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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): 18.0-80.0, Breast Cancer Prostate Cancer Lung Cancer Colorectal Cancer Cervical Cancer Oral Cancer A cancer survivor of breast, prostate, lung, colorectal, cervical or oral cancer survivor and live within the Baltimore Maryland area Finished your active cancer treatment at least three months ago Overweight or obese and do not exercise daily Do not have any physical limitation to do mild to moderate physical activities Have a smart phone (iPhone or Android device) with Wi-Fi internet connection at home Actively using an email account Willing to accept the random study assignment Willing to wear a Fitbit band 'a physical activity tracking device' on your wrist for five weeks every single day Willing to have an Echo speaker 'a smart home speaker with voice assistant' installed in your home and use the digital voice assist for four weeks Willing to receive daily text messages on your phone for four weeks Already doing moderate to high physical activities in their daily life (rapid screener) Planning to relocate within the next 4-5 weeks Stage 4 cancer Already using physical activity tracker or part of a physical activity program Part of another study that may interfere with our outcome of interest, unstable mental condition Mental condition that prevents patient from performing the study activities and requirements 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): 18.0-50.0, Ulcerative Colitis Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. 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. Women of childbearing potential will have a urine pregnancy test, which must be negative, on Study Day 1, prior to receiving FMT. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for 3 months after FMT Ability to understand and the willingness to sign a written informed consent document, including the willingness to accept risk of unrelated donor stool Ability to swallow oral medications Severe, uncontrolled ulcerative colitis Patients with active or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy Delayed gastric emptying syndrome Known chronic aspiration Patients with a history of significant allergy to foods not excluded from the donor diet (excluded foods are tree nuts, peanuts, shellfish, eggs) Pregnant and breast-feeding women Participants who are unable to swallow pills | 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, Pelvic Gynecological Cancer ≥ 18yrs with pelvic gynecological cancer (endometrium, cervix, ovary) at any stage of the disease patient coming for anesthesia consultation before hysterectomy informed signed consent patient affiliated to or beneficiary of social security patient <18yrs patient with a pelvic gynecological cancer that does not require hysterectomy patient with psychiatric history or a depressive syndrome deaf patient (deafness makes the hypnosis session impossible) patient under legal protection | 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): 22.0-65.0, Depressive Disorder Depression Depressive Disorder, Major Depressive Episode Major Depressive Disorder Current episode of Major Depressive Disorder Inadequate response to at least one antidepressant medication in the current episode (Treatment Resistant Depression) Investigator able to identify IAF using EEG Willingness and ability to adhere to treatment schedule (5 treatments per week for six weeks) Unable to unwilling to give informed consent Diagnosed with excluded conditions or treatment histories Currently hospitalized due to severity of depression symptoms Use of prohibited medications (as defined by protocol) within specified time frame of randomization Use of certain cardiac devices Use of certain intracranial devices Currently pregnant or unwilling to practice acceptable means of birth control, and women who are breastfeeding | 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): 22.0-65.0, Depression With Erectile Dysfunction Meet the diagnostic for Western medicine in depression; 2. MADRS score ≥ 12 points and <30 points; 3. Diagnostic for western medicine in line with erectile dysfunction，IIEF -5≤21points; 4. TCM syndrome differentiation of liver depression and kidney deficiency in accordance with depression and erectile dysfunction; 5. Male subjects, aged 22-65 years old; 6. Patients who have not been treated with antidepressants or have been treated with antidepressants for more than 1 months and have reached treatment doses have no need to adjust their medications and dosages within 2 months; 7. The relationship between patients and sexual partners is stable (at least in the last 6 months); 8. Volunteer to participate in clinical trials, and sign informed consent A patient with major depressive disorder with psychotic symptoms or suicidal behavior; 2. A genital anatomical abnormality (such as severe penile fibrosis) or other organic sexual dysfunction with apparent impairment of erection; 3. Erectile dysfunction due to organic disease; 4. Unwilling to stop other patients for depression or erectile dysfunction therapy; 5. A person who has allergies or is sensitive to the ingredients of this test; 6. Combined with severe primary liver and kidney diseases, aspartate aminotransferase , Alanine aminotransferase exceeded 1.5 times the normal value, and creatinine exceeded the normal limit; 7. A patient with severe somatic disease; 8. Patients who have participated in other clinical trials in the past four weeks; 9. A history of drug abuse or alcoholism; 10. The researchers believe that patients who are not eligible for clinical trials are not eligible for clinical trials | 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, Perinatal Depression ≥18 years old Pregnant or 0-12 months postpartum Experiencing clinically significant depressive symptoms (defined as a score of ≥12 on the Edinburgh Postnatal Depressive Scale, EPDS, during screening) Able to access the internet on a device (i.e. mobile phone, tablet, personal computer) with video-visit capacity (including web camera and speakers) Comfortable with email communication Active alcohol/substance use disorder in the past 12 months Active suicidal ideation Current mania or psychosis Unsuitable for virtual care, as per assessment of the treating psychiatrist | 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): 18.0-90.0, Dementia Parkinson Altered Behavior in Alzheimer Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Sensorimotor Neuropathy Corticobasal Degeneration Documented Functional Neurological Damage To Central or Peripheral Nervous System Unlikely To Improve With Present Standard of Care Approaches At least 6 months after onset or diagnosis of disease process Current Medical therapy for the condition is either failing or not tolerated by patient Patient must be capable of interval neurologic exams with investigators or their own neurologic specialists Patient must be capable and determined competent to provide detailed informed consent for study participation In estimation of investigators, that there are minimal or no significant risk of harm to general health or conditions for collection of autologous stem cell collection and use Inability of patient to have diagnostic examinations or studies (MRI) to evaluate and document the disease state or unwilling/unable to cooperate with such documentation Patients not medically stable, or whom may have ongoing conditions which increases may place the patient at significant risk of major complications, to be determined by investigator or patient's medical provider or neurologic specialists History of active cancer or ongoing anticancer therapy within six months of such care Women of childbearing age must not be pregnant at the time of treatment, and should refrain from becoming pregnant of at minimum of 3 month after study treatment | 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 Traumatic Brain Injury Adults aged 18 and older 2. English language proficiency 3. Ability to provide written, informed consent; OR consent provided by legally authorized representative with assent from subject 4. Ability to see and hear (hearing or visual loss cannot impair ADLs or in-room conversation) 5. Has access to a smartphone/tablet/computer with internet and video capabilities for virtual sessions 6. Having been hospitalized for moderate to severe TBI that occurred at least 3 months prior to study entry 7. Meeting ANY ONE of the following severity as documented in electronic medical record (EPIC) or available outside records: 1. GCS 3-12 with GCS motor score ≤ 5 within 4 hours after injury 2. GCS 3-12 with GCS motor score =6 within 4 hours after injury AND documented intracranial abnormalities on imaging 3. GCS 13-15 within 4 hours after injury AND documented intracranial abnormalities on imaging 4. Loss of consciousness (LOC) > 30 min. 5. Post-traumatic amnesia (PTA) > 24 hours 8. Out of PTA at the time of enrollment (GOAT>75) 9. Clinically significant depressive symptoms: meets for Major Depressive Episode on the MINI or has a total score ≥ 23 on the Inventory of Depressive Symptomatology Clinician rated (IDS-C) Uncontrolled medical illness 2. Behavioral dyscontrol, defined as the presence of verbally or physically aggressive behavior in the past month, as evidenced in medical records, pre-screening interviews, or observed by any study staff 3. Presents with PTSD as the primary diagnosis, as determined by a clinician 4. Substance use disorder, moderate or severe, within the past 6 months 5. Has bipolar disorder, a primary psychotic disorder or current psychotic symptoms, or acute suicidality or homicidality 6. Currently receiving regular (≥ 2 times/ mo.) psychosocial treatment for depression 7. Has participated in CBT for depression within the past 6 months 8. Individuals with history of dementia or severe cognitive impairment that is not related to TBI (e.g., cognitive impairment requiring assistance with basic activities of daily living, such as getting ready in the morning) | 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): 18.0-85.0, Hypoparathyroidism Has an understanding, ability, and willingness to fully comply with study procedures and restrictions Is able to voluntarily provide a signed and dated informed consent form before any study-related procedures are performed Is an adult male or female 18 to 85 years of age, inclusive In participants 18-25 years of age, has radiological evidence of epiphyseal closure based on bone age X-ray (single posteroanterior X-ray of left wrist and hand) before randomization Has chronic hypoparathyroidism with onset 12 months or more before screening. The diagnosis of hypoparathyroidism is established based on hypocalcemia in the setting of inappropriately low serum PTH levels During the Week -3 screening visit, the participant reports by history at least 2 of the following symptoms related to hypoparathyroidism occurring within the 2 weeks before Week -3 visit: muscle cramps, muscle spasms or twitching, tingling, numbness, heaviness in arms or legs, physical fatigue, or slowed or confused thinking (brain fog) The participant must have a Hypoparathyroidism Symptom Diary (HPT-SD) symptom subscale Sum Score of greater than or equal to (>=) 10 during the 14-day period immediately prior to the baseline (Week 0) visit (Day -14 to Day -1). In addition, the participant must have at least 4 HPT-SD diaries completed in the first 7 day period and at least 4 HPT-SD diaries completed in second 7 day period Must be treated with active vitamin D (calcitriol or alfacalcidol) alone or in conjunction with calcium supplements for at least 4 months prior to the screening visit. 1. The participant must be taking >= 0.5 microgram (mcg)/day of calcitriol or >=1.0 mcg/day of alfacalcidol. 2. If the participant is treated with a lower dose of active vitamin D the participant must also be taking calcium supplements of at least 800 milligrams per day (mg/day) of elemental calcium Has serum thyroid-stimulating hormone (TSH) results within normal laboratory limits at screening for all participants not receiving thyroid hormone replacement therapy. For participants on thyroid hormone replacement therapy, the thyroid hormone dose must have been stable for at least 4 weeks before screening, and serum TSH level must be within the central laboratory normal range. A serum TSH level below the lower limit of the normal range but not undetectable in participant treated with thyroid hormone may be allowed if there is no anticipated need for a change in thyroid hormone dose during the trial Has serum 25-hydroxyvitamin D levels >=50 nmol/L (nanomoles per liter) (20 nanograms per milliliter [ng/mL]) and less than (<) 1.5 times the upper limit of normal (ULN) for the central laboratory normal range History of hypoparathyroidism resulting from a known activating mutation in the CaSR gene or impaired responsiveness to PTH (pseudohypoparathyroidism) Any disease that might affect calcium metabolism or calcium-phosphate homeostasis other than hypoparathyroidism, such as poorly controlled hyperthyroidism; Paget disease; type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus; severe and chronic cardiac, liver (Child-Pugh score >9) (US FDA, 2003), or renal disease; Cushing syndrome; rheumatoid arthritis; myeloma; active pancreatitis; malnutrition; rickets; recent prolonged immobility; active malignancy (other than low-risk well differentiated thyroid cancer); primary or secondary hyperparathyroidism; or documented parathyroid carcinoma within the previous 5 years, acromegaly, or multiple endocrine neoplasia types 1 and 2 Very low or very high blood calcium level (eg, ACSC <1.87 mmol/L [<7.5 mg/dL] or >=2.97 mmol/L [>=11.9 mg/dL]) at the Week -3 screening visit. Results from the central laboratory must be used for this assessment Blood calcium level above the ULN at the baseline (Week 0) visit. Results from a local laboratory may be used for this assessment Use of prohibited medications, such as loop and thiazide diuretics, phosphate binders (other than calcium carbonate), digoxin, lithium, methotrexate, or systemic corticosteroids, within respective prohibited periods Participation in any other investigational study in which receipt of investigational drug or device occurred within 6 months before screening for this study. Prior treatment with PTH-like drugs (whether commercially available or through participation in an investigational study), including PTH(1-84), PTH(1-34), or other N-terminal fragments or analogs of PTH or PTH-related protein, within 3 months before screening Use of other drugs known to influence calcium and bone metabolism, such as calcitonin, fluoride tablets, or cinacalcet hydrochloride, within the prohibited period Use of oral bisphosphonates within the previous 6 months or intravenous bisphosphonate preparations within the previous 24 months before screening Nonhypocalcemic seizure disorder with a history of a seizure within the previous 6 months before screening. Participants with a history of seizures that occur in the setting of hypocalcemia are allowed The participant is at increased baseline risk for osteosarcoma, such as those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, hereditary disorders predisposing to osteosarcoma, or with a prior history of external beam or implant radiation therapy involving the skeleton | 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, Current Major Depressive Disorder Subject aged 18 to 65 Diagnosis of a characterized depressive episode assessed by the clinician Depression score : MADRS> 20 Introduction or switch of an antidepressant (without combination of molecules) Signed informed consent Able to understand the nature, purpose and methodology of the study French language Able to understand and conduct clinical assessments The following psychiatric comorbidities: Bipolar disorder, schizophrenia, alcohol dependence and / or any other substance objectivized during the clinical evaluation Patient presenting a depressive episode characterized with mixed component, psychotic, melancholic or catatonic characteristics Score MADRS greater than or equal to 5 to one of the items Subject protected by law (guardianship or curatorship) Subject in period from another protocol Subject not affiliated to, or not beneficiary of, a social security scheme Pregnant orbreastfeeding patient | 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): 18.0-50.0, Persistent Post-Concussive Syndrome Man or woman aged 18-50 years. 2. Reports at least one PCS symptom that is mild in severity. 3. It has been two weeks since date of injury Has been previously diagnosed with a psychological/neurological disorder 2. Has been previously diagnosed with a substance abuse disorder/impairment, 3. Is currently seeking therapy/counseling 4. Does not have valid driver's license and 12 months of driving experience | 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, Cardiovascular Diseases Depression Ability to give informed consent Fluent in English Between the ages of 18-65 Lives in the United States Self-report of having experienced depression as assessed by the Mini International Neuropsychiatric Interview (MINI) Self report an elevated risk for or of having cardiovascular disease ( >150 minutes of physical activity a week and BMI >25) Registered a personal account with Fitbit prior to enrollment in the study Unwilling/unable to comply with study procedures Pregnant A total score of a 20 on the PHQ-9 (indicative of "very severe" depression) and/or a total score of a 16 on the ASRM (or indicative of "very severe" mania) Responds to item 9 (Suicidal ideation) on the PHQ-9 with a 2 or higher (i.e., "Thoughts that you would be better off dead or of hurting yourself in some way on more than half the days") Contraindications to exercise or diet interventions as assessed by the DASI Already owns a fitbit device or other activity monitor Suffers from repeated episodes of "blacking out" or "fainting" Survived a cardiac arrest or sudden death Has recurrent chest discomfort with activity that goes away within 10 minutes of rest or with nitroglycerin Has heart failure | 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 Age ≥ 18 years old. 2. Able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines. 3. Histologically-confirmed metastatic or unresectable TNBC that has either progressed on or after anthracycline-based chemotherapy (or other approved standard of care therapy) or subject has refused anthracycline-based chemotherapy, or other taxane and platinum-based therapies. TNBC is defined as breast cancer that lacks estrogen receptor (ER) and progesterone receptor (PR) expression, and human epidermal growth factor receptor 2 (HER2) overexpression and/or amplification. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Have at least 1 measurable lesion of ≥ 1.0 cm. 6. Must have a recent formalin-fixed, paraffin-embedded (FFPE) tumor biopsy specimen following the conclusion of the most recent anticancer treatment. If an historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period, if considered safe by the Investigator. If safety concerns preclude collection of a biopsy during the screening period, a tumor biopsy specimen collected prior to the conclusion of the most recent anticancer treatment may be used. 7. Must be willing to provide blood samples prior to the start of treatment on this study. 8. Must be willing to provide a tumor biopsy specimen 8 weeks after the start of treatment, if considered safe by the Investigator. 9. Ability to attend required study visits and return for adequate follow-up, as required by this protocol. 10. Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception for up to 1 year after completion of therapy, and non-sterile male subjects must agree to use a condom for up to 4 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and abstinence Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications. 2. Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma). 3. History of organ transplant requiring immunosuppression. 4. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis). 5. Inadequate organ function, evidenced by the following laboratory results: 1. Absolute neutrophil count < 1000 cells/mm3. 2. Platelet count < 75,000 cells/mm3. 3. Uncorrectable grade 3 anemia (hemoglobin < 8 g/dL). 4. Total bilirubin greater than the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome). 5. Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) > 2.5 × ULN (> 5 × ULN in subjects with liver metastases). 6. Alkaline phosphatase levels > 2.5 × ULN (> 5 × ULN in subjects with liver metastases, or >10 × ULN in subjects with bone metastases). 7. Serum creatinine > 2.0 mg/dL or 177 μmol/L. 8. Serum anion gap > 16 mEq/L or arterial blood with pH < 7.3. 6. Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication. Subjects with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension prior to study entry. 7. Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection fraction (LVEF) 10% below the institution's lower limit of predicted normal. 8. Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy. 9. Positive results of screening test for human immunodeficiency virus (HIV). 10. Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed. 11. Known hypersensitivity to any component of the study medication(s). 12. Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications. 13. Concurrent or prior use of a strong cytochrome P450 (CYP)3A4 inhibitor (including ketoconazole, itraconazole, posaconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, and grapefruit products) or strong CYP3A4 inducers (including phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St John's Wort) within 14 days before study day 1. 14. Concurrent or prior use of a strong CYP2C8 inhibitor (gemfibrozil) or moderate CYP2C8 inducer (rifampin) within 14 days before study day 1. 15. Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to initiation of treatment on this study, except for testosterone-lowering therapy in men with prostate cancer. 16. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol. 17. Concurrent participation in any interventional clinical trial. 18. Pregnant and nursing women | 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): 11.0-25.0, Depression Youths who meet DSM 5 for Major Depressive Disorder (Group 1) for Youth with MDD (all must be met) Ages 11-17 at the time of enrollment in Characterization Current diagnosis of DSM-5 Major Depressive Disorder (within the last six months from assessment) which are Five or more of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at least one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure Depressed mood most of the day, nearly every day, as indicated by either subjective report (e.g., feeling sad, blue, "down in the dumps,"or empty) or observation made by others (e.g., appears tearful or about to cry). (In children and adolescents, this may present as an irritable or cranky, rather than sad, mood.) Markedly diminished interest or pleasure in all, or almost all, activities every day, such as no interest in hobbies, sports, or other things the person used to enjoy doing Significant weight loss when not dieting or weight gain (e.g., a change of more than 5 percent of body weight in a month), or decrease or increase in appetite nearly every day Insomnia (inability to get to sleep or difficulty staying asleep) or hypersomnia (sleeping too much) nearly every day Psychomotor agitation (e.g., restlessness, inability to sit still, pacing, pulling at clothes or clothes) or retardation (e.g., slowed speech, movements, quiet talking) nearly every day Fatigue, tiredness, or loss of energy nearly every day (e.g., even the smallest tasks, like dressing or washing, seem difficult to do and take longer than usual) (All patients) - for MDD patients (Group 1) Meets for schizophrenia, schizophreniform disorder, schizoaffective illness, bipolar disorder, more than mild Autism Spectrum Disorder, Anorexia Nervosa or other severe Eating Disorder Intellectual disability (clinically identified or IQ less than 70) For subjects with major depression or sub-threshold major depressive episode: Symptoms of depression are due to the direct physiological effects of a drug of abuse, or to a general medical or neurological condition by self and parent report Currently pregnant or lactating by self and parent report and urine pregnancy test Meets DSM-5 for alcohol or substance use disorder (excluding tobacco and nicotine use) within the last three months. This is determined solely by clinical interview of child and parent (e.g. KSADS) Current active suicidal ideation (i.e., presence of intent for engaging in suicidal behaviors). Youths with passive suicidal ideation and/or past active suicidal ideation are still eligible Participants with repeated self-harm occurring in the context of inter-personal conflict NIMH IRP Employees/staff and immediate family members will be excluded from the study per NIMH policy. - | 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): 18.0-100.0, Primary Family Caregivers of ICU Patients Ages 18 years and over Family members (spouse, parents, or children) of patients who stay in the ICU for more than 3 days Provision of the majority of unpaid physical, emotional, and/or instrumental care to the patients Voluntarily agreement with participation in the study A history of cognitive impairment (e.g., dementia), psychiatric disorders or neurological disorders Indication of discernible hearing deficits Difficulties in verbal communication If the caregiver's relationship to a patient is close friend or relatives (not immediate family of patients) Refusal to participate in the 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): 18.0-40.0, Obesity Exercise Reinforcement Participants must be overweight to obese (BMI 25-35 kg/m2) Not pregnant or lactating or planning to become pregnant in the next 6 months No limitations to safely participating in physical activity Currently dieting to lose weight and no weight loss or gain >2kg over the past 3 months Taking any medications that affect energy expenditure or eating Regularly exercising (planned and structured aerobic or resistance activity) Participants must have no major health problems, cannot have known cardiovascular (cardiac, peripheral vascular, cerebrovascular), pulmonary (COPD, interstitial lung disease, cystic fibrosis) or metabolic (diabetes, thyroid disorders, renal or liver disease) disease Tobacco use Have a medical condition that prevents safe exercise | 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): 20.0-55.0, Postpartum Depression Postnatal Complication Nurse's Role Giving birth full term 39 weeks 0 days and 40 weeks 6 days (ACOG 2013) Having a phone with Android feature and having an internet connection Baby's normal birth weight and having APGAR score 8 and above Adolescent pregnants Having anxiety and depression Complication developments in the mother or newborn after delivery Newborn stay in the intensive care unit Visually impaired, hearing impaired | 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, Colon Cancer Pathologically confirmed colon adenocarcinoma (> 15 cm from the anal verge) Radiologic T3/T4 and high risk features by CT scan No metastasis on CT or PET(positron emission computed tomography) Age ≥ 18 and ≤ 70 years ECOG (Eastern Cooperative Oncology Group) performance status 0-1 No history of colorectal cancer within 5 years No history of chemotherapy Patients with childbearing potential should use effective contraception during the study and the following 6 months Adequate bone marrow function : white blood cell count of 2 x 109/L or more with neutrophils of1.5 x 109/L or more, platelet count of 100 x 109/L or more, hemoglobin of 9 g/dL (5,6 mmol/l) or more Adequate hepatobiliary function : total bilirubin of 0.4 mg/dl or less, ASAT (aspartate aminotransferase) and ALAT (alanine aminotransferase) of 2.5 x ULN (upper limits of normal) or less, Alkaline phosphatase of 1.5 x ULN or less Age > 70 years and < 18 years Rectal cancer : 15 cm or less from the anal verge Complicated colon cancer (complete obstruction, perforation, bleeding) Metastatic colon cancer Known hypersensitivity reaction to any of the components of study treatments Inflammatory bowel disease Hereditary nonpolyposis colorectal cancerHNPCC, familial Adenomatous Polyposis Clinically relevant coronary artery disease or history of myocardial infarction in the last 6 months, high risk of uncontrolled arrhythmia Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption Pregnancy or breast-feeding period | 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, Major Depressive Disorder MDD Patients in whom switching to desvenlafaxine is considered by treating psychiatrist as the next treatment option. 2. MDD diagnostic confirmation with the mini-international neuropsychiatric interview (MINI) (Sheehan et al., 1998), 3. Age range between 18 and 60 4. Non-response or incomplete response to a treatment with an SSRI in the current episode. 5. Score of 18 points or higher in the Hamilton depression rating scale (HAM-D-17) (Hamilton, 1967) Subjects will be excluded if they met or had past history for the following disorders: posttraumatic stress disorder, obsessive-compulsive disorder, schizophrenia, psychotic, delusional, bipolar or substance abuse disorders. MINI will be used to these potentially comorbid disorders. 2. Subjects with any present or past disease involving the nervous central system 3. A clinically significant unstable illness or clinically significant abnormal vital signs as determined by the investigator 4. Women entering the study could not be pregnant, and had to be oral contraceptive-free | 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, Colon Cancer Liver Tumors Patients must be undergoing one of the following procedures as part of their routine care in order to meet the Operation for presumed stage I-IV colon cancer including colectomy, hepatectomy, or abdominal surgery (e.g. insertion of HAIP) Colectomy for presumed benign or pre-malignant colon tumors (e.g. large nonneoplastic polyps or adenomas) Open, laparoscopic, or robotic resections ≥18 years old Extrahepatic CRC metastasis No preoperative portal venous phase CT scan performed up to two months prior to day of surgery Pathology demonstrating a malignant tumor other than colorectal adenocarcinoma Stage IV colon cancer with resectable hepatic disease undergoing hepatectomy with active primary colon tumor still in place (despite chemo-radiation therapy) and no plans for colectomy Receipt of experimental therapies for colon cancer (e.g. checkpoint inhibitors or novel targeted agents). Of note, approved targeted agents (such as anti-angiogenic agents, EGFR inhibitors etc) are not an criterion History of non-colonic malignancy w/in 5 years (except non-melanomatous skin cancer) Colon cancer with microsatellite instability (MSI-high) if known preoperatively Known hereditary colon cancer syndrome such as familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC) Known liver disease (e.g. non-alcoholic steatohepatitis, cirrhosis, viral or other form of hepatitis, etc) INR >2 or known clotting factor deficiency Anticipated need for full anticoagulation during 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): 18.0-65.0, Depression Major Depressive Disorder Premenstrual Dysphoric Disorder Depressive Episode for individuals with depressed mood Ages 18-65 years Hamilton Depression Rating Scale score >8 Capacity to understand all relevant risks and potential benefits of the study (informed consent) Low suicide risk which will be determined through the use of both the Structured Clinical Interview for the DSM-5 and by scoring less than 3 (0,1, or 2) in the Hamilton rating depression scale Negative pregnancy test for female participants for individuals with depressed mood DSM-5 diagnosis of alcohol of substance abuse (other than nicotine) within the 12 months DSM-5 diagnosis of alcohol or substance dependence (other than nicotine) within the last 12 months DSM-5 diagnosis of personality disorder Eating disorder (current or within the past 3 months) Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study Neurological disorders, including but not limited to history of seizures (except childhood febrile seizures and electro-convulsive therapy (ECT) induced seizures), dementia, history of stroke, Parkinson's disease, multiple sclerosis, cerebral aneurysm Medical or neurological illness (unstable cardiac disease, AIDS, malignancy, liver or renal impairment) or treatment for a medical disorder that could interfere with study participation History of traumatic brain injury, reoccurring seizures or later cognitive rehabilitation or causing cognitive sequelae History of childhood trauma (determined by the Childhood Trauma Questionnaire) | 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, Obstetric Complication Postpartum Hemorrhage Postpartum Endometritis Female Able to give consent Gestational age > 24 weeks Postpartum Placement of an IBT within the last 2 hours with plans for it to remain in situ for at least 2 hours Primary obstetrician amenable to proceeding with either method of management during the study period Age < 18 years old IBT removed within 2 hours of placement Chorioamnionitis Insufficient documentation of demographics, delivery outcomes, or peripartum events including postpartum hemorrhage, infectious outcomes | 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, Postnatal Depression aged 18 or above married, first-time parents, live together able to speak and read Chinese; and Hong Kong residents a present history of psychiatric illness | 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, Primary Osteoarthritis of Knee Nos Age 18 or older 2. Diagnosed with primary osteoarthritis and cleared to undergo total knee arthroplasty at the Virtua JRI 3. Willing to provide informed consent, participate in study, and comply with study protocol Pregnant or contemplating pregnancy prior to surgery; 2. Worker's compensation or personal injury related to knee (clinical outcomes have been shown to be less predictable and often poorer in this patient group; there may also exist potential issues with reimbursement) 3. Post-traumatic arthropathy (clinical outcomes have been shown to be less predictable; pre-operative deformity and risk factors are greater and difficult to propensity-match between groups) 4. Self-pay patients or patients whose insurance are known to typically decline reimbursement for preoperative CT scans | 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, Dermatomyositis, Adult Type Must understand the risks and the benefits/purpose of the study and provide signed and dated informed consent Must be 18 years at time of signing the informed consent form Willing to participate in all required evaluations and procedures in the study including the ability to swallow pills without difficulty Patients must have a diagnosis of DM based upon the characteristic cutaneous findings proposed by Sontheimer[6] and/or a skin biopsy consistent with DM Patients must be candidate for systemic therapy for their DM skin disease defined by inadequate response to aggressive sun protection along with the use of potent topical corticosteroids and/or immunomodulators Patients with a diagnosis of dermatomyositis on steroid-sparing agent and/or systemic steroids (maximum dose of prednisone 1mg/Kg) and still having cutaneous disease activity of at least 5 on the CDASI scale If on immunosuppressive treatments and/or steroids, patients must be on stable doses for at least 4 weeks (28 days) Patients must undergo age appropriate cancer screening Females of childbearing potential (FCBP) must have a negative pregnancy test at screening (day 0 of the study and every month throughout the study). While on investigational product and for at least 28 days after taking the last dose of investigational product Increasing or changing dose of topical therapy within 14 days of study day 0 (including but not limited to topical corticosteroids, tacrolimus, pimecrolimus) Increasing or changing systemic steroids dosing within 28 days of study day 0 Increasing or changing dosing for concurrent therapy agents within 28 days or 5 half-lives of the biologic agent, whichever is longer, before study day 0: methotrexate, azathioprine, mycophenolate mofetil, hydroxychloroquine, dapsone, leflunomide, cyclosporine, biologic agents (anti-TNFs), IVIG, rituximab History of any clinically significant (as determined by the investigators) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major uncontrolled disease Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Pregnant or breastfeeding Untreated Latent Mycobacterium tuberculosis infection or active tuberculosis infection as indicated by a positive Purified Protein Derivative (PPD) skin test or T-spot Any condition, including the presence of laboratory abnormalities that places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Patients with acute dermatomyositis onset and rapid progression of muscle disease or significant systemic involvement including pulmonary diseases associated with DM Prior major surgery or major life-threatening medical illness within 2 weeks | 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): 5.0-999.0, Glioblastomas Sarcoma Astrocytoma Brain Cancer Leukemia FOR Patients diagnosed with a high-risk/high-grade cancer (e.g., high-grade brain tumors, relapsed/refractory acute lymphoblastic leukemia, acute myeloid leukemia, high-grade sarcoma) characterized by poor prognosis (e.g., estimated 5-year survival rate <30% based on scientific consensus in the literature, where available, or by expert physician report), as confirmed by medical record review Patients with active disease Age greater than or equal to 5 years and less than or equal to 24 years of age Must be able to speak and understand English Must have a parent or adult primary caregiver willing to participate in the study Ability of subject or parent/guardian to understand and the willing to sign a written informed consent document Must have access to a computer/mobile device and the internet FOR Patients will be excluded if there is evidence of pre-morbid severe cognitive or psychiatric disability that would impair their capacity for participation or completion of evaluations in the judgment of the investigators Evidence of disease progression at the time of referral to this study to the extent that it would impede participation or completion of evaluations as determined by the medical advisory investigator in conjuction with the study PI/adjunct PI Patients with treatment-related sequelae so severe that they would be unable to complete the study-related evaluations or intervention (e.g., treatment toxicity) as determined by the medical advisory investigator in conjuction with the study PI/adjunct PI. FOR OR ADULT Must be a parent or primary caregiver of a child (age 5 to 24 years of age) who has been diagnosed with a high-grade/high risk tumor that carries poor prognosis (as defined above); and must live in the same household as the patient for a majority of the time Must have a child willing to participate in the study Must be able to speak and understand English Ability of subject to understand and the willing to sign a written informed consent document Must have access to a computer/mobile device and the internet | 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 Episode Bipolar 1 Depression Subject is 18 to 65 years of age, inclusive, at the time of informed consent with bipolar I disorder, current episode depressed with or without rapid cycling disease course (≥ 4 episodes of mood disturbance but < 8 episodes in the previous 12 months) with or without psychotic features (diagnosed by DSM 5 and confirmed by the SCID 5 CT). The current episode of major depression associated with bipolar I disorder must be confirmed by the Investigator and noted in the source records. 2. Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the investigator. 3. Subject or legally acceptable representative must possess an educational level and degree of understanding of English or the local language that enables them to communicate suitably with the Investigator and the study coordinator. 4. Subject must have a lifetime history of at least one bipolar manic or mixed manic episode. It is strongly recommended that a reliable informant (e.g., family member or caregiver) be available to confirm this history. 5. Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration at Screening. 6. Subject has a MADRS total score ≥ 22 at both Screening and Baseline. 7. Subject has a YMRS total score ≤ 12 at Screening. 8. 8. Female subjects of childbearing potential must have a negative serum ß-hCG test at Screening. 9. Females who participate in this study must be . one of the following unable to become pregnant (e.g., postmenopausal, surgically sterile, etc.) -OR- Practicing abstinence or part of an abstinent lifestyle using and willing to continue using a highly effective form of birth control for at least 28 days prior to administration of the first dose of study drug, during the treatment period, and 2 months after completion or premature discontinuation from the study drug. 10. Male subjects with partners of child bearing potential must be practicing abstinence, part of an abstinent life style or using protocol-specified methods of birth control. See Section 10.4 for further information on acceptable methods of birth control. 11. Subject is in good physical health on the basis of medical history, physical examination, and laboratory screening. 12. Subjects with type 2 diabetes are eligible for study only if all of the following conditions are met within 30 days prior to Screening Subject's random screening glucose is < 200 mg/dL (11.1 mmol/L) Subject's Hemoglobin A1c (HbA1c) ≤ 7.0% If a subject is currently being treated with oral anti-diabetic medication(s), the dose must have been stable for at least 30 days prior to screening. Such medication may be adjusted or discontinued during the study, as clinically indicated Subject has not required hospitalization for diabetes or related complications in the past 12 months Note: Subjects with type 2 diabetes that is newly diagnosed during screening are ineligible for the study. 13. Subject who requires concomitant medication treatment with the following agents may be included if they have been on stable doses for the specified times: 1) oral hypoglycemics must be stabilized for at least 30 days prior to baseline; 2) thyroid hormone replacement must be stable for at least 90 days prior to baseline; 3) anti hypertensive agents must be stable for at least 30 days prior to baseline. The subject's medical condition should be deemed clinically stable following consultation with the Medical Monitor as needed -1. Subject has a lifelong history or presence of symptoms consistent with a major psychiatric disorder other than bipolar I disorder as defined by DSM 5. Exclusionary disorders but are not limited to moderate to severe alcohol use disorder (within past 12 months), substance use disorder (other than nicotine or caffeine) within past 12 months, bipolar II disorder, schizoaffective disorder, obsessive compulsive disorder, posttraumatic stress disorder. 2. Subject demonstrates a decrease (improvement) of ≥ 25% in MADRS total score from Screening to Baseline, or subject's MADRS total score is < 22 at Baseline. 3. Subject has received treatment with antidepressants within 3 days of randomization, fluoxetine at any time within 28 days, an MAO inhibitor within 21 days or clozapine within 120 days. All other psychotropic medications with the exceptions of lorazepam, temazepam,eszopiclone, zopiclone, zolpidem and zolpidem CR require 3 days minimum washout. Depot neuroleptics must be discontinued at least one treatment cycle prior to randomization. 4. Subject has suspected/confirmed Borderline Personality Disorder Subject currently has a clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder such as unstable angina, congestive heart failure (uncontrolled), or central nervous system (CNS) infection that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study. Subjects with a known history of HIVseropositivity will be excluded. Note: Active medical conditions that are minor or well-controlled are not exclusionary if they do not affect risk to the subject or the study results. In cases in which the impact of the condition upon risk to the subject or study results is unclear, the Medical Monitor should be consulted. Any subject with a known cardiovascular disease or condition (even if under control) must be discussed with the Medical Monitor before being randomized in the study Subject has evidence of any chronic organic disease of the CNS such as tumors, inflammation, active (or history of) seizure disorder, vascular disorder, Parkinson's disease, Alzheimer's disease or other forms of dementia, myasthenia gravis, or other degenerative processes. In addition, subjects must not have a history of intellectual disability or persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, is not exclusionary Subject has a history of malignancy < 5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Subjects with pituitary tumors of any duration are excluded Subject demonstrates evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of clinically significant impaired hepatic function through clinical and laboratory evaluation (use screening values for laboratory evaluation). Subject has a history of stomach or intestinal surgery or any other condition that could interfere with absorption, distribution, metabolism, or excretion of medications Subject has knowledge of any kind of cardiovascular disorder/condition known to increase the possibility of QT prolongation or history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome or Brugada Syndrome) or cardiac conduction disorders, or requires treatment with an antiarrhythmic medication Subject has family history of QTc prolongation or of unexplainable sudden death at < 50 years of age Abnormal 12 lead ECG at Screening, including QTcF > 450 ms (male subjects) or > 470 ms (female subjects) QRS > 110 ms | 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 Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 18 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960) Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study Patients with bipolar I or bipolar II disorder Patients with personality disorders Patients with eating disorders Patients with substance dependence or abuse Patients with concurrent active medical condition Patients with history of seizures Patients with history of receiving Electroconvulsive therapy (ECT) Patients with inflammatory disorders Patients with allergy or contraindications to the used medications Patients with finally pregnant or lactating females | 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, Secondary Lymphedema Women who are being enrolled in the Skagen 1 Trial. The for the Skagen 1 Trial and therefore this study is as follows Woman ≥ 18 years who had radical operation for invasive breast cancer pT1-3, pN0-N3, M0 with either mastectomy or breast conservation. The patient can be included no matter the status of estrogen receptor, progesterone receptor, malignancy grade, HER2 status Axillary lymph node dissection of the axilla where the findings give indication for regional nodes radiation therapy to levels (I), II, III, IV, interpectoral nodes and the IMN Sentinel node biopsy documenting limited nodal disease without an indication for axillary lymph node dissection according to institutional, national or other trial guidelines The patient may be a candidate for boost to the tumour bed Adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 treatment is accepted Neoadjuvant chemotherapy to downstage a cT3-cT4 or cN2-cN3 breast cancer is accepted if there is not an indication for a boost in the area of regional nodes after surgery Primary systemic therapy of an operable breast cancer is accepted If the patient is not treated with chemotherapy she must be randomised within 42 days from last surgery. If she has received chemotherapy she must be randomised within 4 weeks after the last series of chemotherapy Breast implants are accepted Previous breast cancer or DCIS of the breast Bilateral breast cancer The patient has an indication for boost to 1 or more regional nodes Previous radiation therapy to the chest region Pregnant or lactating Conditions indicating that the patient cannot go through the radiation therapy or follow up, or a condition where the treating oncologist thinks the patient should not participate in the trial for example due to language problems Known iodide allergy Claustrophobia Foreign objects of metal | 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, Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 Patients who are eligible for chemoradiation therapy of the head and neck Patients must have adequate renal function to undergo platinum based chemotherapy. This will mean a baseline creatinine level (Cr) no greater than 1.5 times the upper limit of normal 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/or retain oral or per tube medication 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 because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events Any patients prescribed medications for chronic and/or long term pain and/or neuropathy will be excluded, including patients under treatment of a pain specialist or substance-abuse programs. Acute post-op medications are allowed if the patient has discontinued them prior to initiating study Any patients prescribed a selective serotonin reuptake inhibitor (SSRI), serotonin and norepinephrine reuptake inhibitor (SNRI), tricyclic antidepressant (TCA), monoamine oxidase inhibitors (MAOIs), dextromethorphan, triptan, tryptophan supplements, IV methylene blue, linezolid or any other medication that may increase risk of serotonin syndrome, as deemed by the investigator?s opinion Any patients with suspected or known, current or recent (within last 5 years) use of cocaine, amphetamines, lysergic acid diethylamide (LSD), 3,4- methylenedioxymethamphetamine (MDMA), or any other drug of abuse that may increase risk of serotonin syndrome, as deemed by the Investigator?s opinion Any patients with history of suicide-related events, or those exhibiting a significant degree of suicidal ideation Patients with acute narrow-angle glaucoma 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 | 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): 40.0-65.0, Type2 Diabetes Major Depressive Disorder Adults 40 to 65 years of age at time of screening visit Women only: Must be post-menopausal at time of screening visit (i.e., defined by NO menstruation for at least the past 12-months) Diagnosis of T2D, as defined by a diagnosis of T2D (for at least 12 months) in the medical record made by a physician (i.e., denoted as 250.XX according to ICD-9/ICD-10 billing codes) OR current use of oral hypoglycemic medications or insulin OR having a fasting plasma glucose ≥126 mg/dL in the medical record OR having a 2-hour oral glucose tolerance test ≥200 mg/dL in the medical record Patients who meet for current MDD without significant co-morbid psychiatric diagnoses, as determined by study PI from screening visit Clinical Psychiatric Interview to determine DSM-V for current MDD AND A minimum score of 18 on the Hamilton Depression Scale (HAM-D) Patients with T2D and current MDD that would benefit from antidepressant therapy, which may Patients with any form of contraindication to Vortioxetine treatment, as outlined in the medication packet insert, (e.g., presence of a known hypersensitivity to the study drug or hypersensitivity to MAO-I use, etc.). MRI-Related Participants weighing >550 lbs (per MRI weight restrictions set by Loyola University Medical Center) Patients with a pacemaker, AICD, ossicular prosthesis, nerve stimulator, or another contraindication to MRI Pregnant patients Patients with an inability to tolerate being in enclosed places/spaces such as MRI Patients with a history of neurosurgery, brain irradiation, or cerebral endovascular treatment Patients with history of epilepsy, stroke, neurodegenerative disorder, severe traumatic brain injury, hydrocephalus or demyelinating disorder Patients with a history of malignant neoplasm to Reduce False Positive Rates of Inflammation Specific pre-existing chronic pain conditions such as rheumatoid arthritis or fibromyalgia. However, this will NOT more localized pain-related conditions such as low-back pain or complications associated with T2D (e.g., diabetic neuropathy) | 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 Written informed consent from the participant has been obtained prior to any study -related procedures (as described in Appendix 3) Male or female participants must be 18 to 65 years of age, inclusive, at the time of signing the informed consent Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) for MDD (based on confirmation from the modified Structured Clinical Interview for DSM disorders [SCID]), with a current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1 Have a minimum score of 26 on the rater-administered Montgomery-Asberg depression rating scale (MADRS) and a minimum score of 24 on the computer-administered MADRS at both Visit 1 (Screening) and Visit 2 (Baseline) Have a difference of no greater than 7 points between the rater-administered MADRS and computer-administered MADRS at both Visit 1 (Screening) and Visit 2 (Baseline) Have a clinical global impression-severity (CGI-S) score ≥ 4 at both Visit 1 (Screening) and Visit 2 (Baseline) Have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test if a woman of childbearing potential (WOCBP) Female participants willing to minimize the risk of becoming pregnancy for the duration of the clinical study and follow-up period. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies not a WOCBP OR A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 of protocol during the treatment period and for at least 5 terminal half-lives after the last dose of study treatment Psychiatric and Treatment-Related DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1. Comorbid generalized anxiety disorder, social anxiety disorder, or specific phobias are acceptable provided they play a secondary role in the balance of symptoms and are not the primary driver of treatment decisions Lifetime history of meeting DSM-5 for Schizophrenia spectrum or other psychotic disorder Bipolar or related disorder Major neurocognitive disorder Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study Dissociative disorder Posttraumatic stress disorder MDD with psychotic features | 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, Physical Activity Obesity Age 18-55 years BMI between 25.0 and <40.0 kg/m2 Either a 'Non-exerciser', defined as reporting exercising at a moderate-intensity for <30 min/week over the past 6 months or an 'exerciser', defined as exercising for ≥150 min/week over the past 6 months Presence of any condition that would limit one's ability to exercise (e.g., orthopedic limitations) History of coronary artery disease (i.e., myocardial infarction or symptoms of angina), stroke, diabetes, or pulmonary disease (e.g., COPD or emphysema) Currently taking any medication that would alter heart rate (e.g., beta blocker) Women who are pregnant or nursing Uncontrolled hypertension (resting blood pressure ≥140/90 mmHg) Exercising >30 min/week but <150 min/week (i.e., neither 'non-exerciser' nor 'exerciser') Use of medications for weight loss, or current participation in another weight loss program Bariatric 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): 20.0-50.0, Taste Disorders Depressed Egyptian adults under antidepressants therapy for at least 3 months/non-pharmacological treatment( psychotherapy) Age from 20 to 50 years old Antipsychotics Hypnotics Anticonvulsants Ages other than the mentioned Olfactory dysfunction Chemosensory dysfunction | 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): 44.0-93.0, Insomnia Participants in the Black Women's Health Study (BWHS) with clinically elevated symptoms of insomnia previously reported on a BWHS questionnaire. 2. Access to a computer or tablet and internet access Intention to change use pattern of prescribed or over-the-counter sleep aid 2. 1 or more unrelated sleep disorders 3. Employed in a position where sleep restriction may endanger others' lives 4. Active shift work employment 5. Untreated, current, and/or severe psychiatric condition 6. Consume 14 or more alcoholic drinks/week 7. Unstable or acute medical condition | 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): 18.0-55.0, Major Depressive Disorder Cognitive Impairment Diagnostic and Statistical Manual (DSM)-5 for past Major Depressive Episode within MDD, confirmed through Mini-International Neuropsychiatric Interview (MINI) diagnosis 2. Age between 18 and 55 years 3. Montgomery-Åsberg Depression Rating Scale < 7 (in remission) 4. Ability to read and understand English 5. Participant has been treated with an antidepressant for ≥ 6 months prior to enrolment 6. Participant agrees to remain on a stable antidepressant regimen for the duration of the trial (8 weeks) 7. Participant is currently experiencing cognitive deficits, as confirmed by an NCI >1 standard deviation below the mean on CNS Vital Signs cognitive battery 8. Women of child bearing potential must agree to use birth control for the duration of the study and 1 month following discontinuation of the study drug Pregnancy/lactation 2. Lifetime history of Bipolar I, II or psychosis; other comorbidities (e.g. Generalized Anxiety, Panic Disorder) may be allowed by clinician judgement 3. Subject has current clinical diagnosis of autism, dementia, intellectual disability, or mild cognitive impairment 4. Meets DSM-5 for active Post-Traumatic Stress Disorder, confirmed through MINI diagnosis 5. Subject meets for current personality disorder 6. Concomitant use of monoamine oxidase inhibitors and/or other psychotropic drugs including lithium, clomipramine, and triazolam 7. Recent (< 6 months) stimulant use, such as medications used for attention deficit hyperactivity disorder 8. Subject is taking antipsychotics 9. Subject is taking herbaceuticals (i.e. natural products that have psychoactive properties, such as St. John's wort) 10. Concomitant use of medications that may interact with modafinil, including warfarin and cyclosporine 11. Medical condition requiring immediate investigation or treatment 12. Recent (< 6 months)/current history of drug abuse/dependence (other than caffeine or nicotine) 13. Previous intolerance or failure to respond to an adequate trial of modafinil 14. Any past history of head injury or concussion, as confirmed by the Ohio State University Traumatic brain injury (TBI) Identification Short Form 15. Current suicidal ideation (MADRS Item 10 ≤2 or by clinician judgement) 16. History of coronary artery disease, recent (<1 year) myocardial infarction, or unstable angina 17. History of left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, or clinically significant manifestations of mitral valve prolapse in association with use of CNS stimulants 18. Involvement in another treatment study during the time of the 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): 18.0-999.0, Depression Pregnancy Related Antenatal Depression Pregnant women Ages 18 or older History of recurrent major depression prior to pregnancy (at least 2 prior episodes, one of which may be currently treated) Euthymic or with residual symptoms (PHQ-9 ≤ 9) No depressive relapse since last menstrual period Currently or recently received antidepressants (within the three months prior to last menstrual period) Presence of ongoing community provider Diagnosis of bipolar or psychotic disorder Active mania, psychosis, or substance abuse (within the last 6 months) Immediate risk of self-harm Non-English speaking and for the participants in the supplemental arms of the study differ from the main study and are as follows: Arm 1 Aim 1a Pregnant women (prior to 16 weeks gestation) Age 18 or older Presence of an ongoing community prescriber / provider Suicidal ideation as noted by item #9 of the PHQ-9 History of recurrent depression, dysthymia or subsyndromal depression | 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): 18.0-80.0, Major Depressive Disorder Depression TRD Patient Patients will be included if they: 1. are outpatients 2. are voluntary and competent to consent to treatment 3. have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of MDD, single or recurrent 4. are between the ages of 18 and 80 years 5. have failed to achieve a clinical response to at least one adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of score ≥ 3 in the current episode OR have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2) 6. have a score ≥ 22 on the IDS item 7. have had no increase or initiation of any psychotropic medication in the 4 weeks prior to initiation of rTMS 8. able to adhere to the treatment schedule 9. pass the TMS adult safety screening (TASS) questionnaire First Episode Depression Patients will be included if they: 1. are outpatients 2. are voluntary and competent to consent to treatment 3. have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of MDD, single or recurrent 4. are between the ages of 18 and 80 years 5. have never received and adequate antidepressant trial and are not currently taking any antidepressant. 6. have a score ≥ 12 on the IDS item 7. are on no psychotropic medication for the 4 weeks prior to initiation of rTMS, with the exception of lorazepam up to 2mg or equivalent dose of benzodiazepine or prescribed sleeping aids including (zopiclone up to 15mg/d, zolpidem up to 10mg/d). 8. able to adhere to the treatment schedule 9. pass the TMS adult safety screening (TASS) questionnaire Patient Patients are excluded if they: 1. have a history of substance dependence or abuse within the last 3 months 2. have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump 3. have active suicidal intent 4. are pregnant 5. have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms 6. have a MINI diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia, assessed by a study investigator to be primary and causing greater impairment than MDD 7. have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD 8. have failed a course of ECT in the current episode or previous episode 9. have received rTMS for any previous indication due to the potential compromise of expectancy effects 10. have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than 5 minutes 11. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed 12. If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study 13. have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators 14. are currently (or in the last 4 weeks) taking lorazepam greater than 2 mg daily (or equivalent) or any dose of an anticonvulsant, due to the potential to limit rTMS efficacy 15. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview). 16. have failed more than 5 adequate trials of medication in the current episode. 17 for MRI: Those with a history of cranial, thoracic or abdominal surgery, with pacemakers, artificial joins or other metallic implants will be excluded from the MRI scan. Subjects that have agreed to participate in the MRI portion of the study will be pre screened for any potential metal fragments in the body (particularly in the orbits) if they have had any history of doing metal work or have been involved in use/deployment of ammunitions/explosives, welding, piping etc.). In these cases a CT scan will be performed prior to the MRI scan ---------- Healthy Control Participants will be included if they: 1. are voluntary and competent to consent to the study 2. are between the ages of 18 and 80 3. are fluent in English, sufficient to complete interviews and cognitive testing 4. have no history of Axis I or Axis II disorders, as determined by the MINI 5. pass the TMS adult safety screening (TASS) questionnaire Healthy Control Participants will be excluded if they: 1. have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms 2. have a MINI diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), dysthymia or any personality disorder 3. have history of bipolar disorder or psychosis in first degree relative (parents, siblings, offspring) 4. are unable to provide family history of biological family (i.e., adopted persons are not eligible) 5. have a history of substance dependence within the last 3 months 6. have a concomitant major unstable medical illness 7. have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 5 minutes 8. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview). 9. have a personal or family history of seizures 10 for MRI: Those with a history of cranial, thoracic or abdominal surgery, with pacemakers, artificial joins or other metallic implants will be excluded from the MRI scan. Those who are pregnant will also be excluded from the MRI scan. Subjects that have agreed to participate in the MRI portion of the study will be pre-screened for any potential metal fragments in the body (particularly in the orbits) if they have had any history of doing metal work or have been involved in use/deployment of ammunitions/explosives, welding, piping etc.) | 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): 18.0-65.0, Major Depressive Disorder (MDD) Patient Population: Males and females with a diagnosis of major depressive disorder 1. Signed an Institutional Review Board (IRB) approved informed consent document indicating that they understand the purpose of and procedures required by the study and are willing to participate in the study and comply with all study procedures and restrictions. Informed consent must be obtained from the patient and/or a designated representative prior to initiating screening procedures to evaluate of the study. 2. Males and females aged 18 and 65 years inclusive. 3. Meet DSM-V R for major depression, single episode or recurrent episode, with or without melancholia and without psychotic features (296.21, 296.22, 296.23, 296.31, 296.32, or 296.33). 4. Had a total score of > 18 on the HAM-D (17-item version), and a score of > 2 on the depressed mood item of the HAM-D at the screening visit and at the baseline visit. 5. Patients who are currently not on any antidepressants or, Patients on antidepressants and agree to the appropriate washout period (certain antidepressants with prolonged effects (e.g., fluoxetine) may need longer than 2 weeks post-discontinuation to obtain relatively uncontaminated baseline evaluation). 6. Agreed not to start psychotherapy or behavior therapy during the trial. Patients currently on these types of therapy for at least 3 months are eligible for the study and could continue to receive therapy during the trial Women who are pregnant, or lactating; or taking a low-estrogen "mini-pill" contraceptive. 2. Individuals who are currently taking either study medication (pramipexole and/or ondansetron). 3. Renal and hepatic dysfunction with Total Bilirubin: >1.5 x UNL AST: >2.5 x UNL ALT: >2.5 x UNL Serum Creatinine: >1.5 x UNL Creatinine Clearance: <30 mL/min (calculated by Cockcroft and Gault equation) 4. Hypersensitivity to any component of either study medication. 5. Lifetime history of hypomania/mania, psychotic disorder, dementia and borderline or antisocial personality disorders. 6. History of a serious suicidal attempt in the past 12 months; presence of serious suicidal tendencies/potential; modified C-SSRS >4. 7. Positive urine screen for benzodiazepines, cocaine/cocaine metabolites, cannabinoids, amphetamines, barbiturates, and opiates or history of moderate or severe substance dependence (drugs or alcohol, DSM-V-R criteria) within the past 6 months of the screening visit. 8. Non-responders to at least two trials of antidepressant treatment in the past. (Therapeutic dose for at least 6 weeks) 9. Patients currently taking or have taken the following medications within the past 6 months Centrally acting dopamine antagonists MAOI 10. Patients considered unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator. 11. Patients who have clinical significant hypotension or any clinical significant ECG abnormality at screening. 12. Any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives. 13. Patients who have participated in another clinical trial with an investigational drug within previous 30 days or 5 half-lives whichever is longer | 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 Patients with a diagnosis of previously untreated Major Depressive Disorder (MDD) of at least 3 weeks duration or new or recurrent MDD untreated before this episode (patients who have previously received treatment for MDD must have stopped taking antidepressant medication at least six weeks prior to entering the trial) Patients requiring pharmaceutical intervention as a treatment for MDD Not suffering from any significant other mental or physical illness, such as confirmed psychosis, or end of life care Receiving stable medical therapy for 30 days or longer before screening assessments Be willing and able to comply with all visits and study related procedures Not infected with coronavirus or needing to self-isolate Understands the study requirements and the treatment procedures and is able to provide written informed consent Already on antidepressant medication Known or suspected hypersensitivity or intolerance to any probes, or any of their excipients Relevant history or presence upon clinical examination, of cardiac, ophthalmologic, gastro-intestinal, hepatic, or renal disease or other condition known to increase risk of side effects of the probe drugs. This criterion is determined by the Site Investigator Have a history or presence of neurological or confounding psychiatric conditions (such as stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, or schizophrenia) Patients with a diagnosis of chronic pain Participation in another trial concurrently or within 30 days preceding enrolment that is deemed to interfere with this trial Patients who are pregnant, or who are likely to become pregnant, will be excluded from the trial, as will breastfeeding mothers Patients using supplements containing psychoactive herbs (for example St Johns Wort or 5-HTP (5-Hydroxytryptophan, also known as oxitriptan) Patients regularly using psychoactive stimulants and recreational drugs (for example MDMA (ecstasy/ methyl enedioxy methamphetamine), amphetamine, LSD (lysergic acid diethylamide), cocaine) Patients infected with coronavirus, or who are advised to self-isolate | 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 Patients Patients with diagnosis of depressive disorder (major depressive disorder MDD and/or dysthymia) under pharmacological treatment Regular users of mobile phones Patients who have consulted their psychiatrist about their depression at least once in the previous 6 months Health professionals: Psychiatrists have no intention of moving from their practice during the study period • Patient Patients with history of current bipolar disorder and/or any psychotic disorder Insufficient language skills 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): 15.0-30.0, Pregnancy and Early Lactation Among Women Living in an Area Endemic for Malnutrition all women who become pregnant during a 9-month period in a set of Nagarpalikas and Gaunpalikas in Sarlahi District, Nepal Women who do not intend to deliver their child in the study area Women who are allergic to milk, nuts or soy Women who are unwilling to commit to daily consumption of the nutritional supplement if they are randomized to an active treatment arm Women who refuse to provide 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): 18.0-999.0, Pancreatectomy Patient of at least 18 years, presenting a good understanding and a practice of the French language Having undergone a pancreatectomy (pancreatic cancer) Signed Consent of participation Affiliating to a national social security or beneficiary of such regimen Other medical or psychiatric affection Level of incompatible cognitive efficiency with the answer to auto-questionnaires Patient in emergency situation, major person being the object of a legal protective measure (major under guardianship, guardianship or protection(saving) of justice), or outside state to express its 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): 18.0-55.0, Behavior and Behavior Mechanisms Information Literacy female at birth and identify as female aged 18-55 report unprotected vaginal or anal sex with a male partner OR any injection drug use in the past 6 months live or have sex in a high risk area or are recruited into the study by someone who lives or has sex in a high risk area understand and read English not known to be HIV-infected are willing to consider a daily pill with low rates of mild side effects to prevent HIV have access to a mobile phone report at least one of the following as 'yes' or 'do not know': current male partner who injects drugs or has sex with men; current male partner who is HIV infected; current male partner who was incarcerated in the last 6 months OR report at least one of the following as 'yes': shared injection equipment in last 6 months; in methadone, buprenorphine or suboxone treatment program in past 6 months; exchange sex for money, drugs, other goods in last 6 months; powder cocaine, crack use, methamphetamines, or ecstasy >1x/week in last 6 months; Chlamydia, syphilis, gonorrhea diagnosed or newly diagnosed genital herpes in last 6 months; alcohol abuse in last 6 months (defined as a score of 2 or higher on the CAGE36); has 3 or more male partners currently using PrEP | 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, Smoking Cessation Hong Kong residents aged 18 to 65 years have used any tobacco products in the past month able to read and speak Chinese have not used NRT for the past month Have severe angina, serious cardiac arrhythmias and hypertension Have suffered from acute myocardial event in the past 4 weeks Pregnant nor breastfeeding Under medication and treatment due to mental illness One of the was "smoke 10 cigarettes or more per day in the past week" and is amended to "have used any tobacco products in the past month". The initial intention of setting the of at least 10 cigarettes per day (CPD) is to recruit smokers who have moderate to strong level of craving and a greater need for NRT. However, we also recognize that one of the objectives of the research is to promote the use of NRT for quit attempts with NRT sampling. In fact, smokers who smoke less than 10 CPD can also benefit from using NRT gums. Therefore, the change in the does not deviate from our research aim. In contrast, with the removal of the criterion for CPD, we will be able to reach out to a larger group of smoking population and encourage more smokers to use NRT to quit smoking | 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): 18.0-68.0, Major Depressive Disorder diagnosed major depressive disorder (ICD10: F32.1, F32.2, F33.1, F33.2) current depressive episode lasts for at least 4 weeks HAM-D17 score ≥15 CGI-Score ≥4 inadequate response to antidepressant therapy diagnosed psychotic disorder diagnosed depressive disorder with psychotic features diagnosed bipolar affective disorder diagnosed posttraumatic stress disorder diagnosed obsessive-compulsive disorder anxiety disorder or personality disorder as primary diagnoses alcohol or drug addiction neurological disorders and brain implants pregnancy former TMS treatment within 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, Post Traumatic Stress Disorder Family Psychological Distress Organ and Tissue Procurement Parent or adult companion of a patient who died of cardiac arrest after organ removal (Inclusion order of priority is husband-wife / father-mother / son-daughter) Only one loved one is included per patient Age < 18 years Refusal to participate in the study Difficulty in communication (foreign, language, etc) | 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, Obesity Mood Disorders Informed of the nature of the study and have agreed to and are able to read, review, and sign the informed consent form. The informed consent document will be written in English, therefore the volunteer must have the ability to read and communicate in English Female participants 18 years of age, inclusive, at the time of screening Available and able to attend weekly group meeting on assigned dates Diagnosis of major depressive disorder or bipolar disorder by a physician within the past 12 months, as indicated in WMC medical records and confirmed by MINI Actively pursuing lifestyle weight management at WMC, with evidence of booked follow-up appointment Weight status of at least 25kg/m2, as indicated by data from last appointment at WMC Access to a computer and email account in order to complete online questionnaires Enrolled in surgical management of obesity at WMC Active substance abuse/dependence disorder, current suicidality, or active episode of psychosis Presence of a hearing or visual impairment that will prevent completing the online surveys and from participating in a group discussion weekly meeting | 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, Postoperative Pain Pregnant women at least 18 years of age 2. Gestational age > or = to 30 weeks 3. Singleton gestation 4. Women undergoing a non-emergent cesarean delivery 5. Spinal anesthesia or combined spinal-epidural anesthesia utilized during cesarean 6. Ability to undergo the informed consent process in English Vertical skin incision 2. General anesthesia for cesarean 3. History of major depression or postpartum depression requiring medication 4. Chronic opiate use during pregnancy, defined as anyone who has taken an opioid or opioid replacement therapy in the 3 days prior to admission for delivery. This does not opioids given for labor anesthesia. 5. Magnesium sulfate treatment postpartum 6. Preexisting fibromyalgia, chronic pain syndrome, or rheumatologic 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): 60.0-999.0, Cognitive Dysfunction Subjects aged ≥60 years. 2. Subjects who provide written Informed Consent to the study Subjects with cognitive dysfunctions or clinically significant coexisting medical conditions (cardiovascular disease, cerebrovascular events, overt dementia defined by MMSE <27 or other neurological disorders, thyroid disorders, or inflammatory diseases) 2. Subjects with a score on the Geriatric Depression Scale (GDS) >11 in order to avoid confounding due to the influence of concomitant depression on the performance on cognitive tests 3. Current smokers 4. Habitual users of antioxidant supplements (including vitamins C and E) 5. Habitual consumers of chocolate or other cocoa products (daily consumption of any amount) 6. Subjects under treatments with medications known to have antioxidant properties (including statins and glitazones) or to interfere with cognitive functions (including benzodiazepines and antidepressants) 7. Subjects with hypersensitivity to any component of the study medications 8. Subjects who are participating in or having participated in another clinical trial within the previous three 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): 18.0-999.0, Depression Depressive Disorder, Major years or older considered an active clinic patient at the start date of the intervention have an active MyChart account that is not managed by a proxy receive care from a participating PCP due for depression screening (screening arms) or active depression (monitoring arms) under 18 years of age bipolar disorder | 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): 21.0-85.0, Major Depressive Disorder to 85 Years of age Diagnosis of Stage I, II or III cancer Histologically-proven malignancy Receiving or within one year of having received cancer treatment with radiation and/or chemotherapy Montgomery and Åsberg Depression Rating Scale (MADRS) ≥ 20 (moderate to severe depressive symptoms) Duration of depressive symptoms ≥ 2 weeks by patient report No active/acute suicidality requiring immediate care or psychiatric hospitalization Sufficient English language proficiency to complete all assessments without assistance Able to swallow pills No severe anemia, defined as hemoglobin < 10 g/dL Have a current or previous diagnosis of or history consistent with obsessive-compulsive disorder, posttraumatic stress disorder, bipolar I or II, manic or hypomanic episodes, schizophrenia, major Axis II disorders which might compromise the study, or major depression with psychotic symptoms, as assessed using the MINI International Neuropsychiatric Interview (MINI Plus) Have a documented history of an intellectual disability Use of any antidepressant medication in the last 2 weeks before visit 1 (4 weeks for fluoxetine) Currently being treated with tamoxifen Subjects who were non-responsive to two or more courses of antidepressant medications given at an adequate dosage* for symptom treatment within four weeks, or by the judgment of the investigator considered to have treatment resistant depression (TRD), or a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or psychosurgery within the last year Have a history of any seizure disorder Any clinically significant abnormal vital sign, ECG, or laboratory values as determined by the investigator which might interfere with the study Have a high suicidal risk as assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). High suicidal risk is indicated by: 1. A positive response to question 4 or 5, indicating endorsement of suicidal ideation with at least some intent to act in the past month; and/or 2. A positive response to part two of question 6, indicating the presence of any suicidal behavior in the past 3 months Have a history of substance dependence/abuse** within the past 6 months or a positive drug screen result during the screening period Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions | 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, Depressive Symptoms Married Divorced Separated Widow Cases diagnosed with mental disorders History of mental disorders Family history of mental disorders | 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): 18.0-65.0, Depression, Unipolar diagnosis of MDD, assessed by the Structured Clinical Interview of DSM-5 (SCID) treatment-resistant, operationally defined as failure to achieve clinical remission (MADRS <7) remit following at least one antidepressant trial in the current major depressive episode Symptoms must be of at least moderate severity (MADRS score >19) medications will be stable for at least six weeks prior to TMS, and there will be no dose changes unless medically necessary * Standard contraindications to TMS and EEG metal in the head and neck history of serious head injury or loss of consciousness over 10 minutes dementia seizure history other serious neurological disorders serious or unstable medical conditions that would affect EEG signal current severe substance use disorders (except for nicotine or caffeine) bipolar or psychotic-spectrum disorders (e.g., schizophrenia, schizoaffective disorder, etc.) Prior non-responders to TMS will also be excluded | 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, Best Possible Medication History Admission to Emergency Department of University Hospital Basel and transfer to medical ward medication history taken at Emergency Department of University Hospital Basel not present | 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, Major Depressive Disorder Participant has a diagnosis of MDD as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Clinical Trial Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period. 2. Participant is in good physical health and has no clinically significant findings, as determined by the Investigator, on physical examination, 12-lead electrocardiogram (ECG), or clinical laboratory tests. 3. Participant has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥28 and a HAM-D total score of ≥20 at Screening and Day 1 (prior to dosing) Participant has attempted suicide associated with the current episode of MDD. 2. Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder. 3. Participant has had vagus nerve stimulation, electroconvulsive therapy, or has taken ketamine (including esketamine) within the current major depressive episode | 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): 18.0-50.0, Healthy Healthy Volunteers Adults age 18-50 years, male and female 2. Weight stable (less than or equal to 5 % over past 6 months) as determined by volunteer report 3. Body mass index (BMI) greater that or equal to 20kg/m2 4. Body weight greater than or equal to 53 kg 5. Able to complete daily bouts of stationary cycling at a moderate rate and intensity with a HR equal to or greater than 0.3(SqrRoot) (220-age-HRrest)+HRrest but not exceeding 0.4(SqrRoot) (220-age-HRrest)+HRrest and no signs of arrhythmia Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, diabetes, thyroid disease) 2. Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, blood pressure medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team) 3. Positive pregnancy test or lactation as determined by volunteer report (women only) 4. Participating in a regular exercise program (> 2h/week of vigorous activity) as determined by volunteer report 5. Hematocrit <37% (women only) 6. Hematocrit < 40% (men only) 7. Caffeine consumption > 300 mg/day as determined by volunteer report 8. Regular use of alcohol (> 2 drinks per day), tobacco (smoking or chewing) amphetamines, cocaine, heroin, or marijuana over past 6 months as determined by volunteer report 9. Psychological conditions such as (but not limited to) eating disorders, claustrophobia, clinical depression, bipolar disorders, that would be incompatible with safe and successful participation in this study, as determined by investigators. 1. Past or present history of eating disorders as determined by volunteer report 2. Past or present history of claustrophobia since part of the protocol will involve being confined to a small room for whole-body indirect calorimetry and being in an MRI scanner for liver fat measures 10. Implants, devices, or foreign objects implanted in the body that interfere with the Magnetic Resonance procedures 11. Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies) 12. Volunteers unwilling or unable to give informed consent 13. Non-English speakers due to unavailability of required questionnaires in other languages | 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): 19.0-999.0, Exercise Neoplasms Patients diagnosed with stage III or stage IV NSCLC who have a documented disease control (stable disease, partial or complete response defined by V1.1) at least 6 months after start of first line treatment. Stage III patients can only be included, if first line treatment consisted of concurrent chemoradiotherapy and a consolidation immunotherapy if indicated (if PDL1 > 1% and no potential contraindications for immunotherapy). Stage IV patients, should have received only immunotherapy (PDL1 > 50%) or a treatment of at least 4 cycles of a platinum based chemotherapy with or without immunotherapy. Maintenance therapy with chemotherapy and/or immunotherapy and administration of local radiotherpy is allowed. Patients with objective response can be included in the study until 2 years after starting up initial treatment. 2. > 18 years 3. Patients who are able to engage in a remote coaching program through the use of a smartphone Patients actively participating in a pulmonary rehabilitation program 2. Patients with sequential chemoradiotherapy for stadium III non-small cell lung cancer 3. The presence of orthopedic problems not allowing an increase in PA levels | 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): 18.0-25.0, Depressive Symptoms All Egyptian medical students at faculty of Medicine, Assiut University in the academic year 2018-2019 Non-Egyptian medical students | 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): 18.0-55.0, Major Depressive Disorder for MDD participants aged 18-55 currently in a depressive episode according to DSM-5 who are currently on antidepressant treatment but remain symptomatic (HAM-D17 score >13) on stable treatment regimen of an approved treatment for at least 6 weeks non-smokers for participants willing to take part in the neuroimaging component: right-handed, no contraindications, non-claustrophobic, weight <126kg for MDD participants eating disorder, bipolar disorder, schizophrenia or psychotic symptoms substance dependence in the past year, except for caffeine active suicidal ideation use of probiotic supplements in the past 2 weeks, or regular use of a probiotic use of antibiotics in the past 12 weeks history of allergic reaction to any of the components of BioKult history of history of a systemic medical illness current presence of significant GI problems or disease or history of major GI surgery pregnancy or breastfeeding | 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): 18.0-65.0, Depression History of Suicide Attempt Being between 18 and 65 years old Meeting the DSM-5 for a current major depressive disorder For suicidal patients : having a lifetime history of suicide attempt For affective controls : having no personal history of suicide attempt Being able to understand the nature, purpose and methodology of the study Having signed the informed consent Being affiliated to a social security system Current depressive episode with psychotic characteristics Mental retardation or sever medical co-morbidity Lifetime Diagnosis of schizophrenia or schizoaffective disorder Current manic or hypomanic episode Sensory or cognitive disability Pregnant or breastfeeding woman Deprivation of liberty (by judicial or administrative decision) Protection by law (guardianship or curatorship) period in relation to another protocol Inability to understand, speak and write French | 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): 0.0-999.0, Health Related Quality of Life All patients diagnosed with colon cancer in Region Västmanland 2012-2016 Language problems, declined | 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, Overweight and Obesity years and older BMI 30 or over BMI over 28 and under 30 with one or more of following: hypertension, prediabetes, type 2 diabetes, coronary heart disease, hyperlipidaemia, liver steatosis, sleep apnoea or polycystic ovary syndrome Severe mental illness Previous or present eating disorder Pregnancy Breast feeding Serious cancer under treatment Use of weight-loss drugs Misuse of alcohol or drugs Type 1 diabetes Not being able to speak/read/write Swedish | 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 B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine 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 B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment | 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, Malignant Glioma ≥ 18 years of age 2. NCCN distress scale ≥ 4 OR at least one of the following problems indicated on the NCCN distress thermometer worksheet: depression, fears, nervousness, sadness, worry, loss of interest in usual activities, sleep, memory, or fatigue 3. Karnofsky Performance Status (KPS) ≥ 70 4. Patient must have histologically confirmed, newly diagnosed WHO grade III or IV malignant glioma 5. Patient must be prior to a planned 6-week standard of care chemoradiation regimen 6. Patient can speak, read, and write English 7. Patient has access to a telephone for mindfulness training 8. Patient has access to internet Patients previously or currently practicing or participating in mindfulness meditation practice 2. Intermittent or active psychosis 3. Psychiatric hospitalization within the last 6 months 4. Hospitalized in a rehab facility within the last 6 months for substance abuse | 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, Breast Neoplasm Female Nutrition Related Cancer Habits, Diet Cancer, Breast Older women than 18 years old Newly diagnosed patients with a breast tumor (Phase I, II or III). Being in one of the following cases: 1. Patient who has not yet received any treatment and the committee has decided that as a first treatment will receive chemo or radiotherapy. 2. Patient who has just undergone surgery and is waiting to start adjuvant treatment with chemo or radiotherapy Sign the informed consent Patients with stage IV disease Associated Eating Disorders Patients with dementia, mental illness or decreased cognitive function Pregnant or lactating women | 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): 13.0-24.0, Suicide Suicidal Ideation Suicidal Intention Suicidal and Self-injurious Behavior American Indian youth aged 13-24 years old who are San Felipe tribal members living in the Pueblo Endorse suicidal ideation or behaviors on a universal screen by their primary care provider Younger than age of 13 years old or Older than the age of 24 Not American Indian Youth who do not receive health services at either of the IHS clinics at the Pueblo of San Felipe Youth who screen negative for suicidal ideation and/or behavior Refuse to participate in the study, and/or Cognitively unable to provide informed consent as demonstrated by a brief cognitive screen prior to completion of the baseline interview | 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): 18.0-90.0, Lung Cancer Lung Injury All surgical procedures with a planned duration of more than 1 hour Patients with a contraindication for electrocautery use Patients with Pacemaker or implantable cardioverter-defibrillator (ICD) Patients with an implanted neurostimulator device | 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): 20.0-999.0, Depressive Disorder Fulfill diagnosis of Major depression disorder based on Diagnostic and Statistical Manual of Mental Disorders(DSM-V) for at least 6 weeks and under medication treatment for at least 4 weeks. 2. at least 20 years old 3. Hamilton Depression Rating Scale(HAMD-17) >= 13 4. No medication change for at least 4 weeks and no medication change will be considered in the next 8 weeks. 5. Agree to participate in this study and sign the permit Seasonal depression disorder 2. Other psychological or neurological disorder 3. Drug or alcohol abuse within 30 days 4. Visual problem 5. Light-induced seizure or migraine 6. Contraindication for MRI study 7. Severe illness and might be admitted in the near future 8. Might have a long trip in the near future | 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, Stage II Colon Cancer Stage III Colon Cancer Adjuvant Therapy Patients who are sick after January 2010 Age is older than 18 Surgical pathology confirmed TNM stage II-III (AJCC 7th edition) colon cancer Combine other tumors Pathological information is not clear Researchers believe that other reasons are not suitable for enrollment | 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): 1.0-24.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Central Nervous System Leukemia Mixed Phenotype Acute Leukemia Testicular Leukemia B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 7 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732 White blood cell count (WBC) for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy) Age 1-9.99 years: WBC >= 50,000/uL Age 10-24.99 years: Any WBC Age 1-9.99 years: WBC < 50,000/uL with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment White blood cell count (WBC) for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy) Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group) With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732 Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patients with acute undifferentiated leukemia (AUL) are not eligible For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma | 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, Colon Cancer Histology confirms colonic adenocarcinoma The distance from the lower edge of the tumor to the anal edge is greater than or equal to 15cm (from sigmoid colon to ileocecal region) Preoperative staging (Satisfying any one out of four conditions below) 1. Tumor infiltrates through the intestinal wall and adheres to tissues and organs around the colon(T4b), imaging assesses that R0 resection is unachievable. 2. Pericolonic lymph node involvement is closely adjacent to the large abdominal vessels, imaging assesses that lymphadenectomy is difficult. 3. Surgical exploration indicates that R0 resection is not achievable. 4. In initial diagnosis, surgeon evaluates the need for extensive multi-organ combined resection and expected to damage the organs, which would seriously affect the postoperative quality of life No obvious signs of intestinal obstruction, or obstruction has been relieved after proximal enterostomy Preoperative CT/MRI/PET-CT has ruled out distant metastasis Blood and biochemical indexes achieve standard (Satisfying all three conditions below): 1. Routine blood test: WBC>4000/mm3; PLT>100000/mm3; Hb>6g/dl. 2. Liver function: SGOT, SGPT and Bilirubin are less than or equal to 1.5 times normal upper limit. 3. Renal function: Creatinine is less than or equal to 1.5 times normal upper limit History: Has colon surgery history; Received chemotherapy or biotherapy in the past 5 years; Received radiotherapy in treatment field Infectious disease: HIV infection history; Active phase chronic hepatitis B or hepatitis C (high copies of virus DNA); Other serious active clinical infection Diagnosed as stage I colon cancer Extraperitoneal distant metastasis is positive in pre-operative stage Dyscrasia or organ decompensation Received radiation therapy in abdominal or pelvic regions Multiple primary cancer Epileptic seizures requiring medical treatment Other malignant tumor history in the past 5 years (except endocervical cancer in situ or skin basal cell carcinoma which had been cured) Chronic inflammatory colorectal disease, unrelieved ileus | 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 Major Depressive Disorder Major Depression Phases I-II 1. 18 to 70 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 protocol 01-M-0254, "The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers". 4. Subjects must fulfill DSM-IV or -5criteria for Major Depression (Major Depressive Disorder) without psychotic features, based on clinical assessment and informed by a structured diagnostic interview (SCID-P). 5. Subjects must have an initial score on the MADRS greater than or equal to 22 and a YMRS score of <12 within one week of study entry and upon entry into Phase II. 6. Lack of response to two adequate antidepressant trials, with [at least] one in the current major depressive episode, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT [or TMS] would count as an adequate antidepressant trial. 7. Current major depressive episode lasting at least four weeks 8. Agree to be hospitalized Open-Label Ketamine Treatment 1. Participants must have met all for and completed Study Phase II as a participant in Group 1 (active crisis) 2. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase III Phases I-II 1. Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-5. 2. Subjects with a history of substance abuse or dependence diagnosis (DSM-IV) or substance use disorder (DSM-5 equivalent) (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 screening and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines or stimulants) at screening. 3. 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. 4. Pregnant or nursing individuals or those who are physically able to become pregnant. Participants who are physically able to become pregnant or cause a pregnancy must use at least one form of effective birth control or remain completely abstinent from sexual intercourse during the entire period of study participation (or until the last clinical labs and ratings). Participants able to become pregnant must have negative urine pregnancy tests no more than 24 hours prior to receiving the study drugs and undergoing imaging procedures. 5. 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. 6. Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications. 7. Clinically significant abnormal laboratory tests. 8. (For imaging procedures) Subjects with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures 9. Positive HIV test 10. Weight > 119 kg 11. Treatment with any concomitant psychiatric medication prior to entering Phase II. [Medications must be tapered during Phase I.] 12. Treatment with any non-psychiatric medication/s. 13. Any use of opioid medication in the past 3 months 14. Treatment with a reversible monoamine oxidase inhibitor (MAOI) prior to entering Phase II. [Medications must be tapered during Phase I.] 15. Treatment with fluoxetine or aripiprazole at the time of screening. 16. Unwilling to stop undergoing structured, individualized psychotherapy. (Such therapy, including CBT, will not be permitted during Phases I and II of the study.) 17. Presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clip). 18. Participants who are uncomfortable in small closed spaces (have claustrophobia). 19. Are unable to lie comfortably supine for up to 90 minutes and would feel uncomfortable in the MRI and MEG machines. 20. Subjects who, in the investigator s judgment, pose a current serious suicidal or homicidal risk. 21. Subjects who have a history of aggressive behavior towards others 22. A current NIMH employee/staff or their immediate family member Open-Label Ketamine Treatment 1. Intolerable or serious adverse reaction to ketamine during Phase II 2. Participants with a positive urine for an illicit substance no more than 24 hours prior to ketamine treatment. 3. Pregnant or nursing individuals or those who plan to become pregnant | 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, Cervical Cancer Breast Cancer Contraceptive Usage Sexually Transmitted Diseases -Scheduled to leave jail within 3 days not actively intoxicated not show severe psychological distress | 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): 25.0-40.0, Traumatic Brain Injury Neurobehavioral Manifestation Sleep Disorder Fatigue Are 25 to 40 years of age Are active duty service members or veterans May be NIH employees/staff who are either active duty service members or veterans; except for those who are employed by NINR or subordinates, relatives, and/or co-workers of NINR employees/staff Have sustained at least 1 TBI, >= 6 months and <= 5 years since their most recent TBI, which includes any self-reported loss of consciousness (LOC) established by the OSU during the pre-screening phone call Are able to provide their own consent Are able to understand the protocol, as shown by scoring a 6 out of 6 on a consent quiz Currently receiving treatment for a medical illness or recent injury that precludes protocol participation, may interfere with study participation, and/or should be treated/stabilized prior to study participation for safety reasons (e.g., cancer, recent fracture(s) requiring therapy and/or pain medication, severe infection). Individuals with stable medical conditions such as hypertension that are controlled by medication will be included Current physical health status will be assessed by self-report, history and physical exam by a credentialed physician or nurse practitioner, and standard laboratory tests Current unstable endocrine disorder (e.g., uncontrolled diabetes). Unstable endocrine disorders require treatment to ensure health and safety of the patient before participation is possible. Individuals with stable endocrine disorders (e.g., controlled diabetes) may participate in the protocol but they will be excluded from the hydrocortisone stimulation test. This will be assessed by self-report during the history and physical exam and by standard laboratory tests Have a major medical illness that is associated with fatigue (e.g., chronic fatigue [diagnosed prior to their TBI or less than 6 months following TBI], multiple sclerosis, or cancer). This will ensure that symptoms of fatigue are as a result of TBI and not another co-morbid illness. This will be assessed by self-report Currently consuming any of the following sleep modifying medications: benzodiazepines; benzodiazepine receptor agonists; opiates; or sedatives. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants currently taking these medications will be excluded. This will be assessed by self-report Currently using the sleep modifying medications melatonin and/or Benadryl greater than 2 times per week and/or unable or unwilling refrain from using them during protocol participation. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants who are unwilling/unable to refrain from using these medications will be excluded. This will be assessed by self-report Current psychiatric condition for which immediate treatment is required to prevent harm to self or others such as active suicidality or active manic phase in someone who has bi-polar disorder. This is to ensure patient safety and care. This will be assessed by self-report and as part of the history and physical exam Are pregnant. Pregnancy is associated with increased fatigue and sleep disturbances, as such this condition will affect the outcomes of this analysis.his will be assessed by self-report. This will also be assessed on visit 2 by a urine pregnancy test. Individuals who are nursing are eligible but will not participate in the hydrocortisone stimulation test Received a diagnosis of severe obstructive sleep apnea (OSA) and/or current reliance on continuous positive airway pressure (CPAP) therapy to aid sleep. Severe OSA and CPAP use will directly affect the result s of this study, as such these participants will be excluded. This will be assessed by self-report. **Participant may be able to participate in the protocol but will not be able to have an MRI if they have any of the following Metal in the body such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if they are a welder or metal worker | 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, Major Depressive Disorder patients aged between 18-64 years old with a history of MDD patients with history of bipolar disorder, schizophrenic-spectrum disorder, substance abuse, alcohol dependence, dementia, patients with history of mental retardation and those unable to give consent | 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): 18.0-45.0, Post Partum Depression Female subjects, ages 18-45 years Experienced a major depressive episode in the postpartum period beginning within the first 4 weeks following delivery and with moderate or severe symptoms (>12 EPDS or >14 HAM-D) No or partial response to adequate doses of SSRI medications to treat PND for longer than 6 weeks PND patients will be requested to maintain the stable dose of antidepressants while enrolled in the study trial Patients that can speak and read the English language, are able to understand the study procedures and sign the informed consent No current or past psychosis or severe personality disorder No current substance abuse or dependence No serious and imminent suicidal or homicidal risk No recent or history of major and unstable medical problems that affect brain anatomy, neurochemistry, or function Not diagnosed with cardiovascular disorders No increased risk of laryngospasm or active upper respiratory infections Not diagnosed with an intellectual disability or neurodegenerative diseases Mothers that are currently breastfeeding No current 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): 18.0-50.0, Pollution; Exposure Smoke Inhalation Exposure to Pollution Healthy on the basis of medical history, blood pressure and test of C-reactive protein, lipids and blood sugar Non-smoker not exposed to second-hand smoke (SHS) as determined by saliva cotinine < 10 ng/ml and tetrahydrocannabinol (THC) < 50 ng/ml Flow mediated dilation of 4% or greater at screening visit Age 18 < or > 50 Physician diagnosis of asthma, heart disease, hypertension, thyroid disease, diabetes, renal or liver impairment or glaucoma. Unstable psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder) or current use of more than two psychiatric medications Systolic blood pressure > 150 Diastolic blood pressure > 100 Blood glucose > 110 LDL >130 Pregnancy or breastfeeding (by urine Human Chorionic Gonadotropin (hCG) and/or history) Alcohol or illicit drug dependence within the past 5 years BMI > 35 and < 18 Current illicit drug use (by history or urine test) More than 1 pack year smoking history Ever a daily marijuana smoker Smoked anything within the last 3 months Unable to hold allergy or other over-the-counter (OTC) medicines Occupational exposure to smoke, dusts and fumes Concurrent participation in another clinical trial Unable to communicate in English No social security number | 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 Diagnosis of Major Depressive Episode evaluated by the MINI-plus instrument. 2. Patients attending the depression outpatient clinic (HCPorto Alegre) for 6 months or more 3. History of two previous appropriate antidepressant treatments (dose: equivalent of 75 mg / day of amitriptyline and time: the minimum of four weeks) 4. Beck Depression Inventory scores above 18 Patients with bipolar disorder 2. Patients with substance abuse disorder, 3. Patients with risk of suicide 4. Patients with antisocial personality disorder 5. Patients with psychotic syndrome, 6. Patients with intellectual disability 7. Patients receiving some kind of psychotherapy at the present time and in the last four weeks. 8. Patients who are unable to communicate. 9. Patients with Dismissive Attachment Style | 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, Cystic Fibrosis Patients attending the adult service with a confirmed diagnosis of CF by sweat test or genotype 2. Able to provide written informed consent 3. Able to understand and comply with protocol requirements and instructions 4. Confirmed Pulmonary Exacerbation requiring treatment with intravenous antibiotics using defined (Physician and patient agreed need for admission for intravenous antibiotic treatment) Previous recipient of a lung or other solid organ transplant 2. Inability to complete questionnaires 3. Current enrolment in other investigational medicinal product randomised trial 4. Admission for reasons other than pulmonary exacerbation of CF | 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, Electroconvulsive Therapy Direct Current Electroencephalogram Ketamine Spreadind Depression Structured Clinical Interview for DSM-5 will confirm diagnosis of MDD or BPD-depressed (with or without psychotic features The clinical indications for ECT including treatment resistance or a need for a rapid and definitive response Hamilton Depression Rating Scale 24-item (HDRS-24) > 21; and Age range between 18 and 65 years of age Defined neurological or neurodegenerative disorder (e.g., history of head injury with loss of consciousness > 5 minutes, epilepsy, Alzheimer's disease) Other psychiatric conditions (e.g., schizophrenia, schizoaffective disorder, bipolar disorder) Current drug or alcohol use disorder, except for nicotine and marijuana Adults unable to consent, pregnant women, prisoner Non-English speakers Patients that cannot tolerate Methohexital and Ketamine | 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, Bipolar Disorder diagnosis of BD type I or II according to DSM-5 euthymic or with subthreshold symptoms (HDRS <14; YMRS <8) absence of an acute mood episode in the 3 months prior to the beginning of the intervention estimated Intelligence Quotient (IQ) lower than 85 significant physical or neurologic illness that can affect neuropsychological performance DSM-5 of substance abuse or dependence inability to understand the purposes of the study absence of psychosocial interventions in the past 2 years (psychoeducation group, functional remediation, mindfulness) | 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): 18.0-90.0, Music Therapy Caregivers Palliative Care Oncological patients in palliative care at their homes, older than 18 years old, and their formal caregiver, in case they have one Patients who have given their consent to be included in the study Oncological patients in palliative care at their homes, with diseases in an advanced stage and a short life expectancy (last days) Oncological patients with late stages dementia or psychological pathologies, not being capable of taking conscious decisions Oncological patients with hypoacusis or profound deafness, hindering the use of the mp3 player or mobile phone | 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, Major Depressive Disorder Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 20 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960) Patients were requested to be free of all the psychotropic and anti-inflammatory medications for at least 4 weeks before participating in the study Patients with bipolar I or bipolar II disorder Patients with personality disorders Patients with eating disorders Patients with substance dependence or abuse Patients with concurrent active medical condition Patients with history of seizures Patients with history of receiving Electroconvulsive therapy (ECT) Patients with inflammatory disorders Patients with allergy or contraindications to the used medications Patients with finally pregnant or lactating females | 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): 18.0-55.0, Major Depressive Disorder Unipolar, major depressive episode (MDE), with 17-item Hamilton Depression Rating Scale score ≥16. Patients may be psychiatric medication free, or if currently taking psychiatric medication, not responding adequately as evidenced by current MDE 55 years old Female patients of child-bearing potential must be willing to use an acceptable form of birth control during study participation such as condoms, diaphragm, oral contraceptive pills Must be enrolled in division's umbrella research protocol Able to provide informed consent Agrees to voluntary admission to an inpatient research unit at The New York State Psychiatric Institute (NYSPI) for baseline PET imaging and Magnetic Resonance Imaging (MRI), ketamine infusion, and repeat PET imaging Unstable medical or neurological illness including: A) baseline hypertension (BP>140/90); B) significant history of cardiovascular illness; C) Platelet count < 80,000 cells/uL; and D) Hemoglobin < 11 g/dL for females and < 12 g/dL for males Significant electrocardiogram (ECG) abnormality (e.g., Ventricular tachycardia, evidence of myocardial ischemia, symptomatic bradycardia, unstable tachycardia, second degree (or greater) atrioventricular (AV) block) Pregnancy, currently lactating, or planning to conceive during the course of study participation Diagnosis of bipolar disorder or current psychotic symptoms Current or past ketamine use disorder (lifetime); any drug or alcohol use disorder within past 6 months Inadequate understanding of English Prior ineffective trial of or adverse reaction to ketamine A neurological disease or prior head trauma with evidence of cognitive impairment. Subjects who endorse a history of prior head trauma and score ≥ 1.5 standard deviations below the mean on the Trailmaking A&B will be excluded from study participation Metal implants or paramagnetic objects contained within the body (including heart pacemaker, shrapnel, or surgical prostheses) which may present a risk to the subject or interfere with the MRI scan, according to the guidelines set forth in the following reference book commonly used by neuroradiologists: "Guide to MR procedures and metallic objects," F.G. Shellock, Lippincott Williams and Wilkins NY 2001. Additionally transdermal patches will be removed during the MR study at the discretion of the investigator Current, past, or anticipated exposure to radiation, that may ** | 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): 18.0-55.0, Recurrent Major Depression Women with past history of recurrent major depressive disorder 1. Women who are not currently pregnant 2. Meeting for prior depression (at least two episodes) and showing residual symptoms of depression (PHQ-9 score of 5-12) 3. Not meeting for a current active depressive episode (SCID criteria) 4. Having access to internet and a smartphone with data plan 5. Receiving no antidepressant/anxiolytic medication or under a stable regime of antidepressants/anxiolytics 2. Healthy control women 1. Women that are not currently pregnant 2. Do not meet for prior or current depression 3. Have access to internet and a smartphone with data plan for all participants Current diagnoses of: psychosis, bipolar disorder/maniac episodes, OCD, persistent antisocial behavior, severe developmental delay, or persistent self-injury needing clinical management or therapy, organic brain injury, substance misuse Past diagnoses of psychosis, bipolar disorder/mania episodes or OCD Use of marijuana equal or more than 4 days per week. Additional related to Magnetic Resonance Imaging safety requirements: We will participants who have metal or electrical equipment including Non-removable metal piercing Tattoos on head or neck, an older tattoo with metal-containing inks, and/or permanent makeup (eyeliner) An implanted (internal) defibrillator or pacemaker Cochlear (ear) implant Some type of clips used on brain aneurysms | 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, Cerebrovascular Disorders Diagnosis of hemorrhagic or ischemic stroke (ICD-10: I61, I63 and I64) Patients with First ever acute stroke | 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): 16.0-24.0, Depression Currently experiencing depression (MDD or PDD) Free of pharmacotherapy (ie. antidepressant medication) for >5 weeks Not currently engaging in regular moderate or vigorous intensity exercise Able to read/understand English Body mass index [BMI] < 40 Medically cleared to engage in aerobic exercise Currently engaged in another exercise trial Another Axis I/II DSM-5 disorder, apart from co-morbid anxiety disorder(s) Current or lifetime history of serious medical or neurological conditions Currently taking psychoactive drugs (occasional use of anti-anxiety medication permitted) Regular user of nicotine products Unstable medical conditions, especially those that prevent exercise Exhibiting significant suicide risk MRI contraindications Currently pregnant or breastfeeding | 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 Episode Depressive Disorder Bipolar Disorder Current mixed depression in any mood disorder (bipolar I, bipolar II or major depressive disorder) assessed with Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20 points AND Young Mania Rating Scale (YMRS) score ≥ 1 point in 3 or more items Any appropriate first or second line pharmacological regimen in accordance with guidelines to treat a major depressive episode in major depressive disorder (Agomelatina 25-50 mg/dia; Bupropiona 150-300 mg/dia; Citalopram 20-40 mg/dia; Desvenlafaxina 50 mg/dia; Duloxetina 60 g/dia; Escitalopram 10 mg/dia; Fluoxetina 20 mg/dia; Fluvoxamina 100 mg/dia; Mirtazapina 15 mg/dia; Paroxetina 20 mg/dia; Sertralina 50 mg/dia; Venlafaxina 75 Concomitant diagnosis of other neuropsychiatric disorders such as: schizophrenia, dementias, mental retardation, organic mental disorder, or epilepsy Acute suicide ideation (assessed by interview and clinical evaluation) Suspected or confirmed pregnancy Women in breastfeeding Severe or unstable clinical disease Specific contraindications to TBS: previous epileptic seizures; change in electroencephalogram at some point in life; previous stroke; previous severe TBI (with neurosurgery); metallic object on head (except mouth) as projectile piece, surgical clip, welding fragments; any implanted device (cardiac pacemaker, intravenous catheter) | 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): 18.0-52.0, Premenstrual Syndrome Premenstrual Dysphoric Disorder Premenstrual Tension Menstrual Related Mood Disorder Regular menstrual cycles, 23-35 days in length. 2. MRMD diagnosis based on the DRSP items, with: at least 1 or more core symptoms occurring during the luteal phase of the menstrual cycle for at least the past three months by patient history, including: 1) low mood, 2) hopelessness, 3) feeling worthless or guilty, 4) feeling anxious or "keyed up" or "on edge," 5) mood swings, 6) more sensitive to rejection or to hurt feelings, 7) feeling angry/irritable, or 8) having interpersonal conflicts. 3. Patients must also have at least 1 associated symptom on the DRSP that is not considered a core symptom that occurs during the luteal/premenstrual phase of the menstrual cycle. 4. Currently experiencing clinically significant MRMD symptoms, defined as ≥ 30% increase in the total Daily Record of Severity of Problems Scale (DRSP) score from the mid-follicular phase (average of DRSP scores for days 6-10) to the late-luteal phase (average of DRSP scores for last 5 days prior to menstrual bleeding). 5. Negative serum Human Chorionic Gonadotropin (HCG) at baseline, and negative urine HCG at visits 3 and 5. 6. Willingness to use adequate contraceptive methods during the study, if sexually active. Hormonal contraceptives are allowed if the premenstrual symptoms still meet study despite use and patient has been on a stable regimen for >3 months. 7. Good general health Amenorrhea or irregular menstrual periods (defined as unable to predict within 7 days) during past 2 months. 2. Pregnant and lactating women. 3. Women taking a prenatal vitamin, methotrexate, fluorouracil, colchicine, bromocriptine, Gonadotropin-Releasing Hormone (GnRH) agonists, vitamin B6 (>100 mg), calcium supplements (>1500 mg per day), or para-aminosalicylic acid. 4. Significant risk for self-harm or harm to others. 5. Meet for a primary diagnosis of schizophrenia, bipolar disorder, an active eating disorder of anorexia or bulimia, dementia, delirium, or other cognitive disorder. 6. Current major depressive episode or anxiety disorder that is a primary focus of current treatment. Patients may be on an antidepressant used for maintenance treatment if the dose is not changed intermittently to address premenstrual symptoms; dose must be stable for at least 8 weeks prior to study entry. 7. Presence of an active substance and/or alcohol abuse disorder within six months prior to screening. 8. Known low B12 levels, pPernicious anemia or history of gastric bypass surgery or bariatric surgery. 9. Seizure disorder or current use of an anticonvulsant medication 10. Allergy to beeswax, soy, fish, nuts, peanuts, egg, wheat, milk, and/or shellfish. 11. Non-English speaking | 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, Perineum; Injury primiparous or multiparous women who have never given birth vaginally term patients (after 37 weeks of amenorrhea) patients delivering a fetus in cephalic presentation patients speaking and understanding French patients suspected of having a fetal macrosomy (greater than the 97th percentile) on the last ultrasound patients with twin pregnancies excised patients patient who has made an acupuncture preparation during pregnancy patients with fetal death in utero patients requiring medical termination of 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): 12.0-999.0, Sedentary Behavior not meeting physical activity guidelines proposed by the World Health Organization any existing diseases with contraindications for moderate intensity physical activity, confirmed by patient's primary care physician or a specialist in cardiovascular diseases/endocrinology/rehabilitation medicine providing care for the patient during the recruitment and follow-ups | 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): 45.0-70.0, Protein Deficiency Training Group, Sensitivity Fatigue Muscular Atrophy Psychological Healthy (no current injuries) Between 45 and 70 years old Active Injuries Never trained before Under 45 or over 70 years old | 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, Depression, Postpartum Mothers with ongoing or former either depression or anxiety diagnosis Other psychiatric comorbidities Premature birth (<37 week) admission to neonatal unit if the infant is born with syndromes or other malformations | 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): 45.0-75.0, Colorectal Adenoma Colorectal Polyp Colorectal Adenocarcinoma Colorectal SSA Primary Criteria. 1. Average risk asymptomatic subjects undergoing a first colonoscopy (screening) or screening colonoscopy at least 10 years after prior colonoscopy. 2. Aged 45 years to aged 75 years at the time of enrollment. 3. Capable of providing written informed consent and willing and able to adhere to all protocol requirements, and/or the subject's legally acceptable representative(s) capable of providing written informed consent. Primary 1. History of any colorectal cancer or colon adenomas. 2. History of inflammatory bowel disease, including Crohn's disease or ulcerative colitis. 3. Family history of colon cancer or precancerous colon polyp in a first degree relative before age 50. 4. Polyposis syndromes including Familial Adenomatous Polyposis, Cowden syndrome, Lynch syndrome, Peutz-Jeghers syndrome, MUTYH Associated Polyposis, Familial Colorectal Cancer Type X. 5. Surveillance, therapeutic, preoperative, or diagnostic colonoscopy. 6. Colonoscopy for work-up of abdominal or pelvic symptoms including abdominal pain, flank pain, pelvic pain, subject report of altered stool, subject report of anemia within the past 12 months, subject report of gastrointestinal bleeding including bright red blood per rectum or tarry stools, constipation, diarrhea, subject reported history of abdominal or pelvic mass, subject report of unintentional weight loss. 7. Workup or referral to diagnose or evaluate abnormal imaging of the abdomen or pelvis. 8. Positive Fecal Immunochemical Test history. 9. Severe co-mobordity, including end-stage cardiovascular, pulmonary, liver, or renal disease. 10. History of colon resection, not including the appendix. 11. Currently receiving a therapy not permitted during the trial, as defined in Section 8.3. 12. Any issue that, in the opinion of the investigator, would render the subject unsuitable for participation in the trial. Enrolled subjects will be eligible for Post-procedure Periods if their colonoscopy meets the following 1. Adequate bowel preparation score per the Boston Bowel Preparation Scoring System (BBPS) > or equal to 2 in all colonic segments. 2. Colonoscopies with successful cecal intubation. 3. Colonoscopies with withdrawal times of at least 6 minutes | 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, Depression, Unipolar patients accept paticipating in reasearch patients don't answer full HRDS | 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): 6.0-20.0, Major Depressive Disorder Be a child aged or an adolescent aged 6-20 years-old (this may be a declaratory age at the time of the consultation or based on a document for a residence request if no other identity documents are available) Be a first or second-generation migrant (born abroad or born from at least one parent who is born abroad) Have a psychological and/or psychiatric follow-up by a first-line care Have been referred for transcultural psychotherapy by their first line care to treat depression resistant to standard management Present a depression according to the clinician who proposes the transcultural treatment (first line therapist), based on usual as well as cultural symptoms of the below list Sadness Diminish interest or pleasure in most of the usual activities Insomnia or hypersomnia Psychomotor agitation Asthenia, loss of energy Patient or family has previously had transcultural psychotherapy Patient presents an acute psychiatric disorder which hinders the realization of the transcultural therapy for example, excited delirium with great psychic disorganization, or high suicidal risk patients. These situations will be excluded during the screening time based on the first line therapist evaluation Patient presents an acute somatic disease which may hinder the well organization of the therapy Patient addressed for a legal expertise Child's/Adolescent's refusal Pregnant or breastfeeding (for women for young women of childbearing age) Participation in another interventional study Patient under guardianship or curatorship | 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, Tobacco Use Cessation Pregnancy Related older than 18 years gave up smoking 6 months before or during pregnancy owns a smartphone has a stable partner/husband offers the partner's contact data signs the informed consent CO level (ppm) below 4 younger than 18 years smoker does not own a smartphone does not have a stable partner/husband refuses to offer the partner's contact data refuses to sign the informed consent refuses the CO level measurement or the CO level (ppm) is above 4 | 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, Major Depressive Disorder 18-60 years old; 2. Meeting with the of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5; 3. Scored 20 or higher on the Hamilton's Depression Scale with 24 items (HAMD-24); 4. With enough audio-visual ability and comprehensive ability to accomplish the visits; 5. Be necessary and suitable to accept the treatment of antidepressants; 6. Scored less than 14 on Hamilton's Anxiety Scale (HAMA) and scored less than 14 on the Hypomania Symptom Checklist-32 (HCL-32); 7. With 2 or more atypical symptoms including significant weight gain or increase in appetite, hypersomnia, leaden paralysis, and a long-standing pattern of interpersonal rejection sensitivity that results in significant social or occupational impairment Severe medical or neurological problems; 2. Previous mania or hypomania episodes; 3. Female patients who are pregnant, planning to be pregnant or breastfeeding; 4. Actively suicide ascertained by research psychiatrist or 3rd item of HAMD scored≥3(suicidality); 5. Had electroconvulsive therapy, modified electroconvulsive therapy or repetitive transcranial magnetic stimulation in the past 6 months; 6. Experienced severe personality disorder, mental retardation, anorexia/bulimia nervosa | 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): 16.0-60.0, Major Depressive Disorder 16-60 years old; 2. Meeting with the of major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5; 3. Scored 20 or higher on the Hamilton's Depression Scale with 24 items (HAMD-24); 4. With enough audio-visual ability and comprehensive ability to accomplish the visits; 5. Be necessary and suitable to accept the treatment of antidepressants; 6. Scored less than 14 on Hamilton's Anxiety Scale (HAMA) and scored less than 14 on the Hypomania Symptom Checklist-32 (HCL-32); 7. With 2 or more atypical symptoms including significant weight gain or increase in appetite, hypersomnia, leaden paralysis, and a long-standing pattern of interpersonal rejection sensitivity that results in significant social or occupational impairment Severe medical or neurological problems; 2. Previous mania or hypomania episodes; 3. Female patients who are pregnant, planning to be pregnant or breastfeeding; 4. Actively suicide ascertained by research psychiatrist or 3rd item of HAMD scored≥3(suicidality); 5. Had ECT, MECT or rTMS in the past 6 months; 6. Experienced severe personality disorder, mental retardation, anorexia/bulimia nervosa | 2 |
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