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64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 20.0-62.0, Ischemic Ulcer Ischemic lower limb based on TASK guide line Rutherford score:2,3 ABI<0.6 Absolute ankle pressure < 60 mmHg Both gender Age:20-62years EF<30% Cr>2 HbA1c>8% Bone marrow disorders:leukemia Cognitive disorders Infections MI with ST elevation during last month Malignancy Immunologic or rheumatologic disorders | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-70.0, Diabetic Foot Ulcer Adult diabetic foot syndrome subjects over 18 years of age of any sex All stages of diabetic foot syndrome including Wagner stage 5 Mid-foot gangrene only after appropriate surgical treatment Patients suffering from type 1 or type 2 diabetes mellitus with diabetic foot syndrome Stable metabolic and pharmacological control at recruitment and during the trial period Adequate perfusion of lower limb as measured by HHD and confirmed by APSV Non-diabetic foot ulceration (traumatic, thermal ulceration etc) Diabetic foot syndrome graded 5 on Wagner's scale hind foot gangrene only Any pathological state or disease which can affect the development and outcomes of diabetic foot syndrome such as liver cell failure and renal failure Severe limb ischemia (by clinical assessment and HHD) unless re-vascularized Presence of slough or sequestrum unless debrided Hemoglobin less than 8 g/dl unless corrected Those receiving NSAIDs, steroids or anti-mitotic drugs Septicemia patients requiring urgent amputation | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 0.0-999.0, Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Patients with insufficiently controlled type 1 or type 2 diabetes mellitus under their previous therapy | 2 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 40.0-75.0, Foot Ulcer, Diabetic between ages 40 and 75 history of diabetic neuropathic plantar ulcer (test subjects) no history of diabetes (control subjects) no peripheral sensory neuropathy (control subjects) amputation or surgery on right Great Toe | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 0.0-999.0, Osteoarthritis, Hip Joint Deformities, Acquired Hip Dislocation, Congenital Osteonecrosis Arthritis, Rheumatoid Undergoing primary unilateral total hip arthroplasty via the anterior supine intermuscular approach Patient is willing and able to complete all follow-up visits at 6 weeks and 1 year Patients with pre-existing known coagulopathy Patients on chronic Coumadin (Warfarin) therapy Patients receiving erythropoietin therapy for anemia | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-75.0, Ottawa Score Adenoma patients undergoing colonoscopy disturbance of water and electrolyte history of colorectal surgery severe colonic stricture or obstructing tumor known or suspected bowel obstruction or perforation toxic colitis or megacolon dysphagia compromised swallowing reflex or mental status significant gastroparesis or gastric outlet obstruction or ileus severe chronic renal failure (creatinine clearance ＜30 mL/minute) severe congestive heart failure (New York Heart Association class III or IV) | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Diabetes Mellitus Diabetic Neuropathic Foot Ulcer More of 18 years old man or woman Type 1 or 2 Diabetes mellitus A new plantar ulcer of the fore foot or the toes GRADE 1A or 2 A of the University of Texas Classification Neuropathy assessed by absence of sensation in 10g monofilament test Severe angiopathy (Grade 3 of the PEDIS classification) Osteomyelitis or cellulitis of the foot Transmetatarsal amputation Other study in course Immunosuppressive drugs, antibiotic therapy Hepatic insufficiency No possibility to follow the patients every 14 days No state health insurance Pregnancy | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Ulcer Skin Ulcer Leg Ulcer Diabetic Foot Patient is 18 years old or older Patient has a diagnosis of arterial, diabetic foot, venous insufficiency, or pressure ulcer or surgical and traumatic wound Patient's target study ulcer/wound is a lower extremity full thickness ulcer/wound not involving tendon, capsule, or bone Patient's target study ulcer/wound and is ≥1.0 cm2 and ≤ 10.0 cm2 in size at the day of initial consult Study ulcer/wound has been present for greater than 6 weeks prior to initial consult Patients with Charcot foot deformities can be entered so long as the Charcot disease is not active, and the ulcer can be offloaded by an orthotic device The patient has adequate circulation to the lower extremity as evidenced by an ABI (measured by Doppler) of ≥ 0.7. If the patient has non-compressible leg arteries, as documented by an ABI >1.3, then the patient must have a Toe-Brachial Index be > 0.6, or a toe pressure >50 mm Hg Patient must have adequate in-home support to comply with all protocol-mandated visits and procedures, offloading or pressure redistribution as required, and proper application of study products and wound care regimen Patient or his/her legal representative has read and signed the Institutional Review Board-approved Informed Consent form before Screening An ulcer/wound that is ≥10.0 cm2 and ≤ 1.0 cm2 in size at the day of initial consult is not eligible for this study Patient has clinical evidence of gangrene or infection on any part of the affected foot The patient is judged by the investigator or study staff to be unable or unlikely to comply with daily wound care instructions, or study visits Patient has clinical evidence of active sepsis or invasive infection (e.g., cellulitis, osteomyelitis) Patient has muscle, tendon, or bone exposure in any ulcer bed Patient has known sensitivity or allergy to any component of the study product Olivamine10 Patient has one or more medical condition(s), including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the Investigator would make the patient an inappropriate candidate for this wound healing study Patient has a malignant disease (other than squamous or basal cell carcinoma of the skin) not in remission for five years or more | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Peripheral Artery Disease Without Critical Limb Ischemia Patients need to be at least 18 years old Patients have to be admitted to the university hospitals of Geneva for a non-healing lower limb ulcer Eligible patients are those presenting with non-healing lower limb ulcers for more than 3 months Patients will be hospitalized in the Dermatology inpatient clinic Patients had to benefit from at least one thin skin autograft at the ulcer level in the past or during the index hospitalization Before in the study, patients must undergo complete angiological diagnostic work-up including A baseline ABI, toe pressure and tcPO2 measurements A non-invasive arterial imaging including an angio-CT scan or an angio-MRI The non-invasive arterial work-up must revel mild to moderate PAD, without any or sign of CLI (see flow-chart) Ankle pressure ≥ 50 mmHg Patients who refused to give their written informed consent Patients, in whom the angiological work-up shows the presence of a CLI, mandating a revascularization procedure attempt (i.e. ankle pressure < 50mmHg, toe pressure < 30mmHg, tcPO2 < 20mmHg) (see particular situation n°2) Patients who do not present with peripheral artery disease (i.e., ABI > 0.9 < 1.3, TP > 100mmHg, tcPO2 > 40mmHg) Patients in whom the angiological-dermatological work-up shows the presence of another reversible cause of the non-healing ulcer Special attention will be given to the presence of a treatable venous insufficiency (e.g. compression stocking, varices stripping), an underlying inflammatory/infectious process (treatable with antibiotics or topic-systemic antiinflammatory medications) or other reversible mechanical factors (unadapted shoes, etc.) Patients without any significant lesion of the arterial tree (ilio-femoro-popliteal and infra-popliteal) In case there will be a single BTK vessel disease not perfusing the ulcer area (e.g. pre-tibial ulcer with a significant stenosis of the posterior tibial artery which does not perfuse the ulcer region), the patient will not be included in the study because any significant ulcer improvement would be expected from this non-target vessel revascularization Patients in whom the scheduled revascularization procedure will be judged too risky for the patient's safety Chronic kidney failure (= Creatinin Clearance < 20ml/min) with an increased risk of contrast induced nephropathy | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 5.0-20.0, Neurogenic Bladder Diagnosis of spina bifida and neurogenic bladder Performing clean intermittent catheterization (CIC) Taking 0.3-0.4 mg/kg/day of oxybutynin for a poorly compliant bladder Has not had previous bladder surgery Has had a urodynamic or videourodynamic study done within the last 6 months Upper motor neuron (UMN) type bladder demonstrated on last urodynamic study Urodynamic study (UDS) showing either detrusor leak point pressure >40cm H2O; 30cm below capacity <60% of total bladder capacity, 20 cm capacity <70% of bladder capacity Able and willing to complete CIC Diaries and Quality of Life Questionnaires Consent and assent given to participate in trial History of lung disease, recurrent aspiration or severe neurological impairment which may increase risk of Botox toxicity or anesthesia Positive urine culture Known allergy to Botox | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 10.0-17.0, Type 1 Diabetes Mellitus English-speaking patients to 18 years diagnosed with type 1 diabetes for at least 12 months poor diabetes control as defined by having a hemoglobin A1c value > 8% type 2 diabetes developmental delay current participation in another study that may impact glycemic control | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Detrusor Function, Overactive Diagnosis of overactive bladder as a result of neurogenic condition, for example following spinal cord injury, multiple sclerosis (slowly worsening disorder of the central nervous system that causes symptoms such as weakness, incoordination, numbness, problems talking and problems seeing), Parkinson's disease (a progressive disorder of the central nervous system, seen usually in older persons, in which there is slow movement [due to muscle weakness], trembling and sweating), or cerebrovascular accidents (CVAs stroke-sudden loss of blood supply to brain) Women must not be pregnant and be of either non-childbearing potential or is using adequate means of birth control Overactive bladder symptoms and/or has urge incontinence episodes Must have normal results on urine culture tests and on urinalysis ECOG (Eastern Cooperative Oncology Group) performance status score of less than or equal to 3 Participants with 1 or more treatable or conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency Any medical or unstable condition that precludes their participation in the study or may confound the outcome of the study (participants with or at risk for urinary retention, gastric retention or uncontrolled narrow angle; heart failure or kidney failure; diabetes mellitus; abnormal muscle weakness [myasthenia gravis]; paralysis or inactivity in the intestines that prevents material moving through the gut [intestinal atony or paralytic ileus]; severe inflammation of the bowel [ulcerative colitis] sudden expansion of the large intestine seen in advanced ulcerative colitis or Crohn's disease [toxic megacolon]; history of major lower urinary tract surgery [transurethral resection will be excluded]) Hypersensitivity to the investigational drug or any of its ingredients (eg, lactose) Pregnant or breast feeding female Significant bacteriuria (presence of bacteria in the urine) or pyuria (presence of white blood cells) in the urine | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 45.0-65.0, Fibromyalgia fibromyalgia diagnosed by physical examination of pain sensitivity, by Dolorimeter and finger pressure any past hyperbaric oxygen therapy chest x-ray pathology which does not allow the income into the hyperbaric chamber middle ear problems patients, who cannot "pump", equals middle ear pressure, effectively patients who suffer from claustrophobia inability or Refusing to sign the Informed Consent Form | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-69.0, Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Glycosylated haemoglobin (HbA1c) below or equal to 10 procent based on central laboratory results Specific for subject with type 1 diabetes Diagnosed with type 1 diabetes mellitus and treated with insulin for at least 12 months prior to screening Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2 (both inclusive) Specific for subject with type 2 diabetes Diagnosed with type 2 diabetes mellitus for at least 12 months prior to screening Treated with insulin for the past 3 months prior to screening Body Mass Index (BMI) between 22.0 and 35.0 kg/ m^2 (both inclusive) Subject with a history of significant multiple drug allergies or with a known allergy or suspected allergy to the trial product or any medicine chemically related to the trial product,as judged by the Investigator Subject with a history of or presence of cancer Any condition that the Investigator and/or Sponsor feels would interfere with study Specific for subject with type 2 diabetes Therapy with oral antidiabetic drugs within the past 3 months prior to screening | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-92.0, Bowen's Disease Korean patients aged ≥ 18 years who had biopsy-confirmed BD lesions on the lower extremities porphyria known allergies to the MAL cream or lidocaine pregnancy lactation any active systemic infectious disease immunosuppressive treatment personal history of malignant melanoma tendency towards melasma or keloid formation prior treatment of the lesions within 4 weeks, and any indication of poor compliance | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Chronic and Acute Wounds, Diabetic Foot Ulcers and Venous Leg Ulcers Below the Knee Subjects who meet the following may be included in the clinical investigation, if they present with ALL of the following Subject is able to understand the evaluation and willing to consent and comply with all post-debridement visits and procedures Age 18 years and older. Subjects may be of either sex and of any race or skin type Subjects fulfilling any one or all of the following chronic wound(s) below the level of the knee, defined by delayed healing or cellular senescence acute wound(s) as a result of a surgical procedure, laceration, abrasion or trauma diabetic foot ulcer(s) subjects with venous leg ulcers below the knee on the leg or foot with one or more documented failure of maximal medical therapy for their study wound >30 days such as compression bandages (low elasticity, elastic, multilayered, elastic and non elastic compression) Subjects with the following lab results within 30 days of treatment serum albumin level >20g/L Subjects will be excluded from the clinical investigation, if they present with ANY of the following Subjects that have tunneling wounds Subject presents with an active infection in the study wound, as defined by purulence and Fever and leukocytosis OR any TWO of the following Malodor, pain or tenderness, warmth, erythema, induration, swelling, lymphangitis Infected bone diagnosed by imaging modality (e.g., Magnetic Resonance Imaging (MRI) and/or radiographic images) Subjects whose study wound does not require debridement Cardiac pacemaker or other electronic implant(s) Subjects with irradiate, burn or ischaemic wounds or history of keloids | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Diabetic Foot Ulcer Is aged ≥ 18 Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria Has an open foot wound with visible inflammation, namely at least 1 skin ulcer located on or below the malleolus that presents with the following clinical manifestations of a moderate or severe infection based on the Infectious Disease Society of America (IDSA) Has received appropriate surgical intervention to remove all necrotic and infected bone if diagnosed with osteomyelitis Meets certain minimal laboratory criteria Has an ulcer infection which, based upon the patient's known history of hypersensitivity cannot be appropriately treated with at least one of the empiric systemic antibiotic regimens per protocol Has received > 48 hours of potentially effective antibiotic therapy and the wounds are clinically improving. If a patient has received an antibiotic within 72 hours, but is not improving or deep-tissue culture results indicate that the infecting pathogen is not susceptible to that antibiotic, the patient may be enrolled Requires or is likely to require treatment with any concomitant topical product or wound therapy during the study period | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Leg Ulcer Diabetic Foot Ulcer Pressure Ulcer Low to highly exuding chronic wound(wound history > 2 months) such as Leg Ulcer, Pressure Ulcer Category III to IV or Diabetic Foot Ulcer Male of female, 18 years and above Signed Informed Consent Form Pregnancy or lactation Wound size not suitable for the wound dressing size Known allergy/hypersensitivity to any of the components in the dressing | 2 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-60.0, Post-concussion Syndrome Adults, age 18-60, both men and women Able to speak and read English as primary language Able and willing to provide written informed consent for study participation Able and willing to complete outcome assessments and provide blood and urine samples as required by the study protocol Able to tolerate the chamber environment and hood placement and to equalize middle ear pressure Past history of at least one mild traumatic brain injury with persistent symptoms that meets all of the following 1) Brain injury occurred at least 1 year but no more than 5 years prior to enrollment; 2) Brain injury occurred as an adult (at least 18 years of age); and, 3) Brain injury occurred due to non-penetrating trauma and is graded as mild At least 3 of the following persistent post-concussive symptoms from the injury: headaches, dizziness or balance problems, blurred vision, tiredness/fatigue or sleep problems, seizures, remembering things or solving problems, managing stress or emotional upsets, controlling temper/irritability, or ringing in the ears Diabetes mellitus Uncontrolled seizure disorder (participants must be on therapy and seizure-free for at least 6 months) Claustrophobia precluding chamber or hood tolerance Implanted devices not cleared for hyperbaric pressurization Pregnancy or plans to become pregnant during the study participation period. Women of childbearing potential will be asked to use an acceptable form of birth control through the 13-week assessment visit Lung disease, such as emphysema, chronic bronchitis, asthma that is not well-controlled, or bullous lung disease, that raises the risk for pulmonary barotrauma due to air trapping Active malignancy, previous malignancy (except basal cell carcinoma) in the last 5 years, or any prior treatment with bleomycin (Blenoxane). Prior treatment with doxorubicin (Adriamycin) is acceptable as long follow-up echocardiography is normal Chronic disease such as heart or renal failure would raise the participant's risk of adverse events during hyperbaric oxygenation Prior military service in theater Alcohol abuse, by self-report, within the last year | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Varicose Ulcer Male or female over the age of 18 years Chronic venous ulceration Defined as wound of greater than four weeks in duration between the foot and the ankle with an Ankle Brachial Pressure Index greater than 0.85 Ulceration present for at least four weeks Colour venous duplex evidence of chronic venous insufficiency showing either reflux or obstruction Acute infection in the studied lower limb within the last four weeks History of malignancy in the lower limb to be studied History of connective tissue disease Patients on medications that can cause immunosuppression Corticosteroids, chemotherapy or radiotherapy for cancer and recombinant immunological medications | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 20.0-999.0, Pressure Ulcer Wound Necrosis over 20 years of age subject who has untreated wounds subject who has wound size over 3cm x 3cm subject who has wound over stage 2 cellulitis | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Diabetic Foot Pedal Ulcers Men or women >18 years old One or more foot ulcers without clinical evidence of osteomyelitis Diagnosis of Diabetes Mellitus* University of Texas Grade 1A, 1C, 2A, or 2C ulcer15 ABI >0.7 and Toe pressure >30mmHg Limited life-expectancy Wounds on calf or shin that would be in contact with the TAG Brace Gangrene, active infection Osteomyelitis of the foot with the ulcer Chronically bedridden/Non ambulatory Unable to keep research appointments Wide spread malignancy or systemically immunocompromising disease Ipsilateral revascularization procedure within the last 30 days Unreliable, unwilling or unable to comprehend informed consent | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 14.0-24.0, Diabetes Mellitus Type 1 diabetes Males and females Age between 14-24 years Any diabetes duration Cared for by the diabetes center for at least 1 year HbA1c ≥ 8% Basal bolus treatment (any insulin) Poor compliance with Self-Monitoring of Blood Glucose (less than 30% of the recommended Blood Glucose measurements recorded in the glucose meter in the two previous weeks, i.e. <16 Blood Glucose measurements in the last two weeks) Written informed consent obtained from patient or legal representative (for minor) Treatment with other insulin regimen or Continuous Subcutaneous Insulin Infusion Refusal or inability to give informed consent to participate in the study Patients with short life expectancy Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint according to physician's judgment Requirement for concomitant treatment that could bias primary evaluation Patients with high likelihood of being unavailable for 6 and/or 12 months visits Subject is the investigator, sub-investigator, research assistant, pharmacist, study coordinator, other study site staff or relative of study site staff thus considered directly involved in the conduct of the study Current addition/abuse of alcohol or drugs Severe visual or dexterity impairment Patients with any mental condition rendering them unable to understand the nature, scope, and possible consequences of the study | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-75.0, Diabetic Foot Ulcer diabetic food ulcer classified byInternational Working Group of the Diabetic Foot (IWGDF) as grade 1 and 2 previous vascular surgery on the side that the ulcer is present uncontrolled diabetes mellitus presence of osteitis, abscess, osteomyelitis, gangrene on the side that the ulcer is present diabetic food ulcer classified byInternational Working Group of the Diabetic Foot (IWGDF) as grade 3 | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 19.0-999.0, Type 2 Diabetes Mellitus age >19 years of age type 2 diabetes mellitus requiring at least one medication (oral hypoglycemic agent and/or insulin) to control diabetes A1C ≥8% in past 1 year willingness/ability to attend the Diabetes education, dietician, and peer sessions and follow up assessments ability to provide informed consent self identify as South Asian (from India, Pakistan, Sri Lanka, or Bangladesh) regardless of generational status or timing of immigration with ability to speak in English or Punjabi life limiting illness <12 months physical inability to exercise recurrent severe hypoglycemia or hypoglycaemic unawareness family member of, or living in same household as a participant pregnancy or gestational diabetes | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-80.0, Atopic Dermatitis Eczema Male or female subjects who are not pregnant or lactating 80 years of age Diagnosis of atopic dermatitis for at least 6 months using the Hanifin and Rajka Diagnostic for atopic dermatitis Presence of lesional atopic dermatitis skin in both antecubital fossae Positive S. aureus colonization based on results of a skin culture taken from one of their AD-affected antecubital fossae during the screening visit Use of any topical AD treatments (including topical steroids, topical calcineurin inhibitors) to either arm within one week of either screening visit Use of any oral/systemic AD therapies (antihistamines, steroids) within 28 days of either screening visit Severe AD that would worsen significantly from holding a participant's usual topical/oral AD medications for the time periods required in the inclusion/exclusion (one week prior to the screening, treatment and follow-up visits for topical medications and 28 days prior to screening, treatment and follow-up visits and for oral medications) Subjects who have taken a bleach bath within a week prior to screening, or who take bleach baths during the study Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study Subjects with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier Any subject who is immunocompromised (e.g. provides researchers with a history lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome) or has a history of malignant disease (with the exception of non-melanomatous skin cancer). This information will be gathered verbally from the patient while taking a medical history from the patient, and will not involve further testing such as an HIV test Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol Active bacterial, viral or fungal skin infections Any noticeable breaks or cracks in the skin on either arm, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-80.0, Diabetes Mellitus Diabetes Complications Diabetic Neuropathies Wound Infection an adult patient (18-80 years) suffering from infected neuropathic fore or mid-foot ulceration originated from type I or II diabetes (PEDIS-classification ≥ Grade II) a patient whose life expectancy is less than 6 months an ulceration of ischemic or neuroischemic origin presence of systemic inflammatory response signs heel ulceration presence of osteomyelitis pregnancy known hypersensitivity to any of the ingredient including in the study or control treatment products a patient who is unable to give informed consent a patient who has an advanced malignant disease | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 5.0-18.0, Ulcerative Colitis (UC) Informed consent Established diagnosis of UC disease Age: 5 years ( inclusive) Mild to moderate active disease, 10 ≤ PUCAI ≤45 Stable medication (IMM/ 5ASA) use for the past 6 weeks For patients who received antibiotic treatment: age 10-18 (inclusive) Any proven infection such as positive stool culture, parasite or C.difficile Use of Antibiotics Use of steroids in the previous two weeks only Patients that are refractory to full dose steroids ( 1 mg/kg/day) Past acute severe UC Current Extra intestinal manifestation of UC Pregnancy A subset of patients who are on steroids and relapse during steroids treatment ≤0.5 mg/kg with mild to moderate disease activity will act as a second subset for this exploratory study | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Diabetic Foot Ulcers Men or women Type 1 or 2 diabetes Age ≥ 18 years Wagner 1 or 2 diabetic foot ulcer Diabetic ulcer for more than 8 weeks duration Willing to participate in the study with signed informed consent Ankle/brachial index < 0.4 (critic ischemia) Use topical or systemic antibiotics Inability to attend to the weekly evaluations Inability to do daily ulcer cleansing Autoimmune diseases Active pharmacologic topical or systemic ulcer treatment Treatment with immunosuppressors such as steroids, radiotherapy, chemotherapy Pregnancy or lactation | 2 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Does Hyperbaric Chaber Treatment Improve Diabetic Retinopathy Patients between ages 18-90 with Diabetes type I or II and diabetic retinopathy who are scheduled for hyperbaric treatment for other indications than DR Patients who signed an informed consent form and agree to undergo an ophthalmic physical examination, Fundus photography and OCT prior to hyperbaric treatment and oCT exam following every 10 treatments in hyperbaric chamber. Total number of hyperbaric treatments will be conducted according to the main indication for which they have been assigned this treatment Patients with Carotid stenosis of more than 70% Anemia of < 10mg/Dl Patients with chest X ray pathology which cannot be admitted to hyperbaric chamber treatment Patients with claustrophobia or that cannot decompress properly Patients with any malignant disease Patients with inability to sign informed consent Decompression treatment will last 90 minutes in 2 atmospheres pressure with 100% oxygen | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Diabetic Foot Ulcer Patients receiving care and treatment in OUH Wound Clinic (Odense University Hospital, Denmark) with a diabetic foot ulcer Wagner groups 1 and 2 (Wagner Ulcer Classification System) Patients with an ulcer duration of less than 2 months Ulcer area less than 0,5 x 0,5 cm (or less than 0,25 cm2) Patients who have had vascular surgery performed within the past 2 months Patients who cannot give informed consent Patients who do not read or speak danish Wagner groups 3 and 4 (Wagner Ulcer Classification System) | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 21.0-999.0, Diabetic Foot Ulcers Bacterial Infection Veterans over 21 years of age with chronic diabetic foot ulcers (wound duration over 8 weeks) who at the clinician's judgment requires wound debridement (25% or more of wound bed covered with non-viable tissue) wound size 1.5 cm (roughly the size of a quarter) or larger in diameter Cognitive impairment that would interfere with patient signing own Informed Consent Veterans on active anticoagulant therapy with most recent (within last week) PT/INR (international normalized ratio of prothrombin time) > 3.0, or other significant bleeding risk Active immune suppression just prior to or during study (on systemic corticosteroids* within 7 days prior, or chemotherapy for cancer or RA treatment within 4 weeks prior to study, or with diagnosis of HIV/AIDS) *Nasal steroid sprays will not be excluded Active systemic antibiotics is an Absent dorsalis pedis pulses and Ankle Brachial Index (ABI) < 0.5 is an (indicates critical limb ischemia) Other possible reasons participants could be removed from this study transfers to other non-VA facilities, participant is unable to tolerate tissue sampling even with local anesthesia, and/or inability to comply with scheduled research visits. Furthermore, if the participant has significant wound healing so that sampling is not possible after the initial sampling, they will be removed from the study | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Diabetic Foot Ulcer Type 2 Diabetes Male or female, age ≥ 18 Type 2 Diabetes A break in the skin on the foot ≥ 0.5cm2 and is Grade 1 or 2 as defined by the Wagner grading system Hemoglobin A1c ≥ 5.9% Ability to provide written informed consent Any experimental drugs taken orally or topically within 4 weeks of study entry Malignant disease at/or in proximity to the DFU Target wound of malignant origin Failure to satisfy at least one criterion for one of the two study groups | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-70.0, Eczema Healthy male or female ≥ 18 and ≤ 70 years of age Body mass index (BMI) ≥ 20 and ≤ 35 kg/m2 Subjects with mild to moderate eczema; determined at screening visit Judged by the Investigator to be in general good health on the basis of medical history Agree to use the Study-supplied cleanser and moisturizer as the only body cosmetic applied to irritated skin Agree to stop all medications and supplements during the entire length of the study Females of child bearing potential must agree to use appropriate birth control methods during the entire study period Agree not to initiate any new exercise or diet programs during the entire study period Agree not to change their current diet or exercise program during the entire study period Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator Clinically significant renal, hepatic, endocrine (including diabetes mellitus), cardiac, pulmonary, pancreatic, neurologic, hematologic, or biliary disorder Known allergy or sensitivity to Herbal products History or presence of cancer in the prior two years, including any skin cancer or suspicious lesions Recent history of alcoholism (within 12 months) or strong potential for alcohol or substance abuse Participation in a clinical study with exposure to any non-registered drug product within 30 days prior Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk. Including subjects who are Bed or wheelchair-bound Pregnant, lactating, or unwilling to use adequate contraception during the duration of the study Smoking must be nonsmoker for at least 12 weeks prior to screening | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Central Retinal Vein Occlusion Patients age 18-80 years with a documented CRVO who treated by Avastin for more than 12 months Patients who signed an informed consent form Patients with Carotid stenosis of more than 70% Anemia of < 10mg/Dl Patients with chest X ray pathology which cannot be admitted to hyperbaric chamber treatment Patients with claustrophobia or that cannot decompress properly Patients with any malignant disease Patients with inability to sign informed consent | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-85.0, Foot Ulcer, Diabetic Infection Has diabetes mellitus, according to the American Diabetes Association (ADA) criteria Has at least 1 skin ulcer located on or below the malleolus that presents with the following clinical manifestations of a moderate or severe infection based on the Infectious Disease Society of America guidelines for the "Diagnosis and Treatment of Diabetic Foot Infections" (CID 2012; 54:132-173) (IDSA guidelines) has ≥ 2 manifestations of inflammation (local swelling or induration, erythema, local tenderness or pain, local warmth, purulent discharge (thick, opaque to white or sanguineous secretion) has ≥ 1 of the following characteristics: erythema > 2cm, or involving structures deeper than skin and subcutaneous tissues (e.g. abscess, osteomyelitis, septic arthritis, fasciitis) For patients with multiple infected ulcers, the ulcer with the highest Diabetic Foot Infection Wound score (DFI score) must be on or below the malleolus and all infected ulcers must be completely coverable using no more than 4 sponges (sponges cannot be cut) Has documented adequate arterial perfusion in the affected limb(s) (either palpable dorsalis pedis and posterior tibial pulses, or normal Doppler wave forms, a toe blood pressure ≥ 45 mm Hg or participation is approved by a vascular surgeon) Has received appropriate surgical intervention to remove all necrotic and infected bone if diagnosed with osteomyelitis Has received appropriate surgical debridement to remove all gangrenous tissue Has a known history of hypersensitivity to gentamicin (or other aminoglycosides) Has a known or suspected hypersensitivity to bovine collagen Has an ulcer infection which, based upon the patient's known history of hypersensitivity and/or as otherwise in the opinion of the investigator, cannot be adequately treated with at least one of the empiric systemic antibiotic regimens allowed by this protocol Has an ulcer associated with prosthetic material or an implanted device Has received any systemic or topical antibiotic therapy for any reason within 7 days of randomization unless it was administered to specifically treat the infected ulcer(s) and only within 36 hours of randomization Requires or is likely to require treatment with any concomitant topical product or wound therapy before the first follow-up study visit Is severely immunocompromised, or likely to become severely immunocompromised during the study, in the opinion of the investigator Has a history of myasthenia gravis or other neurological condition where gentamicin use is contraindicated as determined by the investigator Has a history of epilepsy Has a history of alcohol or substance abuse in the past 12 months | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Diabetes Mellitus, Type 2 Adults 18 years and older (to be confirmed by electronic health record) Individuals who have received a diagnosis for type 2 diabetes mellitus (T2DM) Enrolled as a patient in the Vanderbilt APPC or the Eskind Diabetes Clinic Registered My Health at Vanderbilt user Individuals currently being treated with oral and/or injectable diabetes medication (to be confirmed through electronic health record) Non-English speakers (determined by a trained research assistant) Individuals with a severe hearing or visual impairment (determined subjectively by a trained research assistant) Individuals with delirium or a severe cognitive impairment (determined by a lack of orientation to person, place, and time) Individuals who report a caregiver administers their diabetes medications Individuals who report they do not have a mobile phone or computer with internet access Individuals unwilling and/or unable to provide written informed consent | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Ulcer Wounds A signed and dated informed consent has been obtained from the subject Subject is able and willing to comply with study procedures Subject is able to comply with weekly visits Subject is 18 years of age or older There is presence of at least 50% or greater necrotic tissue (including slough and eschar) in the wound bed and a total wound surface area of > 1cm2 to < 64cm2 Subject will not have currently used parenteral or oral antibiotics except for UTI Diabetic subjects: HbA1c < 12.0 % within 90 days preceding enrollment Pre-albumin greater than 16 mg/dl within 90 days preceding enrollment Subject with a pressure ulcer must be currently receiving adequate pressure redistribution to the affected area via group 2 or 3 specialty bed, a static wheel chair cushion while patient is out of bed Subject with diabetic plantar surface ulcer will use an offloading boot if ambulatory Steroid use >5mg daily Subject is unable to cooperate with offloading and/or compression recommendations ABI = or >0.8 if the wound is located on a lower extremity Wound has the presence of callus requiring sharp or surgical debridement within 3 days prior to randomization and/or needs debridement using any method other than the study agent throughout study treatment Subject has medical instability as deemed by the investigator Subject is pregnant Subject has participated in another clinical trial or wound dressing evaluation in the 30 days prior to enrollment | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-80.0, Foot Ulcer Varicose Ulcer Patients with cutaneous leg ulcers due to diabetes mellitus, venous stasis and arterial insufficiency requiring healing or tissue debrided sent to managing their disease to regional general hospital No. 17, Instituto Mexicano del Seguro Social, Benito Juárez, Quintana Roo Patients of both sexes Patients over 18 years Patients that have basic laboratory at admission (complete blood count with differential) Patients with comorbidities associated as Diabetes Mellitus , Hypertension, stroke, heart disease, nephropathy, venous insufficiency and arterial insufficiency, etc Hemodynamically unstable patients Patients with septic shock from any source Patients with deep skin ulcers with exposed some organ, data osteomyelitis, vascular-nervous exposure Patients with secondary cutaneous ulcer enteral fistula Patients with cutaneous ulcer or cancer tumors Patients with cutaneous ulcer with active bleeding Patients with cutaneous ulcer necrosis Patients with cutaneous ulcer leishmania, insect bite Patients with cutaneous ulcer burns Patients who do not accept their participation in the study through informed consent | 2 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 0.5-85.0, Xerosis Cutis Signed informed consent, or children whose parent(s) or guardian(s) have given their written informed consent for their child's participation in the study Child specific written informed consent, if over 7 years of age Subjects with a general good and stable health condition Subjects with clinically stable medical conditions Accept to abstain from sunbathing and solarium during the study Overall Dry Skin score (ODS) of 1 to 2 at arms and lower legs TEWL > 12 g/m2/h on the left mid volar forearm Any dermatological condition or skin affection which may interfere with the study assessments, e.g. scars Suffering from porphyria Suffering from severe photodermatoses according to the judgment of the investigator Clinically significant, possibly unstable medical conditions such as metastatic tumor Currently having other malignant or benign tumors of the skin in the investigational area Any other acute or chronic pathology that may interfere with the study conduct in the investigator's opinion Known allergy or intolerance to any ingredients of the study product, e.g. propylene glycol Use of (medical) oil-containing bath additives or other oil-containing cleansers Current topical or systemic treatment affecting the skin, e.g. diuretics Treatment of dry and/or inflammatory skin conditions with topical corticosteroids during the 4 weeks before | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-65.0, Infection Cohort 1: Diabetic hyperbaric patients with active, chronic infection Adult patients (ages 18-65) presenting for an anticipated course of at least 4 hyperbaric oxygen sessions for chronic clinical indications (possible indications diabetic lower extremity wounds or refractory osteomyelitis) Diabetes mellitus Current antibiotic use for active infection Prior treatment with hyperbaric oxygen within the last 30 days Consistent vitamin C or vitamin E supplementation in the past year Active tobacco use Pregnancy Cohort 2: Hyperbaric patients without diabetes or active infection Adult patients (ages 18-65) presenting for an anticipated course of at least 4 hyperbaric oxygen sessions for chronic clinical indications (possible indications crush injury, acute peripheral arterial insufficiency, or radiation necrosis) Prior treatment with hyperbaric oxygen within the last 30 days Consistent vitamin C or vitamin E supplementation in the past year Active tobacco use Pregnancy | 2 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Leg Ulcers Patient over 18 years old who has provided his/her written informed consent Patient who can be monitored by the same investigation team throughout the whole duration of the study Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3 Ulcer area > or equal to 5cm2 Ulcer duration > or equal to 6 months Ulcer presenting a the surface wound bed covered with 50% or more by sloughy tissue Moderately or heavily exudative ulcers Clinical infection on the wound bed | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-100.0, Diabetes Diabetes Complications Neuropathy Peripheral Neuropathy Diabetic Foot Ulcer Diabetes (according to AAFP diagnostic ) Presence of neuropathy with Loss of Protective Sensation (LOPS), as defined by any loss of sensation as per the assessments included in the Modified Neuropathy Disability Score (MNDS) Active plantar diabetic foot ulcer (Grade 1A, according to the University of Texas Wound Classification System , ) A minimum size ulcer ≥1cm2 and ≤ 12 cm2 post debridement at time of randomization If the subject has more than one ulcer, they should be identified and at least 2 cm apart The duration of the study ulcer is at least 30 days at the time of the screening visit Age >18 At least one palpable foot pulse Ability to understand all of the study requirements Life expectancy greater than the duration of the study Weight > 400 lb (182 kg) Uncorrected visual impairment Active Infection Non-plantar ulcers on the ankle, posterior heel, or other location More than one active plantar ulcer Presence of severe ischemia (any of: absence of foot pulses, Ankle Brachial Index 0.6 > [ABI] > 1.2, capillary refill time > 5 seconds; see Appendix 3) Current participation in another clinical investigation of a medical device or a drug; or has participated in such a study within 30 days prior to this study Current smokers Active abuse of alcohol o Subject has a history of any of the following intercurrent illnesses or conditions that would compromise the safety of the subject or the normal healing process | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Lower Limb Ulcers Patient is 18 years of age or older Patient has one of the following difficult-to-treat chronic ulcers in the lower limb 1. Neuropathic lower limb ulcer 2. Venous lower limb ulcer 3. Post traumatic lower limb ulcer 4. Post operative lower limb ulcer In case of Neuropathic foot grade according to University of Texas Classification 1A Wound area measurement ranging between 1-20cm2 Acute ulcer Multiple Ulcers on the lower limb Clinical evidence of infection in the soft tissue, joint and/or bone (osteomyelitis) as presented in the physical examination The wound is penetrating into deep structures and involves bone tendon or joint Wound has necrotic tissue Wound with sinus tracts HbA1c>12 Patients with any other skin disorder unrelated to the ulcer that is | 0 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-60.0, Diabetic Foot Ulcer Subject is between 18 years and 80 years of age Subject is diagnosed with Type I or Type II diabetes, and had defined as diabetic foot ulcers presence of wound for more than 4 weeks at the screening visit Ulcer located the foot, and ulcer size is between 1 cm2 and 25 cm2 Ulcer extends into the dermis, subcutaneous tissue, tendon or joint capsule (Wagner grade 1 or 2) Ulcer is free of necrotic debris Subjects had adequate circulation to ulcer as documented by either Palpation of pulses around ulcer using Doppler exam Ankle Brachial index (ABI) values ranging between 0.7 and 1.3, or Transcutaneous Oxygen Pressure (TcPO2) > 30 mmHg Subject is able to give written informed consent prior to study start and to comply with the study requirements Ulcer is of non-diabetic pathophysiology The ulcer has increased or decreased in size by 30% or more during one week after the screening visit Subject is Human Immunodeficiency Virus (HIV) positive Subjects with severe hepatic deficiencies Subjects with a glycated hemoglobin A1c (HbA1c) level of > 15% Subject who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue Subjects requiring intravenous (IV) antibiotics to treat the index wound infection Subjects who are currently receiving dialysis Subjects who are pregnant or breast-feeding Subjects who are unwilling to use an "effective" method of contraception during the study | 1 |
64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing. | eligible ages (years): 18.0-999.0, Diabetes Mellitus Diabetes patients who are users of CVD risk factor medications (antihypertensive therapies, antihyperlipidemics therapies, and oral antihyperglycemic therapies) Diabetes patients considered to be poorly adherent to CVD risk factor medications within the prior 12 months Diabetes patients who have not used the mail order pharmacy to fill any prescribed medications at least once in the prior 12 months | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Bipolar Disorder Patients must have Acute bipolar I illness and be experiencing a manic or depressed episode at the time of study entry Required Current treatment with lithium carbonate | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 8.0-18.0, Bipolar Disorder Depression Free of manic symptoms for at least 4 weeks. Must be treated with valproate or lithium (mood stabilizers) for at least 4 weeks. Meet for major depression and bipolar disorder (BP-I, BP-II, or BP-NOS). Not pregnant Patients with schizophrenia, autism, schizoaffective disorder, organic mood disorder, obsessive-compulsive disorder, eating disorder, and psychosis. IQ less than 70. Significant chronic medical illness such as diabetes, epilepsy. Pregnancy. Substance abuse in last 3 months. Concurrent psychotherapy. Previous lack of response to adequate treatment with fluoxetine or other SSRI. Current use of psychoactive medication other than lithium or valproate | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Tobacco Use Disorder Smoke at least 10 cigarettes per day Report concern about cessation-related weight gain Motivated to quit smoking Currently pregnant, lactating, or no medically approved method of contraception Major medical problem History of seizure disorder or head injury Current or historical psychosis or bipolar disorder History of alcohol or substance abuse within previous year Current or historical eating disorder Use of antidepressant medication, monoamine oxidase inhibitor or lithium with previous month Multiple Drug Allergies Current major depressive disorder | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 15.0-999.0, Bipolar Disorder General current age 15 or older (Best Practice Pathway) or 18 years or older (Randomized Care Pathways) able to give informed consent for data to be harvested meet DSM-IV for Bipolar I Disorder, Bipolar II Disorder, Bipolar Disorder NOS, or Cyclothymic Disorder undergo a complete standard evaluation including clinical interview, self ratings, and laboratory studies meet with Clinical Specialist as scheduled able to complete all Study Registry Forms within 3 months of registration General unwilling or unable to adhere to basic study requirements (i.e., complete rating forms, or attend scheduled evaluations) not competent to give informed consent in the opinion of the investigator (e.g., psychotic) Participants will be asked to remain in the study for up to five years so that the investigators can document and evaluate long-term treatment outcome. Participants will meet with their STEP-BD psychiatrist for periodic evaluations and/or treatment adjustments during the course of the study, fill out various self-rating forms, and when applicable, participate in psychotherapy. One of the psychotherapy options, Family-Focused Therapy, will require participants and their families to attend counseling sessions together. Overall, the estimated amount of time required from participants in the study is 2 to 4 hours per month | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-75.0, Bipolar Disorder ARE NOT BEING FOR THIS STUDY FOR Patients must meet the following in order to participate in the study Male or female inpatients in need of treatment for severe bipolar depression 18-75 years of age Women of childbearing potential must be using an adequate form of contraception as defined by one of the following: 1) a barrier method and 2) oral contraceptives plus a barrier method (women who are on an OCP will be kept on it others must agree to use only a barrier method) DSM-IV diagnosis of bipolar depression I/II, severe, with or without psychotic features A current major depressive episode of at least 6 weeks' duration Score of greater than or equal to 18 on the first 17-item HAM-D at the prestudy visit and at the first baseline phase visit Score of 15 or greater on the HAM-D (17) at the end of the baseline period(s) (i.e., at randomization no more than 20% less than entry enrollment criteria) FOR Patients will be excluded from the study if they meet any of the following Women who are pregnant, intending to become pregnant in the next month or breast-feeding Treatment with any of the following therapies within the specified interval prior to baseline: Fluoxetine weeks; Investigational compounds 4 weeks; MAOIs 1 week; Other antidepressants 1 week Contraindication or history of hypersensitivity to mifepristone as well as cortisol, and CRH Clinically significant organ system disease where mifepristone would be contraindicated or interfere with medical treatment Have evidence of any disorder that represents a contraindication to the use of mifepristone (such as adrenal disease or a condition requiring chronic corticosteroid administration) History of Addison's Disease, Cushing's Disease, insulin dependent diabetes, or other uncompensated endocrine conditions Evidence of infection, severe liver, respiratory, or renal disease | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Schizophrenia Psychotic Disorders Bipolar Disorder You must be between the ages of 18 and 65. If you have reached your 66th birthday, you will not be able to participate You must have been diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or bipolar I disorder and be taking olanzapine You must be able to visit the doctor's office as scheduled for the next 4 months You have a history of an illness that would cause weight loss or gain in the near future You have taken remoxipride within the past 6 months You are allergic to olanzapine or Anti-obesity Agent You have uncontrolled high blood pressure, congestive heart failure, or have had a stroke You have a serious medical illness, such as heart, liver, or kidney disease You are pregnant or breast feeding | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 16.0-999.0, Bipolar Disorder Bipolar I or II Disorder Meet for rapid cycling, defined as four or more episodes over the past 12 months Meet for a major depressive episode History of intolerability of lithium, divalproex, or lamotrigine | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 15.0-999.0, Depression Score of 16 or higher on the Center for Epidemiological Studies Depression (CES-D) Scale Child who is 6 weeks to 30 months old Child who is enrolled in an Early Head Start program Regular use of psychotropic medication Regular use of psychotherapy or drug/alcohol treatment | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 0.0-999.0, Alzheimer Disease Patient is between the ages of 40 and 90 (inclusive) Patient will have a diagnosis of AD; the study will be confined to patients who are able to provide consent (pass a capacity assessment) The modified Hachinski Ischemia Score must be less than 4 Brain MRI performed within 15 months of enrollment must be compatible with the diagnosis of AD Patient and/or caregiver are willing to adhere to protocol requirements as evidenced by written, informed consent Patients meeting any of the following during screening or during the study will not be enrolled or will be immediately excluded from the study, as appropriate Patient has a history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk Patient has clinically significant laboratory abnormalities that would preclude administration of lithium and divalproex Patient is taking a prohibited concomitant medication. The following medications are forbidden for at least one month prior to the treatment phase (unless otherwise noted) and during the course of the study Any investigational drugs Anti-depressants (eligibility will be considered as long as dosage remains stable throughout the study) Anticonvulsants and other mood stabilizing drugs Treatment that may provoke lithium toxicity due to reduced renal clearance, including metronidazole, spectinomycin, tetracycline Treatment that may substantially increase steady-state plasma lithium levels resulting in lithium toxicity, including angiotensin-converting enzyme inhibitors, diuretics | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-55.0, Cannabis Dependence Substance Withdrawal Syndrome DSM-IV diagnosis of cannabis dependence with at least a three-month history Seeking treatment for primary cannabis problem Withdrawal identified as barrier to abstinence Other drug dependency (excluding nicotine) Client is breastfeeding or pregnant Client has contraindicated medical or psychiatric conditions Client currently taking other medications that may interact with lithium Known hypersensitivity / side effects with Lithium Currently receiving Lithium from another source Currently prescribed any antidepressant / mood stabilising / antipsychotic medication Currently receiving opioid pharmacotherapy | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 8.0-17.0, Bipolar Disorder Attention Deficit Hyperactivity Disorder Age: 8-17 BD type I or II comorbid with ADHD Baseline score in the YMRS > or = 20 IQ < 70 Pharmacologic treatment in the last month Pregnancy or absence of a contraceptive method in fertile girls Diagnoses: pervasive development disorder, schizophrenia, drug abuse or dependency Risk of suicide or homicide Clinical condition that might interfere in the study Known sensibility to aripiprazole | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Bipolar Disorders Aged 18-65 Minimum two year history of depressive and hypomanic episodes Mood episodes occuring monthly Meet DSM-IV for Bipolar II Disorder (with exception of minimum 4 day period for hypomanic episodes) Previous treatment with any antidepressant, mood stabilizer or neuroleptic medication History of psychotic symptoms during hypomanic or depressive episodes Current suicidal behaviours Current substantive illicit drug use or alcohol consumption Significant personality disorder Pregnancy or breastfeeding History of heart disease, liver disease, epilepsy or seizures | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 25.0-55.0, Insomnia Primary Insomnia Psychophysiologic Insomnia Ages 25 a stable sleep/wake schedule with a preferred sleep phase between 10:00 p.m. and 8:00 a.m Patients with Primary Insomnia will meet diagnostic for Psychophysiologic Insomnia according to the International Classification of Sleep Disorders manual (ICSD) complaint of disturbed sleep must have the following characteristics: >30 minutes to fall asleep, and/or >30 minutes wake after sleep onset time, a total sleep time of no more than 6.5 hours (or a sleep efficiency of less than 85%), a problem frequency of >4 nights/ week and a problem duration >6 months Unstable medical or psychiatric illness Use of medication that may cause insomnia or may be reduce the effectiveness of zolpidem (e.g. selective serotonin reuptake inhibitors(SSRI's), steroids, bronchodilators, calcium channel blockers, beta blockers, etc.) symptoms suggestive of sleep disorders other than insomnia polysomnographic data indicating sleep disorders other than insomnia Evidence of active illicit substance use or fitting for alcohol abuse or dependence inadequate language comprehension pregnancy first-degree relatives with bipolar disorder or schizophrenia | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Bipolar Disorder Panic Disorder Generalized Anxiety Disorder Subjects must be 18 years of age or older Subjects must have lifetime bipolar I, II, or NOS disorder as defined by DSM-IV criteria Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV (except clause “does not occur exclusively during a mood disorder” of Criterion F for GAD) Subjects’ bipolar symptoms must be no more than moderately severe, defined as a CGI-BP < 4 Subjects’ anxiety symptoms must be at least moderately severe, defined as a CGI-S > 4 Subjects must not be receiving mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for > one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for > four weeks prior to baseline Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, double barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study Subjects who do not have lifetime bipolar disorder by DSM-IV-TR criteria Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria Subjects who are receiving treatment with an antimanic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators’ judgment, require ongoing treatment with that medication Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP > 5) Subjects whose anxiety symptoms are presently less than moderately severe (CGI < 3) Subjects with clinically significant suicidal or homicidal ideation Subjects with current psychotic symptoms Subjects with a current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV diagnosis of a substance dependence disorder within the past six months; a lifetime DSM-IV psychotic disorder (e.g., schizophrenia or schizoaffective disorder) Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo or hyperthyroidism unless stabilized on thyroid replacement > 3 months | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Depression males or females age 18 to 65 years, DSM-IV episode of Major Depression non-psychotic, ≥14 score on the 17-item HRSD, adequate trial with two antidepressants (see definition above of 'adequate trial'), ability to receive and give informed consent, if patients are of child-bearing potential (male or female), use of an effective contraceptive is required for at least one month prior to the screening Visit and documentation of a negative pregnancy (female) test upon entry into the study bipolar or psychotic depression, overt personality disorder, currently suicidal or a history of suicide attempt in the previous 6 months, current substance abuse or history of substance abuse in the previous 12 months, history of hypersensitivity to aripiprazole, treatment with antipsychotic medications in the previous 3 months, serious or unstable medical disorders which in and amongst themselves may lend to morbidity or mortality during study, any medical illness with relative contraindication for aripiprazole use, starting or terminating psychotherapy during the previous 12 weeks, ECT treatment in the previous 3 months, pregnancy or planning pregnancy, history of severe head injury with sequelae, comorbid anxiety condition which has been focus of clinical attention in previous 6 months (remitted GAD, OCD, Panic, Social Anxiety, PTSD may be allowed) | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 20.0-50.0, Sleep Disorders Physically healthy Meets DSM-IV for primary insomnia For subjects interested in PET study only: right-handedness Currently taking antidepressants, antianxiety medications or medications for sleep disorders Currently experiencing symptoms of psychiatric disorders such as major depressive disorder, bipolar disorder, generalized anxiety disorder Significant or unstable acute or chronic medical conditions, such as seizure disorder, tumor, liver disease, active peptic ulcer disease, arthritis, irritable bowel disease Meets DSM-IV for sleep apnea or periodic limb movement disorder | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 50.0-999.0, Bipolar Disorder Must have Bipolar disorder as confirmed by the Mini Neuropsychiatric Interview (MINI) Must be age 50 or older Must have sub-optimal response to current psychotropic management including at least one of the following Behaviors and symptoms of irritability, agitation, mood liability or diminished ability to interact with others in their place of residence Diminished ability to take care of basic personal needs in their place of residence due to symptoms of bipolar disorder Intolerance to current psychotropic medications; and Must live in the Northeast Ohio area An unstable medical illness, or a medical illness, which in the opinion of the study investigators, is likely to affect the outcome of the study DSM-IV substance dependence (except nicotine or caffeine) within the past 3 months; or Receiving carbamazepine | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 15.0-29.0, Bipolar Disorder Schizoaffective Disorder Male and female patients aged 15 to 29 Experiencing a first episode psychosis Meet DSM-IV for bipolar either manic or mixed episode, or schizoaffective disorder manic episode Minimum score of 20 on the YMRS Written informed consent to participation Patients at immediate risk of committing harm to self or others Use of neuroleptics or mood-stabilisers in the two months preceding admission to EPPIC Organic mental disease, including mental retardation History of clinically significant illness (liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological or metabolic disturbances) Clinically relevant biochemical or hematological abnormalities Pregnant or lactating woman History of epilepsy History of severe drug allergy or hypersensitivity Non fluency in English | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 19.0-65.0, Obesity Are men or women, between the ages of 19 and 65, inclusive Have a diagnosis of any type of bipolar disorder or any type of psychotic disorder based on structured diagnostic interview (MINI) Are currently outpatients or inpatients and taking a neuroleptic or mood stabilizer medication (listed below) for the past 6 months, and on a stable dose for the past 2 months Have a body mass index > 25 No substance use disorder in the past 2 months (except for nicotine or caffeine) Agree to not become pregnant during the study and agree to use an adequate method of birth control during the study such as a barrier method, hormonal contraceptive, or surgical sterilization (females only). All women of childbearing potential must have a negative pregnancy test before beginning study medication Are able to swallow the capsules whole Are willing and able to follow Investigator instructions and study procedures, and report adverse events Not currently actively suicidal or homicidal No use of topiramate within the last 6 months Clinically significant renal or hepatic disease History of acute intermittent porphyria, glucose-6phosphate dehydrogenase deficiency or hemolytic anemia Allergy to zonisamide or sulfonamides Have clinically unstable cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or other systemic disease Have laboratory test results that, in the opinion of the Investigator, are clinically significant abnormalities Require treatment with any medication (e.g., carbonic anhydrase inhibitors) that might interact adversely with, or obscure, the action of the study drug Are pregnant or lactating (females only) Have a history of nephrolithiasis Refuse to give informed consent Have previously enrolled in this study or previously been treated with zonisamide | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-70.0, Binge Eating Disorder Associated With Obesity Patients will meet DSM-IV for BED for at least the last 6 months. These are as follows Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following: (1) eating, in discrete period of time (eg, within any two hour period), an amount of food that is definitely larger than most people would eat in a similar period of time under similar circumstances and (2) a sense of lack of control over eating during the episode (eg, a feeling that one cannot stop eating or control what or how much one is eating) The binge eating episodes are associated with at least three of the following Eating much more rapidly than normal Eating until uncomfortably full Eating large amounts of food when not feeling physically hungry Eating alone because of being embarrassed by how much one is eating Feeling disgusted with oneself, depressed, or feeling very guilty after overeating Marked distress regarding binge eating The binge eating occurs, on average, at least two days a week for six months Have current body mass index < 30kg/m2 Women who are pregnant or lactating and women of childbearing potential who are not taking adequate contraceptive measures. If there is a possibility a female subject might be pregnant, a pregnancy test will be performed. (All women of childbearing potential will have a negative pregnancy test before entering the study.) Subjects who are displaying clinically significant suicidality or homicidality Subjects who are displaying a current clinically unstable depressive disorder (e.g., HAM-D > 21) A current or recent (within 6 months of the start of study medication) DSM-IV diagnosis of substance abuse or dependence A lifetime history of a DSM-IV bipolar disorder or dementia History of a personality disorder (eg, schizotypal, borderline, or antisocial) which might interfere with assessment or compliance with study procedures Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease which could interfere with diagnosis, assessment, or treatment of binge eating disorder. Patients should be biochemically euthyroid prior to entering the study History of seizures, including febrile seizures in childhood History of clinically significant nephrolithiasis | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 13.0-75.0, Bipolar Disorder In order to be included in the study patient must meet A, C, D, E, F, G plus any 1 of the 3 listed in section B A. Patients meeting DSM-IV diagnosis of bipolar disorder, I or II Patients meeting DSM-IV diagnostic for a manic/hypomanic episode with the simultaneous presence of (or rapid alteration within minutes) of at least three DSM-IV depressive symptoms excluding psychomotor agitation or Patients meeting DSM-IV symptomatic for a hypomanic/manic episode for a period of 2 days or longer, with the simultaneous presence of (or rapid alteration within minutes) of at least three DSM-IV depressive symptoms excluding psychomotor agitation or Patients meeting DSM-IV for a depressive episode associated with at least three DSM-IV manic/hypomanic symptoms C.MADRS of ≥14 D.YMRS of ≥ 14 E. Age 13years to 75 years F. Male or female G. Outpatient illness precluding the use of LAM Alcohol/drug dependence in the past one month patients with a history of a rash on LAM CNS neoplasms, demyelinating diseases, degenerative neurological condition or active CNS infection history of seizure, known EEG with frank paroxysmal activity, known CT of brain showing gross structural abnormalities, cerebral vascular disease by history or structural brain damage from trauma patients currently taking LAM | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Bipolar Disorder Age above 18 is preceded by an affective episode requiring hospitalisation or outpatient drug treatment (index episode) which can be a manic episode (ICD-10 research criteria), a depressive episode of at least moderate degree (ICD-10 research criteria) or a mixed manic state (manic episode with at least additional three ICD-10 depressive symptoms except for difficulties with concentration or thinking, agitation or dyssomnia). The episode can be with or without psychotic symptoms including Schneiderian first-rank symptoms or bizarre delusions as long as the psychotic symptoms do not occur outside the affective episode No more than 12 months may pass between the onset of the index episode (or admission if that is the case)and date of randomisation (in order to ensure a current risk of relapse as well as reliable psychopathological information) Besides the index episode, at least one previous episode must have occurred within the last five years which meets the mentioned in point number two above. This episode may not necessarily have led to hospitalisation. Two episodes are separated by at least two months without significant symptoms or change in polarity (depression to mania/mixed mania or vice versa) At least one manic episode (or mixed manic episode) within the last 5 years Contraindications to the protocol drugs Severe somatic disease, e.g. epilepsy, which may interfere with study treatment or effect evaluation Pregnancy (or risk of pregnancy) Subject has prior to randomization received prophylactic treatment with lithium or lamotrigine conducted adequately in the sense of sufficient time and dose and ensuring compliance, and experienced a definite lack of prophylactic effect An ICD-10 diagnosis of abuse within the last year with a subsequent risk of protocol violation. Therefore, subjects with a secondary abuse can often be included in the study Anticipated protocol violation for other reasons No written informed consent from the subject can be obtained The subject has previously been randomised in the study | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Obesity Age 18-65 years; BMI 30-50 Secondary obesity; Significant cardiovascular disease; Stroke, seizure disorder or other significant neurological disease; Significant liver or gallbladder disease; Significant renal disease or history of kidney stones; HIV positive status; Diabetes mellitus; Untreated or unstable hypothyroidism Malignancy in the past 5 years; Concomitant medications that cause significant weight gain or weight loss; Concomitant use of prescription or OTC weight loss medications; Had bariatric surgery or planning surgery in the next 1 year; Weight change of more than 4 kg in the past 3 months; Suicidal subjects; Major depression in the past 6 months; History of psychosis, bipolar disorder, or severe personality disorders; Subjects taking antipsychotics or mood stabilisers; Alcohol or substance abuse in the past 6 months; Currently taking zonisamide or other antiepileptic drugs; History of hypersensitivity to zonisamide or sulfonamides; Pregnant or planning pregnancy in the next year, or breastfeeding; Severe physical disability; Current participation in a commercial weight loss program or planning to participate; Currently following low-carbohydrate, high protein, high fat diet; Use of investigational medications or devices (current or past 4 weeks) | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Binge Eating Disorder Obesity Patients will meet DSM-IV-TR for BED for at least the last 6 months, determined by the Structured Clinical Interview for DSM-IV-TR (SCID) (61) and supported by the Eating Disorder Examination (EDE) (62). These are as follows Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following eating, in discrete period of time (e.g., within any two hour period), an amount of food that is definitely larger than most people would eat in a similar period of time under similar circumstances a sense of lack of control over eating during the episode (e.g., a feeling that one cannot stop eating or control what or how much one is eating) The binge eating episodes are associated with at least three of the following eating much more rapidly than normal eating until uncomfortably full eating large amounts of food when not feeling physically hungry eating alone because of being embarrassed by how much one is eating feeling disgusted with oneself, depressed, or feeling very guilty after overeating Have current body mass index < 30 kg/m2 Women who are pregnant or lactating and women of childbearing potential who are not taking adequate contraceptive measures. (All women of childbearing potential will have a negative pregnancy test before entering the study.) Subjects who are displaying clinically significant suicidality or homicidality Subjects who are displaying a current clinically unstable depressive or bipolar disorder, defined as a Montgomery Asberg Depression Rating Scale (MADRS) (63) > 24 or a Young Mania Rating Scale (YMRS) (64) > 8 A current or recent (within 6 months of the start of study medication) DSM-IV-TR diagnosis of substance abuse or dependence A lifetime history of a DSM-IV-TR psychotic disorder or dementia History of a personality disorder (e.g., schizotypal, borderline, or antisocial) which might interfere with assessment or compliance with study procedures Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease which could interfere with diagnosis, assessment, or treatment of binge eating disorder. Patients should be biochemically euthyroid prior to entering the study History of seizures, including febrile seizures in childhood Subjects requiring treatment with any drug which might interact adversely with or obscure the action of the study medication (e.g., stimulants, sympathomimetics, antidepressants, carbonic anhydrase inhibitors, anti-obesity drugs) | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Bipolar Disorder Anxiety Disorder Subjects must be 18 years of age or older Subjects must have lifetime bipolar I, II, or NOS disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV (except clause "does not occur exclusively during a mood disorder" of Criterion F for GAD) Subjects' bipolar symptoms must be no more than moderately severe, defined as a CGI-BP < 4 Subjects' anxiety symptoms must be at least moderately severe, defined as a CGI-S > 4 Subjects must not be receiving mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for > one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for > four weeks prior to baseline Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained If female, subjects must be postmenopausal surgically incapable of childbearing Subjects who do not have lifetime bipolar disorder by DSM-IV-TR (text revision) criteria Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria Subjects who are receiving treatment with an antimanic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP > 5) Subjects whose anxiety symptoms are presently less than moderately severe (CGI < 3) Subjects with clinically significant suicidal or homicidal ideation Subjects with current psychotic symptoms Subjects with a current DSM-IV Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV diagnosis of a substance dependence disorder within the past six months; or a lifetime DSM-IV psychotic disorder (e.g., schizophrenia or schizoaffective disorder) Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo or hyperthyroidism unless stabilized on thyroid replacement > 3 months | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 21.0-64.0, Insomnia MAJOR Must experience sleep disturbances at least 3 nights/week, based on historical data Must meet the diagnostic requirements for Major Depressive Disorder Must have QIDS-SR16 score between 6 and 15 Must be either newly diagnosed or show symptoms of relapse/recurrence of depression while not on medication Age 21-64, inclusive Women must use a medically acceptable form of contraception (steroidal contraceptive, double-barrier, or intra-uterine device) during the entire study period, or: be surgically sterilized, post-menopausal, agree to use double-barrier contraception throughout the study period, or must have a negative urine pregnancy test prior to randomization Subject must be stabilized on all ongoing long-term medication therapy for at least 28 days prior to screening visit MAJOR Severity of depressive episode had been rated as "severe" or "severe with psychotic features." History of a suicide attempt or suicidal ideation History of mania, manic episode or bipolar disease Currently using a benzodiazepine or SSRI or more than 2 days of use within the 28 days preceding randomization Use of prescription and non-prescription sedative drugs given for the purpose of sleep induction or to relieve jet lag Any abnormal pre-study laboratory values that require clinical intervention Prior failure to respond to escitalopram therapy for depression Current depressive episode requiring inpatient hospitalization Shift work or requirement for a regular change in sleep schedule by at least six hours within the previous 28 days History of drug addiction, alcoholism, or drug abuse | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 21.0-64.0, Insomnia Male or female between the ages of 21and 64 years, inclusive Women must use a medically acceptable form of contraception during the entire study period, or: be surgically sterilized, post-menopausal, agree to use double-barrier contraception throughout the study period, or must have a negative urine pregnancy test prior to randomization Must meet the diagnostic requirements of Generalized Anxiety Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders Score at least 18 on the Hamilton Rating Scale for Anxiety (HAM-A) Must be either newly diagnosed or show symptoms of relapse during a period of no drug therapy for anxiety Subject must experience sleep disturbances at least three nights per week, for at least one month prior to study entry, based on historical data Subject must be stabilized on all long-term medication therapy for at least one month prior to study entry History of Post-Traumatic Stress Disorder Concomitant Major Depressive Disorder or Bipolar Disorder Any abnormal pre-study laboratory values that require clinical intervention | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 6.0-17.0, Attention Deficit Hyperactivity Disorder Male or female between the ages of 6 and 17 years, inclusive Children with diagnosed ADHD (as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision [DSM-IV-TR] criteria) Complaint of childhood insomnia as defined by repeated difficulty with sleep initiation or consolidation that occurs despite adequate age, appropriate time, and opportunity for sleep The sleep disturbance must not be attributable to either the direct physiologic effect of drug abuse or misuse of a prescribed medication Subjects should be stabilized on all long-term therapy, including treatment of ADHD, for at least one month prior to study entry Subjects, if females of childbearing potential (as determined by the initiation of menses), must have confirmed negative pregnancy test prior to randomization and be using a recognized effective method of birth control (oral, implant, depot or transdermal oestroprogestatives, intrauterine device, double-barrier with spermicide). Abstinence is an acceptable method of birth control for this study Mental retardation Autistic spectrum disorder A history of sleep apnea A history of bipolar disorder, conduct disorder, major depression, or generalized anxiety disorder (not obsessive compulsive disorder), as determined by clinical interview and DSM-IV-TR Current history of substance abuse/dependence Known hypersensitivity to zolpidem or previous adverse experience with zolpidem Pregnant or breast-feeding Current use of hypnotics, antihistamines, melatonin, herbal products, or other sleep aids | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 13.0-17.0, Bipolar Disorder Between the ages of 13 years, 0 months and 17 years, 11 months Meets The Diagnostic and Statistical Manual of Mental Disorders IV for either of the following conditions: bipolar I or bipolar II disorder with a manic, mixed, or hypomanic episode within 3 months of study entry; or a depressed episode within 3 months of study entry with a prior history of a manic, hypomanic, or mixed episode (if the participant only meets for a current hypomanic episode, there must also be a history of at least one prior depressive, manic, or mixed episode) Has experienced severe depression, hypomania, or mania symptoms for a period of at least 1 week within the 3 months prior to study entry Lives with at least one biological or step-parent who is available and willing to participate in treatment (parents not currently living with the adolescent participant may also participate) Currently in full recovery (experienced minimal symptoms for at least 8 continuous weeks) Meets Diagnostic and Statistical Manual of Mental Disorders, IV for substance abuse disorder or substance dependence disorder within 3 months of study entry (based on the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version ) Meets current for bipolar, not otherwise specified, or substance-induced mood disorder Diagnosis of mental retardation, autism, or organic central nervous system disorder Severe, unremitting psychosis that is unresponsive to neuroleptic medications, and has lasted more than 3 months Requires extended inpatient treatment (although participant can be hospitalized at the time of intake into the study) Current life-threatening eating disorder, neurological condition, or other medical problem that requires immediate treatment Exhibits or expresses serious homicidal tendencies Victim of current sexual or physical abuse by parents or is in an environment marked by domestic violence among the parents or step-parents | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-70.0, Post-Traumatic Stress Disorder Depression Exposure to an interpersonal traumatic event Diagnosis of depression or PTSD (threshold or subthreshold) Functional literacy Apparent incoherence or disorientation Apparent intoxication at recruitment Hearing impairment | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-75.0, Generalized Anxiety Disorder Bipolar Disorder Male and female outpatients, aged 18 to 75 years Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II) Current diagnosis of Generalized Anxiety Disorder (GAD) Participants must be on at least one of the following mood stabilizers at steady dose for at least 4 weeks prior to randomization: lithium with blood levels between 0.4-1.4 meq/L, valproic acid/divalproate sodium (with levels between 50-150 ugm/dl) carbamazepine (blood levels between 4-12 mcg/ml), or lamotrigine (dosed 50-400 mg/day) Pregnant or lactating women or others not using acceptable means of birth control (e.g., IUD, oral contraceptives, barrier devices, condoms and foam, implanted progesterone rods stabilized for at least 3 months) Patients with current or history of schizophrenia, or patients with current mania, hypomania at study entry. Lifetime psychosis and dementia are exclusionary Patients with current obsessive-compulsive disorder or posttraumatic stress disorder are excluded Patients with a history of alcohol or substance abuse or dependence within the last three months Patients with significant unstable medical illness likely to result in hospitalization or acute medical care. In addition, patients with an established diagnosis of diabetes mellitus are excluded Current cognitive behavioral therapy directed toward the treatment of generalized anxiety disorder History of hypersensitivity to or lack of response to ziprasidone Concomitant treatment with other typical or atypical antipsychotics; patients should be off other typical or atypical antipsychotics for at least one week prior to study baseline Patients with significant suicidal ideation or who have enacted suicidal behaviors within 3 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention Patients who have had a psychiatric hospitalization (including for bipolar disorder) in the past 3 months are excluded | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-64.0, Insomnia Insomnia as defined by DSM-IV and supported by subject diary Male or female between the ages of 18-64 years Body mass index (BMI) between 18-34 kg/m^2 Females of childbearing potential must use a medically acceptable method of contraception Capable of understanding and willing to comply with study procedures and has provided informed consent Females who are pregnant, breast-feeding or have a positive pregnancy test Any circadian rhythm disorder including planned travel across several time zones during the study period Known hypersensitivity to Zolpidem Has performed regular shift work with the past several months prior to screening An acute clinically significant illness or surgery as determined by the PI within 30 days of screening Patients that have used any central nervous system (CNS) medication or other medication known to impact the sleep/wake cycle A history of psychiatric disorder as defined by DSM-IV A history of drug addiction or alcohol abuse Any current significant disease, unless adequately controlled with a protocol allowed medication Known history of HIV or Hepatitis B or C | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-75.0, Sleep Initiation and Maintenance Disorders Written informed consent is obtained The patient is an outpatient, man or woman of any ethnic origin, 18-75 years of age (inclusive) Patient reports insomnia for at least six months, and insomnia causes the patient distress The Investigator determines that the patient meets diagnostic for Chronic Insomnia according to International Classification of Sleep Disorders (ICSD) criteria Sleep diary based screening shows sleep onset latency >30 minutes, and /or wake after sleep onset >30 minutes per night at least 3 nights per week, with combined wake-time-in-bed _> 45 minutes The patient is in good health as determined by a medical and psychiatric history, and physical examination Women must be surgically sterile, 2 years post-menopausal, or if of child-bearing potential, using a medically accepted method of birth control, and agree to continued use of this method for the duration of the study The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol Has any clinically significant, uncontrolled medical or psychiatric conditions. (treated or untreated) Has a probable diagnosis of a current sleep disorder other than Chronic Insomnia Used any prescription drugs disallowed by the protocol or clinically significant use of over-the counter(OTC) drugs within 14 days before the screening visit Has a history of alcohol, narcotic, or any other abuse as defined by the DSM-V Has a clinically significant deviation from normal in the physical examination Is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.) Has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery and succinic semialdehyde dehydrogenase deficiency) Has a known clinically significant drug sensitivity to sodium oxybate or sedative hypnotics | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-60.0, Bipolar Depression A principal diagnosis of bipolar 1 or II disorder Ages 18-60 Physically healthy Outpatient status Montgomery-Asberg Rating Scale (MADRS) Score greater than or equal to 15 BMI 23-30 Able and willing to give written informed consent Prior history of diabetes (types I or II) BMI>30 Non-fasting blood glucose >124 Fasting blood glucose >125 or random blood glucose >200 Presence of dyslipidemia (baseline total cholesterol >240, HDL<50, LDL>160, triglycerides >199) Current or past history of a non-affective psychotic disorder Alcohol or other substance abuse or dependence in the 6 months prior to the evaluation (except for caffeine) Current use of any nicotine products Schizoid, schizotypal, or borderline personality disorder Treatment with olanzapine in the prior 3 months or any history of non | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 12.0-21.0, Bipolar Disorder Cannabis-Related Disorder Inclusion/ To be included, all subjects must… have an authorized parent/legal guardian who understands the nature of the study and who provides written informed consent if the study subject is younger than 18 years of age. Additionally, each subject must provide assent to the study be fluent in English be 12 to 21 years of age, inclusive be using a medically accepted means of contraception (i.e., oral contraceptives and barrier methods (diaphragm or condom), medroxyprogesterone acetate injectable suspension, abstinence) if female and of menarche. Oral contraceptives alone are not acceptable means of contraception because concomitant use of topiramate and low estrogen oral contraceptive pills may lead to oral contraceptive failure have a diagnosis of bipolar I disorder in a current manic or mixed episode, in addition to a cannabis use disorder (which includes abuse or dependence) within 28 days prior to screening, as determined by the WASH-U-KSADS have an initial YMRS total score of >16 at screening and baselines use cannabis a minimum of twice per week on average during the 28 days prior to screening Subjects will not be eligible for participation if they… have a known history of mental retardation | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 10.0-18.0, Bipolar Disorder Weight Gain Male or female patients, ages 10-18 years Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence) Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation Patients must have a diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) bipolar disorder, type I and currently display an acute manic or mixed episode as determined by K-SADS (Geller et al 2000) Patients must have a baseline (day 0) Young Mania Rating Scale score of at least 16 Subjects should be fluent in English Female patients who are either pregnant or lactating Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions Any history of current or past diabetes that has been treated with pharmacological intervention Neurological disorders including epilepsy, stroke, or severe head trauma Clinically significant laboratory abnormalities (> 3 times upper limit of normal), on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, or thyroid indices. Clinically abnormal ECG Manic or mixed episode due to a general medical condition or substance-induced mania (DSM-IV-TR) Mental retardation (IQ <70) History of hypersensitivity to or intolerance of olanzapine or topiramate Prior history of olanzapine or topiramate non-response or allergic reaction DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Bipolar Disorder Mania Diagnosis of Bipolar 1 Disorder Hospitalized or in the process of being hospitalized for a manic or mixed episode History of rapid cycling History of hypersensitivity or adverse reaction to lithium | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-60.0, Spinal Cord Injuries Subjects of either gender and 18 years of age (preferably 10 males and females each) Subjects with chronic spinal cord injury (defined as 12 months or more post spinal cord injury), as confirmed by a MRI Subjects with neurological status: ASIA A, B or C Subjects must be able to read, understand, and complete the VAS Subjects who have voluntarily signed* and dated* an informed consent form, approved by an IEC/IRB, prior to any study-specific procedures *If a subject consents to participation but is not in a position to personally sign and date the informed consent form because of his or her physical condition, the consent must be confirmed at the time of consent orally, signed on behalf by the subject's relative, and by an impartial witness who is present throughout the whole informed consent process Subjects are excluded if they have a history of hypersensitivity to lithium significant renal, cardiovascular, hepatic and psychiatric diseases significant medical diseases or infection brain injury Addison's disease debilitation or dehydration recently taken or are taking diuretics or other drugs with known interaction with lithium, such as tricyclic antidepressants, NSAIDs and tetracycline a history of alcohol abuse or drug abuse, or if they are pregnant or lactating women | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 12.0-18.0, Insomnia patients diagnosed as having nonorganic insomnia of nonorganic sleep disorder in ICD10 patients whose age at the time of obtaining consent is 12 years or over and 18 years or below patients with schizophrenia or manic-depressive illness patients with insomnia caused by physical diseases patients having a history of hypersensitivity to zolpidem patients with attention-deficit hyperactivity disorder | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-70.0, Bipolar Disorder Patients with bipolar disorder in major depressive episode according to DSM-IV MADRS score of at least 20 points at screening and baseline 70 years of age Unchanged dose of mood stabilising medication for at least six weeks prior to Voluntary, informed and written consent Non-affective psychotic symptoms at screening Pregnancy or breast-feeding Fertile women without appropriate contraception (the pill, IUD, or contraceptive injection) Substance dependence during the last three months prior to baseline Mental retardation and organic brain disorders Suicide risk that mandates specific measures Novel (within three months) or unstable medical conditions Clinically significant abnormal results on medical examination or blood samples Exposure to escitalopram during the last three months Allergic reactions to citalopram or escitalopram | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-64.0, Insomnia Adults with history of sleeplessness Allergic to investigational drug Any conditions and medications that may interfere with study drug evaluation | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Brain and Central Nervous System Tumors Cognitive/Functional Effects Neurotoxicity Solid Tumor Histopathologically confirmed extracranial primary malignancy Multiple (i.e., > 3) brain metastases OR < 3 metastases with at least 1 metastasis > 4.0 cm in diameter Not eligible for radiosurgery No requirement for immediate whole-brain radiotherapy No metastases to the midbrain or brainstem Zubrod performance status 0-2 Life expectancy ≥ 8 weeks Platelet count > 100,000/mm^3 ANC > 1,500/mm^3 Hemoglobin ≥ 10 g/dL BUN < 25 mg/dL Creatinine < 1.5 mg/dL Bilirubin < 1.5 mg/dL ALT ≤ 2 times normal Sodium > 136 mg/dL | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Bipolar Disorder Male or female in or out-patients at least 18 years of age Patient must have a diagnosis of bipolar I disorder and currently display acute manic or mixed episodes (with or without psychotic features) according to the DSM-IV based on clinical assessment Patients must have a level of understanding sufficient to agree to all tests and examinations required by the protocol Patients must have a Y-MRS total score of greater than or equal to 20 at both visits 1 & 2 Patients must be considered reliable Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months Current or past diagnosis of schizophrenia or other psychotic disorder (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV Documented history of intolerance to olanzapine or Lithium Carbonate Treatment with clozapine within 4 weeks prior to visit 2. Treatment with other antipsychotic drugs or mood stabilizers within 2 days prior to visit 2 | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Chronic Insomnia Chronic insomnia and taking greater than or equal to 10 mg zolpidem at least 4 times per week Has been prescribed zolpidem for difficulty in initiating sleep Must report chronic use of zolpidem greater than or equal to10 mg therapy for a minimum of 3 months prior to entry into Period 1 of the study Must have taken zolpidem greater than or equal to 10 mg therapy for at least 4 of 7 days each week of the 4 weeks immediately prior to entry into the double blind phase, Period 2 Expressed a willingness to discontinue zolpidem therapy Habitual bedtime is between 9:00 PM and 1:00 AM based on sleep history Negative test result for hepatitis B surface antigen and hepatitis C virus antibody Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study Known hypersensitivity to ramelteon, zolpidem, or melatonin Participated in any other investigational study and/or taken any investigational drug within 30 days prior to the first dose of run-in study medication Sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first night of run-in study medication History of fibromyalgia, history of seizures, sleep apnea, restless leg syndrome, periodic leg syndrome, chronic obstructive pulmonary disease, schizophrenia, bipolar disorder, mental retardation, or cognitive disorder History of drug addiction or drug abuse within the past 12 months History of alcohol abuse within the past 12 months, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition revised and/or regularly consumes more than 2 alcoholic drinks per day Current significant hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, unless currently controlled and stable with protocol-allowed medication, within 30 days prior to the first night of run-in study medication Body mass index of less than 18 or greater than 34 (weight /height2) Any clinically important abnormal finding as documented by a medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator Positive hepatitis panel | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 2.0-18.0, Insomnia Sleep Disorder Male or female between the ages of 2 years and 18 years Written consent must be obtained form the parent/legal guardian for all minors. Written assent must be obtained from all minors > 6 years of age Female subjects of child-bearing potential must not be pregnant and if females are fertile and sexually active, must have documented a negative urine HCG and assure use of effective contraception acceptable to the investigator (abstinence accepted) during the study period Subjects must meet the following for a diagnosis of insomnia as determined by the subject's private physician or study investigator and subject's history the complaint is significant difficulty (defined by frequency, severity, and/or chronicity) initiating or maintaining sleep;. The problem is viewed problematic by the child and/or caregiver the sleep disturbance causes clinically significant impairment in school performance, behavior, learning, or development for the child as reported by the child and/or caregiver the sleep disturbance does not occur exclusively in the context of an intrinsic dyssomnia such as narcolepsy, restless legs syndrome, or sleep-related breathing disorders; a circadian rhythm disorder; or a parasomnia the sleep disturbance is not attributable to either the direct physiologic effect of a drug of abuse or misuse of a prescribed medication Pregnancy and/or breastfeeding The presence of any untreated (where treatment is available), or unstable, progressive, or evolving clinically significant renal, endocrine, hepatic, respiratory, cardiovascular, neurologic, hematologic, immunologic, cerebrovascular disease or malignancy Elevations in screening blood tests of renal (SCr) and liver (ALT, AST and/or bilirubin) > 2 times the upper limit of normal for age Receiving any medications that may modulate Zolpidem metabolism, primarily drugs that will enhance or reduce the activity of CYP450 3A, 2C9, or 2D6 activity. Note: If patient is receiving a medication that might be considered an inducer or an inhibitor, please discuss with the PI prior to excluding them Receiving any medications with sleep-impairing properties at a dose/dose interval that would be judged by the study investigator as to interfere with the assessment of Zolpidem sleep response Currently using any systemic contraceptive steroids including: oral contraceptives, transdermal patch, vaginal insert, levonorgestrel implant and medroxyprogesterone acetate contraceptive injection | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Neuroendocrine Tumors Must have histologically confirmed metastatic low-grade neuroendocrine neoplasms. Small cell lung cancers, paragangliomas and pheochromocytomas are excluded. Pathologic diagnosis must be confirmed at UWCCC. Grading must be confirmed by pathologic review performed at UWCCC Must have measurable disease Must have radiographic evidence of disease progression following any prior systemic therapy, chemoembolization, bland embolization, surgery, or observation Must be ≥ 4 weeks from the completion of major surgery, chemotherapy, or other systemic therapy or local liver therapy to study registration Must be ≥ 3 weeks from the completion of radiation therapy to study registration The following laboratory values are to be obtained within 14 days prior to registration: Absolute neutrophils count (ANC) ≥ 1000/mm3; Platelets ≥ 75,000/mm3; Hemoglobin ≥ 8.0 g/dL; Total bilirubin less than or equal 2.0 X the upper limit of normal (ULN); AST less than or equal to 3 X ULN or less than or equal 5 X ULN if liver metastases are present; Creatinine less than or equal ULN; Serum sodium within normal limits PS = 0-2 Capable of understanding the investigational nature, potential risks and benefits fo the study and able to provide valid informed consent Must have available tissue specimens to be analyzed for pathologic confirmation Age ≥ 18 years | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Hepatitis C, Chronic adult patients, >=18 years of age chronic hepatitis C, genotype 1 insulin resistance other forms of liver disease cirrhosis previous treatment for chronic hepatitis C insulin treatment during prior 2 weeks type 1 diabetes | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Bipolar Disorder Provision of written informed consent before initiation of any study-related procedures Men and women aged 18 to 65 years A documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) meeting 296.4x Bipolar I disorder, most recent episode manic, 296.6x Bipolar I disorder, most recent episode mixed, or 296.5x Bipolar I disorder, most recent episode depressed PSQI total score of >=5 MADRS total score of <=12 YMRS total score of <= 12 Female patients of childbearing potential must have a negative urine pregnancy test at enrollment and be willing to use a reliable method of birth control, i.e., double-barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device or tubal ligation, during the study Be able to understand and comply with the requirements of the study, as judged by the investigator Outpatient status at enrollment Patients with a diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status Presence of prohibited medications of antidepressants (including MAOI's) and systemic corticosteroids Patients with a diagnosis of primary insomnia disorders Patients with a diagnosis of severe chronic obstructive pulmonary disease A clinical finding that is untreated (eg, hypertension, poorly controlled diabetes, angina) or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication Patients with active substance abuse diagnoses (except tobacco abuse) Known history of intolerance or hypersensitivity to ramelteon or to any other component in the tablet | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-75.0, Bipolar Disorder Current major depressive episode or mixed episode Bipolar disorder History of suicidal behavior Requires detoxification from alcohol or other substances Blood pressure greater than 160/90 mm Hg Active medical problems Requires long-term antipsychotic maintenance Becomes manic on mood stabilizers and antidepressants Contraindication to the use of lithium 1 or valproate (including failure to respond) Failure to respond to adequate trials of paroxetine, bupropion, and venlafaxine in the 2 years prior to study entry Failure to respond to adequate trials of olanzapine, haloperidol, and perphenazine in the 2 years prior to study entry Unable or unwilling to consent to treatment Pregnant or lactating | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 0.0-999.0, Bipolar Disorder Persons with Bipolar Condition, Depression, Anxiety, Stress and Insomnia Persons with severe mental illness that are confined to mental hospitals etc. as defined by the USA Diagnostic and Statistical Manual of Mental Disorders (DSM) are excluded from this clinical trial | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Bipolar Disorder Panic Disorder Generalized Anxiety Disorder Subjects must be at least 18 years of age and not older than 65 Subjects must have lifetime bipolar I, II, or NOS disorder as defined by DSM-IV TR Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV (except clause "does not occur exclusively during a mood disorder" of Criterion F for GAD) Subjects' bipolar symptoms must be no more than moderate in severity, defined as a CGI-BP< 4 Subjects' anxiety symptoms must be at least moderate in severity, defined as a CGI-S > 4 Subjects must not be receiving regular mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for at least one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for at least four weeks prior to baseline Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study Subjects who do not have lifetime bipolar disorder by DSM-IV-TR Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR Subjects who are receiving treatment with an anti-manic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP>5) Subjects whose anxiety symptoms are presently less than moderately severe (CGI-S<3) Subjects with clinically significant suicidal or homicidal ideation Subjects with a current DSM-IV TR Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV TR diagnosis of a substance dependence disorder within the past six months; a lifetime DSM-IV TR psychotic disorder (e.g., schizophrenia or schizoaffective disorder) Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurological, or hematological disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo-or hyperthyroidism unless stabilized on thyroid replacement > 3 months Subjects with a clinically significant abnormality in their pre-study physical exam, vital signs, EKG, or laboratory tests Subjects who are allergic to or who have demonstrated hypersensitivity or intolerance to either of the active study medications | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Medullary Thyroid Cancer Histologically confirmed MTC with signs of residual/persistent disease based on tumor marker levels and/or radiographic imaging. Pathologic diagnosis must be confirmed at UWCCC. Grading must be confirmed by pathologic review performed at UWCCC Elevated neuroendocrine markers at least 1 month post -op. In MTC, persistently elevated neuroendocrine markers such as calcitonin and CEA are indicative of persistent disease Disease progression is not required for this trial weeks from the completion of major surgery, chemotherapy, or other systemic therapy or local liver therapy to study registration. Subjects will have had standard of care prior to enrollment. Subjects will have had standard of care prior to enrollment (for example it could total thyroidectomy, central lymph node dissection, and when necessary ipsilateral radical neck dissection but is tailored to the patient) weeks from the completion of radiation therapy to study registration The following laboratory values obtained within 14 days prior to registration Absolute neutrophils count (ANC) ≥ 1000/mm3 Platelets ≥ 75,000/mm3 Hemoglobin ≥ 8.0 g/dL Total bilirubin greater than or equal to 2.0 X the upper limit of normal (ULN) Gastrointestinal tract disease resulting in an inability to take oral medication (i.e. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, bowel obstruction, or inability to swallow the tablets) Significant, active cardiac disease Patients must not be taking the following medications: diuretics, ACE inhibitors, NSAIDs (except aspirin or sulindac), neuroleptics, tetracycline, and COX2 inhibitors Patients with radiographic evidence of disease will be presented the option to undergo a tumor biopsy although this is not mandatory Patients already taking Lithium for any reason are not allowed on study | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Bipolar Disorder Patients with diagnosis of Bipolar Disorder (DSM-IV TR) Patients or their legal representatives have provided informed consent Patients are unable to complete or to understand health questionnaires in Spanish language Patients enrolled in clinical trials or other studies | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 12.0-19.0, Adolescent - Emotional Problem Smoking 19 years old Major depression Smoke cigarettes Lives with parents No confidentiality issues related to smoking Non English speaking Suicidal ideation Pregnant | 0 |
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