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A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Mood Social Behavior Age 18 to 65 yrs At least one first-degree family member with MDD, Family History (FH) positive, or no first and -second degree family members with MDD, FH negative Willingness to cooperate, to sign written informed consent Any current or past Diagnostic and Statistical Manual (DSM) IV Axis I mood disorder, anxiety disorder, psychotic disorder, eating disorder, or somatoform disorder as determined by Structured Clinical Interview for DSM interview Any current substance use disorder Any past substance dependence Ongoing medical treatment for a chronic disease, particularly cancer, gastrointestinal disease, phenylketonuria, diabetes, cardiovascular disease, or disease of the liver or kidneys Not speaking Dutch fluently Current or past use of neuroleptics, sedative drugs, antidepressants etc On test days, a positive urine test for drugs of abuse For women, initiation of hormonal contraceptive treatments 3 months prior to screening, or a positive urine test for pregnancy on test days | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Responsible Fatherhood Healthy Marriage To be eligible for the PACT HM Evaluation, the applicant must be part of a couple (as defined by the couple) in which both couple members are applying to the program and that: 1. Both members of the couple are eligible for the program 2. Both members of the couple are 18 years of age or older 3. One member of the couple is female and the other male 4. At least one member of the couple is an expectant parent or a parent of a biological or adoptive child who is living with him or her (That is the children do not need to be children in common and they need to be living with only one parent) To be eligible for the PACT RF evaluation, the individual must: 1. Be male 2. Be 18 years or older 3. Have a living biological or adopted child or is expecting a child Does not meet the | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 0.0-999.0, Postpartum Depression First-time, English-speaking mothers of healthy singleton newborns Positive screen (> 10) on Edinburgh Postnatal Depression Scale Suicidal ideation Currently receiving depression treatment Meets for bipolar disorder and/or lifetime or current psychotic disorder | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Depression Depressive Disorder Behavioral Symptoms Mood Disorders Meets for clinically significant depression based on a score of ≥ 2 for one of the two cardinal depression symptoms (depressed mood or loss of interest) and a Patient Health Questionnaire-9 total score of ≥ 10 Patient with heart disease Has attended Los Angeles County Department of Health Services Comprehensive Health Clinics or the Cardiology Clinic at Los Angeles County+University of Southern California Medical Center Current suicidal ideation Score of 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT) Recent use of lithium or antipsychotic medication | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 11.0-19.0, Major Depressive Disorder, Single Episode, Unspecified Meet the major depression disorder's bipolar disorder, schizophrenia or organic mental disorder any concurrent psychotherapy any concurrent psychotropic medication | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 21.0-65.0, Breast Cancer Histologically confirmed stage I-III breast carcinoma 2. <65 years old 3. Female 4. Scheduled to receive chemotherapy containing doxorubicin/cyclophosphamide once every 3 weeks for 4 cycles and weekly paclitaxel for 12 cycles starting in either the adjuvant or neoadjuvant setting 5. May receive adjuvant endocrine therapy subsequently (endocrine therapy can be either tamoxifen or aromatase inhibitors) for Healthy Controls Each subject must meet the following to be enrolled in this study. 1. <65 years old 2. Female Previous exposure to chemotherapy/anti-hormonal therapy for any other malignancy 2. Concomitant second primary in-situ or invasive carcinoma or previous history of carcinoma/carcinoma-in-situ 3. Known disease or injury to the central nervous system (including neurodegenerative diseases, epilepsy), severe visual or auditory disorders 4. Motor weakness due to any cause which makes using a touchscreen computer difficult 5. Known background of depression, anxiety disorders or other neurobehavioural conditions 6. Previous history of cognitive impairment 7. Ongoing use of tranquilisers or anti-depressants 8. Previous neuropsychological testing 9. Current or previous history of alcohol or drug dependence for Healthy Controls Subjects who meet any of the following will be excluded from the study. 1. Previous exposure to chemotherapy/anti-hormonal therapy for any other malignancy 2. Concomitant second primary in-situ or invasive carcinoma or previous history of carcinoma/carcinoma-in-situ 3. Known disease or injury to the central nervous system (including neurodegenerative diseases, epilepsy), severe visual or auditory disorders 4. Motor weakness due to any cause which makes using a touchscreen computer difficult 5. Known background of depression, anxiety disorders or other neurobehavioural conditions 6. Previous history of cognitive impairment 7. Ongoing use of tranquilisers or anti-depressants 8. Previous neuropsychological testing 9. Current or previous history of alcohol or drug dependence | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 0.635-999.0, Gastroschisis Diagnosis of uncomplicated neonatal gastroschisis treated by primary fascial closure or delayed closure using a pre-formed silo (fascial closure or plastic closure) 2. Expectation of the treating physician that the patient will require intravenous therapy for at least 7 days post-enrolment Presence of other significant congenital malformation (ie life-threatening, requiring surgical intervention, or having an effect on intestinal motility) 2. Presence of intestinal atresia, intestinal necrosis or intestinal perforation (ie complicated gastroschisis) 3. Gestational age <32 weeks 4. Birth weight < 1500 gm 5. Received an investigational product within the past 30 days | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Female Genital Diseases Women between ages of 18 and 65 who complain of localized provoked vulvar pain and meet the for the diagnosis of localized provoked vulvodynia. Patients who have failed or have been unable to tolerate previous attempts at systematic therapy or surgery will be specifically recruited The presence of a dermatologic or neurologic condition which is determined by the investigator to be the primary cause of the patient's pain. 2. Allergy to any of the medications or the base itself. 3. Concurrent use of the following medications. . The patient may enroll in the study after a two week washout from these medications. Patients may need to receive approval from the prescribing physician before stopping these medications. Failure to obtain approval for medication cessation would be cause for exclusion. Gabapentin (NeurontinTM) Amitriptyline (ElavilTM) Nortriptyline (PamelorTM) Desipramine (NorpraminTM) Tramadol (UltramTM, ConZipTM, RybixTM, RysoltTM, Ultram ERTM) Pregabalin (LyricaTM) Baclofen | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 0.0-999.0, Information Seeking Behavior Clinicians and researchers in obstetrics and gynaecology who have an e-mail address Clinicians and researchers who are in the countries where YouTube cannot be accessed (China, Iran, Pakistan and Turkmenistan) | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Major Depressive Disorder (MDD) Be able to understand the requirements of the study and provide written informed consent to participate in this study; a signed and dated ICF will be obtained from each patient before participation in the study Have provided written authorization for the use and disclosure of their protected health information Be ≥18 years of age Suffer from a Major Depressive Episode meeting DSM-IV-TR criteria Have had an inadequate response within the current episode to at least 1 psychotropic treatment. Inadequate response is defined as inadequate efficacy after 6 weeks of a psychotropic treatment or discontinuation of a psychotropic treatment due to AEs or intolerability Have a total baseline score on the QIDS-C16 and QIDS-SR16 rating scale ≥11 Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study, including all visits and tests Patients posing a serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator Patients with a diagnosis of Bipolar I or II disorder Patients with a current Axis I diagnosis of: 1. Delirium 2. Dementia 3. Amnestic and other cognitive disorder 4. Schizophrenia or other psychotic disorder Patients having experienced hallucinations, delusions, or any psychotic symptomatology within the current depressive episode or during prior depressive episodes Patient is currently in an inpatient facility Patients with a history of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months Patients who meet DSM-IV-TR for any significant current substance use disorder Patients with significant unstable medical condition; life threatening disease; hepatic insufficiency (3X ULN for AST and/or ALT); liver transplant recipient; cirrhosis of the liver; need for therapies that may obscure the results of treatment and/or of the study; malignancy (except basal cell carcinoma) and/or chemotherapy within 1 year prior to screening; malignancy more than 1 year prior to screening must have been local and without metastasis and/or recurrence, and if treated with chemotherapy, without nervous system complications Participation in another clinical trial within 30 days of the screening visit Anticipated inability to attend scheduled study visits | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Depression Pregnancy Pregnant women aged > 18 years 2. >12 weeks gestation at enrollment 3. 32 or fewer weeks gestation at first treatment visit (to increase likelihood of all treatment occurring during pregnancy) 4. Diagnosis of Major Depressive Disorder and in a Moderate-severe major depressive episode without psychotic features (as confirmed by the Mini-International Neuropsychiatric Interview, MINI ). 5. Safe for outpatient psychiatric treatment (as assessed by Study PI). 6. Offered, but declined to use an anti-depressant medication 7. Capable to consent to treatment 8. Able to understand study explanations and have questionnaires administered in English DSM-V history of alcohol and/or substance use or dependence in the previous 6 months 2. Concomitant major and unstable medical or neurologic illness or history of seizure 3. Currently taking carbamazepine (which may interfere with the effects of anodal tDCS), 4. Major complications and/or a known fetal anomaly in the current pregnancy as determined by the investigator team 5. Planning to leave Toronto prior to delivery in the current pregnancy. 6. Metal implant(s) in cranium 7. Electrical implant(s) in body 8. Currently taking benzodiazepines daily (Intermittent PRN use of low-dose Lorazepam allowed) 9. Non-intact skin on scalp areas where stimulation electrodes will be placed 10. History of very preterm delivery in previous pregnancy (< 32 weeks gestation) | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | 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 | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Shame Eligible participants will be adults (age 18 or older) who are fluent in English (as all materials will be presented in English) and report elevated levels of trait shame on the Experience of Shame Scale (ESS) at screening. Specifically, based on past research, individuals must score at least 55 on the ESS screening items, which is consistent with levels of shame often reported by clinical samples. In addition, all interested individuals must have a therapist/case manager/psychiatrist who provides them with individual psychotherapy on a regular basis and for whom the participant is willing to sign an Authorization for Release of Health Information Individuals will be excluded from the present study if they do not report significant difficulties with shame (i.e. ESS screening item scores less than 55), do not have an individual therapist/case manager/psychiatrist who monitors and addresses their broader mental health concerns, are experiencing active psychosis (i.e. delusions and/or hallucinations), or are experiencing an episode of mania | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Depression Diagnosis of Major Depressive Disorder based on Structured Clinical Interview for DSM-IV (SCID) Hamilton Depression Rating Scale-24 (HRSD-24) score of 8-24 No antidepressant medication in past 3 months Pregnancy/Breastfeeding/Reproductive age female not using contraception Schizophrenia or other psychotic disorders Bipolar Disorder Cluster B personality disorder Electroconvulsive Therapy (ECT) failure in past Concurrent ECT or repetitive transcranial magnetic stimulation (rTMS) Active substance abuse within past 6 months Use of antiepileptics Thyroid Stimulating Hormone (TSH) greater than 4 Untreated Vitamin B12 deficiency (Vitamin B12 less than 400) | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 45.0-65.0, Post Menopausal Dryness in the Intimate Area of Women healthy women 45-65 years old with subjective dryness in the intimate area postmenopausal with last menstruation more than or equal to 3 years prior to entering the study being willing to abstain sexual intercourse during the study period yeast infection or bacterial vaginosis use of antibiotics or antifungals use of estrogen participation in Another study | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Colon Cancer Primary colon cancer Kidney failure, allergy to contrast, pregnancy | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Metastatic Ureter Carcinoma Metastatic Urethral Carcinoma Stage III Bladder Urothelial Carcinoma AJCC v6 and v7 Stage III Ureter Cancer AJCC v7 Stage III Urethral Cancer AJCC v7 Stage IV Bladder Urothelial Carcinoma AJCC v7 Stage IV Ureter Cancer AJCC v7 Stage IV Urethral Cancer AJCC v7 Ureter Urothelial Carcinoma Urethral Urothelial Carcinoma Patients must have locally advanced or metastatic predominantly urothelial carcinoma of the bladder, ureter, or urethra that is not amenable to curative surgical treatment Patients must have histologically confirmed predominantly urothelial carcinoma of the bladder, ureter, or urethra Patients must have measurable disease per Response Evaluation in Solid Tumors (RECIST) defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam Patients must be ineligible for treatment with cisplatin, based on one of Calculated creatinine clearance (CrCl) >= 30 and < 60 mL/min (Cockcroft-Gault) CTCAE grade (Gr) >= 2 hearing loss CTCAE Gr >= 2 neuropathy Patients must not have received prior systemic therapy for their advanced cancer; prior intravesical therapy completed 4 weeks prior to enrollment and adjuvant/neoadjuvant chemotherapy completed more than 6 months prior to diagnosis of advanced disease are permitted Zubrod performance status =< 2 (Karnofsky >= 60%) Life expectancy of greater than 3 months Patients with a small cell component in their histology are excluded Patients who have had chemotherapy for the treatment of the advanced or unresectable urothelial cancer of the bladder are not eligible; patients who were previously treated for local disease must not have received radiotherapy or chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study and must have recovered from adverse events due to agents administered more than 4 weeks earlier; patients who have received neoadjuvant or adjuvant chemotherapy must have completed treatment at least 6 months prior to diagnosis of metastatic disease Patients who are receiving any other investigational agents Patients with known brain metastases should be excluded from this clinical trial History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and eribulin Uncontrolled intercurrent illness including, but not limited to, a second cancer diagnosis within the past 5 years, or a cancer undergoing any treatment, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with eribulin and gemcitabine Human immunodeficiency virus (HIV)-positive patients with inadequate cluster of differentiation (CD)4 counts or those who are on combination antiretroviral therapy with strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) effects are ineligible for this trial Patients with baseline corrected QT (QTc) prolongation greater than grade 1 are excluded from this study; patients with grade 1 QTc elevation are eligible but must be monitored with electrocardiogram (ECG) (EKG) exams, for the first 3 cycles of treatment; eribulin time to maximum concentration (Cmax) after infusion is about 10 minutes, and half life is 40 minutes; ECG (EKG) should be performed between 10 to 40 minutes after eribulin administration (on day 1 and day 8 of treatment); continued ECG (EKG) monitoring beyond cycle 3 can be done at the discretion of the treating physician Patients with congenital long QT syndrome are excluded from this study | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 0.0-999.0, Intubation; Difficult Anesthesia practitioners including anesthesia attendings, fellows, residents CAIII and CRNA's at Texas Children's Hospital Department of Anesthesiology with clinical experience of >500 intubations with Miller blades Anesthesia practitioners with <500 intubations with Miller blades | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-70.0, Depression Subjects aged 18 or more with a current major depressive episode according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) Depressive treatment currently in process | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Depression **This study never received IRB approval and no participants were enrolled** Veterans Administration Medical Center patients with major depression, mild to moderate treated with an SSRI and not having complete remission of symptoms | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Immediate Postpartum Hemorrhage The trial will women aged 18 years or older who have just had a vaginal delivery between 35 and 42 weeks of gestation with a PPH persisting 15 minutes after the injection of 5 UI or 10 IU of oxytocin by slow IV and uterine massage and who provided informed written consent. If her condition does not allow her consent to be obtained immediately in ethically acceptable conditions, it may be obtained from her healthcare agent, or if there is none, from a family member, if present. In case where neither a healthcare agent nor a family member is present on the day of the patient can nonetheless be included. She will be informed secondarily, and her consent will be requested for the potential continuation of the research and use of her data Patient beneficiary or affiliated to a health insurance The trial will not women who have just had a cesarean delivery with a contraindication to Sulprostone with clinical chorioamnionitis or an in utero fetal death or a medically-indicated termination of pregnancy with PPH secondary to cervicovaginal lacerations without any uterine hemorrhage, uterine rupture, or placenta accreta with arterial bleeding requiring embolization with a purulent infection of the cervix, vagina or uterus with symptoms indicating a hysterectomy with cervical cancer | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-79.0, Major Depression Male and female patients Age between 18 and 80 years Inpatients with a DSM-IV diagnosis of Major Depression single episode or recurrent moderate to severe intensity without psychotic features Inpatients with a DSM-IV diagnosis of bipolar disorder I or II current episode with depressive symptoms moderate to severe intensity without psychotic features Acute suicidality (HAM-D Item 3 score > 2) Acute alcohol-, hypnotics-, analgesics or psychopharmacological intoxication or delirium Current alcohol dependence, or dependencies from other psychotropic substances Severe medical or neurological diseases: patients with severe hepatic (severe impairment of liver function, cirrhosis of the liver), renal (kidney malfunctions), cardiovascular (recent myocardial infarction, instable heart disease), neurological diseases (e.g. multiple sclerosis, Parkinson, dementia) Patients incapable of giving informed consent Pregnant or breast-feeding women Women of reproductive age without effective contraception Simultaneous participation in other clinical trials or participation in an other clinical trial within 6 weeks before the start of the study Hypersensitivity to the study medication or to one of the ingredients of the medication | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Depression Participants are aged 18-65 years. 2. 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. 3. MADRS score of 20 or more. 4. Right handed 5. A history of non-response to ≥ 2 adequate trials of antidepressant medication treatment DSM-V psychotic disorder. 2. Drug or alcohol abuse or dependence (preceding 6 months). 3. Inadequate response to ECT (current episode of depression). 4. Regular benzodiazepine medication 5. Rapid clinical response required, e.g., due to high suicide risk. 6. Clinically defined neurological disorder or insult. 7. Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites. 8. Pregnancy | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 65.0-999.0, Colon Cancer Age 65 or older Newly diagnosed cancer Referred to the geriatrics service for pre-operative evaluation before surgical resection of his/her tumor Inability to comprehend English Deafness , measured by the Hearing Handicap Inventory for the Elderly Screening Version (HHIE-S) [16], score equal or above 30. (appendix 5) Cognitive impairment (score of 0-1 in Mini-Cog Test) Nursing home resident Planned hospital length of stay of one day or less | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 13.0-21.0, Major Depressive Disorder Major Depressive Disorder, Recurrent Major Depressive Disorder, Remitted Adolescents from the ages of 13 to 21, male or female. 2. Subjects with MDD (Groups 2, 3 & 4) Must have a diagnosis of Major Depressive Disorder (MDD) Single episode or recurrent; moderate to severe The MDD diagnosis is based on the Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children Past and Lifetime (K-SADS-PL) This semi-structured psychiatric interview will be administered by a psychiatrist, Ph.D. level psychologist, or equivalent professional with extensive clinical experience Must have a Childhood Depression Rating Scale-Revised (CDRS-R) score of ≥ 40 Must have a Clinical Global Impression Severity (CGI-S) Scale of ≥ 4 3. Group 1: (Healthy Controls; 50 Subjects): Healthy volunteers who are 13-21 years of age with no current or lifetime mental health diagnoses and no current or lifetime psychotropic medication treatment. 4. Group 2: (50 subjects): Subjects with moderate to severe MDD for which an SSRI has been clinically indicated If initiating SSRI treatment, medication must be started ± 7 days of the baseline visit Subjects and parents in group 2 will be eligible to return in 6-8 weeks for a follow up visit that includes mood assessments and evaluations For all Subjects: 1. Contraindications to MRI/MRS, as determined by the MRI safety screen and MRI safety codes. 2. Subjects who are judged by the Principal Investigator to be at imminent risk for self-harm or suicide as indicated by interview or C-SSRS. 3. Pregnancy or suspected pregnancy in females. 4. Metal in the head (except the mouth*), implanted medication pumps, cardiac pacemaker (*subjects with braces will be excluded from MRI/MRS portion of the study only) 5. Prior brain surgery. 6. Risk for increased intracranial pressure such as a brain tumor. 7. Any unstable medical condition. 4.2.1 for Healthy Control Group only: 1. Current or past mental health diagnoses in subjects or first degree relatives of subjects. 2. Current or past mental health medications. 4.2.2 for MDD Groups only: 1. Primary Axis I or II disorder other than MDD. 2. Unprovoked seizure history, seizure disorder, history of febrile seizures, first degree relative with epilepsy 3. Taking medication(s) that lower seizure threshold 4. Any significant findings on the TMS adult safety screen (TASS). 4.2.3 for Group 2 only: 1. Subject has started SSRI medication more than 7 days prior to the baseline visit | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 0.0-45.0, Infants of Diabetic Mothers (understood to only abstemious women) 1. . Pregnant women expected to deliver between 37 and 41 weeks gestation (controls), and their babies 2. . Pregnant women expected to deliver between 37 and 41 weeks gestation who have class A1 diabetes mellitus, and their babies 3. . Pregnant women expected to deliver between 37 and 41 weeks gestation who have class A2 diabetes mellitus, and their babies 4. . Pregnant women expected to deliver between 37 and 41 weeks gestation who were diagnosed with diabetes mellitus prior to their pregnancy, and their babies . Mothers who self-reported any alcohol or any illicit drug use during their pregnancy (and their babies) 2. . Mothers who had a positive drug screen at any point during their pregnancy (and their babies) 3. . Babies whose mothers suffered a placental abruption during their pregnancy. 4. . Babies whose mothers had inadequate prenatal care (defined as <3 prenatal clinic visits prior to admission for delivery) 5. . Non-English-speaking mothers 6. . Babies who pass meconium in utero. 7. . Babies born with multiple congenital anomalies or abdominal wall defects | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 21.0-65.0, Alcohol Dependence Experienced binge drinking episode(s) (5 or more standard drinks for men and 4 or more standard drinks for women consumed in about 2 hours according to NIAAA definition) in the past 30 days DSM-IV diagnosed alcohol dependence, other drug dependencies including nicotine dependence | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Osteoarthritis Chronic Pain Catastrophization joint arthgroplasty (shoulder, hip ou knee) osteoarthritis previous surgery in the same joint | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Depression Meet DSM-IV diagnostic for MDD as confirmed by the telephone administered MINI International Neuropsychiatric Interview version 5.0 and a score a score of 5 or higher on the PHQ-9 screening questionnaire 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 in primary or specialised mental health care Being unable to comprehend the spoken and written Polish Not having access to a PC and fast Internet connection (i.e. broadband or comparable) Not having a Smart phone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smartphone if one is provided with one by the research team for the study duration | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Advanced Breast Cancer HER2/Neu Negative Triple-Negative Breast Cancer No deleterious germline BRCA1 or BRCA2 mutation based on full sequencing and comprehensive rearrangement testing at an external reference laboratory; patients with variants of unknown significance will be eligible Measurable disease per Response Evaluation In Solid Tumors (RECIST) version 1.1 Must have progressed on at least 1 prior chemotherapy regimen for the treatment of advanced breast cancer; there is no upper limit on the number of prior therapies If prior platinum agent (eg, carboplatin or cisplatin) has been administered, no evidence of progression, or within 8 weeks of stopping platinum treatment Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN); if liver function abnormalities are due to hepatic metastasis, then AST and ALT ≤ 5 x ULN Total serum bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert's syndrome) Calculated creatinine clearance ≥ 30 mL/min or serum creatinine ≤ 1.5 mg/dL Hemoglobin ≥ 9.0 g/dL with last transfusion at least 14 days before day 1 of study drug Absolute neutrophil count (ANC) ≥ 1500/mm^3 Any patient with a deleterious mutation in BRCA1 or BRCA2 Hormone receptor positive and/or HER2 positive breast cancer (Cohort A only) HER2 positive breast cancer (Cohort B only) Prior treatment with a PARP inhibitor Non-measurable disease only Pregnant or nursing patients Any anti-cancer therapy within the past 21 days of the first day of treatment Brain or central nervous system (CNS) metastases Exception: Adequately treated brain metastases documented by baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan that have not progressed since previous scans and do not require corticosteroids (except prednisone ≤ 5 mg/day or equivalent) for management of CNS symptoms. A repeated CT or MRI following the identification of CNS metastases (obtained at least 2 weeks after definitive therapy) must document adequately treated brain metastases Subjects with leptomeningeal carcinomatosis are not permitted | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 60.0-79.0, Depression Depressive Disorder, Major Depressive Disorder Unipolar Depression Major Depressive Disorder Ages 20-39 (recruitment complete) and 60-79 years old (open to recruitment) 2. Major depressive disorder (MDD), single or recurrent, as diagnosed by the PRIME-MD 3. MADRS ≥ 15 4. In-town and available to commute to Oakland for a 12-week period 5. Study nurse practitioner approval to participate in a 12-week moderate intense exercise intervention 6. Eligible to undergo MRI Inability to provide informed consent. 2. Modified Mini-Mental Score (3MS) less than 84 or dementia based upon Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) including poor performance on the clinical neuropsychological battery, and all available clinical information. 3. Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms. 4. Abuse of or dependence on alcohol or other substances within the past three months 5. High risk for suicide [e.g., active suicidal ideation (SI) and/or current/recent intent or plan] AND unable to be managed safely in the clinical trial (e.g., unwilling to be hospitalized). Urgent psychiatric referral will be made in these cases. 6. Contraindication to venlafaxine XR as determined by study physician including history of intolerance of venlafaxine XR in the study target dosage range (venlafaxine XR at up to 300 mg/day). 7. Inability to communicate in English (i.e., interview cannot be conducted without an interpreter; subject largely unable to understand questions and cannot respond in English). 8. Non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview) 9. Unstable/uncontrolled medical illness, including delirium, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that are not under medical management. 10. Subjects taking psychotropic medications that cannot be safely tapered or discontinued prior to study initiation 11. If a patient failed a trial of venlafaxine (12 weeks of treatment with venlafaxine including at least 6 weeks on 300mg/day), he/she would not be eligible. 12. Other drugs that may affect the GABA system will be excluded (e.g., Kava, Valerian, Theanine, and GABA supplements). 13. The drug Linezolid (Zyvox) should be discontinued prior to study enrollment and should not be used during the study. 14 for MR scans cardiac pacemaker, aneurysm clip, cochlear implant, pregnancy, intrauterine device, shrapnel, history of metal fragments in the eye, neurostimulators, weight >250 lbs., tinnitus, or claustrophobia. 15. Current medical condition or treatment for a medical condition that could affect balance, gait, or contraindicate participation in moderate intensity physical activity. 16. Observed gait condition or use of walking assisted device that would contraindicate use of treadmill for exercise testing and intervention. 17. Current congestive heart failure, angina, uncontrolled arrhythmia, or other symptoms indicative of an increased acute risk for a cardiovascular event; within the previous 12 months having a myocardial infarction, coronary artery bypass grafting, or angioplasty; conditions requiring chronic anticoagulation (i.e. recent or recurrent DVT). 18. Eating disorders that would contraindicate physical activity. 19. Report exercise on more than three days per week for greater than 20 minutes per day over the past three months. 20. Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance to at least 80 percent of the scheduled intervention sessions and all of the scheduled assessments | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Postpartum Hemorrhage A patient will be considered for in the study if she meets all of the following She has a term (≥37 completed weeks) live singleton gestation in cephalic presentation and has been admitted to the Labor and Delivery Unit She is in the latent phase of labor or has been admitted for induction of labor or at prenatal clinic visit She has had fewer than four prior vaginal deliveries She reports no allergy to misoprostol. The following factors or conditions will a patient from consideration as a subject The fetus has a known major fetal malformation or chromosome abnormality The gestation is multiple There is a breech or other malpresentation The patient reports involvement in another clinical trial currently or previously in this pregnancy The patient is expected to have a cesarean delivery | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 12.0-18.0, Vitamin D Deficiency Obese subjects BMI at or above the 95th percentile for children of the same age and sex. Only obese subjects will be selected given that they are the highest risk group of developing insulin resistance and Type II Diabetes and therefore with be most likely to demonstrate glucose pertubation. 2. Pubertal: Testicular volume ≥ 6 ml Prader (M) and Tanner III breast development or greater (F) 3. 12 years regardless of gender, race or economic circumstance 4. Pre diabetes/high risk of diabetes using of HbA1C between 5.7 4% as defined by the American Diabetes Association (ADA) 5. 25-OH vitamin D level less than 20 ng/ml (50 nmol/liter) 6. Subjects must be willing to comply with study protocol requirements Treatment on medication known to effect vitamin D, calcium and glucose metabolism, such as glucocorticoids, thiazolidinediones, metformin, anticonvulsants metabolized through cytochrome P-450 (phenytoin, carbamazepine, phenobarbital, sodium valproate). 2. Subjects will be excluded from the study if they have taken any form of vitamin D supplementation greater than 400 IU daily in the preceding 3 months. 3. Significant major organ system illness 4. History of nephrolithiasis or hypercalcemia 5. Females who are pregnant 6. Significant psychiatric illness: schizophrenia, bipolar disorder, active substance abuse, and uncontrolled major depression. 7. Attendance at tanning salon | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Major Depressive Disorder Age 18-65 2. Physically healthy and capable of undergoing ketamine infusion 3. Willing and able to provide informed consent 4. Diagnosis of MDE as determined by the MINI (MDD participants) 5. HAM-D 21 score ≥ 16 (MDD participants) 6. Suicide attempt occurred within past 2 weeks (MDD Participants with Suicide Attempt) 7. For the time frame of the past 7 days, C-SSRS score ≥ 3 (MDD Participants without Suicide Attempt, with Suicidal Ideation) 8. For the time frame of the past 7 days, C-SSRS score < 3 (MDD Participants without Suicide Attempt, without SUicidal Ideation) Pregnancy or lactation 2. Post-partum state (being within 2 months of delivery or miscarriage) 3. Homicide risk as determined by clinical interview 4. A lifetime history of psychotic disorder 5. Any history of dissociation or dissociative disorder 6. Bipolar disorder 7. Pervasive developmental disorder 8. Cognitive disorder 9. Cluster A personality disorder 10. Anorexia nervosa 11. Treatment with one of the following medications, known to affect the glutamate-NMDA receptor system (specifically: lamotrigine, acamprosate, memantine, riluzole, or lithium) 12. Alcohol or drug dependence (except nicotine and caffeine) within the last month or the use of any hallucinogen (except cannabis), including phencyclidine in the last month 13. Any known hypersensitivity or serious adverse effect associated with ketamine treatment 14. Any clinically-significant medication condition or therapy that would preclude treatment with ketamine, to Recent myocardial infarction 15. Unstable angina 16. Active neoplasm in the past 6 months 17. Immunosuppressive or corticosteroid therapy within the last month, with the following exceptions: any inhaled, intranasal, topical or vaginal corticosteroids are allowed. 18. Chemotherapy 19. Head injury of loss of consciousness in the past 6 months 20. If the subject reports any of the following disorders Rheumatoid arthritis Lupus erythematosus Autoimmune hepatitis Autoimmune peripheral neuropathy Autoimmune pancreatitis Behcet's disease Chrohn's disease Autoimmune glomerulonephritis Grave's disease | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 12.0-17.0, Major Depressive Disorder Key Male or female outpatients;12-17 years of age Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) for MDD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children--Present and Lifetime (K-SADS-PL) Score ≥ 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2 Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits 1 and 2 Reliable caregiver Physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ECG) normal or not clinically significant Key Psychiatric DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment Mental retardation or amnestic or other cognitive disorders Significant suicide risk Suicide attempt within the past year OR Investigator judgment (based on psychiatric interview and Columbia-Suicide Severity Rating Scale (C-SSRS)) Key Treatment-Related Allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI) Use of prohibited concomitant medication that cannot be discontinued Other Key Medical Any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect participants safety Liver enzyme tests aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2X the upper limit of normal (ULN) Clinically significant cardiovascular disorders | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Mood Disorders Bipolar Disorder Major Depressive Disorder Depression English speaking Valid email address Self-identify as having a mood disorder Under 18 years of age | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-75.0, Major Depressive Disorder Coronary Artery Disease DSM-5 diagnosis of a major depressive disorder based on clinical evaluation by the study psychiatrist 2. At least moderate severity of depression as indicated by a Montgomery-Asberg Depression Rating Scale (MADRS) score of 22 or greater 3. History of coronary artery disease as defined by History of coronary stenosis in one or more vessels that is greater ≥ 70% by coronary angiography or CT angiogram, OR History of abnormal stress test (at least medium-sized, moderate, reversible defect), OR History of documented myocardial infarction including ST elevation myocardial infarction or non-ST elevation myocardial infarction (with elevated troponins), OR 4. Evidence of adequate treatment of the coronary artery disease as defined by at least one of the following that was done at least six months prior to the Screening visit, AND was followed by the patient being clinically stable in the opinion of a cardiologist who has evaluated the case Coronary artery bypass grafting (CABG) Percutaneous coronary intervention (PCI)/ stenting Adequate management with optimal medical treatment (such as one or more of the following medications: aspirin, beta blockers, a statin (e.g., atorvastatin), and either an ACE inhibitor or an angiotensin-receptor blocker.) Key Psychiatric Patients who in the past have failed to respond to a trial of vortioxetine at the minimum recommended dose (10 mg/day) or greater taken for at least six weeks, or had unacceptable adverse effects while taking vortioxetine. 2. Patients must not have failed treatment with more than one antidepressant (taken at an adequate dose and for at least six weeks) in the current episode of major depressive disorder (i.e., did not have > 50% reduction in severity of depression based on patient history) 3. Patients with a current primary DSM-5 diagnosis of: i) Delirium, dementia, amnestic, or other cognitive disorder; ii) Eating Disorder (including Anorexia Nervosa or Bulimia); iii) Obsessive Compulsive Disorder; iv) Panic Disorder; v) Post-Traumatic Stress Disorder (PTSD); 4. Current or past (lifetime) DSM-5 diagnosis of: i) Bipolar I or II disorder; ii) Hypomanic episode iii) Substance-induced manic or hypomanic episode iii) Schizophrenia or other psychotic disorder Cardiovascular Patients who have had a myocardial infarction within 30 days of the screening visit 2. Any cardiovascular condition that is unstable or decompensated 3. In the opinion of the Investigators, the patient is at significant risk of cardiovascular adverse events 4. Coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI)/ stenting within three months of the screening visit 5. Admission to a hospital for any cardiac condition within three months of the screening visit 6. Decompensated heart failure within 6 months of the screening visit 7. QTc prolongation (screening ECG with QTc ≥ 450 msec for men or QTc ≥ 470 msec for women) using QTc Fridericia correction 8. Second-degree (if Mobitz II) or third-degree atrioventricular block 9. Heart rate on ECG of ≤ 50 bpm or ≥ 120 bpm or any heart rate that is clinically symptomatic 10. Premature Ventricular Contractions (PVCs) associated with clinical symptoms and/or any complex premature ventricular contractions (ie, PVCs that are frequent [> 30/hr] or ≥ 2 beats if multifocal, or show bigeminy, trigeminy, quadrigeminy, couplets, triplets [salvos], or the R on T phenomenon) 11. Atrial fibrillation or flutter 12. Supine (after patient has been supine for 5 minutes) systolic BP > 160 mm Hg or < 90 mm Hg or diastolic BP > 100 mm Hg or any systolic or diastolic BP that is symptomatic or clinically significant based on the opinion of the Principal Investigator 13. Patients who are receiving warfarin | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Depressive Disorder, Major Depression Depressive Disorder years of age or older Suffer from a Major Depressive Episode meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria Have had an inadequate response within the current episode to at least one psychotropic treatment in GEN. Inadequate response is defined as inadequate efficacy after 6 weeks of a psychotropic treatment or discontinuation of a psychotropic treatment due to adverse events (AEs) or intolerability Have each a score on the 16-item Clinician Quick Inventory of Depressive Symptomatology (QIDS-C16) and 16-item Self-Report Quick Inventory of Depressive Symptomatology (QIDS-SR16) rating scales ≥ 11 Be able to understand the requirements of the study and provide written informed consent to participate in this study Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study, including all visits and tests Patients posing a serious suicidal risk and/or in need of immediate hospitalization as judged by the Investigator Patients with a diagnosis of Bipolar I or II disorder Patients with a current Axis I diagnosis of Delirium Dementia Amnestic and/or other cognitive disorder Schizophrenia or other psychotic disorder Patients having experienced hallucinations, delusions, or any psychotic symptomatology within the current depressive episode or during prior depressive episodes Patient is currently in an inpatient facility Patients with a history of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for at least 6 months | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Major Depressive Disorder 1 Must be taking either an anti-depressant or an anti-psychotic medication Must provide informed consent Must have Avera Health Plans insurance coverage Must have three months of participation in the Avera Care Coordination Program Must not be pregnant or breastfeeding Must not have an active and/or unstable diagnosis of substance abuse Must not have a primary diagnosis of dementia, bulimia, or anorexia nervosa disorder Must not have had a previous pharmacogenetic evaluation | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Delivery 2nd Stage of Labor Patients will be women who are nulliparas or multiparas (≥ 1 previous child) who attended the complete training session on the types of pushing assessed in this trial; during prenatal childbirth preparation and parenthood classes (regardless of the type of prenatal preparation) for whom a vaginal delivery was planned at the end of pregnancy admitted to the maternity ward between 37 and 42 weeks of gestation (≥ 37 weeks and ≤ 42 weeks) in spontaneous or induced labor with cervical dilatation ≥ 7 cm with a singleton pregnancy in cephalic presentation who provided informed consent in writing and speaks and writes French Women who are minors adults but incapable of providing consent for the study with a disorder contraindicating prolonged pushing with a uterine scar (previous cesarean or other surgery) with a contraindication to vaginal delivery with a maternal disease that could justify in the short-term termination of the pregnancy (HELLP syndrome, preeclampsia [hypertension with albuminuria > 0.3 g by 24 hours], eclampsia, abruptio placentae, etc.) with a major genital hemorrhage with a major fetal malformation and/or hydramnios or oligohydramnios, and/or FGR (<5°percentile), diagnosed in utero with a fetal heart rate anomaly before randomization | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 21.0-55.0, Cigarette Smoking Alcohol Consumption Be between the ages of 21 and 55 and provide informed consent; 2. Smoke > 10 cigarettes per day for > 2 years and have a carbon monoxide (CO) > 10 ppm; 3. Report an interest in quitting smoking in the near future, but currently not in the process of quitting; 4. Report current heavy drinking according to NIAAA guidelines (62): for men, > 14 drinks per week or ≥ 5 drinks per occasion at least once per month over the past 12 months; for women, > 7 drinks per week or ≥ 4 drinks per occasion at least once per month over the past 12 months; 5. Not seeking or receiving treatment for alcohol use; 6. No current (last 12 months) diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V); 7. Negative urine toxicology screen for narcotics, amphetamines, and sedative hypnotics at screening; 8. No lifetime history of psychotic disorders, bipolar disorders, or major depression with suicidal ideation; 9. No current symptoms of moderate depression or higher, indexed by a score ≥ 20 on the Beck Depression Inventory-II (BDI); 10. No serious alcohol withdrawal symptoms as indicated by a score < 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised; 11. Not pregnant, nursing, or planning on becoming pregnant in the next month (if female); 12. Have no medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes); 13. Within normal limit aspartate transaminase (AST), alanine transaminase (ALT), or gamma-glutamyl transferase (GGT) levels; 14. Not currently on prescription medication that contraindicates use of VAR | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 45.0-60.0, Menopause living with their spouse no history of premature menopause no history of hysterectomy no history of oophorectomy no history of acute disease no history of burden chronic disease no participation of spouse in all of training session uncompleted all of equation favorite to from study | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Depression Obesity English-speaking Major Depressive Disorder (assessed using the Structured Clinical Interview for DSM-IV, SCID-IV) Body Mass Index (BMI) greater than or equal to 30 Not taking medications or on stable medication regimens (i.e. no medication changes for six weeks prior to enrollment or during the study) current substance dependence history of psychotic symptoms high risk of suicide/self-harm current enrollment in a weight-loss program weight loss surgery in the past year current psychotherapy inability to postpone weight loss or depression treatment interventions for the duration of the study taking antipsychotic, tricyclic, or oral corticosteroid medication unwilling to be randomized to the study treatments | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-45.0, Sleep-disordered Breathing Major Depressive Disorder 32 weeks gestation with a single, live fetus meet for major depressive disorder per the Structured Clinical Interview for DSM-V (SCID) respiratory distress index (RDI; includes apneas, hypopneas, and respiratory effort-related arousals)≥5 per ambulatory assessment plus apnea symptoms (snoring, witnessed apnea, daytime sleepiness, sleep disturbance, snort arousals) stable dose (for ≥8 weeks) of a selective serotonin reuptake inhibitor (SSRI) OR free of all antidepressant medications past 4 weeks obstetrics care is at the University of Michigan, and the woman plans on delivering her baby at the University of Michigan Diagnosis of bipolar disorder, posttraumatic stress disorder, schizophrenia or psychosis, dissociative disorders, eating disorder, obsessive-compulsive disorder, somatic symptom and related disorders, substance use disorder, panic disorder, agoraphobia per DSM-V diagnosis of, or suspicion for, narcolepsy or REM behavior disorder current SDB treatment; medical conditions for which PAP is contraindicated (e.g., pneumothorax, pneumocephalus, recent trauma, recent surgery) evidence of risk for drowsy driving (excessive daytime sleepiness plus history of motor vehicle accident or near miss due to sleepiness, fatigue, or inattention in past 12 months) | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 20.0-999.0, Triple Negative Breast Cancer Female patients, age ≥20 years 2. Histologically confirmed invasive ER-, PR-, and HER2-negative (triple-negative) adenocarcinoma of the breast 3. Triple-negative tumors are defined as: i. For HER2-negative: Fluorescence in situ hybridization (FISH)-negative (defined by ratio <2.0) or Immunohistochemical (IHC) 0, IHC 1+, or IHC 2+ or IHC 3+and FISH-negative (defined by ratio <2.0) ii. For ER and PR-negative: < 5% tumor staining by immunohistochemistry (IHC) 4. The first TNBC 20 patients with or without EGFR expression or mutation are eligible. Interim analysis of response rate will be calculated to determine the of 21 to 40 patients. 5. All of the newly diagnosed TNBC patients should be met the following clinical node-positive with any T stage patents or clinical node-negative patients with cT2-4. cT1N0M0 lesions are excluded. Patients with metastatic disease are excluded. The measurement method of tumor size can be by physical exam and/or image study. 6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1. 7. Within 2 weeks prior randomization: i. Adequate bone marrow function, hepatic function, and renal function. ii. Controlled blood pressure with or without antihypertensive treatment iii. Normal prothrombin time (PT) and partial thromboplastin time (PTT) iv. Adequate cardiac function assessed by 12-lead ECG and if clinically indicated echocardiography to document LVEF 8. Bilateral, synchronous breast cancer is allowed if one primary tumor meets the criteria. 9. Adequate bone marrow function defined as WBC ≥3.5 x 109/L, ANC ≥1.5 x 109/L, platelets ≥LLN, and hemoglobin ≥10 g/dL. 10. Adequate liver function defined as total serum bilirubin ≤1.5X ULN and serum transaminases ≤2.5X ULN 11. Adequate renal function defined as creatinine ≤1.5X ULN 12. Able and willing to give informed consent and comply with the protocol 13. Written informed consent obtained prior to any Screening/baseline procedures 14. Knowledge of the investigational nature of the study and ability to provide consent for study participation; and ability and willingness to comply with study visits, treatment, testing, and other study procedures ER+ (>5%) or PR+ (>5%) or Her-2 overexpression 2. Active second malignancy during the last five years except non melanomatous skin cancer or carcinoma in situ of the cervix. 3. Prior chemotherapy, radiotherapy or targeted therapy including afatinib or Her-2 or EGFR inhibitors. 4. Participation in another interventional clinical trial in the preceding 30 days prior to trial. 5. Patients with other concurrent severe and/or uncontrolled medical disease or infection which could compromise participation in the study 6. Prior hypersensitivity reactions to a taxane or to Cremophor® EL (polyoxyethylated castor oil) 7. Pregnant or breast feeding (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive β-HCG laboratory test (serum > 5 mIU/mL) 8. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for at least 180 days after study treatment. Highly effective contraception methods True abstinence in line with the preferred and usual lifestyle of the subject Female subject or male partner sterilization or Combination of any two of the following (a+b or a+c, or b+c): 1. Use of oral, injected or implanted hormonal methods of contraception 2. Placement of an intrauterine device (IUD) or intrauterine system (IUS) 3. Barrier methods of contraception: condom for male partner or occlusive cap 4. (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository 9. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Colon Cancer Colon cancer patients treated by chemotherapy adjuvant Patients who have metastasis Patients hospitalized during the experimentation Patients who have major orthopedic or neurologic problems | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Tobacco Smoking Pregnancy the woman presents for her first prenatal visit before 14-week gestation she is a smoker years or older (legal age for consent and for consuming tobacco in Romania) married or in a stable relationship phone service in the home or mobile phone willing to have the partner contacted for participation, upon brief explanation of the study partner declines participation upon phone recruitment attempt | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Head and Neck Squamous Cell Carcinoma Pain Stomatitis Patients who are eligible for chemoradiation therapy of the head and neck Baseline creatinine (Cr) no greater than 1.5 times the upper limit of normal Have a clinical stage II-IV head and neck carcinoma Have a pathologic diagnosis of squamous cell carcinoma of the head and neck region Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 Ability to swallow and retain oral medication or take through a feeding tube Patients of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Patients who have previously been treated with surgery or radiation for head and neck cancer and/or are being treated for recurrent head and neck cancer Patients with known brain metastases will be excluded from this clinical trial Any patients prescribed medications for chronic pain and/or neuropathy will be excluded, including patients under treatment of a pain specialist or substance-abuse programs Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant or nursing female patients Unwilling or unable to follow protocol requirements Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug Received an investigational agent within 30 days prior to enrollment Patients on medications that prolong QT interval Patients on dialysis or with transplanted organs | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Depression Subjects from both sexes aged between 18 and 65 years Patient diagnosed with mild depression episode confirmed by psychiatric and psychometric evaluation, presenting basal scores above 08 and below 24 measured by the Hamilton Rating Scale (HAM-D) Capable of understanding the nature and objective of the study, including risks and adverse effects and intended to cooperate with the researcher and act in accordance with the requirements of the entire protocol, which comes to be confirmed by signing the informed consent Have a known hypersensitivity to Trichilia catigua or history of serious adverse reactions Shows risk of suicide, assault, murder or moral exposure Clinical history of bleeding disorders Drug addiction, including alcohol Known or suspected neoplasia Knowledge positive test result for the human immunodeficiency virus Patient not willing to adhere to the procedures of the Protocol For women, can not be pregnant or nursing and must be in use of a contraception method during the participation in the study Patients using other drugs with sedative or antidepressant action, which can not be suspended for 15 days (wash out) Diabetics | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Depressive Disorder Being 18 years of age or older Meet DSM-IV diagnostic for MDD confirmed by MINI International Neuropsychiatric Interview version 5.0 Having a PHQ-9 score greater than 5 Having access to a PC and Internet connection Having ( or accepting to be loaned) a smartphone that is compatible with the mobile component of the intervention Understanding of the French 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, and suicide risks, as established at the MINI interview Currently receiving psychological treatment for depression | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Pregnancy Pregnant women at ≥37 weeks gestation by reliable dating as determined by the American College of Obstetricians and Gynecologists (i.e. gestational age supported by one of the following: ultrasound prior to 20 weeks of gestation, fetal heart tones auscultated by Doppler for 30+ weeks, or documented serum or urine pregnancy test 36+ weeks ago) 2. Scheduled induction of labor with indication and timing supported by the Family Birth Center induction of labor guideline entitled "Induction of labor: Indications and Timing" 3. Singleton gestation 4. Cephalic presentation 5. Amniotic fluid index greater than or equal to 5 centimeters 6. Formal prenatal ultrasound documenting the absence of placenta previa 7. Bishop score <6 and cervical dilation <3cm 8. The woman is able to give appropriate consent and has undergone an informed consent process. 9. Maternal age ≥ 18 years old at the time of consent New diagnosis requiring immediate hospitalization for monitoring (such as new onset hypertensive disease of pregnancy) 2. Vaginal bleeding 3. Active labor 4. Premature rupture of membranes as determined by positive ferning and as supported by pooling of fluid in the vaginal vault. 5. Uterine tachysystole (>5 contractions in 10 minutes) 6. Nonreassuring fetal heart tracing before or after Foley placement 7. Chorioamnionitis or maternal fever 8. Intrauterine fetal demise 9. Contraindication to vaginal delivery, relative or absolute (i.e. transfundal uterine surgery) 10. Abnormal placentation including a low lying placenta 11. Prior cesarean delivery 12. Intrauterine growth restriction (growth <10th percentile by formal ultrasound) 13. Known fetal anomaly 14. Human immunodeficiency virus, Hepatitis C, or active herpes infection 15. Maternal cardiopulmonary disease requiring cardiac monitoring during labor 16. Pregestational diabetes 17. Rh isoimmunization 18. Non-English speaking 19. Distance from the hospital over 60 minutes by car, unreliable communication via telephone, or unreliable transportation | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Marriage Potential participants will be active duty and/or their active duty or Department of Defense (DoD) beneficiary spouses (adults >= 18 years old) who present to the IBHC in primary care with relationship concerns or questions following referral from their primary care manager or in response to study advertisements. Potential participants will be eligible for enrollment whether both partners are participating in-person or only one partner. Study participants do not have to be married; enrollment is open to active duty or who are not married but in committed romantic partnerships will mirror clinical practice for patients normally not seen in primary care behavioral health, i.e., patients greater than mild risk for self-harm, patients with current alcohol dependence, psychotic disorder, significant dissociative disorder, or moderate or severe brain injury. Civilians along with potential participants that cannot understand, speak or read English will be excluded | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-75.0, Airway Morbidity Emergencies pediatricians residents interns written informed consent form none | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 35.0-60.0, Hypertension Cardiovascular Diseases Caucasian men and women aged 35-60 years in good general health with an average of systolic arterial pressure >130 mmHg and diastolic >80 mmHg smokers Diabetes mellitus diagnosed and treated hypertension history of cardiovascular events (stroke, myocardial infarction or peripheral vascular disease) receiving medications: anti-hypertensives, vasodilators, lipid lowering therapies and fish oil supplements unless willing to discontinue prior to & during study (all other supplements will be assessed on a case by case basis) | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | 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 2. [MDD stream only] Diagnosis of major depressive disorder, currently depressed as determined by DSM-IV diagnostic (confirmed using the MINI) 3. [BD stream only] Diagnosis of bipolar disorder, type I or type II, currently depressed as determined by DSM-IV diagnostic (confirmed using the MINI) 4. Both females and males, aged 18 to 65 years 5. Inpatient status 6. 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 7. The ability to understand and comply with the requirements of the study and capable of providing informed consent 8. 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 2. Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV 3. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV within 4 weeks prior to enrollment 4. Any pervasive developmental disorder (according to DSM-IV criteria) 5. Diagnosis of dementia (according to DSM-IV criteria) 6. Known intolerance or hypersensitivity to ketamine or midazolam as judged by the investigator 7. 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) 8. Medical conditions that would significantly affect absorption, distribution, metabolism, or excretion of ketamine or midazolam 9. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator 10. Any clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator 11. Pregnancy (or female of child-bearing age not using adequate contraception) or lactation 12. A positive β-hCG test at enrollment 13. Involvement in the planning and conduct of the study 14. Previous enrollment or randomisation of treatment in the present study 15. Participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 22.0-75.0, Obesity Osteoarthritis Age 22-75 years Subject is diagnosed with Non-inflammatory Degenerative Joint Disease(NIDJD) Subject is diagnosed with Morbid Obesity (Body Mass Index ≥ 40 kg/m2 or >35 kg/m2 with qualifying comorbid conditions such as obstructive sleep apnea or diabetes) Subject is a suitable candidate for cemented primary TKA with either resurfaced or non-resurfaced patellae Subject is currently not bedridden Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and co-operate with investigational procedures Subject has given voluntary, written informed consent to participate in this clinical investigation Subject is comfortable with speaking, reading, and understanding questions and providing responses in an available translated language Subject has undergone THA or contralateral knee within the past 6 months Subject has had a contralateral amputation Subject requires simultaneous bilateral TKA Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee Subject is currently experiencing radicular pain from the spine Subject was diagnosed with fibromyalgia that is currently being treated with prescription medication Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease) Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.) Subject has had previous bariatric surgery Subject is medically or psychologically not suitable to undergo surgery | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 12.0-18.0, Treatment Resistant Depression Diagnosis of Major Depressive Disorder (MDD) A CDRS-R score of >40 Experiencing a current MDD episode with a duration of ≥ 4 weeks and ≤3 years Resistance to treatment, defined by failure to respond adequately to at least one antidepressant treatment, defined by ATR level 1-4 in current episode Both child and parent/guardian are English speaking Female participants who are sexually active during the course of the study must use a form of birth control for the duration of the study Any subject with a clinically defined neurological disorder or insult including, but not limited to, a condition likely to increase the risk of seizure; such as, space occupying brain lesion; any history of seizure; history of cerebrovascular accident; transient ischemic attack within two years; cerebral aneurysm; dementia; brain surgery; history or stroke or family history of epilepsy Any subject with an increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure or history of significant head trauma with loss of consciousness for ≥ 5 minutes Positive responses to any question on the Transcranial Magnetic Stimulation Adult Safety Screening Questionnaire (TASS) Subjects with cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute unstable cardiac diseases Subjects with conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the head within 30 cm of the treatment coil excluding the mouth that cannot safely be removed should be excluded. Examples cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes Subjects with active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, and vagus nerve stimulators Inability to locate and quantify a motor threshold as defined in the protocol History of treatment with ECT or TMS therapy for any disorders Participation in any investigational drug trial within 4 weeks of the baseline visit Pregnancy | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Healthy Female or male subjects aged 18 to 60 Subject is capable and willing to give informed consent Female volunteers of child bearing potential must use oral, injected or implanted hormonal methods of contraception Female volunteer is pregnant or breastfeeding Gastrointestinal diseases, major abdominal surgery Major psychiatric illnesses Volunteers that use drugs affecting the gastrointestinal tract or the central nervous system Allergy for macrolide antibiotics Allergy for atropine Severe heartburn Enlarged prostate Blockage of urinary tract Acute closed-angle glaucoma | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Non-melanoma Skin Cancer o Ability to understand and willingness to sign a written informed consent document ECOG performance status 0-1 Willing and able to participate for the full duration of the study Greater than 4 weeks from: Prior major surgery for any indication Prior chemotherapy, hormonal therapy or radiation therapy for cancer o Willing to abstain from: The application of topical medications including prescription and over the counter preparations (e.g. Topical preparations containing corticosteroids or vitamin A derivatives) to areas of actinic damage for the duration of the study. Use of moisturizers/emollients and sunscreens on these areas is allowed. Chronic (defined as > 3 times/week for more than 2 consecutive weeks/year) NSAID and COX-2 inhibitor use (other than cardioprotective doses of aspirin < 100 mg po QD) for the duration of the study. For routine analgesia, subjects may take acetaminophen as necessary Normal organ and marrow function defined as laboratory values falling within the specified ranges for the following tests (performed within 14 days of registration) Hematologic • WBC > 3,000/ul • Hemoglobin > lower limit of normal • Platelet count > 100,000/ul Hepatic • Total bilirubin < 1.5 X ULN • AST (SGOT) < 1.5 X ULN ALT (SPGT) < 1.5 X ULN Renal Serum creatinine < 1.5 X ULN BUN < 1.5 X ULN Females of childbearing potential must: Have been using adequate contraception (abstinence, IUD, birth control pills or spermicidal gel with diaphragm or condom) since their last menses Have a documented negative serum pregnancy test within 14 days prior to the first dose of study medication Females are not considered to be of childbearing potential if they are at least 1 year post-menopausal or have had a tubal ligation, bilateral oophorectomy or hysterectomy. o The effects of topical DFMO + topical diclofenac on the developing fetus are unknown. Therefore all females of childbearing potential must agree to use adequate contraception (abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom) for the duration of study participation o Within 6 months prior to randomization: Use of oral or intravenous corticosteroids for more than 2 consecutive weeks Use of inhaled corticosteroids for more than 4 consecutive weeks o Any of the following in the 4 weeks (or as indicated) prior to randomization: Major surgery for any indication Cytotoxic chemotherapy for any indication (including methotrexate for arthritis) Anti-cancer treatment of any type other than for a stage 0-2 non-melanoma skin cancer Hormonal therapy for cancer prevention (including tamoxifen) Note: treatment with finasteride/dutasteride for BPH does not render a participant ineligible. Radiation therapy Topical medications for the treatment of actinic keratosis or skin cancer (retin A, 5-FU, imiquimod) in the 6 months prior to randomization. Laser resurfacing, dermabrasion, cryotherapy, chemical peel and electrodissection ± curettage in the 6 months prior to randomization. Nasally inhaled corticosteroids (except mometasone Nasonex) Aspirin (>100 mg/day) Note: cardioprotective doses (< 100mg/day) are acceptable. NSAIDs (other than aspirin < 100mg/day) or COX-2 inhibitors > 3 times/week for more than a two week period Topical steroids o Any personal history of: Invasive cancer diagnosed or treated within the past 5 years. Participants who have been in remission for 5 years or more and have not required treatment in the past 5 years may be eligible if the principal investigator believes there is little to no risk of recurrence. Solid organ or bone marrow transplant Keloid formation Photosensitivity disorder Hypersensitivity or adverse reactions to nonsteroidal anti-inflammatory agents or to DFMO Any disease that predisposes to NMSC An immunodeficiency disorder or the use of an immunosuppressive drug Any skin disease that would interfere with interpretation of results Any family history of Ornithine diaminotransferase deficiency in a first degree relative Concurrent use of the following medications or treatments Anticoagulants including warfarin and heparin Other NSAIDs (other than aspirin <100 mg/day) on a daily basis Topical chemotherapy, cryotherapy, radiotherapy or any other skin lesion treatment to areas of skin being followed in this study Systemic therapy with psoralens, immunotherapy, retinoids, or radiation therapy Cytotoxic chemotherapy for any reason (including methotrexate for arthritis) Laser resurfacing, dermabrasion or chemical peels Topical or systemic immunosuppressive therapy Females who are pregnant or lactating. Should a woman become pregnant or suspect she is pregnant while she is participating in this study she should notify the study physician immediately Uncontrolled concurrent illness including ongoing or active infection, psychiatric illness/social situations that would limit compliance with study requirements or other underlying serious medical condition which, in the investigator's opinion, might preclude study participation | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-60.0, Schizophrenic Disorders Cognitive Function Diagnosis by DSM-5 (Diagnostic Statistical Manual) diagnosis of SZ or schizoaffective disorder (SA), by consensus diagnosis using chart histories and interviews. 2. Age 18-60 years of age. 3. Patients will be stably treated with antipsychotic medications and are not in acute illness exacerbation of their symptoms. For the double-blind phase only qualification for cognitive deficits will use the following 4. Subjects will have baseline MCCB battery scores which meet the following criteria. Subjects will meet the following cognitive performance a). Maximum performance level: Performance at least 1.0 standard deviation (SD) from perfect on the following three measures: Letter-number span (< 24), Hopkins Verbal Learning Test (HVLT) total (<31), Continuous Performance Test (CPT) d-prime (< 3.47) and b. 5. Minimum performance level: subject must be able to validly complete the baseline assessment History of mental retardation or pervasive developmental disorder. 2. Subjects with a current serious neurological/central nervous system (CNS) disorder (such as seizure disorder, stroke or multiple sclerosis) or brain trauma. 3. Current treatment with valproic acid, butyrate drugs, sulforaphane, or other drugs or chemicals known to have high HDAC inhibitory activity. 4. Pregnancy. 5. Severe unstable current medical condition. 6. Current suicidal or homicidal thoughts. 7. Current alcohol or substance abuse (other than nicotine or occasional marijuana) in the last month. 8. Subjects with diagnosis of congestive heart failure, or those on sodium restricted diet | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 30.0-60.0, Major Depressive Disorder Current diagnosis of major depressive episode Hamilton Depression Rating Scale (HDRS) score of >20 In treatment for depression for a minimum of 8 weeks Active drug or alcohol disorder in the last three months History of psychosis, mania or hypomania Acute suicide or homicide risk History of liver disease including HCV and HBV HIV History of heart disease or a heart attack Active or latent tuberculosis, a history of a positive tuberculosis test, or having received the Bacillus Calmette-Guérin (BCG) vaccine Epilepsy or a history of seizures Abnormal thyroid-stimulating hormone (TSH <0.4 or >5.0mlU/L) Abnormal liver function tests on screening (ALT>50 U/L or AST>50 U/L) | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 0.0-999.0, Smoke Surgical patients who receive head-neck or breast surgery or surgical patients who receive abdominal laparoscopic surgery Emergency cases | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Depression Sedentary, i.e., have not participated regularly in moderate-to-vigorous physical activity (MVPA) for 90 minutes per week or more for the past 12 weeks. 2. Medically cleared for MVPA, documented by a note from their primary care provider. 3. No significant medical condition or physical disability that would interfere with physical activity or study participation. The investigators will individuals with significant cardiovascular disease, hematologic disorders, and autoimmune disorders. The investigators will also individuals who are planning a surgery in the next 9 months and those with dementia. 4. Elevated depression symptoms. To meet for elevated symptoms, participants must have a QIDS score of 10 or greater (i.e., at least moderate depression levels), and must have a score of "1" or greater on at least one of the two core DSM-V depressive symptoms, i.e., sad mood or anhedonia. - 5. No current bulimia or anorexia (past 3 months); no history of bipolar disorder, schizophrenia, or a chronic psychotic condition (assessed using the SCID). 6. No hazardous drug or alcohol use in the past 6 months, as assessed by: a. no substance abuse treatment in the past 6 months; and b. does not meet for a substance use disorder in the past 6 months. 7. Depression is not very severe, i.e., QIDS score is < 20. 8. No suicidality requiring immediate treatment. 9. Not pregnant or planning on becoming pregnant in the next year. 10. Understands English sufficiently well to consent and complete study assessments. 11. Aged 18-65. 12. Able to make one of the 2 available exercise class times. 13. Able to walk 1 mile | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Depression Adult primary care patients Hispanic Meets diagnostic for depression currently in treatment for depression | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Acute Pancreatitis At least two episodes of acute pancreatitis in the past 12 months; acute pancreatitis is defined any 2 of the following: (1) typical upper abdominal pain; (2) elevation in serum amylase or lipase >= 3 times upper limit of normal; (3) features of acute pancreatitis on cross-sectional imaging Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%) Leukocytes >= 2,500/microliter Absolute neutrophil count >= 1,500/microliter Platelets >= 100,000/microliter Hemoglobin > 10 g/dL Total bilirubin =< 3.0 x institutional upper limit of normal (ULN) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x institutional ULN; patients whose AST/ALT levels normalize by screen 2 after an abnormal test will be included in the trial Creatinine < 1.5 mg/dL Women of child-bearing potential must have a confirmed negative pregnancy test result prior to enrollment Prior or current use of statin medication, or current use of gemfibrozil, cyclosporine, danazol, lomitapide, verapamil, diltiazem, dronedarone, amiodarone, amlodipine, ranolazine, or strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, human immunodeficiency virus [HIV] protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, or cobicistat-containing products) History of chronic myopathy Current use of any other investigational agents History of adverse effects, intolerance, or allergic reactions attributed to compounds of similar chemical or biologic composition to simvastatin (i.e., other statin medications) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Women who are pregnant or breastfeeding; pregnant women are excluded from this study because simvastatin is a lipid-lowering agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with simvastatin, breastfeeding should be discontinued if the mother is treated with simvastatin Presence of gallstones and hypertriglyceridemia (level greater than 800 mg/dl) that requires medical or surgical intervention; note: we will patients who had an independent episode of pancreatitis after a cholecystectomy, but patients who are candidates for cholecystectomy History of pancreatic adenocarcinoma (at any time) History of active malignancy in the past 2 years (excluding basal/squamous cell skin cancer or prostate cancer with a Gleason score 6 or less) Known active infection with HIV | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-70.0, Major Depressive Disorder, Bipolar I and Bipolar II Diagnosed with BDI, BDII, or MDD, confirmed with the Structured Clinical Interview for DSM-5 (SCID) Currently depressed for ≥4 weeks and ≤104 weeks, without psychotic features MADRS score ≥ 20 (consistent with at least moderately-severe depression) YMRS score ≤ 8 (consistent with the absence of hypomanic symptoms) At high risk for suicide, defined as a score ≥4 on item 10 of the MADRS Current depression has psychotic features, diagnosed with the SCID Meeting for severe alcohol, cannabis, or THC use disorders, as defined by DSM-5 and confirmed by the SCID, in the past 3 months, or meeting for other substance use disorders of any severity (eg. cocaine use disorder). For substances other than alcohol, cannabis, and opioids, a positive drug screen at both the screening and baseline visits is also exclusionary. Caffeine and nicotine use disorders of any severity will not be exclusionary Diagnosis of borderline personality disorder, diagnosed with the Zanarini Rating Scale for Borderline Personality Disorder Medical conditions with neurological sequelae (eg. stroke, brain cancer, multiple sclerosis, loss of consciousness > 30 min, HIV) Severe chronic pain, at the discretion of the investigator Receiving treatment with high-potency immune-modulating medications, such as corticosteroids, chemotherapy, monoclonal antibodies, or disease-modifying agents for arthritis, multiple sclerosis Any acute unstable medical illness (at the discretion of the site investigator) In MDD patients: strong risk factors for bipolarity, including 1) short (1-3 day) mood elevations not meeting DSM-5 time for hypomania; 2) a family history of BDI or BDII in a first-degree relative; and 3) a history of antidepressant-induced symptoms suggestive of bipolarity, particularly antidepressant-induced hypo/mania | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Major Depressive Disorder Persistent Depressive Disorder a diagnosis of MDD or PDD established with the Structured Clinical Interview for DSM-5 (SCID-5), and depression being the primary problem requiring clinical attention (judgement of intake clinician) a minimum current severity of 14 on the 17-item Hamilton Rating Scale for Depression (HRSD-17) a cumulative duration of depression of at least two months (this will short-lasting first depressive episodes that do not require treatment of this intensity), age 18 or more (no upper limit) capacity to provide informed consent lifetime diagnosis of bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, or current alcohol or drug use disorder pregnancy recent receipt of adequate trial of psychological treatment (10 or more sessions in the past 12 months) recently introduced antidepressant medication (new antidepressant in past 12 weeks or dose increase in the past 6 weeks) previous non-response to two or more of study medications acute suicide risk (MADRS suicide item≥4) current psychotic symptoms | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Depression, Postpartum Within 6 months postpartum Meet DSM-V diagnostic for MDD Score ≥ 20 on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder version (SIGH-SAD) current diagnosis of bipolar disorder, posttraumatic stress disorder, schizophrenia or psychosis, dissociative disorders, eating disorder, obsessive-compulsive disorder, somatic symptom and related disorders, substance use disorder, panic disorder, agoraphobia per DSM-V past history of mania/hypomania chronic medical conditions associated with depression (e.g., thyroid conditions) ocular or retinal pathology history of seizures or epilepsy color blindness Lupus currently taking an antibiotic, medication that contains hydrochlorothiazide, or isotretinoin (Accutane) | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Urothelial Carcinoma Urothelial Cancer Lung Neoplasms Small Cell Lung Cancer Prostate Cancer Phase I Patients must have advanced solid tumor that is resistant or refractory to standard therapy A minimum of 2 weeks will be required from any prior therapy, including chemotherapy, immunotherapy and/or radiation. In addition, recovery to Grade less than or equal to 1 from all reversible toxicities related to prior therapy is required at study entry Patients do not need to have measurable disease to enroll on phase I Age greater than or equal 18 years ECOG performance status less than or equal to 2 Patients with treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least 2 weeks and the patient is off steroids or is on a stable dose of steroids. Patients with brain metastases should not require use of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital) within 14 days before first dose and during study. Use of newer antiepileptics that do not produce enzyme induction drug-drug interactions (DDIs) is allowed Patients must have normal organ and marrow function as defined below leukocytes greater than or equal to 3,000/mcL absolute neutrophil count >1,500/mcL without growth factor support | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Desmoplastic Melanoma A: Patients must have histologically or cytologically confirmed primary desmoplastic melanoma that is deemed resectable; the decision to perform surgery on patients must be based on good clinical judgment; eligible patients for surgical resection must have disease that, in the judgment of the surgeon, is deemed completely resectable resulting in free surgical margins; patients must have residual disease after initial biopsy which can be measurable or non-measurable disease per Response Evaluation in Solid Tumors (RECIST) 1.1; residual disease can either be confirmed with fine-needle aspiration (FNA) or if measurable disease is present, no FNA needs to be obtained OR B: Patients must have histologically or cytologically confirmed primary desmoplastic melanoma that is unresectable; patients in Cohort B must have measurable disease per 1.1 Contrast-enhanced computed tomography (CT) scans of the chest, abdomen and pelvis are required; a whole body positron emission tomography (PET)/CT scan with diagnostic quality images and intravenous iodinated contrast may be used in lieu of a contrast enhanced CT of the chest, abdomen and pelvis; imaging of the head and neck is required only if the patient has a head/neck primary; contrast may be omitted if the treating investigator believes that exposure to contrast poses an excessive risk to the patient; if skin lesions are being followed as measurable disease, photograph with a ruler included and physician measurements, must be kept in the patient's chart as source documentation; all measurable lesions must be assessed within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; all disease must be assessed and documented on the baseline tumor assessment form (RECIST 1.1) Patients must not have known brain metastases unless brain metastases have been treated and patient is asymptomatic with no residual neurological dysfunction and has not received enzyme-reducing anti-epileptic drugs or corticosteroids for at least 14 days prior to registration Patients must not have received prior systemic treatment for this melanoma Patients must not be planning to receive concomitant other biologic therapy, radiation therapy, hormonal therapy, other chemotherapy, anti-cancer surgery or other anti-cancer therapy while on this protocol Patients must not have received radiation therapy, non-cytotoxic agents or investigational agents or systemic corticosteroids within 14 days prior to registration Patients may have received prior surgery; all adverse events associated with prior surgery must have resolved to =< grade 1 (per Common Terminology for Adverse Events [CTCAE] 4.0) prior to registration Absolute neutrophil count (ANC) >= 1,500/mcl (obtained within 28 days prior to registration) Platelets >= 50,000/mcl (obtained within 28 days prior to registration) | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-60.0, Mild Depression Romanian-speaking adults (18 years or older) Access to a computer, a smartphone (Android or iOS) and Internet A Patient Health Questionnaire-9 (PHQ-9) score of 4 or below (for the healthy participants sample) A PHQ-9 score no greater than 9 (for the mildly depressed participants sample) Undergoing therapy Substance abuse problems Psychotic symptoms Organic brain disorders (e.g., dementia) Self-injury or harming others Serious legal or health issues that would prevent from using the app Reporting scores larger than 1 to Question 9 (suicidal ideation) on the (PHQ-9) | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Chronic Renal Insufficiency Will be included in the study , patients From 18 years or more Achieved with chronic renal failure Under hemodialysis fluent in French With a social security scheme. Will not be included in the study , patients Having cognitive problems hindering understanding of the tool Having participated in Phase I of the research project Under Backup Justice (guardianship)." | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Triple Negative Breast Cancer Pancreatic Carcinoma Melanoma Endometrial Carcinoma Signed informed consent prior to any procedures Patients with advanced melanoma, endometrial carcinoma, pancreatic or TNBC, with measurable or non-measurable disease who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists Patient having out of range laboratory values defined as Creatinine clearance < 40 mL/min Total bilirubin > 1.5 x ULN Absolute neutrophil count < 1.0 x 109/L Hemoglobin (Hgb) < 9 g/dL Impaired cardiac function or clinically significant cardiac disease Active autoimmune disease Malignant disease, other than that being treated in this study Presence of ≥ CTCAE Grade 2 toxicity due to prior cancer therapy Pregnant or lactating women Other protocol-defined inclusion/exclusion may apply | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 10.0-16.0, Pediatric Obesity BMI > 97 percentile at least one of the following symptoms respiratory functional signs orthopedic complications sleep apnea cardiovascular complications metabolic syndrome lack of motivation uncontrolled psychological issue ambulatory care more appropriate to treat the same issues any related psychiatric pathology likely to worsen with weight loss patient or family not committed to therapeutics program psychological inability to deal with separation behavior disorders making collective activity impossible | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-70.0, Major Depressive Disorder Patients with Major Depressive Disorder (HAMD≥15) Level of resistance ≥ 3 (Thase and Rush) Participants who gave their informed, written consent Contraindication of Electroconvulsive therapy (ECT), repeated Transcranial Magnetic Stimulation (rTMS), Magnetic Resonance Imaging (MRI), anesthesia History of epilepsy; severe neurological or systemic disorder that could significantly affect cognition Pregnancy | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-75.0, Myocardial Infarction acute st elevation myocardial infarction dementia, cognitive dysfunction bypass surgery previous or during the study periods living from more 200 Km from hospital | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Patients must be enrolled on APEC14B1 and consented to Screening on the Part A consent form prior to enrollment on AALL1131 White Blood Cell Count (WBC) Age 1-9.99 years: WBC >= 50 000/uL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131 With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131 Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction DS HR B-ALL patients with Induction failure or BCR-ABL1 Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs Lactating females are not eligible unless they have agreed not to breastfeed their infant Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-64.0, Depressive Disorder, Major Body mass index (BMI) must be between 18 and 32 kilogram per square meter (kg/m^2) inclusive Related to symptoms of depression: Participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV or V diagnostic for Major Depressive Disorder [MDD] (International Classification of Diseases (ICD)-code F32.x and F33.x), without psychotic features, as confirmed by the MINI 6.0; participant must have an IDS-C30 total score greater than or equal to (>=) 30 using the semi-structured interview guide for the IDS-C30 Participant is, during this episode of depression, treatment naïve OR treated with at most one Selective serotonin reuptake inhibitor (SSRI) over a minimum of 6 weeks and a maximum of 6 months, and subject is being treated at an adequate dose, showing a partial response at enrolment A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test upon admission A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 3 months after receiving the last dose of study drug Has a primary DSM-IV or V diagnosis of general anxiety disorder (GAD), panic disorder, obsessive compulsive disorder, posttraumatic stress disorder, anorexia nervosa, or bulimia nervosa. Participants with comorbid GAD, social anxiety disorder, or panic disorder for whom MDD is considered the primary diagnosis are not excluded Has a length of current major depressive episode greater than (>) 24 months despite adequate treatment Has failed more than 2 treatments with a different pharmacological mode of action despite an adequate dose and duration during a previous, or the current depressive episode Participant has a history of substance use disorder according to DSM-V except nicotine or caffeine, within 6 months before Screening. However, participants who have completed a treatment for (alcohol) addiction more than 8 weeks prior to first dose administration and are under continuous control of the study center, may be included if the risk to fall back is considered minimal and no significant abnormalities are shown in clinical laboratory or other predose safety assessments Obstructive sleep apnea/hypopnea (apnea/hypopnea index >10) or restless legs syndrome (periodic leg movements with arousal index >15) as assessed on the first or second polysomnography (PSG) recording during screening | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 9.0-16.0, Child all children should be ages 9-16 years they should be able to speak and read Chinese they should have been diagnosed with cancer for at least 2 months and be currently undergoing active treatment they should aware of their diseases (cancer) children with cognitive and learning problems identified from their medical records | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 65.0-999.0, Dementia Depression Delirium Evidence of dementia, depression, and/or delirium, based on diagnostic codes found in medical claims data and based on screening at time of study screening Living in the community, including assisted living facility, at time of randomization Plan to live in geographic area for 12 months Speak or understand English Willing to be randomly assigned to intervention or active comparator group Diagnosed schizophrenia or bipolar disorder Bedbound and non-communicative Life expectancy <12 months Already enrolled in active comparator program For individuals with dementia, family caregiver is unavailable or unwilling to enroll in study | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Stress Disorders, Post-Traumatic Intimate Partner Violence Alcohol-Related Disorders Female Veterans Lifetime history of ST with at least one risk factor: heavy drinking within the past 3 months, screen positive for current PTSD or for IPV within last 12 months Age 18-65 Seeking treatment through the Women's Primary Care Clinics at the Central Texas VA Healthcare System Ability to understand study procedures in English Not actively in suicidal or homicidal crisis warranting imminent hospitalization | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-70.0, Vulvodynia 70 years of age Vulvar pain of at least 3 months' duration Localized (e.g. vestibulodynia, clitorodynia) or Generalized or Mixed Provoked or Spontaneous or Mixed Onset Temporal pattern <18 or >70 years of age pregnant Not able to provide consent Patients with active vulvar dystrophies | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Cryptococcosis Cryptococcal Infections AIDS-Related Opportunistic Infections HIV-infected Cryptococcal antigen (CrAg) positive in blood Age >=18 years Written informed consent Women of childbearing potential who are participating in sexual activity that could lead to pregnancy must agree to use one reliable method of contraception while receiving fluconazole >=400mg/day Prior history of cryptococcal meningitis Suspected meningitis or mania Suspected/known cirrhosis, jaundice, or alanine aminotransferase (ALT) >5x upper limit of normal Receiving an antidepressant medicine Receiving antifungal therapy, >1 week Pregnant or Breastfeeding Contraindication to sertraline or fluconazole Current rifampin use or other prohibited medication Electrocardiogram corrected QT interval (QTc) >450ms | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-50.0, PostTraumatic Stress Disorder Able to give informed consent Right-handed Age between 18-50 years old Physically and neurologically healthy [confirmed by a comprehensive medical history] Current PTSD diagnosis clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function and/or task performance and/or interfere with the study protocol any current (or within past 2 months) medical condition requiring medication that would interact with dronabinol or interfere with the study protocol risk of harm to self or others that requires immediate intervention presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to cannabinoid-like substances (dronabinol/marijuana/cannabis/THC, cannabinoid oil, sesame oil, gelatin, glycerin, and titanium dioxide) lack of fluency in English positive drug screen or alcohol breathalyzer unwilling/unable to sign informed consent document currently pregnant (positive pregnancy test), planning pregnancy, or lactating (women) under 18 or over 50 years of age traumatic brain injury (as defined by The American Congress of Rehabilitation as a person who has had a traumatically induced physiological disruption of brain function (i.e., the head being struck, the head striking an object, and/or the brain undergoing an acceleration/deceleration movement (i.e., whiplash) without direct external trauma to the head), as manifested by at least one of the following: any loss of consciousness; any loss of memory for events immediately before or after the injury; any alteration in mental status at the time of the incident; or focal neurological deficits that may or may not be transient) | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-50.0, Maternal Depression Survey for the maternal depression 1. Managers, special educators, psychologists, therapists, depressed mothers, and family members of the depressed mothers 2. Psychiatrists, Pediatricians, medical doctors, working in the collaborating medical institutions who are involved with ASD care. 3. Parents of children with ASD enrolled in other schools that offer ASD services. 4. Policy makers who are involved in the Ministry of Health, the Ministry of Family Welfare, Autism cell etc. for developing the national strategic plan and policies for strengthening ASD care in Bangladesh. Intervention Phase: We will identify those mothers who would be diagnosed as having a current major depressive episode (MDE) at the baseline survey as assessed by PHQ-9 and SCID, and willing to participate in the intervention for the next 6 months Survey for the maternal depression 1. Participants who are too ill to commute 2. Participants who are mentally compromised to give a voluntary consent for her own. Intervention Phase: Any mother diagnosed as having a severe forms of depression with any suicidal ideation or unsafe thoughts will be referred for urgent hospital based mental health services in the community (as per standard of care and ethical obligations), and will not be invited to participate in the study or will be withdrawn from the study if such a condition develops in the course of intervention | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Depression, Postpartum Over age 18 Female Currently pregnant approximately no more than 34 weeks gestational age Able to read and write in English fluently MDD Group: Meet DSM-IV/DSM-5 for at least 1 past episode of Major Depressive Disorder MDD Group: DO NOT meet DSM-IV/DSM-5 for any episodes of Major Depressive Disorder in past 2 months (currently in symptom remission) Previous birth to a living child (i.e., this pregnancy is not their first child) Imminently suicidal or homicidal History of severe head trauma, stroke, neurological disease History of brain tumors or surgery Severe medical illness (e.g., autoimmune disorder, blindness, cardiovascular disease, HIV/AIDS) Endocrine disorders (e.g., Cushing's disease, thyroid disorder) Alcohol/substance abuse or dependence within the past six months Current psychotic episode (impairing ability to consent, participate, or keep patient and experimenter safe) Inability to follow study procedures CTL Group: Current or lifetime Axis I disorder (i.e., anxiety disorders, major depression, mania/hypomania, dysthymia, schizophrenia, schizoaffective disorder, substance abuse/dependence, eating disorders, hypochondriasis, pain disorder, or adjustment disorders) | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Stroke A stroke caregiver is eligible to participate in the study if: 1. He / She is a Chinese adult aged 18 or above; 2. He / She has a family member has the first stroke (ischaemic or haemorrhagic stroke) at the age of 50 or above and has been discharged from the acute hospital for no more than 6 months; 3. He / She provides care or being with the stroke survivor for no less than two hours per day after discharge from the acute hospital; 4. He / She reports significant caregiver burden as measured by the 12-item Zarit Burden Interview (a total score ≥ 12). A stroke survivor is eligible to participate in the study if: 1. He / She is a Chinese adult aged 50 or above; 2. He / She has been discharged from the acute hospital for no more than 6 months; 3. His / Her family caregiver participates in this study; 4. He/ She is able to communicate with interventionists and interviewers; 5. He/ She is competent to give written informed consent. Stroke survivors whose caregivers in the intervention group will receive both the intervention and the questionnaire interviews. Stroke survivors whose caregiver in the control group will only need to take part in the questionnaire interview A stroke caregiver will be excluded from participation if: 1. His / Her family member has a transient ischaemic attack without a major ischaemic or haemorrhagic stroke; 2. His / Her family member with stroke is residing in a residential care facility after discharge from the acute hospital; 3. He / She is diagnosed as having Alzheimer's disease or other dementias; 4. He / She is unable to understand Cantonese. A stroke survivor is not eligible to participate in the study if: 1. He / She is residing in a residential care facility after discharge from the acute hospital; 2. He/ She has a transient ischaemic attack without a major ischaemic or haemorrhagic stroke; 3. His / Her family caregiver refuses to participate in this study; 4. He/ She is not able to communicate with interventionists and interviewers; 5. He/ She is not competent to give written informed consent | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Depressive Disorder, Major Depressive Disorder, Treatment-Resistant Males between 18 and 65 years of age, inclusive; and females between 18 and 65 years of age, inclusive, who are >1 year postmenopausal. 2. Diagnosed with recurrent MDD as defined by the Diagnostic and Statistical Manual, Fifth Edition (DSM-5), and confirmed by the Mini International Neuropsychiatric Interview, Version 7.0.2 (MINI). 3. Diagnosed with a current MDE lasting 8 weeks to 36 months as defined by the DSM-5 and confirmed by the MINI. 4. Treated with an adequate dosage of a SSRI, SNRI, or bupropion during the current MDE for at least 8 weeks prior to Screening with the same, adequate dosage for the last 4 weeks. Minimum adequate doses are defined in the (ATRQ). The maximum dose allowed for paroxetine is 40 mg QD, for fluoxetine is 60 mg QD, and for sertraline is 200 mg QD. 5. Have experienced an inadequate response to 1 to 3 courses of treatment with an antidepressant medication in the current episode, as defined as <50% improvement with an antidepressant medication at doses listed on the SAFER Interview State versus trait; Assessability; Face validity; Ecological validity; and Rule of three Ps (pervasive, persistent, and pathological). 6. Hamilton Depression Rating Scale-17 (HAM-D-17) ≥19 at Screening and Check-in (Day -1). 7. BMI between 18.0 and 35.0 kg/m2, inclusive, and a minimum weight of 50.0 kg. 8. Per the Investigator's judgment, able to meet all study requirements, including the confined/inpatient portion of the study, adherence with both approved ADT and study drug regimen, and completion of all assessments and all scheduled visits. 9. Male patients of reproductive potential must be using and willing to continue using medically acceptable contraception, from Screening and for at least 2 months after the last study drug administration. 10. Must be able to read, speak, and understand English and must provide written informed consent prior to the initiation of any protocol-specific procedures History or presence of clinically significant abnormality as assessed by physical examination, medical history, 12-lead ECG, vital signs, or laboratory values, which in the opinion of the Investigator would jeopardize the safety of the patient or the validity of the study results, including torsades de pointes, any bradyarrhythmias, or uncompensated heart failure. 2. Chronic use of prescribed opioids (i.e., >120 days in a 6-month period) up to 6 months prior to Screening or any recreational use of opioids. 3. Evidence of clinically significant hepatic or renal impairment, including ALT or AST >1.5 x upper limit of normal (ULN), bilirubin >1 x ULN, or endocrine laboratory values (including clinically significant thyroid parameters, i.e., thyroid stimulating hormone [TSH], triiodothyronine [T3], and thyroxine [T4]). 4. History or family history of sudden unexplained death or long QT syndrome (measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle). 5. Any 12-lead ECG with repeated demonstration of QTc ≥450 msec or a QRS interval >120 msec at Screening. 6. History of clinically diagnosed hypotension requiring treatment. 7. History or presence of any condition in which an opioid is contraindicated (e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, bronchitis, or has/is suspected of having paralytic ileus). 8. No more than 3 prescribed doses of an opioid within the 6 months prior to Screening and no use at all within the last month. 9. Use of an antipsychotic, anticonvulsant, or mood stabilizer, regardless of indication, within the 3 months prior to Screening. 10. History of allergy or hypersensitivity to methadone or related drugs (e.g., opioids). 11. Positive test for hepatitis B or HIV. Patients with a positive hepatitis C test may be considered for with approval from the Medical Monitor. 12. Any current and primary psychiatric disorder, as defined as a condition that is the primary focus of distress and/or treatment, other than MDD. 13. Any lifetime history of bipolar I or II disorder, any psychotic disorder, post-traumatic stress disorder, borderline personality disorder, antisocial personality disorder, obsessive compulsive disorder, eating disorder, intellectual disability, or pervasive developmental disorder. 14. History in the past 12 months of a primary diagnosis of anxiety disorder or panic disorder not related to the current MDE. 15. Current diagnosis of alcohol or substance use disorder, as defined by DSM-5, at Screening or within the 12 months prior to Screening. Patients with the following diagnoses within the past 12 months, however, may be included at the Investigator's discretion: mild alcohol use disorder, mild cannabis use disorder, and any severity tobacco use disorder. 16. A confirmed positive result on the urine drug/alcohol screen at Screening or Check-in. If the urine drug/alcohol screen is positive at Screening, retesting or rescreening may be scheduled with prior approval from the Medical Monitor. 17. Patients who, in the Investigator's judgment, are at significant risk for suicide. A patient with a Columbia-Suicide Severity Rating Scale (C-SSRS) ideation score of 4 or 5 within the last 6 months or any suicide attempt within the past year must be excluded, as should a patient with an ideation score of 4 or 5 or any suicide attempt at the Check-in or Baseline Visit. 18. Patients with a 20% improvement between Screening and Check-in (Day -1) on the HAM-D-17. 19. Patients who did not safely discontinue medications prohibited. 20. Patients receiving new onset psychotherapy (individual, group, marriage, or family therapy) within 2 months prior to Screening or plans to start at any time during participation in the study. 21. Patients who have received electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or vagus nerve stimulation (VNS) or who have participated in a ketamine study within the last 6 months. 22. Patients with any clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, chronic pain, or gastrointestinal disorder. Medical conditions that are minor or well-controlled may be permitted if they will not increase the safety risk to the patient or compromise interpretation of the safety or efficacy endpoints. 23. Patients taking fluvoxamine or St. John's Wort. 24. Patients who have participated in a clinical study with an investigational medication in the past 6 months, or who have participated in more than 4 clinical studies with investigational medications in the past 2 years | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-60.0, Moderate Depression Romanian-speaking adults (18 years or older) Access to a computer, a smartphone (Android or iOS) and Internet A PHQ-9 score between 10 and 16 Undergoing treatment medication and/or psychotherapy Substance abuse problems Psychotic symptoms Organic brain disorders (e.g., dementia) Self-injury or harming others Serious legal or health issues that would prevent from using the app Reporting scores larger than 1 to Question 9 (suicidal ideation) on the (PHQ-9) | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 0.0-65.0, Bipolar Disorder Major Depressive Disorder Conforms to the diagnosis of bipolar disorder or major depressive disorder Take antibiotics continuously less than 3 days in recent 3 months 5≦BMI≦30 Age≦65 who is diagnosed with physical diseases and other mental diseases pregnant or lactational women who is diagnosed with mental retardation | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Healthy Volunteer Major Depressive Disorder Depression All Subjects (Main Study) 1. 18 to 65 years of age. 2. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document. 3. All subjects must have undergone a screening assessment under either protocol 01-M-0254, "The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers" or protocol 17-M-0181 ("Recruitment and Characterization of Research Volunteers for NIMH Intramural Studies"). 4. Agree to be hospitalized Additional Patients with MDD (Main Study) 1. At the initial study enrollment, subjects must have fulfilled DSM-IV or DSM-V for Major Depression, single episode or recurrent. Subjects must be experiencing a current major depressive episode of at least 2 weeks duration. 2. At the initial screening and beginning of Phases II and III, subjects must have a baseline score on the MADRS greater than or equal to 20 and YMRS of < 12. 3. Current or past history of lack of response to one adequate antidepressant trial, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT would count as an adequate antidepressant trial. Ketamine Metabolites Substudy Healthy Volunteers 1. 18 to 65 years of age. 2. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document. 3. All subjects must have undergone a screening assessment under either protocol 01-M-0254, "The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers") or 17-M-0181 ("Recruitment and Characterization of Research Volunteers for NIMH Intramural Studies"). 4. Agree to be hospitalized Additional Patients with MDD (Main Study) 1. Current diagnosis of Bipolar Disorder including Bipolar I, Bipolar II, or Bipolar NOS diagnoses. 2. Current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-V. 3. Subjects with a history of DSM-IV or DSM-V drug or alcohol dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3 months. In addition, subjects who currently are using drugs (except for caffeine or nicotine) must not have used illicit substances or known drugs of abuse in the 2 weeks prior to screen and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines or stimulants) urine test at screening. 4. Treatment with a reversible MAOI within two weeks prior to Phase II. 5. Subjects who, in the investigator s judgment, pose a current serious suicidal or homicidal risk All Subjects (Main Study) 1. Pregnant or nursing women or women who plan to become pregnant. Women who are able to get pregnant must be willing to use at least one form of effective birth control during the entire period of study participation (or until last clinical labs and rating) and have a negative pregnancy test that was obtained no more than 24 hours prior to MRI and infusion of ketamine. 2. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, coronary artery disease, atherosclerotic ischemic stroke, and atrial fibrillation), endocrinologic, neurologic, immunologic, or hematologic disease. 3. Clinically significant abnormal laboratory tests. 4. Subjects with one or more seizures without a clear and resolved etiology or current use of medication known to lower seizure threshold. History of seizure (regardless of age or etiology), history of epilepsy in self or first-degree relatives, stroke, brain surgery, head injury, or known structural brain lesion will be excluded from the TMS procedures. 5. Treatment with any other concomitant medication 14 days prior to Phase II. An exception of this would be necessary for those who are taking Fluoxetine or Aripiprazole. Prior to Phase II, treatment with Fluoxetine must be discontinued for at least 5 weeks and treatment with Aripiprazole must be discontinued for at least 3 weeks. 6. Any use of opioid medication in the past 3 months 7. Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip) (for subjects doing imaging component of the study only). 8. Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications. 9. Subjects who have hearing loss that has been clinically evaluated and diagnosed 10. Participants who are uncomfortable in small closed spaces (have claustrophobia), unable to lie comfortably supine for up to 90 minutes, and would feel uncomfortable in the MRI machine (for subjects doing imaging component of the study only). 11. Positive HIV test 12. Weight > 119 kg 13. A current NIMH employee/staff or their immediate family member 14. [for participants undergoing NPU Threat Test with Auditory Startle] Known history of hearing loss Additional Healthy Volunteers (Main Study) 1. Current or past history of any DSM-IV or DSM-V Axis I disorder based on clinical assessment and confirmed by a structured diagnostic interview (SCID). Ketamine Metabolites Substudy Healthy Volunteers 1. Current or past history of any DSM-IV or DSM-V Axis I disorder based on clinical assessment and confirmed by a structured diagnostic interview (SCID). 2. Current (within the past 3 months) or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine) 3. Pregnant or nursing women or women who plan to become pregnant. Women who are able to get pregnant must be willing to use at least one form of effective birth control during the 4-days of the study participation (or until last clinical labs and rating) and have a negative pregnancy test that was obtained no more than 24 hours prior to infusion of ketamine. 4. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, coronary artery disease, atherosclerotic ischemic stroke, and atrial fibrillation), endocrinologic, neurologic, immunologic, or hematologic disease. 5. Clinically significant abnormal laboratory tests. 6. Subjects with one or more seizures without a clear and resolved etiology or current use of medication known to lower seizure threshold. 7. Treatment with any other concomitant medication. 8. Any use of opioid medication in the past 3 months 9. Positive HIV test 10. Weight > 119 kg 11. A current NIMH employee/staff or their immediate family member 12. Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip) (for subjects doing neuroimaging component of the study only). 13. Participants who are uncomfortable in small closed spaces (have claustrophobia), unable to lie comfortably supine for up to 90 minutes, and would feel uncomfortable in the MRI machine (for subjects requiring clinical MRI scans for safety and/or structural MRI scans for MEG coregistration) | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Distress Cancer Chemotherapy Effect active member of Kaiser Permanente Northern California a diagnosis of cancer, and currently undergoing chemotherapy or completed chemotherapy in the past 6 months at time of recruitment English literacy/fluency, access to a smartphone, a tablet (e.g., iPad) or a computer with internet Caregivers: a partner, other family member, or a close friend who identify him/herself as the patient's primary unpaid caregiver. English literacy/fluency, access to a smartphone, a tablet (e.g., iPad) or a computer with internet access Deafness severe mental illness Hospital Anxiety and Depression Scale score <8 or >14 on either anxiety or depression scale (patient only) current stress reduction practice | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Depressive Symptoms Adults (aged ≥18 years) Adults with possible mild to moderately severe depression reflected by a score of between 10 and 23 (i.e. moderate to moderately severe depressive symptoms) on the Patient Health Questionnaire (PHQ-8) as has been done in previous studies looking at low mood and depressive symptoms Adults living in the UK Having access to the internet Able to walk continuously and unaided for a minimum of 5 minutes Provision of informed consent to participate Adults (aged <18 years) Adults without possible mild to moderately severe depression reflected by a score of between 10 and 23 (i.e. moderate to moderately severe depressive symptoms) on the Patient Health Questionnaire (PHQ-8) as has been done in previous studies looking at low mood and depressive symptoms Adults not living in the UK No access to the internet Not able to walk continuously and unaided for a minimum of 5 minutes Lacking capacity to give informed consent to participate | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 40.0-65.0, Chronic Depressive Disorder Dysthymic Disorder Persistent depressive disorder including chronic major depressive disorder and dysthymic disorder assessed by the Structured Clinical Interview for DSM Scores of at least 14 on the GRID-HAMD Psychiatric treatment duration for depression of at least 3 years Psychiatric hospitalization within 30 days prior to the enrollment Ineligible to receive the protocol treatment during 2 years Schizophrenia Bipolar disorders Intellectual disabilities Neurocognitive disorders Substance-related disorders | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Hematologic Disorders Recipient Ages 18-80 years inclusive Diagnosed with high risk hematologic disorders warranting stem cell transplant per institutional standard of care Lack HLA-identical related donor Availability of at least one HLA haploidentical (i.e. => 5/10 and <= 8/10 HLA match) related donor (HLA-A, B, C, DR, and DQ loci) who is available to donate CD34+ cells Availability of at least one 4/6 HLA-matched (HLA-A, B, and DR loci) cord blood unit from the National Marrow Donor Program (NMDP). The cord blood unit must contain a minimum TNC (prior to thawing) of at least 2x107 cells per kilogram of recipient body weight Ability to comprehend the nature of the treatment 6.2 Recipient (any of the following) HLA identical (6/6) related donor available and readily accessible at time of transplantation evaluation Any patient not meeting institutional standard guidelines for transplant | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-50.0, Major Depressive Disorder in Pregnancy Women with uncomplicated pregnancy within the 1st or 2nd trimester of pregnancy 2. Score of 10 or greater on the nine item Patient Health Questionnaire (PHQ-9) for depression antidepressant use in preceding month 2. use in previous 4 weeks of psychotropic medications other than hypnotics or benzodiazepines in diazepam dose-equivalents greater than or equal to 2mg/day for insomnia 3. Fish allergy 4. initiation of regularly scheduled course of psychotherapy within previous 2 months | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Depression Diagnosis of Major Depressive Disorder (MDD) Normal or corrected-to-normal vision | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Feelings Attitude Practicing general practitioners, registered with the Order, caring for or having treated other doctors whatever their specialties | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Bipolar Disorder Obesity Men and women, ages of 18-65 years, inclusive. 2. Participants will have a DSM-5 bipolar disorder that is clinically stable. 3. Participants will have received a stable major psychotropic drug regimen (except for minor dosage adjustments) for at least 3 months prior study entry. Major psychotropic drugs are antipsychotics, mood stabilizers, and antidepressants. Subjects may have had changes in adjunctive benzodiazepines and hypnotic agents. 4. Participants will be obese (defined as a BMI ≥ 30 mg/kg2) or overweight (defined as BMI ≥ 27 kg/m2) with at least one weight-related comorbidity, such as hypertension, type 2 diabetes, or dyslipidemia. 5 Participants in treatment for a weight-related comorbidity (hypertension, type 2 diabetes, and/or dyslipidemia) must be on a stable and allowed treatment regimen for that condition for at least 3 months prior to study enrollment. 6 Participants will be able to provide informed consent before any trial-related activities Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. The following are considered to be adequate methods of birth control: 1.Intrauterine device (IUD); 2. Barrier protection; 3.Contraceptive implantation system (Norplant); 4.Oral contraceptive pills; 5. A surgically sterile partner; and 6. Abstinence. Women who are > 2 years post-menopausal or surgically-sterile are not considered of childbearing potential. All female participants will have a negative pregnancy test prior to randomization. 2. Participants who have made a suicide attempt in the last 10 years, who are displaying clinically significant psychotic features, suicidality, or homicidality on mental status examination, or who have suicidal ideation or behavior as assessed with the C-SSRS. 3. Participants who are receiving behavioral weight loss treatment (BWLT) (e.g., Weight Watchers) that was begun within the 3 months before study entry. Participants who are receiving BWLT that was started 3 months prior to the beginning of the study will be allowed to continue to receive their BWLT during the trial only if they have had no weight loss in the past 3 months and they agree to not make any changes in the frequency or nature of their BWLT during the course of the drug trial. 4. A DSM-5 diagnosis of a substance-related or addictive disorder (except a tobacco-related disorder) within the 3 months prior to enrollment. 5. A DSM-5 diagnosis of dementia, a psychotic disorder, or a depressive disorder. 6. History of any psychiatric disorder which might interfere with a diagnostic assessment, treatment, or compliance. 7. Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, neurological, metabolic, endocrine, or other systemic disease. Clinically stable hypertension, type 2 diabetes, or dyslipidemia are not exclusionary. 8. Have a history of a structural cardiac abnormality, valvular cardiac disease, cardiomyopathy, serious heart rhythm abnormality, coronary artery disease, congestive heart failure, stroke, or other serious cardiovascular problem. 9. Have an ECG with significant arrhythmias or conduction abnormalities, which in the opinion of the physician investigator preclude study participation. 10. Have clinically relevant abnormal laboratory results. 11. Participants requiring treatment with any drug which might interact adversely with or obscure the action of the study medication. This includes anti-obesity drugs, psychostimulants, modafinil or armodafinil, topiramate or zonisamide, and antipsychotics. Participants receiving metformin at a stable dose for ≥ 3 months can be included. 12. Participants receiving GLP-1 based therapies, sodium-glucose co-transporter 2 inhibitors (SGLT2s), thiazolidinediones, sulfonylureas, or insulin. 13. Participants with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. 14. Participants who have received any investigational medication within three months prior to randomization. 15. Participants previously screen-failed or randomised to participate in this trial. 16. Participants who have a known or suspected allergy to liraglutide 3.0 mg sc injection, its constituents, or related products. 17. Participants with a urine drug screen positive for a drug that, in the opinion of the investigator, is being abused. 18. Participants with a past medical history of pancreatitis. 19. Participants who had received any investigational drug within 3 months prior to this trial. 20. Participants who require bariatric surgery or are anticipated to require it during the course of the trial. If such surgery becomes warranted during the study, such patients will be excluded from the primary endpoint analysis | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-75.0, Colon Cancer Agreement of the patient to participate in trial 2. Colon cancer (only adenocarcinoma ) 3. The tumor located between the cecum and the right 1/3 of transverse colon 4. Tumors T3,Т4а,b N0-2 (II-III stages) 5. Tolerance of chemotherapy 6. ECOG 0-2 Patients with distant metastases 2. Tumors T1-2 (I stage) 3. Complications of tumor (perforation and full bowel obstruction) 4. Previous radiotherapy or chemotherapy 5. Synchronous or metachronous tumors 6. Women during Pregnancy or breast feeding period | 0 |
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