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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): 18.0-999.0, Major Depression Dysthymia Patients age 18 and older Diagnosis of major depression or dysthymia Willing and able to provide informed consent There are no for this study | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Major Depression Dysthymia Age >=18 years Diagnosis of major depression or dysthymia as documented in the patient's EMR There are no for this study | 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): 18.0-64.0, Major Depressive Disorder (MDD Subjects) All genders, races, and ethnic origins, aged between 18 and 64 DSM-5 diagnostic for MDD (diagnosed with the use of the Structured Clinical Interview for DSM-5 (SCID-5)) A score of ≥32 on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Capable of providing written informed consent, and fluent in English Right-handed Treatment Resistant (as assessed using the MGH Antidepressant Response Questionnaire) Have already decided to receive ketamine treatment as part of their standard clinical care (Control Subjects) All genders, races, and ethnic origins, aged between 18 and 64 Absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse), as assessed by subject history and a structured clinical interview (SCID-I/NP) (All Subjects) Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease History of seizure disorder History or current diagnosis of any of the following DSM-5 psychiatric illnesses: schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, substance abuse disorder Clinical or laboratory evidence of hypothyroidism, hyperthyroidism, or other thyroid disorder that is not controlled by medication Substance use assessed by physician as dangerous for ketamine treatment Untreated glaucoma Complex post-traumatic stress disorder (PTSD) with dissociation Patients with a lifetime history of electroconvulsive therapy (ECT) Participants with a lifetime history of ketamine use | 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, Patellofemoral Dislocation The potential person is of legal age, capable of providing informed consent and must sign the Informed Consent Form approved by the Ethics Committee (EC) Diagnosis of MPFL injury, performed before surgery, documented by Magnetic Resonance Imaging (MRI) of the affected knee Absence of osteochondral lesions larger than 3 cm2 at the baseline The contralateral knee was and is asymptomatic, stable and functional The patient must be physically and mentally inclined and must have completed post-operative rehabilitation according to the protocol provided at the time of discharge Local or systemic infection Knee osteoarthritis documented radiographically at baseline Articular cartilage injury greater than grade I of Outerbridge detected during surgery History of anaphylactic reaction Systemic therapy with all types of corticosteroids or immunosuppressants in the 30 days prior to surgery Evidence of osteonecrosis in the involved knee History of rheumatoid arthritis, inflammatory arthritis or autoimmune pathologies Neurological pathologies or conditions that the patient is unsuitable for the rehabilitation protocol Untreated meniscal tissue loss greater than 50% at baseline State 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): 0.167-999.0, Muscular Atrophy, Spinal All Participants Not eligible for treatment with currently approved treatments for SMA, or cannot continue treatment with currently approved medications as documented by the treating physician, or in the treating physician's judgment, the participant is at risk of lack/loss of treatment efficacy of the current therapy The participant does not qualify for and has no access to SMA treatment in the context of an ongoing clinical trial Adequately recovered from any acute illness at the time of screening, and considered clinically well enough to participate, in the opinion of the treating physician Participants with retinopathy of prematurity should have evidence of stable disease. Type 1 SMA Participants Confirmed diagnosis of 5q-autosomal recessive SMA. Type 2 SMA Participants Confirmed diagnosis of 5q-autosomal recessive SMA Negative blood pregnancy test at screening (all women of childbearing potential, including those who have had a tubal ligation), and agreement to comply with measures to prevent pregnancy and restrictions on egg and sperm donation Males with female partners of reproductive potential must agree to use highly effective contraception during therapy, and for at least 4 months after treatment discontinuation Inability to meet program requirements Concomitant or previous participation in any investigational drug or device study within 90 days prior to screening or 5 half-lives, whichever is longer Administration of other SMN-2 targeting therapy within 120 days of starting risdiplam therapy Administration of SMA gene therapy within the last 3 months (12 weeks) of receiving risdiplam therapy Any serious medical condition, treatment, or abnormality in clinical laboratory tests that, in the treating physician's judgment, precludes the participant's safe participation in the program Ascertained or presumptive hypersensitivity (e.g., anaphylactic reaction) to risdiplam or to the constituents of its formulation Suspicion of illicit drug or alcohol abuse, in the treating physician's judgment Any prior use of an inhibitor or inducer of flavin-containing monooxygenases 1 (FMO1) or flavin-containing monooxygenases 3 (FMO3) taken within 2 weeks (or within 5 times the elimination half-life, whichever is longer) prior to dosing | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 21.0-55.0, Electronic Cigarette Use Men and women, aged 21-55 years Able to read and write English Able to give voluntary, written informed consent Current cigarette smoking or e-cigarette use Non-treatment seeking Exhaled CO > 10 ppm or urine cotinine > 50 ng/ml Agreement to only use e-cigarette products provided in the study Not naïve to vaping (3 or more months and 12 or more times) Current medical condition such as neurological, pulmonary, cardiovascular, endocrine, renal, liver, or thyroid pathology History of or current neurological or psychiatric disorder including drug or alcohol dependence (as per SCID for DSM-5) except Nicotine Dependence Regular or current use of any prescription, herbal or illegal psychotropic medications in the past 1 year, with no current illegal drug use confirmed by urine toxicology (including cannabis) Drink more than 14 drinks per week for women or 21 drinks per week for men Women who are pregnant or nursing Individuals who are currently taking medication that may affect cholinergic system or nicotine replacement therapy prescribed for smoking cessation Contraindications to MRI such as claustrophobia or metal in their body, or to PET such as history of cancer Patient unlikely to be able to complete the study as determined by the PI or research assistants Blood donation within eight weeks of the start of the study History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto) Known hypersensitivity to propylene glycol | 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): 1.5-999.0, Quality of Life Endometrial Cancer Surgery--Complications Gynecologic Cancer Woman over 18 years of age scheduled for primary surgery for histologically verified endometrial cancer (regardless of histological type or degree) tumor clinically restricted to the uterus (presumptive FIGO stage I or II) speaks and reads Swedish capable of completing the questionnaire independently Clinical or radiological cancer outside the uterus preoperative radio / chemotherapy | 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): 11.0-16.0, Low Mood Depression Aged 11 to 16 years at the date of consent Experiencing low mood or depression symptoms as defined by a score of ≥20 on the Mood and Feelings Questionnaire In agreement that their primary care provider and a parent/guardian can be informed of any concerns the lead researcher has about their wellbeing during participation Within the normal range on the measure of depressive symptoms (i.e. attaining a score of ≤19 on the Mood and Feelings Questionnaire) Experiencing severe low mood or depression symptoms Having a comorbid mental health diagnosis of Bipolar Disorder or Psychosis Non-English speaking (due to the small scope of this study, the option of providing translated versions of BALM and the outcome measures was not feasible) Deemed to be actively at risk of self harm or suicide Have no access to the internet and therefore no programme access | 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): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia | 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, Medical Termination of Pregnancy Patient having experienced a medical termination of pregnancy in Brest Hospital Medical termination of pregnancy after 14 weeks Induction for natural delivery No opposition Medical termination of pregnancy before 14 weeks Selective termination of pregnancy (multiple pregnancy) Caesarean Patient not speaking french Patient's refusal | 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, Hip Arthropathy Postoperative Pain primary THA with lateral approach under general anesthesia Hip fracture allergy to local anesthetics peripheral neuropathy creatinin clearance inferior to 30ml/min weight inferior to 50 Kg or superior to 100 Kg neurological disorder affecting the lower extremity, significant psychiatric conditions patients receiving corticosteroid therapy chronic consumption of opioids (>2 months) | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-70.0, Moderate Depressive Episodes (Major Depression) Study Phase 1 Age 18-70 years Diagnosis according to DSM-IV-TR: 296.32: Outpatients with a mediocre depressive episode requiring treatment for recurrent major depression At least 5 of the following symptoms must persist for 2 weeks, with at least one of the main symptoms Depressed mood (main symptom) Loss of interest or pleasure (main symptom) Significant weight loss without diet or weight gain Increased sleep or insomnia Psychomotor restlessness or slowing down Excessive, inappropriate guilt or feelings of worthlessness on almost every day General (phase 1 and phase 2) Unable to work and patients cared for according to the BtG (working group "Stay") and "Medical Measures") Simple mourning reaction Clinically relevant laboratory abnormalities due to severe organ and systemic diseases Taking immunosuppressants (eg after organ transplants) Taking oral contraceptives with low levels of hormones (estrogen ≤ 50 μg, micropillus) Thyroid dysfunction (patients with non-euthyroid TSH levels) Known intolerance to the test medication Known photosensitivity Diabetes mellitus type I and II requiring treatment | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 0.0-999.0, Pelvic Organ Prolapse Stage II-IV pelvic organ prolapse Bothersome bulge symptoms At least 725 MET-minutes/week on International Physical Activity Questionnaire Short Form English-speaking Undergoing treatment of prolapse Surgery occurring at least 7 days from date of randomization (to allow for collection of at least 7 days of preoperative accelerometer data) Able and willing to follow up at 3 months for in-office exam Enrollment in another research study of pelvic organ prolapse Concomitant non-urogynecologic surgery Planned further surgery in the next 3 months or anticipated treatment which would result in prolonged inactivity (such as a cancer diagnosis) 3 months postoperatively | 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, COVID 19 Patients who have shown at Institute of Liver & Biliary Sciences (ILBS) between 1st January 2018 and 31st March 2020 will be considered as currently being enrolled at ILBS for treatment Incomplete questionnaires | 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, Pregnancy Related Cesarean Wound Disruption Cesarean Section; Infection Pregnant female age great than 18 years 2. Singleton gestation 3. Plan for cesarean delivery 4. Planned gestational age of at least weeks at the time of delivery 5. English speaking 6. Able to provide own informed consent 7. Intention of being available for entire study period and complete all relevant study procedures, including follow-up study visits and phone calls at screening/enrollment: 1. Diabetes requiring therapy (type I or type II diabetes, gestational diabetes on medical therapy) 2. BMI greater than or equal to 40 kg/m2 at the time of enrollment 3. Placenta previa or placenta accreta 4. Prior bowel or urologic surgery (except un-ruptured appendectomy or uncomplicated cholecystectomy) 5. Multiple gestation 6. Previous history of postpartum hemorrhage requiring medical or surgical treatment 7. Known or suspected impairment of immunologic function including infection with HIV, hepatitis B or C 8. Known tobacco or drug use 9. Any condition which, in the opinion of the investigator, may pose a health risk to the subject or interfere with the evaluation of the study objectives 10. History of keloid formation at time of surgery: 1. Labor at time of presentation to labor and delivery (regular, painful uterine contractions occurring every 5 minutes with evidence of cervical change) 2. Chorioamnionitis or other systemic infection at time of presentation for cesarean section, including evidence of lower abdominal skin infection (i.e. yeast, etc) 3. Need for urgent Cesarean section (examples but not limited to: non-reassuring fetal status (category II or III tracing), placental abruption, severe preeclampsia or eclampsia) 4. Rupture of membranes prior to the start of the surgery 5. Meconium-stained or blood-stained amniotic fluid 6. Experiences intraoperative hemorrhage requiring transfusion, disseminated-intravascular coagulopathy (DIC), or other medical or surgical condition during the delivery deemed by the investigator to pose a prohibitively high risk for surgical re-exploration or wound complication. 7. Who, in the investigator's opinion, would have any clinically significant condition that would impair the patient's ability to comply with the study procedures 8. Need for vertical skin incision 9. Intraoperative use of hemostatic agent (examples and 10. Plan for use of staples at closure of the skin incision 11. Preeclampsia with severe features | 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 COVID19 Anxiety PTSD Pregnancy Related Pregnant women between 12 and 18 weeks of gestation Viable intrauterine pregnancy History of severe psychiatric Substance abuse disorder Requiring medical treatment Presence of fetal chromosomal/structural abnormality | 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 Samples from triple negative BC patients, patients treated by neoadjuvant chemotherapy ( FEC or EC than taxanes) Patients consent to use their samples Samples not available before or after neoadjuvant chemotherapy | 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, Alcohol Drinking Alcohol-Related Disorders Pandemic Psychological Stress Participants who have enrolled in the NIAAA Screening Protocol (14-AA-0181) and completed screening and phenotyping assessments. 2. Willing and able to complete frequent (weekly to monthly) surveys either online or by phone As this is a natural history protocol, there are no formal exclusionary for this study. Participants who are determined by the interviewer to be uncooperative or unable to provide consent via telephone will not be enrolled into 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): 18.0-999.0, Colon Cancer Diagnosed with colon cancer years old or older Written and verbally informed consent Pacemakers, implanted medical pumps, and nerve stimulators Cochlea implants and cerebral aneurism clips will in some cases be absolute contraindications to MRI examinations Previous treatment with radiation and or chemotherapy Serious disease that contraindicates surgical treatment, including severe heart disease Any type of cancer other than of the colon (excluding skin cancer, cancer in situ, endometrial cancer, malignant melanoma) Any other condition or disease that from the investigator's point of view makes it inappropriate for the patient to participate | 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, Contraception Women 18 years and older currently using COCs or who have a COC prescription and are intending to initiate COCs for contraception Women who have contraindications to using a COC or a contraceptive implant (Category 3 or 4 in the CDC Medical [MEC]) Because the CDC MEC are continuously revised, the most updated will be used (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5904a3.htm) Women who are currently participating in a clinical trial or have participated within the past 30 days Less than 2 weeks from the end of a 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): 18.0-60.0, Sexual Behavior any partners between 18-60 years any husband or wife that have organic sexual problems | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-64.0, Depressive Disorder, Major Participant with diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and 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 has a Hamilton Rating Scale for Depression (HAM-D) total score ≥24 at screening and Day 1 (prior to dosing). 3. Participants taking antidepressants must have been taking these medications at the same dose for at least 60 days prior to Day 1. Participants who have stopped taking antidepressants within 60 days must have stopped for longer than 5 half-lives of the antidepressant prior to Day 1. Participants receiving psychotherapy must have been receiving therapy on a regular schedule for at least 60 days prior to Day 1. 4. Participant is willing to delay start of other antidepressant or antianxiety medications and any new pharmacotherapy regimens, including as-needed benzodiazepine anxiolytics and sleep aids, until after completion of the Day 42 visit Participant is currently at significant risk of suicide, as judged by the Investigator, or has attempted suicide associated with the current episode of MDD. 2. Participant has onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant has presented for screening during the 6-month postpartum period. 3. Participant has a body mass index (BMI) ≤18 or ≥45 kg/m^2 at Screening, which is subject to a broader evaluation of medical comorbidities. 4. Participant has treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants within the current major depressive episode (excluding antipsychotics) from two different classes for at least 4 weeks of treatment. 5. Participant has a medical history of seizures, bipolar disorder, schizophrenia, and/or schizoaffective disorder. 6. Participant has a history of mild, moderate, or severe substance use disorder (including benzodiazepines) diagnosed using DSM-5 in the 12 months prior to screening. 7. Participant is taking psychostimulants (eg, methylphenidate, amphetamine) or opioids, regularly or as-needed, at Day -28 | 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): 18.0-85.0, Advance Care Planning Aged 18 and over 2. A palliative care diagnosis confirmed by a referring healthcare professional, i.e. a diagnosis of a life-threatening or life-limiting illness 3. Have completed one or multiple ACP discussions as defined below, at any time prior to referral to study, with a healthcare professional 4. Sufficient cognitive capacity to provide informed consent and complete an interview For the purposes of recruitment for this study, ACP is defined as: Any significant discussion with a healthcare professional where patients have discussed their values, goals or preferences for future care. These can discussions about wishes for further disease-modifying treatment, wishes for intensity of general medical care, preferred places of care and death, discussions around resuscitation and transfer to hospital, and completion of advanced directives. Healthcare professionals can any doctor, nurse or allied health professional Any patient the researcher has ever met or cared for in a clinical capacity, or knows in any other capacity 2. Any patient who has only had ACP discussions with a volunteer (trained or untrained) or non-healthcare professional 3. Inability to provide informed consent 4. Any patient deemed by the referring healthcare professional to be potentially too unwell or frail to undertake an 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): 18.0-999.0, Mental Health Issue Musculoskeletal Pain The are students at selected universities/colleges in the Stockholm attending selected educational programs with at least one remaining academic year before graduating. Students from matriculation to master level studies are invited to participate. Participants need to be 18 years of age or older, have access to a smart phone, laptop or tablet and speak sufficient Swedish or English | 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, Non Small Cell Lung Cancer Surgery EGFR Activating Mutation Chemotherapy EGFR TKI Histologically or cytologically confirmed NSCLC, performed on a biopsy that occurred within the last 60 days Computed tomography (CT) or PET-CT within the last 30 days showing radiographic stage Ⅱa to Ⅲb lung cancer (mediastinal staging biopsy is allowed but not required) by the American Joint Committee on Cancer (AJCC) 8th edition Deemed surgically resectable by a senior thoracic surgeon Age≥18 years, and ≤75 years Measurable disease per Response Evaluation in Solid Tumors (RECIST) 1.1 as assessed by the investigator Adequate tissue specimens for correlative biomarker analysis. The patient should be willing to provide tissue from a newly obtained biopsy of a tumor lesion and surgical resected tumor lesion Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Resolution of all acute toxic effects of prior chemotherapy, radiotherapy or surgical procedures to NCI CTCAE version (v)5.0 grade 1 Be willing and able to provide written informed consent for the trial Absolute neutrophil count (ANC) >= 1500 cells/ microlitre(uL) (within 10 days prior to the start of trial treatment) Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 years prior to initiation of study treatment; however, the following are allowed Hormone-replacement therapy or oral contraceptives Herbal therapy > 1 week prior to Cycle 1, Day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to Cycle 1, Day 1) Malignancies other than the disease under study within 3 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score ≤ 6, and prostate-specific antigen (PSA) ≤ 10 mg/mL, etc.) Patients who are receiving any other investigational agents concurrently History of allergic reactions attributed to compounds of similar chemical or biologic composition to afatinib, cisplatin, carboplatin, pemetrexed or gemcitabine Patients with active hepatitis B or C infections or a history of HIV infection Patients with past or resolved hepatitis B infection, defined as having a negative hepatitis B surface antigen (HBsAg) test and a positive for the antibody test to detect antibodies to hepatitis B core antigen (anti-HBc) are eligible Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection including tuberculosis (TB), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study 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): 18.0-999.0, Single Embryo Pregnancy Gestational Weeks 24-42 Pain/Sensitivity >5 on Numeric Rating Scale (NRS) Women > 18 years Single embryo pregnancy in week 24-42 was diagnosed with symphysiolisis according to written above Pain/sensitivity >5 on NRS scale in symphysis pubis area for more than two weeks Lack of proficiency in Hebrew or English Pain from a different source pelvic bone disease or history of severe pelvic bone injury Thrombocytopenia (plt<50.000) Acupuncture treatment is contraindicated High risk 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): 18.0-65.0, Major Depressive Disorder Advanced Cancer Age: 18 to 65 years of age 2. Sex: Male or female 3. Major depressive disorder (MDD) diagnosis as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5). 4. Palliative stage cancer diagnosis (advanced-disease stage) 5. Who can read and write in spanish 6. Eastern Cooperative Oncology Group (ECOG) 0-2 7. Karnofsky ≥ 50 8. Palliative prognostic index A 9. Not currently undergoing systemic oncologic treatment 10. Patients who agree to participate in the study by signing an informed consent Comorbidities including other psychiatric diseases (additional to MDD, generalized anxiety or panic disorder). 2. Magnetic resonance or computerized tomography with major structural alterations. 3. Pregnant or breastfeeding women. 4. Patients with hypersensitivity to ketamine 5. Cardiac insufficiency 6. Patients with a history of psychosis 7. Patients with first-degree relatives with a history of psychosis 8. Patients with uncontrolled glaucoma 9. Current neurological illness | 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): 18.0-64.0, Depressive Disorder, Major Diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Clinical Trials Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period HAM-D-17 total score of ≥24 at Screening and Day 1 Participant 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 Participant is willing, able, and eligible to take at least 1 of the 5 ADTs specified in the protocol (an eligible ADT is an ADT that has not been taken during the current depressive episode and for which the participant has no contraindications; further, a participant is not eligible for citalopram if escitalopram has been taken during the current depressive episode, and vice versa) Has attempted suicide associated with the current episode of MDD Participant had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant has presented for screening during the 6-month postpartum period Participant has treatment-resistant depression History of bipolar disorder, schizophrenia, and/or schizoaffective disorder Known allergy to SAGE-217, allopregnanolone, or related compounds Has taken antidepressants within 30 days prior to Day 1, and/or has taken fluoxetine within 60 days prior to Day 1 | 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): 18.0-90.0, Music Therapy Caregivers Sleep Palliative Care Being informal carer of a domiciliary palliative care patient Having given informed consent to take part in the study Informal carer with severe hypoacusia, making it difficult to listen to the music on the phone/use of headphones Informal carer allergic to plastic and/or metal Informal carer with a programmed trip in the 2 weeks the study takes place Informal carer without 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): 18.0-50.0, Major Depressive Disorders a current episode of MDD diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) age between 18 and 50 years a total score of HAMD-17 ≥ 17 take antidepressants less than 3 days Patients are compliant with treatment according to the judgement of the treating clinician. Participant or guardian has to sign informed consent. The patients' guardians will sign the informed consent on behalf of the participants when the capacity of participants to consent is compromised A history of manic episode Use of mood stabilizer History of substance abuse or dependence Severe somatic diseases that might interfere with regular antidepressant treatment including conditions such as kidney and liver failure, uncontrolled hypertension, cardiovascular, cerebrovascular and pulmonary disease, thyroid disease, diabetes, epilepsy and asthma Use of anti-inflammatory medication for longer than 7 days in the last two months preceding the trial Use of immunosuppressive medication such as oral steroid hormones Women in pregnancy or lactation period | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Depressive Symptoms Must live in Hillsdale County, Michigan for at least one year Positive screen for at least mild depressive symptoms based on the the Patient Health Questionnaire-9 (PHQ-9>=5) Non-English speaking Currently receiving cognitive behavioral therapy (CBT) for depression Ever completed a course of cognitive behavioral therapy (CBT; >=8 sessions) Diagnosis of a psychotic disorder Current use of opiates or freebase cocaine Prominent suicidal/homicidal ideation with imminent risk | 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, Depressive Disorder, Major --Established diagnosis of Major Depressive Disorder (MDD), single episode or recurrent, as confirmed at the time of screening by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th version (DSM-5) (SCID-5), with a duration of current depressive episode ≥ 8 weeks and ≤ 12 months at the time of screening visit Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 26 at screening, as confirmed by a trained site based rater AND interactive, computer administered MADRS. The difference in the rater and computer administered MADRS must not exceed more than 7 points (for details refer to section 6.2). In addition, trial participants must have a score of ≥ 3 on the Reported Sadness Item on both MADRS scales (computer administered and rater-administered MADRS) A documented ongoing monotherapy treatment of ≥ 8 weeks at the screening visit, with a protocol specified Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) (refer to the ISF) at adequate dose (at least minimum effective dose as per prescribing information and as confirmed per detectable drug levels in the screening blood sampling) Male and female participants, 18 to 65 years of age, both inclusively at the time of consent Women who are of child-bearing potential (WOCBP)1 must be able and willing to use two methods of contraception which one highly effective method of birth control per ICH M3 (R2) that result in a low failure rate of less than 1%, plus one additional barrier Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Able to communicate well, and to understand and comply with trial requirements Per DSM-5, had ever met diagnostic for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, delusional disorder or MDD with psychotic features as assessed by the Structured Clinical Interview for DSM-5 Clinical Trials (SCID-5) at the time of screening Diagnosis of any other mental disorder (in addition to those as described in Criterion #1) that was the primary focus of treatment within 6 months prior to screening or at baseline (as per clinical discretion of the investigator) Diagnosis with antisocial, paranoid, schizoid or schizotypal personality disorder as per DSM-5 at the time of screening visit. Any other personality disorder at screening visit that significantly affects current psychiatric status and likely to impact trial participation, as per the judgement of investigator Diagnosis of a substance related disorder within 3 months prior to screening visit (with exception of caffeine and tobacco) History of seizure disorders, stroke, brain tumor or any other major neurological illness that can impact participation in the trial History of more than 2 unsuccessful monotherapy treatments (at adequate dosage and duration, per local prescribing information of the product) with an approved antidepressant medication for the current ongoing major depressive episode. These ongoing monotherapy treatment with a protocol specified SSRI or SNRI as described in Criterion #3 Any suicidal behavior in the past 12 months prior to screening (per investigator judgement including an actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour) Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (CSSRS) in the past 3 months prior to screening or at screening or baseline visit (i.e. active suicidal thought with method and intent but without specific plan, or active suicidal thought with method, intent and plan) | 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, Lower Gastrointestinal Neoplasms Benign Pancreas Cancer Posttraumatic Stress Disorder Depression, Anxiety Consecutive adult patients of both genders ≥ 18 years subjected to major (oncological) surgery due to pathologies of the pancreatic and lower gastrointestinal tract at our department The initial diagnosis does not date back longer than 6 months prior the planned surgery. Neoadjuvant radio-/chemotherapy is not an Able to speak and understand German or English Signed written informed consent by the participant after extensive oral and written information about the research project and its aims Thresholds of primary outcome: anxiety levels measured with STAI-form Y-1 (state) and Y-2 (trait). Thresholds: scores between 20 (minimum) and 80 (maximum) in each subscore Woman who are pregnant or breast feeding Known or suspected non-compliance regarding the execution of painting art therapy and/or the proper completion of the needed forms Drug or alcohol abuse Regular intake of antidepressant medication with the exception of medication prescribed for chronic insomnia Acute suicidality Life expectancy less than 9 months after planned surgery Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, ect. of the participant | 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, Colorectal Cancer Liver Metastases The primary tumor was confirmed by histology as colorectal adenocarcinoma 2. primary right-sided colorectal adenocarcinoma 3. Radiologic evidence suggests that the initial unresectable liver metastases 4. RAS/BRAF gene wild-type states 5. ECOG was 0 ~ 1 6. Life expectancy ≥ 3 months 7. Good hematological function: neutrophil ≥ 1.5x109/l and platelet count ≥ 100x109 / L; HB ≥ 9g / dl (within one week before randomization) 8. Normal liver and kidney function: serum bilirubin ≤ 1.5x normal upper limit (ULN), alkaline phosphatase ≤ 5x ULN, serum transaminase (AST or ALT) ≤ 5x ULN (within one week before randomization); 9. Sign the written informed consent to participate in the experiment Patients with liver metastases from colorectal cancer who have previously received targeted therapy, chemotherapy, radiotherapy or interventional therapy 2. Known or suspected extrahepatic metastasis 3. Patients with known hypersensitivity to any component of the study treatment 4. Clinical related coronary heart disease or history of myocardial infarction in the last 12 months or left ventricular ejection fraction below normal range 5. Acute or subacute intestinal obstruction 6. Pregnancy (no pregnancy confirmed by serum / urine β hCG) or breastfeeding. 7. She had other malignant tumors within 5 years, except for those with skin basal cell carcinoma or cervical cancer 8. Known drug / alcohol abuse 9. No legal capacity or limited legal capacity 10. There is peripheral 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): 18.0-60.0, 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. No medication or washout period of at least 2 weeks 6. Scored less than 14 on the Hypomania Symptom Checklist-32 (HCL-32) Existing serious and active physical diseases that may interfere with treatment (abnormal indicators> 2 times the normal value), or there is a pharmacological conflict between the current medical medication and the study drug; 2. Previous mania or hypomania episodes; 3. Female patients who are pregnant, planning to be pregnant or breastfeeding; 4. Current high suicide risk (e.g. 3rd item of HAMD-24 scored≥3(suicidality)); 5. Had ECT, MECT or rTMS in the past 6 months; 6. Experienced a history of dependence on psychoactive substances, organic mental disorders, personality disorders, mental retardation, neurodegenerative diseases, brain trauma and cerebrovascular diseases | 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): 21.0-999.0, Major Depressive Disorder Age greater than or equal to 21 US resident Can receive packages to their home via UPS/Fedex/USPS Major Depressive Disorder PHQ-8 Score greater than 10 (show some signs of mild to moderate depression) PHQ-8 Score less than 20 (given remote study serious depressed should be excluded) Read/write English have not contemplated suicide in the past year not been institutionalized for mental health issues not currently experiencing problems with alcohol or drug abuse | 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): 1.0-30.0, Down Syndrome Recurrent B Acute Lymphoblastic Leukemia Patients must be >= 1 and < 31 years at time of enrollment Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories Isolated bone marrow relapse Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes Patients with Down syndrome (DS) are eligible in the following categories Isolated bone marrow relapse Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Patients with B-lymphoblastic lymphoma (B-LLy) Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia Patients with Philadelphia chromosome positive (Ph+) B-ALL Patients with mixed phenotype acute leukemia (MPAL) Patients with known Charcot-Marie-Tooth disease Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype Patients with active, uncontrolled infection defined as Positive bacterial blood culture within 48 hours of study enrollment Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed as long as blood cultures are negative for > 48 hours | 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, Type 1 Diabetes Mellitus Covid19 Having been diagnosed with Type 1 Diabetes Mellitus Willing to participate in the study Participants whose native language is Turkish Unwilling to participate in the study Having a cognitive disorder Not being literate Individuals who do not have sufficient knowledge and functional levels to fill out the online form | 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): 0.0-0.058, Maternal Depressive Disorder Complicating Childbirth Preterm Birth Maternal Anxiety Disorder Complicating Childbirth Mother Commitment to finish all questionnaires and to participate in the creation of a CD to be played to her baby Older than 18 years of age Infant • Gestational age between 26 0/7 and 30 6/7 weeks Mother • Younger than 18 years Infant • Major congenital or chromosomal anomalies | 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, Depression Normal body mass index ≥ 18.5 until ≤ 29.9 Mild to moderate major depression diagnosed by psychiatrists according to the diagnostic for depressive episodes in DSM-5 (American Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition)) Hamilton Rating Scale for Depression (HAMD-17) score not less than 8 Agreed to intake study product during the study period Agreed to sign written informed consent Use of systemic antibiotics or antimycotics medication in the 30 days prior to the study Investigator's uncertainty about the willingness or ability of subject to comply with the protocol requirements Persons with a milk protein allergy, lactose intolerance Pregnant or breastfeeding women Subject had other serious diseases | 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, Dementia Alzheimer Disease Anomia Person with mild/moderate dementia Self-reported proper naming difficulty which we will then assess at Time Point 1 English as their dominant language Able to tolerate MRI brain scan Able to give informed consent Able to use the DNI (app) No diagnosis of developmental language disorders No diagnosis of severe dementia or primary progressive aphasia No major co-existing neurological or psychiatric diagnosis No contraindications to brain scanner (e.g. the presence of ferromagnetic implants or other metallic or electronic objects in the body, weight over 24 stone, claustrophobia or pregnancy) | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Major Depressive Disorder Signed ICF 2. 18 years of age or above at Screening (V1) 3. Currently meet for MDD (single or recurrent episode as defined by DSM 5; if single episode, duration of more or equal to 3 months) based on medical records, clinical assessment and documented completion of the MINI version 7.0.2 4. A diagnosis of a malignant neoplasm with a diagnostic code from C00 to C97 according to the International Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) 5. HAM D 17 score ≥18 at Screening (V1) and at Baseline (V2) 6. Are not currently taking any antidepressant and/or antipsychotic medications, or medical cannabis, at Screening (V1) 7. Able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits 8. Has capacity to consent (assessed via investigator judgement) Psychiatric Current or past history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history and a structured clinical interview (MINI version 7.0.2) 2. Current (within the past year) alcohol or drug use disorder as defined by DSM 5 (MINI 7.0.2) at Screening (V1) 3. Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, at Screening or at Baseline, or; (2) suicidal behaviors within the past year, or; (3) clinical assessment of significant suicidal risk during subject interview 4. Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin General Medical Women who are pregnant, nursing, or planning a pregnancy. Women and men of child bearing potential and who are sexually active must agree to use an acceptable contraceptive method throughout their participation in the study. Women of child bearing potential must have a negative urine pregnancy test at Screening (V1) and Baseline (V2) 6. Cardiovascular conditions: recent stroke (<1 year from signing of ICF), recent myocardial infarction (<1 year from signing of ICF), uncontrolled hypertension (blood pressure >140/90) or clinically significant arrhythmia within 1 year of signing the ICF 7. Uncontrolled or insulin dependent diabetes 8. Seizure disorder 9. Positive urine drug screen for illicit drugs or drugs of abuse at V1 and V2. Any positive urine drug test will be reviewed with participants to determine the pattern of use and will be determined at the investigator's discretion in conjunction with the medical monitor 10. Current enrollment in any investigational drug or device study or participation in such within 30 days of Screening. 11. Abnormal and clinically significant results on the physical examination, vital signs, ECG, or laboratory tests at Screening (V1) that in the investigator's opinion may consistute a risk for an individual who is explosed to psilocybin. This includes platelets below 50,000 platelets per cubic millimeter of blood, liver function tests three times the upper limit of normal, creatine two times above the normal range. Clinically significant abnormal electrolytes or low hemoglobin (below 8 g/L) should be corrected and rechecked 12. Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he/she takes part in the study 13. Use of psychedelics, including psilocybin but excluding medical marijuana, within the past 12 months and use of psychedelics during the current episode of depression 14. Concurrent or recent chemotherapy or radiation therapy, that impairs general level of phsyical functioning | 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 Disorder, Treatment-Resistant Participant must meet the Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) diagnostic for single-episode MDD or recurrent MDD, without psychotic features, based upon clinical assessment and confirmed by the MINI. Participants 65 years of age or older must have had the first onset of depression prior to 55 years of age Participant must have had nonresponse (<=25% improvement) to >=2 oral antidepressant treatments in the current episode of depression, assessed using the MGH-ATRQ, and confirmed by documented records (example, medical/pharmacy/prescription records or a letter from a treating physician) Participant must have an Inventory of Depressive Symptomatology-Clinician rated, 30-item (IDS-C30) total score of >=34 The participant's current major depressive episode, depression symptom severity, and antidepressant treatment response in the current depressive episode, must be confirmed by the State vs. Trait, Assessibility, Face Validity, Ecological Validity, Rule of Three P's (SAFER) Interview Participant must be medically stable on the basis of physical examination, medical history, vital signs (including blood pressure), and 12-lead electrocardiogram (ECG) performed in the screening phase. If there are any abnormalities that are not specified in the and the determination of their clinical significance must be determined by the investigator and recorded in the participant's source documents and initiated by the investigator Participant must be medically stable on the basis of clinical laboratory tests performed in the screening phase. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator: (a) Participants with a pre-existing history of thyroid disease/disorder who are treated with thyroid hormones must be on a stable dosage for 3 months prior to the start of the screening phase; (b) For any participant (regardless of thyroid history), if the thyroid-stimulating hormone (TSH) value is out of range, a free thyroxine (FT4) will be conducted. If the FT4 value is abnormal and considered to be clinically significant (after discussion with the medical monitor), the participant is not eligible Participant must be comfortable with self-administration of nasal spray medication and be able to follow the nasal spray administration instructions provided The participant has used ketamine/esketamine (lifetime) The participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral/bilateral ECT Participant has received vagal nerve stimulation (VNS) or has received deep brain stimulation (DBS) in the current episode of depression Participant has a current or history of seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary) Participant has any anatomical or medical condition that, per the investigator's clinical judgment based on assessment, may impede delivery or absorption of nasal spray study drug | 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): 18.0-30.0, Sexual Violence Female students Ages 18-30 years First year students Female students Ages 31+ Post graduate students Students enrolled for at institution for more than 1 year | 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, Healthy Minimum age of 18 internet access and device fluent English speaker Children are excluded from this study Individuals who do not speak or read English If individuals have undergone an in-person BrainHealth Index (previously BrainHealth Physical), they will need to wait 6 months have passed to participate Individuals who will complete the imaging component must pass an fMRI screener and score a 26 or above on the TICS-M A history of neurological disorders, injuries or disabilities (dementia, multiple sclerosis, Parkinson's, traumatic brain injury, stroke) A history of psychiatric disorders (schizophrenia, bipolar disorder, or others related to anxiety, depression, panic) A history of uncontrolled health issues (substance abuse, hypertension, hypo or hyper-thyroidism) | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-50.0, Major Depressive Disorder women who meet current Diagnostic and Statistical Manual 5 (DSM-5) for major depressive disorder (MDD) have experienced a perinatal loss (including early and late fetal death, death of a liveborn neonate within the first 28 days, and medically recommended termination) within the last 1-12 months are 18 to 50 years old speak and understand English well enough to understand questionnaires when they are read aloud can provide the name and contact information of at least two locator persons have access to a telephone through owning one, a relative/friend, or an agency onset of current major depressive episode prior to news of difficulties with the pregnancy or health risk to the infant (women with prior episodes will be included) current or past diagnosis of bipolar disorder, schizophrenia or other psychotic disorder primary diagnosis of current substance use disorder acute suicidal or homicidal risk non-stable course of antidepressant medication or psychotherapy (i.e., beginning or changing dose of either within the previous 12 weeks) any IPT or cognitive-behavioral treatment in the previous 12 weeks | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-45.0, Obesity Weight Loss Eating Behavior overweight to obese (BMI 25-45 kg/m2) not currently engaged in exercise or weight loss activities free of any cardiac, pulmonary, or metabolic health conditions able to safely engage in exercise female participants must be premenopausal and not pregnant or nursing Lost or gained over 5% of their current bodyweight in the previous 12 months taking any medications or dietary supplements which may influence energy expenditure or intake have not been diagnosed with an eating disorder, clinical depression, or an anxiety disorder engage in less than 150 minutes of moderate to vigorous physical activity per week (assessed via accelerometry at baseline) | 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, Alcohol Use Disorder Depression female between 18 and 65 years of age meet DSM-5 for AUD and current Major Depressive Disorder, as assessed by the SCID-P Are sedentary/low active (i.e. less than 150 minutes/week of moderate-intensity exercise for the past 6 months) are currently engaged in alcohol treatment own a smartphone to allow for EMA software and Fitbit application current DSM-5 diagnosis moderate/severe substance use disorder or anorexia or bulimia nervosa a history of psychotic disorder or current psychotic symptoms current suicidality or homicidality current mania marked organic impairment according to either the medical record or responses to the diagnostic assessments physical or medical problems that would not allow safe participation in a program of moderate intensity physical activity (i.e., not medically cleared by study physician) current pregnancy or intent to become pregnant during the next 12 weeks | 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, Thoracic Cancer Abdominal Cancer Patients must be willing and capable to provide informed consent to participate in the protocol. 2. Patient with presumed pulmonary function capable of holding breath for at least 30 seconds later to be confirmed. 3. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, and until study imaging is complete. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 3.1 A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 3.2 Patients must be compliant to all required pretreatment evaluations Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus 2. Patients are not compliant to all required pretreatment evaluations | 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): 60.0-105.0, Post Traumatic Stress Disorder Major Depressive Disorder Individual has completed IRB 7489 2. Diagnosed with DSM 5 MDD 3. HRSD >=18 4. Willing to and capable of providing informed consent and complying with study procedures History of allergic or adverse reaction to 2. Non-response to adequate trial of escitalopram (at least 4 weeks at dose of 20mg) and duloxetine (at least 4 weeks at dose of 60mg)during the current episode. 3. Current treatment with psychotherapy, antidepressants, or other psychotropic medications | 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): 14.0-999.0, Adolescent Pregnancy All subjects must be able to read and write Spanish RCT will be limited to pregnant adolescents who are between the ages of 14-19 years and 12-34 weeks gestational age. Other caregivers (age 14 years or older) will be eligible if they are planning to be involved in infant care Only pregnant adolescents receiving outpatient prenatal care at INMP or San Bartolomé will be approached as potential participants Only pregnant adolescents who have been cleared by their attending doctor/nurse to engage in the approach/recruitment and interview procedure will be approached as potential participants All infants born to adolescents enrolled during pregnancy will be eligible to be enrolled after birth Anyone unable to read and write Spanish Any pregnant adolescent known to have a severe fetal anomaly will not be approached Infants who are advised not to participate by their attending doctor or pediatrician Children or adolescents who are wards of the state will not be enrolled | 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): 16.0-999.0, Antenatal Depression Age 16 or over Capacity to give informed consent to participate in the study Mild to moderate chronic Perinatal mental health (PMH) problems Score ≥3 on PHQ 32 week gestation Severe Perinatal mental health problem schizophrenia, bipolar disorder Substance abuse/dependence Active risk of self-harm Insufficient English language to engage with intervention No access to 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): 18.0-60.0, Obesity Does not exercise regularly (as determined by International Physical Activity Questionnaire (IPAQ) short form Able to perform 1 hour of moderate-intensity exercise on a treadmill Pregnancy/ lactation Have significant dysphagia, gastric outlet obstruction, or any other factor which prevents the consumption of a meal Have a significant food allergy or dietary restriction Have a systemic or gastrointestinal condition that may affect food intake or preference Taking medication or supplements that affect energy intake or appetite Taking medication that affects blood pressure or heart rate Have an irregular sleep or shift work patterns Travel across > one time zone in the last month Fitted with pacemaker Smokes or uses vaping products | 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, Advanced Malignancies Is willing and able to provide written informed consent for the trial. Is ≥18 years of age on the day of signing informed consent. Has a histologically confirmed advanced malignancy. Subjects with CTCL [MF or SS] who satisfy the Phase 2a, Cohort 3-specific may be enrolled into the Phase 1 part of the study. Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy. Has at least 1 measurable disease lesion as defined by Is able to safely undergo a baseline tumor tissue biopsy prior to first dose of BI-1808 (on non previously irradiated lesions only). The biopsy must be performed at least 4 weeks following the last dose of tumor directed therapy. Has a life expectancy of ≥12 weeks. Phase 2: 1. Cohort 1 and Cohort 4 (NSCLC): 1. For subjects whose tumors have programmed death-ligand 1 (PD-L1) ≥50%: Required prior therapies will anti-PD-1 therapy as monotherapy. Prior standard of care chemotherapy will be allowed but not required. 2. For tumors with unknown PD-L1 or PD-L1 <50%, required prior therapies will anti PD 1/PD-L1 therapy and standard of care chemotherapy either combined with anti PD 1/PD-L1 therapy or given separately. 3. For subjects with known anaplastic lymphoma kinase, ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) or epidermal growth factor receptor sensitizing molecular rearrangements, 1 line of targeted therapy will be required in addition to anti-PD-1/PD-L1 therapy. Cohort 2 and Cohort 5 (OC): 1. Histologically confirmed and documented recurrent ovarian, fallopian tube, and peritoneal cancer. 2. Platinum-resistant OC (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) or platinum-refractory OC (defined as progressing while on a platinum-based chemotherapy). 3. At least treated with 1 line of platinum-based chemotherapy. 4. Prior treatment with poly-ADP ribose polymerase inhibitors is allowed. Cohort 3 (CTCL MF or SS) 1. Stage IB-IV MF or SS with failure of at least 1 systemic therapy. 2. No current large cell transformation. 3. Prior therapy No prior allo hematopoietic stem cell transplantation (HSCT); >90 days since auto HSCT; >4 weeks since systemic therapy and >2 weeks since skin-directed therapy. 4. Stable doses of systemic steroids (≤20 mg prednisone equivalent) and of low-to-medium potency topical steroids permitted (no change in preceding 4 weeks). 5. Prior lines with mogamulizumab or vorinostat are allowed Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Has adequate organ function as confirmed by laboratory values - Target population: Phase 1, Parts A and Part B of the trial will recruit subjects with all types of malignancies whose tumors have progressed after standard anticancer treatment. Phase 2a, Parts A and Part B of the trial will recruit patients with NSCLC, OC, and CTCL (specifically MF or SS). The following must be met for a subject to be eligible for in the trial: 1. Is willing and able to provide written informed consent for the trial. 2. Is ≥18 years of age on the day of signing informed consent. 3. Has a histologically confirmed advanced malignancy. Subjects with CTCL [MF or SS] who satisfy the Phase 2a, Cohort 3-specific may be enrolled into the Phase 1 part of the study. 4. Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy. 5. Has at least 1 measurable disease lesion as defined by 6. Is able to safely undergo a baseline tumor tissue biopsy prior to first dose of BI-1808 (on non previously irradiated lesions only). The biopsy must be performed at least 4 weeks following the last dose of tumor directed therapy. 7. Has a life expectancy of ≥12 weeks. 8. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 9. Has adequate organ function as confirmed by laboratory values listed in the table below. Laboratory Test Value Required Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L (criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks) Absolute neutrophil count ≥1500/µL Platelet count ≥100,000/µL Total bilirubin ≤1.5 ×ULN or direct bilirubin ≤ULN for subjects with total bilirubin levels >1.5 × ULN ALT and AST ≤2.5 × ULN (≤5 × ULN for subjects with liver metastases) Creatinine or Measured or calculated creatinine clearance (per institutional standard [GFR can also be used in place of creatinine or creatinine clearance]) ≤1.5 × ULN or mL/min for subjects with creatinine levels >1.5 × institutional ULN INR or PT aPTT ≤1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants ALT=alanine aminotransferase (serum glutamic-pyruvic transaminase); aPTT=activated partial thromboplastin time; AST=aspartate aminotransferase (serum glutamic-oxaloacetic transaminase); GFR=glomerular filtration rate; INR=international normalized ratio; PT=prothrombin time; ULN=upper limit of normal Phase 2a Expansion Cohort-Specific In addition to the general above, subjects must also meet the for the specific cohort. Additional requirements may be added or modified based on learnings from subjects enrolled in the Phase 1 portion of the trial. 1. Cohort 1 and Cohort 4 (NSCLC): 1. For subjects whose tumors have programmed death-ligand 1 (PD-L1) ≥50%: Required prior therapies will anti-PD-1 therapy as monotherapy. Prior standard of care chemotherapy will be allowed but not required. 2. For tumors with unknown PD-L1 or PD-L1 <50%, required prior therapies will anti PD 1/PD-L1 therapy and standard of care chemotherapy either combined with anti PD 1/PD-L1 therapy or given separately. 3. For subjects with known anaplastic lymphoma kinase, ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) or epidermal growth factor receptor sensitizing molecular rearrangements, 1 line of targeted therapy will be required in addition to anti-PD-1/PD-L1 therapy. 2. Cohort 2 and Cohort 5 (OC): a. Histologically confirmed and documented recurrent ovarian, fallopian tube, and peritoneal cancer. b. Platinum-resistant OC (defined as relapsing within 6 months after the last administration of platinum-based chemotherapy) or platinum-refractory OC (defined as progressing while on a platinum-based chemotherapy). c. At least treated with 1 line of platinum-based chemotherapy. d. Prior treatment with poly-ADP ribose polymerase inhibitors is allowed. 3. Cohort 3 (CTCL MF or SS) 1. Stage IB-IV MF or SS with failure of at least 1 systemic therapy. 2. No current large cell transformation. 3. Prior therapy No prior allo hematopoietic stem cell transplantation (HSCT); >90 days since auto HSCT; >4 weeks since systemic therapy and >2 weeks since skin-directed therapy. 4. Stable doses of systemic steroids (≤20 mg prednisone equivalent) and of low-to-medium potency topical steroids permitted (no change in preceding 4 weeks). 5. Prior lines with mogamulizumab or vorinostat are allowed Needs doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Has known or suspected hypersensitivity to BI-1808 or pembrolizumab Has cardiac or renal amyloid light-chain amyloidosis. Has received the following: 1. Chemotherapy or small molecule products within 4 weeks of first dose of BI-1808. 2. Radiotherapy within 2 weeks of first dose of BI-1808. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) for non-CNS disease. Subjects who have previously had radiation pneumonitis are not allowed. 3. Immunotherapy within 4 weeks prior to the first dose of BI-1808. Has not recovered from AEs to at least Grade 1 by NCI CTCAE Has had Grade ≥3 autoimmune manifestations of previous immune checkpoint inhibitor treatments (eg, anti-PD-1, anti-PD-L1, or anti-CTLA-4). Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis. Has an active, known, or suspected autoimmune disease. Is a female subject and has the ability to become pregnant (or already pregnant or lactating/breastfeeding). However, those female subjects who have a negative serum or urine pregnancy test before enrollment and agree to use a highly effective method of birth control for 4 weeks before entering the trial, during the trial, and for 12 months after last dose of BI-1808, are considered eligible. Is a male subject with partner(s) of childbearing potential (unless he agrees to take measures not to father children by using 1 form of highly effective contraception [condom plus spermicide gel] during the trial and for 12 months after completing treatment) Has had major surgery from which the subject has not yet recovered. Is at high medical risk because of nonmalignant systemic disease including severe active infections on treatment with antibiotics, antifungals, or antivirals. Has presence of chronic graft versus host disease. Has had an allogenic tissue/solid organ transplant. Has known human immunodeficiency (HIV) and/or history of hepatitis B or C infections, or has a positive test for HIV antibody, hepatitis B antigen/hepatitis B virus DNA or hepatitis C antibody or RNA. A Has a history of active tuberculosis (Bacillus tuberculosis). Has received a live vaccine within 30 days before the first dose of study treatment. Has uncontrolled or significant cardiovascular disease. Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the trial. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator. Is participating or planning to participate in another interventional clinical trial, or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to first dose of study drug. Has a known additional malignancy of another type, with the exception of adequately treated cone biopsied carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) and basal or squamous cell carcinoma of the skin. Male subjects with asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for >1 year prior to start of trial therapy are eligible. Has a diagnosis of primary or acquired immunodeficiency disorder or taking any other form of immunosuppressive therapy within 7 days prior the first dose of study drug | 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): 0.0-0.019, Family Centered Care Born at 34 weeks of gestation or earlier in Nagano Children's Hospital and need admission into NICU in the same hospital Having any major anomalies including suspicion of chromosomal disorder on admission At least one parent is Not Japanese The consent is not obtained by day 7 Do not survive until discharge home | 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 Symptoms Depressive Disorder, Major Mood Disorders Diagnosed with Major Depressive Disorder (MDD) No psychotic symptoms Based on psychiatrist's clinical judgement currently in need for antidepressant treatment Functional English literacy and language skills (to use the decision aid and fill out the questionnaires) Provides consent Psychosis Communication barriers (visual impairment, language barrier) | 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, Cancer Neoplasms Neoplasm Metastasis Being over 18 years old Suffering from advanced cancer Having a clinically estimated life expectancy over 3 months Being diagnosed from having a depressive syndrome by a Hospital Anxiety and Depression Scale-D over 11 Being in need of an antidepressant treatment Suffering from at least one under-controlled symptom (defined as a score over 3 on the Edmonton Symptom Assessment Scale) among: pain, nausea, vomiting, breathlessness, lack of appetite, sleep disorders, anxiety or impaired wellbeing Having or not a cancer treatment Being able to understand the information related to the study, and to sign informed consent Having agreed to take part to the study Being able to fill Patient Reported Outcomes questionnaires Being treated by an antidepressive agent during the four weeks before inclusion Having had a hypersensitivity event to mirtazapine, escitalopram of any excipient Having had a prior inefficient treatment by mirtazapine or escitalopram Having postural hypotension or arterial systolic hypotension inferior to 90 mmHg measured following the guidelines of the European Society of Cardiology Having a QT interval over 420 ms Having uncontrolled hearth rhythm disorder or uncontrolled conduction disorder Having had or having bipolar disorder Having uncontrolled seizure or epilepsy (relative non-inclusion needing a neurology specialist opinion) Having or having history of closed-angle glaucoma Having bone marrow aplasia | 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, Moderate Depression Fulfill the for moderate depression Have symptoms for two weeks or more A minimum of six of the following nine symptoms must have been present: 1. Depressed mood most of the day 2. Markedly diminished interest or pleasure in all activities 3. Significant weight loss or weight gain (more than 5%) 4. Insomnia or hypersomnia 5. Psychomotor agitation or retardation 6. Fatigue 7. Feelings of worthlessness 8. Excessive or inappropriate guilt 9. Diminished ability to concentrate Minimum one of the six symptoms must be either depressed mood or loss of interest and pleasure Symptoms as a direct physiological effects of a substance or a general medical condition Substance abuse Chronic major or bipolar depression or axis I diagnosis Endocrine abnormality; medical disorder or treatment that could cause depression Suicidal potential Dementia Depression due to uncomplicated grief History of psychosis or mania Heart valve disease Poorly controlled hypertension and diabetes mellitus | 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, Bipolar Disorder Type I or II (According to DSM-5) Suffering from bipolar disorder (type 1 or 2) according to DSM-5 Not presenting a mood episode according to DSM-5 Stable for at least 1 month with scores on YMRS < 8 and MADRS < 8 Owning a smartphone Agreeing to attend group psychoeducation sessions Having no problem understanding fluent French Having given free and informed consent and signed the consent to participate in the study Available for 12 onth follow-up Not having a smartphone compatible with the SIMPLe application Cannot attend psychoeducation group sessions on a regular basis Not having given their consent to participate in the study or unable to give their informed consent Not affiliation with a social security scheme Having a legal protection measure (safeguard of justice or guardianship) | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Alcohol Drinking Pregnancy pregnant woman over 18 years old, presenting in one of the three maternities of the study for her prenatal care and having returned her self-report and having given her written consent woman under 18 years old or not pregnant or not having returned her self-report or woman who refused to participate in the study (absence of written 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): 50.0-999.0, Major Depressive Disorder Patients meeting one of the following may be eligible to participate in this study. 1. Patients with medication-resistant MDD who have undergone rTMS or ECT and responded to it but whose benefit has lapsed, and they need repeat a rTMS or ECT course that they cannot access 2. Patients with medication-resistant MDD who have undergone rTMS or ECT and responded to it but whose benefit has lapsed, and they need repeat a rTMS or ECT course that they cannot access 3. Patients with medication-resistant MDD who are undergoing rTMS or ECT and responding, but cannot continue to get the rTMS or ECT course due to COVID-19 pandemic-related regulations or other access concerns 4. Patients with medication-resistant MDD who are referred to rTMS or ECT and are found well qualified but cannot access rTMS or ECT due to COVID-19 pandemic-related regulations or other access concerns. The benefits of this project address a present need due to the COVID-19 pandemic, but also go beyond the present situation and address a larger, pre-existing need. Across all these potential groups of participants, prospective participants will need to have a primary psychiatrist who agrees to their participation in the study and is willing to continue to follow the patient and work collaboratively with the study team need to be assessed by their primary psychiatrist to be stable enough to be able to remain at home and participate in the present study without undue risk to their safety need to be living with an adult willing and capable to provide oversight and learn to deliver the home-based tDCS have the capability to connect with the study team for daily supervision of the intervention sessions and close safety monitoring, and be willing to commit to doing so Individuals with MDD Participants will be men and women who Are aged 50 or older Able to read, write, and communicate in English Have a caregiver who is willing and able to provide the home tDCS sessions Participants must be under the care of a treating psychiatrist who approves of the study participation and believes that TMS or ECT is indicated for his/her patient but that it would not endanger the patient to participate in the present study rather than pursue such alternative, or for participants with MDD will be Any DSM-psychotic disorder Drug or alcohol abuse or dependence in the preceding three months Concurrent benzodiazepine medication High suicide risk (Utilizing the Beck Depression Inventory and the Hamilton Depression Scale, suicide risk will be assessed at baseline by the study psychiatrist) History of clinically defined neurological disorder or insult; Metal in the cranium or skull defects Skin lesions on the scalp at the proposed electrode sites Pregnancy Medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagus nerve stimulator) Previous skull surgery with resultant skull defects | 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, Major Depressive Disorder New or first recurrent diagnosed as major depression disorder Having total score HAM-D 17 ≥ 17 point Can not answer the question in HAM-D 17 Having psychosis, anxiety disorder, obsessive-compulsive disorder Having risk of suicide now or 3 months past having medical history: diabetes mellitus, hypothyroidism, hypopituitarism, epilepsy, renal failure, heart failure, stroke, myocardial infarction, liver failure, cirrhosis 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): 3.0-6.0, Color Perception Typically developing children without color blindness Children with color blindness | 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): 13.0-999.0, Pregnancy Related Perinatal Depression English or Spanish speaking ≤16 weeks' gestation Established prenatal care at EleVATE site High-risk for postpartum depression by ≥1 risk factor (personal/family history, baseline EPDS≥10, low-income, 13-19 years old, single, history of physical/sexual abuse, unplanned/undesired pregnancy, history of pregnancy loss) Ability to attend group prenatal visits at specified days/times Willingness to be randomized Ability to give informed consent Multiple gestation Major fetal anomaly Serious medical co-morbidity/psychiatric illness necessitating more care than can be safely provided in group setting Serious medical co-morbidity necessitating more care than can be safely provided in group setting | 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, Post Partum Depression less or equal (≤) to 24 weeks postpartum meet for current major depressive disorder per the Structured Clinical Interview for Diagnostic (SCID) and Statistical Manual of Mental Disorders version 5 (DSM-V) not currently receiving treatment for depression (for example, prescription medications or psychotherapy) Current diagnosis of Posttraumatic stress disorder (PTSD), obsessive compulsive disorder, eating disorder, substance abuse or dependence, lifetime history of mania/hypomania or thought disorder per SCID current diagnosis of, or high risk for, sleep-disordered breathing, insomnia disorder, restless leg syndrome, and/or narcolepsy retinal pathology or history of eye surgery current use of photosensitizing medications current use of exogenous melatonin or medications that may interfere with the measurement of melatonin (nonsteroidal anti-inflammatory drugs (NSAIDs) if used daily, and beta-blockers) medical conditions for which bright light therapy is contraindicated (for example, epilepsy/seizures) | 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): 18.0-45.0, Energy Intake Substrate Utilization Hormones Satiety 45 years old regularly participate in exercise for at least 150 min per week run at least 3 days per week for 30 minutes able to complete a VO2max test able to exercise for 45 min moderate intensity exercise at one time without breaks not participating in structured exercise of 150 min/week for the past 6 months not running at least 3 days per week for 30 minutes not attaining a VO2max of 50 ml/kg/min (60th percentile fitness classification according to the American College of Sports Medicine) currently smoke or quit smoking less than one year ago diagnosed with or are being treated for a cardiovascular disease, high blood pressure, fibromyalgia, irritable bowel syndrome or a metabolic disorder such as diabetes, thyroid disorder, or high cholesterol food allergies or sensitivities not willing to have blood drawn on 4 occasions during each trial (16 total times) | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 0.0-999.0, HIV Infections Pregnancy A woman may be eligible for this study if She is HIV-positive She is at least 34 weeks pregnant She has a history of at least 4 weeks of continuous oral ZDV during her current pregnancy and tolerated it well She has given consent for her newborn to participate in this study. (The father must also give consent if he is available after reasonable attempts to contact him. A woman under 18 needs the consent of a parent or legal guardian for her and her infant to participate.) A woman will not be eligible for this study if She is taking part in another study of HIV treatment during pregnancy Her infant has a life-threatening illness indicated in an ultrasound Her infant does not appear to be growing normally in the womb She has a cesarean section She has abnormal blood test results She has severe nausea, vomiting, or other problems of the stomach and intestines at the time of study entry She has an active opportunistic (AIDS-related) infection or other serious infection at the time of study entry The study staff cannot find a usable vein The study doctor feels that she cannot take drugs by mouth | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 0.0-999.0, HIV Infections Pregnancy A patient may be eligible for this study if she Is an HIV-positive woman Is receiving care at a study site during the study period or her infant is receiving care at a study site and whose delivery information is available Had a baby on or after January 1, 1998 | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 8.0-99.0, Pulmonary Disease Patients 8 years old and older with signs or symptoms of pulmonary disease of medical interest to the professional staff of CPB will be eligible for participation in this protocol. Only standard diagnostic procedures and conventional therapy will be performed. Patients will not be subjected to any research procedures. This protocol does not commit the NIH to medical or surgical treatment of protocol participants after discharge. Patients will be discharged to the referring physician. Consenting to pregnancy testing in minors of childbearing age: We will inform the minor during the assent process that for safety, we need to do a pregnancy test. She will also be told that if it is positive, we will counsel her and help her tell her parents. If the minor does not want to proceed she will be advised not to sign assent and her enrollment on this training protocol will end Patients without symptoms of pulmonary disease will be excluded from this protocol | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 20.0-100.0, Lung Diseases Sleep Apnea Syndromes Stratified random sample based on risk severity obtained during phone interview | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-40.0, Hyperinsulinism Polycystic Ovary Syndrome ENTRY --Disease Characteristics-- Obese women with chronic anovulation due to polycystic ovary syndrome (PCOS) Must have oligoamenorrhea and hyperandrogenemia --Prior/Concurrent Therapy-- At least 2 months since prior standard therapy (including over the counter drugs) At least 2 months since prior investigational agents --Patient Characteristics-- Hematopoietic: Hematocrit greater than 38% Hepatic: Liver function normal No clinically significant hepatic disease Renal: No clinically significant renal disease Creatinine less than 1.4 mg/dL No proteinuria Cardiovascular: No clinically significant cardiac disease Pulmonary: No clinically significant pulmonary disease Hormonal: Thyroid function normal Prolactin normal Fasting 17 alpha-hydroxy progesterone less than 200 mg/dL OR No late onset adrenal hyperplasia 21 alpha-hydroxylase deficiency Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No diabetes mellitus No clinically significant neurologic, psychiatric, infectious, neoplastic, or metabolic disease No clinically significant malignant disease except nonmelanomatous skin cancer At least 1 year since any prior drug abuse or alcoholism | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 0.0-999.0, Lipodystrophy All ethnic groups Males and females Age greater than 14 years Clinically-significant lipodystrophy, identified by the study physician during the physical examination as an absence of fat outside the range of normal variation and/or identified as a disfiguring factor by the patient. Circulating leptin levels less than 4.0 ng/ml in females and less than 3.0 ng/ml in males as measured by Linco assay on at least 2 occasions. Presence of at least one of the following metabolic abnormalities: Presence of diabetes as defined by the 1997 ADA a) fasting plasma glucose greater than or equal to 126 mg/dL, or b) 2 hour plasma glucose greater than or equal to 200 mg/dL following a 75 gram oral glucose load, or c) diabetic symptoms with a random plasma glucose greater than or equal to 200 mg/dL. Fasting insulin greater than 30 micrograms/ml; Fasting hypertriglyceridemia greater than 200 mg/dl. General: Pregnant women, women in their reproductive years who do not use an effective method of birth control, women currently nursing or lactating within 6 weeks of having completed nursing, and persons who are unable to provide informed consent will be excluded from the study. Exclusions for underlying disease likely to increase side effects or to hinder objective data collection: Known liver disease due to causes other than non-alcoholic steatohepatitis Current alcohol or substance abuse Psychiatric disorder impeding competence or compliance Active tuberculosis Use of anorexiogenic drugs Other condition which in the opinion of the clinical investigators would impede completion of the study Subjects who have a known hypersensitivity to E. Coli derived proteins | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Obesity BMI 25-40 kg/m2 inclusive | 1 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Cutaneous T Cell Lymphoma Peripheral T Cell Lymphoma Based on the outlined below, patients will accrue to one of the cohorts of the trial. Cohort chemotherapy regimens allowed. Cohort Status Cohort 1 Cutaneous T-cell Lymphoma (mycosis fungoides or Sezary syndrome)-2 or fewer. Closed to accrual Cohort 2 Peripheral T-cell Lymphoma, unspecified, or Anaplastic large cell lymphoma (T and null cell) Primary Cutaneous Type -2 or fewer. Open and accruing Cohort 3 Cutaneous T-cell Lymphomas or Peripheral T-cell Lymphoma-More than 2. Closed to accrual Cohort 4 Other Mature T cell Lymphomas-Any number. Open and accruing Cohort 5 Cutaneous T-cell Lymphoma (mycosis fungoides or Sezary syndrome)-2 or fewer-Cohort 5 is a replicate cohort, identical to #1 Cohort 6 Peripheral T-cell Lymphoma (PTCL), unspecified, or Anaplastic large cell lymphoma (T and null cell) Primary Cutaneous Type-More than 2. Patients with PTCL in cohort 3 migrated to this cohort Cohort 7 Cutaneous T-cell Lymphoma (mycosis fungoides or Sezary syndrome) Prior vorinostat required-Any number Patients with cutaneous T-cell lymphoma [CTCL (mycosis fungoides or Sezary syndrome) stage IB to IVB are eligible. Patients with stage IB and IIA should be refractory to, intolerant to, or have reached a six-month or longer response plateau on at least two prior therapies from the following list: psoralen plus ultraviolet A irradiation (PUVA), ultraviolet B (UVB), electron beam therapy (EBT), photophoresis, interferon, systemic cytotoxic chemotherapy, topical nitrogen mustard, or topical carmustine (BCNU). One qualifying prior treatment must have been topical nitrogen mustard, topical carmustine or a phototherapy (UVB, PUVA or EBT). Topical steroids, systemic retinoids or biologicals do not qualify. Patients with stage IB or IIA who are not candidates for topical nitrogen mustard, topical carmustine or phototherapy (UVB, PUVA or EBT) are eligible for enrollment. Patients may not have received more than two systemic cytotoxic chemotherapy regimens. Steroids, retinoids, and biologic agents, will not be considered as systemic cytotoxic chemotherapy. Radiolabeled monoclonal antibody therapy is considered equivalent to a systemic cytotoxic chemotherapy regimen and must be counted toward the two prior systemic cytotoxic regimens. Patients with stage IIB-IVB who have had no more than 2 prior systemic cytotoxic chemotherapeutic regimens are eligible. There is no restriction regarding number of prior topical therapies, skin irradiation, or non-cytotoxic systemic therapies (i.e. PUVA, retinoids or biologic, with the exception of radiolabeled monoclonal antibody therapy) in this patient group. After 24 patients were enrolled in this arm, the arm was closed, and a replicate arm constituted of this same patient population was opened (Cohort 5). Patients with peripheral T-cell lymphoma (PTCL), unspecified, or anaplastic large cell lymphoma, T and null cell, primary cutaneous type, as defined by the Revised European American Lymphoma (REAL)/World Health Organization (WHO) classification (16-18), who have experienced disease progression after receiving prior standard treatment and who have had no more than 2 prior systemic cytotoxic chemotherapeutic regimens are eligible. Patients with cutaneous T cell lymphoma (Mycosis fungoides or Sezary Syndrome) or peripheral T cell lymphoma as defined above who have received more than 2 prior systemic therapies and who have experienced disease progression will be included in a third and independent arm. This arm of the protocol was closed to accrual for CTCL with Amendment H. Patients with mature T cell lymphomas not included above will be enrolled in a fourth arm. These but are not exclusively limited to: Enteropathy-type T cell lymphoma; Hepatosplenic T-cell lymphoma; Subcutaneous panniculitis-like T cell lymphoma; Angioimmunoblastic T-cell lymphoma; Anaplastic large cell lymphoma. Patients must have experienced disease progression after receiving prior standard treatment. There will be no limit on the number of prior regimens. Primitive T cell neoplasms and T cell leukemias will not be enrolled. Patients with peripheral T-cell lymphoma, unspecified, or anaplastic large cell lymphoma, T and null cell, primary cutaneous type, as defined by the REAL/WHO classification (16-18), who have experienced disease progression after receiving prior standard treatment and who have had more than 2 prior systemic cytotoxic chemotherapeutic regimens are eligible for enrollment to a sixth arm of the trial. Patients with cutaneous T cell lymphoma (Mycosis fungoides or Sezary Syndrome) or peripheral T cell lymphoma as defined in #1 who have received any number of prior systemic therapies and who have previously been treated with vorinostat will be included in a third and independent arm. Patients can be enrolled in this arm if they received prior vorinostat and experienced disease progression, subsequent relapse, or had to discontinue to agent due to toxicity. Disease that is measurable by radiographic imaging, assessing skin lesions, or by quantitating Sezary cell count. Patients must: be age greater than or equal to 18 years have a performance status of Eastern Cooperative Oncology Group (ECOG) 0-2 have no serious or intercurrent illness and have a life expectancy of greater than 12 weeks give written informed consent female patients of childbearing potential must have a negative pregnancy test within 4 weeks and must use effective contraception sexually active males must use effective contraception Laboratory values (performed less than or equal to 14 days prior to registration): absolute neutrophil count greater than or equal to 1000/microliter, platelets greater than or equal to l00,000/microliter, bilirubin (total and direct) less than or equal to 1.5x upper limit of normal, and aspartate aminotransferase (AST) less than or equal to 3x upper limit of normal, unless impairment is due to organ involvement by lymphoma, creatinine less than or equal to 1.5x upper limit of normal, or documented creatinine clearance of greater than or equal to 60mL/min Cardiac studies (performed within 4 weeks of registration): Ejection fraction of greater than 50% by Echocardiogram or Cardiac magnetic resonance imaging (MRI), or greater than or equal to 45% by multi-gated acquisition scan (MUGA) Scan. A stable dose (greater than 1 month) of corticosteroids administered for symptom management will not preclude enrollment. Tapering will be initiated following administration of depsipeptide Patients with unconfirmed diagnosis, or with B-cell lymphomas will be excluded. Prior or concurrent malignancies that have not been curatively treated. Known central nervous system (CNS) lymphoma. Chemotherapy within 4 weeks, 6 weeks for nitrosoureas or mitomycin C. Biologics, Immunotherapy within 2 weeks. Human Immunodeficiency virus (HIV) seropositivity. Pregnant or breast-feeding patients. Major surgery within 21 days. Uncontrolled infection or uncontrolled medical illness. Patients having received prior histone deacetylase (HDAC) inhibitor therapy for T cell lymphoma will be excluded except for patients eligible to enroll in cohort 7. Patients with the following cardiac risk factors will be excluded from the study: Patients with known cardiac abnormalities such as: Congenital long QT syndrome Corrected QT interval (QTc) interval greater than 480 milliseconds Patients who have had a myocardial infarction within 12 months of study entry. Patients who have active coronary artery disease as, e.g. angina as defined by Canadian Class II-IV Patients with an electrocardiography (ECG) recorded at screening showing evidence of cardiac ischemia (ST depression of greater than or equal to 2 mm). Any patient in whom coronary artery disease is suspected should be referred for a cardiology consultation and if active myocardial ischemia is demonstrated the patient should be excluded. If a noninvasive imaging study is equivocal, it may be necessary to proceed to coronary angiography. Patients with congestive heart failure that meets New York Heart Association (NYHA) Class II to IV definitions and/or ejection fraction less than 45% by MUGA scan or less than 50% by echocardiogram and/or MRI. Patients with a history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD). Patients with a history of arrhythmia should have Holter monitoring and evaluation by cardiology. Patients with dilated, hypertrophic, or restrictive cardiomyopathy from prior treatment or other causes (in doubt, see ejection fraction above). Patients with left ventricular hypertrophy should be discussed with the Principal Investigator or Study Chairman. Patients with uncontrolled hypertension, i.e., systolic blood pressure (SBP) greater than or equal to 160 mm Hg or diastolic blood pressure (DBP) greater than or equal to 95 mm Hg. Patients with cardiac arrhythmia requiring anti-arrhythmic medication other than beta blocker or calcium channel blocker. Patients in whom digitalis cannot be discontinued are excluded from study. Patients with Mobitz II second degree heart block who do not have a pacemaker. Patients with first degree or Mobitz I second degree heart block, bradyarrhythmias or sick sinus syndrome require Holter monitoring and evaluation by cardiology. Patients with other cardiac disease may be excluded at the discretion of the principal investigator (PI) following consultation with cardiology | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Extensive Stage Small Cell Lung Cancer Patients must have histologically-confirmed small cell carcinoma of the lung or unequivocally positive cytological evidence (sputum [at least 2] or aspirate biopsy), with extensive disease (disease beyond the hemithorax and adjacent nodes, supraclavicular node involvement or pleural effusion with positive cytology), who have required induction chemotherapy, who have responding or stable disease, and who meet the following Induction chemotherapy including platinum (cisplatin or carboplatin) plus either etoposide (VP-16) or irinotecan (CPT-11) A minimum of 3 and a maximum of 6 cycles of induction chemotherapy have been administered Recovered from all toxicity related to prior chemotherapy (except alopecia and/or neuropathy) No less than 4 and no more than 8 weeks have elapsed between the last treatment of induction chemotherapy and randomization No more than 32 weeks have elapsed between the first dose of induction chemotherapy and date of randomization The patient has responding or stable disease using since the initiation of systemic chemotherapy (i.e., patients who have exhibited disease progression are NOT Patients must be disease-free for >= 5 years if they have had a prior second malignancy other than treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix Baseline measurements/evaluations of disease must be obtained =< 4 weeks prior to randomization WBC >= 4000/mm³ or | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 16.0-999.0, Breast Neoplasms Metastases, Neoplasm Patients will be eligible for this trial if Female, non-pregnant, non-lactating, and, if of child-bearing potential, have a negative serum pregnancy test, and use approved contraception Sixteen years of age or older Histologically or cytologically confirmed breast cancer (stage III or IV) with evidence of inoperable local recurrence or metastasis, with measurable disease If patient has received taxane therapy as an adjuvant he/she has not relapsed within one year of completing adjuvant taxane No other malignancy present within the past 5 years, except non-melanoma skin cancer, cervical intraepithelial neoplasia or in-situ cervical cancer Suitable candidate for paclitaxel therapy Hematology levels at baseline of: absolute neutrophil count of at least 1500 cells/mm3; platelet count of at least 100,000 cells/mm3; hemoglobin of at least 9 g/dL Chemistry levels at baseline of: AST and ALT of less than or equal to 2.5 x the upper limit of normal, if no evidence of liver metastasis; total bilirubin of less than or equal to 1.5 mg/dL; creatinine of less than or equal to 2 mg/dL; alkaline phosphatase of less than or equal to 5 x the upper limit of normal, unless there is bone metastasis but not liver metastasis Expected survival of at least 12 weeks | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-52.0, Obesity clinically severe obesity candidate for bypass surgery new york city local address willing to visit hospital weekly | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 15.0-39.0, Contraception Pregnancy Patient at a participating clinic Pregnant Medical or surgical procedure preventing pregnancy (e.g., tubal ligation, hysterectomy) Norplant or IUDs Desires to become pregnant | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 21.0-80.0, Obesity Hypertension Hypercholesterolemia Hyperglycemia Participants with the Metabolic Syndrome, which is defined as having 3 or more of the following 5 alterations Abdominal obesity (waist measurement >39.8 inches in men, >34.4 inches in women) Elevated triglycerides (>150 mg/dl) Low HDL or "good" cholesterol (<40 mg/dl in men or <50 mg/dl in women) Elevated blood pressure (>130/85) or treatment for high blood pressure Elevated fasting blood sugar (>100 mg/dl) Diabetes treated with medication Blood pressure >160/100 mmHg Clinical Congestive Heart Failure Anemia with hematocrit <32% Asthma or Chronic Obstructive Pulmonary Disease (COPD) requiring daily medication or use of home oxygen therapy Major surgery planned within the next six months A recent, unexplained weight loss of >10% of body weight in the past 6 months A known allergy or hypersensitivity to Metformin History of hepatitis or cirrhosis History of kidney disease (defined as serum creatinine >1.4 mg/dL in men, >1.3 mg/dL in women) | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Obesity Morbid Obesity Weight Loss years old Subjects approved for gastric bypass surgery Subjects not approved for gastric bypass surgery | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 35.0-85.0, Cardiovascular Diseases Coronary Disease Risk Reduction Heart Diseases Abbreviations: FBS = fasting blood sugar, SBP = systolic blood pressure, DBP = diastolic blood pressure, LDL = low-density lipoprotein, HDL = high-density lipoprotein, BMI = body mass index, TC = total cholesterol, TG = triglycerides, HbA1c = hemoglobin A1c The patient has CAD or CAD risk equivalent (abdominal aortic aneurysm, peripheral vascular disease, transient ischemic attack, stroke, diabetes, or FBS ≥ 126 mg/dL × 2) and has at least one of following: SBP ≥ 130 mmHg, DBP ≥ 80 mmHg, LDL ≥ 100 mg/dL, HDL ≤ 40 mg/dL, TG ≥ 150 mg/dL, FBS ≥ 126 mg/dL, BMI ≥ 30, or is a current smoker The patient does not have CAD or CAD risk equivalent but has at least one of the following: SBP ≥ 160 mmHg, DBP ≥ 100 mmHg, LDL ≥ 190 mg/dL, TC ≥ 240 mg/dL, TG ≥ 500 mg/dL, HbA1c ≥ 8.0%, BMI ≥ 35, or is a current smoker The patient does not have CAD or CAD risk equivalent but has at least two of the following: a) SBP ≥ 140 mmHg or DBP ≤ 90 mmHg, b) HDL ≤ 40 mm/dL or TG ≥ 200 mg/dL, c) LDL ≥ 160 mg/dL or TC ≥ 240 mg/dL, d) FBS ≥ 110 mg/dL × 2, or e) male age ≥ 45 or female age ≥ 55 or with positive family history of CAD Resident of long-term facility Lack of spoken English or Spanish by patient or household member 18 years or older who can serve as an interpreter Moving before end of intervention (30 months) Age between 35 and 85 (inclusive) Significant comorbidities such as: uncontrolled metabolic disorders (renal failure, liver failure, etc.), active symptoms suggesting acute myocardial infarction or decompensated congestive heart failure, Malignancy or other condition limiting life expectancy, psychiatric disorder with active manifestations Substance abuse No telephone or means of contacting patient Family household member already enrolled Homeless and not living with relatives/friends Anticipated absence for more than 4 consecutive months | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-40.0, Obesity Body mass index (BMI) of greater than 40 or a BMI between 35.5-39.9 and has a weight related health problem, such as diabetes or high blood pressure Failed medical weight loss Ages of 18-40 Not using hormonal contraception or sex steroids Subject is premenopausal and has not undergone a bilateral oophorectomy or hysterectomy Subject's obesity has no medical explanation (hypothyroidism, Cushing's Syndrome, genetic) Not willing to make a lifelong commitment to the diet and exercise guidelines following bariatric surgery Subject is pregnant or lactating Not willing to use barrier contraceptives or intrauterine device (IUD) to prevent pregnancy for one year following bariatric surgery Post-menopausal, either surgical or natural Subject has had a vasectomy Subject is a smoker | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 15.0-38.0, Malaria A pregnant woman who has either a positive blood smear for P.falciparum with at least 1000 asexual parasites/uL in an asymptomatic woman or any of the following symptoms within 2 days prior to consultation history of fever headache vomiting chills/rigors and/or any of the following signs: temperature >37.50C and <39.50C, Hb>5 and <9 g/dl together with P.falciparum parasitaemia at any density and (in both cases) the following: 1. Has no criterion (see below); 2. Is 14-34 weeks pregnant on the day of attending the ANC clinic or OPD; 3. Has a viable foetus, defined by presence of foetal heartbeat by sonicaid or pinnard (foetal heartbeat is not heard until 14 weeks); 4. Is able to take study drugs by the oral route; 5. Is able to attend stipulated days for follow up clinic and provide specimens; 6. Gives informed written or witnessed verbal consent to participate by herself, and also through her parent/guardian if aged <15 years (in conformity to Tanzania Law) Severe and complicated forms of malaria (as defined by WHO, 1996); 2. Pregnancy in the first trimester; 3. A mixed plasmodial infection; 4. Complicated pregnancy, e.g. signs/symptoms of toxaemia of pregnancy; 5. 23 or more abortions or stillbirths; 6. Presence of concomitant disease masking assessment of the response to treatment ; 7. An intake of drugs contraindicated in pregnancy, e.g. tetracycline, cotrimoxazole or a macrolide antibiotic; 8. An intake of drugs with effective antimalarial activity within the last 2 weeks. 9. Significantly abnormal baseline haematology (except anaemia) or clinical chemistry parameters, e.g. laboratory evidence of renal impairment (serum creatinine >2 mg/dl) or of hepatitis (alanine aminotransferase [ALT] >5 times upper limit of normal); 10. Previous participation in the study: Women having a second episode of malaria after completing the 28-day follow up will have details recorded and offered quinine but not be re-enrolled. 11. Multiple gestation pregnancies, eg twins 12. Mother aged 38 years or above | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Head and Neck Cancer Patients must have documented advanced, locally recurrent, or metastatic head and neck carcinoma, which is untreatable by surgical resection or radiation therapy Prior chemotherapy for advanced/metastatic disease is allowed (1 regimen only) Patients must be taxane-naïve (no prior docetaxel or paclitaxel) Patients who have received chemoradiation as a primary therapy for advanced head and neck cancer are eligible Patients must have measurable or evaluable disease. Pre-study imaging for disease assessment must be done within 28 days of registration Patients with brain metastases are eligible if they have been stable for at least six weeks post-radiation therapy Aged 18 years or older Performance status of 0-2 by Zubrod criteria Life expectancy of at least 12 weeks Hematologic: absolute neutrophil count (ANC) equal to or > 1,500/mm3; hemoglobin equal to or > 8.0 g/dl; platelets equal to or > 100,000/mm3 Patients with congestive heart failure, second or third degree heart block or recent myocardial infarction within 12 months from registration are not eligible Peripheral neuropathy equal to or greater than grade 2 Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 Use of standard chemotherapy or investigational agents for treatment of head and neck cancer within 28 days of 1st dose of study drug Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test (PPT) at baseline, or sexually active females not using a reliable contraceptive method while on study and for at least six months after chemotherapy. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.) Sexually active patients not using a reliable contraceptive method while on study and for at least six months after chemotherapy Patients with malabsorption syndromes will be excluded. Administration of capecitabine through feeding tubes is permitted Serious concurrent infections | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Hyperlipidemia Subject is >= 18 years of age, any race, and any gender Subjects must have the following fasting parameters LDL-C > 100 mg/dL and < 190 mg/dL TG level >= 175 mg/dL and < 1000 mg/dL HDL-C < 40 mg/dL (men) and < 50 mg/dL (women) Subjects must have one or more of the following Treated or untreated hypertension defined as blood pressure (BP) mmHg >= 85 mmHg (systolic / diastolic) Waist circumference > 88 cm (35 inches) for women or > 102 cm (40 inches) for men Fasting glucose defined as >= 100 mg/dL but <= 125 mg/dL Subject has a known hypersensitivity to fenofibrate, ezetimibe, or atorvastatin Subject has been previously enrolled in this study Subject has used an investigational drug within 30 days of study entry Subject has been diagnosed with Type I or Type II Diabetes Mellitus or is currently being treated with anti-diabetic medication, or has a fasting glucose >= 126 mg/dL Subject has a history of pancreatitis or cholelithiasis or a history of gastric or duodenal ulcer within 3 months of study entry Subject has hematologic, digestive, or central nervous system disorder including cerebrovascular disease or degenerative disease that would limit study evaluation or participation Subject has had a myocardial infarction, coronary bypass surgery, or angioplasty within 6 months of study entry Subject has unstable or severe peripheral artery disease within 3 months of study entry Subject has unstable angina pectoris or uncontrolled cardiac arrhythmias Subject has congestive heart failure (CHF) as defined by NYHA Class III or IV | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-40.0, Polycystic Ovary Syndrome Obstructive Sleep Apnea PCOS subjects will be recruited from the Endocrinology Clinics of the University of Chicago. All will be at least 2 years post-menarche and less than 40 years of age. A diagnosis of PCOS will require the presence of oligo/amenorrhea hyperandrogenemia, defined by a supranormal plasma free testosterone level (> 10 pg/ml) hyperandrogenism, as evidenced by infertility, hirsutism, acne, or androgenetic alopecia; and of nonclassic 21-hydroxylase deficiency congenital adrenal hyperplasia, Cushing's syndrome, hypothyroidism, or significant elevations in serum prolactin. Thus, all subjects will meet the National Institutes of Health (NIH) consensus for PCOS Control subjects will be matched, as closely as possible, for age, ethnicity, body mass index (BMI), and body fat distribution [as assessed by single cut abdominal computed tomography (CT) scan and dual energy x-ray absorptiometry (DEXA) scan] Normal lean (BMI <25 kg/m2) women will be between 18 and 40 years of age, in good health, with normal menstrual cycles, no sleep complaints, no history of endocrine disorder. All studies will be initiated in the early follicular phase (days 2-4) For at least 2 months before the study, all subjects (PCOS and control) must not take steroid preparations (including oral contraceptives), medications known to alter insulin secretion and/or action, or medications known to influence sleep | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-65.0, Obesity Type 2 Diabetes Mellitus Patient of the Nutrition and Weight Management Center at Boston Medical Center Obese ( BMI equal or greater to 30 kg/m2 Men and women Age more than or equal to 18 years Type 2 diabetes mellitus controlled by diet or use of Metformin or Impaired fasting glucose (FBS more than or equal to 100 mg/dl) Only diet-controlled diabetics or those on Metformin will be considered since all classes of anti-diabetic agents have different effects on appetite and body weight, which may confound the interpretation of study results Currently not a patient at the Nutrition and Weight Management Center at Boston Medical Center Need for oral anti-diabetic agents (other than Metformin) Abnormal thyroid status: hyperthyroidism or hypothyroidism (TSH less than 0.5 or more than 5.0) Significant liver disease (bilirubin more than or equal to 2.0 or liver enzyme more than 3 times upper limited of normal range) Significant renal disease (creatinine more than or equal to 2.0) On the following medications known to affect carbohydrate and lipid metabolism: steroids, Beta adrenergic blockers, diuretics, insulin, and hypolipidemic agents Use of prescription or over the counter weight loss medications Weight loss of >5% or more in the last three (3) months Anorexia nervosa or bulimia nervosa Pregnancy or lactation | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-60.0, Morbid Obesity Male or female patients with BMI of 40-60 kg/m2 or 35 kg/m2 with comorbidities 2. Good health status with acceptable operative risk (good cardiopulmonary function) 3. Willingness to follow protocol requirements: Signing informed consent, follow-up, and completing protocol diagnostic tests Prior upper abdominal surgery except cholecystectomy 2. Large abdominal ventral hernia 3. Patients with hiatal hernia 4. Inadequate prior medical management 5. Lack of patient's motivation and contribution to long-term success 6. Unacceptable operative risk 7. Minors and pregnant women are excluded as these patients do not qualify for the bariatric procedures. Minors are not psychologically fit to undergo such surgery and pregnant women are excluded because of safety for the fetus | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Preeclampsia Pregnant women >18 years of age significant medical conditions that would be expected to affect maternal fetal outcomes need for admission to hospital, so that it transfer to the sleep would compromise maternal-fetal safety | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-50.0, Obesity Chronic Sleep Deprivation to 50 year old obese men and premenopausal women BMI between 29-55 Chronically (for more than 6 months) sleep-deprived, defined as sleeping on a regular basis less than or equal to approximately 6-1/2 hours/night by history and objective devices (wrist activity monitors and sleep logs). External comparison subjects for extension of Effectiveness Study must meet the above Diagnosed sleep disorders including Chronic insomnia Untreated sleep disordered breathing (sleep apnea at a level of severity [using standardized for measurement], or diagnosed UARS [upper airway resistance syndrome] that would impair the ability to increase sleep duration [Intervention Group] or maintain sleep duration [Comparison Group]. CPAP treatment that has been in place for 3 months or more and improves sleep is acceptable) Restless leg syndrome or periodic limb movement disorder Parasomnias (including REM sleep behavior disorders, confusional arousals, sleep terrors, sleepwalking, sleep violence) Primary bruxism is allowed as long as it does not interfere with the ability to sleep an additional 90 minutes a night Narcolepsy Central apnea. Unstable weight (voluntary losses in BMI greater than 5% over the past 6 months); currently being enrolled in a weight loss program Untreated or uncontrolled diabetes Severe uncontrolled hypertension Other chronic organ disease diagnosis including COPD Chronic cardiac arrhythmia requiring treatments | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-70.0, Cardiovascular Diseases Heart Diseases Obesity Hyperlipidemia Insulin Resistance Metabolic Syndrome X Sedentary (exercises fewer than two times per week) Overweight or mildly obese (body mass index [BMI] of 25 to 35 kg/m2) with mild to moderate lipid abnormalities (either LDL cholesterol 130 to 190 mg/dl or HDL cholesterol less than 40 mg/dl for men or 5 less than 45 mg/dl for women) Diabetes Hypertension Other metabolic or musculoskeletal diseases Current use of or intent to diet Use of confounding medication Overt presence of coronary heart disease Unwilling to be randomized to any group | 1 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Head and Neck Cancer Histologically or cytologically confirmed squamous cell carcinoma of the head and neck Stage III or IV disease No evidence of distant metastases No salivary gland or paranasal sinus squamous cell carcinoma No disease with close proximity to a major vessel Measurable disease No known CNS or brain metastases Patients with intracranial extension without cerebral involvement may be eligible ECOG performance status 0-1 Life expectancy > 12 weeks | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-55.0, Narcolepsy Patients -18 to 55 year old men and pre-menopausal women with current narcolepsy, otherwise healthy. Controls -18 to 55 year old healthy men and pre-menopausal women. WITH Having a current diagnosis of narcolepsy with moderate or severe daytime sleepiness for at least 6 months, according to the International Classification of Sleep Disorder (ICSD) Both new and previously diagnosed patients are eligible Females of childbearing potential must have a negative serum pregnancy test A valid barrier contraception method is required over the duration of the study Patients must agree to refrain from operating a motor vehicle and from being involved in any other potentially hazardous activity during the tapering off and the drug-free periods. WITH Pregnancy and lactation (women only) Use of birth control pills Menopause, defined as 6 consecutive months without mensis Clinical diagnosis of polycystic ovary disease, chronic history of anovulatory cycles or other alterations of the menstrual cycle (for women only) | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 0.0-70.0, Lymphoma Histologically proven extranodal NK/T-cell lymphoma, nasal type according to the WHO classification (must be pathology-proven EBV DNA positive as well as cytoplasmic CD3 +, while CD56+ is not an essential diagnostic criteria. ). Newly diagnosed patients. 2. Any of lymphomatous involvement exist in nasal cavity and/or paranasal sinuses, orbit, Waldeyer's ring, and oral cavity performance status with ECOG scale 0-2. 3. Stage I or contiguous stage II, measurable or evaluable lymphoma by clinical imaging No previous chemotherapy and/or radiotherapy. 4. ANC ≧ 2,000/mm3, Platelet ≧ 100,000/mm3 of peripheral blood. 5. Age <70. 6. Total bilirubin < 2.5 mg/dl, Serum creatinine ≦1.5 mg/dl, Blood urea nitrogen (BUN) ≦ 25 mg/dl Pregnancy or lactation period 2.Severe intercurrent illness, eg. Infection, heart failure 3.Myocardial infarction within recent 12 months 4.Known hypersensitivity to any component drug of the treatment regimen - | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-75.0, Heart Failure, Congestive Metabolic Syndrome X Obesity Must meet 3 or more of the NCEP defined for metabolic syndrome Waist circumference greater than 40 inches (102 cm) for men and 35 inches ( 88 cm) for women Serum triglyceride level greater than or equal to 150 mg/dL HDL level less than 40 mg/dL for men or 50 mg/dL for women Blood pressure greater than 130/85 or treatment for hypertension Fasting glucose greater than 110 mg/dL or treatment for diabetes Individuals with heart failure of ischemic or nonischemic etiologies * NYHA class II - III symptoms Left ventricular ejection fraction less than 40% Age 18-75 years BMI greater than 25 kg/m2 NYHA IV or 6 minute walk less than 300 meters Blood pressure greater than 160/100 mmHg Patients undergoing active titration of their cardiac medications Other comorbid illnesses which limit expected lifespan or affect the safety of interventions Weight loss of more than 10 pounds of non-edematous body weight within the past 3 months Pregnancy HIV+, active tuberculosis or hepatitis C Cancer requiring treatment within the past 5 years, unless the prognosis is excellent Unstable angina, myocardial infarction, coronary artery bypass surgery, or angioplasty within the last 3 months Angina with exertion | 1 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-70.0, Obesity participants (20 men, 21 women) were included in the study. They were between 24-62y, healthy, non-athletic, weight stabile (< 3 kg in last 2 mo) but overweight to obese (BMI: 28-40 kg/m2) evidence of metabolic or systemic diseases other than obesity. Frequent use of medication, a systolic blood pressure >165 mmHg and diastolic blood pressure >95 mmHg | 1 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 0.0-999.0, Morbid Obesity Obstructive Sleep Apnea morbidly obese patients with BMI > 30 confirmed obstructive sleep apnea with RDI > 10/hr able to sign consent patients undergoing weight reduction surgery sleep apnea other than obstructive sleep apnea untreated endocrine disorder patient refusal | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 21.0-45.0, Contraception Healthy adult females who meet the following selection Have regular menses occuring every 25-35 days Acceptable body mass (< 30) and the weight is < 90 kg Has completed her last term pregnancy at least 4 months prior to study admission, is not lactating and has at least one normal menstrual period since her last pregnancy and not breast feeding Has a sitting blood pressure systolic < 140 mm/Hg and diastolic < 90 mm/Hg Has not received a DepoProvera injection or any other depot hormone injection within six months prior to the screening visit Has not used / or in current use of barbiturates, antiepileptics, rifampin, griseofulvin, Hypericum perforatum, or other hepatic enzyme-inducing drugs within 30 days prior to the pre-study visit Has not a uncontrolled disorder No women over the age 35 who smoke | 0 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Sleep Apnea Syndromes Clinical diagnosis of obstructive sleep apnea No previous use of CPAP Must be a Veteran with residence within San Diego County Home oxygen therapy Fatal comorbidities (i.e., life expectancy less than 6 mos) Contraindications for CPAP use | 2 |
The patient is a 34-year-old obese woman who comes to the clinic with weight concerns. She is 165 cm tall, and her weight is 113 kg (BMI: 41.5). In the past, she unsuccessfully used antiobesity agents and appetite suppressants. She is complaining of sleep apnea, PCO and dissatisfaction with her body shape. She is a high-school teacher. She is married for 5 years. She doesn't use any contraceptive methods for the past 4 months and she had no prior pregnancies. She rarely exercises and movement seems to be hard for her. She is not able to complete the four-square step test in less than 15 seconds. She does not smoke or use any drugs. Her BP: 130/80, HR: 195/min and her BMI is: 41.54. Her lab results: FBS: 98 mg/dl TG: 150 mg/dl Cholesterol: 180 mg/dl LDL: 90 mg/dl HDL: 35 mg/dl She is considering a laparoscopic gastric bypass. | eligible ages (years): 18.0-999.0, Hypercholesterolemia Patients are eligible for study entry based on the following 1. Males or females greater than or equal to 18 years of age 2. Females must not be pregnant or lactating. Females of childbearing potential and males must use a reliable means of contraception. 3. LDL-C level greater than the NCEP goals, as determined by patients' risk category according to NCEP ATP III 4. Risk category for coronary heart disease and coronary heart disease equivalent with LDL goal of < 100 mg/dL 5. Baseline lipid LDL-C = 100 to160 mg/dL and triglyceride level = 100 to 500 mg/dL 6. Normal thyroid function tests (total T3, total T4, and thyroid-stimulating hormone [TSH]) 7. Hemoglobin A1C < 8.5% on a stable oral hypoglycemic or insulin regimen 8. On stable lipid modification pharmacotherapy (including a statin) for at least 2 weeks prior to study entry. Patients must be on at least half of the maximal doses of statins (as assessed by the Investigator), or be intolerant to statins such that the doses are not achievable. 9. Able to give informed consent Pre-Randomization Patients will not be eligible for the study based on the following 1. History of thyroid disorders of any form within 24 weeks prior to study entry 2. Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal 3. Active myocarditis, hypertrophic cardiomyopathy, uncorrected primary valvular disease, restrictive cardiomyopathy, uncorrected congenital heart disease, or constrictive pericarditis 4. Myocardial infarction, unstable ischemic heart disease, stroke, or coronary revascularization procedure within 24 weeks prior to study entry 5. Moderate or severe symptomatic congestive heart failure (New York Heart Association class III and IV) 6. Drug or alcohol dependence, or other conditions which may affect study compliance 7. Renal insufficiency (serum creatinine > 2 mg/dL) 8. Subjects taking other hormonal therapies (other than oral contraceptive agents and postmenopausal hormone replacement therapy) e.g., glucocorticoids, androgens, or growth hormones 9. Use of thyroid supplements (levothyroxine, liothyronine, etc.) or any preparation containing thyromimetic agents within 24 weeks prior to study entry 10. History of coagulopathy or use of anticoagulants such as warfarin 11. Unstable endocrine/metabolic syndrome that may affect lipid metabolism 12. History of atrial or ventricular arrhythmia 13. Diagnosis of other non-cardiac underlying medical conditions expected to impact mortality within 24 weeks after randomization | 2 |
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