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You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Patient Centered Evaluation of Computerized Patient Records System <BriefSummary:>The VHA is a leader in electronic medical records (EMR) use for patient care. It is believed that EMR use by doctors will improve patient-centeredness of visits, and improve clinical care. The proposed study will determine how doctors should use the EMR during patient consultations. We will also develop a training program to improve doctors ability to communicate with patients while using EMR. <EligibilityCriteria:>Inclusion Criteria:
* Adult (age\>18) male and female patients from participating study providers' practices who have an established a doctor-patient relationship with their provider and require a minimum of 2 primary care clinic visits/year based on historical clinic data.
Exclusion Criteria:
* Patients with significant communication disability (severe speech and hearing impairment, severe dementia, or a mental health condition resulting in a non-communicative patient);
* patients are considered mentally incompetent to provide informed written consent;
* a life expectancy of less than 1 year. <Conditions:>Electronic Medical Records <Interventions:>Physician training in patient-centered emr use | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes) <BriefSummary:>The objective of this study is to determine the effect of 8 weeks of treatment with colesevelam HCl 3.75 g once daily with the evening meal on ß-cell function by evaluating the acute insulin response (AIRg) to an intravenous glucose load in subjects with prediabetes (impaired fasting glucose). <EligibilityCriteria:>Inclusion Criteria:
* Males or females (postmenopausal, surgically sterile or using double-barrier method of contraception), aged 18-75 years, FPG 100-115 mg/dl at screening (average of 2 measurements during screening; no individual measurement outside of the range 92-125 mg/dl)
* In good health as determined by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis
* HbA1c \<6.5% at screening
* Body mass index (BMI) in the range of 22-40 kg/m2 inclusive and with a stable (+/-2.5 kg) weight for the last 6 months
* Subjects must be willing to:
* Maintain prior exercise and dietary habits throughout the study
* Comply with all study requirements
* Provide written informed consent
Exclusion Criteria:
* Pregnant or lactating females
* Patients diagnosed with type 2 diabetes or that have taken glucose-lowering agents or insulin, except during pregnancy
* Chronic oral or parenteral corticosteroid treatment (\>7 consecutive days of treatment) within 8 weeks prior to screening
* HIV protease inhibitors
* Warfarin or phenytoin use
* Triglycerides \>500 mg/dl
* History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
* History of dysphagia, swallowing disorders or intestinal motility disorder
* History of pancreatitis
* Uncontrolled hypothyroidism
* Individuals with clinical hepatic disease or liver function tests greater than ≥2 times upper limits of normal within 30 days preceding the first dose of study drug
* On a weight loss program with ongoing weight loss, or starting an intensive exercise program within 4 weeks of study initiation
* Current or prior (within the past 3 months) treatment with a bile acid sequestrant (colesevelam, colestipol, colestimide, or cholestyramine)
* Use of any investigational drug in the last 30 days
* Donation of one unit (500 ml) or more of blood, significant blood loss equaling at least one unit of blood within the past 2 weeks or a blood transfusion within 8 weeks prior to screening
* Employment by the research center <Conditions:>Impaired Fasting Glucose, Prediabetes <Interventions:>Colesevelam, placebo | 'Age, Categorical', 'Age Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Adherence to Nintedanib Among Idiopathic Pulmonary Fibrosis Patients <BriefSummary:>This is a non-interventional cohort study using existing administrative data from the U.S. Medicare program.
This study has two objectives:
* Identification of adherence trajectories of nintedanib among Idiopathic Pulmonary Fibrosis (IPF) patients.
* Understanding characteristics of patients within each nintedanib adherence trajectory among IPF patients. <EligibilityCriteria:>Inclusion criteria:
* Newly initiated nintedanib during 10/01/2014 to 12/31/2018
* Were at least 66 years old as of the date of their first nintedanib prescription claim (index date)
* Qualified for Medicare based on age
* Had at least 12 months (365 days) of continuous enrollment in Medicare Parts A, B and D before (baseline period) and 12 months (360 days) after the index date (follow-up period)
* Had at least one inpatient or two outpatient claims (\>14 days apart) with a diagnosis code for Idiopathic Pulmonary Fibrosis (IPF) during the baseline period
Exclusion criteria:
* Had any history of pirfenidone or nintedanib use during the baseline period
* Had any history of lung transplant during the baseline, index date or follow-up periods
* Had any claims for skilled nursing facility, long-term care facility or hospice during the baseline, index date or follow-up period
* Had evidence during the baseline period of any of the following conditions: lung cancer, autoimmune, or connective tissue diseases (i.e. rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus (SLE), dermatopolymyositis, systemic sclerosis, Sjogren's, and mixed connective tissue disease (CTD)) during the baseline period
* Had dual eligibility of Medicare and Medicaid
* Had history of using pirfenidone at the same time with nintedanib during follow-up <Conditions:>Idiopathic Pulmonary Fibrosis <Interventions:>Nintedanib | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Comparison of the Effectiveness of USG and Palpation Guidance Steroid Injection in Patients With Plantar Fasciitis <BriefSummary:>Plantar fasciitis, often described as overloading of the plantar fascia, is the most common cause of heel pain in adults. It is characterized by a sharp pain along the medial aspect of the heel, which is worse with the first step taken in the morning or at the beginning of an activity and decreases as the person warms up. The etiology of plantar fasciitis is multifactorial and not well understood. Poor biomechanics and changes in the structure of the foot can lead to repeated micro-trauma at the beginning of the plantar fascia, causing inflammation and degeneration. Plantar fasciitis is more common in sedentary individuals and athletes and those participating in running sports. Other risk factors associated with plantar fasciitis include reduced ankle dorsiflexion, increased body mass index (BMI), and work-related weight loss activities.
Current treatments for plantar fasciitis, such as plantar fascia stretching exercises, strapping, extracorporeal shock wave therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), arch braces, and heel pads are mainly aimed at reducing inflammation. Corticosteroid injections are usually reserved for refractory plantar fasciitis after conservative noninvasive attempts have failed. It has been shown to effectively reduce heel pain in patients with plantar fasciitis. The strong anti-inflammatory effect of corticosteroids can speed up the process of pain relief.
In our study, we aimed to compare the effectiveness of USG and palpation guidance blind steroid injection in patients diagnosed with plantar fasciitis. <EligibilityCriteria:>Inclusion Criteria:
1. Patients diagnosed with plantar fasciitis
2. Between the ages of 18-75
3. Who have failed conservative treatment (stretching exercises, non-steroidal anti-inflammatory drugs and heel pads) for at least 3 months
4. Visual Anolog Scale value of 5 and above will be included in the study.
Exclusion Criteria:
1. Having received any local injection therapy and physical therapy for heel pain within the last 4 months,
2. Any history of surgery for heel pain, tarsal tunnel syndrome, calcaneal fracture, Achilles tendinopathy, any deformity of the foot and ankle including pes, planus or pes cavus deformity
3. with systemic disorders such as diabetes mellitus, rheumatoid arthritis, hematological disease, or gout
4. Pregnancy
5. A recent history of aspirin or aspirin-like medication
6. mental disability <Conditions:>Plantar Fasciitis <Interventions:>USG-guided steroid injection, Palpation-guided steroid injection | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment', 'Body Mass Index' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV-18 Related Vulvar HSIL (Also Referred as: VIN 2 or VIN 3) <BriefSummary:>The purpose of this study is to test the safety and efficacy of an investigational immunotherapy VGX-3100, in combination with a study device, to treat women with vulvar high-grade squamous intraepithelial lesion (HSIL) \[vulval intraepithelial neoplasia 2 or 3 (VIN 2 or VIN 3)\] associated with human papilloma virus (HPV) types 16 and/or 18. VGX-3100 is being assessed as an alternative to surgery with the potential to clear the underlying HPV infection. For more information visit our study website at: www.VINresearchstudy.com <EligibilityCriteria:>Inclusion Criteria:
* Women aged 18 and above;
* Have high grade squamous intraepithelial lesion (HSIL) of the vulva (VIN2 or VIN3) caused by infection with HPV types 16 and/or 18 confirmed at screening visit;
Exclusion Criteria:
* Biopsy-proven differentiated VIN;
* Any previous treatment for vulvar HSIL within 4 weeks prior to screening;
* Allergy to imiquimod 5% cream or to an inactive ingredient in imiquimod 5% cream;
* Pregnant, breastfeeding or considering becoming pregnant within 6 months following the last dose of investigational product;
* Immunosuppression as a result of underlying illness or treatment;
* Significant acute or chronic medical illness. <Conditions:>Vulvar High Grade Squamous Intraepithelial Lesion (HSIL), Vulvar Dysplasia, Vulvar Intraepithelial Neoplasia (VIN), VIN2, VIN3, Pre-cancerous Lesions of the Vulva, Human Papillomavirus (HPV) <Interventions:>VGX-3100, Imiquimod 5% Cream, CELLECTRA™ 2000 | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race/Ethnicity, Customized', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor <BriefSummary:>This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase inhibitor (AI) treatment. <EligibilityCriteria:>Key Inclusion Criteria:
* Locally advanced or metastatic breast cancer
* HER2-negative and hormone receptor-positive status (common breast cancer classification tests)
* Postmenopausal woman
* A tumor sample must be shipped to a Novartis designated laboratory for identification of biomarkers (PI3K activation status)
* Progression or recurrence of breast cancer while on or after aromatase inhibitor treatment
* Measurable disease or non measurable disease bone lesions in the absence of measurable disease as per RECIST 1.1
* Adequate bone marrow and organ function defined by laboratory values
Key Exclusion Criteria:
* Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitor or fulvestrant
* More than one prior chemotherapy line for metastatic disease
* Symptomatic brain metastases
* Increasing or chronic treatment (\> 5 days) with corticosteroids or another immunosuppressive agent
* Active heart (cardiac) disease as defined in the protocol
* Certain scores on an anxiety and depression mood questionnaires <Conditions:>Breast Cancer <Interventions:>Fulvestrant, BKM120, BKM120 matching placebo | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'ECOG Performance Status' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>FR901228 in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma <BriefSummary:>RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with unresectable stage III or stage IV malignant melanoma. <EligibilityCriteria:>Inclusion Criteria:
* Stage III unresectable or American Joint Committee on Cancer (AJCC) stage IV cutaneous, mucosal, ocular, or unknown primary melanoma with measurable disease by physical examination or imaging studies.
* Palpable cutaneous or nodal metastases suitable for punch, trucut, or similar biopsy if the patient agrees.
* Normal electrocardiogram (EKG)
* Left ventricular ejection fraction (LVEF) \> 40% by Multi Gated Acquisition Scan (MUGA)
* Corrected QT (QTc) \< 500 msec
* Age greater than or equal to 18
* Negative pregnancy test
* Fertile patients must use effective contraception
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* Normal organ and marrow function
* Patients on hydrochorthiazide should be switched to a potassium-sparing diuretic or another antihypertensive
* At least 4 weeks since prior radiotherapy
* Patients with cardiac hypertrophy may be enrolled but should be carefully monitored.
Exclusion Criteria:
* Prior FR901228 (depsipeptide)
* Prior chemotherapy
* Other concurrent chemotherapy
* Active central nervous system (CNS) metastases by brain computed tomography (CT) scan or magnetic resonance imaging (MRI)
* History of coronary atherosclerotic heart disease
* History of myocardial infarction
* History of congestive heart failure
* Non-melanoma malignancy within the past 5 years except carcinoma in situ or squamous cell or basal cell skin cancer
* Pregnant or nursing women
* Conditions that in the opinion of the investigator would interfere with the ability of the patient to complete this protocol
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Depsipeptide
* Co-medication with an agent that causes QTc prolongation
* Human immunodeficiency virus (HIV) positive patients receiving combination anti-retroviral therapy
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
* Concurrent radiotherapy
* Left ventricular hypertrophy (LVH) on their baseline EKG tracing <Conditions:>Malignant Melanoma, Melanoma <Interventions:>Depsipeptide | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients <BriefSummary:>The purpose of this study has 2 phases, a Dose Finding Phase will determine the maximum tolerated dose . The Dose Expansion Phase will explore the safety, tolerability, and anti-tumor activity of the combination. <EligibilityCriteria:>Inclusion Criteria:
* Histologically or cytologically proved diagnosis of locally advanced recurrent or metastatic non-squamous NSCLC that is not suitable for local curative treatment.
* Alk-positive NSCLC as determined by a test that is approved or validated for use as a companion diagnostic test.
* No prior systemic therapy for metastatic disease.
* Adjuvant chemotherapy more than 12 months prior to study enrollment.
* Measurable disease as per RECIST 1.1
* ECOG PS 0 or 1.
Exclusion Criteria:
* Prior exposure to ALK receptor tyrosine kinase inhibitor, anti-PD1, anti-PDL1 or any drug targeting T-cell checkpoint pathways.
* known diagnosis of immunodeficiency or is receiving systemic steroid therapy or other form of immunosuppressive therapy within 7 days of clinical trial treatment.
* Active autoimmune disease that has required systemic treatment in the past 3 months.
* History of extensive disseminated interstitial fibrosis or any grade of interstitial lung disease. <Conditions:>ALK-positive Advanced NSCLC <Interventions:>Crizotinib, Pembrolizumab | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Aging Brain Changes, Executive Dysfunction and Depression <BriefSummary:>The purpose of this study is to look at the relationship between age related structural brain changes and changes in depressive symptoms,disability and several aspects of cognitive functioning following treatment with escitalopram. <EligibilityCriteria:>Inclusion Criteria:
1. Age: Two strata: 60-74 years (n=60) subjects and 75-84 years (n=60).
2. Diagnosis: Major depression, unipolar (by DSM-IV criteria); or, for control subjects, no diagnosis of major depression, no history of depression or other psychiatric conditions.
3. Severity of depression: A 24-Item HDRS above 19; Level of Executive Dysfunction: Two strata within each age stratum: Stroop Color-Word scores below and above 24 (1 SD below the median of our normal elderly sample).
Exclusion Criteria:
1. Psychotic depression by DSM-IV, i.e., presence of delusions with a score higher than 2 (questionable delusion) rated by the Scale for Assessment of Positive Symptoms (SAPS; 51).
2. High suicide risk, i.e. intent or plan to attempt suicide in near future.
3. Presence of any Axis I psychiatric disorder or substance abuse other than unipolar major depression.
4. Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV).
5. History of psychiatric disorders other than unipolar major depression or generalized anxiety disorder (bipolar disorder, hypomania, are exclusion criteria).
6. Cognition: MMSE scores below 24 or diagnosis of dementia by DSM-IV.
7. Acute or severe medical illness, i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs known to cause depression, e.g., reserpine, alpha-methyl-dopa, steroids.
8. Failure to respond to an adequate trial of escitalopram (10 mg/day or more for 6 weeks or longer) during the current or previous depressive episodes.
9. Current involvement in psychotherapy.
10. History of hypersensitivity to escitalopram or need to receive drugs that may interact with escitalopram.
11. Inability to perform any of the ADLs (MAI: ADL subscale) even with assistance, e.g. walking with a cane is not an exclusion criterion.
12. Inability to speak English.
13. Aphasia.
14. Residence outside a 45-minute drive from Cornell's clinical facilities.
15. Patients taking MAOI's and Fluoxetine will be excluded. <Conditions:>Depression <Interventions:>Escitalopram | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Hamilton Scale for Depression', 'Mini Mental Status Examination (MMSE)', 'WHODAS-II Disability Score', 'Stroop Color-Word Test' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Systemic Chemotherapy and Subtenon Carboplatin, and Local Ophthalmic Therapy in Children With Intraocular Retinoblastoma <BriefSummary:>Phase III trial to determine the effectiveness of combining systemic chemotherapy and subtenon carboplatin with ophthalmic therapy in treating children who have intraocular retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether systemic chemotherapy and subtenon (under the conjunctiva of the eye) carboplatin combined with ophthalmic therapy is effective in treating intraocular (within the eyeball) retinoblastoma. <EligibilityCriteria:>Inclusion Criteria:
* Diagnosis of bilateral retinoblastoma with at least 1 eye group C or D intraocular retinoblastoma by ophthalmologic examination, defined by the International Classification System for Intraocular Retinoblastoma as the following:
* Group C: Discrete localized disease with minimal subretinal and/or vitreous seeding
* Subretinal fluid, without prior or concurrent seeding, involving ≤ one quarter of the retina
* Local fine vitreous seeding may be present close to discrete tumor
* Local subretinal seeding \< 3 mm from tumor
* Group D: Diffuse disease with significant vitreous and/or subretinal seeding
* Tumor(s) may be massive or diffuse
* Subretinal fluid, without prior or concurrent seeding, involving up to total retinal detachment
* Diffuse or massive vitreous disease may include "greasy" seeds or avascular tumor masses
* Diffuse subretinal seeding may include subretinal plaques or tumor nodules
* Prior enucleation of 1 eye allowed provided the remaining eye is group C or D
* No tumor present on histologic examination at the cut end of the optic nerve on any eye enucleated prior to study entry
* Evidence of choroidal and/or optic nerve invasion past the lumina cribrosa is allowed
* No extraocular retinoblastoma clinically or by MRI of brain and orbits with and without gadolinium or CT scan with and without contrast of brain and orbits
* No evidence of systemic metastases by bone marrow, lumbar puncture, bone scan, and/or any other additional test
* Performance status - Karnofsky 50-100% (over 16 years of age)
* Performance status - Lansky 50-100% (16 and under)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
* AST and ALT \< 2.5 times ULN for age
* Creatinine adjusted according to age as follows:
* No greater than 0.4 mg/dL (≤ 5 months)
* No greater than 0.5 mg/dL (6 months -11 months)
* No greater than 0.6 mg/dL (1 year-23 months)
* No greater than 0.8 mg/dL (2 years-5 years)
* No greater than 1.0 mg/dL (6 years-9 years)
* No greater than 1.2 mg/dL (10 years-12 years)
* No greater than 1.4 mg/dL (13 years and over \[female\])
* No greater than 1.5 mg/dL (13 years to 15 years \[male\])
* No greater than 1.7 mg/dL (16 years and over \[male\])
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min/1.73m\^2
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Negative pregnancy test in postmenarchal females
* No prior chemotherapy
* No other concurrent chemotherapy
* No prior radiotherapy
* No other concurrent radiotherapy <Conditions:>Intraocular Retinoblastoma <Interventions:>liposomal vincristine sulfate, cryosurgery, laser surgery, carboplatin, etoposide, filgrastim | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>The Pharmacokinetics of Ketamine in the Breast Milk of Lactating Women <BriefSummary:>Quantification of Ketamine in Breast Milk at 3 hour Intervals up to 30 hours-- obtained from lactating women who receive 2 different Intramuscular injections of ketamine on two separate days at least 5 days apart. <EligibilityCriteria:>Inclusion Criteria:• Age 21-45
* Postpartum with established lactation for a minimum of 3 months.
* Ability to pump breast milk and to provide a reservoir for infant feeding prior to the study; or acceptance of bottle feeding by the infant.
* In good health-normal BP/P; afebrile-temp ascertained; review of systems by MD; absence of diagnosed illnesses.
* Not pregnant--Pregnancy tested for before each administration by urine assay.
Exclusion Criteria:• Hypertension with a BP greater than 145/90
* Subjects must be off all psychiatric medications specifically; medications and supplements, or evaluated by the PI for non-interference
* No alcohol or other substances such as marijuana for 72 hours or more.
* Weight \<50kg or \> 90kg.
* Pregnancy <Conditions:>Ketamine, Lactation <Interventions:>ketamine in lactation | 'Age, Customized', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Postpartum with Established Lactation for a Minimum of 3 Months' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-α Therapy <BriefSummary:>People affected by rheumatoid arthritis are often suffering from fatigue and decreased QOL. In this study we are measuring the impact of SC biologics on these parameters. <EligibilityCriteria:>Inclusion Criteria:
Patients who:
* Are active RA patients (as judged by treating MD)
* Are 18 years of age or older at time of consent
* Are scheduled by their rheumatologist to initiate SC anti-TNF-α therapy + MTX
Exclusion Criteria:
Use of biologics (or any experimental drug) in the last 3 months before initiation of SC anti-TNF-α therapy.
Participation in other clinical or observational trials <Conditions:>Rheumatoid Arthritis <Interventions:>SC anti-TNF | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Correlation Endoscopic View of Airway Obstruction With RRa in OSA Patients Under DEX Monitored With SedLine EEG <BriefSummary:>Patients with obstructive sleep apnea (OSA) could have several anatomical causes of obstruction. A sleep endoscopy study is a technique to help determine the anatomical cause of OSA. This study will be using standard of care practice and infuse dexmedetomidine (DEX) to induce sleep. The goals of the study are to (1) confirm airway obstruction with endoscopic view and correlate that with Acoustic Respiratory Rate (RRa) signal at the moment of airway obstruction, and (2) characterize the EEG signals when subjects are under DEX sedation alone. <EligibilityCriteria:>Inclusion Criteria:
* Adult patients more than 18 years old with American Society of Anesthesiologists (ASA) classification of I, II, or III.
* Patients undergoing sedation for sleep endoscopy with DEX alone, and possible surgical follow-up.
Exclusion Criteria:
* ASA classification higher than III.
* Any deformities or diseases that may prevent application of SedLine (Masimo Sedation Monitoring) or RAM (Masimo Rainbow Acoustic Monitoring) sensors with a proper fit
* Inability to obtain any physiological, vital, demographics and real time anaesthesia data
* Subjects who have known intolerance to any of the drugs to be used according to the study protocol
* Subjects deemed not suitable for study at the discretion of the Principal Investigator. <Conditions:>Obstructive Sleep Apnea (OSA) <Interventions:>SedLine EEG, RRa monitoring | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Red-Rubber Catheter to Facilitate Nasotracheal Intubation in Adult Patients <BriefSummary:>This study was designed to compare the effectiveness of using a red-rubber catheter versus standard, direct insertion of a thermosoftened, lubricated nasal endotracheal tube into the naris to facilitate nasotracheal intubation in adults. This study will assess if the red-rubber catheter method leads to lower incidence and severity of epistaxis, faster time to intubation, and higher patient satisfaction compared to the current standard of care. <EligibilityCriteria:>Inclusion Criteria:
* Age \> 18, male and female
* Subjects undergoing surgery requiring NTI
* ASA 1-3
Exclusion Criteria:
* History of anticoagulant use or coagulopathy
* History of latex allergy
* History of difficult airway
* Anticipated difficult airway requiring awake intubation
* Abnormal anatomy of the nasal passage (due to prior trauma, surgery, congenital defects, etc.) or basilar skull fracture
* Patients unable to be placed in the sniffing position
* Morbid obesity with BMI \> 40
* Pregnancy
* ASA 4 <Conditions:>Intubation;Difficult <Interventions:>Red Rubber Catheter, Standard nasal tracheal Intubation | 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Region of Enrollment', 'Body Mass Index (BMI)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin in Paediatric Subjects With Fibrinogen Deficiency <BriefSummary:>This study will assess the efficacy of Octafibrin, a fibrinogen concentrate in in the on-demand treatment of spontaneous or traumatic bleeding episodes in paediatric patients less than 12 years of age.The planned study duration is up to 5 years. The study will be considered completed when a minimum of 6 subjects (i.e., at least 3 subjects aged between 0 and \<6 years and 3 subjects aged between 6 and \<12 years) have at least one documented bleeding episode and when in total a minimum of 2 surgical procedures have been performed.
All patients will undergo a pharmacokinetic (PK) study after screening. This will have a duration of 14 days, after which a patient can be treated for a bleeding episode or planned surgical procedure when they occur. <EligibilityCriteria:>Inclusion Criteria:
* Aged \<12 years (at the start of treatment).
* Documented diagnosis of congenital fibrinogen deficiency, expected to require on-demand treatment for bleeding or surgical prophylaxis:
* Fibrinogen deficiency manifested as afibrinogenaemia or severe hypofibrino-genaemia.
* Historical plasma fibrinogen activity of \<50 mg/dL or levels below the limit of detection of the local assay method.
* Expected to have an acute bleeding episode (spontaneous or after trauma) or planning to undergo elective surgery.
* Informed consent signed by the subject's legal guardian.
Exclusion Criteria:
1. Life expectancy \<6 months.
2. Bleeding disorder other than congenital fibrinogen deficiency, including dysfi-brinogenaemia.
3. Prophylactic treatment with a fibrinogen concentrate.
4. Treatment with:
* Any fibrinogen concentrate or other fibrinogen-containing blood product within 2 weeks prior to start of treatment for the PK phase, a bleeding episode, or surgery.
* Any coagulation-active drug (i.e., non-steroidal anti-inflammatory drugs, war-farin, coumarin derivatives, platelet aggregation inhibitors) within 1 week prior to start of the PK phase or treatment for the bleeding episode or surgery, or as a planned or expected medication during the time period from Day 1 until 24 hours (i.e., 1 day) after the last Octafibrin infusion.
5. Presence or history of:
* Hypersensitivity to study medication.
* Deep vein thrombosis or pulmonary embolism within 1 year prior to start of treatment for the bleeding episode or surgery.
* Arterial thrombosis within 1 year prior to start of treatment for the bleeding episode or surgery
* Hypersensitivity to human plasma proteins.
* Oesophageal varicose bleeding.
* End-stage liver disease (i.e., Child-Pugh score B or C).
6. Known positive HIV infection with a viral load \>200 particles/μL or \>400,000 copies/mL.
7. Polytrauma 1 year prior to start of treatment for the bleeding episode or surgery.
8. Diagnosis or suspicion of a neutralizing anti-fibrinogen inhibitor currently or any time in the past.
9. Acute or chronic medical condition which may, in the opinion of investigator, affect the conduct of the study, including subjects receiving immune-modulating drugs (other than anti-retroviral chemotherapy), such as alpha-interferon, predni-sone (equivalent to \>10 mg/day), or similar drugs, at study start.
10. Treatment with IMP in another interventional clinical study currently or during the past 4 weeks. <Conditions:>Congenital Fibrinogen Deficiency <Interventions:>Octafibrin | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Body Mass Index (BMI)', 'Weight', 'Height' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study of Tadalafil for Duchenne Muscular Dystrophy <BriefSummary:>The main purpose of this study is to determine if tadalafil can slow the decline in walking ability of boys who have Duchenne muscular dystrophy (DMD). The study will also assess the safety of tadalafil and any side effects that might be associated with it in boys who have DMD. Participants will receive study treatment (tadalafil or placebo) for the first 48 weeks of the study, and can then continue into an open label extension (OLE) that consists of two periods during which all participants will receive tadalafil. In OLE period 1, all participants will receive tadalafil for 48 weeks. Participants completing OLE period 1 will continue into OLE period 2 and will receive tadalafil for at least another 48 weeks. <EligibilityCriteria:>Inclusion Criteria:
* Ambulant males with Duchenne muscular dystrophy (DMD) confirmed by typical clinical presentation (onset of clinical signs or symptoms before 6 years of age supported by an elevated serum creatinine kinase level, and ongoing difficulty with walking) together with either a record of a genetic confirmation of the DMD diagnosis, or a record of muscle biopsy showing near-complete dystrophin deficiency (excluding revertant fibers)
* Receiving systemic corticosteroids for a minimum of 6 months immediately prior to screening, with no significant change in total daily dosage or dosing regimen (except those adjusting for weight changes) for a minimum of 3 months immediately prior to screening and a reasonable expectation that total daily dosage and dosing regimen will not change significantly (except for adjustments for weight) for the duration of the study
* Able to complete the six minute walk distance (6MWD) test with results within 20% of each other at a minimum of 2 pre-randomization assessments
* Left ventricular ejection fraction (LVEF) ≥50% as determined by echocardiogram
* Written informed consent from parents/legal guardian will be obtained prior to any study procedure being performed. In addition, the child may be required to give documented assent, if capable.
Exclusion Criteria:
* Symptomatic cardiomyopathy or heart failure
* Change in prophylactic treatment for heart failure within 3 months prior to start of study treatment
* Cardiac rhythm disorder
* History of participation in gene or cell-based therapy , or antisense oligonucleotide or stop codon read-through therapy
* Unable to take orally administered tablets
* Use of any pharmacologic treatment, other than corticosteroids, that might have an effect on muscle strength within 3 months prior to the start of study treatment (for example, growth hormone, anabolic steroids including testosterone)
* New or changed treatment with herbal or dietary supplements being taken with an expectation of an effect on muscle strength or function during 1 month prior to first dose of study drug
* Surgery that might have an effect on muscle strength or function within 3 months before study entry or planned surgery at any time during the study
* Evidence of a lower limb injury that may affect performance on the 6MWD
* Severe behavioral problems, including severe autism or attention deficit disorders, that may interfere with completion of the 6MWD
* Any contraindication to tadalafil (use of any form of organic nitrate, either regularly and/or intermittently, or known serious hypersensitivity to tadalafil)
* History of significant renal insufficiency or clinical evidence of cirrhosis
* Have known allergy to any of the excipients in tadalafil tablets, notably lactose
* Current Phosphodiesterase Type 5 (PDE5) inhibitor therapy or treatment within the past 6 months <Conditions:>Muscular Dystrophy, Duchenne <Interventions:>Tadalafil, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Clinical Trial of Efficacy and Safety of ММН-407 in Acute Respiratory Viral Infection <BriefSummary:>To evaluate the efficacy and safety of ММН-407 in treatment of acute respiratory viral infection (ARVI). <EligibilityCriteria:>Inclusion Criteria:
1. Patients of either gender aged 18-70 years.
2. Diagnosis of ARVI based on medical examination: axillary temperature ≥ 38.0°C at examination + total general symptoms score ≥4, nasal/throat/chest symptoms score ≥2.
3. The first 24 hours after ARVI onset.
4. Patients giving their consent to use reliable contraception during the study.
5. Signed patient information sheet (informed consent form).
Exclusion Criteria:
1. Clinical symptoms of severe influenza/ARVI requiring hospitalization.
2. Suspected pneumonia, bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring administration of antibiotics from the first day of illness.
3. Suspected initial manifestations of diseases with symptoms similar to ARVI at onset (other infectious diseases, flu-like syndrome at the onset of systemic connective tissue diseases, and other pathology).
4. Patients requiring antiviral medication prohibited within the study.
5. Medical history of primary and secondary immunodeficiency.
6. Medical history/suspicion of oncology of any localization (except for benign neoplasms).
7. Aggravation or decompensation of chronic diseases affecting a patient's ability to participate in the clinical trial.
8. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
9. Allergy/ hypersensitivity to any component of the study drug.
10. Pregnancy, breast-feeding; childbirth less than 3 months prior to the inclusion in the trial, unwillingness to use contraceptive methods during the trial.
11. Course administration of the drug products specified in the section "Prohibited Concomitant Therapy" within two weeks prior to inclusion in the study.
12. Patients who will not fulfill the requirements during the study or follow the order of administration of the studied drug products, from the Investigator's point of view.
13. Medical history of mental diseases, alcoholism or drug abuse that according to the investigator's opinion will compromise compliance with the study procedures.
14. Participation in other clinical trials for 3 months prior to enrollment in this study.
15. Patients who are related to any of the on-site research personnel directly involved in the study or are an immediate relative of the investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
16. Patients who work for OOO "NPF "MATERIA MEDICA HOLDING" (i.e. the company's employees, temporary contract workers, designated officials responsible for carrying out the research or any immediate relatives of the aforementioned). <Conditions:>Viral Respiratory Infection <Interventions:>MMH-407, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study of Lenalidomide and Ofatumumab for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma <BriefSummary:>The purpose of this trial is to investigate the efficacy (how well the drug works) of ofatumumab and lenalidomide in patients with lymphoma and to investigate if any possible unwanted side effects may occur. The purpose of the Phase I portion of this trial will be to determine the maximum dose of these medications that can be given with minimal side effects. <EligibilityCriteria:>Inclusion Criteria:
* Histologically confirmed diagnosis of CD20+ non-Hodgkin's lymphoma that is recurrent or refractory after at least one prior therapy and for which no other potentially curative therapy is available.
* Subject, age \> or = 19 years
* Patients must have relapsed or refractory disease after at least one prior systemic therapy, with at least a 3 week interval from the completion of the most recent chemotherapy or radiotherapy regimen (unless the patient has had progressive disease prior to the 3 weeks). Patient has resolved all toxicities to ≤ grade 1, felt to be related to prior therapy.
* Patients must be ineligible or relapsed after an autologous or allogeneic stem cell transplant if clinically appropriate.
* Adequate Laboratory Parameters:
* ANC ≥ 1500/μL
* Platelet count ≥75,000/μL
* Total bilirubin ≤ 1.5 times the institutional Upper Limit of Normal (ULN)- unless due to NHL
* Hepatic enzymes (AST, ALT ) ≤ 2.5 times the institutional ULN - unless due to NHL
* Serum Creatinine \< 3.0 times the institutional ULN - unless due to NHL
* Creatinine clearance ≥60ml/min during phase I (See Appendix A) Creatinine clearance ≥ 30ml/min during phase II and patients with creatinine clearance ≥ 30ml/min and \< 60ml/min should start Lenalidomide at a reduced dose. See Section 5.3.1
* Females of child-bearing potential (FCBP) must agree to:
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours prior to prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. See Appendix B: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
Note: A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (i.e., amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Male patients must:
* Agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and 28 days after cessation of study therapy.
* Agree to not donate semen during study drug therapy and for a period after end of study drug therapy
* ECOG Performance status of 0-2 (See Appendix C)
* Signed written informed consent including HIPAA according to institutional guidelines
Exclusion Criteria:
* No malignancy \[other than the one treated in this study\] which required systemic treatment within the past 3 years.
* Patients not willing to take DVT prophylaxis
* Pregnant or lactating females
* Positive serology for hepatitis B (HB) defined as positive test of HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded. Patients with documented vaccination against Hepatitis B will not be considered positive.
* Known seropositive for active viral infection with human immunodeficiency virus (HIV), or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
* Patients with ≥ Grade 2 neuropathy
* Active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
* Known CNS involvement with lymphoma
* Significant concurrent, uncontrolled medical condition, that in the judgment of the investigator, may affect the patient's ability to sign the informed consent and comply with study procedures. <Conditions:>Non-Hodgkin's Lymphoma <Interventions:>Lenalidomide, ofatumumab | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking <BriefSummary:>The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients. <EligibilityCriteria:>Inclusion Criteria:
* Participants must have stable, documented cardiovascular disease (including at least one of the following diagnosed \> 2 months prior to the Screening visit - angina, myocardial infarction (MI), revascularization, transient ischemic attack (TIA), and peripheral vascular disease (PVD).
* Participants that smoke \> 10 cigarettes / day.
Exclusion Criteria:
* Participants with unstable cardiovascular disease
* Cardiovascular events in the past 2 months
* Moderate or severe chronic obstructive pulmonary disease (COPD) <Conditions:>Smoking Cessation <Interventions:>placebo, Varenicline | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study of the Safety and Tolerability of PCI-24781 in Patients With Lymphoma <BriefSummary:>The first part of the study will determine the highest dose of study drug that can be taken without causing serious side effects in patients with lymphoma. The appropriate dose determined from the first part of the study will be used in the second part of the study to assess disease response in 2 different types of lymphoma patients. <EligibilityCriteria:>Inclusion Criteria:
* • age ≥ 18 years
* Phase I: Any measurable, histologically confirmed, and previously treated lymphoma
* Phase II: Measurable, histologically confirmed, and previously treated lymphoma in one of the following categories:
1. Follicular non-Hodgkin's Lymphoma
2. Mantle cell lymphoma
* Ability to swallow oral capsules without difficulty
* Estimated life expectancy \> 12 weeks
* ECOG performance status ≤ 1
* Willing and able to sign a written informed consent
Exclusion Criteria:
* • More than four prior systemic treatment regimens (not counting maintenance rituximab; salvage therapy/conditioning regimen preceding autologous bone marrow transplantation \[ABMT\] and ABMT count as one regimen)
* Allogeneic bone marrow transplant
* Immunotherapy, chemotherapy, radiotherapy or experimental therapy within 4 weeks before first day of study drug dosing
* Major surgery within 4 weeks before first day of study drug dosing
* CNS lymphoma or a history of meningeal carcinomatosis
* Prior treatment with an HDAC inhibitor (unless for treatment of Mycosis fungoides or Sézary syndrome)
* Creatinine \> 1.5 x institutional upper limit of normal (ULN) or creatinine clearance ≤ 50 mL/min
* Total bilirubin \> 1.5 x institutional ULN (unless elevated from documented Gilbert's syndrome)
* AST and ALT \> 2.5 x institutional ULN
* Platelet count \< 75,000/µL for Phase I and \<100,000\>µL for Phase II
* Absolute neutrophil count (ANC) \< 1500/µL
* Malabsorption
* Corticosteroids \> 20 mg prednisone equivalent per day (topical, inhaled, or nasal corticosteroids are permitted)
* Concurrent therapeutic anticoagulation (Phase I only)
* Uncontrolled illness including but not limited to: ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV heart failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric illness that would limit compliance with study requirements
* Risk factors for, or use of drugs known to prolong QTc interval or that may be associated
* QTc prolongation (defined as a QTc ≥ 450 msecs) or other significant ECG abnormalities including 2nd degree AV block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min). If the screening ECG has a QTc ≥ 450 msecs, the ECG can be submitted for a centralized, cardiologic evaluation.
* History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty and/or stenting within the past 6 months.
* For patients with history of myocardial infarction, congestive heart failure, abnormal left ventricular ejection fraction (LVEF), and/or prior anthracycline exposure, LVEF \< 50%, as assessed by ventriculography (nuclear or heart catheterization) or echocardiogram, when performed within 28 days of first dose of study drug.
* For patients with history of coronary artery disease, a cardiac stress test (either exercise or pharmacologic) that demonstrates clinically significant abnormalities when performed within 28 days of first dose of study drug.
* Known HIV infection.
* Other medical or psychiatric illness or organ dysfunction which, in the opinion of the investigator, would either compromise the patient's safety or interfere with the evaluation of the safety of the study agent.
* Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound).
* Women of child-bearing potential, or sexually active men, unwilling to use adequate contraceptive protection during the course of the study. <Conditions:>Lymphoma, Hodgkin Disease, Lymphoma, Non-Hodgkin <Interventions:>PCI-24781 | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Evaluation of Postoperative Blood Pressure Changes After Benign Gynecologic Surgery <BriefSummary:>The purpose of this study is to establish normal postoperative changes in blood pressure in women undergoing scheduled gynecologic surgery requiring inpatient postoperative care. Also, to establish if there is a difference in normal postoperative blood pressure changes between elderly and non-elderly women undergoing scheduled gynecologic surgery requiring inpatient postoperative care. <EligibilityCriteria:>Inclusion Criteria:
* Women who underwent scheduled gynecologic surgery requiring inpatient postoperative care between January 2007 - January 2008
Exclusion Criteria:
* Women who experienced myocardial infarction, cardiac arrest or failure, pulmonary embolism, infection requiring intravenous antibiotics, intra- or postoperative hemorrhage requiring blood transfusion, renal failure <Conditions:>Urogynecology <Interventions:>No Interventions | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment', 'Postmenopausal', 'Hypertension', 'Diabetes', 'Gastroesophageal Reflux Disease', 'depression/anxiety' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>To Assess the Relative Bioavailability (BA) of TRIUMEQ® and Dolutegravir and Lamivudine (DTG/3TC) Pediatric Dispersible Tablet Formulations in Healthy Volunteers <BriefSummary:>This is a 2-part, single-dose, open label, randomized 3-way cross-over study to compare BA of pediatric study drugs TRIUMEQ and (DTG/3TC) in healthy volunteers under fasted conditions. Study will be conducted in 2-parts. Each part 1 and part 2 will comprise of 3-treatment periods (TP) where Part 1, will assess BA, of pediatric TRIUMEQ dispersible tablets with an adult TRIUMEQ conventional tablet formulation and Part 2, will assess BA, of pediatric DTG/3TC dispersible tablets with adult DTG and 3TC conventional tablets formulation. Total duration of study is 9-weeks and will be conducted in approximately 36 subjects. The 2-parts, may be run in parallel as they are independent of each other. TRIUMEQ is a registered trademark of GlaxoSmithKline group of companies. <EligibilityCriteria:>Inclusion Criteria:
* Between 18 and 65 years of age, inclusive, at the time of signing the informed consent.
* Healthy subjects as determined by the investigator or medically qualified designee based on a medical evaluation, including medical history, physical examination, laboratory tests, and cardiac evaluation (history and ECG).
* Body weight \>=50 kilogram (kg) for males and \>=45 kg for females and body mass index (BMI) within the range 18.5 - 31.0 kilogram per square meter (kg/m\^2) (inclusive).
* Male and female subjects where the male subjects must agree to use contraception during the TP and for at least 2 weeks plus an additional 90 days (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period. For the female subjects, female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin \[hCG\] test), not lactating, and at least 1 of the following conditions applies: Female with non-reproductive potential, defined as Premenopausal females with one of the following like documented tubal ligation, documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, documented hysterectomy, documented bilateral oophorectomy, the Postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone and estradiol levels consistent with menopause. Females on hormone replacement therapy (HRT), and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment; Females with reproductive potential and agrees to follow one of the options for avoiding pregnancy in females of reproductive potential, from 30 days prior to the first dose of study medication and until 2 weeks after dosing with study medication and completion of the follow-up visit; the investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception; All female subjects participating in the study should be counselled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of human immune virus (HIV) transmission to an uninfected partner.
* Subjects capable of giving signed informed consent.
* For participation in Part 1, documentation that the subject is negative for the human leukocyte antigen (HLA)-B\*5701 allele.
Exclusion Criteria:
* The medical conditions included where ALT and bilirubin \>1.5 × upper limit of normal (ULN) (isolated bilirubin \>1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin \< =35%).
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination) where the heart rate for the male subjects be \<45 and \>100 beats per minute (bpm) and that for females be \< 50 and \> 100 bpm; the PR interval for both be \< 120 and \> 220 millisecond (msec); the QRS interval be \< 70 and \> 120 msec and the corrected Q-T interval (QTc) obtained using the Fridericia's formula (QTcF) be \>450 msec ; ECG with evidence of previous myocardial infarction (does not include ST segment changes associated with repolarization; any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular block \[2nd degree or higher\], Wolf-Parkinson-White syndrome); Sinus pauses \> 3 seconds; any significant arrhythmia which, in the opinion of the principal investigator or ViiV/GlaxoSmithKline (GSK) medical monitor, will interfere with the safety of the individual subject; non-sustained or sustained ventricular tachycardia (3 consecutive ventricular ectopic beats).
* Subjects with use of prior or concomitant therapy who are unable to refrain from the use of prescription (e.g., dofetilide) or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and ViiV Healthcare Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
* History of regular alcohol consumption within 6 months of the study, defined as an average weekly intake of \>14 drinks for males or \> 7 drinks for females. One drink is equivalent to 12 gram of alcohol: 12 ounces (360 milliliter \[mL\]) of beer, 5 ounces (150 mL) of wine, or 1.5 ounces (45 mL) of 80 proof distilled spirits.
* Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 1 month prior to screening.
* Contraindications like history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation. The subject has participated in a clinical trial and has received an investigational product (IP) within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the IP (whichever is longer).
* The subject has participated in a clinical trial and has received an IP within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the IP (whichever is longer).
* Creatinine clearance (CrCL) \< 90 mL per minute.
* Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
* A positive pre-study drug/alcohol/cotinine screen.
* A positive test for HIV antibody.
* Where participation in the study would result in donation of blood or blood product in excess of 500 mL within 60 days.
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day. <Conditions:>HIV Infections <Interventions:>Treatment A, Treatment B, Treatment C, Treatment D, Treatment E, Treatment F | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Treatment of Cognitive Impairment in Men With Schizophrenia (MK5757-005)(COMPLETED) <BriefSummary:>This study is to evaluate the safety and efficacy of the study drug compared to placebo in the treatment of cognitive impairment in men with schizophrenia. <EligibilityCriteria:>Inclusion Criteria:
* Patient is male between 21 and 55 years of age
* Duration of the illness must be longer than 1 year
* Patient's current antipsychotic medication regimen must be stable
* Patient is negative for selected drugs of abuse at Screening
* Must be in a stable living arrangement for at least 3 months prior to screening (not a homeless shelter)
Exclusion Criteria:
* Patient has mental retardation
* Undergone Electroconvulsive Therapy (ECT) treatment within 6 months prior to screening
* Has suicidal attempts or ideation within the last 12 months
* Patient has a history of alcohol/drug dependence within 1 year or alcohol/drug abuse within 12 months of starting the study <Conditions:>Schizophrenia <Interventions:>MK5757, Comparator: Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race/Ethnicity, Customized', 'Study Region' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>The College, Alcohol and Peers Study (CAPS) <BriefSummary:>The present study will evaluate college students (N=100) from 2- and 4-year colleges/universities between 21-24 years old to assess anxiety, affect, broad social motives (BSM) and peer group influences on drinking and other risk-taking behaviors. This study will employ two sound scientific methods for testing behavior during drinking events (i.e., lab alcohol administration and daily diary) and use novel strategies to compare results of these two methods in the same sample. Using an ad-lib drinking paradigm, students' risk-taking, as measured by the Balloon Analogue Risk Task (BART), will be assessed when alone and during one of two randomly assigned peer group conditions (close friends or new peers). Participants will be allowed to freely drink (within safety limits) with their peer group prior to completing the BART again. These same students will complete daily electronic diaries on four weekends (Thursday - Sunday; total 24 assessments) regarding BSM, motives to drink, peers in their social group, alcohol use and consequences, and if/how their social group changed (e.g., few close friends to large party with many new peers) during the drinking event. Competing hypotheses will be tested such that: 1) anxiety is expected to be a stronger predictor of drinking behavior and greater differences in risk-taking in the new peer condition than close friend condition or 2) BSM is expected to be a stronger predictor of drinking behavior and greater differences in risk-taking in the close friend condition than new peers condition. Results are expected to be replicated in the daily diary reports. Further, this multimethod approach will allow us to evaluate how behavior assessed in the lab predicts naturally occurring behaviors in an uncontrolled setting. For example, the investigators will assess whether greater increases in self-reported risk-taking from baseline to after entering peer groups in the bar lab setting will predict heavier drinking on nights when most drinking companions are close friends reported during daily diary. <EligibilityCriteria:>Inclusion Criteria:
* currently enrolled in college
* has consumed 3 or more alcoholic drinks in one sitting at least once in the past month
* drinking frequency of once a week
Exclusion Criteria:
* past-month alcohol
* past-month other substance dependence,
* past-month mood disorder
* past-month anxiety disorder
* past-moth suicidal ideation
* excessive alcohol use reaching a BAC greater than .30% in past month
* history of serious medical conditions
* regular use of prescription psychotropic or pain medication
* history of negative reactions to alcohol
* history of treatment for alcohol use disorder
* pregnancy
* nursing <Conditions:>Alcohol Drinking <Interventions:>Peer Type - New Peer, Peer Type - Close Friends | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Broad Social Motives for Friends', 'Broad Social Motives for New Peers', 'Negative Affect', 'Positive Affect', 'Prior 30 day Alcohol Consequences', 'Prior 30 day Alcohol Use' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>European Safety Registry in Ulcerative Colitis (P04808) <BriefSummary:>This is a prospective, safety surveillance registry in participants with moderate-to-severe active ulcerative colitis (UC). <EligibilityCriteria:>Inclusion Criteria:
* 18 years of age, of either sex, and of any race.
* Moderate-to-severe active UC, as defined by assessment by the treating physician.
* Must, within 30 days of Baseline, either:
* Initiate or have a dose increase of immunosuppressive drug(s), including but not limited to systemic steroids (budesonide is considered a topical steroid), azathioprine (AZA), or methotrexate (participants in this category must be Remicade naïve) or
* Initiate Remicade. Participants who have been treated in the past with Remicade, but who have discontinued for any reason and who are scheduled to receive Remicade within 30 days of the baseline visit must have a Remicade-free interval of no less than 90 days from the date of the next expected infusion
* Must be willing to give written informed consent and must be able to adhere to the procedural requirements of the registry.
* Must be evaluated for active and inactive (latent) tuberculosis (TB) as suggested by local guidelines or as required by the Remicade label for participants starting Remicade.
Exclusion Criteria:
* Female who is known to be pregnant or nursing.
* Previously treated with any other (investigational) biological drug for UC( other than Remicade) prior to Baseline.
* In a situation or have any condition that, in the opinion of the treating physician, may interfere with their optimal participation in the registry.
* Participating in a blinded trial.
In addition, participants with conditions that are contraindicated in the Remicade Summary of Product Characteristics (SPC) should not be treated with Remicade. <Conditions:>Ulcerative Colitis <Interventions:>infliximab, Standard Therapy | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Vismodegib in Treating Patients With Recurrent or Refractory Medulloblastoma <BriefSummary:>This phase II trial is studying how well vismodegib works in treating adult patients with recurrent or refractory medulloblastoma. Vismodegib may slow the growth of tumor cells and may be an effective treatment for medulloblastoma. <EligibilityCriteria:>Inclusion Criteria:
* Patients with a histologically confirmed diagnosis of medulloblastoma (including posterior fossa PNET) that is recurrent, progressive, or refractory to standard therapy and for which there is no known curative therapy are eligible; there must be evidence of residual measurable disease or lesion in pre-study MRI as described in section; patients with spinal disease that is measurable will be eligible
* The diagnosis should be confirmed at the treating institution and tissue (either from the diagnosis or relapse or preferably from both time points) must be available for biological studies
* Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration; this is to be documented in the database
* Eastern Cooperative Oncology Group (ECOG) performance status 0- 2
* No other myelosuppressive chemotherapy or immunotherapy within 4 weeks prior to study entry (6 weeks if prior nitrosourea)
* Decadron dose should also be stable or decreasing for at least 1 week (7days) prior to starting therapy
* Radiation therapy (XRT) \>= 3 months prior to study entry for craniospinal irradiation (\>= 23 Gy); \>= 8 weeks for local irradiation to primary tumor; \>= 2 weeks prior to study entry for focal irradiation for symptomatic metastatic sites
* Off all colony stimulating factors \>= 1 week prior to study entry (GCSF, GM CSF, erythropoietin)
* Absolute neutrophil count (ANC) \>= 1000/μL
* Platelet count \>= 50,000/uL (transfusion independent)
* Hemoglobin \>= 8.0 gm/dL (may receive RBC transfusions)
* Creatinine clearance or radio-isotope GFR \>= 70ml/min/1.73 m2 or
* A serum creatinine =\< 2.0 mg/dL
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age
* Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2.5 x institutional ULN
* Serum glutamic-oxalacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 2.5 times institutional ULN
* Serum albumin \>= 2.5 g/dL
* Patient must have recovered from the significant acute toxicities of all prior therapy before entering this study and meet all other eligibility criteria
* Pregnancy should be avoided for 12 months after the last dose of GDC-0449 for females of child-bearing potential; female patients of childbearing potential must not be pregnant or breast-feeding; female patients of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to beginning treatment
* Women of childbearing potential are required to use 2 forms of acceptable contraception, including one barrier method during participation in the study and for the 12 months following the last dose; for medical or personal reasons, 100% commitment to abstinence is considered an acceptable form of birth control. All patients should receive contraceptive counseling either by the investigator, or by an OB/gynecologist or other physician who is qualified in this area of expertise; prior to dispensing GDC-0449, the investigator must confirm and document the patient's use of two contraceptive methods, dates of negative pregnancy test, and confirm the patient's understanding of the of GDC-0449 to cause spontaneous abortion or birth defects
* Signed informed consent according to institutional guidelines must be obtained
Exclusion Criteria:
* Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that would compromise the patient's ability to tolerate protocol therapy or would likely interfere with the study procedures or results
* Patients receiving any other anticancer or investigational drug therapy
* Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy
* Life expectancy \< 12 weeks as determined by treating physician
* Inability to swallow capsules
* Prior treatment with GDC-0449 or other antagonists of the HH pathway
* Malabsorption syndrome or other condition that would interfere with enteral absorption
* History of congestive heart failure
* History of ventricular arrhythmia requiring medication
* Uncontrolled hypocalcemia, hypomagnesemia, hyponatremia or hypokalemia defined as less than the lower limit of normal for the institution despite adequate electrolyte supplementation
* Congenital long QT syndrome <Conditions:>Adult Medulloblastoma <Interventions:>Pharmacological Study, Vismodegib | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Diagnosis' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Afatinib in NSCLC With HER2 Mutation <BriefSummary:>The purpose of this study is to investigate the control of disease in pretreated patients with advanced non small cell lung cancer (NSCLC) harbouring HER2 exon 20 mutations as well as the safety and tolerability (how severe the side effects are) of the treatment with afatinib. <EligibilityCriteria:>Inclusion Criteria:
* Histologically or cytologically confirmed non small cell lung cancer
* Stage IIIB (non amenable to curative-intent multimodal treatment) or IV NSCLC, according to 7th TNM classification.
* Contrast-enhanced CT of thorax and upper abdomen (incl. liver, kidney, adrenals);
* brain MRI or CT within 28 days before the date of enrolment.
* Non-predominant squamous subtype (\<50% squamous cells).
* Previous treatment with a platinum based chemotherapy for advanced disease; or Disease relapse or progression within \<6 months after adjuvant platinum based chemotherapy, or (definitive) platinum-based chemo(radio)therapy for stage I-III NSCLC
* Measurable or evaluable disease (according to RECIST 1.1 criteria). Not eligible: patients with only one measurable or evaluable tumour lesion which was resected or irradiated prior to enrolment.
* Locally documented HER2 mutation
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Life expectancy \>3 months.
* Adequate haematological function:
* WBC ≥ 2000/μL
* haemoglobin ≥ 9 g/dL
* neutrophils count ≥1.5×109/L
* platelet count ≥ 100 × 109/L
* Adequate liver function:
* Total bilirubin ≤ 1.5 × ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
* ALT \< 2.5 × ULN
* AST \< 2.5 × ULN
* GGT \< 2.5 × ULN.
* Adequate renal function: Calculated creatinine clearance ≥ 45mL/min (Cockroft-Gault)
* Patient capable of proper therapeutic compliance, and accessible for correct followup.
* Women of childbearing potential (\< 1 year without menstruation or \< 2 years without menstruation following chemotherapy) must have a negative serum or urine pregnancy test within 7 days before beginning trial treatment.
* Sexually active men and women of childbearing potential must use an effective contraceptive method (two barrier methods or a barrier method plus a hormonal method) during the trial treatment and for a period of at least 28 days following the last administration of trial drug.
* Recovered from any previous therapy related toxicity to ≤Grade 1 at date of enrolment (except for recovery to ≤Grade 2 of alopecia, fatigue, creatinine increased, lack of appetite as well as stable sensory neuropathy)
* Written Informed Consent (IC) for trial treatment must be signed and dated by the patient and the investigator prior to any trial-related intervention.
* Tumour block available for central review of HER2 mutation status.
Exclusion Criteria:
* Patient with mixed small-cell and non-small-cell histologic features
* Uncontrolled lepto-meningeal metastatic disease. Radiotherapy-treated or asymptomatic brain metastases are allowed (no systematic screening). Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids or have been on stable dose of corticosteroids for at least 4 weeks before starting trial treatment. Any symptoms attributed to brain metastases must be stable for at least 4 weeks before date of enrolment.
* Previous treatment with HER2 targeted antibody or tyrosine kinase inhibitor including afatinib.
* Major surgery within 4 weeks before starting trial treatment or scheduled for surgery during the projected course of the trial.
* Patient who has had in the past 3 years any previous or concomitant malignancy EXCEPT adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, in situ ductal carcinoma of the breast.
* History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of III or IV (see Table 2 below), unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to enrolment.
* Patient with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection and any other serious underlying medical processes that could affect the patient's capacity to participate in the trial.
* Known HIV, active Hepatitis B or Hepatitis C infection (screening not required).
* Known or suspected hypersensitivity to afatinib or any of its excipients.
* Interstitial lung disease or pulmonary fibrosis.
* Women who are pregnant or in the period of lactation.
* Patients with any concurrent systemic anticancer therapy.
* Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. Crohn's disease, ulcerative colitis, chronic diarrhea, malabsorption.
* Patient who received treatment with an investigational drug agent during the 3 weeks before enrolment in the trial. <Conditions:>NSCLC <Interventions:>Afatinib | 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Region of Enrollment', 'Smoking history', 'ECOG Performance status', 'T parameter', 'N parameter', 'M parameter', 'TNM staging', 'Type of prior platinum treatment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma <BriefSummary:>RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Vaccines may help the body build an effective immune response to kill cancer cells. Giving lenalidomide together with vaccine therapy may make a stronger immune response and kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving lenalidomide together with vaccine therapy works in treating patients with relapsed or refractory multiple myeloma. <EligibilityCriteria:>DISEASE CHARACTERISTICS:
* Diagnosis of multiple myeloma (MM) meeting all of the following criteria:
* Relapsed or refractory disease
* Previously received ≥ 2 courses of antimyeloma treatment
* Measurable levels of myeloma paraprotein in serum (\> 0.5 g/dL) or urine (\> 0.2 g/24-hour urine collection) OR serum-free light-chain disease
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,000/mm\^3
* Platelet count ≥ 75,000/mm\^3
* Creatinine ≤ 2.5 mg/dL
* Bilirubin ≤ 2.0 mg/dL
* AST and ALT ≤ 3 times upper limit of normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 methods of highly effective contraception ≥ 4 weeks before, during, and for 4 weeks after completion of study therapy
* No other malignancy within the past 5 years except treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
* No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study treatment or put patient at unacceptable risk
* No known hypersensitivity to thalidomide or lenalidomide
* No development of erythema nodosum in the presence of a reaction characterized by a desquamating rash while taking thalidomide or similar drugs
* No known hypersensitivity to any component of the pneumococcal polyvalent vaccine, including diphtheria toxin or CRM 197
* No known HIV positivity
* No infectious hepatitis type A, B, or C
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No more than 3 prior treatment regimens for MM
* More than 6 months since prior lenalidomide
* More than 28 days since prior experimental drug or therapy
* More than 1 month since prior systemic antimyeloma therapy
* More than 1 month since prior and no concurrent systemic corticosteroids
* No other concurrent anticancer agents or treatments or investigational agents
* No concurrent thalidomide
* No concurrent radiotherapy
* No other concurrent immune therapy or immunomodulatory agents <Conditions:>Multiple Myeloma and Plasma Cell Neoplasm <Interventions:>pneumococcal polyvalent vaccine, lenalidomide | 'Age, Continuous', 'Age, Categorical', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study to Evaluate Sildenafil for the Treatment of Lymphatic Malformations <BriefSummary:>There is an unsatisfied medical need for a first-line treatment of lymphatic malformations with a good benefit/risk profile. Based on a patient experience in the institution, the investigators plan to verify whether or not the medication sildenafil has a beneficial effect on lymphatic malformations. The investigators plan to do this by treating patients with lymphatic malformations with the medication sildenafil for a 20 week period. This is an investigator initiated study funded by an Innovations in Patient Care grant and a SPARK grant. <EligibilityCriteria:>Inclusion Criteria:
1. Written informed consent(s) for study participation and (where applicable) the use of the participant's images are obtained according to national regulations from the participant's parent(s) or guardian(s) prior to performing any study procedures.
2. The participant is 6 months to 10 years of age at inclusion.
3. The participant weight is at least 8kg.
4. A diagnosis of LM or mixed venous lymphatic malformation involving the skin and subcutaneous tissue and at least 3cm based on clinical and radiographic criteria.
5. LMs may benefit from systemic therapy based on clinical criteria.
6. Females must not be pregnant or breast-feeding.
7. If participant is a child, parent/guardian must be able to follow instructions and must be willing and able to ensure that the subject is present for all required study visits.
8. Subject has no contraindication for use of sildenafil.
9. LMs may involve any part of the body.
10. Subject will have normal results on screening tests (eye exam, blood tests).
11. Subject has no contraindication for MRI examinations, such as metal implants, etc.
12. Subject must not be a smoker.
Exclusion Criteria:
1. The participant has a medically unstable health status that may interfere with his/her ability to complete the study.
2. The participant presents with one or more of the following medical conditions: hepatic impairment; severe renal impairment; lymphedema conditions such as Milroy disease, Meige lymphedema, Hennekam syndrome, Njolstad syndrome, Aagenaes syndrome, and Fabry disease; hypotension or at risk for hypotension; seizures or history of seizures; any significant cardiovascular risk factors and any condition which requires participants to use nitric oxide donors or nitrates in any form; underlying anatomic or vascular risk factors for developing non-arteritic anterior ischemic optic neuropathy (NAION) including low ocular cup to disc ratio, age over 10, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking. (Participants with Down syndrome, Turner syndrome, and Noonan syndrome will be considered on a case-by-case basis).
3. The participant has received at least one of the following medications contraindicated in association with sildenafil within 15 days of inclusion: Alprostadil, Azole antifungals, Clarithromycins, Conivaptan, Delavirdine, Erythromycins, Fluvoxamine, Grapefruit, Imatinib, Nefazodone, Nitrates/sodium thiosulfate, Non-selective and selective alpha blockers, Protease inhibitors, Rufinamide, Tadalafil, Telithromycin, Vardenafil, Yohimbe, Yohimbine, Amifostine, Lapatinib, Warfarin
4. The participant requires concomitant use of potent cytochrome P450 3A4 inhibitors (such as ketoconazole, itraconazole, erythromycin, saquinavir) or concomitant use of ritonavir.
5. The patient has had extensive prior surgery or sclerotherapy to treat LM such that scarring may interfere with the treatment effect of sildenafil.
6. The participant has previously been administered treatment for LMs or surgical procedures have been performed to remove the index LMs.
7. Participant is currently pregnant or considering becoming pregnant in the next 20 weeks.
8. The participant is known to have an allergy to sildenafil.
9. Ulcerated or currently infected LMs with pain.
10. Diagnosis of the soft tissue tumor as LM is not clinically certain.
11. The participant is participating in another clinical study.
12. The participant has a history of priapism or is diagnosed with sickle cell anemia or any other disorder which may predispose to priapism.
13. The investigator may declare any subject ineligible for a valid medical reason. <Conditions:>Lymphangioma <Interventions:>Sildenafil | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment', 'Weight' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Fesoterodine Flexible Dose Study <BriefSummary:>This Phase 3B study is designed to test if a fesoterodine flexible dose regimen is more effective than placebo in reducing micturition frequency and other overactive bladder (OAB) symptoms, e.g., urgency, urgency incontinence episodes in patients with overactive bladder and if the fesoterodine regimen is safe and well tolerated. <EligibilityCriteria:>Inclusion Criteria:
* Overactive bladder symptoms for greater than or equal to 3 months.
* Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in bladder diary.
* Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder diary.
Exclusion Criteria:
* Contraindication to fesoterodine (antimuscarinics).
* Known etiology of OAB (e.g., neurogenic, local urinary tract pathology).
* Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
* Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires. <Conditions:>Overactive Bladder <Interventions:>Fesoterodine, Placebo | 'Age Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Bevacizumab, Docetaxel, and Gemcitabine Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer <BriefSummary:>RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with docetaxel and gemcitabine hydrochloride may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and gemcitabine hydrochloride works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer. <EligibilityCriteria:>DISEASE CHARACTERISTICS:
* Histologically confirmed non-squamous cell non-small cell lung cancer
* Stage IIIB (with pleural effusion), stage IV, or recurrent disease
* Bidimensionally measurable disease
* No known CNS disease, except for previously treated brain metastasis defined as no evidence of progression or hemorrhage after treatment AND no ongoing requirement for dexamethasone as documented by clinical examination, MRI, or CT scan
* Treatment for brain metastases may have included whole brain radiotherapy, radiosurgery (gamma knife, LINAC, or equivalent), or a combination of therapy as deemed appropriate by the treating physician
* Stable dose of anticonvulsants allowed
* No known metastatic disease to the gastrointestinal tract (e.g., stomach, small bowel, or large bowel)
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Life expectancy \> 3 months
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* Bilirubin ≤ 2.0 mg/dL
* AST or ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5.0 times ULN if hepatic metastases are present)
* Serum creatinine ≤ 1.8 mg/dL
* Urine protein:creatinine ratio \< 1.0 OR proteinuria \< 2+ by urine dipstick OR ≤ 1 g of protein by 24-hour urine collection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Available for regular follow-ups
* No inadequately controlled hypertension, defined as systolic BP \> 150 mm Hg and/or diastolic BP \> 100 mm Hg despite antihypertensive medications
* No history of hypertensive crisis or hypertensive encephalopathy
* No NYHA class II-IV congestive heart failure
* No myocardial infarction or unstable angina within the past 6 months
* No stroke or transient ischemic attack within the past 6 months
* No significant vascular disease (e.g., aortic aneurysm, aortic dissection requiring surgical repair, or recent peripheral arterial thrombosis) within the past 6 months
* No symptomatic peripheral vascular disease
* No evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
* No history of colonic diverticular disease (i.e., diverticulosis or diverticulitis)
* No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
* No serious, nonhealing wound, ulcer, or bone fracture
* No known hypersensitivity to any component of bevacizumab
* No hemoptysis (bright red blood of ≥ ½ teaspoon per episode) within the past 3 months
* No significant traumatic injury within the past 28 days
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy or biological therapy
* No prior radiotherapy to an area of measurable disease unless there is documented progressive disease after completion of therapy
* More than 2 weeks since prior radiotherapy
* More than 4 weeks since prior and no concurrent participation in another experimental drug study, except for a Genentech-sponsored bevacizumab cancer study
* More than 28 days since prior major surgical procedure or open biopsy
* More than 3 months since prior abdominal surgery
* More than 3 months since prior neurosurgical resection or brain biopsy
* More than 7 days since prior core biopsy or other minor surgical procedure, except placement of a vascular access device
* No concurrent major surgical procedure <Conditions:>Lung Cancer <Interventions:>bevacizumab, docetaxel, gemcitabine hydrochloride | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Safety and Efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine for Facial Augmentation in Asian Population <BriefSummary:>The purpose of this study is to evaluate the safety and efficacy of Restylane Lidocaine and Restylane Perlane Lidocaine after the first and second treatment when used for facial augmentation in Asian population. <EligibilityCriteria:>Inclusion Criteria:
* Subjects intent to undergo facial filler treatment for either volume loss or contouring
* Subjects requiring treatment in two to four of pre-defined areas in the face (upper cheeks, nasolabial folds, temples, nose and chin)
* Require 3-5 ml of investigational products to achieve a clinically meaningful improvement in appearance
* Facial appearance as Han Chinese
* Non-pregnant, non-breast feeding female
* Signed informed consent
Exclusion Criteria:
* Previous facial surgery (e.g. rhinoplasty) or permanent implant in the area to be treated.
* History of chronic sinusitis or rhinitis (only applicable for subjects injected in the nose).
* Subjects who needs to use heavy glasses during the study (only applicable for subjects injected in the nose).
* Previous tissue augmenting therapy or contouring with permanent filler or fat injection in the facial area.
* Previous treatment with Hyaluronic acid (HA) fillers or Restylane Skinboosters in the facial area within 12 months before treatment.
* Previous treatment with non-HA fillers such as CaHA (Calcium Hydroxylapatite) or PLLA (Poly L-Lactic Acid) within 24 months before treatment.
* Previous revitalization with neurotoxin in the facial area within six (6) months before treatment.
* Previous tissue revitalization treatment with laser or light, mesotherapy, chemical peeling or dermabrasion in the facial area within six (6) months before treatment.
* Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study). <Conditions:>Healthy Volunteers <Interventions:>Restylane, Perlane | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Patient-Centered Intervention to Reduce Cancer Patients' Financial Toxicity <BriefSummary:>The purpose of this study is to incorporate feedback from cancer patients and providers to adapt, implement, and test an intervention. The intervention aims to prompt screening for financial distress, facilitate discussions about care costs with cancer patients, support health insurance selection, and ultimately reduce cancer patients' financial toxicity associated with cancer care. <EligibilityCriteria:>Eligibility criteria for I Can Pic Arm only:
Inclusion Criteria:
* 18 years of age or older
* Must have been diagnosed with colorectal cancer, lung cancer, or gynecologic cancer \< 5 months ago and be patients of one of the 15 providers
* This cancer diagnosis must be the first and primary diagnosis
Exclusion Criteria:
* Not able to read and understand English
* Cannot give informed consent due to cognitive or emotional barriers <Conditions:>Gynecologic Cancer, Colorectal Cancer, Lung Cancer <Interventions:>I Can PIC, Historical control survey, Post-intervention survey (I Can PIC participants), Follow-Up survey (I Can PIC participants) | 'Age, Continuous', 'Sex/Gender, Customized', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Soccer-based Adaptation of the Diabetes Prevention Program <BriefSummary:>This is a longitudinal pre-post pilot intervention study evaluating feasibility of implementation of a soccer-based Diabetes Prevention Program (DPP) and preliminary changes in physical activity and diet-related measures. Overweight participants at high risk for type 2 diabetes mellitus (T2DM) will be recruited through soccer interest groups, local leagues and Hispanic health organizations. After a baseline assessment visit, participants will attend soccer practice twice a week for 12 weeks while completing the National Diabetes Prevention Program (NDPP) core curriculum online modules with facilitated discussion by trained coaches during each soccer practice. Participants will then be invited to join an established small-sided soccer league in their community (for 12 weeks) offering one game per week and will also complete the NDPP maintenance modules and physical activity and diet self-tracking via mobile health technologies. After the core (first 12 weeks) and maintenance intervention periods (second 12 weeks) baseline measurements will be repeated. Data on the feasibility of this DPP soccer-based adaptation will inform future randomized, controlled trials testing the effectiveness of this translation model to reduce T2DM risk while extrapolating to other sports-based adaptation and age, gender and racial sub-populations. <EligibilityCriteria:>Inclusion Criteria:
* Hispanic/Latino men aged 35-55 years
* Body Mass Index (BMI) ≥ 25 kg/m\^2
* Centers for Disease Control and Prevention (CDC) pre-diabetes risk score ≥ 9
* Not currently engaged in soccer practice or league or other physical activity or lifestyle intervention program
* Ability to read in English or Spanish and provide inform consent
Exclusion Criteria:
* T2DM diagnosis or medication
* BMI ≥ 41
* Resting blood pressure ≥165/100 at screening
* Any mobility issues or contraindications for high intensity interval training (HIIT) physical activity program <Conditions:>Diabetes <Interventions:>Soccer-based adaptation to the DPP | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Region of Enrollment', 'Family history of diabetes', 'Country of origin', 'Body Mass Index (BMI)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>AB103 Peptide Antagonist in Healthy Volunteers <BriefSummary:>The primary objective of this study is to establish the safety profile and maximum tolerated dose (MTD) of AB103 given as a single intravenous (IV) infusion in healthy volunteers. <EligibilityCriteria:>Inclusion Criteria:
* Be able to read, understand and sign the Informed Consent form and be willing to participate in all study procedures for the duration of the study.
* Be 18-to-40 years-of-age.
* Have adequate venous access.
* Have a body mass index between 20 and 29 kg/m2.
* Have a history and physical examination that demonstrate no clinically significant contraindication for participating in the study, in the judgment of the admitting physician and/or the site investigator.
* Have vital signs as follows: resting heart rate between 50 and 90 beats per minute (bpm), systolic blood pressure (BP) below 150 mm Hg and diastolic BP below 90 mm Hg.
* Have all blood chemistry, hematology, coagulation, and urinalysis analyte levels within 10% of normal laboratory limits.
* If female, not be pregnant or breast-feeding, nor plan to become pregnant for the duration of the study, have a negative pregnancy test.
* Agree to exercise adequate birth control from the time of the screening procedures to 14 days after the investigational agent administration (both males and females).
* Have an electrocardiogram (ECG) performed that demonstrates normal sinus rhythm, normal conductivity, and no clinically significant arrhythmias.
Exclusion Criteria:
* Be pregnant or lactating.
* Have autoimmune disease or asthma.
* Have been febrile within 3-days of the first infusion.
* Have a history of migraine headaches, as diagnosed by a physician.
* Have any acute or chronic medical illnesses or other condition that, in the opinion of the Investigator, might jeopardize the safety of the patient, or the adequate evaluation of study results.
* Be taking any medications to treat a chronic medical condition.
* Have participated in a research study where they received any experimental products within 30 days prior to study entry.
* Have ongoing drug abuse/dependence (including alcohol) by medical history.
* Have taken, within 14 days of planned dosing, any prescription or non-prescription medication (including ibuprofen, aspirin, of non-steroidal anti-inflammatory drugs) unless the Principal Investigator/Sub-Investigator, in consultation with the Medical Monitor, provides a statement justifying that the medication taken will not impact the results of this study (with rare exceptions taking prescription drugs will be grounds for exclusion).
* Have donated a unit of blood within the preceding 4-week period.
* Have allergy to either sulfa- or penicillin-based drugs.
* Have a history of vagal responses resulting in bradycardia. <Conditions:>Healthy Volunteer Safety Study <Interventions:>AB103, Placebo | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation <BriefSummary:>The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of N6022, and to obtain descriptive information on the effect of N6022 on biomarkers of CFTR function and inflammation in adult cystic fibrosis subjects who are homozygous for the F508del-CFTR mutation. <EligibilityCriteria:>Inclusion Criteria:
* Homozygous for F508del-CFTR gene
* Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis
* Body weight ≥ 40 kg
* FEV1 ≥ 40% predicted
* Oxygen saturation ≥ 90% breathing ambient air
* Hematology and clinical chemistry of blood and urine results with no clinically significant abnormalities that would interfere with the study assessments
* Negative pregnancy test for women of child bearing potential
* Sexually active subjects of child bearing potential willing to follow contraception requirements
Exclusion Criteria:
* Previous enrollment in another cohort for this study.
* Any acute infection, including acute upper or lower respiratory infections and pulmonary exacerbations that require treatment within 4 weeks of Study Day 1.
* Any change in chronic therapies for CF lung disease within 4 weeks of Study Day 1.
* Blood hemoglobin \<10 g/dL at screening.
* Serum albumin \<2.5 g/dL at screening.
* Abnormal liver function defined as ≥ 3 x upper limit of normal (ULN) in three or more of the following: AST, ALT, GGT, ALP, total bilirubin at screening.
* History of abnormal renal function (creatinine clearance \< 50 mL/min using Cockcroft-Gault equation) within a year at screening.
* History, including the screening assessment, of ventricular tachycardia or other ventricular arrhythmias.
* History, including the screening assessment, of prolonged QT and/or QTcF interval (\> 450 msec).
* History of solid organ or hematological transplantation.
* Intranasal medication changes within 14 days prior to Study Day 1
* Required Use of continuous (24 hr/d) or nocturnal supplemental oxygen.
* Concomitant use of any inhibitors or inducers of CYP3A4. <Conditions:>Cystic Fibrosis <Interventions:>N6022, Normal saline | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Body Mass Index (BMI)', 'Weight', 'FEV1 (L)', 'FEV1 Percent Predicted', 'Sweat Chloride' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>RBM-007 in Subjects witH ExudatIve Age-related Macular Degeneration <BriefSummary:>This is an open label, non-controlled, dose-escalating study assessing the safety, tolerability, and bioactivity of a single intravitreal (i.vt.) injection of RBM-007 in approximately nine subjects with exudative age-related macular degeneration. <EligibilityCriteria:>Inclusion Criteria:
1. Male or female 55 years of age or older on the date of signing the informed consent form and able and willing to comply with all treatment and follow-up study procedures.
2. At Screening Visit, subjects must meet all the following inclusion criteria:
3. Must have had prior treatment in the study eye with any intravitreal vasoactive endothelial growth factor (VEGF) medication (at least 3 anti-VEGF) treatments within the prior 2-6 months), throughout which clinical examination and SD-OCT imaging has shown recurrent or persistent exudative activity, as shown by the presence of intraretinal or subretinal fluid, and/or subretinal exudation or hemorrhage.
4. Best corrected visual acuity of 65 to 20 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (20/50 to 20/400) in the study eye.
5. Presence of significant subretinal fluid and/or cystoid macular edema secondary to exudative age-related macular degeneration as assessed by optical coherence tomography in the study eye, with a minimum of 300 µm within the central subfield.
6. Total lesion size of ≤9 disc areas, lesion containing ≤50% hemorrhage and ≤50% subretinal fibrosis and ≤50% retinal pigment epithelial atrophy in the study eye.
7. Reasonably clear media and reasonable fixation ability in the study eye to allow for good quality tomography and fundus photography.
At Baseline Visit (Day 0), subjects must meet all the following inclusion criteria:
8. Best Corrected Visual Acuity (BCVA) of 65 to 20 ETDRS letters (20/50 to 20/400) in the study eye.
9. Presence of significant subretinal and/or intraretinal fluid secondary to exudative age-related macular degeneration as assessed by SD-OCT in the study eye, with a minimum of 300 µm within the central subfield.
10. Total lesion size of ≤9 disc areas, containing ≤ 50% hemorrhage and ≤ 50% fibrosis and ≤ 50% retinal pigment epithelial atrophy in the study eye.
Exclusion Criteria:
Ocular exclusion criteria:
1. BCVA better than 65 ETDRS letters (20/50) in the study eye.
2. BCVA worse than 20 ETDRS letters (20/400) in study eye.
3. Fellow eye BCVA worse than 35 ETDRS letters (20/200).
Use of any of the following treatments to the study eye:
4. Intravitreal anti-VEGF injection (ranibizumab, aflibercept or bevacizumab) in the study eye within the past 4 weeks or less prior to Baseline Visit and RBM-007 injection.
5. Intravitreal or periocular corticosteroid, within 3 months prior to Baseline Visit (Day 0) and throughout the study;
6. Fluocinolone acetonide intravitreal implant, within 12 months prior to Baseline Visit (Day 0) and throughout the study;
7. Visudyne® (verteporfin) photodynamic therapy, within 3 months prior to Baseline Visit (Day 0) and throughout the study.
8. Uncontrolled or advanced glaucoma, defined by an intraocular pressure (IOP) of \>21 mmHg or cup/disc ratio \> 0.8 while on medical therapy, or chronic ocular hypotony (\<6 mmHg) in the study eye.
9. Evidence of ocular disease other than exudative AMD in the study eye that may confound the outcome of the study (e.g., active diabetic retinopathy, posterior uveitis, adult vitelliform dystrophy, moderate/severe myopic degeneration).
10. History of vitrectomy surgery in the study eye.
11. Anticipated need for any ocular surgery involving the study eye during the course of the study.
12. Nd:YAG laser capsulotomy within 28 days prior to Baseline Visit (Day 0) in the study eye.
13. Intraocular surgery, including lens removal or ophthalmologic laser procedure, within 90 days prior to Baseline Visit (Day 0) in the study eye.
14. Ocular or periocular infection in either eye.
15. Pupillary dilation inadequate for good quality fundus photography in the study eye.
16. Media opacity that would limit clinical visualization, fundus photography, fluorescein angiography, or SD-OCT evaluation in the study eye.
17. History of herpetic ophthalmic infection in the study eye or adnexa.
18. Presence of known toxoplasmosis or toxoplasmosis scar in either eye.
19. Presence or history of any form of ocular malignancy including choroidal melanoma in the study eye. <Conditions:>Age-related Macular Degeneration <Interventions:>RBM-007 Injectable Solution | 'Age, Customized', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Ocular safety as assessed using biomicroscopy to investigate ocular tolerability', 'Ocular safety as assessed using ophthalmoscopy to investigate ocular tolerability' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005) <BriefSummary:>This study will evaluate the tolerability and immunogenicity of administration of the first dose of V503 at the same time as Menactra™ and Adacel™ versus administration of V503 one month prior to administration of Menactra™ and Adacel™. <EligibilityCriteria:>Inclusion Criteria:
* Subject is in good health
* Subject's parent/legal guardian can read, understand, and complete the vaccine report card
* Subject is not sexually active and does not plan on becoming sexually active during the study
* Subject has received a documented full primary immunization series against diphtheria, tetanus, and pertussis (not in the last 5 years)
Exclusion Criteria:
* Subject has a known allergy to any vaccine component of V503, Menactra™, or Adacel™
* Subject has a condition that is a contraindication to vaccination with Menactra™ or Adacel™
* Subject has any coagulation disorder
* Female subject is pregnant
* Subject is immunocompromised or immunodeficient
* Subject has had a splenectomy
* Subject has received immunosuppressive therapies in the prior year
* Subject has received any immune globulin product or blood-derived product in the last 3 months
* Subject has received inactivated vaccines within 14 days or live vaccines within 21 days of the first study vaccination
* Subject has received a marketed HPV vaccine or has participation in an HPV vaccine trial
* Subject has received a meningococcal vaccine
* Subject has a fever \>= 100F within 24 hours of vaccination
* Subject has a history of HPV <Conditions:>Human Papillomavirus Infection <Interventions:>V503, Comparator: Menactra™ (Concomitant), Comparator: Adacel™ (Concomitant), Comparator: Menactra™ (Non-Concomitant), Comparator: Adacel™ (Non-concomitant) | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Ghrelin in Healthy and Frail Older Women <BriefSummary:>The purpose of this research study is to see if giving women a hormone called "ghrelin" will increase levels of growth hormone in the blood and increase appetite. Ghrelin is a naturally occurring hormone that is produced mostly by the stomach and causes secretion of another hormone called growth hormone. It also increases short-term appetite and may lower the amount of inflammation in the body.
Some people lose their appetite as they age and have unintentional weight loss. This may be caused by a break in the communication between the stomach and the brain. We are particularly interested in seeing if there is a difference in the effects of ghrelin in older women who have lost weight recently without wanting to and those who have not. <EligibilityCriteria:>Inclusion Criteria:
Frail group:
* Women aged 70 or greater
* Able to give informed consent
* Undiagnosed weight loss (\>5% over the previous year)
* Two of the following four criteria (from Fried L et al, 2001): low grip strength, slow walking speed, subjective exhaustion, low levels of physical activity
Healthy group:
* Women aged 70 or greater
* Able to give informed consent
* None of the frailty criteria
Exclusion Criteria:
* Prior diagnosis of Parkinson's Disease
* History of cerebrovascular accident with residual hemiparesis
* Hospitalization for treatment of vascular disease (including, coronary heart disease, cerebrovascular disease, peripheral vascular disease) in the past 6 months
* Congestive heart failure
* Rheumatoid arthritis or other inflammatory conditions
* Depression (defined as a score of \>11 on the Geriatric Depression Questionnaire)
* History of cancer requiring treatment in the past 5 years, with the exception of cancers which have been cured, or, in the opinion of the investigator, carry a good prognosis
* Cognitive deficit as defined by a Folstein Mini Mental State Exam score \< 18/30
* Current use of corticosteroids or immune-modulating agents other than topical, ophthalmic, and inhaled preparations, in past 3 months
* Diabetes mellitus
* Thyroid stimulating hormone (TSH) measured as \<0.5 U/L or greater than 10 U/L. If participant is taking replacement thyroid hormone, they should be on a stable dose for at least 2 months
* History of liver disease or abnormal liver function tests (LFTs \> 2x upper limit of normal)
* Renal insufficiency (serum creatinine ≥ 1.4 mg/dL).
* Hemoglobin \< 11g/dL
* History of surgery within the last 30 days.
* Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
* Participation in an investigational drug study within 6 weeks prior to screening visit
* Self reported history of HIV disease
* Hospitalization for chronic obstructive pulmonary disease or asthma in the past 3 months
* History of alcohol abuse as defined as any one of the following:
1) average consumption of 3 or more alcohol containing beverages daily; 2) consumption of 7 or more alcoholic beverages within a 24 hr period in the past 12 months; or 3) clinical assessment of alcohol dependence based on two or more positive responses to an alcoholism questionnaire (if confirmed by further probing) or on other evidence available to clinic staff. If any of these exclusion criteria are met, the subject may still be considered eligible if, after an explanation of the importance of limiting alcohol intake during the study, the clinic staff believes that the volunteer can and will limit future alcohol intake to acceptable levels.
* History of gastrectomy
* Current therapy with an appetite stimulant, i.e. medroxyprogesterone acetate, within the last 6 weeks.
* Weight \>85 kg <Conditions:>Frailty <Interventions:>Ghrelin Infusion - Healthy, Ghrelin Infusion - Frail, Placebo Infusion -Healthy, Placebo Infusion - Frail | 'Age, Continuous', 'Sex/Gender, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease <BriefSummary:>OSCAR (Otilimab in Severe COVID-19 Related Disease) is a multi-center, double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of otilimab for the treatment of severe pulmonary COVID-19 related disease. The study is being conducted in 2 parts (Part 1 and Part 2). Otilimab is a human monoclonal anti-granulocyte macrophage colony stimulating factor (GM-CSF) antibody that has not previously been tested in participants with severe pulmonary COVID-19 related disease in Part 1. The aim of this study is to evaluate the benefit-risk of a single infusion of otilimab in the treatment of hospitalized participants with severe COVID-19 related pulmonary disease with new onset hypoxia requiring significant oxygen support or requiring early invasive mechanical ventilation (less than or equal to \[\<=\] 48 hours before dosing). Participants will be randomized to receive a single intravenous (IV) infusion of otilimab or placebo, in addition to standard of care. <EligibilityCriteria:>Inclusion criteria for Part 1:
* Participants aged \>=18 years and \<=79 years at the time of obtaining informed consent.
* Participants must:
1. have positive severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) result (any validated test, for example. reverse transcription polymerase chain reaction \[RT-PCR\] \[performed on an appropriate specimen; for example: respiratory tract sample\])
2. and be hospitalized due to diagnosis of pneumonia (chest X-ray or computerized tomography \[CT\] scan consistent with COVID-19)
3. and be developing new onset of oxygenation impairment requiring any of the following:
1. high-flow oxygen (\>=15L/min)
2. non-invasive ventilation (for example. CPAP, BIPAP)
3. mechanical ventilation \<=48 hours prior to dose
4. and have increased biological markers of systemic inflammation (either C-reactive protein \[CRP\] \>upper limit of normal \[ULN\] or serum ferritin \>ULN).
* No gender restriction.
* Female participants must meet and agree to abide by the contraceptive criteria detailed in the protocol. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* A female participant is eligible to participate if she is not pregnant or breastfeeding or if she is using highly effective contraceptive methods. Women of non-childbearing potential can also participate. A negative highly sensitive pregnancy test at hospital admission or before the first dose of study intervention.
* Capable of giving written informed consent.
Inclusion Criteria for Part 2:
* Participants aged 70 years or above at the time of obtaining informed consent.
* Participants must:
1. have positive SARS-CoV-2 result (any validated test, for example. RT-PCR \[performed on an appropriate specimen; for example. respiratory tract sample\])
2. and be hospitalized due to diagnosis of pneumonia (chest X-ray or CT scan consistent with COVID-19).
3. and be developing new onset of oxygenation impairment requiring any of the following:
1. high-flow oxygen (\>=15L/min)
2. non-invasive ventilation (for example. CPAP, BiPAP)
3. mechanical ventilation \<=48 hours prior to dose
4. and have increased biological markers of systemic inflammation (either CRP \>ULN or serum ferritin \>ULN.
* No gender restriction.
* Capable of giving written informed consent.
Exclusion Criteria for Part 1:
* Progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator.
* Multiple organ failure according to the investigator's judgement or a Sequential Organ Failure assessment (SOFA score) \>10 if in the ICU.
* Extracorporeal membrane oxygenation (ECMO) hemofiltration/dialysis or high-dose (\>0.15 micrograms \[mcg\]/kilograms \[kg\]/min) noradrenaline (or equivalent) or more than one vasopressor.
* Current serious or uncontrolled medical condition (for example: significant pulmonary disease \[such as severe chronic obstructive pulmonary disease (COPD) or pulmonary fibrosis\], heart failure \[New York Heart Association {NYHA} class III or higher\], renal dysfunction, acute myocardial infarction or acute cerebrovascular accident within the last 3 months) or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study.
* Untreated systemic bacterial, fungal, viral, or other infection (other than SARS-CoV-2).
* Known active tuberculosis (TB), history of untreated or incompletely treated active or latent TB, suspected or known extrapulmonary TB.
* Known Human Immunodeficiency Virus (HIV) regardless of immunological status.
* Known hepatitis B surface antigen (HBsAg) and/or anti-hepatitis C virus (HCV) positive.
* Currently receiving radiotherapy, chemotherapy or immunotherapy for malignancy.
* Received monoclonal antibody therapy (for examplee. tocilizumab, sarilumab) within the past 3 months prior to randomization, including intravenous immunoglobulin, or planned to be received, during the study.
* Received immunosuppressant therapy including but not limited to cyclosporin, azathioprine, tacrolimus, mycophenolate, Janus Kinase (JAK) inhibitors (for examplee. baricitinib, tofacitinib, upadacitinib) within the last 3 months prior to randomization or planned to be received during the study.
* History of allergic reaction, including anaphylaxis to any previous treatment with an anti-GM-CSF therapy.
* Received COVID-19 convalescent plasma within 48 hours of randomization.
* Currently receiving chronic oral corticosteroids for a non-COVID-19 related condition in a dose higher than prednisone 10 milligrams (mg) or equivalent per day.
* Treatment with an investigational drug within 30 days of randomization.
* Participating in other drug clinical trials, including for COVID-19.
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>5 times ULN.
* Platelets \<50,000/cubic millimeters (mm\^3)
* Hemoglobin \<=9 grams per deciliter (g/dL)
* Absolute neutrophil count (ANC) \<1.5 times 10\^9/L (neutropenia \>= Grade 2)
* Estimated glomerular filtration rate (GFR) \<=30 milliliters (mL)/min/1.73 meter square (/m\^2).
* Pregnant or breastfeeding females.
Exclusion Criteria for Part 2:
* Progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator.
* Multiple organ failure according to the investigator's judgement or a SOFA score \>10 if intubated in the ICU.
* ECMO hemofiltration/dialysis, or more than one inotrope/vasopressor of any class.
* Current serious or uncontrolled medical condition (for example. significant pulmonary disease \[such as severe COPD or pulmonary fibrosis\], heart failure \[NYHA class III or higher\], severe renal dysfunction, acute myocardial infarction or acute cerebrovascular accident within the last 3 months), severe dementia, severe disability, or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study.
* Untreated systemic bacterial, fungal, viral, or other infection (other than SARSCoV-2).
* Known active TB, history of untreated or incompletely treated active or latent TB, suspected or known extrapulmonary TB.
* Known HIV regardless of immunological status.
* Known HBsAg and/or anti-HCV positive (participants demonstrating a sustained virologic response (SVR) are not excluded from participation).
* Currently receiving radiotherapy, chemotherapy (hormone based therapies are permitted) or immunotherapy for malignancy.
* Received monoclonal antibody therapy (for example. tocilizumab, sarilumab) within the past 3 months prior to randomization, including intravenous immunoglobulin, or planned to be received during the study.
* Received immunosuppressant therapy including but not limited to cyclosporin, azathioprine, tacrolimus, mycophenolate, JAK inhibitors (for example. baricitinib, tofacitinib, upadacitinib), nintedanib, disease modifying antirheumatic drugs (DMARDs) (for example. methotrexate) within the last 3 months prior to randomization or planned to be received during the study.
* History of allergic reaction, including anaphylaxis to any previous treatment with an anti-GM-CSF therapy.
* Received COVID-19 convalescent plasma within 48 hours of randomization.
* Currently receiving chronic oral corticosteroids for a non-COVID-19 related condition at a dose higher than prednisone 10 mg or equivalent per day.
* Treatment with an investigational drug or substance within 30 days of randomization unless approved by the Medical Monitor.
* Participating in other drug clinical trials, including for COVID-19.
* AST or ALT \>5 times ULN.
* Platelets \<50,000/mm\^3.
* Hemoglobin \<=9 g/dL
* ANC \<1.0 x 10\^9/L (neutropenia \>= Grade 3).
* Estimated GFR \<=30 mL/min/1.73 m\^2. <Conditions:>Severe Acute Respiratory Syndrome <Interventions:>Otilimab, Placebo 1, Placebo 2, Standard of care | 'Age, Customized', 'Sex: Female, Male', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM) <BriefSummary:>The primary purpose of this study was to test the whether high-risk, HIV-seronegative persons with mild-to-moderate depression would be more likely to adopt protective behavior change when provided with pharmacotherapy for their depression than when treated with placebo. High-risk behaviors include using illegal drugs and participating in unprotected sexual intercourse. The specific pharmacotherapy used in this study was the anti-depressant, bupropion. The subject population consisted of HIV negative men who have sex with men (MSM) with mild-to-moderate depression. <EligibilityCriteria:>Inclusion Criteria:
* Available for at least 9 months, or the duration of the study
* Willing to complete HIV testing and counseling
* History of HIV testing and counseling
* At high risk of HIV infection, indicated by more than one male sexual partner in the 3 months prior to study entry
* Meets criteria for either (a) major depression or dysthymia within a mild-to-moderate level according to standard criteria DSM-IV, or (b) minor depression as defined by one or more of the following symptoms at any time and for any duration during the past 12 months: significant weight loss or gain, or significant decrease or increase in appetite; poor sleep pattern; noticeable irritability or slowness; fatigue or lack of energy; inappropriate feelings of worthlessness or guilt; inability to concentrate; indecisiveness; and recurrent thoughts of death or suicide.
Exclusion Criteria:
* HIV infected
* Sexual intercourse in the 3 months prior to study entry with only one partner, and in a monogamous relationship
* Currently enrolled in another study involving repeated HIV testing and counseling
* Receiving treatment for depression with antidepressant medication for any length of time within the year prior to study entry
* Currently in psychotherapy, psychoanalysis, or any other form of talk therapy for any reason
* Severe depression or at suicidal risk
* No evidence or prior history of depression
* Homicidal or other similar problem that, in the opinion of the investigator, may endanger study staff and participants
* Currently taking monoamine oxidase inhibitors (MAOIs). Participants may be allowed to enroll 14 days after discontinuing use of a MAOI.
* History of seizures
* History or current symptoms of bipolar disorder <Conditions:>HIV Infections, Depression <Interventions:>Bupropion, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Nintendo WII and Exercises at Rehabilitation of Individuals With Parkinson's Disease <BriefSummary:>Patients with Parkinson's disease present motor dysfunctions such as stiffness, tremor, postural instability and bradykinesia, which leads to alterations of balance, necessitating specialized physiotherapeutic treatment. In this way this study aims to determine the effectiveness of two tools used in physiotherapy, kinesiotherapy and the Nintendo Wii. 45 patients will be evaluated through the Berg Balance Scale, Dynamic Gait Index, Timed up and go and PDQ-39, and will then be randomized to receive 16 sessions of Exercises or Nintendo Wii alone or together. After this period the patients will be reassessed to verify the effects of the techniques. <EligibilityCriteria:>Inclusion Criteria:
* Age between 40 and 80 years,
* Stage 1 to 3 on the Hoehn and Yahr scale,
* Absence of visual or auditory impairment,
Exclusion Criteria:
* Presence of cognitive alterations according to MEEM: illiterate 19 points; 1 to 3 years of schooling 23 points; 4 to 7 years 24 points and above 7 years of 28 points
* Presence of other neurodegenerative diseases,
* Uncontrolled osteomioarticular or chronic diseases
* Participation in other rehabilitation programs. <Conditions:>Parkinson Disease <Interventions:>Exercises, Nintendo Wii, Exercises and Nintendo Wii | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Ipilimumab Administered to Stage IIIC Stage IV Melanoma After Reg. T Cell Depletion With Denileukin Diftitox <BriefSummary:>This is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42 patients with radiographically measurable melanoma who have received at least one cycle of Denileukin Diftitox will be enrolled and treated in the study. <EligibilityCriteria:>Inclusion Criteria:
1. Male or female patients ≥18 years of age;
2. Patients with histological confirmed melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer);
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2;
4. Life expectancy ≥3 months;
5. Treatment with Denileukin Diftitox within 42 days prior to first dose of Ipilimumab;
6. At least 1 site of radiographically measurable disease by immune-related response criteria (irRC);
7. Adequate hematologic, renal, and liver function as defined by laboratory values performed within 42 days prior to initiation of dosing:
* Absolute neutrophil count (ANC) ≥1.0 x 109/L;
* Platelet count ≥100 x 109/L;
* Hemoglobin ≥8 g/dL;
* Serum creatinine ≤3 x upper limit of normal (ULN)
* Total serum bilirubin ≤2 x ULN;
* Serum aspartate transaminase (AST/SGOT) or serum alanine transaminase (ALT/SGPT) ≤2x ULN, and ≤3 x ULN if liver metastases are present.
8. Fertile males should use an effective method of contraception during treatment and for at least 3 months after completion of treatment, as directed by their physician;
9. Pre-menopausal females and females \<2 years after the onset of menopause should have a negative pregnancy test at Screening. Pre-menopausal females must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 90 days after the last dose of study drug. Females of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year;
10. Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.
Exclusion Criteria:
1. Prior treatment with Ipilimumab;
2. Known hypersensitivity to Ipilimumab or any of its components;
3. Steroids within one week prior to initiation of Ipilimumab.
4. Pre-existing autoimmune colitis.
5. Patients with an allograft requiring immunosuppression;
6. Known positive human immunodeficiency virus (HIV)
7. Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures;
8. Have any other uncontrolled infection or medical condition that could interfere with the conduct of the study. <Conditions:>Metastatic Melanoma <Interventions:>Ipilimumab | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study of MEDI0382 in Combination With Dapagliflozin and Metformin in Overweight/Obese Participants With Type 2 Diabetes <BriefSummary:>A Phase 2 study Comparing the effects on glucose control of MEDI0382 in combination with Dapagliflozin and Metformin compared to placebo in combination with Dapagliflozin and Metformin in overweight/obese participants with Type 2 Diabetes Mellitus (T2DM). <EligibilityCriteria:>Inclusion Criteria:
1. Male and female participants aged \>= 18 years at screening.
2. Provision of signed and dated informed consent form (ICF) prior to any study specific procedures.
3. Body mass index between 25 kg/m\^2 and 40 kg/m\^2 (inclusive) at screening.
4. Hemoglobin A1c range between 7.0% and 10.0% (inclusive) at the time of screening.
5. Diagnosed with T2DM and treated with of metformin monotherapy (MTD \> 1 g) at least 8 weeks prior to screening or treated with stable, oral doses of dapagliflozin 10 mg and metformin (MTD \> 1 g) for at least 3 months prior screening.
6. Participants prescribed oral dual therapy with sulphonylurea, glitinide, or dipeptidyl peptidase-4 inhibitor (in addition to metformin) may be eligible to enter the study following a washout period of these medications totaling at least 28 days before initial screening evaluations have been completed.
7. Participants treated with stable doses of metformin (MTD \> 1 g) with canagliflozin (maximum dose of 300 mg/day), or metformin (MTD \> 1 g) with empaglifozin (maximum dose of 25mg/day) for at least 3 months prior to screening may be eligible to enter the study after switching to dapagliflozin.
8. Female participants of childbearing potential must have a negative pregnancy test at screening and randomization and must not be lactating.
9. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from screening and must agree to continue using such precautions through to the end of the study. It is strongly recommended for the male partner of a female participant to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
Exclusion Criteria:
1. History of, or any existing condition that in the opinion of the investigator would interfere with evaluation of the investigational product, put the participant at risk, influence the participant's ability to participate, or affect the interpretation of the results of the study and/or any participant unable or unwilling to follow study procedures.
2. Any participant who has received another investigational product not included in the protocol as part of a clinical trial or a glucagon-like peptide-1 (GLP-1) analogue or sodium-glucose cotransporter-2 (SGLT2)-containing preparation (excluding dapagliflozin, canagliflozin, empagliflozin) within the last 30 days or 5 half-lives of the drug (whichever is longest) at the time of screening.
3. Any participant who has received any of the following medications prior to the start of the screening period (Visit 1) or prior to the study start period (Visit 4):
* Concurrent use of any medicinal products, or herbal or over-the-counter (OTC) preparations licensed for control of body weight or appetite at the time of screening (Visit 1)
* Concurrent or previous use of drugs approved for weight loss (eg, orlistat, bupropion-naltrexone, phentermine-topiramate, phentermine, lorcaserin) within the last 30 days or 5 half-lives of the drug (whichever is longest) at the time of screening (Visit 1)
* Concurrent use of aspirin (acetylsalicylic acid) at a dose greater than 150 mg once daily and within the last 72 hours prior to the start of the study (Visit 4)
* Concurrent use of paracetamol (acetaminophen) or paracetamol-containing preparations at a total daily dose of greater than 3000 mg and within the last 72 hours prior to the start of the study (Visit 4)
* Concurrent use of ascorbic acid (vitamin C) supplements at a total daily dose greater than 1000 mg and within the last 72 hours prior to the start of the study (Visit 4)
* Concurrent use of opiates, domperidone, metoclopramide, or other drugs known to alter gastric emptying and within the last 72 hours prior to the start of the study (Visit 4)
4. Concurrent participation in another study of any kind and repeat randomization in this study is prohibited.
5. Severe allergy/hypersensitivity to any of the proposed study treatments or excipients.
6. Diagnosis of type 1 diabetes mellitus, maturity-onset diabetes of the young, or latent autoimmune diabetes of adulthood or presence of anti-glutamic acid decarboxylase, anti-islet cell, or anti-insulin antibodies.
7. Symptoms of acutely decompensate blood glucose control (eg, thirst, polyuria, weight loss) at screening or randomization, a history of diabetes ketoacidosis (DKA), or hyperosmolar nonketotic coma or treatment with daily subcutaneous insulin within 90 days prior to screening.
8. Fasting hyperglycemia (\> 250 mg/dL/ \> 13.9 mmol/L) prior to randomization.
9. C-peptide level \< lower limit of normal (LLN).
10. History of acute or chronic pancreatitis or pancreatectomy.
11. Hypertriglyceridemia (\> 400 mg/dL) at screening.
12. Significant inflammatory bowel disease, gastroparesis, or other severe disease or surgery affecting the upper gastrointestinal (GI) tract (including weight-reducing surgery and procedures) which may affect gastric emptying or could affect the interpretation of safety and tolerability data.
13. Significant hepatic disease (except for nonalcoholic steatohepatitis or nonalcoholic fatty liver disease without portal hypertension or cirrhosis) and/or participants with any of the following results at screening:
* Aspartate transaminase (AST) \>= 3 × upper limit of normal (ULN)
* Alanine transaminase (ALT) \>= 3 × ULN
* Total bilirubin (TBL) \>= 2 × ULN
14. Impaired renal function defined as estimated glomerular filtration rate (eGFR) \<= 60 mL/minute/1.73m\^2 at screening (eGFR according to Modification of Diet in Renal Disease \[MDRD\] using the isotope dilution mass spectrometry-traceable MDRD Study Equation (SI units).
15. Use of loop diuretics within 1 month prior to screening.
16. Poorly controlled hypertension as defined below:
* Systolic blood pressure (BP) \> 160 mm Hg
* Diastolic BP or \>= 100 mm Hg After 10 minutes of supine rest and confirmed by repeated measurement at screening (Visit 1 for all participants).
17. Unstable angina pectoris, myocardial infarction, transient ischemic attack, or stroke within 3 months prior to screening, or participants who have undergone percutaneous coronary intervention or a coronary artery bypass graft within the past 6 months or who are due to undergo these procedures at the time of screening.
18. Severe congestive heart failure (New York Heart Association Class III and IV)
19. Basal calcitonin level \> 50 ng/L at screening or history/family history of medullary thyroid carcinoma or multiple endocrine neoplasia.
20. Hemoglobinopathy, hemolytic anemia, or chronic anemia (hemoglobin concentration \< 11.5 g/dL \[115 g/L\] for males and \< 10.5 g/dL \[105 g/L\] for females) at screening or any other condition known to interfere with interpretation of HbA1c measurement.
21. History of neoplastic disease within 5 years prior to screening, except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer.
22. Any positive results for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus antibody.
23. Recent viral infection or illness requiring the use of antibiotics in the month prior to screening (Visit 1) for participants on dual therapy or prior to run-in period (Visit 2) for participants on monotherapy.
24. History of recurrent (at least 2) urinary tract and/or genital tract infections (including mycotic infections such as thrush) within 6 months prior to screening.
25. Substance dependence likely to impact participant safety or compliance with study procedures.
26. Involvement of any AstraZeneca, MedImmune, contract research organization, or study site employees and their close relatives. <Conditions:>Type 2 Diabetes Mellitus <Interventions:>MEDI0382, Placebo, Dapaglifozin, Metformin | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>An Observational Study to Evaluate Efficacy and Safety of Risperidone Long-Acting Injection for Treatment of Schizophrenia <BriefSummary:>The purpose of this study is to evaluate the long-term treatment efficacy, and safety of risperidone long-acting injection in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). <EligibilityCriteria:>Inclusion Criteria:
* Male or female, age 18-65 years
* Participant must meet the diagnostic criteria for schizophrenia or schizophreniform disorder according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)-TM
* Total course of disease no more than 5 years
* According to physician's discretion, participants need to be changed to risperidone long-acting injection and other atypical anti-psychotic drug
* Participant or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion Criteria:
* Significant risk of suicidal or violent behavior, as clinically assessed by the Investigator
* Have aggressive behavior and excited , restless
* History or current symptoms of tardive dyskinesia; neuroleptic malignant syndrome; evidence of dysfunction of liver and kidney and other severe physical diseases; and severe, life-threatening allergic reaction to any drug
* Known hypersensitivity to risperidone
* Female participant who is pregnant or breastfeeding or planning to become pregnant during the study period <Conditions:>Schizophrenia <Interventions:>Risperidone, Oral atypical anti-psychotic | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population <BriefSummary:>Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions in Japanese population by comparing to approved metallic drug eluting stent. <EligibilityCriteria:>Inclusion Criteria:
1. Subject must be at least 20 years of age.
2. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
3. Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia) suitable for elective percutaneous coronary intervention (PCI).
4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
5. Subject must be able to take dual antiplatelet therapy for up to 1 year following the index procedure and anticoagulants prior/during the index procedure. Therefore the subject has no known allergic reaction, hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine or heparin.
6. Female subject of childbearing potential must not be pregnant\* at the index procedure and does not plan pregnancy for up to 1 year following the index procedure.
\* Except for non-pregnancy is apparent, negative pregnancy result within 7 days prior to the index procedure is required.
7. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
8. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 13 months following the index procedure
Exclusion Criteria:
1. Elective surgery is planned within 1 year after the procedure that will require general anesthesia or discontinuing either aspirin or Thienopyridine.
2. Subject has known hypersensitivity or contraindication to device material and its degredants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
3. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
4. Subject had an acute myocardial infarction (AMI) within 72 hours of the index procedure
* The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes
* Creatine Kinase (CK) and Creatine Kinase - Muscle and Brain (CK-MB) have not returned to within normal limits at the time of index procedure.
5. Subject has an unstable cardiac arrhythmia which is likely to become hemodynamically unstable due to arrhythmia.
6. Subject has a known left ventricular ejection fraction (LVEF) \< 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and the investigator believes it is necessary).
7. The target vessel was treated by PCI within 12 months.
8. Prior PCI within the non-target vessel is acceptable if performed anytime \> 30 days before the index procedure or between 24 hours and 30 days before the index procedure if successful and uncomplicated.
9. Subject requires future staged PCI either in target or non target vessels.
10. Subject has a malignancy that is not in remission.
11. Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.,). Note: corticosteroids are not included as immunosuppressant therapy, diabetes mellitus is not regarded as autoimmune disease.
12. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
13. Subject has previously received or scheduled to receive radiotherapy to coronary artery (brachytherapy), or chest/mediastinum.
14. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin or any other agent for any reason).
15. Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3.
16. Subject has a documented or suspected cirrhosis of Child-Pugh ≥ Class B.
17. Subject has known renal insufficiency;
* Dialysis at the time of screening.
* An estimated Glomerular filtration rate (GFR) \< 30 ml/min/1.73m2
18. Subject is high risk of bleeding, or difficult to have appropriate treatment;
* Has a history of bleeding diathesis or coagulopathy
* Has had a significant gastro-intestinal or significant urinary bleed within the past six months
* Has prior intracranial bleed
* Has prior intracranial bleed (including severe permanent neurologic deficit that seem to be caused by previous intracranial bleeding)
* Has known intracranial pathology that may cause intracranial bleeding per an investigator assessment (e.g. untreated aneurysm \> 5 mm, arteriovenous malformation)
* Subject will refuse blood transfusions
19. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months,
20. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
21. Subject has life expectancy \< 3 year.
22. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
23. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
24. Subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g. subordinate hospital staff or sponsor staff) or subject is unable to read or write. <Conditions:>Coronary Artery Disease, Myocardial Ischemia <Interventions:>XIENCE PRIME®/XIENCE Xpedition™, Absorb™ BVS | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) In The Treatment Of Peri- And Postmenopausal Women With Major Depressive Disorder (DVS 3364) <BriefSummary:>A multicenter, 10-week study to evaluate the efficacy and safety of 50 mg of desvenlafaxine succinate sustained-release formulation (DVS SR) versus placebo in the treatment of peri- and postmenopausal women with major depressive disorder <EligibilityCriteria:>Inclusion Criteria:
* Peri- and postmenopausal women aged 40 to 70 years who are fluent in both written and spoken English.
* Postmenopausal status defined by 12 consecutive months of spontaneous amenorrhea; less than 12 consecutive months with at least 6 consecutive months of spontaneous amenorrhea and a pre-baseline follicle-stimulating hormone (FSH) level \>40 mIU/mL; or 6 months postsurgical bilateral oophorectomy (with or without hysterectomy). Perimenopausal women defined by the presence of any of the following within 6 months before baseline:
1. an absolute change of 7 days or more in menstrual cycle length within 6 months before baseline;
2. a change in menstrual flow amount (2 or more flow categories, eg, from light or moderately light to moderately heavy or heavy);
3. a change in duration (absolute change of 2 or more days); or
4. periods of amenorrhea lasting at least 3 months.
* A primary diagnosis of major depressive disorder (MDD) based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR), single or recurrent episode, without psychotic features using the modified Mini International Neuropsychiatric Interview (MINI).
* A Montgomery and Asberg Depression Rating Scale (MADRS) total score \>=25 at the screening and baseline (day -1) visits and no more than a 5-point improvement from screening to baseline.
Exclusion Criteria:
* Treatment with DVS SR (Pristiq®) at any time in the past and/or venlafaxine, ie, Effexor® or Effexor XR®, 1 year prior to baseline.
* Treatment-resistant; eg, in the past 3 years if any of the following treatments have failed: (a) 3 or more previous adequate trials of \>=2 classes of antidepressant medication, (b) electroconvulsive therapy, or (c) 2 adequate trials of psychotherapy (eg, behavior therapy, behavior-marital therapy).
* History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.
* Known presence of raised intraocular pressure or history of narrow-angle glaucoma. <Conditions:>Major Depressive Disorder <Interventions:>desvenlafaxine succinate sustained-release, placebo | 'Age Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Phase 1 Safety Study of Dimethyl Sulfoxide Cryopreserved Platelets <BriefSummary:>This study is to evaluate the safety of intravenous (IV) infusion of dimethyl sulfoxide (DMSO) cryopreserved platelets (CPP) in participants with World Health Organization (WHO) Grade 2 bleed in spite of receiving a transfusion of liquid stored platelets (LSP) in the past 48 hours by collecting adverse events (AEs) and by evaluating coagulation-related parameters to assess the evidence of any thrombotic events after CPP or LSP transfusion. <EligibilityCriteria:>Inclusion Criteria:
* Male or female, at least 18 years of age.
* Ability to comprehend the study procedures and signed informed consent.
* If pre-menopausal female, must have a negative serum pregnancy test, and, if of child bearing potential, must be using an acceptable method of contraception.
* Diagnosed with any the following: acute leukemia (ALL or AML), chronic leukemia (CML, CLL, CMML, or hairy cell leukemia), myelodysplasia, aplasia, hematopoietic or non-hematopoietic solid tumor, or therapy (chemotherapy or radiation) induced bone marrow aplasia or hypoplasia. Either autologous or allogeneic bone marrow transplant or peripheral or cord blood stem cell recipients may be enrolled.
* WHO grade 2 or greater bleeding.
Exclusion Criteria:
* Acute or chronic DIC as evidence by D-dimer greater than 8 μg/mL and fibrinogen less than 100 mg (0.1 g)/dL. Both criteria must be met. If data are in the medical record for fibrin degradation products (FDPs), then FDP must be \<=40 μg/mL (FDP \>40 μg/mL is indicative of DIC).
* PT or aPTT \> 1.3 times the upper limit of normal for the laboratory.
* History of major operative procedures that required general anesthesia in the past 2 weeks.
* History of any prior major unprovoked thrombotic events and/or known inherited disorder of coagulation or platelet function (by history) (not to include clots in catheters, etc).
* A history or diagnosis of immune thrombocytopenia, thrombotic thrombocytopenic purpura, or hemolytic uremic syndrome.
* Females who are breastfeeding.
* Veno-occlusive disease or possible veno-occlusive disease.
* Receiving active, inpatient treatment with anti-platelet drugs and/or full anticoagulation therapy. Note: a heparin flush may be given daily and before and after blood draws to patients with a central line to keep the line patent.
* Subject previously enrolled in this study and received a study transfusion. <Conditions:>Thrombocytopenia <Interventions:>CPP, LSP | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Baseline Weight (kg)', 'Baseline Height (cm)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury <BriefSummary:>The purposes of this study are to make Omegaven® available to cancer patients with liver disease and to determine if Omegaven® can improve or prevent further liver disease. The study will also look at the effects Omegaven® has on immune function. <EligibilityCriteria:>Inclusion Criteria:
1. Male or Female; ages 18 to 80 years old
2. Receiving treatment at Cancer Treatment Centers of America
3. Receiving PN (either in the infusion center or at home)
4. Have existing hepatic dysfunction defined as Elevation of \> 3x the normal level of one or more of the following:Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), or Alanine Aminotransferase ALT) and/or Bilirubin \> 2 mg/dl in the absence of biliary obstruction
5. Able to provide informed written consent
Exclusion Criteria:
1. Hypertriglyceridemia (triglycerides \[TG\] \> 400)
2. Allergy to fish or egg protein
3. Currently on therapeutic doses of Coumadin, heparin, or low molecular eight heparin
4. Hemodynamically unstable
5. Bilirubin \> 5 mg/dL
6. Documented liver metastases
7. Unstable diabetes with known diabetic ketoacidosis within 7 days of screening
8. Recent cardiac infarction (within 6 months) and taking plavix
9. Severe hemorrhagic disorders
10. Current anticoagulation therapy for deep venous thromboembolism or pulmonary embolism
11. Active sepsis
12. Undefined coma status
13. In patients with abnormal kidney function, renal insufficiency with calculated creatinine clearance \< 30 mL/min
14. Pregnancy or lactation <Conditions:>Cancer, Hepatic Injury <Interventions:>Omegaven | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast Magnetic Resonance Imaging (MRI) <BriefSummary:>The purpose of this study is to look at the efficacy (how does it work) and safety of gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of breast cancer by mammogram (X-ray examination of the breasts) may benefit from MRI of the breasts as MRI may detect additional breast cancers <EligibilityCriteria:>Inclusion Criteria:
* Recent histologically proven diagnosis of breast cancer after having obtained X-Ray Mammography (XRM) of both breasts (according to American College of Radiology \[ACR\] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to surgery of the breast.
* if female, a digital XRM is required if any of the following criteria is met:
* a. patient is younger than 50 years;
* b. patient has heterogeneously or extremely dense breasts;
* c. is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).
* if female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle.
* has an estimated glomerular filtration rate (eGFR) value \>/= 60 mL/min/1.73m\^2 derived from a serum creatinine result within 2 weeks prior to study enrollment.
Exclusion Criteria:
* is a female patient who is pregnant or lactating
* has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.
* has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.
* has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction \[\< 14 days\], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (\< 48 hours)).
* has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate \< 60 mL/min/1.73m\^2).
* has received chemotherapy or hormonal therapy for breast cancer within 6 months.
* has received hormone replacement therapy within 4 weeks prior to study drug administration.
* is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application
* has prior excisional biopsy or breast surgery less than 6 months before enrollment and between XRM and study MRM <Conditions:>Breast Cancer <Interventions:>Gadobutrol (Gadavist, Gadovist, BAY86-4875) | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Country' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease <BriefSummary:>The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks. <EligibilityCriteria:>Inclusion Criteria:
1. Male and/or female subjects 18 years to 75 years of age
2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.
3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.
4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.
5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:
•Steroids; Immunosuppressants (azathioprine \[AZA\], 6 MP, or methotrexate \[MTX\]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).
6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below:
* Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.
* Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.
* Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.
Exclusion Criteria:
1. Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.
2. Presence of active (draining) fistulae or intra abdominal or perineal abscesses.
3. Strictures with obstructive symptoms.
4. Short bowel syndrome.
5. History of bowel perforation requiring surgical intervention within the past 12 months.
6. Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.
7. History of bowel surgery within 6 months prior to baseline.
8. Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
9. Subjects with primary sclerosing cholangitis.
10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.
11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.
12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.
13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period:
1. \>9 mg/day of oral budesonide or \>25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.
2. IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.
3. Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.
4. Anti TNF inhibitors (or biosimilars thereof) as described below:
* Infliximab within 8 weeks prior to baseline;
* Adalimumab within 8 weeks prior to baseline;
* Certolizumab within 8 weeks prior to baseline;
5. Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.
6. Ustekinumab within 8 weeks prior to baseline.
7. Interferon therapy within 8 weeks prior to baseline.
8. Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath\[alemtuzumab\], alkylating agents \[eg, cyclophosphamide or chlorambucil\], total lymphoid irradiation, etc).
9. Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.
10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.
11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.
12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.
13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.
14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.
14) Subjects with history of thrombotic event(s), including deep venous thrombosis (DVT), and known inherited conditions that predispose to hypercoagulability. <Conditions:>Crohn's Disease <Interventions:>PF-06651600 Placebo, PF-06651600, Placebo PF-06700841, PF-06700841 | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>AC105 in Patients With Acute Traumatic Spinal Cord Injury <BriefSummary:>The principal aim of this study was to establish the feasibility of rapid administration, safety, and tolerability of AC105 in patients with acute spinal cord injury. <EligibilityCriteria:>Inclusion Criteria:
* Male or female between 18 and 65 years of age, inclusive
* Acute traumatic SCI, at a neurological level between C4 and T11
* No evidence of penetrating or transection injury (e.g. caused by projectile or stab wound)
* Neurological ASIA Impairment Scale A, B or C
* Patient is able to provide written or verbal witnessed consent. If unable to provide either, consent may be provided by legally authorized representative (LAR)
* Patient is able to initiate treatment within time window of injury
Exclusion Criteria:
* Known allergy or hypersensitivity to polyethylene glycol
* Mental impairment or other conditions that would preclude a reliable ASIA exam or adequate consent
* Positive urine pregnancy test result
* Serum creatinine level ≥ 2 mg/dL
* History or active renal failure or dialysis
* Mean arterial blood pressure \< 60 mmHg despite vasopressor treatment
* On a current regimen of digoxin
* Chronic use of magnesium salts prior to the SCI (within 1week of presentation) and/or the use of magnesium salts in the acute care setting prior to the administration of investigational product
* Any other medical condition that, in the judgment of the investigator, would preclude provision of informed consent, make participation in the study unsafe, or unreasonably complicate follow-up or the interpretation of study outcome data or may otherwise interfere with achieving the study objectives
* In the judgment of the Investigator, cannot adequately provide informed consent, is likely to be non-compliant, or may be unable to cooperate with study requirements <Conditions:>Acute Spinal Cord Injury <Interventions:>AC105, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO <BriefSummary:>A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA, triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT) injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein occlusion (RVO). <EligibilityCriteria:>Inclusion Criteria:
* diagnosis of macular edema following RVO
* History of ME ≤ 12 months
* 20-70 letters inclusive BCVA using ETDRS
Exclusion Criteria:
* has had an IVT injection of anti-VEGF for RVO in the study eye
* has had a corticosteroid injection in the past 3 months in the study eye
* any uncontrolled ophthalmic condition in the study eye other than RVO <Conditions:>Macular Edema, Retinal Vein Occlusion <Interventions:>4 mg CLS-TA, Sham, IVT aflibercept | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens <BriefSummary:>The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 7 days of daily wear. <EligibilityCriteria:>Inclusion Criteria:
* Understand and sign an Informed Consent that has been approved by an Institutional Review Board.
* Successful wear of spherical daily wear frequent replacement soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
* Willing to stop wearing habitual contact lenses for the duration of study participation.
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Any condition that contraindicates contact lens wear, as determined by the Investigator.
* Any use of systemic or ocular medications that contraindicates contact lens wear, as determined by the Investigator.
* History of refractive surgery or plan to have refractive surgery during the study.
* Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
* Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
* Other protocol-defined exclusion criteria may apply. <Conditions:>Refractive Errors <Interventions:>LID021201 contact lenses, OPTI-FREE multipurpose solution | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease <BriefSummary:>The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease. <EligibilityCriteria:>Inclusion Criteria:
* Subjects 18 years of age or older
Exclusion Criteria:
* No active ocular conditions of disease <Conditions:>Dry Eye Disease <Interventions:>bromfenac ophthalmic solution 0.06% | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Bispectral Index and Levels of Sedation With Propofol With/Without Remifentanil in Healthy Volunteers (SONORA) <BriefSummary:>The purpose of this study is investigate the relationship between BIS™ and propofol with/without remifentanil across a wide range of hypnotic states. <EligibilityCriteria:>Inclusion Criteria:
1. Healthy (ASA physical status 1), male or female subjects between the ages of 18 to 60 years;
2. Completion of a health screening for a medical history by a licensed physician, nurse practitioner or physician assistant;
3. Vital signs must be within the following ranges to be included: Vital signs measured sitting after 3 minutes rest; heart rate: 45-90 bpm; systolic blood pressure: 110-140; diastolic blood pressure: 50-90. Out-of-range vital signs may be repeated once. \[Pre-dose vital signs will be assessed by the Principal Investigator or designee (e.g., a medically qualified sub-investigator) before study drug administration. The Principal Investigator or designee will verify the eligibility of each subject before dosing\];
Exclusion Criteria:
1. Has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes, or other medical sensors \[self-reported\];
2. Known neurological disorder (e.g., epilepsy, the presence of a brain tumor, a history of brain surgery, hydrocephalic disorders, depression needing treatment with anti-depressive drugs, a history of brain trauma) \[self-reported and assessment by PI or delegate\];
3. Known cardiovascular disease (e.g., hypertension, coronary artery disease, prior acute myocardial infarction, any valvular and/or myocardial disease involving a decrease in ejection fraction, arrhythmias, which are either symptomatic or require continuous medication/ pacemaker/ automatic internal cardioverter defibrillator), current implanted pacemaker or automatic internal cardioverter defibrillator \[self-reported and assessment by PI or delegate\];
4. Has a clinically significant abnormal finding on medical history, physical examination, clinical laboratory tests, or ECG at the screening \[self-reported and assessment by PI or delegate\];
5. Recent use of psychoactive medication (e.g., benzodiazepines, antiepileptic drugs, ADHD medication, Parkinson's medication, anti-depressant drugs, opioids) \[self-reported and assessment by PI or delegate\];
6. Subjects with known gastric diseases \[self-reported and assessment by PI or delegate\];
7. Has a positive urine cotinine test or urine drug screen or oral ethanol test \[POC testing\];
8. Known history of allergic or adverse response to drugs to be administered \[self-reported\];
9. Known history of complications relating to previous general anesthesia or conscious sedation \[self-reported and assessment by PI or delegate\];
10. Known history of malignant hyperthermia \[self-reported and assessment by PI or delegate\];
11. Has a room air saturation less than 95% by pulse oximetry \[measurement by PI or delegate\];
12. Has a clinically significant abnormal ECG \[assessment by PI or delegate\];
13. Has a clinically significant abnormal pulmonary function test via spirometry \[assessment by PI or delegate\];
14. Pregnant or lactating women \[assessed by urine test and self-reported\];
15. Subjects with tattooed skin specific to the sensor placement areas (forehead, fingers, chest) \[self-reported and assessment by PI or delegate\];
16. The subject must not take any prescription medication, except female hormonal contraceptives or hormone replacement therapy, from 146 days before the dosing until the end-of-study visit without evaluation and approval by the Investigator. Subjects who participated in a previous clinical trial who received a required FDA approved concomitant medication, for example, naltrexone, but were not randomized may be considered for participation in this study if they meet the washout requirement \[assessment by PI or delegate\]; <Conditions:>Anesthesia <Interventions:>BIS | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Skin Pigmentation' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Testing AZD1775 inC Combination With Radiotherapy and Chemotherapy in Cervical, Upper Vaginal and Uterine Cancers <BriefSummary:>This phase I trial studies the side effects and best dose of adavosertib when given together with external beam radiation therapy and cisplatin in treating patients with cervical, vaginal, or uterine cancer. Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. External beam radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving adavosertib, external beam radiation therapy, and cisplatin may work better in treating patients with cervical, vaginal, or uterine cancer. <EligibilityCriteria:>Inclusion Criteria:
* Patients must have one of the following biopsy proven gynecological cancer and a decision to treat with radiotherapy and concurrent cisplatin chemotherapy (RT-CT)
* Newly diagnosed epithelial carcinoma of the cervix, cT1B-3B, N0/1, M0/1
* Patient may have small volume metastatic disease in para-aortic or supraclavicular lymph nodes or at other metastatic sites as long as, in the best judgment of the treatment team, a radical course of pelvic radiotherapy is warranted to assure local disease control
* Newly diagnosed epithelial carcinoma of the upper 1/3 vagina, T1-3, N0/1, M0/1
* Patient may have small volume metastatic disease in para-aortic or supraclavicular lymph nodes or at other metastatic sites as long as, in the best judgment of the treatment team, a radical course of pelvic radiotherapy is warranted to assure local disease control
* Newly diagnosed endometrioid adenocarcinoma of the uterus, cT1-3, N0/1, M0 unsuitable for primary surgery because of the extent of local disease; these patients are eligible if a prior decision has been made to treat radically with neoadjuvant chemoradiation followed by surgery or further radiotherapy (including brachytherapy) depending on response
* Central pelvis or sidewall recurrence of epithelial carcinoma of the cervix of endometrioid adenocarcinoma of the uterus after previous surgery without previous pelvic radiotherapy
* Patients must be planned to receive whole pelvic radiotherapy to a total dose of 45 Gy or greater
* Patients must be able to receive weekly cisplatin
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Karnofsky \>= 60%)
* Life expectancy of greater than 3 months
* Leukocytes \>= 3,000/mcL
* Absolute neutrophil count \>= 1,500/mcL
* Platelets \>= 100,000/mcL
* Hemoglobin \>= 9 g/dL
* Blood transfusions are allowed at any time during the screening, treatment or follow-up period, according to the center recommendations
* Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =\< 1.5 upper limit of normal (ULN)
* Total bilirubin: serum bilirubin within normal limits (WNL) or =\< 1.5 x ULN in patients with liver metastases; or total bilirubin =\< 3.0 x ULN with direct bilirubin WNL in patients with documented Gilbert's syndrome
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]): Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x upper limit of normal (ULN) or =\< 5 x ULN if known hepatic metastases
* Creatinine clearance (CrCl) \>= 60 mL/min as calculated by the Cockcroft-Gault method
* Patients must be able to swallow whole capsules
* The effects of AZD1775 on the developing human fetus are unknown; the preclinical chromosomal aberrations assays have shown potential to induce chromosomal aberrations; in addition, cisplatin and radiotherapy are known to be teratogenic; for this reason, women of child-bearing potential must agree to use two birth control methods (two barrier methods or a barrier method plus a hormonal method) or abstinence prior to study entry, for the duration of study participation prior to study entry, for the duration of study participation, and for 4 months after coming off study; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately
* Females with child-bearing potential must have had a negative serum pregnancy test result =\< 28 days prior to the first dose of study treatment
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients who have received any radiotherapy or chemotherapy for their current gynecological cancer
* Patients who received prior pelvic radiotherapy for any indication
* Patients who have a mean resting correct corrected QT (QTc) interval using the Fridericia formula (QTcF) \> 470 msec (as calculated per institutional standards) obtained from 3 electrocardiograms (ECGs) 2-5 minutes apart at study entry, or congenital long QT syndrome; AZD1775 should not be given to patients who have a history of Torsades de pointes unless all risk factors contributed to Torsades have been corrected; AZD1775 has not been studied in patients with ventricular arrhythmias or recent myocardial infarction
* Patients requiring para-aortic radiotherapy
* Patients who are receiving any other investigational agents or anticancer therapy concurrently or within 4 weeks (i.e. 28 days)
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD1775 or cisplatin
* Uncontrolled intercurrent illness including, but not limited to, myocardial infarction within 6 months, congestive heart failure, symptomatic congestive heart failure, unstable angina pectoris, active cardiomyopathy, unstable ventricular arrhythmia, uncontrolled hypertension, uncontrolled psychotic disorders, serious infections, active peptic ulcer disease, active liver disease or cerebrovascular disease with previous stroke, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant women are excluded from this study because AZD1775 and chemoradiation are agents with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD1775 and cisplatin, breastfeeding must be discontinued if the mother is treated with AZD1775 and cisplatin; these potential risks may also apply to other agents used in this study
* Patients with another uncontrolled malignancy; patients with a previous malignancy, treated curatively and without evidence of disease relapse are eligible
* Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD1775; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
* History of active clinically significant bleeding
* History of bowel obstruction or malabsorption syndromes (within the last 3 months) which might limit the absorption of the study drug <Conditions:>Cervical Carcinoma, Endometrioid Adenocarcinoma, Malignant Female Reproductive System Neoplasm, Recurrent Cervical Carcinoma, Stage I Uterine Corpus Cancer AJCC v7, Stage I Vaginal Cancer AJCC v6 and v7, Stage IA Uterine Corpus Cancer AJCC v7, Stage IB Cervical Cancer AJCC v6 and v7, Stage IB Uterine Corpus Cancer AJCC v7, Stage IB2 Cervical Cancer AJCC v6 and v7, Stage II Cervical Cancer AJCC v7, Stage II Uterine Corpus Cancer AJCC v7, Stage II Vaginal Cancer AJCC v6 and v7, Stage IIA Cervical Cancer AJCC v7, Stage IIB Cervical Cancer AJCC v6 and v7, Stage III Cervical Cancer AJCC v6 and v7, Stage III Uterine Corpus Cancer AJCC v7, Stage III Vaginal Cancer AJCC v6 and v7, Stage IIIA Cervical Cancer AJCC v6 and v7, Stage IIIA Uterine Corpus Cancer AJCC v7, Stage IIIB Cervical Cancer AJCC v6 and v7, Stage IIIB Uterine Corpus Cancer AJCC v7, Stage IIIC Uterine Corpus Cancer AJCC v7, Vaginal Carcinoma <Interventions:>Adavosertib, Cisplatin, External Beam Radiation Therapy | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'ECOG Performance Status', 'Primary Site', 'Prior Therapy', 'FIGO Stage', 'Grade', 'Histology' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis <BriefSummary:>This is a study to compare the efficacy of bimekizumab versus secukinumab in subjects with moderate to severe chronic plaque psoriasis (PSO). <EligibilityCriteria:>Inclusion Criteria:
Double-blind Treatment Period
* Male or female at least 18 years of age
* Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening visit
* Subject must have Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Investigator's Global Assessment (IGA) score \>=3 on a 5 point scale
* Subject must be a candidate for systemic PSO therapy and/or phototherapy
* Subject must be considered, in the opinion of the Investigator, to be a suitable candidate for treatment with secukinumab per regional labeling and has no contraindications to receive secukinumab as per the local label
* Female subject of childbearing potential must be willing to use highly effective method of contraception
Open-label extension (OLE) Period
* Completed the double-blind Treatment Period without meeting any withdrawal criteria
* All Week 48 visit assessments completed
* Compliant with ongoing clinical study requirements
* Signed a separate OLE Period Informed Consent Form (ICF)
* Female subject of childbearing potential must be willing to use highly effective method of contraception
OLE2 Period (USA and Canada)
* Completed the OLE Period without meeting any withdrawal criteria
* Compliant with ongoing clinical study requirements
* Female subject of childbearing potential must be willing to use highly effective method of contraception
* Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long as they have no active symptomatic disease (US only)
* Signed a separate OLE2 Period ICF
Exclusion Criteria:
Double-blind Treatment Period
* Subject has an active infection (except common cold), a serious infection, or a history of opportunistic, recurrent or chronic infections
* Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
* Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
* Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
* Presence of active suicidal ideation or severe depression
* Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
OLE2 Period (USA and Canada)
* Subject has developed any medical or psychiatric condition, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in OLE2 Period
* Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the OLE study to Week 144, unless appropriately evaluated and treated
* Presence of active suicidal ideation or severe depression
* Subject has developed any active malignancy or history of malignancy prior to the OLE2 Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer <Conditions:>Chronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis <Interventions:>Bimekizumab, Secukinumab, Placebo | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Anti-TGF-beta Therapy in Patients With Myelofibrosis <BriefSummary:>TGF-β is a cytokine that is found to be upregulated in the bone marrow of patients with myelofibrosis. This cytokine likely plays a dual role in promoting myelofibrosis and myeloproliferation, both of which are the bone marrow morphologic hallmark of MF. The investigators propose that inhibiting the TGF-β signaling pathway in MF will decrease the fibrogenic stimuli leading to myelofibrosis and concomitantly interrupt myeloproliferation. This is a novel approach to the treatment of patients with myelofibrosis. <EligibilityCriteria:>Inclusion Criteria:
* Age \>18
* ECOG 0-2
* Intermediate-1 or higher by IWG-MRT Post PV/ET MF patients OR intermediate-1 or higher JAK2V617F negative PMF
* Bone marrow MF-2 or higher as assessed by the European consensus grading score AND grade 3 or higher by modified Bauermeister scale.
* Patients must be able to give written informed consent to participate. Patients may not be consented by a durable power of attorney.
* Male and female patients of child-producing potential must agree to use effective contraception while enrolled on study and receiving the investigational agent, and for at least 3 months after the last treatment.
* At the time of enrollment, patients must be \>4 weeks since major surgery, radiotherapy, chemotherapy (except hydroxyurea) immunotherapy, or biotherapy/targeted therapies and recovered from the toxicity of prior treatment to \< Grade 1, exclusive of alopecia. Concurrent cancer therapy is not permitted for the exception of hydroxyurea if already being used at a stable dose for 3 weeks prior to screening.
* Patients must have negative tests for human immunodeficiency virus (HIV) and for hepatitis viruses B and C (antibody and/or antigen) unless the result is consistent with prior vaccination or prior infection with full recovery.
* Marrow: Absolute neutrophil count ≥ 500/mm3, and platelet count ≥50,000/mm3 without the need for platelet transfusion within 4 weeks
* Hepatic: Serum total bilirubin \>1.5 X upper limit of normal (ULN) (Patients with Gilbert's Disease may be included if their total bilirubin is \>3.0 mg/dL); alanine aminotransferase (ALT), and aspartate aminotransferase (AST) \>2.5 X ULN.
* Renal: Serum creatinine of \< 1.5 x upper limit of normal (ULN) or, if higher, estimated or measured creatinine clearance \>45 mL/min.
* Coagulation:
1. Prothrombin Time (PT) \< 1.5 X ULN
2. Partial thromboplastin time (aPTT) \< 1.5 X ULN
Exclusion Criteria:
* Central nervous system (CNS) cancer or metastases, meningeal carcinomatosis, malignant seizures, or a disease that either causes or threatens neurologic compromise (e.g., unstable vertebral metastases).
* Pregnant or nursing women, due to the unknown effects of GC1008 on the developing fetus or newborn infant.
* Patients with known bleeding diathesis or signs of uncontrolled active bleeding (hematuria, GI bleeding) other than self-limited causes of benign etiology that have been adequately investigated at the discretion of the investigator.
* Patients requiring anticoagulation with aspirin \> 81mg daily, unfractionated heparin, low molecular weight heparin (LMWH), direct anti-thrombin inhibitors, or vitamin K antagonists (e.g. warfarin). This does not apply to patients actively receiving aspirin at a dose of ≤ 81mg a day.
* Patients diagnosed with another malignancy - unless following curative intent therapy, the patient has been disease free for at least 5 years and the probability of recurrence of the prior malignancy is \>5%. Patients with curatively treated early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia (CIN) are eligible for this study.
* Patients with an organ transplant, including those that have received an allogeneic bone marrow transplant.
* Use of investigational agents within 4 weeks prior to study enrollment (within 6 weeks if the treatment was with a long-acting agent such as a monoclonal antibody).
* Significant or uncontrolled medical illness, such as congestive heart failure (CHF), myocardial infarction, symptomatic coronary artery disease, significant ventricular arrhythmias within the last 6 months, or significant pulmonary dysfunction. Patients with a remote history of asthma or active mild asthma may participate.
* Active autoimmune disorders or concurrent immunosuppressive medications such as prednisone, interferon, cyclosporine, methotrexate or azathioprine.
* Active infection requiring antibiotics.
* A known allergy to any component of GC1008.
* Patients who, in the opinion of the Investigator, have significant medical or psychosocial problems that warrant exclusion. Examples of significant problems include, but are not limited to:
1. Other serious non-malignancy-associated medical conditions that may be expected to limit life expectancy or significantly increase the risk of SAEs.
2. Any condition, psychiatric, substance abuse, or otherwise, that, in the opinion of the Investigator, would preclude informed consent, consistent follow-up, or compliance with any aspect of the study <Conditions:>Myelofibrosis, Primary Myelofibrosis, Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase, Post-essential Thrombocythemia Related Myelofibrosis <Interventions:>monoclonal antibody to TGF-beta | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study for Participants With Small-Cell Lung Cancer <BriefSummary:>Part A: This study evaluates an experimental treatment in participants with extensive-disease in small-cell lung cancer.
Part B: This study evaluates an experimental treatment in participants with extensive-disease in small-cell lung cancer. <EligibilityCriteria:>Inclusion Criteria:
* Have histological or cytological evidence of extensive-disease small-cell lung cancer
* Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
* Have received at least 1 prior chemotherapy regimen with agents known to provide clinical benefit for small-cell lung cancer and be, in the opinion of the investigator, an appropriate candidate for experimental therapy
* Have discontinued all previous therapies for cancer, including chemotherapy, biologic therapy, hormone therapy, or radiotherapy. Participants must have recovered from the acute effects of therapy (except alopecia and fatigue) before study enrollment
* Part A: Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group scale
* Part B: Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale
Exclusion Criteria:
* Have received treatment within 28 days of the first dose of LY2523355 with a drug that has not received regulatory approval for any indication
* Have a mixed histological diagnosis of small-cell lung cancer and non-small-cell lung cancer
* Have serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study
* Part A: Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases. Participants with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and corticosteroid use has been discontinued for at least 2 weeks prior to the first dose of study drug. Screening of asymptomatic participants without history of CNS metastases is not required
* Part B: Have symptomatic, untreated, or uncontrolled CNS metastases or a history of CNS metastases. Participants who have received prophylactic radiation are not excluded. Screening of asymptomatic participants without history of CNS metastases is not required <Conditions:>Small Cell Lung Cancer <Interventions:>LY2523355, Granulocyte colony-stimulating factor (G-CSF) | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Randomized, Double-Blinded, Placebo-Controlled Trial of Corticosteroid Therapy Following Portoenterostomy <BriefSummary:>The Children Liver Disease Research and Education Network (ChiLDREN) is conducting a clinical trial to evaluate whether long-term treatment with corticosteroids improves the outcome of the Kasai or gall-bladder Kasai in infants with biliary atresia. In this clinical trial, ChiLDREN is testing whether corticosteroid therapy following the Kasai will improve bile drainage and long term outcome in infants with biliary atresia. Subjects in this trial must start treatment within 72 hours of the Kasai procedure and be part of a prospective study of the natural history of biliary atresia also being conducted by ChiLDREN (http://www.clinicaltrials.gov/ct/show/NCT00061828?order=3). <EligibilityCriteria:>Inclusion Criteria:
* Portoenterostomy or gall bladder Kasai operation for biliary atresia within the previous 72 hours
* Post-conception age ≥ 36 weeks
* Weight at enrolment ≥ 2000 gm
* Written informed consent to participate in the study obtained prior to or within 72 hours of completion of portoenterostomy. (Note: Families of potential subjects may be approached prior to the portoenterostomy.)
Exclusion Criteria:
* Known immunodeficiency
* Diabetes mellitus
* Presence of significant systemic hypertension for age (persistent systolic blood pressure ≥112 mmHg)
* A serum indirect (unconjugated) bilirubin ≥ 5 mg/dL for infants under 4 weeks of age or ≥ 7 mg/dL for infants between 4 and 8 weeks of age
* Known sensitivity to corticosteroids
* Documented bacteremia or other tissue infection which is felt to be clinically relevant
* Known congenital infection or disease with herpes simplex virus, toxoplasmosis, or cytomegalovirus inclusion disease of the liver
* Infants whose mother is known to have human immunodeficiency virus infection
* Infants whose mother is known to be HBsAg or hepatitis C virus positive
* Infants with other severe concurrent illnesses such as neurological, cardiovascular, pulmonary, metabolic, endocrine, and renal disorders that would interfere with the conduct and results of the study
* Any other clinical condition that is a contraindication to the use of corticosteroid (e.g., bowel perforation)
* Infants who have received the live attenuated rotavirus vaccine (e.g., Rotateq) within 5 days prior to proposed administration of study drug <Conditions:>Biliary Atresia <Interventions:>Corticosteroids, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Biliary atresia splenic malformation (BASM)', 'OHI Main Type', 'Total Bilirubin', 'Length Z Score', 'Weight Z Score' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Training in Exercise Activities and Motion for Growth <BriefSummary:>To determine if an exercise program of passive range of motion (ROM) is safe and feasible in infants with single ventricle (SV) physiology after their Norwood procedure. <EligibilityCriteria:>Inclusion Criteria:
* Hospitalized infants with SV physiology
* \>37 weeks gestation
* \<30 days of age
* Hemodynamically stable (as defined by the attending physician) after surgical or interventional palliation with closed sternum
* Parent or guardian willing to comply with protocol and provide written informed consent
Exclusion Criteria:
* Intrauterine growth restriction
* Chromosomal or recognizable phenotypic syndrome of non-cardiac congenital abnormalities associated with growth failure (for example Trisomy, Noonan or Turner syndromes)
* Unstable hemodynamics as defined by the attending physician
* Non-cardiac diagnosis associated with growth failure
* Severe neurologic injury resulting from stroke or intracranial hemorrhage confirmed by head CT/ MRI or cranial ultrasound
* Anticipated discharge within 14 days of screening <Conditions:>Single Ventricle Physiology <Interventions:>Passive range of motion (ROM) exercise | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Build Better Bones With Exercise <BriefSummary:>The long-term goal of our research team is to conduct a large multicentre study to evaluate whether tailored home exercise can prevent fractures in high-risk individuals. The proposed project will address the feasibility of such a trial, but will also evaluate the effect of exercise on quality of life, posture and many other outcomes important to individuals with vertebral fractures. Physiotherapists will conduct 6 home visits with participants to deliver the intervention (or social visit for controls) using a similar model to previous work by our team and others. The purpose of this pilot study is determining the feasibility of recruitment, retention and adherence of an international multicentre randomized controlled study evaluating the efficacy of thrice-weekly home exercise for one year among women with vertebral fracture. As secondary objectives, the investigators will examine the effects of exercise on function, balance, quality of life, pain, falls and fractures. The primary hypothesis is that the investigators will successfully recruit and retain the target sample, and achieve an adherence rate of 60%. <EligibilityCriteria:>Inclusion Criteria:
* Has a) a known or suspected vertebral fracture of non-traumatic etiology OR b) one of the following:
* documented height loss of ≥2cm
* historical height loss of ≥6cm
* visible hyperkyphosis
* age greater than or equal to 65 years of age
* able to understand instructions in english
* able to give informed consent (no cognitive impairment)
Exclusion Criteria:
* Current or prior cancer
* On dialysis, known liver, kidney or malabsorption disease
* Progressive neurological disorder, unable to stand or walk for 10 metres, with/without gait aid or progressive disorder likely to prevent study completion, palliative care.
* Current participation in muscle strengthening or similar exercise program ≥ 3 times per week
* Uncontrolled hypertension or other contraindications to exercise <Conditions:>Osteoporotic Fractures, Spinal Fractures <Interventions:>Exercise and behaviour change strategies | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Long-Term, Open Label Atomoxetine Study <BriefSummary:>To learn about the safety and any side effects of atomoxetine when given to children and adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for about 5 years (long-term).
Study participants can be atomoxetine naive, atomoxetine experienced whose therapy has been interrupted or, atomoxetine experienced on a known stable dose. <EligibilityCriteria:>Inclusion Criteria:
* Must be at least 6 years old but less than 18 years old when enrolled in first atomoxetine study
* Must meet the study criteria for ADHD
* Must be willing to have blood drawn and to complete other test required for this study
Exclusion Criteria:
* allergic to more than 1 kind of medicine or have had multiple bad reactions to any drug
* taking certain medicines that could interact with atomoxetine
* plan to move too far away from a doctor participating in this study in the next 5 years
* current or past history of any of the following: alcohol or drug abuse within the past 3 months, bipolar I or II disorder, high blood pressure, organic brain disease or seizures, psychosis, other disorders or conditions diagnosed by a doctor that might make you unsuitable to participate in this study <Conditions:>Attention Deficit Hyperactivity Disorder <Interventions:>atomoxetine | 'Age Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Region of Enrollment', 'Height', 'Weight', 'Attention Deficit Hyperactive Disorder (ADHD) Subtype' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Evaluation of Ocular Comfort With ISTA Tears vs Systane <BriefSummary:>To assess the comfort preference of ISTA Tears vs Systane in patients with dry eye disease (DED) <EligibilityCriteria:>Inclusion Criteria:
* OSDI \>12
Exclusion Criteria:
* Presence of any active ocular disease other than dry eye <Conditions:>Dry Eye Disease <Interventions:>ISTA Tears, Systane | 'Age, Customized', 'Sex/Gender, Customized', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer <BriefSummary:>Primary Objective:
To determine whether amcenestrant per overall survival (os) improves progression free survival (PFS) when compared with an endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer
Secondary Objectives:
* To compare the overall survival in the 2 treatment arms
* To assess the objective response rate in the 2 treatment arms
* To evaluate the disease control rate in the 2 treatment arms
* To evaluate the clinical benefit rate in the 2 treatment arms
* To evaluate the duration of response in the 2 treatment arms
* To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms
* To evaluate the pharmacokinetics of amcenestrant as single agent
* To evaluate health-related quality of life in the 2 treatment arms
* To compare the overall safety profile in the 2 treatment arms <EligibilityCriteria:>Inclusion criteria :
* 18 years or older.
* Histological or cytological diagnosis of adenocarcinoma of the breast.
* Locally advanced not amenable to radiation therapy or surgery in a curative intent, and/or metastatic disease.
* Estrogen receptor(ER) positive status.
* Human epidermal growth factor receptor 2 negative status.
* Participants must have received no more than 1 prior chemotherapeutic or 1 targeted therapy regimen for advanced/metastatic disease.
* In the main study, a prior treatment with a Cyclin-dependent kinase 4 and 6(CDK 4/6) inhibitor is mandatory if this treatment is approved and can be reimbursed for this participant. The percentage of participants without previous CDK 4/6 inhibitor will be capped to 20%. In the Chinese extension cohort, previous treatment with a CDK 4/6 inhibitor will not be mandatory, and there will be no limitation to the number of participants naïve to CDK4/6 inhibitor.
* Participants must present a secondary endocrine resistance to endocrine therapy defined as: progression while on endocrine therapy after at least 6 months of treatment for advanced breast cancer, or relapse while on adjuvant endocrine therapy but after the first 2 years, or with a relapse within 12 months after completing adjuvant endocrine therapy.
* Male or Female.
Exclusion criteria:
* Eastern Cooperative Oncology Group performance status =\>2.
* Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of amcenestrant. Participants unable to swallow normally and to take capsules.
* Participant with any other cancer. Adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or any other cancer from which the participant has been disease free for greater than 3 years are allowed.
* Severe uncontrolled systemic disease at screening .
* Participants with known brain metastases that are untreated, symptomatic or require therapy to control symptoms.
* Prior treatment with mammalian target of rapamycin inhibitors or any other selective estrogen receptor degrader(SERD) compound, except fulvestrant if stopped for at least 3 months before randomization.
* Treatment with drugs that have the potential to inhibit Uridine'5 Diphospho-Glucuronosyl Transferase(UGT) less than 2 weeks before randomization.
* Treatment with strong Cytochrome P450 (CYP)3A inducers within 2 weeks before randomization.
* Ongoing treatment with drugs that are sensitive substrate of organic anion transporting polypeptide 1B1/B3(OATP1B1/B3) (asunaprevir, atorvastatin, bosentan, danoprevir, fexofenadine, glyburide, nateglinide, pitavastatin, pravastatin, replaglinide, rosuvastatin, and simvastatin acid).
* Treatment with anticancer agents (including investigational drugs) less than 3 weeks before randomization.
* Inadequate hematological, coagulation, renal and liver functions.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. <Conditions:>Breast Cancer Metastatic <Interventions:>Amcenestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane, Tamoxifen | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>PackHealth: Asthma Engagement Tool <BriefSummary:>The purpose of this study is to test the impact of an innovative patient engagement solution on patient's quality of life and asthma-related outcomes, and evaluate the correlation between a patient reported outcome measure and clinical outcomes. <EligibilityCriteria:>Inclusion Criteria:
* Patients with a physician diagnosis of asthma for at least the previous 12 months.
* Asthma that is not well controlled by NAEPP guidelines.
* Ability and willingness to provide informed consent
Exclusion Criteria:
* Significant alcohol consumption of more than three alcoholic drinks per day or active substance abuse.
* Chronic disease (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system or immunodeficiency that are not well addressed or controlled.
* A diagnosis of cancer with ongoing treatment.
* Any terminal illness or conditions that results in a life expectancy less than one year. <Conditions:>Asthma <Interventions:>Patient engagement toolkit | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Weight' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Treatment of Resistant Nephrotic Syndrome With ACTH Gel (ACTHAR) <BriefSummary:>This study will examine the safety and effectiveness of ACTHAR Gel, when used to treat 15 patients diagnosed with "treatment resistant nephrotic syndrome."
Nephrotic syndrome is a group of symptoms that includes low levels of protein in the blood, swelling of tissue (edema), especially around the eyes, feet and hands; and high plasma levels of cholesterol. It is caused by a variety of diseases and underlying disorders that damage the kidneys, resulting in excessive excretion of protein in the urine. These diseases damage the glomeruli, which are small blood vessels that filter wastes and excess water from the blood and pass them into the bladder as urine. As a result of protein loss in the urine, the blood is deficient in protein. Normal amounts of blood protein are needed to help regulate fluid throughout the body. Protein in the blood normally draws water from the tissues and into the bloodstream. When blood protein levels are low, the normal movement of water is reversed, and fluid is drawn from the blood and accumulates in the tissues. This excess tissue fluid causes the swelling and puffiness (edema) that is a symptom of nephrotic syndrome.
Nephrotic syndrome is described as "treatment resistant" when a patient fails to achieve a sustained partial or complete remission after treatment with at least two first line therapies.
The goal of this study is to determine whether injections of ACTHAR Gel (an FDA approved treatment for nephrotic syndrome) over a six month period will lead to a correction of treatment resistant nephrotic syndrome in these patients. <EligibilityCriteria:>Inclusion Criteria:
1. Adult nephrotic patients, at least 18 years of age
2. Diagnosis of focal segmental glomerulosclerosis (FSGS), resistant or relapsing minimal change disease with failure to achieve a sustained partial or complete remission of the nephrotic syndrome after therapy with at least two first line therapies: corticosteroids and at least one other immunosuppressive regimen
3. Diagnosis of membranous nephropathy with failure to achieve a sustained partial or complete remission of the nephrotic syndrome after therapy with at least two first line therapies: either the "Ponticelli protocol" of alternating months of pulse steroids followed by oral steroids and then an alkylating agent with each regimen repeated for six full months of therapy or a calcineurin inhibitor, cyclosporine or tacrolimus, and at least one other therapy
4. Diagnosis of immunoglobulin A nephropathy (IgAN) with persistent nephrotic range proteinuria in patients on ACE inhibition or angiotension receptor blockers (ARB) therapy to reduce proteinuria
5. Willing and able to sign informed consent
6. Patients of childbearing age must agree to use birth control
Exclusion Criteria:
1. Patients under 18 years of age
2. Patients unable to sign informed consent
3. Patients having received rituximab or another monoclonal antibody within 6 months of the trial
4. Patients of childbearing age who refuse to use birth control
5. Patients with an estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m2
6. Patients with other renal diseases (e.g. diabetic nephropathy, renal vascular disease) that would interfere with interpretation of the study.
7. Patients with comorbid conditions that would interfere with completion of the trial (malignancies, congestive heart failure (CHF), recent myocardial infarction).
8. Patients with known contraindications to the use of H.P. ACTHAR Gel, including: scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, and allergies to pork or pork products. <Conditions:>Treatment Resistant Nephrotic Syndrome <Interventions:>ACTHAR gel | 'Age, Categorical', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Previous Immunosuppressive therapy', 'Renal Function' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers <BriefSummary:>This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).
This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.
At least 440 subjects will participate. The study is going to be conducted in approximately 5 countries at approximately 50 sites across the European Union. <EligibilityCriteria:>Inclusion Criteria:
* Provide informed consent.
* Age ≥ 18 years and of either sex.
* Willing to comply with protocol instructions, including allowing all study assessments.
* Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 12.0 cm2
* Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
* Arterial supply adequacy confirmed
* Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone.
* Target ulcer duration ≥ 6 weeks but ≤ 104 weeks (24 months).
* Acceptable state of health and nutrition
Exclusion Criteria:
* History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B.
* Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication.
* Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
* A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
* Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
* Refusal of or inability to tolerate compression therapy.
* Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
* History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
* Any prior exposure to HP802-247 or its vehicle. <Conditions:>Venous Ulcer, Venous Stasis Ulcer, Ulcer <Interventions:>HP802-247, HP802-247 Vehicle | 'Age, Continuous', 'Age, Customized', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Phase I/II Descending Age Study of P2VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers and Infants <BriefSummary:>This is is a study of a parenteral rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study will examine the safety and immunogenicity of this vaccine first in healthy South African toddlers. If the safety profile is deemed appropriate, the study will continue to explore the safety and immunogenicity of the vaccine in healthy South African infants.
The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and well-tolerated in healthy toddlers and infants. The primary immunogenicity hypothesis is that the P2-VP8 subunit rotavirus vaccine is immunogenic in infant participants and will induce an immune response in at least 80% of participants in at least one of the study groups. <EligibilityCriteria:>Inclusion Criteria:
* healthy infants/toddlers as established by medical history and clinical examination before entering study
* age:
* toddler cohort: \> or = 2 and \<3 years old at the time of enrollment
* infant cohort: \> or = 6 and \<8 weeks at the time of enrollment
* parental ability and willingness to provide informed consent
* parental intention to remain in the area with the child during the study period.
Exclusion Criteria:
* Presence of fever on the day of enrollment
* Acute disease at the time of enrollment
* Concurrent participation in another clinical trial throughout the entire timeframe for this study
* Presence of malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination that would compromise the participant's health or is likely to result in nonconformance to the protocol
* For infant cohort, history of premature birth (\<37 weeks gestation)
* History of congenital abdominal disorders, intussusception, or abdominal surgery
* Known or suspected impairment of immunological function based on medical history and physical examination
* For infant cohort only, prior receipt of rotavirus vaccine
* A known sensitivity or allergy to any components of the study vaccine
* History of anaphylactic reaction
* Major congenital or genetic defect
* Participant's parents not able, available or willing to accept active weekly follow-up by the study staff
* Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period
* History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study
* Any medical condition in the parents/infant that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give informed consent
* HIV infection
* For toddlers, to be assessed by HIV ELISA
* For infants, to be assessed by PCR, if mother is not known to be negative (negative test result between 24 weeks gestation and screening) <Conditions:>Evaluation of a Rotavirus Vaccine <Interventions:>P2-VP8 Subunit Vaccine 10mcg, P2-VP8 Subunit Vaccine 30 mcg, P2-VP8 Subunit Vaccine 60mcg, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>BL-8040 and Nelarabine for Relapsed or Refractory T-Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma <BriefSummary:>The outcome of patients with relapsed or refractory adult T-acute lymphoblastic leukemia (T-ALL) and the related disease T-lymphoblastic lymphoma (T-LBL) is extremely poor with 30% of the patients responding to first salvage therapy and long-term survival of only 10%. Therefore, novel therapies for patients with relapsed/refractory T-ALL/LBL represent an unmet clinical need.
Recent data provide strong evidence that CXCR4 signaling plays a major role in T-cell leukemia cell maintenance and leukemia initiating activity, and targeting CXCR4 signaling in T-ALL cells reduces tumor growth in an animal model. In this study, the investigators propose that the addition of BL-8040 to nelarabine as a salvage therapy for patients with relapsed/refractory T-ALL/LBL will result in a higher complete remission (CR) rate than nelarabine alone without an increase in toxicity and will allow patients to proceed to a potentially curative allogeneic hematopoietic cell transplant. <EligibilityCriteria:>Inclusion Criteria:
* Diagnosis of T-acute lymphoblastic leukemia/ lymphoblastic lymphoma according to WHO criteria which has relapsed or is refractory to chemotherapy.
* Peripheral blood lymphoblasts ≤ 50,000 mcL. Hydroxyurea and/or leukapheresis is permitted to reduce the peripheral blast count prior to enrollment and treatment.
* Age ≥ 18 years
* ECOG performance status ≤ 2.
* Adequate organ function defined as:
* Calculated creatinine clearance ≥ 50 ml/min using the Cockroft-Gault formula
* AST, ALT, total bilirubin ≤ 2 x institutional ULN except for Gilbert's disease or when in the opinion of treating physician elevated levels are due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia), in which case ALT and AST may be elevated up to ≤ 5 x IULN.
* Women of childbearing potential and men must agree to use adequate contraception with a highly effective method (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Abstinence is acceptable if this is the established and preferred contraception for the subject.
* Female subjects must have a negative urine or serum pregnancy test within 72 hours prior to start of study treatment if of childbearing potential or be of non-childbearing potential. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the subject to be eligible. Non-childbearing potential is defined as:
\*≥ 45 years of age and has not had menses for \> 2 years
* Amenorrheic for \> 2 years without a hysterectomy and oophorectomy and a FSH value in the postmenopausal range upon pretrial (screening) evaluation
* Post-hysterectomy, oophorectomy, or tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.
* Able to understand and willing to sign an IRB-approved written informed consent document.
Exclusion Criteria:
* Previous treatment with nelarabine for relapsed or refractory disease.
* Pregnant or nursing.
* Received any other investigational agent or systemic cytotoxic chemotherapy within the preceding 2 weeks.
* Active CNS involvement with leukemia
* Active HIV or hepatitis B or C infection.
* Any medical condition which, in the opinion of the clinical investigator, would interfere with the evaluation of the patient. Subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, laboratory tests, and according to the investigator's judgment. <Conditions:>T-Acute Lymphoblastic Leukemia, Adult T Lymphoblastic Lymphoma <Interventions:>BL-8040, Nelarabine | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Dose Optimisation Study of ASLAN003 in Acute Myeloid Leukemia <BriefSummary:>ASLAN003-003 is a multi-center, Phase IIA study to evalute the efficacy of ASLAN003 in AML patients who are ineligible for standard treatment with an expansion cohort in relapsed/refractory patients, and to determine the appropriate dose of ASLAN003 in combination with azacitidine in older (more than or equal to 60 years) AML patients who have exhausted any approved and available treatment options. <EligibilityCriteria:>Inclusion Criteria:
1. Patients who are of or older than 18 years old in the United States or are of or older than the legal age in the respective countries at the time when written informed consent is obtained
2. Patients who are able to understand and willing to sign the informed consent form (ICF)
3. Patients who are diagnosed with AML according to the 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia (refer to Appendix 1: WHO Classification of Acute Myeloid Leukemia)
4. Patients who have a sufficient archival or fresh BM aspiration sample for the evaluation of relevant exploratory endpoint.
Note: Patients who do not have sufficient archival BM aspiration sample and refuse to repeat the procedure may be enrolled in the trial only after written confirmation by ASLAN 5. Part 1: Patients who are ineligible for standard treatment of AML including to the following conditions:
* Patients who are ineligible for chemotherapy, and have exhausted any approved and available treatment options. More details on patients who are considered as ineligible or unfit for chemotherapy as per Ferrara et al, Leukemia, 2013 can be found in Appendix 4.
* Patients who have relapsed from prior remission;
* Patients who have failed to respond to prior therapy including chemotherapy, hypomethylating agents, and bone marrow transplantation.
5. Part 2A: Patients who have relapsed or refractory AML to treatments including chemotherapy, hypomethylating agents, bone marrow transplantation, and other anti-leukemic agents
* Relapsed patients who have bone marrow blasts ≥5%; or reappearance of blasts in the blood; or development of extramedullary disease after prior CR or CRi
* Refractory patients who have no CR or CRi after 2 courses of intensive induction treatment 5. Part 2B: Older patients (more than or equal to 60 years) AML patients who have exhausted any approved and available treatment options.
6. Patients who have an ECOG performance status of ≤ 2 7. Patients with adequate renal and hepatic function, as defined below:
* Estimated Glomerular Filtration Rate (eGFR) or creatinine clearance (CrCl) (CrCl calculated by the Cockroft and Gault method) ≥ 40 ml/min/1.73 m2
* Total bilirubin, AST, and ALT ≤ 1.5 × ULN
Exclusion Criteria:
1. Patients who are diagnosed with de novo myeloid sarcoma without BM involvement
2. Patients who are diagnosed with acute promyelocytic leukemia/retinoic acid receptor alpha (PML-RARA)
3. Patients who received any other standard or investigational treatment for their leukemia within the last 7 days before starting the first dose of study drug, with the exception of leukapheresis and hydroxyurea
4. Patients with unresolved serious toxicity (≥ CTCAE 4.03 Grade 2) from prior administration of standard or investigational treatment for their leukemia
5. Patients who have a positive test for human immunodeficiency virus (HIV), viral hepatitis C infection (patients with sustained viral response are not excluded), active viral hepatitis B infection (positive hepatitis B surface antigen \[HBsAg\]) with hepatitis B virus deoxyribonucleic acid (DNA) exceeding 2000 IU/ml
6. Patients who have a known history of liver cirrhosis Child-Pugh score B or C
7. Patients who have any history of other malignancy unless in remission for more than 1 year (skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent is not exclusionary)
8. Female patients who are pregnant or breast-feeding
9. Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment
10. Patients with a history or presence of a clinically significant condition which in the opinion of the Investigator could jeopardize the safety of the patient or the validity of the study results
11. Patients who have been previously treated with ASLAN003 <Conditions:>Acute Myeloid Leukemia <Interventions:>ASLAN003 | 'Age, Categorical', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Region of Enrollment', 'Height', 'Weight', 'BMI' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Alogliptin Tablets Specified Drug-use Survey "Type 2 Diabetic Patients Receiving Combination Therapy With a Hypoglycemic Agent (e.g., Insulin Preparations or Rapid-acting Insulin Secretagogues)" <BriefSummary:>The purpose of this survey is to evaluate the safety and efficacy of long-term use of alogliptin tablets (Nesina Tablets) in type 2 diabetic patients who have had an inadequate response to hypoglycemic agents (e.g., insulin preparations or rapid-acting insulin secretagogues)\* in addition to dietary/exercise therapy. Participants will receive alogliptin as part of routine medical care.
\* Patients receiving these hypoglycemic agents (excluding α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides) were excluded from existing specified drug-use surveys for alogliptin tablets. <EligibilityCriteria:>Inclusion Criteria:
-Type 2 diabetic patients meeting the following criteria are included in this survey:
Patients who have had an inadequate response to the following medications/therapies:
• Use of one hypoglycemic agent such as insulin preparations and rapid-acting insulin secretagogues, excluding other types of hypoglycemic agents (e.g., α-glucosidase inhibitors, thiazolidines, sulfonylureas, and biguanides)\*, in addition to dietary/exercise therapy
\* For use of alogliptin tablets in combination with these agents, a specified drug-use survey is currently ongoing.
Exclusion Criteria:
-Type 2 diabetic patients who meet any of the following criteria are excluded from this survey: Patients with contraindications for alogliptin tablets
1. Those with severe ketosis, in a state of diabetic coma or precoma, or with type 1 diabetes mellitus \[Quickly rectifying hyperglycemia with administration of intravenous fluid or insulin is essential in these patients; therefore, administration of alogliptin tablets is not appropriate.\]
2. Those with severe infections, before or after surgery, or with serious trauma \[Controlling blood glucose with an injection of insulin is desirable for these patients; therefore, administration of alogliptin tablets is not appropriate.\]
3. Those with a history of hypersensitivity to any of the ingredients of alogliptin tablets <Conditions:>Type 2 Diabetes Mellitus <Interventions:>Alogliptin | 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Region of Enrollment', 'Duration of Diagnosis of Type-2 Diabetes Mellitus (Years)', 'Height', 'Weight', 'BMI', 'Waist Circumference (Male)', 'Waist Circumference (Female)', 'Healthcare Category', 'Medical Complications', 'Concomitant Diabetes Mellitus', 'Concomitant Hypertension', 'Concomitant Hyperlipidemia', 'Concomitant Hyperuricaemia', 'Concomitant Hepatic Disorder', 'Degree of Hepatic Dysfunction', 'Concomitant Renal Disorder', 'Degree of Renal Dysfunction (eGFR)', 'Degree of Renal Dysfunction (Cr)', 'Concomitant Cardiac Disease', 'Concomitant Heart Failure', 'New York Heart Association (NYHA) Heart Failure Classification', 'Concomitant Stroke-Related Disease', 'Concomitant Allergic Condition', 'Concomitant Malignant Tumor', 'Medical History', 'Predisposition to Hypersensitivity', 'Drinking Habits', 'Smoking Classification', 'Hemoglobin A1c (HbA1c)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension <BriefSummary:>The purpose of this study is to determine the long term safety and tolerability of azilsartan medoxomil, once daily (QD), in participants with Essential Hypertension. <EligibilityCriteria:>Inclusion Criteria
1. Has essential hypertension (diastolic blood pressure ≥ 95mm Hg and ≤ 119 mm Hg. For participants with diabetes or chronic kidney disease diastolic blood pressure must be ≥ 85 mm Hg and ≤ to 109 mm Hg.
2. Female participant is not of childbearing potential (eg, sterilized, postmenopausal).
3. Female participants 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.
4. Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) are within the reference range for the testing laboratory unless the results are deemed not clinically significant for inclusion into this study by the investigator.
Exclusion Criteria
1. Systolic blood pressure greater than 185 mm Hg.
2. Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
3. Is hypersensitive to AII receptor blockers.
4. Recent history (within the last 6 months) of myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, cerebrovascular accident, or transient ischemic attack.
5. History of moderate to severe heart failure or hypertensive encephalopathy.
6. Has clinically significant cardiac conduction defects (eg, third-degree atrioventricular block, sick sinus syndrome).
7. Has secondary hypertension of any etiology.
8. Known or suspected unilateral or bilateral renal artery stenosis.
9. Has severe renal dysfunction or disease (based on calculated creatinine clearance \< 30 mL/min/1.73 m2) at Screening. <Conditions:>Hypertension <Interventions:>Azilsartan medoxomil, Azilsartan medoxomil, with or without chlorthalidone and other non-angiotensin II receptor blocker antihypertensive medications., Placebo | 'Age, Customized', 'Age, Customized', 'Sex/Gender, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Relative Bioavailability Trial of L-Praziquantel in Healthy Volunteers <BriefSummary:>This is a phase I, open-label, randomized, 5 period, crossover, single-center trial. The purpose of this trial is to assess the relative bio-availability of L-praziquantel (L-PZQ \[MSC2499550A\]) oral dispersible tablet (ODT) formulation (150 milligram \[mg\]) versus the current marketed racemate praziquantel (PZQ) (Cysticide® 500 mg) formulation in healthy male volunteers under fed conditions. <EligibilityCriteria:>Inclusion Criteria:
* Healthy males aged 18-55 years of age (inclusive at screening)
* Male subjects with partners of childbearing potential must have had a vasectomy or use acceptable methods of birth control (that is, condoms) and not donate sperm during, and until 90 days after the last dose of the trial medication
* Written informed consent prior to any trial related procedure
* Have a body weight of greater than or equal to (\>=) 55.0 kilogram (kg) to less than (\<) 95.0 kg and a body mass index (BMI) of 18.5 to 29.9 kilogram per square meter (kg/m\^2) (inclusive)
* Able to communicate well with the Investigator, understanding the protocol requirements and restrictions, and willing to comply with the requirements of the entire trial
* Non-smoker (= 0 cigarettes, pipes, cigars or others) since at least 3 months
* Electrocardiogram (ECG) recording (12-lead) without signs of clinically relevant pathology in particular corrected QT Interval (QTc) (Bazett) \< 450 milliseconds (ms)
* Vital signs (systolic and diastolic blood pressure, pulse) in supine position and body temperature within the normal range or showing no clinically relevant deviation as judged by the medical Investigator
Exclusion Criteria:
* Any surgical or medical condition, including findings in the medical history or in the prestudy assessments, or any other significant disease, that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation of the subject in the study or that could interfere with the study objectives, conduct or evaluation
* History of surgery of the gastrointestinal tract (GI), history of other GI tract diseases, or acute GI tract infections in the last 2 weeks, which could influence the GI absorption and/or motility according to the Investigator's opinion
* Any clinically relevant abnormality in the safety laboratory parameters as judged by the Investigator
* Have positive results from serology examination for Hepatitis B surface antigen (HBsAg), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)
* Allergy: ascertained or presumptive hypersensitivity to the active drug substance and/or formulations ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the trial
* History or presence of drug abuse (amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine (phenylcyclohexalpiperidine), tetrahydrocannabinol, tricyclic antidepressants, methadone, methamphetamine, oxycodone and propoxyphene) or alcohol abuse at screening and on each admission as defined by the Investigator
* Loss or donation of more than 400 milliliter (mL) of blood within 90 days prior to first praziquantel (PZQ) administration
* Administration of any investigational product or use of any investigational device within 60 days prior to first PZQ administration
* Subjects who have used drugs that may affect the pharmacokinetics (PK) of PZQ from 14 days before dosing until the last PK sample, for example, phenytoin, barbiturates, primidone, carbamazapine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, oral ketoconazole, on discretion of the Investigator
* Consumption of substances known to be potent inhibitors or inducers of cytochrome -P450 enzymes (CYP P450s) such as grapefruit juice, grapefruit juice containing products, and herbal remedies or dietary supplements containing St. John's Wort, in the 2 weeks before dosing
* Unlikely to comply with the protocol requirements, instructions and trial-related restrictions, for example, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the trial
* Non-acceptance of study breakfast (for example, vegetarians, vegans and subjects who follow special diets)
* Excessive consumption of beverages -containing xanthine (\> 5 cups ) of coffee a day, or equivalent or inability to stop consuming caffeine from 48 hours prior to drug administration until discharge from the clinic
* Subject is the Investigator or any Sub-Investigator, research assistant, pharmacist, trial coordinator, other staff or relative thereof directly involved in the conduct of the trial
* Vulnerable subjects (for example, persons kept in detention)
* Legal incapacity or limited legal capacity <Conditions:>Healthy <Interventions:>MSC2499550A, Cysticide, MSC2499550A, MSC2499550A, MSC2499550A, MSC2499550A | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma <BriefSummary:>The goal of this trial is to test the ability of MK-3475 (pembrolizumab) to improve locoregional recurrence and distant metastatic rates in high-risk patients with locally advanced head and neck squamous cell carcinomas (HNSCCs) that are treated with current standard of care surgical approaches. <EligibilityCriteria:>Inclusion Criteria:
* Histologically or cytologically confirmed stage III or IV HNSCC oral cavity, hypopharynx, oropharynx, larynx (excluding p16 or HPV-positive oropharynx primaries and sinonasal primaries).
* Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>10 mm with CT scan, as \>20 mm by chest x-ray, or \>10 mm with calipers by clinical exam by RECIST 1.1.
* At least 18 years of age.
* ECOG performance status ≤ 1
* Normal bone marrow and organ function as defined below:
* Absolute neutrophil count ≥ 1,500/mcl
* Platelets ≥ 100,000/mcl
* Hemoglobin ≥ 9 g/dL
* Total bilirubin ≤ 1.5 x IULN OR Direct bilirubin ≤ IULN for patients with total bilirubin \> 1.5 x IULN
* AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN (or ≤ 5 x IULN for patients with liver metastases)
* Serum creatinine ≤ 1.5 x IULN OR Creatinine clearance by Cockcroft-Gault ≥ 30 mL/min/1.73 m2 for patients with creatinine levels \> 1.5 x IULN
* INR ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or PTT is within therapeutic range of intended use of anticoagulants
* aPTT ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR or PTT is within therapeutic range of intended use of anticoagulants
* Sexually active women of childbearing potential and men must agree to use 2 methods of contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for 120 days after last dose of MK-3475. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
* Prior treatment for head and neck cancer.
* Patients with HPV-positive or p16-positive oropharyngeal SCCA.
* Patients with sinonasal SCCAs
* Patients with metastatic SCCA neck disease with an unknown primary tumor site
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
* Received a live vaccine within 30 days prior to the first dose of MK-3475. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated viruses and are not allowed.
* A history of other malignancy ≤ 3 years previous with the exception of previous head and neck cancer treated only by surgery, basal cell or squamous cell carcinoma of the skin which were treated with local resection only, or carcinoma in situ of the cervix.
Note: patients with synchronous head and neck cancer primaries are an exception to this criterion and may qualify for the study.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of MK-3475.
* Currently receiving any other investigational agents or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of MK-3475.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-3475 or other agents used in the study.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, immunosuppression, autoimmune conditions, underlying pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
* Pregnant and/or breastfeeding. Patient must have a negative serum or urine pregnancy test within 72 hours of study entry.
* Known history of active TB (bacillus tuberculosis).
* Known history of hepatitis B (defined as hepatitis B survace antigen \[HBsAg\] reactive) or known active hepatitis C (defined as HCV RNA \[qualitative\] is detected) infection. Note: know testing for hepatitis B and hepatitis C is required unless mandated by local health authority.
* Known history of HIV (HIV 1/2 antibodies). <Conditions:>Cancer of Head and Neck, Head and Neck Cancer, Neoplasms, Head and Neck, Carcinoma, Squamous Cell of Head and Neck, Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma, Head and Neck <Interventions:>MK-3475 (neoadjuvant), Surgery, Intensity modulated radiation therapy, Image-guided radiation therapy, Cisplatin, MK-3475 (adjuvant), Peripheral blood | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Very Low Carbohydrate Diet as an Adjunctive Therapy for Youth Type 1 Diabetes <BriefSummary:>This prospective, open-label pilot/feasibility study of 10 youth with T1D is to evaluate glycemic and metabolic changes taking place with a very low carbohydrate diet. <EligibilityCriteria:>Inclusion Criteria:
* BMI 19-30 m2 for individuals at least 18 years old or BMI \< 95 percentile for individuals less than 18 years old
* Participants 18 years of age must be able to read and provide written consent
* Participants under 18 years of age must be able to read and provide written assent
* Participants are managed using an insulin pump or injections
* Participant has or is willing to wear a CGM for the duration of the study
* Participant is willing to complete diet logging procedures stated above
Exclusion Criteria:
* A1c \< 6.5% or \> 10%
* Recent history of more than 1 of diabetic ketoacidosis (DKA) in the past 6 months
* Treatment with glucose-lowering drugs other than insulin
* Unstable psychiatric disorders, including eating disorders (DSM-V criteria)
* Weight loss medications within the last 6 months
* Females who are pregnant, lactating or planning to become pregnant in the next 6 months
* Another medical condition that precludes participation in the study <Conditions:>Type 1 Diabetes <Interventions:>Very Low Carbohydrate Diet | 'Age, Customized', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>PilAm Go4Health Weight Loss Program to Prevent Heart Disease <BriefSummary:>This is a pilot randomized controlled trial intervention to improve lifestyle behaviors (physical activity and health diet) for Filipino Americans with type 2 diabetes on metformin. If the PilAm Go4Health intervention demonstrates potential efficacy, it may identify effective intervention strategies to significantly reduce risks for heart disease risks (i.e., metabolic syndrome) in Filipino Americans. <EligibilityCriteria:>Inclusion Criteria:
1. Self-identified as Filipino
2. Age \> 18 years
3. BMI for Asians \> 23 kg/m2
4. Physician diagnosed T2DM diabetes confirmed by clinical data (e.g. documentation of fasting blood glucose \>126 mg/dL or a positive oral glucose tolerance test (OGTT) \> 200 mg/dl, HbA1c \> 6.5%)
5. On metformin for T2DM
4) waist circumference: men \> 40 inches, women \> 35 inches 6) Physically inactive - most leisure time spent without much physical activity 7) No cognitive impairment per the Mini-Cog test 8) has a mobile smart phone (iPhone 4s or above, or android phone) 9) English speaking. Only one member per household allowed to enroll in the study.
Exclusion Criteria:
1. Uncontrolled T2DM
2. Glucose metabolism associated disease (Cushing's syndrome, Acromegaly, and Pheochromocytoma currently under treatment, chronic pancreatitis), 2) Thyroid disease - sub-optimally treated
3. Known medical conditions or other physical problems needing a special exercise program (e.g., prior myocardial infarction, history of angioplasty or angina, admission for hospital evaluation of chest pain, use of nitroglycerin for angina, chronic obstructive pulmonary disease, or uncontrolled hypertension)
4. Recent acute coronary syndrome, congestive heart failure
5. Currently participating in a lifestyle modification program
6. Planning a trip outside of the US during the 6-month study period
7. Known eating disorder
8. Planning a surgery in the next 7-months
9. Taking long-term antibiotics (including HIV-related agents), anti-tuberculosis agents (except isoniazid alone as prophylaxis), or prescription weight-loss drugs <Conditions:>Type2 Diabetes <Interventions:>PilAm Go4Health Weight-loss Program, Active Control | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Phase I/II Study of Azacitidine, Docetaxel, and Prednisone for Metastatic Prostate Cancer Patients <BriefSummary:>Azacitidine can reverse clinical resistance to docetaxel through upregulation of Growth Arrest and DNA Damage inducible alpha (GADD45α) and other epigenetically regulated genes. <EligibilityCriteria:>INCLUSION CRITERIA:
* Patient who had histologically confirmed adenocarcinoma of the prostate.
* Patient must have radiologically documented metastatic disease.
* Patients should have received at least 12 weeks of docetaxel chemotherapy or a cumulative docetaxel dose of 300 mg/m2 and have disease progression on docetaxel-based therapy. Patients must have progressed after prior hormonal therapy (e.g. medical or surgical castration) as defined by a castrate level of testosterone (less than 50 ng/mL). If patient underwent medical castration, it must be continued during the study.
* Progressive disease may be documented by:
* Non-measurable disease:
* Serum PSA progression defined as a rise in at least 2 consecutive serum PSA values, each obtained at least 1 week apart and an absolute value greater than 2.0 ng/ml or,
* Appearance of two or more new lesions on bone scan.
* Patients with treated epidural lesions and no other epidural progression will be eligible.
* Measurable disease
* Documented progression of disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria demonstrating at least one visceral or soft tissue metastatic lesion (including new lesion).
* Nodal or visceral progression will be sufficient for trial entry independent of PSA
* Only lymph nodes ≥ 2 cm in diameter will be used to assess for a change in size.
* Previously irradiated lesions, primary prostatic lesion, and bone lesions will be considered non-measurable disease.
* Patient is 18 years or older.
* Patient had a Karnofsky Performance Status (KPS) of at least 70% or Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2.
* Life expectancy of \> 6 months.
* Patient with adequate organ function as defined as
* Absolute Neutrophils Count greater than 1500 cells/mm3
* Platelets greater than 100,000 cells/mm3
* Hemoglobin greater than 8 g/dL,
* Adequate liver function as documented by:
* Total Bilirubin \</= 1.5 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.
* AST and ALT \</= 2.5 ULN. (In determining eligibility the more abnormal of the two values (AST or ALT) should be used.)
* Serum creatinine \</= 2.0 mg/dl or \</= 1.5 x institutional upper limit of normal.
* Male patient must be willing to use an acceptable barrier method for contraception; and must agree not to father a child whilst receiving treatment with Azacitidine and up to six months after last dose.
* Patients may have a history of prior malignancy (≥ 5 years prior) provided that the patient is currently disease free and off all therapy for that malignancy. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
* Patients must be informed of the investigational nature of the treatment and must give signed written and informed consent.
EXCLUSION CRITERIA:
* Patients who have received strontium 89 (metastron®), Samarium 153 (quadramet®) radiation therapy within 8 weeks of enrollment.
* Evidence of significant active infection during screening for eligibility.
* Patients who have had a psychiatric illness that could potentially interfere with completion of treatment according to protocol.
* Patients who had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. There is no wash-out period for patients who received Zytiga.
* Patient who had brain metastases.
* Patient who had history of allergic reactions attributed to compound or similar chemical or biological composition to azacitidine (Vidaza®) or docetaxel or other drugs formulated with polysorbate 80 or mannitol.
* Patient had major surgical procedure within 28 days before Day 1 of treatment.
* Hepatic malignancy. <Conditions:>Prostate Cancer, Pain <Interventions:>Azacitidine, Docetaxel, Prednisone, GADD45α methylation and expression analysis, Pegfilgrastim, Filgrastim | 'Age, Customized', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Effects of Transdermal Nicotine on Response Inhibition to Emotional Cues in Schizophrenia <BriefSummary:>The purpose of this study is to test whether nicotine, a drug that activates receptors called nicotinic acetylcholine receptors in the brain, improves the ability to make or withhold responses to faces that are either emotionally neutral or emotionally negative. This study will also test whether the drug affects brain activity while making or withholding responses using electroencephalography. Previous studies in people with schizophrenia have shown that more errors in response to negative emotional cues are related to greater likelihood of impulsive aggressive behavior. Therefore, the aim of this study is to determine whether nicotine might be a new strategy to reduce aggressive behavior. The investigators' goal is 25 individuals with schizophrenia and 25 healthy controls to complete the study at Vanderbilt. <EligibilityCriteria:>Inclusion Criteria for schizophrenia subjects:
1. Men and women age 18 - 65.
2. Communicative in English.
3. Provide voluntary, written informed consent.
4. Physically healthy by medical history,and ECG examination.
5. BMI \> 17.5 and \< 45.
6. Diagnosis of schizophrenia (ICD-10 F20) or schizoaffective disorder (ICD-10 F25) confirmed by Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-V (SCID) or diagnostic interview with a trained clinician.
7. Stable medication regimen over at least the past two weeks, including the use of either an oral or intramuscular administration of an antipsychotic medication. Additionally, subjects may take any prescribed medication aside from a nicotine-containing product as long as it has been regularly taken over the past two weeks, including as-needed ("PRN") medication.
8. Negative urine toxicology and negative urine cotinine (to confirm no recent nicotine use) at screening.
9. Does not meet criteria for substance or alcohol use disorder per the SCID over the past 6 months
10. For females, no longer of child-bearing potential, or agreeing to practice effective contraception during the study (e.g., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device \[IUD\] or intrauterine system \[IUS\]; barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap \[diaphragm or cervical/vault caps\] with spermicidal foam/gel/film/cream/suppository; male partner sterilization; or true abstinence when this is in line with the preferred and usual lifestyle of the subject); and,
11. For females of child-bearing potential, must have negative urine pregnancy test at time of screening visit and before each testing day.
12. Not breastfeeding/nursing at time of screening or at any time during the study.
Exclusion Criteria for schizophrenia subjects:
1. Age less than 18 or greater than 65.
2. Not communicative in English.
3. Unable to provide written informed consent.
4. Active suicidal ideation or suicidal behavior.
5. Current, unstable medical or neurological illness or significant abnormality on ECG.
6. History of severe head trauma.
7. BMI \< 17.5 or \> 45.
8. History of allergy to transdermal patches.
9. Screening visit resting heart rate \> 110 or \< 50 beats per minute, or known history of clinically significant cardiac rhythm abnormalities.
10. Screening visit systolic blood pressure \> 160 or \< 90, or diastolic blood pressure \> 95 or \< 50.
11. Positive urine toxicology or positive urine cotinine during screening.
12. Meets criteria for diagnosis of substance or alcohol use disorder by SCID within the past 6 months.
13. Reports any tobacco smoking or nicotine use over the past month.
14. Not taking an antipsychotic medication.
15. Positive urine pregnancy test at time of screening, before each testing day, or any potential concern for pregnancy at any time during the study
16. Breastfeeding/nursing at time of screening or at any time during the study.
Inclusion Criteria for healthy volunteer subjects:
All of the above except for subjects will be psychiatrically healthy and not taking psychotropic or potentially psychoactive prescription medication.
Exclusion Criteria for healthy volunteer subjects:
All of the above and in addition:
1. Current use of psychotropic or potentially psychoactive prescription medication.
2. Major psychiatric disorder as determined by DSM-5 (schizophrenia, major depression, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder, etc.) <Conditions:>Schizophrenia, Impulsive Behavior <Interventions:>Nicotine Patch, 7 Mg/24 Hr, Placebo patch | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Bard® LifeStent® Vascular Stent Delivery System Study <BriefSummary:>The purpose of this study is to evaluate the effectiveness and safety of a new delivery system for the Bard® LifeStent® Vascular Stent System. <EligibilityCriteria:>Inclusion Criteria:
1. The subject or legal representative has been informed of the nature of the evaluation, agrees to its provisions, and has signed the informed consent form (ICF).
2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
3. The subject is ≥ 21 years old.
4. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within seven days prior to index procedure. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.
5. The subject has lifestyle-limiting claudication or ischemic rest pain defined as: Rutherford Category1 2-4 (moderate claudication to ischemic rest pain).
6. The target lesion(s) has angiographic evidence of stenosis or restenosis ≥50% or occlusion (by visual estimate) and is amenable to PTA and stenting.
7. The total treated segment(s) must be ≤ 240 mm.
8. The target vessel reference diameter is ≥4.0 mm and ≤6.5 mm (by visual estimate) and therefore appropriate for treatment with available stent diameters of 6.0 mm and 7.0 mm.
9. There is angiographic evidence of at least one vessel runoff to the foot (at the level of the malleolus).
Exclusion Criteria:
1. The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study follow-up procedure and visits.
2. The subject has claudication or critical limb ischemia described as Rutherford Category1 1 (mild claudication), 5 (minor tissue loss) or 6 (major tissue loss).
3. The subject has a known contraindication (including allergic reaction) or sensitivity to antiplatelet/anticoagulant medications, nickel, titanium or tantalum.
4. The subject has a known sensitivity to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.
5. The subject has a history of bleeding diatheses or coagulopathy.
6. The subject has concomitant renal failure with a creatinine of \>2.5 mg/dL.
7. The subject has concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or deep vein thrombosis (DVT) at the time of the study procedure.
8. The subject is receiving dialysis or immunosuppressive therapy.
9. The subject is participating in an investigational drug or another investigational device study.
10. The subject has another medical condition, which, in the opinion of the investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with limited life expectancy of less than two years.
11. The subject has extensive peripheral vascular disease, which, in the opinion of the investigator, precludes safe insertion of an introducer sheath.
12. The target lesion(s) is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion(s).
13. The subject has angiographic evidence of poor inflow, which would be deemed inadequate to support a vascular bypass graft.
14. The subject is diagnosed with septicemia at the time of the study procedure.
15. Patients with a stent previously implanted into the target vessel.
16. Bilateral disease in the native SFA and/or proximal popliteal artery where both limbs meet the inclusion/exclusion criteria and it is planned to treat both limbs within 30 days. Note: One limb may be enrolled in the study, but only if the second limb is planned to be treated after the 30-day follow-up visit has taken place. The limb that may be enrolled has to be the limb with the more severe lesion and the reasons for treating this specific limb will need to be stated in the CRF. <Conditions:>Peripheral Vascular Disease <Interventions:>Bard® LifeStent® Vascular Stent System | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease <BriefSummary:>To assess motor function and quality of life (QoL) in Parkinson's disease (PD) subjects with end-of-dose wearing off, comparing immediate and delayed switch to carbidopa/levodopa and entacapone. <EligibilityCriteria:>Inclusion Criteria:
* Males or females 30-80 years of age (inclusive). Patients aged 81-85 years were eligible to participate if the principal investigator considered the patient to be in otherwise good health.
* Clinical diagnosis of Parkinson's disease exhibiting two of three symptoms (rigidity, resting tremor, bradykinesia).
* All patients were required to have end-of dose wearing off (EODWO, re-emergence of PD symptoms at the end of at least two daily doses of levodopa during waking hours).
* Taking regular doses of immediate release carbidopa/levodopa
Exclusion Criteria:
* Unstable Parkinson's Disease requiring booster doses or treatment with as needed dose regimens of levodopa
* Female subjects who are pregnant, trying to become pregnant or nursing an infant
Other protocol-defined inclusion/exclusion criteria applied to this study. <Conditions:>Parkinson's Disease With End of Dose Wearing Off <Interventions:>Carbidopa/levodopa/entacapone | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes <BriefSummary:>This trial is conducted in Africa, Asia, Europe, North and South America. The aim of the trial is to compare the effect of once-weekly (OW) dosing of subcutaneous semaglutide (1.0 mg) versus once-daily dosing of oral canagliflozin (300 mg) on glycaemic control in subjects with type 2 diabetes (T2D) on a background treatment of metformin <EligibilityCriteria:>Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - Male or female, age equal to or above18 years at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus (T2D) - HbA1c of 7.0-10.5% (53-91 mmol/mol, both inclusive) - Stable daily dose of metformin (equal to or above1500 mg or maximum tolerated dose as documented in the subject medical record and in compliance with current local label) for at least 90 days prior to the day of screening Exclusion Criteria: - Known or suspected hypersensitivity to trial product(s) or related products - Previous participation in this trial. Participation is defined as signed informed consent - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) - Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days prior to the day of screening - Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - Subject with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL) - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative - History or presence of pancreatitis (acute or chronic) - History of diabetic ketoacidosis (DKA) - Any of the following: myocardial infarction (MI), stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening - Subjects presently classified as being in New York Heart Association (NYHA) Class IV - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Renal impairment measured as eGFR below 60 ml/min/1.73 m\^2 as defined by Kidney Disease Improving global outcomes (KDIGO 2012) classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation - Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed - Medical history of diabetes-related lower limb amputations or signs of critical lower limb ischemia, (e.g. skin ulcer, osteomyelitis, or gangrene) within the last 26 weeks prior to screening <Conditions:>Diabetes, Diabetes Mellitus, Type 2 <Interventions:>Semaglutide, Canagliflozin, Placebo (canagliflozin), Placebo (semaglutide) | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race/Ethnicity, Customized', 'HbA1c' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>GSK3739937 First-Time-In-Human (FTIH) Study in Healthy Volunteers <BriefSummary:>This study is a Phase 1, double-blind (sponsor-unblinded), randomized, placebo-controlled, single- and repeat-dose escalation study including a weekly oral dose (MAD) cohort and a relative bioavailability (RBA) and food effect (FE) cohort to investigate the safety, tolerability and PK of VH3739937 in healthy participants. This is a three part study. Part 1 and Part 2 is designed to gain information on the safety, tolerability, and pharmacokinetic (PK) properties of GSK3739937 when administered as powder-in-a-bottle (PiB). Part 3 will evaluate the RBA of the GSK3739937 PiB and GSK3739937 Tablet and the safety, tolerability and PK parameters of the tablet formulation when administered under fasting and fed conditions. <EligibilityCriteria:>Inclusion Criteria:
* Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
* Participants who are overtly healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
* Participants who are negative on two consecutive tests for severe acute respiratory syndrome coronavirus-2 (SARs-CoV-2), performed at Screening and on admission and (re-)admission to the Phase I unit, using an approved molecular test polymerase chain reaction (PCR).
* Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.
* Body weight \>=50.0 kilograms (kg) (110 pound \[lbs\]) for men and \>=45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kilogram per square meter (kg/m\^2).
* Male participants are eligible to participate if they agree to use contraceptive methods
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and is not a woman of childbearing potential (WOCBP). - Capable of giving signed informed consent
Exclusion Criteria:
* Signs and symptoms which in the opinion of the investigator are suggestive of coronavirus disease 2019 (COVID-19) (i.e. fever, cough etc) within 14 days of inpatient admission.
* Contact with known COVID-19 positive persons in the 14 days prior to inpatient admission.
* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, distribution, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
* Pre-existing clinically relevant, in the opinion of the principal investigator (PI), gastro-intestinal pathology or diagnosis - e.g. irritable bowel syndrome, inflammatory bowel disease, and/or significant baseline signs and symptoms.
* Medical history of cardiac arrhythmias or cardiac disease or a family and personal history of long QT syndrome.
* Any known or suspected pre-existing psychiatric condition
* Any positive (abnormal) response confirmed by the investigator or clinician (or qualified designee) administered Columbia Suicide Severity Rating Scale (CSSRS) at screening .
* Any other clinical condition (including but not limited to active substance use) or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits; or a condition that could affect the absorption, distribution, metabolism or excretion of the drug.
* Estimated glomerular filtration rate (eGFR) \<90 milliliters/minute (mL/min) or serum creatinine \>1.1 x upper limit of normal (ULN).
* Hemoglobin \<12.5 grams/deciliter (g/dL) for men and \<11 g/dL for women.
* ALT or AST \>1.1x ULN.
* Bilirubin \>1.1 x ULN (isolated bilirubin \>1.1 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction in the past 3 months (does not include ST segment changes associated with repolarization), symptomatic bradycardia, non-sustained or sustained atrial arrhythmias, non-sustained or sustained ventricular tachycardia (\>=3 consecutive ventricular ectopic beats), second-degree atrioventricular (AV) block Mobitz Type II, third-degree atrioventricular block, complete heart block, or conduction abnormality (including but not specific to left or right complete bundle branch; AV block \[2nd degree or higher\]; Wolff-Parkinson-White \[WPW\] syndrome), Sinus Pauses \> 3 seconds, which, in the opinion of the investigator or ViiV Healthcare (VH)/ GlaxoSmithKline (GSK) Medical Monitor, will interfere with the safety for the individual participant.
* Exclusion criteria for Screening ECG. Heart rate \<45 or \>100 beats per minute (bpm) for males and \<50 or \>100 bpm for females; PR interval \<120 or \>220 millisecond (msec); QRS duration \<70 or \>120 msec; the Fridericia's QT correction formula (QTcF) interval \>450 msec.
* Past or intended use of over-the-counter or prescription medication \[including cytochrome p450 enzyme inducers or inhibitors, vitamins, herbal and dietary supplements \] within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing and for the duration of the study, unless in the opinion of the Investigator and Sponsor, the medication will not interfere with the study medications, procedures, or compromise participant safety.
* Unwillingness to abstain from ingestion of any food or drink containing grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos within 7 days prior to the first dose of study treatments or until the end of the study.
* Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days
* Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day
* Current enrolment or past participation within the last 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) before signing of consent in this or any other clinical study involving an investigational study intervention or any other type of medical research
* Presence of Hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention
* Positive Hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
* Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention
* Positive pre-study drug/alcohol screen
* Positive HIV antibody/antigen test
* Regular use of known drugs of abuse
* Regular alcohol consumption within 6 months prior to the study defined as: An average weekly intake of \>14 units for males or \>7 units for females.
* Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (e.g. nicotine patches or vaporizing devices) within 6 months prior to screening and at admission.
* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study. <Conditions:>HIV Infections <Interventions:>GSK3739937 (PIB), Placebo, GSK3739937 (Tablet) | 'Age, Customized', 'Sex: Female, Male', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Neurobiology of Sleep and Sleep Treatment Response in Returning Veterans <BriefSummary:>The overarching objectives of this study are: 1) To investigate the neurobiology of posttraumatic stress disorder (PTSD) during Rapid Eye Movement (REM) and Non-Rapid Eye Movement (NREM) sleep relative to wakefulness; 2) To identify the neurobiological underpinnings of sleep treatment response to prazosin or placebo during wakefulness, REM sleep, and NREM sleep in Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) ( veterans with PTSD; and 3) To explore pre-treatment brain activity patterns during wakefulness, REM sleep, and NREM sleep that predict sleep treatment response. We will also explore the stability of the Positron Emission Tomography (PET) signal by comparing pre- and post-placebo changes in brain glucose metabolism in non-responders. For non-PTSD veterans, the stability of the PET signal will be evaluated in a subsample of 6 veterans without PTSD who will repeat the PET imaging procedures 8 weeks after the initial PET series.
The overarching hypothesis is that PTSD is characterized by neurobiological alterations in the amygdala, medial prefrontal cortex (mPFC), and brain centers involved in the regulation of NREM and REM sleep, and that these neurobiological changes are normalized with effective sleep treatment. <EligibilityCriteria:>Inclusion Criteria:
* OIF/OEF veteran
* Between the ages of 18 and 50 years old
* Not taking medications known to affect sleep or wake function for 2 weeks
Additional selection criteria for PTSD subjects are:
* Trauma occurred three months or more before study entry
* Meeting diagnostic criteria for current PTSD according to the Clinician Administered PTSD Scale (CAPS)
* Participants will remain in ongoing counseling services
Additional selection criterion for non-PTSD healthy subjects:
* Not meet DSM-IV diagnostic criteria for current PTSD
* Have a total score \< 13 on the Beck Depression Inventory
* Participants who are active-duty military personnel will be required to obtain permission from their commander to participate in this study.
Exclusion Criteria:
* Current diagnosis of untreated, severe depression as determined by the Structured Clinical Interview for Diagnostic and Statistical Manual- IV Edition (DSM-IV), non-patient version
* Beck Depression Inventory \> 30
* History of psychotic or bipolar disorder
* Current history (within 3 months) of substance or alcohol abuse
* Significant or unstable acute or chronic medical conditions
* Other current sleep disorders
* Presence of implanted devices or metal in body such as cardiac pacemaker, aneurysm clip, ear implant, shrapnel, neurostimulators or other metal devices
* Fear of closed spaces
* Previous radiation exposure (past year) that exceeds recommended safety limits
* Pregnancy or breast feeding
* Resting blood pressure \< 90/60 at the screening physical examination
* Heart rate \> 100 beats/minutes
* Current use of a beta-blocker
* Use of an alpha-1 antagonist agent in the previous 3 weeks
* Refusal to follow the safety measures in the case of use of a phosphodiesterase 5 inhibitor (Cialis, Viagra, Levitra)
* Unexpected, untreated, or serious EKG findings <Conditions:>Non PTSD, PTSD <Interventions:>Prazosin, Placebo | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>To Compare the Effectiveness of Suvorexant vs Placebo on Sleep Pressure in Hypertensives With Insomnia <BriefSummary:>The purpose of this study is to compare the effectiveness and safety of suvorexant versus placebo on sleep pressure and circadian rhythm in hypertensives with insomnia. <EligibilityCriteria:>Inclusion Criteria:
\[At interim registration\]
Patients who meet the following criteria are eligible for the study:
1. Patients who give written consent of agreement to voluntarily participation in the clinical study
2. Age 20 years or older
3. Sex: Male or female
4. Treatment classification: Outpatient
5. Hypertensive patient who meet at least one of the following:
* Under antihypertensive medications
* Clinic systolic blood pressure (SBP) less than 160 mmHg
6. Patients with insomnia who meet at least one of the following:
* Patients with any one of the following symptoms twice a week or more and at least 1 month-continuation: difficulty initiating sleep (time to sleep onset 2 hours or more longer than usual), difficulty maintaining sleep (awakening twice or more in the night), early morning awakening (awakening 2 hours or more earlier in the morning than usual), difficulty sleeping deeply (no soundly asleep feeling at the time of awakening in the morning).
b. Patients with interference with social or occupational function due to the above insomnia symptoms
\[At official registration\]
Patients who meet the following criteria at the end of run-in period are eligible for the study:
1. Stable unchanged antihypertensive medication for run-in period.
2. Average morning home SBP more than 135 mmHg during 5 days before the end of run-in period.
Exclusion Criteria:
1. Patients with serious liver disease.
2. Patients with serious respiratory disease.
3. Patients with secondary hypertension
4. Patients with sleep apnea syndrome
5. Patients with history of narcolepsy or cataplexy
6. Patients with history of organic cerebral disorders
7. Patients with history of hypersensitivity to suvorexant
8. Patients received CYP3A strongly-inhibitors including itraconazole, clarithromycin and ritonavir, saquinavir, nelfinavir, indinavir, telaprevir and voriconazole at the start of the run-in period
9. Patients with average clinic SBP of 160 mmHg or more at the start of the run-in period
10. Patients received suvorexant and other hypnotic at the start of the run-in period on a regular basis
11. Patients who are breast-feeding, pregnant, possibly pregnant, or plan to become pregnant
12. Patients who are considered not to be eligible for this study by their investigator or sub-investigator <Conditions:>Hypertension, Insomnia <Interventions:>suvorexant, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'BMI', 'Nighttime systolic blood pressure', 'Nighttime diastolic blood pressure' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD) <BriefSummary:>The aim of this Phase III study was to assess the efficacy of idebenone on pulmonary function, motor function, muscle strength and quality of life in patients with DMD. Furthermore, the safety and tolerability of idebenone was assessed. <EligibilityCriteria:>Inclusion Criteria:
1. Patients 10 - 18 years of age at Baseline.
2. Signed and dated informed consent.
3. Documented diagnosis of DMD or severe dystrophinopathy and clinical features consistent of typical DMD at diagnosis (i.e. documented delayed motor skills and muscle weakness by age 5 years). DMD should be confirmed by mutation analysis in the dystrophin gene or by substantially reduced levels of dystrophin protein (i.e. absent or \<5% of normal) on Western blot or immunostain.
4. Ability to provide reliable and reproducible repeat PEF within 15% of the first assessment (i.e. Baseline vs. Screening).
5. Patients assessed by the investigator as willing and able to comply with the requirements of the study, possess the required cognitive abilities and are able to swallow study medication.
Exclusion Criteria:
1. Patients dependent on assisted ventilation at Screening and/or Baseline (defined as non-invasive nocturnal ventilation, daytime non-invasive ventilation or continuous invasive ventilation).
2. Patients with documented DMD-related hypoventilation for which assisted ventilation is needed according to current standard of care guidelines (e.g. FVC\< 30%) or is required in the opinion of the Investigator.
3. Patients with a percent predicted PEF \> 80% at Baseline.
4. Patients unable to form a mouth seal to allow precise respiratory flow measurements and mouth pressures.
5. Symptomatic heart failure (high probability of death within one year of Baseline) and/or symptomatic ventricular arrhythmias.
6. Participation in the previous Phase II or Phase II Extension study (SNT-II-001 or SNT-II-001-E) for idebenone.
7. Participation in any other therapeutic trial and/or intake of any investigational drug within 90 days prior to Baseline.
8. Use of carnitine, creatine, glutamine, oxatomide, or any herbal medicines within 30 days prior to Baseline.
9. Use of coenzyme Q10 or vitamin E (if taken at a dose of 5 times above the daily physiological requirement) within 30 days prior to Baseline.
10. Any previous use of idebenone.
11. Any concomitant medication with a depressive or stimulating effect on respiration or the respiratory tract.
12. Planned or expected spinal fixation surgery during the study period (as judged by the investigator).
13. Asthma, bronchitis/COPD, bronchiectasis, emphysema, pneumonia or the presence of any other non-DMD respiratory illness that affects PEF.
14. Chronic use of beta-2 agonists or any use of other bronchodilating medication (e.g. inhaled steroids, sympathomimetics, anticholinergics).
Please note: Chronic use if defined as a daily intake for more than 14 days.
15. Moderate or severe hepatic impairment or severe renal impairment.
16. Prior or ongoing medical condition or laboratory abnormality that in the Investigator's opinion could adversely affect the safety of the subject.
Please note: Patients who suffer from a severe, unstable condition including (but not limited to) cancer, auto-immune diseases, haematological diseases, metabolic disorders or immunodeficiencies, and who are at risk of an aggravation unrelated to the study condition, can only be included in the study if accepted in writing by the Sponsor's Medical Monitor.
17. Relevant history of or current drug or alcohol abuse or use of any tobacco/marijuana products/smoking
18. Known individual hypersensitivity to idebenone or to any of the ingredients/excipients of the study medication
19. Systemic glucocorticoid therapy
1. Chronic use of systemic glucocorticoid therapy for DMD related conditions within 12 months of Baseline (the "12 month non-use period")
2. More than 2 rounds of acute systemic glucocorticoid burst therapy (of ≤2 week duration) for non-DMD related conditions within the 12 month non-use period
3. Use of any round of systemic glucocorticoid burst therapy of longer than 2 weeks duration within the 12 month non-use period
4. Use of systemic glucocorticoid burst therapy less than 8 weeks prior to baseline <Conditions:>Muscular Dystrophy, Duchenne, Ambulatory Care <Interventions:>Placebo, Idebenone | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study of Colorectal Procedures With the Levita Magnetic Surgical System <BriefSummary:>The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing colorectal procedures. <EligibilityCriteria:>Inclusion Criteria:
* Subject is at least 18 years of age
* Subject is scheduled to undergo elective colorectal surgery
Exclusion Criteria:
* Significant comorbidities
* Subjects with pacemakers, defibrillators, or other electromedical implants
* Subjects with ferromagnetic implants
* Clinical history of impaired coagulation
* Subject has an anatomical abnormality noted after initiation of index procedure that would prevent device use
* Subject is not likely to comply with the follow-up evaluation schedule
* Subject is participating in another clinical trial <Conditions:>Colorectal Procedures <Interventions:>Levita Magnetic Surgical System | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>An Extension Study to Provide Continued Bevacizumab Therapy to Participants With Solid Tumors Who Were Previously Enrolled in a Roche/Genentech Sponsored Study <BriefSummary:>This single-arm, open-label, multicenter extension study will provide continued bevacizumab therapy to participants with solid tumors who were previously enrolled in a Roche/Genentech sponsored study and who derived benefit from the bevacizumab therapy. Participants will receive the same dose and regimen of bevacizumab as used in the previous parent trial and continue this treatment until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first. <EligibilityCriteria:>Inclusion Criteria:
* Participant is treated with bevacizumab at the end of the Roche/Genentech sponsored parent trial and continues to have benefit as judged by the investigator
* Eligible for continuation of bevacizumab treatment at the end of a parent trial, according to parent trial protocol
* Able to comply with this extension study protocol (MO25757)
Exclusion Criteria:
* Evidence of disease progression assessed according to parent trial protocol during the screening phase for this extension study
* Evidence of any adverse event potentially attributable to bevacizumab, for which the local label recommends permanent discontinuation
* A treatment interruption with bevacizumab of more than 42 days since the last administration of bevacizumab in the parent trial
* Evidence of any other disease that would put the participant at high risk for treatment-related complications <Conditions:>Neoplasms <Interventions:>Bevacizumab | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy <BriefSummary:>Prospective, open-label, controlled (active comparator), randomized study of 8 weeks follow-up for the evaluation of the efficacy of extended release quetiapine (quetiapine XR) versus Sertraline in addition to previous mood stabilizer treatment (lithium or valproate at stable and clinically therapeutic blood levels) in the treatment of the adult bipolar depression. This multicentric study will be featured in two sites in Spain. <EligibilityCriteria:>Inclusion Criteria:
* Adult ambulatory patients diagnosed of bipolar disorder I or II, current depressive episode (DSM-IV-TR 4ª Ed: 296.5x or 296.89 codes)
* Have been treated with only one mood stabilizer (lithium or valproate) in optimal and stable doses during at least the previous 4 weeks to randomization
* Hamilton Depression Rating Scale (HDRS-17) total score ≥ 20 and Young Mania Rating Scale (YMRS) total score ≤ 14 at the screening and randomization visits - Informed consent signed
Exclusion Criteria:
* Patients with any axis I or II Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) diagnoses different from bipolar disorder I or II - Length of current depressive episode less than 2 weeks or more than 12 months
* Having been treated with more than one mood stabilizer or any mood stabilizer other than Lithium or valproate, any antidepressant, any antipsychotic or any CP450-3A inductor/inhibitor within the 7 days period prior to randomization <Conditions:>Bipolar Disorder, Bipolar Depression <Interventions:>Extended release quetiapine (quetiapine XR), Sertraline, adequate mood stabilizer | 'Age Continuous', 'Sex: Female, Male', 'Montgomery Asberg Depression Rating Scale (MADRS) total score, Continuous', 'Clinical Impression Global Scale - Bipolar total score (CGI-BP-M), Continuous', 'Hamilton Anxiety Rating Scale (HARS) total score, Continuous' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study to Evaluate Immunogenicity & Safety of an Investigational Influenza Vaccine in Adults <BriefSummary:>The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A. <EligibilityCriteria:>Inclusion Criteria:
* A male or female aged 18 years or above at the time of the first vaccination.
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject.
* Satisfactory baseline medical assessment by history and physical examination. Stable health status is defined as the absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrolment.
* Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
* Female subjects of childbearing potential may be enrolled in the study, if the subject:
* has practiced adequate contraception for 30 days prior to vaccination, and
* has a negative pregnancy test on the day of vaccination, and
* has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion Criteria:
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. Potential subjects in the follow-up phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
* Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
* Presence of an axillary temperature \>= 37.5ºC, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
* Diagnosed with cancer, or treatment for cancer, within the past 3 years.
* Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
* Persons with a history of histological-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enrol within 3 years of diagnosis, but other histological types of skin cancer require a 3 year untreated and disease-free window as above.
* Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic hormonal therapy are excepted and may enrol.
* Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
* Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period.
* Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period.
* Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
* An acute evolving neurological disorder or history of Guillain-Barré syndrome.
* Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
* Administration of any vaccines within 30 days before vaccination.
* Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
* Pregnant or lactating female
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study. <Conditions:>Influenza <Interventions:>GSK investigational vaccine GSK2340272A | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study of RO7172508 in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors <BriefSummary:>This study was to determine the maximum-tolerated dose (MTD) and/or the optimal biological dose (OBD) as well as the optimal schedule for intravenous (IV) and subcutaneous (SC) administrations of RO7172508 as monotherapy, with or without obinutuzumab pre-treatment, in participants with locally advanced and/or metastatic carcinoembryonic antigen (CEA)-positive solid tumors who have progressed on standard of care (SOC) treatment, are intolerant to SOC, and/or are non-amenable to SOC. This study was conducted in two parts. Part I of the study consisted of an IV single participant cohort/multiple-ascending dose-escalation to evaluate the safety of RO7172508. Part II was a multiple participant cohort/multiple-ascending dose-escalation to define the MTD and/or OBD of RO7172508 administered as single agent, IV and/or SC, in participants with tumors that are expressing high as well as moderate/low-CEA. The study switched from Part I to Part II when the maximum planned dose for Part I was reached or the occurrence of a RO7172508-related Grade \>= 2 adverse event (AE) or dose-limiting toxicity (DLT) was observed, whichever comes first. The Sponsor may decide to switch from Part I to Part II in the absence of an observed RO7172508-related Grade \>= 2 toxicity or prior to maximum planned dose for Part I. <EligibilityCriteria:>Inclusion Criteria:
* For Part I: participants with locally advanced and/or metastatic solid tumor with confirmed cytoplasmic and/or membranous high CEA expression in tumor tissue is required. Participants must have progressed on a SOC therapy, be intolerant to SOC, and/or are non-amenable to SOC.
* For \<12 mg dose cohorts, serum CEA levels below a certain threshold is required as follows:
* For dose cohorts 65-159 microgram, a sCEA level of \< 22 ng/mL
* For dose cohorts 160-399 microgram, a sCEA level of \< 28 ng/mL
* For dose cohorts 400-799 microgram, a sCEA level of \< 44 ng/mL
* For dose cohorts 800-1599 microgram, a sCEA level of \< 70 ng/mL
* For the dose cohort of 1.6-3.1 milligram, a sCEA level of \< 123 ng/mL
* For the dose cohort of 3.2-6.3 milligram, an sCEA level of \< 229 ng/mL.
* For the dose cohort of 6.4-11.9 milligram, an sCEA level of \< 440 ng/mL. If dose fractionation is implemented, the sCEA threshold for inclusion should correspond to the dose range of the first dose administered.
* For Part II, participants with locally advanced and/or metastatic solid tumor expressing cytoplasmic and/or membranous high-CEA or moderate/low-CEA on archival material, who have progressed on a SOC therapy, are intolerant to SOC, and/or are non-amenable to SOC. Participants must have a lesion amenable to biopsy (except participants with NSCLC, which may be enrolled with archival tissue available only). For participants with colorectal cancer (CRC) only, the CEA assessment by immunohistochemistry should be performed but the result is not required to enroll the participant.
* Radiologically measurable disease according to RECIST v1.1.
* Life expectancy of \>= 12 weeks
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.
* All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade \<= 1 or returned to baseline except alopecia (any grade) and Grade 2 peripheral neuropathy.
* Adequate hematological, liver, renal, and lung function
* For women: agree to remain abstinent or use two contraceptive methods that result in a failure rate of \<1% per year from screening until 2 months after the last dose of RO7172508 and have a negative pregnancy test within one week prior to the first study treatment administration
* For men: remain abstinent or use contraceptive measures such as a condom plus an additional contraceptive method that together result in a failure rate of \<1% per year, with partners who are woman of childbearing potential and refrain from donating sperm during the study
Exclusion Criteria:
* History or clinical evidence of central nervous system (CNS) primary tumors or metastases unless they have been previously treated, are asymptomatic, and have had no requirement for steroids or enzyme-inducing anticonvulsants in the last 14 days before screening.
* Non-irradiated lesions \> 2 cm at critical sites where tumor swelling induced by RO7172508 is expected to lead to significant complications.
* Another invasive malignancy in the last 2 years
* Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or contraindicate the use of an investigational drug.
* Uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia that requires treatment with the exceptions of atrial fibrillation and paroxysmal supraventricular tachycardia, and history of myocardial infarction within 6 months of enrollment.
* Active or uncontrolled infections.
* Known hepatitis B or C
* Major surgery or significant traumatic injury \< 28 days prior to the first RO7172508 administration or anticipation of the need for major surgery during study treatment.
Specific Exclusion Criteria if Pre-treatment with Obinutuzumab is Implemented:
* Known HIV
* Positive test results for HBV infection, HBcAb indicating an active viral infection and positive test results for HCV.
* Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA).
* History of progressive multifocal leukoencephalopathy.
* Active TB requiring treatment within 3 years prior to baseline.
* Latent TB diagnosed during Screening.
* Positive test results for human T-lymphotropic virus 1 <Conditions:>Solid Tumors <Interventions:>RO7172508, Obinutuzumab, Tocilizumab | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Lapatinib and Trastuzumab With or Without Endocrine Therapy <BriefSummary:>We think that lapatinib will help to shrink your tumor when given prior to the main or primary therapy for the kind of breast cancer you have been diagnosed with. When treatment is given before the main or primary therapy, it is called neoadjuvant therapy. We will compare lapatinib with lapatinib plus trastuzumab (herceptin) for 12 weeks. If your tumor is estrogen receptor positive (ER positive), estrogen deprivation will also be given to you. Tumors that are ER positive have a lot of estrogen receptors found in them. This is also called "over expression" or amplification of estrogen receptors.
The most important information we will get from this study is to see the response to "neoadjuvant" (treatment given before the main treatment), lapatinib with trastuzumab (herceptin) in your tumor tissue sample. <EligibilityCriteria:>Inclusion Criteria:
* All patients must be female.
* Signed informed consent.
* Locally advanced breast cancers or primary breast cancers are eligible. Locally advanced cancers must be of clinical and/or radiologic size \>3 cm, or \>2 cm with clinical evidence of axillary nodal involvement. (If tumors are less than 3 cm, we will use radiologically measured tumor size to determine the minimal tumor size for eligibility and in assessing tumor size during follow-up).
* HER2 overexpressing tumors defined as HercepTest score of 3+, or \> 10% cells moderately or strongly HER2 positive by other methods, or Allred semi-quantitative score of \>5, or gene amplified.
* Negative serum pregnancy test (HCG) within 7 days of starting study, if of child-bearing potential.
* Kidney and liver function tests - all within 1.5 times the institution's upper limit of normal.
* Performance status (WHO scale) less than 2 and life expectancy more than 6 months.
* Age at least 18 years.
* No brain or leptomeningeal disease.
* No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
Note: The presence of pathological involvement of axillary nodes will be assessed and agreed upon by two investigators.
Exclusion Criteria:
* Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
* Severe underlying chronic illness or disease.
* Cardiomyopathy or baseline LVEF less than 50%.
* Other investigational drugs while on study.
* Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded
* Taking any lapatinib-prohibited medication within 7 days of first dose of study medications. (See Prohibited Medications List in protocol.) <Conditions:>Breast Cancer <Interventions:>Lapatinib, Trastuzumab, Endocrine | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Invasive Candidiasis in Saudi ICUs <BriefSummary:>Epidemiology and clinical outcomes of invasive candidiasis in critically ill patients in Saudi Arabia is not well studied. This observational study objectives include to determine the epidemiology, risk factors and outcomes of invasive Candida infection in critically ill patients in Saudi Arabia. <EligibilityCriteria:>Inclusion Criteria:
* adult patients (\> 18 years)
* develop invasive candidiasis as per prespecified definitions during ICU stay
* In addition, patients who had invasive candidiasis within 72 hours of ICU admission will be included
Exclusion Criteria:
* Diagnosis of invasive candidiasis (definite or probable) more than 72 hours before ICU admission.
* Diagnosis of invasive candidiasis (definite or probable) within 72 hours of ICU admission, but the admission to ICU for an unrelated reason.
* Readmission to the ICU during the same hospitalization with invasive candidiasis occurring during one of the previous admissions. <Conditions:>Invasive Candidiasis <Interventions:>No Interventions | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study to Compare TP-434 and Ertapenem in Community-acquired Complicated Intra-abdominal Infections <BriefSummary:>This is a Phase 2, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of two dose regimens of TP-434 compared with ertapenem in the treatment of adult community-acquired complicated intra-abdominal infections (cIAIs). <EligibilityCriteria:>Inclusion Criteria:
* Abdominal pain/discomfort with onset prior to hospitalization
* Evidence of a systemic inflammatory response
* Physical findings consistent with intra-abdominal infection (IAI)
* Clinical diagnosis of community-acquired IAI requiring urgent surgical or percutaneous intervention and not expected to require antibacterial therapy for longer than 14 days
* Body mass index (BMI) of ≤ 30 kilograms per square meter (kg/m\^2)
* Able to provide informed consent. If the participant is unable to provide informed consent, the participant's legally acceptable representative may provide written consent in accordance with institutional guidelines
* If female, not pregnant or nursing or, if of child-bearing potential either: will commit to use at least two medically accepted, effective methods of birth control (for example, condom, oral contraceptive, indwelling intrauterine device, hormonal implant/patch, injections, approved cervical ring) during study drug dosing and for 90 days following last study drug dose or practicing sexual abstinence
Exclusion Criteria:
* Symptoms related to diagnosis of complicated appendicitis (if current diagnosis) for \< 24 hours prior to current hospitalization
* Previously hospitalized or admitted to a healthcare facility within the last 6 months
* Managed by Staged Abdominal Repair or other open abdomen technique
* Known at study entry to have an IAI caused by a pathogen(s) resistant to both study drug antibiotics
* Acute Physiology and Chronic Health Evaluation (APACHE) II score \> 25
* Unlikely to survive the 6-8 week study period
* Any rapidly-progressing disease or immediately life-threatening illness, including acute hepatic failure, respiratory failure and septic shock
* Requirement for vasopressors at therapeutic dosages
* Renal failure
* Presence or possible signs of hepatic disease
* Hematocrit \< 25% or hemoglobin \< 8 grams per deciliter (g/dL)
* Neutropenia with absolute neutrophil count \< 1000 cells per cubic millimeter (mm\^3)
* Platelet count \< 50,000/mm3
* Abnormal coagulation tests or participant on anticoagulants
* Immunocompromised condition, including known human immunodeficiency virus (HIV) positivity or acquired immune deficiency syndrome (AIDS), organ (bone marrow) transplant recipients, and hematological malignancy. Immunosuppressive therapy, including use of high-dose corticosteroids (for example, \> 40 milligrams \[mg\] prednisone or equivalent per day for greater than 2 weeks)
* History of hypersensitivity reactions to tetracyclines or carbapenems
* Participation in any investigational drug or device study within 30 days prior to study entry
* Known or suspected central nervous system (CNS) disorder that may predispose to seizures or lower seizure threshold
* Previously received TP-434 in a clinical trial
* More than 24 hours duration of systemic antibiotic coverage for current condition
* Received ertapenem or any other carbapenem, or tigecycline for the current infection
* Need for concomitant systemic antimicrobial agents other than study drug or received systemic (IV or oral) antibiotics in the last 3 months
* Refusal of mechanical ventilation, dialysis or hemofiltration, cardioversion or any other resuscitative measures and drug/fluid therapy at time of consent
* Known or suspected inflammatory bowel disease or associated visceral abscess <Conditions:>Complicated Intra-abdominal Infection <Interventions:>TP-434, Ertapenem, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study of Certain Prevail Implants Used to Treat All Types of Edentulism in the Maxilla and Mandible <BriefSummary:>This observational, prospective clinical study evaluates the performance of the Certain Prevail implant system to show potential crestal bone and soft tissue preservation following the crestal bone. It will also evaluate implant performance.
Study (null) hypothesis: The preservation of crestal bone for the Certain Prevail implants will be the same as that for standard non-platform switched implants from contemporaneous studies (historical controls). <EligibilityCriteria:>Inclusion Criteria:
* patients of either sex and any race greater than 18 years of age
* patients for whom a decision has already been made to use dental implants for treating an existing dental condition specifically:
1. dental implants restored as single tooth replacements, short and long fixed bridges, overdenture, or fixed full denture.
2. a temporary healing abutment will be placed on implant during implant placement surgery (single stage procedure).
* patients must be physically able to tolerate conventional surgical and restorative procedures
* patients must agree to be evaluated for each study visit, especially the yearly follow-up visit
Exclusion Criteria:
* patients with active infection or severe inflammation in the areas intended for implant placement
* patients with a \>10 cigarette per day smoking habit
* patients with uncontrolled diabetes mellitus
* patients with metabolic bone disease
* patients who have had treatment with therapeutic radiation to the head within the past 12 months
* patients in need of allogenic bone grafting at the site of the intended study implant for augmentation purposes. Grafting for treatment of dehiscence or fenestration must have occurred at least 8 weeks prior to implant placement surgery
* patients who are pregnant at the screening visit
* patients with evidence of severe para-functional habits such as bruxing or clenching
* patients with less than 6 weeks of healing time post tooth extraction at the intended treatment site <Conditions:>Partial Edentulism <Interventions:>No Interventions | 'Age, Categorical', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Oxaliplatin, Capecitabine, and Radiation Therapy in Patients Undergoing Surgery for Stage II, III, IV Esophageal Cancer <BriefSummary:>RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with radiation therapy works in treating patients undergoing surgery for stage II, stage III, or stage IV esophageal cancer. <EligibilityCriteria:>DISEASE CHARACTERISTICS:
* Diagnosis of squamous cell carcinoma of the esophagus or adenocarcinoma of the esophagus
* Stage II-IVA disease as determined by clinical staging, including endoscopy and CT scan with or without endoscopic ultrasound
* Bulk of gastroesophageal junction tumor should be in the esophagus
* Bronchoscopy with biopsy and cytology required if primary esophageal cancer is \< 26 cm from incisors
* No known brain metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Life expectancy \> 4 months
* WBC \> 4,000/mm³
* ANC \> 1,500/mm³
* Platelet count \> 100,000/mm³
* Hemoglobin \> 9 g/dL
* Bilirubin normal
* Creatinine normal
* AST \< 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 3 times ULN
* Able to take oral medication or undergo enteral administration of medication
* No peripheral neuropathy ≥ grade 2
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 90 days after completion of study treatment
* No hypersensitivity to platinum compounds, fluoropyrimidines, or antiemetics administered in combination with protocol-directed chemotherapy
* No concurrent uncontrolled illness, including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness or social situation that would preclude study compliance
* No history of second malignancy except for curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
* Other cured tumors allowed at discretion of the principal investigator
* No known HIV or hepatitis B or C (active and/or previously treated)
PRIOR CONCURRENT THERAPY:
* No prior therapy for esophageal cancer
* No other concurrent investigational agents <Conditions:>Esophageal Cancer <Interventions:>capecitabine, oxaliplatin, gene expression analysis, microarray analysis, reverse transcriptase-polymerase chain reaction, adjuvant therapy, biopsy, conventional surgery, neoadjuvant therapy, quality-of-life assessment, radiation therapy | 'Age Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study of NGR-hTNF in Combination With Doxorubicin in Solid Tumors <BriefSummary:>The main objective of the trial is to document the safety of the combination (escalation doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of doxorubicin, 75 mg/sqm). Safety will be established by clinical and laboratory assessment according to National Cancer Institute Common Toxicity Criteria (NCI-CTC ). <EligibilityCriteria:>Inclusion Criteria:
* Patients ≥18 years old with proven advanced or metastatic solid tumor not amenable to any clinical improvement by current standard treatments and previously treated with a non cumulative dose of anthracyclines (\<300 mg/sqm) or chemotherapy naïve.
* Life expectancy more than 3 months.
* ECOG performance status 0 - 2.
* Normal cardiac function (left ventricular ejection fraction \[LVEF\] ≥55%) and absence of uncontrolled hypertension.
* Absence of any conditions involving hypervolemia and its consequences.
* Adequate baseline bone marrow, hepatic and renal function, defined as follows:
Neutrophils \> 1.5 x 10\^9/L and platelets \>100 x 10\^9/L Bilirubin \< 1.5 x ULN AST and/or ALT \< 2 x ULN Serum creatinine \< 1.5 x ULN
* Patients may have had prior therapy providing the following conditions are met:
* Chemo, radio, hormonal, immuno or anti-vascular therapy: wash-out period of 28 days.
* Surgery: wash-out period of 14 days.
* Patients must give written informed consent to participate in the study.
Exclusion Criteria:
* Concurrent anticancer therapy
* Patients must not receive any other investigational agents while on study
* Patients with a LVEF \<55%
* New York Heart Association class III or IV cardiac disease
* Acute angina
* Patients with myocardial infarction within the last six (6) months
* Patient with significant peripheral vascular disease
* Thrombosis of main portal vein
* Previous signs of severe toxicity doxorubicin related
* Previous signs of cardiotoxicity doxorubicin related
* Patients previously treated with a cumulative dosage of anthracyclines ≥300 mg/m\^2
* Clinical signs of CNS involvement
* Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
* Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
* Pregnancy or lactation. Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of child-bearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration <Conditions:>Cancer <Interventions:>NGR-hTNF, Doxorubicin | 'Age, Categorical', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>TVB- 2640 in Combination With Bevacizumab in Patients With First Relapse of High Grade Astrocytoma <BriefSummary:>Randomized phase 2 study TVB-2640 in combination with Bevacizumab versus Bevacizumab alone. <EligibilityCriteria:>Inclusion Criteria:
* At least 18 years of age
* Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
* Histologically confirmed high-grade astrocytoma
* Progression following standard combined modality treatment with radiation and temozolomide chemotherapy
* Recovered from reversible toxicities of prior therapy to Grade 0 or Grade 1
* ECOG Performance Status of 0 to 2
* Life expectancy of at least 3 months
* Adequate renal and liver function: AST/ALT ≤ 3 x ULN, Bilirubin ≤ 1.5 times ULN, Creatinine ≤ ULN
* Adequate hematologic status (without hematologic support): Hemoglobin ≥ 9 g/dL, ANC ≥ 1500 cells/ml, Platelets ≥ 100,000 cells/ml
* All women of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (for example, surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through six months after the last dose.
Exclusion Criteria:
* Receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug
* Evidence of acute intracranial or intratumoral hemorrhage either by MRI or CT scan. Subjects with resolving hemorrhage changes punctuate hemorrhage, or hemosiderin are eligible
* Unable to undergo MRI scan (e.g., pacemaker)
* Received enzyme-inducing anti-epileptic agents within 14 days of study drug (e.g., carbamazepine, phenytoin, phenobarbital, primidone)
* Not recovered to a NCI CTCAE v.4.03 Grade ≤ 1 from AEs (except alopecia and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other medications that were administered prior to study drug
* Evidence of wound dehiscence
* Pregnant or breast-feeding
* Clinically significant Dry Eye or necessary contact lens use
* Serious intercurrent illness such as: Hypertension (two or more blood pressure readings performed at screening of \> 150 mmHg systolic or \> 100 mmHg diastolic) despite optimal treatment, Non-healing wound or ulcer, Uncontrolled life threatening cardiac arrhythmias, Untreated hypothyroidism, Uncontrolled active infection, Symptomatic congestive heart failure or unstable angina pectoris within 3 months prior to study drug, Gastrointestinal perforation, abdominal fistula, intra-abdominal abscess within 1 year
* Inherited bleeding diathesis or coagulopathy with the risk of bleeding
* HIV , Hepatitis B or C documented infections
* Received any of the following prior anticancer therapy: Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy (RIT), or intra-operative radiotherapy (IORT). Note: stereotactic radiosurgery (SRS) is allowed, Non-antiangiogenic therapy (including investigational agents and small molecular kinase inhibitors) within 7 days or 5 half-lives, whichever is shorter, prior to the first dose of study drug, Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug, Nitrosoureas or mitomycin C within 42 days or metronomic/protracted <Conditions:>Astrocytoma <Interventions:>Bevacizumab, TVB-2640 | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Clinical Trial of Sound-Based Versus Behavioral Therapy for Tinnitus <BriefSummary:>The purpose of this study is to determine if a novel sound-based therapy in comparison to standard of care (cognitive behavioral therapy) results in reducing tinnitus-related effects for people with bothersome tinnitus. <EligibilityCriteria:>Inclusion Criteria:
* Age ≥18 years
* Primary and persistent tinnitus (6 months or longer in duration)
* Tonal tinnitus
* Dominant tinnitus frequency measured between 0.2 and 10 kHz
* Tinnitus Questionnaire score
* No current participation in other tinnitus therapy program
* Willing and able to listen to the acoustic prescription for 4-6 hours daily during the trial
* Able to pass the Tone Audibility Assessment with factor of 1.1
Exclusion Criteria:
* Secondary/somatic tinnitus due to a suspected underlying disease
* Atonal, pulsatile, intermittent, or occasional tinnitus
* Any hearing threshold \>70 dB HL from .25-8kHz, unless subject passes the Tone Audibility Assessment screening with a factor of 1.1
* Any health or other problems that may prevent the person from completing the study procedures as determined by investigator
* Participant reports current suicidal ideation and/or homicidal ideation
* Use of medication which may trigger tinnitus \[e.g., quinine derivatives, aminoglycoside antibiotics, daily high dose non-steroidal anti-inflammatory drugs ≥1000 mg, salicylates (when not prescribed as a low dose for cardiac health), loop diuretics and chemotherapy agents like cis-platin\]
* Conductive hearing loss
* Visible congenital or traumatic deformity of the ear
* History of active drainage from the ear within the past 90 days
* History of sudden or rapidly progressive hearing loss within the past 90 days
* Inability to read and respond appropriately to instructions that appear on the computer screen, and/or to perform all of the procedures
* Previous use of Desyncra for Tinnitus Therapy System <Conditions:>Tinnitus <Interventions:>Desyncra, Cognitive Behavioral Therapy | 'Age, Categorical', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |