disorder (All three groups) age 18-55 years satisfactory physical health education level and a degree of understanding to communicate effectively with the investigator c capable of providing informed consent female subjects of childbearing potential, a medically accepted means of contraception Additional for the patient groups DSM-IV-TR for a diagnosis of BD or MDD currently meeting for an MDE and a Hamilton Depression Rating Scale 17 Item (HDRS-17) score of > 17 (All three groups) DSM-IV-TR for substance abuse or dependence (except nicotine or caffeine) within the past 6 months comorbid neurological or other major psychiatric disorders as defined in the DSM-IV-TR history of neurological trauma resulting in loss of consciousness uncorrected hypothyroidism or hyperthyroidism, including elevated thyroid stimulating hormone (TSH) other unstable medical condition female subjects who are pregnant or nursing Additional for the BD and MDD group prior failure to respond to fluoxetine and olanzapine in combination at adequate dose and duration
1
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-65.0, Atypical Depression adults 18-65 years of age DSM-IV for major depressive episode with atypical features as assessed by the Atypical Depression Diagnostic Scale minimum score of 18 on the Hamilton Depression Scale (29-item version) at baseline baseline Clinical Global Impressions Severity score of 4 or more written informed consent negative serum pregnancy test for women of childbearing potential any current primary DSM-IV Axis I disorder other than depression history of DSM-IV diagnosis of bipolar I disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder, or cognitive disorder due to a general medical condition history of substance abuse or dependence within the last 3 months suicide risk or serious suicide attempt with the last year clinically significant medical condition or laboratory or EKG abnormality history of non-response to three prior adequate trials of antidepressants women of childbearing potential who are unwilling to practice an acceptable method of contraception history of hypersensitivity to modafinil use of an investigational medication within the last 28 days use of antidepressant medication with 28 days of screening
1
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Diabetes Diabetes Mellitus, Type 2 Diagnosis of type 2 diabetes HbA1C <= 12.0% within the past 12 months BMI <= 45.0 kg/m2 Initiation, addition of, change to, or continuation of basal insulin therapy with insulin detemir as deemed necessary by Investigator Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors Proliferative retinopathy or maculopathy that has required acute treatment within the last 6 months Any glucose lowering medication that is not indicated in combination with insulin, such as GLP-1 Analogues Known hypoglycemia unawareness or recurrent major hypoglycemia, as judged by the Investigator
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-65.0, Major Depressive Disorder Male or female patients 18-65 years of age, inclusive
2
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-65.0, Atypical Depression DSM-IV Major Depression or Dysthymia with Atypical Features Age 18-65 Physically healthy HAMD(24) > 14 Prior experience with Duloxetine History of Psychosis or Bipolar Disorder, Borderline Personality Disorder Unstable medical disorder; any history of Epilepsy Currently taking medication that can interact with Duloxetine Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol) Serious suicidal ideation judged at least somewhat likely to be acted upon or require hospitalization Current (past two weeks) use of psychoactive medication (four weeks for Fluoxetine) Pregnancy Currently breast feeding Fecund women failing to use acceptable birth control
2
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 0.0-999.0, Depression Anxiety Student with above average levels of depression and anxiety symptoms (students with average or below average symptoms will be enrolled into the study space permitting) Not a student in a participating school Not a student in grades six through eight
2
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Advanced Cancers Have weight loss of > 5% within the last 6 months Present with anorexia, fatigue and one of the following: anxiety, depression or sleep disturbances, during the preceding 24 hours, with an average intensity of each symptom >/= 3 on a scale of 0 to 10, in which 0=no symptom, and 10= the worst possible symptom Describe the symptoms as being present every day for a minimum of 2 weeks Have no clinical evidence of cognitive failure Must be 18 years or older Expect to live at least >/= 4 weeks Must have negative serum pregnancy test within 24 hours of study enrollment in women of childbearing potential. FDA for the status of not of childbearing potential, hysterectomy, or menopausal for 24 consecutive months Understand and sign written informed consent Have no concurrent steroids with the exception of steroids used concurrently with chemotherapy as part of a regimen or to reduce nausea Willing and able to comply with S.T.E.P.S.[System for Thalidomide Education and Prescribing Safety] Have major contraindication to thalidomide, i.e. hypersensitivity Present with National Cancer Institute (NCI) Common Toxicity Grade 3 or more peripheral neuropathy Are not able to complete the baseline assessment forms Are pregnant or lactating Patients with clinical history of seizures Patients with an ANC of </= 750 at time of study enrollment will be excluded (to be drawn within 14 days prior to registration) Patients with a history of Acquired Immune Deficiency Syndrome (AIDS), systemic lupus erythematous, or renal failure as defined by a serum creatinine of > 2.0 mg/dl at baseline will be excluded (to be drawn within 29 days prior to registration) Patients on Revlimid (lenalidomide) Patients on investigational chemotherapy/agents
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 21.0-45.0, Depression Anxiety Disorders No more than 28 weeks pregnant at the time of study entry History of depression or anxiety Current symptoms of distress Score of 9 or greater on the Edinburgh Postnatal Depression Scale (EPDS) English-speaking Plans to move away from the area prior to giving birth Current use of steroids for medical conditions
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Major Depressive Disorder Not currently participating in a drug or medical device clinical trial Male or female over the age of 18 DSM IV Diagnosis of major depression Positive family history of bipolar disorder or completed suicide Not able to give informed consent Pregnant or breast-feeding Current additional psychiatric diagnoses including Panic Disorder, Post -Traumatic Stress Disorder (PTSD) or Psychosis History of mania or hypomania Active substance abuse or dependence in the last 6 months Current depressive episode less than 4 weeks or greater than 12 months in duration Current or prior adequate trial of lithium or paroxetine Current use of other medications such as antidepressants for the treatment of depression Clinically significant medical illness, in particular kidney problems
1
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Advanced Cancer Anorexia Weight Loss Insomnia Advanced cancer patients seen in outpatient clinics or inpatient units at MD Anderson Cancer Center, with presence of anorexia for at least one month, and accompanied by weight loss of > 5 % of pre-illness body weight in the last 6 months. Anorexia on the day of enrollment (day 0 +/-3) must be > 4/10 on ESAS Patients > 18 years of age Karnofsky Performance score of > 40 at time of into study Ability to provide informed consent and comply with study procedures Ability and willingness to return to engage in telephone follow-up by research nurse on days 2 (+/ days), 8 (+/ days), 16 ( +/ days), and 22 (+/ days) and return to outpatient clinic for evaluation on days 15 (+/ days), and 29 (+/ Patients who have known dementia or delirium at time of enrollment as determined by a physician Known hypersensitivity to any ingredient of Mirtazapine Inability to maintain oral intake over the course of the study, such as with mechanical obstruction of the alimentary tract or intractable vomiting Ongoing use of tube feeding or parenteral nutrition Current use of corticosteroids (with the exception of scheduled doses during time of chemotherapy), dronabinol, testosterone and progesterone derivatives such as megestrol acetate, or in the preceding 1 week prior to study enrollment Pregnancy or lactation or unwillingness to use contraceptives A score of 11 or more, in each subscale of the Hospital Anxiety and Depression scale (HADS) indicating clinical depression or anxiety. Those with HADS scores of > 11 at baseline indicating moderate or severe depression will be excluded from the study and will be referred for appropriate follow up by counselor and psychiatry evaluation Patients on chronic use of benzodiazepines are excluded
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-50.0, Circadian Dysregulation Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study Willing to travel from Hawaii to the East Coast and have a minimum stay of 6 days at the destination in a sleep laboratory during the entire study Has lived in Hawaii for at least 12 months and has not been traveling outside of Hawaii for 4 consecutive days within 30 days prior to the Outpatient Screening Visit History of sleep disturbance associated with jet lag symptoms, with at least two occurrences in the last three years, as defined in the International Classification of Sleep Disorders Habitual bedtime should be determined by sleep history as between 9:00 PM and 12:00 AM as determined by sleep history prior to randomization Have regular bedtime (within 1 hour) for 1 week prior to travel The subject has a subjective sleep latency of less than 30 minutes and a subjective total sleep time of 6.5 hours but less than 9 hours, as determined by sleep history Mean subjective sleep latency of less than 30 minutes and a mean subjective total sleep time of greater than 6.5 hours but less than 9 hours in 3 of 5 nights after the outpatient screening visit, as determined by post-sleep questionnaire Willingness and ability to comply with study procedures, including travel time, sleep, and waking-hour activities, light-exposure restriction, and food intake Body mass index between 18 and 34, inclusive Known hypersensitivity to ramelteon or related compounds, including melatonin, and melatonin related compounds History of primary sleep disorders as determined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised within the past 6 months Current sleep disorder as assessed by presence of sleep apnea, period leg movement syndrome, insomnia, daytime napping of more than 20 minutes, chronic fatigue Ever had a history of seizures, sleep apnea, restless leg syndrome, periodic limb movement syndrome, or chronic obstructive pulmonary disease History of psychiatric disorder (including schizophrenia, bipolar disorder, mental retardation, or cognitive disorder, anxiety, or depression) within the past 12 months Current, clinically significant neurological (including cognitive), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, as determined by the investigator History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised, or regularly consumes more than 14 alcoholic drinks per week History of drug abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised Positive urine drug screen or a positive urine drug screen or alcohol breathalyzer test Sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the administration of single blind study medication
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Breast Cancer Fatigue Gastrointestinal Cancer Patient diagnosed with breast, gastrointestinal, lymphoma, myeloma or lung cancer undergoing chemotherapy or hormonal treatment Patient is > or = 18 years of age Patient has Brief Fatigue Inventory "fatigue worst" score of > or = 4 at baseline Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of < or = 2 at baseline Patient has a life expectancy > or = 6 months from the start of the study Patient is using acceptable birth control methods. Female participants (if of child bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) must use medically acceptable methods of birth control. Medically acceptable methods of contraception abstinence, birth control pills, diaphragm with spermicide, condom with foam or spermicide, vaginal spermicidal suppository or surgical sterilization Patient must speak and understand English Patient has provided written informed consent to participate in the study prior to enrollment to the study History of hypersensitivity reaction to methylphenidate History of or current seizure disorder, glaucoma, major psychiatric diagnosis, narcolepsy, Tourette's syndrome, tension or agitation History of clinically significant cardiac disease Uncontrolled hypertension: has not been on a stable treatment dose for the past month, or has a systolic pressure consistently (defined as 3 consecutive blood pressure readings within the last 30 days) greater than 150 mm Hg or diastolic pressure consistently greater than 85 mm Hg History of fibromyalgia Use of alcohol while participating in the study Current use of illicit drugs or history of alcohol or drug abuse and/or abuse potential (see protocol for criteria) Moderate to severe depression (> or = 20 on Beck Depression Index II) If taking antidepressants, no changes in dose and/or no start of new course of treatment in the last 30 days Currently taking psychostimulants (including appetite suppressants), monoamine oxidase (MAO) inhibitors, anticoagulant or anticonvulsant therapy
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-65.0, Obsessive Compulsive Disorder primary OCD diagnosis according to DSM IV current symptoms were responsible for significant distress previous trial of at least 12 weeks with SSRI (being at least 8 weeks at maximum tolerated dosage) failed to produce full remission of OCD symptoms presence of clinical or neurological diseases that may be worsen by the medications included in treatment protocol current substance dependence or abuse current psychotic symptoms current suicide risk and current pregnancy or intention to get pregnant before the end of the treatment protocol
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-65.0, Atypical Depression age 18 to 65 years DSM-IV episode of Major Depression non-psychotic with atypical features ≥19 score on the 29-item HAM-D ability to give informed consent, if patients are of child-bearing potential A minimum 2-week washout from existing psychotropics (5 weeks for fluoxetine) bipolar depression Any Axis I psychotic disorder currently suicidal or suicide risk history of substance abuse in the previous 12 months history of hypersensitivity to escitalopram, or citalopram serious or unstable medical disorders starting or terminating psychotherapy during the previous 12 weeks ECT treatment in the previous 3 months pregnancy or planning pregnancy
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Postpartum Depression Major Depressive Disorder adult female subjects age 18 and above if onset of depression within 4 weeks of delivery,or onset of depression antenatally either during pregnancy or before pregnancy must score greater than or equal to 12 on the Edinburgh Postnatal Depression Scale speak English or Spanish have access to a telephone provide written and verbal consent have current or lifetime psychosis an unstable medical condition hypertension narrow-angle glaucoma liver disease seizure disorders bulimia anorexia mania substance abuse disorders
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-70.0, Obsessive-Compulsive Disorder Meets DSM-IV-TR for a principal current diagnosis of OCD which is confirmed by both clinical evaluation and by structured interviews. OCD subjects with other comorbidities will be included provided OCD is judged to be the chief complaint Subjects must continue to experience clinically significant symptoms of OCD (Y-BOCS score ≥19 and a rating of "moderate" or greater on the Clinical Global Impressions (CGI) scale) despite at least two adequate SRI monotherapy trials. One unsatisfactory trial can the SRI currently being taken by the patient provided that the duration of treatment is 12 weeks or more and that the dose has been adequate. Subjects must be taking a clinically effective dose of a SRI (i.e., clomipramine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline) for at least 12 weeks. Subjects must be on their current dose for at least 12 weeks and must maintain their current dose throughout the study Between the ages of 18-70 years of age Only subjects with OC symptoms of at least one-year duration will be included Eligible subjects must be in good physical health. Screening procedures will detailed medical history, complete physical and neurological exams, routine blood studies (CBC, liver function tests, electrolytes), ECG, urine toxicology screen, and serum pregnancy test in women of child-bearing potential Primary depression, schizophrenia or other psychotic disorders Active bipolar disorder Non-responder in the past to atypical antipsychotic augmentation. This criterion was chosen to prevent recruiting a sample of chronically refractory OCD cases that would otherwise be suited for more extreme interventions such as deep brain stimulation Non-responder in the past to an adequate trial (> 20 hours) of cognitive-behavioral therapy that will be assessed by records review Current clinically significant suicidality or individuals who have engaged in suicidal behaviors within 6 months will be excluded and referred for appropriate clinical intervention Alcohol or other significant substance abuse within the last 6 months History of neurosurgery, encephalitis or significant head trauma or a significant medical condition such as heart, liver, or renal disease Nursing mothers or women of childbearing potential who do not use adequate contraception will be excluded Subjects at an increased risk for seizures will also be excluded from this study (e.g., subjects with a history of seizures [other than childhood febrile seizures], subjects taking concomitant medications known to lower the seizure threshold) Estimated IQ < 80, mental retardation, dementia, brain damage, or other cognitive impairment that would interfere with the capacity to participate in the study and complete measures. If needed, the WASI will be used to assess this at screening
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 0.0-999.0, Depression Anxiety Female Student in grades 6 through 8 Student in participating school Male
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-65.0, Major Depressive Disorder All subjects will meet DSM-IV for depression on the basis of a SCID-P interview, with subjects having a score on the 17-item Ham-D > 17 (with item #1 > 2) Subjects will meet both at recruitment and after a one-week single blind placebo wash-in. Study includes outpatients only All subjects will have no serious medical illness. The investigators will patients also meeting for the following groups of axis I diagnoses delirium or dementia substance-related disorders schizophrenia or other psychotic disorders, or eating disorders In addition, patients meeting for cluster A or B axis II diagnoses will be excluded Subjects with a history of current or past active suicidal ideation, or suicide attempts will be excluded from the study
1
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-75.0, Sleep Initiation and Maintenance Disorders Depression Meets for Major Depressive Disorder Between 18 and 75 years of age and adequately fluent in English Meets for an insomnia disorder Women who are currently pregnant, breast-feeding, or not using a reliable birth control method People for whom the antidepressant medication(s) provided in the study is not indicated People who have had minimum adequate trials of (or have not been able to tolerate) all three study medications People with uncontrolled medical conditions People with moderate or severe sleep disorders other than insomnia Individuals on a fixed night shift or rotating work schedule that requires a night shift Patients with a current principal diagnosis of a psychiatric disorder that necessitates treatment that is not offered in the study
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-65.0, Schizophrenia Key The patient has a diagnosis of schizophrenia according to the DSM-IV-TR and the patient has been clinically stable in a nonacute phase of their illness Documentation that the patient has received treatment with olanzapine, oral risperidone, or paliperidone for schizophrenia for at least 6 weeks prior to the screening visit and has been on a stable dose of that antipsychotic medication for at least 4 weeks prior to the screening visit The patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or documented abstinence The patient has a PANSS negative symptom score of 15 or more at the screening and baseline visits Key The patient has a severity rating of moderate or worse on any item of the PANSS positive symptom subscale The patient has any Axis I disorder according to DSM-IV-TR including schizoaffective disorder, apart from schizophrenia and nicotine dependence, or any Axis II disorder that would interfere with the conduct of the study The patient has moderate to severe depressive symptoms, as indicated by the CDSS The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present The patient has tardive dyskinesia, akathisia, moderate or worse level of extrapyramidal symptoms, or any other clinically significant movement disorder The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or has a history of multiple clinically relevant allergies The patient is a pregnant or lactating woman The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Arthritis, Rheumatoid The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria The patient has active disease at both Screening and Baseline, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis Patient has washed out of all DMARDs other that antimalarials Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3.0 x 109/L; 3. Absolute neutrophil count <1.2 x 109/L; 4. Platelet count <100 x 109/L History of any other autoimmune rheumatic disease other than Sjogren's syndrome No malignancy or history of malignancy History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 13.0-18.0, Major Depressive Disorder for Major Depressive Disorder Participants Participants must meet DSM-IV-TR for Major Depressive Disorder, with current mood state depressed for ≥ 2 weeks Participants must be females Participants must be between the age of 13 and 18 years Participants must have had an adequate trial of fluoxetine, defined as a trial of ≥ 8 weeks of treatment, with a dose of ≥ 40mg daily for ≥ 4 weeks. If the participant had a trial of 40mg daily and was unable to tolerate it, a dose of 20mg for ≥ 8 weeks is acceptable; OR Participants must have had an adequate trial of escitalopram, defined as a trial of ≥ 8 weeks of treatment, with a dose of ≥ 20 mg daily for ≥ 4 weeks. If the participant had a trial of 20 mg daily and was unable to tolerate it, a dose of 10 mg for ≥ 8 weeks is acceptable Participants must have a CDRS-R score of ≥ 40 and a CGI-S score of ≥ 4 Participants must be able to give informed consent or assent, and where applicable, parent(s)/guardian(s) must be able to give informed permission for study participation for Healthy Control Participants Participants must be females for Treatment-Resistant Major Depressive Disorder Participants Unstable co-morbid medical, neurological or psychiatric disorder Pre-existing renal disease Proteinuria or microalbuminuria Pregnant females, nursing mothers, or females of childbearing potential who are unable or unwilling to practice birth control during the study. Participants who are of child-bearing potential must have a negative urine pregnancy test before each MRI/MRS brain scan High risk for suicidal behavior, homicidal behavior or self-harm Adolescents who are unlikely to be able to comply with the study protocol DSM-IV-TR for current substance abuse or substance dependence, with the exception of nicotine abuse or dependence Contraindication to MRI/MRS brain scans, such as ferromagnetic implants or claustrophobic anxiety Documented or suspected history of intellectual disability (Full-Scale I.Q. < 70)
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 20.0-50.0, SSRI-Refractory Obsessive-Compulsive Disorder Male or female, 18 years of age or over Patients were diagnosed as having obsessive-compulsive disorder by the Structured Clinical Interview for DSM-IV Patient version (SCID-P) They received standardized treatment for at least 1 year at the OCD clinic in our university hospital Each subject gave written informed consent to take part after receiving a complete description of this study All subjects were free of medical illness based on results of physical examination and screening tests of blood and urine, and no subjects received any lipid lowering or hypoglycemic agent during the 1-year study period Current clinically significant medical conditions such as diabetes
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Epilepsy Depression Healthy For Control Group Healthy adults of 18 years of age or older Subject has no history of affective disorders Subject scores higher than 5 on Hamilton Depression Rating Scale Subject with prior primary diagnosis of any psychotic disorder, bipolar disorder, anxiety disorder, or any other serious medical or neurological disorder Subject is pregnant Subject is unable to undergo a MRI Epilepsy Only Group Subject is at least 18 years of age Subject has confirmed temporal lobe epilepsy (TLE) Subject has a history of depression Subject scores higher then 5 on Hamilton Depression Rating Scale
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-70.0, Atypical Depression Main Mild to moderate depression (ICD-10 F32.0, F32.1) with atypical features according to DSM-IV, lasting at least 3 months Female and male Caucasians aged 18 to 70 years At least one of HAMD-28 scale items 22-26 scores >1
2
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-30.0, Obesity Diabetes Normal weight Healthy Normal sleep times Sleep disorders Overweight Diabetes Other health conditions Excessive caffeine and alcohol intake Smoking
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-65.0, Major Depressive Disorder Adults between ages 18 to 64 years who meet the for a depressive episode as measured by a score of ≥ 16 on first 17 items of HAM-D (Urdu version Patients with low normal B12 levels in serum (>191 but < 300 pg/ml) Those who will provide informed consent Patients with concurrent unstable medical illness History of manic episodes or psychotic illness Psychotic symptoms within depressive episode
2
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 14.0-19.0, Community Adolescents at Risk for Depression and Suicide willing to participate group assignment and grant consents unwilling to participate potential group activity and grant consents severe physical or psychiatric disorders
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 0.0-999.0, Serotonin Syndrome Male or female patients with a diagnosis of PD Rasagiline treatment as mono or adjunct therapy for PD with concomitant antidepressant medication (SSRIs, SNRIs, St. John's wort and/or TCAs) at any time during the specified review period, OR Rasagiline treatment as mono or adjunct therapy for PD without concomitant antidepressant medication (SSRIs, SNRIs, St. John's wort and/or TCAs) at any time during the specified review period. OR Antidepressant therapy (SSRIs, SNRIs, St. John's wort and/or TCAs) and any other dopaminergic anti-PD treatment besides rasagiline or selegiline at any time during the specified review period Willing to consent to review of office chart and to review of records of ER visits and/or hospitalizations corresponding to the review window, if required Patients previously participating in a rasagiline clinical trial (and their follow-up protocols) are eligible, provided that they did not receive antidepressant therapy during trial participation In addition to the above each group has specific stated below Group R+AD: Enrollment in this group requires that patients must have taken rasagiline and an antidepressant (SSRIs, SNRIs, St. John's wort and/or TCAs, regardless of indication) within 14 days of each other (or five weeks, if fluoxetine preceded rasagiline) Group R: Enrollment in this group requires patients must have at least 2 months of rasagiline use Group AD: Patients must be taking an approved dopaminergic medication for PD. Enrollment in this group requires that patients must have at least 2 months of treatment with an antidepressant medication Use of rasagiline for any indication other than PD Patients taking a monoamine oxidase inhibitor (MAOI) antidepressant and/or selegiline Inability or unwillingness to request records of ER visits and/or hospitalizations corresponding to the review period
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Major Depressive Disorder Diagnosis of Major Depressive Disorder Allowed comorbidities: Dysthymia, Anxiety Disorders years old or older Males + Females English-speaking Women of reproductive age must be on adequate birth control, either oral contraceptives or using condoms or other barrier methods with spermicidal agents Subjects may be undergoing psychotherapy, but must maintain current psychotherapy status. Must not start therapy if not already in therapy. If in therapy, must have received at least 6 sessions prior to entering the study Subjects may continue taking herbals or supplements during the study, but they may not start any new herbals or supplements during the study or more failed trials of antidepressants (adequate dose and duration, and documented) Substance dependence in the past 6 months Current substance use or abuse (MJ, benzodiazepines, narcotics). If BZD use, patient must be tapered off and wait 1 month before being included in the trial Psychosis Bipolar Affective Disorder Type I, II or NOS Pregnancy (current or planned) Unstable medical illness (pt has to be stable for at least 3 months, and may be excluded per investigator discretion) Dementia Mental retardation Traumatic Brain Injury
2
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Advanced Cancer Male patients with any advanced cancer (metastatic or locally recurrent) who have a bioavailable testosterone (BT) of < 70 ng/dL Male patients who have fatigue present every day for the last two weeks and have an Edmonton Symptom Assessment System (ESAS) fatigue score during the last 24 hours of >/= to 4 on a 0 to 10 scale (in which 0 = no fatigue and 10 = worst possible fatigue) Male patients who are willing to receive intramuscular injections every 2 weeks and are 18 years of age or older are eligible for this study Participants must be willing to have blood samples drawn at screening and/or baseline and every two weeks until the end of treatment Prostatic Specific Antigen (PSA) level must be lower than 4.0 ng/mL to be eligible for this study and Digital Rectal Exam (DRE) must be normal ECOG PS </= 3 and participants must be able to stand up with or without assistance and to ambulate Hemoglobin (Hgb) >/= 9 g/dL. If the patient has not had blood drawn for a hemoglobin level in the past 28 days, one will be done to determine eligibility. Patients with a hemoglobin < 9 g/dL will be referred for treatment of their anemia Patients who are determined incapable of completing questionnaires due to cognitive or physical deficits are ineligible for this study Abnormal Digital Rectal Exam (DRE) at baseline or history of severe untreated benign prostatic hypertrophy (BPH) with International Prostatic Symptom Score (IPSS) >19 Patients with a history of prostate cancer, a history of breast cancer or adenocarcinoma of unknown origin A history of untreated obstructive sleep apnea Uncontrolled severe heart failure (NYHA Class III or IV), uncontrolled cardiac arrhythmia or severe COPD requiring home oxygen Patients who have evidence of pre-existing hypopituitarism/hypogonadism including status post bilateral orchiectomy, for which replacement therapy is mandated, are ineligible for this study Patients exhibiting clinically diagnosed severe dehydration are ineligible Patients with a history of uncontrolled arrhythmia Patients who are currently receiving androgen therapy or dehydroepiandrosterone (DHEA) Diabetics with a history of frequent episodes of hypoglycemia or uncontrolled diabetes mellitus (DM) defined as a fasting glucose over 200 mg/dL or HbA1c above 8%
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-40.0, Self Concept Body Fat Composition Depression Perceived Social Support Healthy males aged 18-40 years Available twice a week for 10 weeks and willing to participate in moderate intensity exercise for 50 minutes at each session Not regularly physically active (i.e., engages in a structured exercise session once or less per week) Willing to participate in the internet-based CBT intervention once per week for 10 weeks Current illness or history of clinical conditions that prevents participation in exercise Currently alcohol/drug abusing Major cognitive or psychiatric impairments Currently receiving medication for major psychiatric disorders, including depression
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 25.0-999.0, Breast Cancer over the age of 25 enrolled in one of the following protocols IRB # 08-005522: Evaluation of Molecular Breast Imaging in Patients with a High Likelihood of Ductal Carcinoma in Situ. 07-004241: Molecular Breast Imaging in the Preoperative Evaluation of Women with Biopsy Proven Breast Cancer. 1204-03: Evaluation of a Small Field of View Gamma Camera for Scintimammography in Patients with Atypical Ductal Hyperplasia, Atypical Lobular Hyperplasia, and Lobular Carcinoma In Situ. 07-003397: Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation. 17-05: Determination of the Sensitivity of a Dual-Headed Small Field of View Gamma Camera for the Detection of Small Breast Lesions Digital mammogram at the Mayo Clinic within the past 30 days They are unable to understand and sign the consent form They are pregnant or lactating They are physically unable to sit upright and still for 40 minutes Recently enrolled on one of the ongoing tomosynthesis vs. mammography studies (rationale avoid performing duplicate tomosynthesis studies in the same patient)
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
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 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 8.0-11.0, Sleep Obesity Age 8-11 years old BMI for age and gender > 5th percentile (but no greater than 100% overweight) Sleep approximately 9-10 hours nightly Attend elementary school Like at least 1 food and 1 activity used in the reinforcement paradigm Able to understand and complete the reinforcement paradigm Existence of a diagnosable sleep disorder Medical or psychiatric condition that could influence sleep or weight Onset of menarche Inability to complete study materials, including diagnosed disabilities Dietary restrictions/allergies to foods used in the study that preclude them from study participation
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Depression and over with chronic pain and score of 27 or higher on CES-D scale or younger, no chronic pain cognitively unable to participate in programming
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
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 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Depressive Disorder Cancer Cancers diagnosed within 12 months of initiation (i.e., new use) of antidepressant pharmacotherapy will be excluded to account for a minimum period for the development of cancer (cancer latency) and to be consistent with other studies of antidepressants and cancer Patients with a history of any cancer (cancer diagnosis recorded in the tumor registries anytime before the first antidepressant prescription recorded during the study period) Any antidepressant use within 6 months of January 1, 1996
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-80.0, Gastroesophageal Disease Male/Female or more episodes of heartburn a week for last 3 months Previous upper GI surgery Underlying co-morbidity Narcotic medications Psychotropic's and Benzodiazapines medications Hx of psychological abnormalities Hx of ETOH in previous 6 mos Diabetes Mellitus Neuropathy Seizures Sleep Apnea
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 16.0-25.0, Depression A score of 19 or more on the Beck Depression Inventory Currently enrolled at the University of Santo Tomas Able to read, understand, and complete forms
1
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 12.0-18.0, Depression Overweight Adolescents must: 1) be between the ages of 12 and 18 years (18 year olds must still be in high school and living at home); 2) be at or above the 85th percentile with reference to age and gender-specific Body Mass Index (BMI); 3) have at least one parent available to participate in the treatment protocol; 4) speak English; 5) agree to study participation and random assignment; and 6) be available for follow-up. In order to meet the depressed mood criterion, adolescents must have a primary diagnosis of major depressive disorder (single or recurrent), based on the KSADS-PL with a CGI-Severity ≥ 3 for depression and CDRS ≥ 36. Participants must be healthy, as established by their primary care physician, in order to participate in the exercise program - Adolescents will be excluded if: 1) they are currently receiving psychotherapy or participating in another weight loss program (only can have been in a weight loss program in the past); 2) they have a medical condition that would interfere with the prescribed dietary plan or participation in physical activity; 3) they are developmentally delayed such that the intervention materials will not be appropriate; 4) they are actively suicidal at intake; 5) they have not been on a stable dose of a psychostimulant for 6 months to ensure that a recently prescribed psychostimulant is not contributing to weight loss; 6) teens on an SSRI will not be allowed to participate due to potential effects of medication on weight loss; 7) they have a substance abuse or dependence diagnosis; or 8) they have failed a medication or psychotherapy trial for depression in the past
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-64.0, Depressive Disorder, Major Patients who meet the following will be included in the study aged 18 to 64 years diagnosis of major depressive disorder during the study timeframe (ICD 9 codes 296.2, 296.3, 311) evidence of at least 6 consecutive claims for traditional antidepressant therapy with a 30 day supply or at least 2 claims with a 90 day supply (consecutive defined as ≤15 days gap) must be continually enrolled during the study timeframe and have both medical and pharmacy benefits evidence of at least 4 consecutive claims for an atypical antipsychotic prescription with a 30 day supply or 2 claims with a 90 day supply (consecutive defined as ≤15 days gap) evidence of antidepressant therapy for at least 60 consecutive days prior to the initiation of atypical antipsychotic After at least a 60 day trial of traditional antidepressant medications, patient augments with an atypical antipsychotic medication for at least 4 months Patients are excluded if they have any claims for a diagnosis of schizophrenia, schizoaffective or bipolar disorder during the study period have Electroconvulsive therapy (ECT) during the study period new augmentation with mood stabilizers, L-thyroxine (T4), L-Thyronine (T3), buspirone, stimulant, or others during the post-period (table 1) are pregnant during the study period patients with Medicare or Medicaid
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-90.0, Major Depression A primary psychiatric diagnosis of Major Depressive Disorder as defined by: a score of 18 or above in the 17-item Hamilton Depression Scale; Male or female ages 18+ Ability to give consent Diagnosis of Breast Cancer Patients may be either English or Spanish speaking Lifetime history of psychosis or bipolar disorder Patients meeting diagnostic statistic manual for mental disorder for alcohol or substance use disorders who require acute detoxification Current suicide risk Advanced cancer or other condition that limits remaining life expectancy to less than 6 months Patients who are receiving effective medication for Depression
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 0.0-999.0, Depression h and 8th grade students at 4 participating middle schools Score 14 or above on the Mood and Feelings Questionnaire at screening (approximately top 25%) No imminent plans to move or change to non-participating school At minimum 6th grade language skills Agree to participate in random assignment and research interviews One Parent/caregiver willing to complete research interviews Student with past or current Major Depressive Disorder (MDD) or Probable MDD Students with parents who do not speak English or Spanish Students in concurrent treatment Students in self-contained classroom, or with cognitive delays, or emotional behavioral problems that would preclude them from benefiting from the group or being a good group member Parent not willing to complete research interviews
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Insomnia Depression Clinical level of Insomnia (more than 10 on ISI) Meets for Insomnia according to DSM-IV-TR Enough language skills Only Trial 2: Meets for Major Depressive Disorder according to DSM-IV-TR Sleep disorders requiring other treatment High consumption of alcohol/drugs that affect sleep Started to use or changed the dose of antidepressant drug during the last 2 months Somatic or psychiatric conditions requiring acute care Working night shifts Only Trial 1: Meets for Major Depressive Disorder according to DSM-IV-TR
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Depressive Disorder, Major ≥1 fill for an augmentation therapy medication from Table 1 during the identification period of 01 January 2005 November 2008 months of continuous enrollment with medical and pharmacy benefits each before the index date (pre-index period) and after the index date (post-index period) ≥1 medical claim with a primary International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) diagnosis for MDD (296.2x, 296.3x, 311.xx) during the pre-index period Age ≥18 years as of the year of the pre-index period No pharmacy claims for atypical antipsychotics, mood stabilizers, anxiolytics, anticonvulsants, or stimulants, during the pre-index period No medical claims with primary or secondary diagnoses for non-MDD episodic mood disorders or schizophrenia during the pre-index or post-index periods
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Sleep Deprivation All subjects will be sedentary. Sedentary will be defined as those with an occupational calorie expenditure that is not estimated at greater than 50% above basal (desk job or light activity at work: on feet 30-50% of the work day) and whose exercise activity is defined as sedentary according to a self-reported activity questionnaire, and confirmed by actigraphy measurements. Sedentary lifestyle will be defined as fewer than four 20 min episodes of moderate or vigorous intensity activity in the previous four weeks We will subjects who have any medical or psychiatric disorders, including history of anxiety or depression, and those taking any medications Those found to have depression on a depression screening tool (BDI-II) will be excluded Current smokers will be excluded All female subjects will undergoing a screening pregnancy test and excluded if positive Subjects found to have significant sleep disorders will be excluded. - Subjects found to have occult coronary artery disease by exercise treadmill testing will be excluded
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-65.0, Major Depressive Disorder DSM-IV for major depressive disorder Age being age 18-65 Capacity and willingness to give written informed consent Any major medical illnesses A recent or past history of any Axis-I diagnoses besides major depressive disorder, including psychotic disorders; cognitively impaired mental disorders; impulse control disorders; substance use disorder or substance abuse (last 6 months prior to the studies); primary anxiety disorders, including post-traumatic stress disorder and panic disorder; and bipolar disorders; or Axis-II diagnoses, i.e. borderline and antisocial personality disorder
2
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Advanced Cancers Solid Tumors All patients with a histological diagnosis of cancer Rate fatigue on a numerical scale during the previous 24 hours as >/= 4 on a 0 to 10 scale (0 = no fatigue and 10 = worst possible fatigue) Describe fatigue as being present every day for most of the day for a minimum of 2 weeks Memorial delirium assessment scale </= 13 Are 18 years or older Hemoglobin level of >/=8 g/dL within 2 weeks of enrollment. If the patient has not had blood drawn for a hemoglobin level in the previous two weeks, one will be performed to determine eligibility. Patients with a hemoglobin level <9g/dL will be evaluated for treatment of anemia Able to understand and sign the informed consent No concurrent use of chronic systemic steroids (defined as currently on more than 1 week of treatment) Controlled pain and depression symptoms, if present ( defined as no change in the Morphine equivalent dose of 30% or change in the dose of antidepressant medication in the past 2 weeks) Patients should have a Zubrod </= 2 Major contraindication to ginseng: allergy/hypersensitivity to Panax species or their constituents (history of arrhythmias, agitation, or motor tics, or severe angina pectoris) Currently taking ginseng, methylphenidate or modafinil or have taken it within the previous 10 days Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study Currently with a diagnosis of major depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia) Symptomatic tachycardia and uncontrolled hypertension (determined to be clinically significant by the PI) Currently receiving phenobarbital, diphenylhydantoin, primidone, phenylbutazone, MAOIs, clonidine and tricyclic antidepressant drugs Uncontrolled diabetes mellitus as defined by a random blood sugar of >200mg/dl not being monitored by their primary care physician No concurrent full dose anticoagulant therapy. </= 1 mg/day of coumadin for preventing catheter clots allowed History of hepatitis A, B and C Women who are nursing
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Depression Participants must have a score ≥ 10 on the self-report Patient Health Questionnaire (PHQ-8), indicative of clinically significant, moderate depression Participants must identify their primary healthcare provider in one of the 8 performance sites, and give permission to contact him or her for the purpose of periodic progress reports as well as a referral contact in case any emergent crises are detected Participant must be 18 years of age have access to a computer with internet and a working email address Participants must also indicate they are planning to continue receiving services from one of the performance site clinics/organizations for at least the next 6 months
1
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 21.0-65.0, Major Depressive Disorder age 21-65 years including males, females and minorities diagnosis of DSM-IV major depression or Bipolar I or II with current episode of depression HDRS-17 > 20 and HDRS-24 > 24 negative pregnancy test for women of childbearing potential not breast feeding stable on current dose of psychotropic medication or free from all psychotropic medications for 4 weeks prior to EUH CIN admission (8 weeks for fluoxetine) no suicide attempt within six months of screening evidence of untreated or poorly controlled endocrine, cardiovascular, pulmonary, hematological, renal, or neurological disease history of CNS trauma or active seizure disorder requiring medication unless otherwise approved by principle investigator autoimmune or inflammatory disorder of any kind chronic infection (e.g. hepatitis B or C or HIV) chronic use of agents known to affect the immune system including glucocorticoid therapy within the past 1 year, methotrexate within the past 1 year, chemotherapy of any kind (past or present), immunotherapy of any kind (past or present), aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) (within the past 2 weeks) and statins (within the past 1 month) unless otherwise approved by principle investigator hemoglobinopathies (e.g. thalassemia) a positive pregnancy test organ transplants cancer of any type a score of <28 on the Mini Mental Status Exam (MMSE)unless otherwise approved by principle investigator
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-45.0, Borderline Personality Disorder Major Depression age between 18 and 45 female noncontrols diagnosis: major depression &/or borderline personality disorder Control participants should have neither major depression or borderline pers meet Structured Controlled Interview for DSM II cut off scores meet Beck Depression Inventory (BDI)cut off scores meet Borderline Evaluation of Severity Over Time(BEST) cut off scores based on having none of the below diagnoses from patient history, prior clinical records and based on MINI Plus International Neuropsychiatry Interview schizophrenia psychosis Attention Deficit Hyperactivity Disorder Obsessive Compulsive Disorder bipolar disorder mental retardation dementia CNS disease Post-Traumatic Stress Disorder in non-borderline personality disorder groups
1
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 20.0-999.0, Depressive Disorder, Major Age over 20 years DSM-IV episode of MDD non-psychotic with atypical features characterized by mood reactivity and 2 or more symptoms of vegetative reversal (including overeating, oversleeping, severe fatigue or leaden paralysis, and a history of rejection sensitivity) More than 19 score on the 29-item HAM-D Ability to give informed consent Bipolar depression Any Axis I psychotic disorder A history of suicide attempt, self-injurious action (excluding action with no intention of suicide) or overdosage (excluding apparently accidental overdosage) Patients with more than 3-point score of suicide (HAM-D-29 Item 18) or patients whose C-SSRS assessment suggests that they are or have been at significant risk for harming themselves or have actually harmed themselves, or who, in the opinion of the investigator (sub-investigator), are at significant risk for harming self or others A history of substance abuse in the previous 12 months A history of hypersensitivity to bupropion or any other components of the preparations used in the study (Wellbutrin SR 150mg and Wellbutrin XL 300 mg tablets) Serious or unstable medical disorders Starting or terminating psychotherapy during the previous 12 weeks ECT treatment in the previous 3 months Subject has a life time diagnosis of anorexia nervosa or bulimia within the past 12 month
1
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-55.0, Major Depressive Disorder Outpatients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) for major depressive disorder Those who are in remission, which is defined as a MADRS score 8 on two consecutive visits at a 4-week interval Their primary psychiatric clinician determined that they would benefit from an adjuvant treatment of Korean red ginseng for residual symptoms Those who have a history of substance abuse or dependence within 1 month Those who have clinically significant abnormal laboratory values or any other abnormal baseline laboratory findings considered by psychiatrists to be indicative of conditions that might affect the study results Those who have a past history of hypersensitivity or intolerance to Korean red ginseng Those who participated in clinical trials within 1 month before entering the study entry Those who are pregnant or are breast feeding Those who have a immediate risk of harming self or others or history of suicide attempts in the year before the screening precluded in the study The patients unable/unlikely to comprehend/follow the protocol
1
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Fatigue Traumatic Brain Injury mTBI GROUP Diagnosis of at least one mTBI during deployment At least six months from time of injury Age range 18 or older A self-report of somatic or behavioral symptoms that developed within 3 months following mTBI and were not present before injury, and may or may not be present at enrollment Easy fatiguability Sleep disturbance Headache or other chronic widespread pain that does not seem related to extremity injury Emotional lability Lack of spontaneity or apathy mTBI GROUP Daily use of stimulants, narcotics, hypnotic or anxiolytics Diagnosis of sleep apnea, thyroid disorder, or rheumatoid arthritis Any history of head injury associated with a loss of consciousness that lasted longer than 24 hours (not including sedation) Daily use of more than 600mg caffeine (equivalent to approximately five cups of coffee) Headaches more than once a month prior to deployment Pregnancy Claustrophia Inability to comfortably lie supine for two hours companion group
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, MDD Management Strategies MDD Diagnosis Participants of the PismaEP study 18 yo. or older No specific
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 25.0-999.0, Major Depressive Disorder Has body mass index (BMI) [weight in kilograms / (height in meters x height in meters)] between 18 and 30 kg/m2 For young healthy participants: female, 25 to 45 years of age; elderly healthy participants: female: ≥ 65 years of age & with baseline C-reactive protein (CRP) > 5 mg/mL; (partially) remitted MDD patients: female, 25 to 45 years of age specific for patients with MDD: -Patients with a history (within 24 months) of MDD must have a Montgomery-Asberg Depression Rating Scale (MADRS) total score < 15 and symptom remission (temporary absence of disease symptoms) relative to the acute episode must have been present for at least 3 months Has a current Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) axis I diagnosis (other than MDD) Has recently experienced a psychosocial stressor within 6 months Has acute symptoms of suicidality (the likelihood of an individual completing suicide) Has a DSM-IV diagnosis of substance abuse or dependence within 6 months prior to screening evaluation Has been exposed to an experimental medication or experimental medical device within 90 days before screening Has a serology (scientific study of blood serum and other bodily fluids) positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or HIV antibodies at screening Has been exposed to typhoid or typhoid vaccine within 5 years before screening Has been prior exposed to the Trier Social Stress Test (TSST) Has received electroconvulsive therapy (shock therapy) within 3 months before screening Has been involuntarily committed to psychiatric hospitalization
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-50.0, Perinatal Depression, Substance Use pregnant or has delivered in the past year reports the use of an illegal drug and/or consumption of 4 or more drinks on one occasion within the last 6 months; if postpartum, report the use of an illegal drug and/or consumption of 4 or more drinks on one occasion or 7 or more drinks in a week within the last 6 months; if pregnant, report the use of an illegal drug within the last 6 months and/or the consumption of 2 or more drinks in one month while pregnant, along with a history of consumption of 4 or more drinks on one occasion or 7 or more drinks in a week within 3 months pre-pregnancy meets DSM-IV of current Major Depressive Disorder (MDD) by Structured Clinical Interview for the DSM-IV(SCID) interview has a 17-item Hamilton Rating Scale for Depression (HRSD) score > 16, indicating moderate to severe depression is between 18 and 50 years old; and is able to speak and read English sufficiently to be able to complete the study procedures meets lifetime for bipolar disorder a primary psychotic disorder anorexia nervosa bulimia nervosa has started an SUD or MDD medication dose within the 8 weeks prior to enrollment is imminently suicidal
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-55.0, Major Depressive Disorder For Patients with Major Depressive Disorder • Male and female outpatients, aged 18-55 years Subjects meeting full for the diagnosis of current Major Depressive Disorder (MDD) without psychotic features, as determined by clinical evaluation and Mood Module of structured diagnostic interview (SCID), completed by the study clinician HAM-D17 score of 14 or higher Able to provide informed consent Right handed, normal (corrected) vision and normal hearing • Other primary diagnoses including major depressive disorder with psychotic features, bipolar disorder, schizoaffective disorder, schizophrenia, dementia, attention deficit hyperactivity disorder (ADHD) Substance use disorder (abuse or dependence with active use within the last 6 months) Significant sensory deficits such as deafness or blindness Severe or unstable medical illness, including history of closed head injury resulting in loss of consciousness, seizure disorder; history of neurological disorders Pregnant or nursing females who are not using an accepted method of contraception (birth control pill, IUD, combination of barrier methods) Clinically significant abnormal laboratory values or electrocardiogram For Healthy Controls Males and females, aged 18-55 years Subjects who do not meet full for any of the major psychiatric diagnosis including MDD, bipolar disorder, schizophrenia, substance abuse/dependence, attention deficit hyperactivity disorder (ADHD), as determined by clinical evaluation and structured diagnostic interview, completed by the study clinician Right handed, normal (corrected) vision and normal hearing Any current primary psychiatric, or medical condition determined to be clinically significant
2
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Depressive Disorder, Major Depressive Disorder, Minor Dysthymic Disorder Males and Females, ages 18 and older who are self-reporting generally good health Newly started on an antidepressant medication, switched to a different antidepressant medication or prescribed an increased dosage of antidepressant medication within the past 2 weeks A Hamilton Depression Rating Scale (HAM-D) score of greater than 10 A Patient Health Questionnaire (PHQ-9) score of 10 or greater, with endorsement of depressed mood or anhedonia, and endorsement of impaired daily function Meets diagnostic for Major Depressive Disorder, persistent Minor Depressive Disorder (i.e., > 1 month duration), or Dysthymic Disorder via a structured interview with the PRIME-MD Able to read, understand, and sign the Informed Consent in English Willing and able to comply with study requirements Well-versed in using a personal computer and the internet and must have easy access to a computer connected to the internet everyday (both weekdays and weekends) Enrollment in Surescripts Pharmacy benefit plan Currently under care with a Provider in Family Medicine at Cheshire Medical Center / Dartmouth-Hitchcock Keene Subjects must not have a major psychiatric co-morbid condition (schizophrenia, bipolar affective disorder, obsessive-compulsive disorder, PTSD, or a depressive disorder with psychotic features, as determined from chart review and patient report) Subjects must not have a substance use disorder or dependence as assessed by: CAGE Alcohol Dependence Questionnaire score >3 Subjects must not have a history of treatment -resistant depression as defined by the following: Psychiatric hospitalization within the past year; More than 2 clinically ineffective antidepressant medication trials, of adequate duration and adequate dose, within the current depressive episode; Any history of Electroconvulsive Therapy (ECT); A trial of Monoamine Oxidase inhibitor (MAO) within the past year Subjects must not report being actively suicidal Subjects must score 4 or greater on the Callahan Six-Item Cognitive Screening assessment Subjects must not be diagnosed with a terminal or near terminal medical illness such that their primary care provider has estimated the patient has less than 6 months to live Subjects reporting any medical condition that would make it unsafe to participate in a research study Participation in any other clinical research study within the past 30 days Participation in any on-line depression-related coaching or lifestyle improvement program within the past 5 years
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-24.0, Depression Alcohol Abuse Currently enrolled in college as an undergraduate student Ages 18-24 years (inclusive) Presence of two binge drinking episodes in the past month (defined as consumption of 5 or more drinks in 2 hours for males and 4 for females; NIAAA, 2004) BDI-II 12 (12 is often used to indicate the presence of at least mild depressive symptoms) and <30 (indicating severe depression) Meeting for substance dependence or abuse (any substance) in the past six months (students with alcohol abuse will not be excluded) Diagnosis of bulimia, psychosis, or bipolar disorder Having received any psychosocial treatment for depression or substance abuse in the past month Having received CBT for depression and/or alcohol use in the previous 6 months If receiving pharmacological treatment for depression or substance abuse, has not been on a stable dose for at least 4 weeks Discontinued an antidepressant medication less than 1 month ago Meeting for severe depression or posing a serious suicide or homicide risk
1
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 21.0-65.0, Daily Oral Pexacerfont for 28 Days (300 mg/Day Loading Dose for 7 Days, Followed Placebo Body Mass Index (BMI) > 22 kg/m(2) Score of 15 or higher on the Dietary Restraint Scale, with endorsement of the Restraint Scale item Do you give too much time and thought to food? Age 21 years (4a) For women of childbearing potential: must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study drug, and agree to use an adequate method of contraception to avoid pregnancy for a period of 6 months beginning from first dose of randomized treatment. Women of childbearing potential any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Adequate methods of contraception for sexually active women are having a male sexual partner(s) who is surgically sterilized prior to inclusion; having a sexual partner(s) who is/are exclusively female; using oral contraceptives (either combined or progesterone only) with a single-barrier method of contraception consisting of spermicide and condom or diaphragm; using double-barrier contraception, specifically, a condom plus spermicide and a female diaphragm or cervical cap; or using an approved intrauterine device (IUD) with established efficacy (4b) Men, unless surgically sterilized (vasectomy with documentation of azoospermia), must agree to practice abstinence or use barrier contraception, and not donate sperm, for a period of 6 months beginning from first dose of randomized treatment Current employment at NIDA IRP or Bristol-Myers Squibb (BMS), or being in the immediate family of an employee. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted Current participation in another clinical study that includes exposure to an investigational or non-investigational drug or device Participation in a clinical study for a condition related to weight or dieting within the preceding month Any history of participation in a trial involving pexacerfont or closely related compounds Any medical condition or laboratory finding that, in the judgment of the investigators, could adversely affect safety or study integrity. Examples but are not limited to diabetes type 1 and type 2, ischemic heart disease, uncontrolled hypertension, and history of cerebrovascular accident or transient ischemic attack For women: pregnancy, breastfeeding, or planning to become pregnant within 6 months from the administration of first dose of study drug Past or present diagnosis of any eating disorder, including Anorexia Nervosa, Bulimia Nervosa, and Eating Disorder NOS (e.g., Binge-Eating Disorder). (Eating-disordered individuals probably represent a distinct population and should therefore be studied separately.) Past or present diagnosis of schizophrenia, bipolar disease, or any psychotic disorder; past or present diagnosis of dementia or any other disorder that has led to a clinically significant cognitive impairment; present diagnosis of any mood or anxiety disorder; any other psychiatric condition that presently requires, or in the past month has required, pharmacological intervention Past or present diagnosis of any substance-use disorder except nicotine dependence Urine tests positive for illegal drugs
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Insomnia Major Depression Minor Depression Clinical level of Insomnia (more than 10 on ISI) Meets for Insomnia according to DSM-IV-TR Enough language skills Only Trial 1: Meets for Major or Minor Depressive Disorder according to DSM-IV-TR (for minor depression a MADRS-S-level of >19 is required) Sleep disorders requiring other treatment Alcohol/drugs abuse Started to use or changed the dose of antidepressant drug during the last 2 months Somatic or psychiatric conditions requiring acute care Working night shifts Only Trial 2: Meets for Major or Minor Depressive Disorder according to DSM-IV-TR (for minor depression a MADRS-S-level of >19 is required for exclusion)
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
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 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Major Depressive Disorder Metabolic Syndrome Thyroid Dysfunction patient with major depressive disorder age over 18 years subject who cannot give information
2
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Major Depressive Disorder Neoplasms Diagnosed with a malignancy Informed consent obtained and signed Greater than or equal to 18 years of age Life expectancy determined to be greater than or equal to 6 months Diagnosed with Major Depressive Disorder based on clinical examination and the DSM-IV-TR PHQ-9 depression assessment completed by subject, with a score of 10 or greater Able to take whole or crushed tablets by mouth or by feeding tube Unable to complete self-report instruments due to illiteracy, neurologic illness, visual problems, inability to speak or read English, or other causes Treatment with antidepressants or antipsychotics within the last 3 months Psychotic or manic behavior Active suicidal ideation or plan Current illicit substance abuse Severe renal impairment as defined by creatinine clearance of <15 milliliters/minute/1.73 meters squared (mL/min/m2) Severe hepatic impairment as defined by Aspartate Aminotransferase (AST) or alanine aminotransferase (ALT) >5x the upper limit of normal, or a total bilirubin > 3.0 milliliters/deciliter (mL/dL) History of congenital long QT syndrome Clinically significant congestive heart failure or bradyarrhythmias Treatment with a concomitant medication that is known to have a strong association with corrected QT interval (QTc) prolongation AND a QTc >460 for men or >470 for women. Applicable to the citalopram arm only
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 12.0-999.0, Major Depressive Disorder Adult Cohort A. MDD Mothers Cohort Current or past Major Depressive Disorder English as first language or English fluency Biological daughter who meets inclusion/ for High Risk Female Adolescent B. Healthy Control Mothers Cohort No history of psychopathology English as first language or English fluency Biological daughter who meets inclusion/ for Healthy Female Adolescent Adolescent Cohort General for Adolescent Cohorts Female Ages 12-14
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-65.0, Depression All those who fulfil the diagnostic of Depressive episode (F32) or Recurrent depressive disorder (F33 except 33.4 ) using ICD10 RDC (based on interviews using SCAN Urdu version) Are between the ages of 19-60 Score 8 or more on HADS, Depression Subscale, and Who live within traveling distance of the psychiatry department will be approached Excessive use of alcohol or drugs (using ICD 10 RDC for alcohol or drug abuse or dependence) Significant cognitive impairment (for example learning disability or dementia) and Active psychosis
2
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, College Student Mental Health for Counselors Currently working at a College Counseling Center Willingness to take the ACT guided self-help training through the counselor portal until reaching a passing criterion of 80% Willingness to distribute flyers about the study to five students, in an attempt to recruit 3 clients to participate in the self-help modules for Counselors Prior participation in this study for Student Clients Currently being treated at a College Counseling Center Willingness to participate in three half-hour modules as part of a web-based guided self-help program and complete pre and post assessments across a period of 4 weeks Referred to the study/self-help modules by counselor Participation will comply with targeted enrollment plans, and attention will be paid to selecting an ethnically/racially diverse group Student is clinically stable as per counselor judgment (e.g., not actively suicidal, psychotic, or disruptive) for Student Clients Under 18
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 15.0-19.0, Depression Beck Depression Inventory > o = 10 Meets diagnostic of a depressive disorder according Kiddie Sads Present and Lifetime Version interview (K-SADS-PL) Parent or caregiver giving informed consent and adolescent giving informed assent Suicidal risk requiring in-patient care Bipolar Disorder Current substance dependence Current alcohol dependence Current psychosis Low intellectual abilities Current treatment with antidepressant and/or psychotherapy
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Treatment Resistant Depression Primary diagnose of unipolar treatment resistant depression Patients diagnose of: bipolar disorder, psychosis, high suicide risk, Intellectual disability, illicit drug dependence Currently in or having received psychotherapy in the last 4 weeks
0
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 12.0-17.0, Depression Currently in the 6th to 11th grades Adolescent and parent must be English-speaking Parental consent and adolescent consent Presence of current Major Depressive Disorder, dysthymia, bipolar disorder, or significant psychosis Suicide attempt in the past week or significant suicidal ideation in the past week Presence of significant psychopathology or significant pervasive developmental delays that would make the group inappropriate
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A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Depression Anxiety Suicidal Ideation Eating Disorders Student enrolled in a participating campus as a full-time, residential undergraduate during the 2009-2010 or 2010-2011 academic years. Student must have been living in a participating residence hall Students under 18 years of age
2
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-55.0, Depressive Disorder, Major Age between 18-55, male or female The diagnosis of MDD consistent with DSM-IV (M.I.N.I) First-episode or relapsed Certain ability of reading and writing to complete the questionnaire survey and psychological assessment All participants provide written confirmation of informed consent prior to engaging the study protocol Current psychopathology or a history of neurologic conditions, including alcohol/substances dependence, the diagnosis of cognition impairment Severe somatic diseases, such as severe cardio-cerebral vascular diseases, respiratory diseases, liver diseases, kidney diseases, or malignant tumors Not signed the informed consent Been engaging other studies
2
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Dementia English speaking Have a family member or friend with dementia who resides in Long Term Care persons who are non-autonomous adults cognitively impaired as determined by the Registered Nurse (RN) researcher unable to participate, in the opinion of the RN researcher non-English speaking does not have a family member or friend with dementia in Long Term Care
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A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-80.0, Multiple Sclerosis Definite diagnosis of MS (14,15) or CIS (16);according to the most recent standard Expanded Disability Status Scale (EDSS) score < 7.0 (17) Last magnetic resonance imaging (MRI) within the previous 12 months Male or female >18 years old Willing to perform the study procedures Signed Informed consent Mini Mental Status Examination (MMSE) score < 24 Relapse within the last 3 months Radiologically isolated syndrome (RIS) History of drug and/or alcohol abuse Any serious general medical condition like decompensated cardiopulmonary disease, cancer or decompensated renal failure, as well as any neurological condition (other than MS) that can interfere with the correct execution of the study design
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A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Depression Anxiety Fatigue Sleepiness Sleep Disruption Being a first year medical student Good academic standing after the first module Reporting attending morning lectures regularly No reported history of psychiatric illness,sleep illness, ophthalmic illness No current use of photosensitizing medications
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A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-80.0, Healthy Young and Older Adults right handedness unobtrusive neuropsychological screening ability to provide written informed consent no pathological findings in head MRI age: 18 to 35 years (young adults) or 50-80 years (older adults) Highly effective contraception (Pearl Index < 1) or reliable abstinence from any heterosexual relationships in women of childbearing potential severe internal or psychiatric disease (especially depression or suicidal thoughts) epilepsy cognitive impairment (< SD under age adjusted norm in neuropsychological testing) concurrent taking of serotonin precursors (tryptophan, 5-HTP) or MAO inhibitors concurrent taking of tramadol or triptans concurrent taking of pimozide or linezolid concurrent taking of other drugs prolonging the QT-interval long-QT-syndrome hypokalemia or hypomagnesemia known intolerance of the study medication
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A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 12.0-18.0, Adolescent - Emotional Problem Depression Prevention Harmful Effects enrolled in one of the participating schools parental consent and student assent is required for the web-based survey not enrolled in the participating schools
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A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Marital Relationships Family Relations Low-Income Population Child Behavior Adolescent Behavior To be eligible for the study, couples were supposed to be low income, married, at least 18 years old, and either expecting a child or parents of a child under age 18 who was living in their home - though couples were not required to provide any documentation verifying that they met these criteria They also had to understand one of the languages in which SHM services were offered (English or, in some locations, Spanish) Indication of domestic violence in the relationship
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A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-65.0, Depressive Disorder, Major Moderate to severe major depressive disorder Prior treatment with botulinum toxin of any serotype for any reason Use of antidepressant medication for depression within 2 weeks of study Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
2
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Depression Anxiety Alcohol Abuse Tobacco Abuse English-speaking US residents ages 18 and older below 50% of the area median income have a regular Internet connection non-English speakers non-US residents children history of or current enrollment in other incentivized savings programs
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A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-24.0, Physical Activity be currently enrolled in full-time university coursework be between 18 and 24 years old understand and respond to screening questions in English be able to read at a Grade 6 level have adequate health, as assessed by having a body mass index between 18.5 and 29.9 (anyone with a BMI of 30+ is considered obese; National Heart, Lung, & Blood Institute, 2012) to ensure that regular, moderate to intense exercise activity will not negatively affect health identify as individuals who have tried to initiate and continue an exercise regimen sometime in the past but have been unable to maintain the activity indicate the desire to initiate physical activity at the current time be willing to attempt to maintain an exercise schedule during the three-week intervention period to which they will be randomly assigned be willing to participate in the 2-month and 6-month follow up periods not already be meeting current physical activity recommendations (i.e., at least 150 minutes of moderate-intensity exercise per week) not have major cognitive impairments (i.e., assessed by whether they can understand and respond adequately to all screening questions) not report consuming more than three (women) or four (men) alcoholic drinks per day (as this may interfere with their ability to engage in physical activity and confound study results) not be pregnant not have children not have preexisting physical limitations or recent injuries not have major cognitive impairments (i.e., assessed by whether they can understand and respond adequately to all screening questions)
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A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Depression Participant ≥ 18 years Participant meets for a DSM-V Major Depressive episode. are as follows: Five or more symptoms present during the same 2-week period, including either 1 or 2: 1) depressed mood, 2) loss of interest or pleasure, 3) significant weight loss or gain, 4) insomnia or hypersomnia, 5) psychomotor agitation or retardation, 6) fatigue or loss of energy, 7) feelings of worthlessness or excessive or inappropriate guilt, 8) diminished ability to think concentrate or make decisions, and 9) recurrent thoughts of death, recurrent suicidal ideation, suicide attempt or plan MADRS score of 20 or more DSM-V psychotic disorder Drug or alcohol abuse or dependence (preceding 6 months) Inadequate response to ECT (current episode of depression) Regular benzodiazepine medication Rapid clinical response required, e.g., due to high suicide risk Clinically defined neurological disorder or insult Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites Pregnancy
1
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 45.0-60.0, Cardiovascular Diseases Diabetes Dyslipidemias Metabolic Syndrome Quality of Life Age: 45-60 years Not to have other severe somatic or psychiatric disorders, or other diseases that prevent physical loading (Answer "no" to all questions on the Physical Activity Readiness Questionnaire-PAR-Q) Not to be engaged in regular physical activity >20 min on >3 days/week Able to ambulate, with or without assistance Able to communicate Informed consent: Must be capable and willing to provide consent Acute or terminal illness Myocardial infarction in the past 3 months Not capable to ambulate Unstable cardiovascular disease or other medical condition Upper or lower extremity fracture in the past 3 months Severe dementia (MMSE < 10) Unwillingness to either complete the study requirements or to be randomised into control or training group Presence of neuromuscular disease or drugs affecting neuromuscular function
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A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Schizophrenia Major Depressive Disorder Bipolar Depressive Disorder Parkinson's Disease With Hallucinations at least 18 years-old have a diagnosis of schizophrenia, major depressive disorder, bipolar depressive disorder, parkinson's disease with hallucination such patients should receive antipsychotics as their usual treatment they should give informed consent before participating no treatment with atypical antypsichotics other diseases
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A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Depressive Disorder, Major Being 18 years of age or older • Meet DSM-IV diagnostic for MDD confirmed by MINI International Neuropsychiatric Interview version 5.0 Informed Consent • Having access to a PC and Internet connection • Having a Smartphone that is compatible with the mobile component of the intervention • Understanding of the German language spoken and written • Current high risk for suicide according to the MINI Interview section C • Serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview • Currently receiving psychological treatment for depression • Being unable to comprehend the spoken and written language (German) • Not having access to a PC and fast Internet connection (i.e. broadband or comparable) • Not having a Smartphone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smartphone during the duration of treatment
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A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 20.0-65.0, Major Depressive Disorder For MDD subjects Subject meets the DSM-IV for MDD Subject has a minimum score of 18 on the 17-item HAMD total score Subject has a minimum score of 2 on item 1, depressed mood, of HAMD Subject is free from prior antidepressant medication for at least 5 times of elimination half-lives For healthy subjects Subject without past or current neuropsychiatric illnesses based on a clinical interview including Mini-International Neuropsychiatric Interview (M.I.N.I.) and a physical examination Subject without exposure to psychotropic medication or other substances known to affect the brain serotonin system within 1 year prior to entering the study Subject with history of any co-morbid neuropsychiatric disease Subject with history of treatment resistant to at least two full doses and courses of antidepressant medication Subject with history of alcohol or substance dependence or abuse Subject with allergic history to the investigational products Subject with severe cardiovascular disease or cerebrovascular disease which is judged by investigators for safety concerns as inappropriate for this study Subject with malignancy within past 5 years Subject with any diseases judged by investigators as inappropriate for this study Female subject being pregnant, nursing, or lactating Female subject of childbearing potential not using a medically acceptable form of birth control Subject is unable to undergo MRI scan to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations
1
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-65.0, Depression Depressive Disorder patients referred to the recruitment sites for treatment for depression mild, moderate or severe depression mild, moderate or severe episode of recurrent depression bipolar or psychotic depression psychotic disorder severe substance abuse disabilities in senses that affect functioning and severely threat completing the trial diseases that affect vitamin D metabolism (such as sarcoidosis, hypercalcemia, hypofunction of kidney) pregnancy or lactation current use of high dose vitamin D supplementation current use of high dose calcium supplementation
2
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Major Depressive Disorder Bipolar, Depression We will recruit up to 80 participants who are adults (≥18yrs) have a confirmed psychiatric assessment of Major Depressive Disorder (MDD) and/or Bipolar II, depressive are of moderate or higher severity (PHQ-9 >14) are community-dwelling and able to attend Group Medical Visits in the Lower Mainland are able to comply with scheduled visits, treatment plan, and other procedures read, write, and speak English with acceptable auditory and visual acuity provide signed/dated informed consent; and able to walk independently Active psychotic symptoms a primary active diagnosis of substance abuse Participants will need to have a working proficiency in English as group discussions, accompanying texts, and instructions will all be in English. To provide adequate translation services for these elements in one or more other languages is beyond our budget and may also influence the dynamics of the GMV. It could be considered in a future iteration of this research program
1
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-65.0, Major Depressive Disorder Bipolar I Disorder Bipolar II Disorder Bipolar Depression Suicidal Ideation Provision of written informed consent [MDD stream only] Diagnosis of major depressive disorder, currently depressed as determined by DSM-IV diagnostic (confirmed using the MINI) [BD stream only] Diagnosis of bipolar disorder, type I or type II, currently depressed as determined by DSM-IV diagnostic (confirmed using the MINI) Both females and males, aged 18 to 65 years Inpatient status Female patients of childbearing potential must have a negative urine human chorionic gonadotropin (hCG) test at enrolment and must be taking or willing to take some acceptable form of birth control during the course of the study if they are or plan to be sexually active The ability to understand and comply with the requirements of the study and capable of providing informed consent Suffering from suicidal ideation/attempts as evidenced by a score of >0 on either of the SSI or CSSRS or both Current or past psychotic symptoms Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV within 4 weeks prior to enrollment Any pervasive developmental disorder (according to DSM-IV criteria) Diagnosis of dementia (according to DSM-IV criteria) Known intolerance or hypersensitivity to ketamine or midazolam as judged by the investigator Significant medical condition that would contraindicate the use of ketamine, midazolam or that is untreated and would need urgent attention (as determined by treating physician) Medical conditions that would significantly affect absorption, distribution, metabolism, or excretion of ketamine or midazolam Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator Any clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator
1
A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 18.0-999.0, Depression Anxiety Stress Participants must be at least 18 years of age. Participants must have self-reported mild to severe symptoms of depression (5-27+) according to PHQ-9, self-reported mild to severe symptoms of anxiety (5-21+) according to GAD-7, or self-reported mild to severe symptoms of stress (15-34+) according to the stress sub-scale of DASS-21 Students who currently are in face-to-face therapy at UCCS or BHS will be excluded. Students who score in the "red zone" in terms of risk of self-harm on the screening questions routinely used at UCCS will not be referred to the study. Students who score greater than 0 on the PHQ-9 self-harm item during the initial screening phase will be automatically directed to be further evaluated and alerted that a counselor will try to reach them. Based on this further evaluation, they may be recommended to seek help from their health/counseling service and may/may not be eligible to participate in the study. They will be telephoned within 1 working day and contacted by email if they cannot be reached by phone
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A 20 yo female college student with no significant past medical history presents with a chief complaint of fatigue. She reports increased sleep and appetite over the past few months as well as difficulty concentrating on her schoolwork. She no longer enjoys spending time with her friends and feels guilty for not spending more time with her family. Her physical exam and laboratory tests, including hemoglobin, hematocrit and thyroid stimulating hormone, are within normal limits.
eligible ages (years): 20.0-65.0, Major Depression unipolar major depressive disorder neurological diseases or relevant psychiatric diseases other than major depressive disorder current medication other than SSRI or Mirtazapine manic episodes (lifetime) psychotic symptoms (lifetime) treatment with psychotherapy within the past 2 years treatment with electroconvulsive therapy (lifetime)
2
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class.
eligible ages (years): 0.0-999.0, Lung Diseases Sleep Apnea Syndromes
0