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Target Study Title: The Impact of a Pharmacist Intervention on Post-discharge Hypnotic Drug Discontinuation in Geriatric Inpatients: a Before-after Study Target Study Description: #Study Description Brief Summary This study investigated whether a multifaceted approach was associated with hypnotic drug discontinuation at one month after discharge Detailed Description Chronic use of hypnotic agents is prevalent in older adults, who as a result are at increased risk for certain adverse events, such as day-time drowsiness and falls. Multiple strategies to discontinue hypnotics have been tested in geriatric patients, but evidence remains scarce. Hence, we aimed to investigate a multicomponent intervention to reduce hypnotic drug use in geriatric inpatients. A before-after study was performed on the acute geriatric wards of a teaching hospital. The before cohort received usual care while intervention patients were exposed to a pharmacist-led deprescribing intervention, comprising education of health care personnel, access to standardized discontinuation regimens, active patient involvement and support of transitional care. The primary outcome was hypnotic drug discontinuation at one month after discharge. #Intervention - OTHER : multifaceted pharmacist-led intervention - * Educational sessions were provided to the physicians and nursing staff. * Discontinuation regimens were developed. Prescribers were free to choose whether or not to actually use them. The regimens were derived from the regimen used by Petrovic et al. and encouraged a switch from any benzodiazepine to lorazepam 1 mg OD for one week followed by drug stop. Z-drugs were switched to zolpidem 5 mg OD for one week followed by drug stop. If deemed necessary, a pro re nata regimen of lorazepam 1 mg or zolpidem 5 mg for one additional week was prescribed respectively. The discontinuation regimens were incorporated into the hospital's electronic prescribing system. Furthermore, a clinical decision support system provided additional support. * Patient education sessions were provided upon enrolment and at discharge. Specific patient leaflets were used to facilitate patient education. * The patient's primary care physician and, if applicable, the nursing home were informed by phone. - OTHER : Usual care group - all patients received comprehensive geriatric care without any systematic clinical pharmacist involvement regarding deprescribing of hypnotics. Treating physicians were not actively informed on the patient's participation in this particular study. Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Patients aged >= 75 years * Admitted to an acute geriatric ward of UZ Leuven * Documented chronic use of a hypnotic drug (hypnotics were defined as benzodiazepines and Z-drugs and chronic hypnotic drug use was defined as hypnotic use for at least five days a week during a minimum of four consecutive weeks. * Indication: insomnia, anxiety or an undefined reason Exclusion Criteria: * Concomitant use of multiple benzodiazepines and/or Z-drugs * Discontinuation of the hypnotic drug prior to enrollment * Estimated discharge from the hospital within 72 hours of admission * No command of the Dutch language * Severe psychiatric or neurological disease (e.g. bipolar disorder, epilepsy or dystonia) or a severe acute medication condition in the opinion of the treating physician * End-of-life care. Study participants who died during their hospital stay were excluded from the analysis as their medication at discharge could not be evaluated. In case of any readmission, only the first admission was included in the analysis. Sex : ALL Ages : - Minimum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	300
Target Study Title: REgistry of CrossBoss and Hybrid Procedures in FrAnce, the NetheRlands, BelGium and UnitEd Kingdom Target Study Description: #Study Description Brief Summary The successful re-opening of a blocked coronary artery has a beneficial effect on the further clinical course (e.g. improvement of clinical symptoms, improved quality of life, increased heart function, etc.). However, some types of blockages are more difficult to open by means of percutaneous coronary intervention (PCI), a procedure which is commonly used for these kind of problems. This procedure makes use of a technique in which special wires, balloons, stents (metal or polymeric tube-like structures) and devices are utilized to re-open or revascularize a blockage in one of the blood vessels of the heart. This type of blockages are chronic total occlusions (CTO). CTOs have certain characteristics which impede the revascularization of the blood vessel. Nevertheless, remarkable progress has been achieved over the past few years in the area of CTO revascularization or CTO PCI. A large range of CTO dedicated materials, such as guidewires, guiding catheters, devices, balloons and stents, as well as different techniques have been developed. However, at present, reluctance to open CTOs still exists, due to the indications and outcomes of percutaneous revascularization as well as the technical difficulties which commonly arise during these interventional procedures. The presence of these difficulties results in suboptimal success rates worldwide (±70-80%), despite these many innovations. To increase these success rates and to make sure more interventional cardiologists will treat CTOs, a hybrid treatment algorithm has been developed with the materials (e.g. CrossBoss™ catheter; Bridgepoint Medical, Inc.) and techniques, currently already available. The main purpose of this study is to evaluate the efficacy and efficiency of this hybrid algorithm as well as validating the efficacy of one of the materials (CrossBoss™ catheter), used in this algorithm. To be able to do this, data concerning the patients' demographics, CTO characteristics, procedure and outcome will be collected in the form of a registry. This registry will be performed in several European centra (Belgium, the Netherlands, United Kingdom, France). Since the study will only collect data and no intervention is performed, this will be an observational study. At regular time points, the data will be checked for errors or inconsistencies. To do this, site visits will be performed at pre-defined times. #Intervention - OTHER : Data registration - Patients diagnosed with the presence of one or more chronic total occlusions (CTOs) and who will receive treatment via percutaneous coronary intervention (PCI), which is standard medical practice for these types of lesions. This study will collect data on the patients' demographics, CTO characteristics, procedure and outcome. This will be done in the form of a registry Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Subject shows the presence of at least one coronary chronic total occlusion (CTO), either with or without the presence of one or more other diseased coronary arteries. This CTO must be located in a native coronary artery and have a visually estimated stenosis of 100%, corresponding with Thrombolysis in Myocardial Infarction (TIMI) flow 0. Following the operators judgment, this occlusion is present for more then 3 months. * Subject will be/is treated percutaneously for one or more CTOs via the hybrid techniques. * Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written informed consent before any study-specific procedures are performed. * Subject is willing to comply with all protocol-required follow-up evaluation (patient will be followed during 1 month after PCI procedure to assess any complications and clinical status). Exclusion Criteria: * The occlusion is considered to be less than 3 months present. * Subject is treated via PCI without application of the hybrid algorithm and/or use of the CrossBoss™ and Stingray™ technology (Bridgepoint Medical, Inc.). * Subject is participating in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation. * Subject intends to participate in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation. Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	301
Target Study Title: Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack Target Study Description: #Study Description Brief Summary It is hypothesized that the addition of formal cardiac rehabilitation to standard care will result in long-term improvements in cardiovascular fitness and functional capacity in individuals who have suffered a transient ischemic attack (TIA) or minor stroke. Furthermore, it is proposed that the addition of cardiac rehabilitation will influence depressive symptoms and cognition. Detailed Description A transient ischemic attack (TIA) is defined as an episode of neurological dysfunction caused by focal brain ischemia lasting less than 24 hours. Once an individual has suffered a TIA, preventative measures can be taken to target modifiable risk factors, one of which is physical inactivity. The current proposal focuses on the use of an established model of care (cardiac rehabilitation (CR)) and applies it to those who have suffered a TIA in order to maximize physical activity and minimize risk of future cardiovascular events. This will be a one-group pre/post design study with a 3 month non-intervention period. Participants will undergo measures at baseline and 3 months (non intervention period) then after 6 months of cardiac rehabilitation (cardiovascular fitness, 6 minute walk test, cognition, and depressive symptoms). #Intervention - BEHAVIORAL : Cardiac Rehabilitation - Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training. Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Diagnosed with TIA * Three months post-TIA * Ability to understand the process and instructions for exercise training and provide informed consent Exclusion Criteria: * Resting Blood Pressure greater than 160/100 despite medication * Other cardiovascular morbidity which would limit exercise tolerance (heart failure, abnormal BP responses or STsegment depression > 2 mm, symptomatic aortic stenosis, complex arrhythmias) * Current and extensive exercise participation * Hypertrophic Cardiomyopathy * Unstable Angina * Orthostatic BP decrease of > 20 mm Hg with symptoms * Other musculoskeletal impairments which would limit the participants ability to walk sufficient durations * Pain or other co-morbidities (e.g., unclipped aneurysms, uncontrolled seizures etc.) which would preclude participation * Cognitive or behavioural issues that would limit participation in exercise testing and training Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 100 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	302
Target Study Title: Comparison of Vitrectomy Without Internal Limiting Membrane Peeling Versus Inverted ILM Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes Target Study Description: #Study Description Brief Summary The aim of this study was to determine whether inverted ILM peeling technique could contribute to high reattachment and closure rates after vitrectomy in patients with myopic macular hole retinal detachment (MHRD) in comparison to no ILM peeling. This retrospective study will include 40 patients presenting by myopic macular hole retinal detachment. Exclusion criteria will include history of trauma, choroidal neovascularization, and the presence of a peripheral retinal break or proliferative vitreoretinopathy before the initial surgery. Subjects will be divided into 2 groups; Group 1 will include 20 patients that were treated by vitrectomy without ILM peeling and postoperative gas or silicone oil tamponade with or without cataract surgery. Group 2 will include 20 patients that were treated by vitrectomy with ILMflap technique and postoperative gas or silicone oil tamponade with or without cataract surgery. #Intervention - PROCEDURE : vitrectomy with or without inverted ILM flap technique - vitrectomy without ILM peeling versus vitrectomy with inverted ILM flap technique in cases of macular hole retinal detachment in high myopic eyes. Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: macular hole retinal detachment in high myopic eyes. * Exclusion Criteria: * eyes with previous vitreoretinal surgery, trauma, diabetic retinopathy, retinal vein occlusion, uveitis, and other retinal diseases were excluded. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	303
Target Study Title: Open-Label, Phase IIIb Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab Monotherapy or Combination Therapy With Methotrexate (MTX) or Other Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Patients With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-Tumour Necrosis Factor (Anti-TNF) Biologic Agent Target Study Description: #Study Description Brief Summary This open-label study will evaluate the efficacy and safety of tocilizumab as monotherapy or in combination with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) in participants with active rheumatoid arthritis (RA) and an inadequate response to current non-biologic DMARD therapy or the first anti-tumour necrosis factor (anti-TNF) agent. Participants will receive tocilizumab 162 milligrams (mg) subcutaneously once a week for 52 weeks. #Intervention - DRUG : Tocilizumab - Tocilizumab 162 mg will be administered once a week by SC injection and as a single fixed dose, irrespective of body weight, for the treatment duration of 52 weeks. - Other Names : - RoActemra, Actemra - DRUG : DMARDs - Treatment with non-biologic DMARDs, at a stable dose that was initiated at least 4 weeks prior to baseline, is permitted during the study. The study protocol does not specify any particular therapy. - DRUG : Oral Corticosteroids - Stable oral corticosteroids doses (≤10 mg/day prednisone or equivalent) are allowed. The study protocol does not specify any additional detail on types of oral corticosteroids. - DRUG : Methotrexate - Methotrexate per investigator's discretion. Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria * Participants who have an inadequate response to current non-biologic DMARD therapy or the first anti-TNF agent (in monotherapy or in combination with MTX or other non-biologic DMARDs). Inadequate response to anti-TNF treatment is defined as DAS28 score improvement of less than 1.2 or participants achieving a DAS28 score improvement of 1.2 but not achieving low disease activity (current DAS28-ESR above 3.2) according to a treat-to-target strategy and have not been previously exposed to treatment with tocilizumab. Inadequate response to non-biologic DMARD therapy will be assessed according to local guidelines and the participants will need to be eligible for biologic therapy according to local guidelines * Oral corticosteroids (<=10 mg/day prednisone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs; up to recommended dose) are permitted if on stable dose regimen for greater than or equal to [>=] 4 weeks prior to baseline * Permitted non-biologic DMARDs are allowed if on stable dose for at least 4 weeks prior to baseline * Receiving treatment on an outpatient basis, not including tocilizumab * Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception as defined by protocol during the study and for at least 3 months following the last dose of tocilizumab Exclusion Criteria: * Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline * Rheumatic autoimmune disease other than RA * Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis * Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16 * Prior history of or current inflammatory joint disease other than RA * Exposure to tocilizumab either intravenous or SC at any time prior to baseline * Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening * Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline * History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies * Known active current or history of recurrent infections * Major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening * Active tuberculosis (TB) requiring treatment within the previous 3 years * Positive for hepatitis B or hepatitis C virus infection * Primary or secondary immunodeficiency (history of or currently active) * Pregnant or lactating women * Inadequate hematologic, renal or liver function Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	304
Target Study Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Subjects With Acute Coronary Syndromes Target Study Description: #Study Description Brief Summary The purpose of this study is to evaluate the safety of rivaroxaban in patients with recent acute coronary syndrome (ACS) and to assess the ability of rivaroxaban to reduce the occurrence of death, myocardial infarction (heart attack), repeat myocardial infarctions, stroke, and ischemia (inadequate blood supply to a local area) in patients with recent ACS. Detailed Description This is a randomized (patients will be assigned to study treatment by chance), double-blind (neither the patient nor the study doctor will know the identity of the assigned study treatment) study to evaluate the safety and efficacy of rivaroxaban (study drug) compared to placebo (a tablet identical in appearance to study drug but contains no active drug) in patients with acute coronary syndrome (ACS \[a condition where blood flow in a blood vessel in the heart is restricted because of a blood clot\]). Rivaroxaban is a drug that acts as a blood thinner and is being tested to see if it will be safe and effective in patients diagnosed ACS. The goal of this study is to identify the dose and dosing schedule (once-a-day or twice-a-day dosing) of rivaroxaban that will be safe and effective in preventing adverse cardiovascular outcomes such as death, myocardial infarctions (MI) including repeat myocardial infarction (reMI), stroke, or ischemia (inadequate blood supply to a local area) requiring revascularization (ie, the re-establishment of blood supply to a part or an organ) in patients with ACS who are receiving antiplatelet therapy (ie, aspirin alone or aspirin plus an approved thienopyridine, a type of drug such as clopidogrel that acts to inhibit the formation of blood clots). Approximately 3500 patients are planned to participate in the study for approximately 7 months. At study entry, all patients who are currently receiving treatment for ACS with antiplatelet therapy will be permitted to continue this therapy during the study. Patients will be enrolled and randomized to receive placebo, rivaroxaban administered as a once-daily dose, or rivaroxaban administered as a twice-daily dose at each dose level of rivaroxaban tested. Patients randomized at each dose level will continue to receive the same treatment for 6 months. Near the end of enrollment at the first dose level, available safety and efficacy data from patients will be assessed by an Operations Committee before enrolling and randomizing additional patients to the next higher dose level of rivaroxaban. Increasing dose levels of rivaroxaban are planned; however, progression to each higher dose level will be at the discretion of the Operations Committee. Patient safety will be monitored by evaluating adverse events reported, results from clinical laboratory tests, findings from electrocardiograms (ECGs) and vital signs measurements, findings from physical examinations, and the number of patients with protocol-defined major or minor bleeding, or bleeding requiring medical attention. All patients will take study drug or placebo tablets orally (by mouth) twice daily for 6 months starting at an initial total daily dose of 5 mg. Both once- and twice-daily dosing regimens will be tested at each rivaroxaban dose level planned. #Intervention - DRUG : Rivaroxaban/Placebo - 1 rivaroxaban tablet once daily (and 1 placebo tablet once daily) for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level. - DRUG : Placebo - 1 placebo tablet twice daily for 6 months. - DRUG : Rivaroxaban - 1 rivaroxaban tablet twice daily for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level. Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Have symptoms suggestive of ACS that lasted at least 10 minutes at rest occurring within 7 days of randomization * Have a diagnosis of ST-elevation myocardial infarction or non-ST elevation myocardial infarction/unstable angina (ie, chest pain or discomfort) (ST elevation is an abnormal finding from an ECG test) with at least 1 protocol-defined high risk feature Exclusion Criteria: * Active bleeding or high risk of bleeding or intracranial hemorrhage (bleeding within the skull enclosing the brain) * Need for continued anticoagulant therapy * Significantly impaired renal (kidney) or hepatic (liver) function * Severe concomitant diseases such as cardiogenic shock (heart damage that results in insufficient blood supply to other parts or organs of the body), refractory ventricular arrhythmias (irregular contractions of the heart unresponsive to treatment), or any severe condition that would limit life expectancy of the patient to less than 6 months Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	305
Target Study Title: Effects of a PUFA-rich Diet on Acute Metabolic and Inflammatory High-Fat Meal Responses Target Study Description: #Study Description Brief Summary This study evaluates whether a diet rich in poly-unsaturated fats can compensate for the negative effects of high saturated fat meals on metabolic, inflammatory, and coagulation responses. Half of the participants will receive a high polyunsaturated fat diet )50% carbohydrate, 15% protein, and 35% fat. 21% of total energy will be poly-unsaturated fatty acids, 9% mono-unsaturated fatty acids, and 5% saturated fatty acids) for 7 days, while the other half will receive a control diet 50% carbohydrate, 35% fat, and 15% protein 50% carbohydrate, 35% fat, and 15% protein. Only, 7% of total energy will be poly-unsaturated fatty acids, 15% of total energy will be mono-unsaturated fatty acids, and 13% of total energy will be saturated fatty acids.) for 7 days. Detailed Description Eating more saturated fats has been shown to decrease how many calories an individual burns and increase chronic disease risk by increasing inflammation, coagulation (blood clotting) potential, blood pressure, and cholesterol. Conversely, eating more poly-unsaturated fats has been linked to decreased risk of chronic diseases. The goal of this study is to determine whether or not eating a diet containing a lot of poly-unsaturated fats can compensate for the damaging effects of eating occasional high-fat meals that are high in saturated fats. Those damaging effects we are interested in studying include how much fat and calories a person's body burns, and measuring some markers of chronic disease risk in the blood (inflammation markers and blood clotting markers). #Intervention - OTHER : PUFA Diet - The 7-day diet will consist of 50% carbohydrate, 15% protein, and 35% fat. 21% of total energy will be poly-unsaturated fatty acids, 9% mono-unsaturated fatty acids, and 5% saturated fatty acids. - OTHER : Control Diet - The 7-day diet will consist of 50% carbohydrate, 35% fat, and 15% protein. Furthermore, 7% of total energy will be poly-unsaturated fatty acids, 15% of total energy will be mono-unsaturated fatty acids, and 13% of total energy will be saturated fatty acids. Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Apparently healthy men and women between the ages of 18 and 45y with a normal weight based on body mass index (BMI=18 <= age <= 24.9kg/m2), must be sedentary (perform less than 3 hours per week of structured exercise) and , if participant has fasting total cholesterol >200 gm/dL, high-density lipoprotein <40 mg/dL, low-density lipoprotein cholesterol >100 mg/dL, and/or triglycerides >150 mg/dL (based on fasting blood lipids). Exclusion Criteria: * Weight loss or gain exceeding 5% of body weight in the past 3 months * Current participation in a weight loss program * Any current exercisers (greater than 3h per week) * Any person who is on a medically prescribed diet * Any person who is vegan, or any type of vegetarian other than pesco-vegetarian * Any chronic or metabolic disease, hyperlipidemia, gastrointestinal disorder, or history of medical or surgical events that could affect digestion and absorption of nutrients * Any current supplement use other than a daily multivitamin (this includes fish oil supplements) * Any current medication use other than birth control (this includes anti-inflammatory NSAID use). * Anyone who is pregnant, lactating, or planning a pregnancy * Anyone who has donated blood or plasma in the last 20 days * Any tobacco users * Anyone who has allergies to the most common food allergens (milk, eggs, peanuts, almonds, cashews, walnuts, fish, shellfish, soy and wheat) or to any of the food that will provided during the study * Anyone who has allergies to any of the components of the liquid meals Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 35 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes </FORMATTED_CRITERIA>	306
Target Study Title: The Use of Armeo®Spring Device to Assess the Effect of Trunk Stabilization Exercises on the Functional Capabilities of the Upper Limb - an Observational Study of Patients After Stroke Target Study Description: #Study Description Brief Summary The aim of the study was to analyze the effect of trunk stabilization exercises on coordinated movement of the affected upper limb in patients after stroke, using the Armoe®Spring device and the 'wall' and 'abacus' functional tests. The study group had physiotherapy based on the NDT Bobath concept and the control group used classic exercises. Detailed Description Almost half of the stroke patients report impaired function of the upper limb and hand. Stability of the trunk is required for the proper movement of the body, including the legs and arms. The aim of the study was to analyze the effect of trunk stabilization exercises on coordinated movement of the affected upper limb in patients after stroke, using the Armoe®Spring device and the 'wall' and 'abacus' functional tests. Material and method: this is a randomized, double-blinded study. The research was carried out in the Rehabilitation Clinic on a group of 60 stroke patients who were randomly assigned to groups differing in the rehabilitation program. The study group had physiotherapy based on the NDT Bobath concept and the control group used classic exercises. The importance of the trunk for upper limb coordination was assessed on the Armeo®Spring device using three evaluation programs: 'perpendicular hunting'; 'horizontal hunting'; 'reaction time' and two proprietary tests: 'wall' and 'abacus'. #Intervention - OTHER : NDT Bobath therapy - Their physiotherapy was based on exercises that heavily employed the core muscles to equalize tension and strength, according to the NDT Bobath concept. The duration of the treatment session for each patient in both groups was 120 minutes. - OTHER : The classic exercises. - They underwent classical neurological rehabilitation. such as passive exercises, but also an approximation. In addition, the patients performed self-assisted exercises on a manual rotor, and in order to relieve the directly affected limb, the patients exercised in a suspension system. As the physiotherapy progressed, the patients performed active exercises, and then active exercises with resistance, e.g. using the Thera Band. Patients also exercised their balance with the use of large gymnastic balls or sensor pads. A large part of the physiotherapy was locomotion training and gait re-education. The duration of the treatment session for each patient in both groups was 120 minutes. Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: 1) patients 5 to 7 weeks after ischemic stroke; 2) patients with hemiparesis after stroke; 3) subjects with poor trunk control; 4) subjects who were in a functional state allowing movements of the upper extremity; 5) muscle tension that allows movement; 6) no severe deficits in communication, memory, or understanding what can impede proper measurement performance; Exclusion Criteria: 1) lack of possibility to adjust the orthosis to the patient's treated limb, 2) bone instability (non-fused fractures, advanced osteoporosis), 3) permanent contracture of the treated limb, 4) open skin lesions in the area of the treated upper limb, 5) sensory deficits, disturbances, 6) shoulder subluxation or pain 7) increased spasticity, 8) increased involuntary movements, e.g. ataxia, dyskinesia, myoclonic seizures, 9) unstable life functions: contraindications related to the respiratory system or the cardiovascular system (instability or the need to use supportive devices), 10) the need for long-term intravenous therapy, 11) postural instability, 12) contraindication to a sitting position, 13) confused or uncooperative patients, 14) severe cognitive impairment, 15) patients requiring isolation due to infections, 16) severe vision problems (the patient is not in the ability to observe the elements displayed on the computer screen), 17) epilepsy. Sex : ALL Ages : - Minimum Age : 35 Years - Maximum Age : 85 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	307
Target Study Title: Intramyometrial and Intravenous Oxytocin Compared to Intravenous Carbetocin for Prevention of Postpartum Hemorrhage in Elective Cesarean Sections - a Monocentric Randomized Controlled Study Target Study Description: #Study Description Brief Summary Objective is to proof non-inferiority of intramyometrial and intravenous oxytocin application compared to intravenous carbetocin for prevention of postpartum hemorrhage in planned, uncomplicated cesarean deliveries. #Intervention - DRUG : Oxytocin - Oxytocin given in a combined regimen: after delivery 10 IE of oxytocin are applied intramyometrially and 10 IE of oxytocin are given over an infusion of 1000ml of 0.9% NaCL over 12 hours intravenously. - DRUG : Carbetocin - Carbetocin is given 0.1mg intravenously as a bolus after delivery. Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * elective cesarean section * present informed consent * completed 36 weeks of gestation Exclusion Criteria: * need for intubation (carbetocin is only licensed for epidural or spinal anesthesia) * multiple fetus pregnancy * known coagulopathy * Placenta praevia * morbidly adherent placenta * placental abruption * thrombocyte dysfunction * HELLP-syndrome * preeclampsia * history of uterine atony Sex : FEMALE Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes </FORMATTED_CRITERIA>	308
Target Study Title: The Drug-drug Interaction of SP2086 and Metformin Target Study Description: #Study Description Brief Summary This is an open single and self-control study,planning to recruit 24 cases of healthy male volunteers.In the study,subjects were given SP2086 and metformin,and collects blood samples before and after medcine.The purpose is to evaluate the drug interaction between SP2086 and Metformin. #Intervention - DRUG : SP2086 - DRUG : Metformin Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 19 and 26 kg/m2,weight among of 50 <= age <= 100kg. * willing to using contraception during the study and after the 6 months. Exclusion Criteria: * History of diabetes * History of heart failure or renal insufficiency * Urinary tract infections, or vulvovaginal mycotic infections * History of or current clinically significant medical illness as determined by the Investigator * History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose * Known allergy to SP2086 or metformin or any of the excipients of the formulation of SP2086 or metformin Sex : MALE Ages : - Minimum Age : 18 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes </FORMATTED_CRITERIA>	309
Target Study Title: The Effect Of Interactive Robot on Children's Anxiety, Mobilization and Parental Satisfaction After The Surgery Target Study Description: #Study Description Brief Summary This project will be conducted with 5-10-year-old children who will undergo an outpatient surgery in Trakya University Health Research and Application Center at Pediatric Surgery Clinic and their parents. It is reported in the literature that technology-based applications and robot use are promising innovations in reducing pain, anxiety, and fear in children. This was the main starting point in the planning of the study. In this study, by using interactive robot, it was aimed to reduce postoperative mobilization anxiety, to increase frequency / duration of the mobilization and to increase parental satisfaction of the children undergoing outpatient surgery. Detailed Description The use of interactive robots is expected to reduce the child's anxiety by ensuring that the child is physically, psychologically, and socially optimal. It is foreseen that the child with reduced anxiety will be willing to mobilize with the interactive robot and it will increase the mobilization time and the frequency of the mobilization during the day. Decreasing the anxiety of children and increasing the desire for mobilization will increase the satisfaction of the families. The study will be conducted with 84 children (42 Experiment + 42 Control) aged 5-10 years. The study was planned as a randomized controlled study. Data will be collected by 'Questionnaire Form' and 'Child Anxiety Scale-State Anxiety' and Parental Satisfaction Scoring-Visual Analog Scale' and 'Mobilization Chart'. Families will be informed about the research and before the surgery, families, and children in both groups will be informed about the benefits of mobilization. Two hours after the operation, just before the mobilization, the children in the experimental group will be introduced to the robot, and the children in the control group will be asked to mobilize with their parents. When the child is first mobilized at the time recommended by the physician for all groups after the surgery, the child's anxiety for mobilization will be assessed using the Child Anxiety Scale (State Anxiety). The mobilization time of the children will be measured by stopwatch and recorded in the Mobilization Schedule together with the frequency of mobilization. Parental Satisfaction Scale- Visual Analogue Scale will be applied to evaluate the satisfaction of the parents towards the application. #Intervention - OTHER : Interactive robots - Children will mobilize with the interactive robot when control group will mobilize with nurse. Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Undergo day surgery, * Speaking Turkish, * Being a volunteer to participate in the study, * Being 5 <= age <= 10 aged, * Do not have a visual, auditory, or mental problem and their parents will be included in the research. Exclusion Criteria: * No undergo day surgery, * No Speaking Turkish, * Not being a volunteer to participate in the study, * Not being 5 <= age <= 10 aged, * Have a visual, auditory, or mental problem and their parents will be included in the research. Sex : ALL Ages : - Minimum Age : 5 Years - Maximum Age : 10 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: Yes </FORMATTED_CRITERIA>	310
Target Study Title: Effect of Inorganic Nitrates on Arterial Hemodynamics and Exercise Capacity Target Study Description: #Study Description Brief Summary The main objective is to test the hypothesis that inorganic nitrate supplementation will: (1) Improve exercise efficiency and performance; (2) Enhance the systemic vasodilator reserve during exercise and specifically, the vasodilator response in exercising muscle; (3) Reduce arterial wave reflections and arterial load; (4) Improve skeletal muscle mitochondrial function in subjects with heart failure with preserved ejection fraction. Detailed Description This represents a series of double-blind, controlled pilot randomized studies in which the effects of nitrate-rich beetroot juice and nitrate-depleted beetroot juice will be assessed in patients with heart failure and preserved ejection fraction (n=20). A total of 20 subjects will be enrolled over a 1.5 year period and randomized in a cross-over design to a single dose of nitrate-rich beetroot juice and nitrate-depleted beetroot juice. The order of the interventions will be randomized; thus, all subjects will receive the nitrate-rich and nitrate-depleted juice, with a 4-7 day washout period in-between studies. #Intervention - DIETARY_SUPPLEMENT : Nitrate rich beetroot juice - Subjects will receive 140 mL of Nitrate-rich concentrated beetroot juice. - Other Names : - Beet It Stamina Sports shots - DIETARY_SUPPLEMENT : Nitrate depleted beetroot juice - Subjects will receive 140 mL of nitrate-depleted beetroot juice. - Other Names : - Beet It nitrate extracted (depleted) placebo shots Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: The investigators will enroll 20 subjects >18 years who have a diagnosis of heart failure with preserved ejection fraction (>50%) by 2d echocardiography, with current New York Heart Association Class II-IV symptoms. In addition, subjects with heart failure must meet the following inclusion criteria: * Chronic treatment with a loop diuretic for control of HF symptoms. * If EF is normal, subjects must demonstrate elevated filling pressures as evidenced by at least one of the following: a) left atrial enlargement (LAVI > 32 mL/m2); b) at least stage II diastolic dysfunction; c) Documentation of elevated NT-pro BNP levels or other natriuretic peptide marker (BNP, ANP) according to the laboratory and assay upper limit of normal in the previous year. * Stable medical therapy as defined by: (I) No addition or removal of ACE, ARB, beta-blockers, or calcium channel blockers (CCBs) for 30 days. (II) No change in dosage of ACE, ARBs, beta-blockers or CCBs of more than 100% for 30 days. (III) No change in diuretic dose for 10 days. Exclusion Criteria: * Rhythm other than sinus rhythm (i.e., atrial fibrillation). * Neuromuscular, orthopedic or other non-cardiac condition that prevents patient from exercising. * Valve disease (> mild aortic or mitral stenosis; > moderate aortic or mitral regurgitation). * Hypertrophic cardiomyopathy. * Known infiltrative or inflammatory myocardial disease (amyloid, sarcoid). * Pericardial disease. * Primary pulmonary arteriopathy. * Have experienced a myocardial infarction or unstable angina, or have undergone percutaneous transluminal coronary angiography (PTCA) or coronary artery bypass grafting (CABG) within 60 days prior to consent, or requires either PTCA or CABG at the time of consent. * Other clinically important causes of dyspnea such as morbid obesity or significant lung disease defined by clinical judgment or use of steroids or oxygen for lung disease within the past 6 months. * Systolic blood pressure < 110 mmHg or > 180 mm Hg. * Diastolic blood pressure < 40 mmHg or > 100 mmHg. * Resting heart rate (HR) > 100 bpm. * Hemoglobin <10 g/dL. * Patients with known severe liver disease (AST > 3x normal, alkaline phosphatase or bilirubin > 2x normal). * Patients with a clinically indicated stress test demonstrating significant ischemia within a year of enrollment which was not followed by percutaneous or surgical revascularization. * Current therapy with phosphodiesterase inhibitors, such as sildenafil, vardanafil or tadalafil. * Known allergies to beetroot or lemon juice. * Current use of organic nitrates or phosphodiesterase inhibitors. * Pregnancy. Although beetroot juice has not knows teratogenic effects, we feel that not enough data exist in this regard. Therefore, all females patients of reproductive age will be required to undergo a pregnancy test prior to enrollment. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	311
Target Study Title: Time of Device Positioning of LISA Rigid Catheter vs LISA Soft Catheter in a Very Preterm Manikin: A Crossover Randomized Controlled Trial Target Study Description: #Study Description Brief Summary Less invasive surfactant administration (LISA) can be provided using rigid or soft catheters, but possible differences in terms of easiness of use and success of the procedure are unknown. A difficult procedure may have some drawbacks such as the prolonged duration of the laryngoscopy needed to insert the device, which is likely to aggravate the invasiveness of the procedure and result in stressful consequences such as bradycardia, hypoxia, and hemodynamic changes. Objectives: i) time of device positioning, ii) success of the procedure of positioning the device, iii) participant's satisfaction. Detailed Description This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA with a rigid catheter vs. LISA with a soft catheter in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the total time of device positioning. The secondary outcomes will be the success of the first attempt, the number of attempts to achieve the correct positioning of the device in the trachea, the achievement of the correct depth of the catheter in the trachea, and the participant's opinion on using the device. #Intervention - DEVICE : Rigid catheter - Participants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration - Other Names : - Less invasive surfactant administration (LISA) with a rigid catheter - DEVICE : Soft catheter - Participants will be invited to positioning a rigid catheter in the manikin's trachea for surfactant aministration - Other Names : - Less invasive surfactant administration (LISA) with a soft catheter Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Level III NICU consultants and residents will be eligible to participate in the study Exclusion Criteria: * There are no exclusion criteria for this study Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	312
Target Study Title: A Prospective, Randomized, Controlled, Study Evaluating the Safety and Effectiveness of EVARREST® Sealant Matrix in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic and Thoracic (Non-cardiac) Surgery in Paediatric Patients Target Study Description: #Study Description Brief Summary The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft tissue \& parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in paediatric patients. Detailed Description This is an open label, prospective, randomised, multicentre, controlled, clinical study comparing EVARREST to SURGICEL (oxidized regenerated cellulose (ORC)) (Control) as an adjunct to haemostasis when conventional methods of controlling mild or moderate bleeding are ineffective or impractical during surgery in paediatric patients. At least 40 qualified paediatric subjects with an appropriate mild or moderate bleeding Target Bleeding Site (TBS) will be randomised in a 1:1 allocation ratio to either EVARREST or SURGICEL (control). Absolute time to haemostasis will be assessed as well as haemostasis at 4 and 10 minutes from randomisation. Enrolment will be staggered by age (as required by the European Medicines Agency (EMA) Paediatric Committee). The first 36 subjects enrolled will be aged ≥1 years to \<18 years of age. Enrolment of a subsequent group will include 4 subjects from 1 month (≥ 28 days from birth) to \<1 year of age will follow. Ongoing safety assessment will ensure adequate safety monitoring occur during the staged enrolment. Subjects will be followed post-operatively through hospital discharge and at 30 days (+/-14 days) post-surgery. #Intervention - BIOLOGICAL : EVARREST™ Sealant Matrix - EVARREST® Fibrin Sealant Patch is a sterile, bio-absorbable combination product, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component. - Other Names : - EVARREST™ Fibrin Sealant Patch - DEVICE : SURGICEL® - SURGICEL® Absorbable Hemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. - Other Names : - oxidized regenerated cellulose Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Paediatric subjects aged >=28 days (>= 1 month) to <18 years, requiring non-emergent open hepatic, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures. i) The first 36 subjects to be enrolled will be subjects aged >=1 years to <18 years. ii) The next 4 subjects to be enrolled will be subjects aged >=28 days to <1 year. * The subject's parent/legal guardian must be willing to give permission for the subject to participate in the trial, and provide written informed consent for the subject. In addition, assent must be obtained from paediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the paediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the trial), the parent/legal guardian's written Informed Consent for the subject will be acceptable for the subject to be included in the study. * Presence of an appropriate mild or moderate bleeding soft tissue or hepatic parenchyma Target Bleeding Site (TBS) identified intra-operatively by the surgeon; * Ability to firmly press trial treatment at TBS until 4 minutes after randomisation Exclusion Criteria: * Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products; * Female subjects, who are of childbearing age (i.e. adolescent), who are pregnant or nursing; * Subject is currently participating or plans to participate in any other investigational device or drug without prior approval from the Sponsor; * Subjects who are known, current alcohol and/or drug abusers * Subjects admitted for trauma surgery * Subjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure. * Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected) * TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of the EVARREST™ or SURGICEL® to blood flow and pressure during healing and absorption of the product; * TBS with major arterial bleeding requiring suture or mechanical ligation; * Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine. Sex : ALL Ages : - Minimum Age : 28 Days - Maximum Age : 17 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	313
Target Study Title: Opti-WIN: Effectiveness of the Optifast Program Compared With a Reduced-energy Food Based Diet Plan on Body Weight Target Study Description: #Study Description Brief Summary Compare percent change in loss of body weight between the OPTIFAST program and a food-based energy-deficit program #Intervention - OTHER : Optifast - medically-supervised weight management program - OTHER : Food-Based - low-energy, low-fat diet Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Adult males and females between 18 and 70 years * Obese (BMI > 30 kg/m2 and 55 kg/m2) * Non-smokers or smoking cessation > 6 months * < 14 alcoholic beverages per week * Willing and able to give informed consent Exclusion Criteria: * Active participation in any weight loss program within previous 3 months * Weight changes of > 5% body weight within previous 3 months * Participated in an Optifast program within prior 5 years * Prior bariatric surgery or liposuction * Use of any medication prescribed for weight loss in the past 3 months * Current major disease or GI disease that is poorly controlled (Crohn's, ulcerative colitis) * Type 1 DM * Current ESRD * Current COPD * Any major or active hepatic disease requiring inpatient or outpatient treatment * History of acute pancreatitis in the past year * Active cancer treatment in the past 2 years other than non-malignant skin cancers * Uncontrolled hypertension (Blood pressure 160/100 or greater) * Hemoglobin A1c > 10% * Recent CV event in past 6 months * Pregnancy, childbirth, or nursing within prior 6 months * Eating Attitudes Test (EAT-26) > 30 * Current major depressive disorder with Center for Epidemiological Studies Depression Scale-Revised (CESD-R) score > 16 * Schizophrenia, history of bipolar disorder * Recent hospitalization for psychiatric illness in past 6 months * Dependence on alcohol or sedative-hypnotic drugs * Intolerance or allergy to Optifast product * Unable to read/speak English * Orthopedic limitation preventing participation in regular physical activity * Untreated thyroid disease, abnormal TSH, non on stable dose of hormone replacement for hyperthyroidism * Major surgery defined as any surgical procedure that might require prolonged convalescence or limit participation in the program in any way * Inability to complete the 7-day run-in satisfactorily Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes </FORMATTED_CRITERIA>	314
Target Study Title: A Phase II Study for Evaluating Anti-tumor Efficacy of TAGRISSO (Osimertinib) in NSCLC Patients in Whom T790 Mutations Are Detected by Liquid Biopsy Using Bronchoalveolar Lavage Fluid, Plasma or Pleural Effusion Target Study Description: #Study Description Brief Summary In this trial, anti-tumor efficacy of TAGRISSO in NSCLC patients in whom T790 mutations are detected by liquid biopsy. Detailed Description This study is designed to be a phase II, Open-label, single-arm, single-center study to evaluate anti-tumor efficacy of TAGRISSO in NSCLC patients in whom T790 mutations are detected by liquid biopsy using at least one of the samples such as plasma, bronchoalveolar lavage fluid, and pleural effusion. Approximately 63 patients will be enrolled into the trial, and expected study duration is 43 months from IRB and Korea: MFDA approval date. Each subject will continue the study drug (Osimertinib) until disease progression or manifestation of unacceptable toxicity during the study period. The study drug will be administered orally as one 80 mg tablet once a day. The initial dose of the study drug 80 mg daily can be reduced to 40 mg once daily. A cycle of study treatment is defined as 28 days. Patients will be enrolled for 31 months and will be followed-up regularly, and duration of follow-up for each patient will be 12 months. #Intervention - DRUG : Osimertinib - A cycle of study treatment is defined as 28 days. Each subject will continue the study drug(Osimertinib) until disease progression or manifestation of unacceptable toxicity during the study period. The study drug will be administered orally as one 80 mg tablet once a day. The initial dose of the study drug 80 mg daily can be reduced to 40 mg once daily. Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Age >= 20, and patients who understand information about the trial and voluntarily agree to participate in the trial * Histological or cytological confirmation diagnosis of NSCLC and inoperable stage IIIB or IV at the time of study enrolment * Patients with EGFR sensitizing mutation (E19Del, L858R, L861Q, G719X) positive, who had shown clinical benefits (responders (CR or PR) and SD >=6 months) from EGFR-TKIs and had developed progressive disease following those therapy * Patients who have histories of previous exposure to EGFR-TKIs or other systemic chemotherapies are permitted (regardless of the order of treatment) * Treated with at least one of KGFR-TKIs (regardless of treatment with or without systemic chemotherapies) * In case the patient previously received any of the treatments including systemic chemotherapy, radiation therapy, surgery, and hormonal therapy, there should be at least 2 weeks of time interval between the last day of the previous treatment and the start of TAGRISSO™, and the remaining toxicity should be <= CTCAE grade 1 at the time of starting study treatment (except alopecia and grade 2, prior platinum-therapy related neuropathy) * ECOG performance status 0 <= age <= 2 * Patients in whom T790 mutations are detected in at least one of the samples including tumor tissues, BALF (cell-free DNA), plasma (cell-free DNA), and pleural effusion (cell-free DNA) * At least one measurable lesions according to RECIST v 1.1 * Female with childbearing potential (within 1 year of time interval between last menses and the date of informed consent) who use appropriate contraception methods and are not on breast-feeding, and tested negative for pregnancy test or are sure to have a proof for infertility prior to drug initiation * Males willing to use barrier contraception methods during study period (Patients should inform their sexual partners of the use of the allowed contraception methods.) * Patients willing to provide informed consent with date and signature included prior to all study-specific procedures, samplings and analyse * Patients who have proper organ functions as follows: * ANC >= 1500/mm3, * PLT counts >= 100,000/mm3, * Hb >= 9.0g/dL, * Serum creatinine <= upper normal limit, * AST/ ALT/ ALP <= 3 times upper normal limit, Total bilirubin <=2.0mg/dL (In case of liver metastasis AST/ ALT/ ALP <= 5 times upper normal limit, in case of bone metastasis, ALP <= 5 times upper normal limit) * Patients must have a life expectancy >= 12 weeks Exclusion Criteria: * Patients who were previously treated with any of the drugs targeting T790M mutation such as AZD9291 (Osimertinib), HM61713 (Olmutinib), and CO-1686 (Rociletinib) * Patients currently receiving medications known to be potent inhibitors of CYP3A4 and potent inducers of CYP3A4 (at least 1week prior study enrolment) * Patients who have preexisting or coexisting malignancies in other parts except for effectively treated non-melanoma skin cancer, CIS cervical cancer, DCIS breast cancer, thyroid cancer or malignancies that were effectively treated, have maintained at least 3 years of remission state and can be regarded as completely cured * Patients who have severe or unstable medical conditions such as prior or current clinically significant cardiovascular abnormality in accordance with the investigator's judgment such as uncontrolled hypertension, heart failure (NYHA classification >=3), unstable angina or uncontrolled arrhythmia, and acute myocardial infarction within 6 months before study enrolment corrected QTcB >450msec in 12 lead EKG * Patients with current or prior interstitial lung disease * Patients with current or prior uncontrolled gastrointestinal diseases (e.g., crohn's disease, ulcerative colitis, chronic diarrhea, malabsorption) that would preclude adequate absorption of IP. * Patients with active hepatitis B (identified by the presence of HBsAg and/or HBV DNA), active hepatitis C (identified by the presence of HCV RNA), and known human immunodeficiency virus (HIV) * Patients with histories of hypersensitivity to IP or any components of the agent * Patients with any of the following genetic predispositions including galactose intolerance, lactose intolerance, or glucose-galactose malabsorption * Patients with symptomatic CNS metastases who are neurologically unstable (Cases with radiologically and neurologically stable disease after discontinuation of the administration of corticosteroids and anticonvulsants for at least 4 weeks are excluded) * Patients with uncontrolled infective diseases (Patients who require non-oral antibiotics injection must be excluded, but they can be included if the diseases are completely resolved.) * Patients who are difficult or unlikely to comply with study procedures, restrictions, requirements, and follow-up managements according to the investigator's judgment * Patients who were administered other study drugs within 30 days before starting the study treatment (Patients are permitted if they were given any of the drugs including gefitinib, erlotinib, and afatinib) * Patients with any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy. * Males and females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry Sex : ALL Ages : - Minimum Age : 20 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	315
Target Study Title: The Indian Diabetes Prevention Programme Shows That Lifestyle Modification and Metformin Prevent Type 2 Diabetes in Asian Indian Subjects With Impaired Glucose Tolerance (IDPP1) Target Study Description: #Study Description Brief Summary Three year prospective randomised controlled trial in IGT subjects to study the effect of metformin and lifestyle modification in preventing the conversion to diabetes Detailed Description Lifestyle modification helps in primary prevention of diabetes in multiethnic Americans, Finnish and Chinese populations. In a prospective community based study, we tested if the conversion to diabetes could be influenced by interventions in native Asian Indians with impaired glucose tolerance (IGT) who were younger, leaner and more insulin resistant than the above populations. We randomized 531 (Men : Women, 421 : 110) subjects with IGT \[mean age of 45.9 + 5.7 years and body mass index (BMI) of 25.8 + 3.5 kg/m2 into four groups. Group 1 was the control (CON), Group 2 was advised lifestyle modification (LSM), Group 3 was treated with metformin (MET) and Group 4 with LSM plus MET. Primary outcome measure was type 2 diabetes diagnosed by the WHO criteria. In a median follow up of 30 months, three year cumulative incidence of diabetes were 55.0%, 39.3%, 40.5% and 39.5% in group 1 to 4 respectively. The relative risk reduction was 28.5% with LSM (95 % confidence interval (CI), (20.5 - 37.3), (p=0.018), 26.4% with MET (95% CI, 19.1 - 35.1) (p = 0.029) and 28.2% with LSM plus MET (95% CI, 20.3 - 37.0), (P=0.022) versus control group. The numbers needed to treat to prevent one incident case of diabetes were 6.4 for LSM, 6.9 for MET and 6.5 for LSM+MET. Conversion of IGT to diabetes is high in native Asian Indians. LSM and metformin significantly reduced the incidence of diabetes in Asian Indians with IGT. There was no added benefit by combining both. #Intervention - DRUG : Metformin Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Both male and female. 35 - 55 years. No Known history of diabetes. Willing and available for a three years study. Exclusion Criteria: * Pregnant women. Subjects with major illness such as cancer, hepatic or cardiac diseases. Tranferable jobs. Sex : ALL Ages : - Minimum Age : 35 Years - Maximum Age : 55 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes </FORMATTED_CRITERIA>	316
Target Study Title: Improving Access to Quality Care for Children and Adolescents Presenting to the Pediatric Emergency Department With Musculoskeletal Problems: a Pilot Randomized Control Trial Target Study Description: #Study Description Brief Summary The goal of this clinical trial is to compare two methods of managing low acuity musculoskeletal complaints in children and adolescents ages 6 to 17.99 years in the pediatric emergency department. The main question it aims to answer is whether delivering care in two methods is feasible. Participants will receive care while in the emergency department and will be followed for a period of 1-month post-presentation. #Intervention - OTHER : Interdisciplinary management - assessment and treatment in an interdisciplinary model - OTHER : usual care - assessment and treatment in usual care model Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * aged 6.00 <= age <= 17.99 years * present to the Montreal Children's Hospital Emergency Department with a suspected MSK complaint, traumatic or not * are given a triage score of 3 (urgent), 4 (less urgent), or 5 (nonurgent) according to the Canadian Triage and Acuity Scale (CTAS) * are able to communicate in French or English Exclusion Criteria: * present with a major MSK condition requiring urgent care (e.g., open fracture, open wound) * a red flag (e.g. progressive neurological disorder, infectious symptoms) * a co-morbid unstable condition. Sex : ALL Ages : - Minimum Age : 6 Years - Maximum Age : 17 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	317
Target Study Title: Impact of Various Interfaces of Non-invasive Ventilation on Performance During Exercise in Patients With Chronic Obstructive Pulmonary Disease Target Study Description: #Study Description Brief Summary The purpose of this study is to determine wether the interface (facial or nasal mask) influences performance in patients with chronic obstructive pulmonary disease exercising with non-invasive ventilation. #Intervention - DEVICE : Non invasive ventilation during exercise with facial or nasal mask. - Every patients will achieve 3 constant work load test (CWLT) at 75% Wpic. The first CWLT will be realized without any ventilatory support. The 2 others CWLT will be achieved with non-invasive ventilation support using facial or nasal interface in a randomized order. Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Age > 18 years * Chronic obstructive pulmonary disease Gold III-IV * Eligible for pulmonary rehabilitation * Exercise limitation : at least respiratory limitation (ventilatory reserve <= 30%) Non-inclusion Criteria: * Pregnant woman or likely to be * Familiar with home non-invasive ventilation * Patient under guardianship Exclusion Criteria: * Acute exacerbation of chronic obstructive pulmonary disease Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	318
Target Study Title: A Study to Determine the Efficacy of a Denture Adhesive Formulation to Seal Out Food Particles From Under the Mandibular Partial Denture Target Study Description: #Study Description Brief Summary The objective of this study is to evaluate the effectiveness of two denture adhesives at keeping food particles (seeds) from becoming trapped underneath partial denture(s). #Intervention - DEVICE : Experimental Denture Adhesive - Adhesive will be applied to the partial denture(s) by a dental professional separate from the examiner and subject. - DEVICE : Fixodent True Feel Denture Adhesive - Adhesive will be applied to the partial denture(s) by a dental professional separate from the examiner and subject. Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * give written informed consent prior to their participation; * be 18 years or older; * have a Kennedy Class I or class II partial mandibular denture with a minimum of three consecutive teeth on the prosthesis; * have a history of food particles getting under their partial, mandibular denture; * agree not to use any denture adhesive on the day of their study visits, prior to the visit; * agree to not participate in any other oral/dental product studies during the study; * be willing to use or not use denture adhesive as instructed during the treatment periods; * be willing to eat a poppy seed muffin; * be in good general health as determined by the Investigator/designee based on a review of the medical history/update; and * have a minimum of 4 total poppy seeds on their mandibular denture base and gingiva after eating the muffin. Exclusion Criteria: * present with any disease or conditions that could be expected to interfere with examination procedures or the subject's safe completion of the study; * self-report that they are allergic to denture adhesives or to the test food (gluten intolerance to muffin or intolerance to poppy seeds); or * have appliances with intracorneal attachments, crowns with precision attachments or implant overdentures: * have any condition or medication which, in the opinion of the investigator, is currently causing xerostomia. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: Yes </FORMATTED_CRITERIA>	319
Target Study Title: Study Protocol: Observational Cohort Study to Improve Rebleeding Risk Stratification for Patients With Cirrhosis and Portal Hypertension on Non-selective Beta-blockers Target Study Description: #Study Description Brief Summary Background: In patients with cirrhosis on secondary prevention of variceal rebleeding with non-selective beta-blockers (NSBBs), the risk of rebleeding and death is markedly higher in those failing to achieve a good hemodynamic response (HVPG reduction ≥20% of baseline values or ≤12mmHg). However a substantial proportion of non-responders will never rebleed, thus appearing protected by NSBBs although non-detected by HVPG response. This low sensitivity hampers risk stratification and diminishes the cost-effectiveness of assessing the hemodynamic response to NSBBs. This is particularly relevant in prevention of rebleeding since in this scenario the risk of rebleeding and of other portal hypertension related complications is very high, which calls for early institution of effective therapy. Baseline HVPG bears prognostic significance with regards to risk of developing varices, decompensation, hepatocellular carcinoma and death1,2,7,8,18-27. However, no studies have investigated whether adding data from baseline HVPG may improve the sensitivity of the criteria defining a good or poor hemodynamic response. Hypothesis: Adding data from baseline HVPG may improve the sensitivity of the criteria defining a good or poor hemodynamic response. Objective: Exploring the prognostic value of basal HVPG that better discriminate those non-responders who do not re-bleed under prophylactic treatment with NSBBs. Methods: Observational cohort study. Training set: patients from two longitudinal studies conducted at the Hepatic Hemodynamic laboratory of the Hospital Clínic of Barcelona to assess the prognostic value of HVPG changes during continuous therapy with NSBBs for preventing variceal rebleeding. Validation set for chronic hemodynamic response: patients from two longitudinal studies conducted at the Hepatic Hemodynamic laboratory of the Hospital de Sant Pau of Barcelona to assess the prognostic value of HVPG changes during continuous therapy with NSBBs for preventing variceal rebleeding; a third cohort composed of patients undergoing acute hemodynamic response to intravenous propranolol will be studied. All patients received a preplanned follow-up in the outpatient clinic at 1, 3, and 6 months, and every 6 months thereafter in the original studies. End-point: bleeding from portal hypertensive sources (esophago-gastric varices or portal hypertensive gastropathy) (defined according to Baveno criteria 32), death or liver transplantation. Ethical aspects: All patients have given their written informed consent to use their data in the original studies. Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: Liver Cirrhosis Admission for bleeding from esophageal varices in the previous 7 days Baseline HVPG >12 mmHg Subsequent long-term treatment with NSBB (propranolol or nadolol) Second measurement of HVPG after 1 <= age <= 3 months of therapy Exclusion Criteria: Hepatocellular carcinoma Portal vein thrombosis Contraindications to beta-blockers Cholestatic liver disease Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	320
Target Study Title: Phase 2 Study of Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Patients With Advanced Esophageal Cancer Target Study Description: #Study Description Brief Summary Esophageal cancer is a highly aggressive malignancy with a poor overall outcome. * Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases. * No standard postoperative adjuvant chemotherapy has ever been established. #Intervention - DRUG : paclitaxel; cisplatin - The adjuvant chemotherapy regimen consisted of paclitaxel 150mg/m2 intravenously (IV) over 3 hours on day 1, followed by cisplatin 50mg/m2 IV on day 2 every 14 days for 4 to 6 cycles. - Other Names : - Paclitaxel Injection, Beijing Union Pharmaceutical Factory Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * ability to give informed consent * histological proof of thoracic esophageal squamous cell carcinoma with negative proximal and distal margins * node-positive and pathologic stage M0 . * Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 1 * Patients were enrolled 4 to 10 weeks after surgery. * Adequate organ function was required in 2 weeks of registration and was defined as: serum creatinine within normal institutional limit, and creatinine clearance (CrCl) >=60ml/minute. Aspartate aminotransferase and bilirubin<2 times of upper normal institutional limits. Exclusion Criteria: * prior chemotherapy or concurrent radiation therapy before esophagectomy * R1 or R2 resection * clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	321
Target Study Title: PROgenitor Cells Role in Restenosis and Progression of Coronary ATherosclerosis After Percutaneous Coronary Intervention (PROCREATION) Study Target Study Description: #Study Description Brief Summary The aim of this study is to prospectively investigate the relationship of circulating endothelial progenitor cells at time of percutaneous coronary intervention to the subsequent development of in-stent restenosis or progression of coronary atherosclerosis. Detailed Description Research on stem cells has identified a population of bone marrow-derived cells, called circulating endothelial progenitor cells (EPCs), that incorporate into sites of neovascularization and are home to sites of endothelial denudation thus contributing to the maintenance of vascular homeostasis. Although extensive work has been conducted to verify if EPCs impairment plays a key role in coronary atherogenesis, it is still matter of debate if the extension and severity of coronary artery disease are associated with reduced or increased numbers of EPCs, as it remains unclear if these cells exert favorable or unfavorable effects at sites of percutaneous coronary intervention (PCI). One should consider, however, that most previous investigations have been hampered by discordant definitions of EPCs and by different timing of EPCs sampling, thus determining much uncertainty on the role of EPCs in restenosis and atherosclerosis progression. Furthermore, development of de novo lesions and post-PCI restenosis, which are pathophysiologically dissimilar, have not been examined concomitantly and serially over time. Accordingly, the aim of this study is to carry out the first prospective assessment of the significance of subpopulations of circulating EPCs in the subsequent occurrence of restenosis or progression of coronary atherosclerosis after PCI. To this end, a pool of EPCs subtypes that are suggested to play some role in atherosclerosis is measured in a homogenous population of candidates to PCI. At variance with previous work, counts of EPCs are obtained in baseline conditions before PCI in order to avoid the confounding effect that the procedure exerts on EPCs. Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * evidence of complete revascularization of clinically important stenoses by PCI * willing to undergo 8-month control angiography. Exclusion Criteria: * in-hospital death after PCI * myocardial infarction during follow-up to exclude potential subacute stent * unstable angina * any increase in creatine kinase-myocardial band, troponin I, myoglobin, or liver enzymes above upper normal limit before PCI * left ventricular ejection fraction<30% * renal failure with creatinine>2 mg/dl * treatment with statins at referral Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	322
Target Study Title: Volumetric Assessment of Volume Stable Collagen Matrix in Soft Tissue Ridge Augmentation At Maxillary Single Implant Site Target Study Description: #Study Description Brief Summary This proposal suggests the use of a collagen scaffold as a core material for GBR in the case of a missing tooth between two existing teeth, in situations where there is sufficient bone to place an implant but a horizontal defect is present in the ridge. The tested question is whether a thick, reinforced, resorbable collagen scaffold can provide a stable basis for restoring the lost volume of a deficient ridge. As a secondary aim, a positive result could present an option to replace the connective tissue interpositional graft procedure. Detailed Description • Surgical procedure and clinical measurements: Pre-surgical phase: 1. Full Conventional non-surgical periodontal therapy involving supra, sub gingival scaling and root planning will be performed 2. Oral hygiene instructions will be repeated until patients had achieved a proper degree of oral hygiene where plaque index (PI) ≤ 1. 3. Four weeks later, patients will be re-evaluated in order to confirm the efficacy of cause related therapy phase. 4. Clinical parameters and CBCT will be recorded prior to surgery. 5. Full arch impressions will be recorded with high viscosity impression material. Baseline casts will be made to be used as a reference for volumetric measurements. * Surgical protocol: * Patients will undertake implant surgery under local anesthesia for the missing tooth using mid crestal incision at the edentulous area and sulcular incisions at the neighboring mesial and distal teeth. * A combined full / partial thickness flap will be made followed by implant placement and healing screw is connected to the implant. * For group 1 VCMX will be utilized to graft the buccal defect and primary closure will be achieved using simple interrupted sutures. * For group 2 CTG will be utilized to graft the buccal defect and primary closure will be achieved using simple interrupted sutures. * Postoperative medications will include (Augmentin 1g twice/day, Flagel 500 mg twice daily and 2 weeks of antiseptic mouth wash ).(Deeb et al , 2015) * Patients will be given post-operative instruction and sutures will be removed after 2 weeks. * The final abutment will be secured to the implant within 12 weeks after gingival healing for definitive crown placement. Postoperative surgical evaluation and assessment: * The follow up period will include oral examination, plaque removal when necessary, at the surgical site. * Clinical parameters will be measured, impressions redone, and models will be casted 3, 6 and 9 months postoperatively for both groups. * Radiographic examination using CBCT will be done at 9 months follow up. Methods of evaluation: 1. Clinical Measurements: * Probing depth (Glavind \& Loe, 1967). * Plaque index (O'leary T, 1972). * Bleeding index (Newbrun, 1996) * Volumetric changes at the augmented implant site digitally through scanning model casts. To assess the volumetric differences between the baseline, 3, 6 and 9 months postoperatively and all the cast models will be transferred to digital replica using an optical scanner. Digital replicas will be produced resembling various time intervals during treatment. Superimposing the different replicas of each case utilizing the best fit algorithm by using reference points from the tooth surfaces. The implant site region will be delineated by the mucogingival line, the mesial and distal papillary midline and the alveolar crest. Thus, any.alterations in volume between the digitized superimposed replicas could be recorded. (Akcali et al., 2015) • Pink esthetic score. Pink esthetic score will be recorded for five variables: 'mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, and root convexity/soft tissue color and texture at the facial aspect of the implant site'. A score of 2, 1, or 0 will be assigned to all five PES parameters. The two papillary scores (mesial and distal) will be assessed for the complete presence (score 2), incomplete presence (score 1) or absence (score0) of papillary tissue. The curvature of the facial soft tissue line, also defined as the line of emergence of the implant restoration from the soft tissues, will be evaluated as being identical (score 2 ), slightly different (score 1), or markedly different (score 0) compared to the natural control tooth and thus, provided a natural symmetrical or disharmonious appearance and in comparison to the contralateral tooth in terms of an identical vertical level (score 2), a slight (\<1 mm) discrepancy (score 1), or a major (\>1 mm) discrepancy (score 0). Finally, the combined three additional specific soft tissue parameters as one variable: the presence, partial presence, or absence of a convex profile (in analogy to a root eminence) on the facial aspect, as-well-as-the-related-mucosal-color-and-surface texture. To achieve a score of 2 for this-combination-variable, all-three-parameters-were more-or-less-identical-compared-to-the-control-tooth. A value of 1 will be given if two criteria are fulfilled, whereas a score of 0 will be given if none or only one parameter matches the control site. (Tettamanti et al, 2014) * Visual analogue scale to measure postoperative pain. Pain.score.reported.by.the.patient. directly.through.Visual.Analogue.Scale.score (from 0 to 10. 0: no pain, 1: minimal pain, 5: moderate pain, 10: severe pain) VAS will be recorded after 2 weeks (Yıldırım et al., 2017) * The OHIP (OHIP-14 questionnaire) Will be used to assess limitation of function , pain , discomfort, social , psychological ,physical disability and general satisfaction. The OHIP-14 utilizes a scale with five categories (1 = never, 2 = hardly ever, 3 = occasionally, 4 = fairly often, and 5 = very often).A lower score in any of the five categories indicates higher satisfaction. (Al-zubeidi et al, 2011) * Soft tissue thickness will be measured at baseline and 9 months postoperatively using.an.anesthetic.needle.with.a.rubber.stopper to pierce the gingiva horizontally and perpendicular to the long axis of the tooth till bone contact 2mm coronal to the MGJ and in the mid distance mesiodistally * The part of the instrument penetrating into soft tissue will be measured in mm. (Cairo et al 2017) 2. Radiographic Examination: * Cone Beam Computed Tomography (CBCT) will be taken at baseline before implant placement and 9 months later to measure soft tissue thickness. Statistical analysis: The collected data will be revised, coded, tabulated and introduced to a PC using Statistical package for Social Science (SPSS 15.0 for windows; SPSS Inc, Chicago, IL, 2001). Data will be presented and suitable analysis will be done according to the type of data obtained for each parameter. #Intervention - BIOLOGICAL : volume stable collagen matrix placement - volume stable collagen matrix placement to augment the buccal defect.in class I siebert at the same time of implant placement - PROCEDURE : connective tissue grafting - connective tissue placement to augment the buccal defect.in class I siebert at the same time of implant placement Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Adult patients in a healthy systemic condition. * Both genders with age ranging from 20 <= age <= 50 old. * Patients should have single missing tooth in anterior or premolar area. * Seibert Class I ridge defect. * Sufficient bone height and width that doesn't necessitate bone grafting or any other ridge augmentation protocols. * Healing period of 3 months after extraction prior to surgical procedures. * Patients should approve to deliver a signature to a written consent after study nature explanation. Exclusion Criteria: * Patients with any smoking habits. * Pregnant females, decisional impaired individuals, Prisoners and handicapped patients. * Patients having poor oral hygiene or not wanting to carry out oral hygiene measures. * Patients with infections either periodontally or periapically. Sex : ALL Ages : - Minimum Age : 20 Years - Maximum Age : 50 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes </FORMATTED_CRITERIA>	323
Target Study Title: Association of the Pulsatility Index and Vasomotor Reactivity With White Matter Lesions in Brain MRI of Fabry Disease Patients Target Study Description: #Study Description Brief Summary We hypothesize that Fabry disease - FD is associated with elevated vascular resistance induced by cerebral small-vessel disease, indicating increased distal resistance to blood flow. The findings of this study may be used as a precursor for neuroimaging manifestations related to stroke in FD patients. #Intervention - DIAGNOSTIC_TEST : Transcranial Doppler (TCD) and Transcranial Color-Coded Duplex (TCCD) ultrasonography - Transcranial Doppler (TCD) and Transcranial Color-Coded Duplex (TCCD) ultrasonography will be performed in consecutive FD patients. All TCD and TCCD studies will be performed by stroke neurologists experienced in vascular sonography. Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: Fabry disease diagnosis, genetically confirmed Age> 16 years Exclusion Criteria: Insufficient temporal bone window MRI contra-indication Inability to cooperate for breath-holding test Detection of atrial fibrillation Refuse to sing informed consent Sex : ALL Ages : - Minimum Age : 16 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: Yes </FORMATTED_CRITERIA>	324
Target Study Title: Improving OutcoMes in the Pediatric to Adult Care Transition in Inflammatory Bowel Disease Target Study Description: #Study Description Brief Summary The transition from pediatric to adult IBD care can be stressful and wrought with challenges including access to care and establishment of new physician-patient relationships. There a few studies which characterize patterns of healthcare utilization during this critical period and its impact on outcomes. We hypothesize that uninterrupted healthcare utilization in academic centers and optimized communication with patients during the pediatric-adult transition period is associated with lower hospitalizations and surgery. This hypothesis will be addressed by a randomized clinical trial to determine the impact of monthly regular telephone contact with an IBD Registered Nurse versus standard of care during the pediatric-adult transition period. Outcomes will include healthcare utilization, health-related quality of life, patient satisfaction, and treatment adherence over 12 months of follow-up. Randomization and analyses will be stratified by whether subjects were transferred to adult care in an academic center or in a community practice. We hope that this research will facilitate optimal delivery of healthcare during the pediatric-adult transition. Detailed Description Rationale: The years marking the transition from pediatric-to-adult transition can be particularly difficult and transitioning patients with IBD may be at increased risk for loss to follow-up. As patient advocates, we need an intervention that would enable continuity of care especially among young adults who may face obstacles in accessing regular office visits. An intervention such as regular email contact with an IBD nurse may especially benefit those who are transitioning to community gastroenterology practices or to geographic regions where there is difficulty in accessing gastroenterology care. The lack of continuity of care may lead to delayed treatment which may be associated with poor clinical outcomes. Research Question and Hypothesis: Our primary question is whether regular email contact with an IBD nurse can improve health outcomes. We hypothesize that such interaction, through augmented continuity of care will lead to increased patient satisfaction, increased medical adherence, improved transition readiness, decreased disease activity, and consequently decreased costly visits to the emergency department and hospitalizations. Study Design: Multi-center randomized controlled clinical trial Study population and inclusion/exclusion criteria: This study comprise adolescent subjects recruited from the IBD clinics of the Hospital for Sick Children, McMaster Children's Hospital or Children's Hospital of Eastern Ontario who meet the following inclusion criteria: (1) diagnosis of IBD; (2) at least age 16 years or older; (3) planning to undergo transition of care and will be followed by a gastroenterologist in either an academic center or the community; (4) have access to email or other means of telecommunication. We will exclude any subjects who will not be residing in Canada or who will not be enrolled in the Ontario Health Insurance Plan after exiting pediatric care. Registration with OHIP, even if residing in a different province, is required for monitoring of health utilization. Health Implications: Our study may demonstrate cost-savings from decreased non-routine healthcare utilization coupled with improvement in health outcomes that may support the more widespread use of routine email-based interactions with IBD allied health providers in the pediatric-adult transition period. #Intervention - BEHAVIORAL : Telephone and email correspondence with an Inflammatory Bowel Disease Nurse - The IBD pediatric-adult transition nurse will send an email each month containing: Brief Questionnaire: A link to a secured website will be provided where participants will respond to a questionnaire. Direct Nurse Contact: Telephone and email correspondence with an Inflammatory Bowel Disease Nurse Educational module: Every other month, we will include in the email another link to an optional educational module that will be part of a curriculum to facilitate transition readiness. MyHealth Passport Study Questionnaire: A personalized link to a more comprehensive study questionnaire similar to the baseline questionnaire will be emailed in the 6th and 12th (final) email. - BEHAVIORAL : Minimal Intervention Arm - Patients randomized to the control group will have receive email based questionnaires and information relating to the MyHealth Passport application. This intervention is not expected to significantly improve outcomes. Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * This study comprises adolescent subjects recruited from the IBD clinics of the Hospital for Sick Children and McMaster Children's Hospital who meet the following inclusion criteria: (1) diagnosis of IBD; (2) at least age >= 16 years; (3) planning to undergo transition of care and will be followed by a gastroenterologist in either an academic center or the community; (4) have access to email or other means of telecommunication. Exclusion Criteria: * We will exclude any subjects who will not be residing in Canada or who will not be enrolled in the Ontario Health Insurance Plan (OHIP) after exiting pediatric care. Registration with OHIP, even if residing in a different province, is required for the monitoring of health utilization. Sex : ALL Ages : - Minimum Age : 16 Years - Maximum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	325
Target Study Title: Monetary Incentives and Intrinsic Motivation to Sustain Hypertension Control Pilot Study Target Study Description: #Study Description Brief Summary Despite unequivocal proof that tight control of blood pressure with antihypertensive medication can prevent hypertensive complications-including strokes, myocardial infarcts, heart failure, end-stage renal disease, and death- blood pressure remains uncontrolled in the majority of individuals with hypertension. We propose a novel patient-centered intervention that combines monetary incentives and a social psychological intervention to help patients sustain blood pressure control once incentives are no longer offered by strengthening intrinsic motivation to control blood pressure among two vulnerable populations: African Americans, who suffer disproportionately from hypertension, and Mexican Americans, who have the lowest hypertension control rates of any demographic group in the United States. If the intervention is successful, it could be adapted as a set of tools to apply in clinical practice to improve outcomes of a range of chronic diseases, by maximizing the motivation of patients to optimize their treatment. Detailed Description We propose to test the translation of behavioral economics and social psychology theory and experience in other domains into an intervention that has the potential to improve control of hypertension and diminish its health impact. Blood pressure control requires that: (1) the patient see a physician; (2) the disease be recognized by the physician, (3) a medicine be prescribed; (4) the patient take the medicine; (5) the patient come back for additional visits to monitor the treatment; (6) the provider make adjustments as needed in the therapy; and (7) the patient adhere to the changes and continue to come in for monitoring. Factors interfere with this chain of events even among patients with a regular source of care, such as a community clinic. Due to the asymptomatic nature of the disease, lack of awareness of the consequences of uncontrolled BP, discounting of these consequences because they occur in the distant future, health beliefs that lead the individual not to believe that the treatment would be beneficial, competing demands, financial barriers, or medication side effects, these patients may not monitor their BP as often as they should, press their physicians about BP control, or adhere to medication regimens. For their part, physicians may not intensify treatment as indicated. How would the combination of incentives that we propose in this study work in hypertension management? Monetary incentives could improve BP control by leading patients to monitor their BP and make physician visits for hypertension more frequently, 'activating' patients to be more assertive about discussing treatment intensification with their providers when their BP is elevated or other issues regarding their therapy, and improving medication adherence. Thus a patient whose BP readings continue to be elevated because he or she is receiving inadequate monotherapy for their level of hypertension might be more motivated to remember to take their pills, check their readings regularly, and most importantly, get to the doctor to intensify the regimen when faced with a monetary incentive to reduce BP. Similarly, another patient might be more motivated to speak up and tell their physician that they are having trouble taking their current BP medicine because of its side-effects; rather that stopping their medication and suffering the consequences of uncontrolled hypertension, this 'activated' patient may stimulate the physician to prescribe a different class of medicine that effectively controls the BP without side-effects. Although this experience may give the patient insight that they can get their blood pressure under control and keep it there for some time, the same concerns that initially interfered with BP control may lead patients to return to previous habits after the monetary incentive is withdrawn. They may be busy and not make the time to check their blood pressure, refill prescriptions, take their medicine, or see their doctor. For this reason, helping the patient identify intrinsic motivations to control their BP is necessary. Intrinsic motivations would help keep the patient continually aware of what is at stake (in terms of the people they care about, their roles in society, and their activities) if they do not take their medicines, fill their prescriptions, or follow up with the provider when blood pressure readings are not at target. The challenge of achieving and sustaining hypertension control might usefully borrow terminology from clinical oncology, in which many treatments have 3 phases: induction, consolidation, and maintenance. For hypertension, we can envision a similar framework: induction of normal blood pressure through initiation and adjustment of medications and adherence to them (for which we expect monetary incentives to be most effective); consolidation in which the patient maintains a normal blood pressure for a period of time (reinforced by frequent feedback, ongoing incentives, and interventions aimed at making intrinsic motivations salient); and maintenance after withdrawal of the incentives, which can be reinforced by success reducing blood pressure coupled with identity priming and identity labeling to engender strong intrinsic motivation to continue. #Intervention - BEHAVIORAL : Monetary Incentives - Subjects will receive a payment of $2 per mm. drop in BP from the baseline value at each follow-up visit. If a subject reaches their target BP, they will receive a minimum of $30 each time to motivate continued participation in the study and reinforce continued improvement relative to baseline BP. Lottery incentives will be added to motivate attainment of intermediate goals. For remembering to do certain actions that assist in the management of their BP, the subject will receive one entry into a lottery with an expected value of $3 per ticket. For the lottery payment, the subject will be given 3 chances to randomly select a card that may or may not show a winning monetary prize. - Other Names : - Behavioral economics - BEHAVIORAL : Intrinsic Motivation - A)Subjects will complete an additional component to the baseline questionnaire that probes systematically for areas of experience that currently are of importance to them. Their answers will help to identify patients' intrinsic motivations for controlling their BP. B)Answers to this component will be analyzed to characterize a role self-identity that will be used by study personnel to frame their interactions with the subject for the remainder of the study. C) Role identity will be kept highly salient throughout the study by using identity primes that remind the individual that improving blood pressure levels is an important responsibility associated with that role. - Other Names : - Social Psychology Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Adults aged >= 18 years who are receiving ongoing medical care at the clinic (one or more routine visits in the year prior to the visit during the study enrollment period at which their blood pressure is found to be abnormal), are capable of giving consent, and live at a fixed address. * Must state that they intend to continue to receive care in the clinic. * Measured BP is greater than 140mm systolic or 90mm diastolic (or 130/80 respectively for 'high risk' subjects with: diabetes, established coronary artery disease, prior cardiovascular event, left ventricular hypertrophy by ECG, chronic kidney disease, or diagnosed heart failure). Exclusion Criteria: * Those whose BP's have returned to normal 1 <= age <= 2 weeks after the original obtained average reading. * Children, prisoners, institutionalized individuals, or pregnant women. Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	326
Target Study Title: Very Low-dose Total Body Irradiation in Combination With Total Lymphoid Irradiation and Anti-Thymocyte Globulin to Improve Donor Engraftment in Patients Undergoing Non-Myeloablative Hematopoietic Cell Transplantation Target Study Description: #Study Description Brief Summary The purpose of this study is to evaluate whether addition of a low dose of total body irradiation (TBI) to a standard preparation for transplant \[total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG)\] conditioning will help to augment donor chimerism without reducing tolerability of this regimen or increasing the risk of graft-vs-host disease (GVHD) Detailed Description Primary Objective: • Determine the proportion of patients with full donor T-cell chimerism at Day 28 following hematopoietic cell transplantation. Secondary Objectives: * Determine the risk of disease progression, overall and event free survival, and non-relapse mortality, following treatment with TLI; ATG; and TBI. * Determine the incidence of acute and chronic GVHD following treatment with TLI; ATG; and TBI. Exploratory Objectives: • Determine the changes in frequency of hematopoietic stem, progenitor, and mature cell subsets and the changes in cytokine milieu and cellular architecture in the bone marrow of patients receiving TLI compared to TLI+TBI. #Intervention - RADIATION : Total body irradiation (TBI) - Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning - DRUG : Anti-thymocyte globulin (ATG) - Given intravenous (IV), Dose 1.5 mg/kg x 5 days - DRUG : Tacrolimus - Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV) - Other Names : - Fujimycin - DRUG : Mycophenolate mofetil (MMF) - Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors. - Other Names : - Cellcept, MMF - RADIATION : Total lymphoid irradiation (TLI) - 9 x 120 cGy over 11 days Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria * Has a human leukocyte antigen (HLA)-matched or single allele mismatched adult sibling donor or unrelated donor. * Acute myeloid leukemia (AML); myelodysplastic syndrome (MDS); myeloproliferative disease syndrome (MPD)]; chronic lymphocytic leukemia (CLL); B- or T-cell non Hodgkin lymphoma (NHL); Hodgkin lymphoma (HL); or chronic myelomonocytic leukemia (CMML), suitable for treatment with allogeneic transplant after TLI and ATG reduced intensity conditioning. * Considered at high-risk for regimen-related toxicity from fully-ablative transplant conditioning (therefore reduced-intensity conditioning is recommended). * Ability to understand and the willingness to sign a written informed consent document. Patients must have signed informed consent to participate in the trial. Exclusion Criteria * Uncontrolled bacterial, viral or fungal infection defined as currently taking medication and progression of clinical symptoms. * Progressive hemato lymphoid malignancy despite conventional therapy. * Chronic myelogenous leukemia (CML). * Active CNS involvement of the underlying malignancy. * HIV positive * Pregnant or lactating * Prior malignancy (EXCEPTION: diagnosed > 5 years ago without evidence of disease, OR treated <= 5 years ago but have a greater than 50% chance of life expectancy of >= 5 years for that malignancy). * Have a psychiatric disorder(s) or psychosocial circumstance(s) which in the opinion of the primary physician would place the patient at an unacceptable risk from transplant. * Left ventricular ejection fraction (LEVF) < 30%, or uncontrolled cardiac failure * Diffusing capacity of lung for carbon monoxide (DLCO) < 40% predicted * Total bilirubin > 3 mg/dL * Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) > 4 x upper limit of normal (ULN) * Creatinine > 2 mg/dL and an estimated creatinine clearance < 40 mL/min * Poorly-controlled hypertension despite multiple antihypertensive medications * Karnofsky Performance Status (KPS) < 60% Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	327
Target Study Title: Multi-modality Imaging in Acute Myocardial Infarction Target Study Description: #Study Description Brief Summary The goal of this study is to use three (3) different imaging techniques:Fractional Flow Reserve (FFR) allows precise measurement of blood flow in the arteries to the heart, and is more reliable than pictures alone to determine the significance of blockages in the heart; Near Infra-Red Spectroscopy-Intravascular Ultrasound (NIRS IVUS) provides information about the amount of lipid and cholesterol in the plaque, and plaque volume; and Optical Coherence Tomography (OCT) allows physicians to assess tears in the surface of plaque and plaque thickness; to evaluate high risk non-infarct-related coronary lesion in patients who have suffered a recent heart attack, underwent successful opening of the artery with a stent, and have blockages greater than or equal to 50% in one or more of the other arteries to the heart; and to correlate this findings with cardiovascular outcomes at 1 year. Detailed Description This is a prospective, open-label, single center registry. The study is designed to characterize plaque (i.e., assess vulnerable plaque features such as plaque tears, plaque thickness, plaque volume, and lipid content in plaque) in heart arteries in patients who have suffered a recent acute heart attack, and who have blockages \>50% in one or more of the other arteries in the heart. The procedure to do this will not be the same procedure that was done to open the artery that caused the heart attack, but will be scheduled 2-40 days after the first procedure, depending on the urgency to evaluate the other arteries and the stability of the patient after the first procedure. The study will specifically evaluate the plaque characteristics in the arteries that didn't cause the heart attack, to see if these arteries have vulnerable plaque and is at risk for future heart attacks. If FFR shows abnormal blood flow, these arteries will be treated with stents. All patients will be followed for 12 months after the second catheterization. The purpose of the study is to determine how commonly vulnerable plaques are identified in patients with acute heart attacks, and how often these lead to future cardiac problems. Identification of plaque features that lead to future problems may allow the development of new medications and devices to prevent future heart attacks and death. These same plaque features are also thought to be operative in patients with blockages in the arteries to the brain, so this study may have important implications for stroke prevention as well. All patients will be considered eligible for participation if they had a recent acute heart attack resulting from complete occlusion of an artery to the heart, if the stent procedure to open the artery was successful, and if they have blockages \> 50% in at least one other major heart artery. Patients will not be eligible for participation if they are too unstable with regard to heart, lung, brain, or kidney function, or if they have previous bypasses to the heart. In selected patients, Coronary CT Angiography (CCTA) will be performed after the initial procedure to open the artery within 40 days. CCTA images will be evaluated for plaque characteristics, and correlated with the invasive findings.Fractional flow reserve via computed tomography (FFRCT), a non-invasive computed tomography method of measuring blood flow in the blocked arteries; will also be determined and correlated with invasive FFR. The standard portion of the procedure includes the angiogram (X-ray pictures of the arteries), FFR (measurement of blood flow in the artery), IVUS and/or OCT (to assess the diameter of the artery and the size of the stent), medications, and all office visits. The research portion of the study requires all imaging studies be performed (NIRS IVUS, OCT, FFR) rather than just one or two of these imaging studies, and the CCTA. #Intervention - PROCEDURE : Coronary Angiography - Coronary angiography which includes fractional flow reserve (FFR),that allows precise measurement of blood flow in the arteries to the heart; the Near Infra-Red Spectroscopy-Intravascular Ultrasound (NIRS IVUS) provides information about the amount of lipid and cholesterol in the plaque, and plaque volume;the Optical Coherence Tomography (OCT) allows physicians to assess tears in the surface of plaque and plaque thickness; and Coronary CT Angiography (CCTA) to evaluate plaque characteristics, and correlate with the invasive findings. The research portion of the study requires all imaging studies be performed (NIRS, IVUS, OCT, FFR) during coronary angiography, rather than just one or two of these imaging studies, and the CCTA. Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: All patients with ST-elevation acute myocardial infarction (STEMI) and > 18 yearsyears who meet all of the following criteria: * Successful primary Percutaneous Intervention (PCI) of the Infarcted Related Artery (IRA) defined as final stenosis < 30%, Thrombolysis In Myocardial Infarction (TIMI) 3 flow * At least 1 non-IRA with diameter stenosis >= 50% and reference vessel diameter > 2mm * None of the exclusion criteria Exclusion Criteria: Patients will be excluded if any of the following are present: * Cardiogenic shock that persists > 24 hours after primary PCI * Diffuse disease in non-IRA that precludes successful stenting * Estimated Glomerular Filtration Rate (eGFR) < 30 cc/min/1.73 m2 after hydration or optimization of Congestive Heart Failure (CHF) for cardiac death * eGFR <60 cc/min/1.73 m2, will be in the MIAMI study for invasive imaging treatment group/cohort but will not get the coronary CCTA * eGFR < 60 cc/min/1.73 m2, for coronary CCTA * Active bleeding as defined as a fall in hemoglobin (HGB) concentration > 3 g/dL within 24 hours requiring blood transfusion, vasopressors to maintain Systolic BP > 100mmhg, or emergency surgical, endovascular, or endoscopic intervention. * Mechanical complication of MI such as severe Mitral-Valve Regurgitation (MR), Ventricular Septal Defect (VSD) or pulmonary edema * Uncontrolled Ventricular Tachycardia (VT) after primary PCI * Inability to provide informed consent * Ventilator-dependent respiratory failure * Only non-IRA is a chronic total occlusion * Non-IRA is in a Saphenous Vein Graft (SVG) or arterial graft * Non-IRA is in the left main, ostial Left Anterior Descending (LAD), or ostial Left circumflex (LCX) * Non-IRA includes a bifurcation with side branch > 2mm, medina 1 <= age <= 1-1 * Need for multivessel primary PCI during the index procedure Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	328
Target Study Title: Impact of Formulation on Ciprofloxacin Oral Absorption Target Study Description: #Study Description Brief Summary The purpose of this research is to see if certain tablet formulation factors affect oral drug absorption. Medications taken by mouth, such as tablets, need to be absorbed into the body in order to do any good. Tablets contain a drug, but also contain non-drug ingredients that are called excipients or fillers. Excipients in the tablet, and the way in which the tablet is manufactured, both can impact how much drug is absorbed into the body. That is, tablet formulation factors can cause a tablet to be effective or not effective. Tablets in this research contain the drug ciprofloxacin hydrochloride. Ciprofloxacin is an antibiotic to treat infections, such as lung infections. This drug is being used since it has low water solubility and is probably sensitive to tablet formulation factors. Detailed Description Dogs and humans exhibit differences in gastrointestinal physiology. The development of pharmaceuticals for both humans and dogs typically depends upon pharmacokinetic studies in the other species. Product design and quality attributes for dogs (and for humans)generally conduct such extrapolations in a simplistic fashion, without a systematic account of the differential intestinal physiology between dog and human. This project aims to elucidate product quality differences between human and dog oral solid dosage forms as a result of the differential physiology between the two specifies. This insight will facilitate the regulation of canine medicines by highlighting how product standards for human medicines are either too liberal or too restrictive for canine medicines. Ciprofloxacin hydrochloride will be used as a model poorly soluble drug. A range of immediate-release (IR) tablets will be formulated to map the design space. Formulations will be fast, medium, and slow, with respect to dissolution rate of drug. Ciprofloxacin is expected to exhibit formulation-dependent pharmacokinetics, which is additionally impacted by the differential physiology between dog and humans. In particular, the investigators anticipate a greater sensitivity to formulation for dogs than for humans. Consequently, the investigators anticipate dogs to be more sensitive to formulations, where such critical formulation factors must be considered in canine product design and regulation. Objectives: 1) The primary objective of this human study is to assess whether specific formulation factors impact the rate and extent of ciprofloxacin oral absorption, as well as the absolute absorption profile of ciprofloxacin. 2) The secondary objective is to assess if dogs exhibit a greater sensitivity to formulation than do humans. Hypotheses: The investigators anticipate that humans exhibit a modest sensitivity to specific tablet formulation factors. 1) Hence, the hypothesis of this human study is that humans do not exhibit a sensitivity to specific formulation factors and show no in vitro - in vivo correlation to dissolution rate. 2) Alternative hypothesis is that humans do exhibit a sensitivity to specific formulation factors and show an in vitro - in vivo correlation to dissolution rate. #Intervention - DRUG : ciprofloxacin - ciprofloxacin 200mg tablet (single dose) Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Male or female * Age 18 <= age <= 55 * Healthy volunteers: Subjects in good health, as determined by screening evaluation that is not greater than 30 days before the first drug study visit * Willing to avoid caffeine containing products 24 hours prior to and day of study visits * Willing to stop all OTC medications for 24 hours prior to and during study visits * Able to provide informed consent Exclusion Criteria: * Presence of significant medical disease (including cardiovascular, pulmonary, hematologic, endocrine, immunologic, neurologic, gastrointestinal or psychiatric) * Presence of hepatic, renal disease * Pregnant women, breast feeding or trying to become pregnant * Excessive alcohol use (i.e. current physical, behavioral, or personal manifestations related to the abuse or dependency on alcohol) * Routine use (i.e. daily or weekly) prescription medication except birth control pills * Routine use (i.e. daily or weekly) use of acid blockers, antacids, anti-diarrhea, stimulants, appetite suppressants, or anti nausea medication or other drugs that modulate GI function * Currently taking ciprofloxacin or tizanidine * Allergic to ciprofloxacin or any quinolone-type antibiotic (e.g. levofloxacin) * Currently taking a corticosteroid drug (e.g. prednisone) * Had a kidney, heart, or lung transplant * Any condition in which in the opinion of the PI or medical physician would increase risk to the subject or interfere with the integrity of the study Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 55 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes </FORMATTED_CRITERIA>	329
Target Study Title: LH Hormone Pulsation in the Luteal Phase in GnRH Antagonist IVF Cycles Triggered by GnRH Agonist for Final Oocyte Maturation Target Study Description: #Study Description Brief Summary Monitoring the LH pulsatility during the Luteal phase in GnRH antagonist IVF cycles triggered by GnRH agonist for final oocyte maturation. Detailed Description About two decades ago the GnRH antagonist has been used in IVF cycles to prevent premature LH surge. In recent review GNRH antagonist has been found comparable to GnRH agonist in term of live birth rate but with reduced risk of OHSS. another advantage of using GnRH antagonist is the ability to use GnRH agonist for final oocyte maturation which has been shown to nearly eliminate the risk of OHSS. The exact mechanism of this risk reduction is still unknown. Our aim is to do a frequent blood tests every 20 minutes for 6 hours duration in the day of ovum pick up or the day of embryo transfer to measure the level of LH, estradiol and progesterone in women triggered with GnRH agonist for final oocyte maturation. Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * age: 18 <= age <= 42 years BMI < 32 kg/m2 Exclusion Criteria: * Hypogonadotropic hypogonadism Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 42 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes </FORMATTED_CRITERIA>	330
Target Study Title: Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law]) of Berotec® N 100 µg Metered-dose Inhaler in Chronic Obstructive Respiratory Tract Disease Target Study Description: #Study Description Brief Summary Study to obtain data about changing from the chlorofluorocarbon (CFC) - containing Berotec® 200 µg metered - dose inhaler to the CFC - free Berotec® N 100 µg metered - dose inhaler #Intervention - DRUG : Berotec® N 100 µg Metered-dose Inhaler Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Patients were included in the study only if they had been treated with Berotec® 200 µg metered - dose inhaler before switching to the CFC-free Berotec® N 100 µg metered - dose inhaler Exclusion Criteria: * Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Berotec® N 100 µg metered - dose inhaler Sex : ALL Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	331
Target Study Title: Neurokinin 3 Receptor Antagonism as a Novel Treatment for Menopausal Hot Flushes Target Study Description: #Study Description Brief Summary Placebo-controlled, double-blinded, cross-over clinical trial of a new investigational product Detailed Description Double-blinded, placebo-controlled, 2-way crossover study in 30 menopausal women with untreated hot flushes treated with a neurokinin 3 receptor (NK3R) antagonist Aims: To investigate whether an NK3R antagonist can reduce menopausal flushing Treatment: 4 weeks administration of active drug and placebo in random order #Intervention - DRUG : NK3R antagonist - AZD4901 - Neurokinin 3 receptor antagonist - Other Names : - nil others - DRUG : Placebo - Placebo - Other Names : - nil others Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Menopausal women (>=12 months since last menstrual period or bilateral oophorectomy or with a follicle stimulating hormone (FSH) level >=20 milli-international units/millilitre (mIU/mL) and an estradiol level <190pmol/l in the absence of a reliable menstrual marker (hysterectomy with ovarian preservation or endometrial ablation)) aged 40 <= age <= 62 years with >7 hot flushes/day some of which are reported as severe or bothersome who have not been on treatment for menopausal symptoms for the preceding 8 weeks. Exclusion Criteria: * Significant illness, as judged by the Investigator, within 2 weeks of first study visit. * Volunteer has clinical, laboratory, or electrocardiogram (ECG) evidence of uncontrolled hypertension (defined as systolic blood pressure of >= 160 mmHg and/or diastolic blood pressure of >=100 mmHg); uncontrolled diabetes; or significant pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the Investigator. * Participant has a history of Gilbert's syndrome, infectious hepatitis, or other significant hepatic disease (e.g. chronic hepatitis, cirrhosis, autoimmune hepatitis, primary sclerosing cholangitis, non-alcoholic steatohepatitis, or hereditary liver disease) in the opinion of the Investigator. * Participant has a history of surgery which in the opinion of the investigator could cause malabsorption (e.g. gastric or small intestinal surgery or gastric bypass surgery or banding), or patient has a disease that causes malabsorption. * Clinically significant abnormal ECG and/or abnormalities in ECG at screening as judged by the Investigator. * A marked prolongation of QT/corrected QT (QTc) interval (e.g. repeated demonstration of a QTc interval > 450 ms). * Confirmed history of ischaemic heart disease. * Past (within 1 year of enrollment) or present alcohol or substance abuse * Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within at least 3 months of the first administration of AZD4901 in this study. The period of exclusion begins 3 months after the final dose. (Note: patients consented and screened, but not randomised in a previous study are not excluded.) * Participant has a history of neoplastic disease within 5 years prior to signing informed consent or is currently on ongoing treatment to prevent cancer recurrence. * Involvement in the planning and/or conduct of the study (applies to any AstraZeneca employee and their close relatives and/or staff at the study site directly involved in the study, regardless of their role in accordance with their internal procedures) * Inability to understand or cooperate with the requirements of the study * Participant is legally or mentally incapacitated * Participant has significant psychiatric disease or treatment for psychiatric disease e.g. selective serotonin re-uptake inhibitors (SSRIs) which in the opinion of the Investigator may influence the results of the study. * Participant has abnormal screening laboratory values as per the guidelines listed below or other clinically significant, unexplained laboratory abnormality according to the Investigator: * Aspartate aminotransferase (AST) >1.5 times upper limit of normal (ULN) * Alanine aminotransferase (ALT) > 1.5 times ULN * Total bilirubin >1.5 times ULN * Serum creatinine >2.0 times ULN * Clinically relevant disease and abnormalities (past or present), which in the opinion of the Investigator, may either put the patient at risk to participate in this study or may influence the results of the study or the patient's ability to participate in the study. * Participant has a history of hyperthyroidism or hypothyroidism or abnormal screening thyroid tests, as judged by the Investigator. Patients with hypothyroidism who are stable on treatment with normal thyroid function tests may be included in the study if in the opinion of the Investigator this will not influence the results of the study. * Participant has seizures, patients with history of seizures or with conditions that increase the risk of seizures. * Participant has a history of hypersensitivity to more than 2 chemical classes of drugs, including prescription and over-the-counter medications. * Participant has taken any potent or moderate CYP3A4 or CYP2C9 inhibitors, potent or moderate CYP3A4 or CYP2C9 inducers, hormonal contraceptives, antiandrogenic drugs, or other medications specified for the time frame Sex : FEMALE Ages : - Minimum Age : 40 Years - Maximum Age : 62 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT Accepts Healthy Volunteers: Yes </FORMATTED_CRITERIA>	332
Target Study Title: A Feasibility Study Using the CoronaCheck Device to Identify Incident Cases of SARS CoV-2 - FIND SARS CoV-2 Covid-19 Target Study Description: #Study Description Brief Summary Point of care testing is urgently required to enable the immediate detection of SARS-CoV-2 infection to allow effective transmission prevention precautions to succeed. Detailed Description The Coronacheck device is a hand-held, portable, point-of-care device which will allow the safe collection of EBC. It provides an automated platform for the detection of SARS-CoV-2 using an existing sensor repurposed with immobilised recombinant ACE-2 to bind the virus. This produces a measurable signal indicating whether SARS-CoV-2 is present or not. EBC is collected by the CoronaCheck device during tidal breathing, making this investigation non-invasive, repeatable and easy to perform. Previous studies using Inflammacheck™ in people with respiratory conditions have shown it is well tolerated, even in people with severe lung disease. The full test cycle including sample collection and test assay typically occurs in less than 5 minutes. Given the risk of infection, this CoronaCheck™ device has an integrated sensor and breath collection system combined in a fully enclosed, disposable unit to mitigate the risk of cross-infections between users and also reduces any exposure risk to healthcare staff. It is appreciated that disposable plastic has a negative environmental impact, however due to the highly contagious nature of SARS-CoV-2 it is felt unavoidable at present. Using the CoronaCheck does not require laboratory equipment or expertise, and is a quick, easy-to-use point-of-care investigation which provides an immediate result. This could potentially be applied to screening for SARS-CoV-2 in a wide variety of environments for example: GP practices, drive-thru centres, colleges, universities, airports and sports arenas. Any person undergoing a swab for a possible SARS CoV-2 infection is eligible for inclusion, participants will not be assigned an intervention. The participants will breathe into the CoronaCheck device. This involves breathing for up to 6 minutes into a single use, fully sealed unit attached to the hand-held device. This disposable unit has a bacterial-viral filter attached to both the breathing inlet and the exhale outlet to eliminate any risk of contamination. The CoronaCheck device then provides a reading reflecting EBC ACE2 binding which will be documented on the eCRF. This result will not be recorded in the clinical notes as it is not intended to inform patient management decisions in this study. #Intervention - DEVICE : CoronaCheck Device - All participants breath normally into the device for up to 6 minutes Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: o Any adult (>= 16 years) who is: * undergoing a swab for possible SARS-CoV-2 infection * willing and able to give informed consent for participation in the study * unlikely to suffer harm as a result of testing in the opinion of the investigator Exclusion Criteria: o Participants receiving: * invasive ventilation, non-invasive ventilation or nasal high flow oxygen * supplementary oxygen with symptomatic hypoxia or oxygen saturations <=92% (<=88% in COPD) despite 4L oxygen via nasal cannulae * unable to comprehend the study or provide informed consent Sex : ALL Ages : - Minimum Age : 16 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: Yes </FORMATTED_CRITERIA>	333
Target Study Title: Efficacy of a Commercial Dentifrice Containing Ilex Rotunda Thunb Extract for Dental Plaque and Gingivitis: A 3-month Clinical Study in Adults in China Target Study Description: #Study Description Brief Summary The objective of the present study was to compare the anti-plaque and anti-gingivitis effects of a commercially available dentifrice containing 0.6% Ilicis Rotundae Cortex extract to those of a control dentifrice without any active ingredient in 12 weeks of home use. Detailed Description This 12-week, randomized, double-blind, parallel-group study was conducted at the State Key Laboratory of Oral Diseases, Sichuan University, Chengdu, China. The clinical study protocol and informed-consent forms were reviewed and approved by the institutional review board at the West China College of Stomatology at Sichuan University. Prospective patients aged 18 to 70 years in good oral and general health were examined during the screening visit.Patients were included according to inclusion and exclusion criteria. The study participants refrained from all oral hygiene procedures for at least 12 hours as well as from eating, drinking and smoking for 4 hours prior to the baseline examinations. Eligible patients were randomly assigned to receive a commercially available dentifrice containing 0.6% Ilicis Rotundae Cortex extract (experimental group) or a dentifrice without any active ingredient (control group). Random assignment to groups was performed externally by another dentist, using a computer-generated randomization sequence; all other study personnel were neither involved in the randomization process nor aware of treatment assignments in any outcome evaluation. All dentifrices were supplied in their original packaging (the experimental and control dentifrices were identical in appearance \[including size, color, and shape\] and taste). The dentifrices were covered to mask their identity and provided with a unique code that was not decoded until the conclusion of the study. The test product was distributed in a separate area, and all other study personnel and study participants were blinded to treatment assignment. Patients were provided with their assigned product and the same soft-bristled toothbrush for unsupervised brushing for 12 weeks. Patients were instructed to brush their teeth twice a day (in the morning and in the evening) for 1 minute, using enough toothpaste to cover the entire brush, and to refrain from any other oral hygiene procedures throughout the duration of the study. There were no restrictions regarding diet or smoking habits during the course of the study. Patients were requested to return to the clinic after 6 weeks and 12 weeks for follow-ups, having refrained from all oral hygiene procedures for at least 12 hours before, and from eating, drinking and smoking for 4 hours before, the scheduled visit. Patients were evaluated at baseline, after 6 weeks, and after 12 weeks of use. At each point, patients received oral examinations of their hard and soft tissues, followed by an evaluation of gingivitis and dental plaque. Patients were asked whether they had the presence of adverse events such as any discomfort while brushing and alterations in taste. All examinations were performed by the same investigator throughout the study. However, after each examination, the gingivitis and plaque scores were kept by the facilitator, and the investigator did not have access to the scores of the patients. Dental plaque examination: Supra-gingival plaque on the facial and lingual surfaces of each tooth was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Gingivitis examination: Gingivitis was scored according to the Löe-Silness Gingival Index. Adverse Events: Clinical evaluations by an investigator at each scheduled visit included assessments of both oral hard and soft tissue. Patients were interviewed during these examinations for any adverse events or changes in their health status. All patients underwent their final clinical examination at the conclusion of the study. #Intervention - DRUG : Dentifrice Containing Ilex Rotunda Thunb - Use the dentifrice to brush teeth twice a day for 12 weeks - DRUG : Control dentifrice - Use the dentifrice to brush teeth twice a day for 12 weeks Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Patients had to be aged 18 and 70 (inclusive) years in good oral and general health. * Patients had to possess at least 20 uncrowned permanent natural teeth (excluding third molars). * Patients should have a whole mouth mean plaque score of at least 1.5(Turesky modification of the Quigley-Hein Plaque Index 12 <= age <= 13) and a whole mouth mean gingivitis score of or greater than 1.0(Löe-Silness Gingival Index14). Exclusion Criteria: * Patients were excluded from the study if they had moderate to advanced periodontal disease, 5 or more decayed untreated dental sites at screening, other disease of the hard or soft oral tissues. 2. Patients were excluded from the study if they began taking medications that can influence the study outcome, antibiotics or antimicrobial drugs, within one month prior to the start of the study or if they started taking them during the course of the study. * Pregnant or lactating women, patients who were participating in any other clinical study or who had participated in a study within one month prior to enrollment of study, were not allowed to participate in the study. * Patients were excluded from the study if they presented orthodontic bands; or partial or removable dentures; or received a dental prophylaxis anytime during the past two weeks prior to the baseline examination; or a history of alcohol or drug abuse; or used the study dentifrice within the last 3 months. * Patients with a history of allergies to the test products, or allergies to oral care/personal care consumer products or their ingredients, or patients with existing medical conditions, which prohibits them eating and drinking for periods up to four hours, were also excluded from the study. Sex : ALL Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	334
Target Study Title: Phase I/II Trial to Evaluate Ethyol as a Protective Agent for Irinotecan (CPT-11) Toxicities in Patients With Advanced Colorectal Cancer Target Study Description: #Study Description Brief Summary RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus irinotecan in treating patients with metastatic colorectal cancer. Detailed Description OBJECTIVES: I. Assess the toxicity profile of irinotecan and amifostine when administered together in patients with metastatic colorectal cancer. II. Assess the total dose of irinotecan received per 6 week course in these patients. III. Determine the incidence of irinotecan-induced leukopenia, neutropenia, and diarrhea in these patients. V. Determine the response rate for this patient population. OUTLINE: This is an open label study. Amifostine is administered by 10 minute IV infusions. Irinotecan is administered by IV infusions 15 minutes after completion of amifostine. Treatment is repeated every 2 weeks for 6 weeks. This 6 week course is repeated in the absence of disease progression. Treatment may be delayed up to 2 weeks after a course to allow for recovery from toxic effects. Patients are followed at the end of study and at 30 days after study. PROJECTED ACCRUAL: There will be 25-30 patients accrued into this study. #Intervention - DRUG : amifostine trihydrate - Ethyol 740 mg/m2 will be administered intravenously over 10 minutes. Administered every two weeks for 3 cycles. - Other Names : - Ethyol - DRUG : irinotecan hydrochloride - 10 minutes after completion of the Ethyol infusion, Irinotecan 250 mg/m2 will be given over 90 minutes IV. Administered every 14 days for 3 cycles Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * 18 years or older * ECOG 0 <= age <= 2 * Life expectancy of at least 12 weeks * Pathologically confirmed diagnosis of metastatic colorectal cancer * Measureable disease * Have not received therapy for cancer within 4 weeks of enrollment on study * Prior radiation therapy to the pelvis for treatment of colorectal cancer is allowed. Radiation therapy delivered elsewhere is allowed as long as the patient has been off treatment for at least six weeks and measurable lesions are present outside the radiation field * Pretreatment granulocyte count of > 1500/mm3, hemoglobin > 9.0 g/dL (without transfusion), and platelet count of > 100,000/um * Serum creatinine < 2.0 mg/dL * Adequate hepatic function as documented by a serum bilirubin < 2.0 mg/dL regardless of whether patients have liver involvement secondary to tumor. AST must be < 3x the upper limit of normal unless the liver is involved with tumor, in which case the AST must be < 5x institutional upper limit of normal Exclusion Criteria: * Prior therapy with Irinotecan * Patients with any active or uncontrolled infection * Patients with psychiatric disorders that would interfere with consent or follow-up * Patients with a history of myocardial infarction within the previous six months, congestive heart failure, or cerebrovascular disease * History of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years * Presence of clinically apparent central nervous system metastases or carcinomatous meningitis * Patients with uncontrolled diabetes mellitus * Any other sever concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study * Patients unable to stop taking antihypertensive medication 24 hour prior to administration of Ethyol (off x 1 day) Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	335
Target Study Title: L'impact De La Raideur Articulaire Pelvienne Sur La Peur De Chuter Du Sujet Âgé Hospitalisé Ou En Institution. Target Study Description: #Study Description Brief Summary 1. / evaluation of the fear of falling using an FES-I questionnaire, distribution of subjects according to the score into 3 groups (16-19: little concerned by the fear of falling, 20-27 moderately concerned, 28-64 very concerned by fear of falling) 2. / evaluation of lumbar articular mobility by the schober index, coxofemoral by hip goniometry in flexion and extension (no evaluation of other amplitudes because lack of abduction / abduction / external and internal rotation of the hip remain functional in walking and the balance) Detailed Description 1. / evaluation of the fear of falling using an FES-I questionnaire, distribution of subjects according to the score into 3 groups (16-19: little concerned by the fear of falling, 20-27 moderately concerned, 28-64 very concerned by fear of falling) 2. / evaluation of lumbar articular mobility by the schober index, coxofemoral by hip goniometry in flexion and extension (no evaluation of other amplitudes because lack of abduction / abduction / external and internal rotation of the hip remain functional in walking and the balance) #Intervention - DIAGNOSTIC_TEST : anthropomorphic measurements - anthropomorphic measurements + FES questionnaire + demographic data and medications - Other Names : - FES questionnaire Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * > 75 years, * Ability to understand and answer a questionnaire in French * Ability to stand up * Patient from the Melun hospital (santé pole center + nursing home of the GHSIF) * Affiliated with a social security scheme Exclusion Criteria: * mental disorders, * lumbar surgery Sex : ALL Ages : - Minimum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT Accepts Healthy Volunteers: Yes </FORMATTED_CRITERIA>	336
Target Study Title: A Phase 3, Randomized, Double-blind, Multi-center, Placebo Controlled, Dose-Optimization, Safety and Efficacy Study of SHP465 in Children and Adolescents Aged 6-17 Years With Attention-Deficit Hyperactivity Disorder (ADHD) Target Study Description: #Study Description Brief Summary The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD in children and adolescents (aged 6-17 years). The primary objective of this study is to evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in the treatment of children and adolescents (6-17 years of age inclusive) diagnosed with ADHD. #Intervention - DRUG : SHP465 - 12.5mg and 25mg capsules (one capsule daily) - DRUG : Placebo - Matching placebo capsule that appear identical in size, weight, shape, color Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Subject must be 6 <= age <= 17 years, inclusive, at the time of consent. * Subject's parent or legally authorized representative (LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions in accordance with the ICH GCP Guideline E6 (1996) and applicable regulations before completing any study-related procedures. * Subject and parent/LAR are willing and able to comply with all of the testing and requirements defined in the protocol, including oversight of morning dosing. Specifically, the parent/LAR must be available at approximately 7:00AM (±2 hours) to dispense the dose of investigational product for the study duration. * Subject, who is a female and of child-bearing potential, must not have a positive serum beta human chorionic gonadotropin pregnancy test at the Screening Visit (Visit 1) and must have a negative urine pregnancy test at the Baseline Visit (Visit 2) and agree to comply with any applicable contraceptive requirements of the protocol. * Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities. * Subject meets DSM-IV-TR criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation. * Subject has an ADHD-RS-IV Total Score >28 at the Baseline Visit (Visit 2). * Subject is functioning at an age-appropriate level intellectually, as determined by the study Investigator. * Subject is currently not on ADHD therapy, or is not completely satisfied with any aspect of their current ADHD therapy. * Subject is able to swallow a capsule whole. Exclusion Criteria: * Subject has a current, controlled (with medications prohibited in this study) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any significant comorbid Axis II disorder or significant Axis I disorder (such as post-traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, depressive or anxiety disorder) or other symptomatic manifestations that, in the opinion of the examining clinician, will contraindicate treatment with SHP465 or confound efficacy or safety assessments. Comorbid psychiatric diagnoses will be established with the Screening Visit (Visit 1) interview of the K-SADS-PL and additional modules if warranted by the results of the initial interview. Subjects may continue participation in a behavioral modification program during the study as long as they have been participating in the program for at least 1 month at the time of the Baseline Visit (Visit 2). * Subject meets DSM-IV-TR diagnosis of conduct disorder. Oppositional defiant disorder is not exclusionary. * Subject is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator. * Subject is underweight based on Centers for Disease Control and Prevention body mass index (BMI)-for-age sex-specific values at the Screening Visit (Visit 1). Underweight is defined as a BMI <3rd percentile * Subject is significantly overweight based on Centers for Disease Control and Prevention BMI-for-age sex specific values at the Screening Visit (Visit 1). Significantly overweight is defined as a BMI >97th percentile for this study * Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments conducted in the study or that might increase risk to the subject. Similarly, the subject will be excluded if he or she has any additional condition(s) that, in the Investigator's opinion, would prohibit the subject from completing the study or would not be in the best interest of the subject. The additional conditions would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol. Mild, stable asthma is not exclusionary. * Subject has a history of seizure (other than infantile febrile seizures), a chronic or current tic disorder, or a current diagnosis of Tourette's Disorder. Subject has a history of tics that are judged by the Investigator to be exclusionary. * Subject's blood pressure measurements exceed the 90th percentile for age, sex, and height (based on the Blood Pressure Levels by Age and Height Percentile [for boys and girls]) at the Screening Visit (Visit 1) and the Baseline Visit (Visit 2) * Subject has a known history of hypertension * Subject has a known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place him/her at increased vulnerability to the sympathomimetic effects of a stimulant medication. * Subject has a known family history of sudden cardiac death or ventricular arrhythmia. * Subject has any clinically significant ECG or clinically significant laboratory abnormality at the Screening Visit (Visit 1). * Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating hormone and thyroxine at the Screening Visit (Visit 1). Treatment with a stable dose of thyroid medication for at least 3 months is permitted. * Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product. * Subject has failed to respond, based on Investigator judgment, to an adequate course(s) (dose and duration) of amphetamine therapy * Subject has a history of suspected substance abuse or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR criteria. Subjects with a lifetime history of amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded. * Subject has a positive urine drug result at the Screening Visit (Visit 1) (with the exception of subject's current stimulant therapy, if any) or the Baseline Visit (Visit 2), if repeated unless the Investigator can verify that the positive result at the Screening Visit (Visit 1) is attributed to medication that has been prescribed to the subject and will be discontinued prior to the Baseline Visit (Visit 2). A positive result at the Screening Visit (Visit 1) attributed to a prescribed medication requires a re-test and a negative result at the Baseline Visit (Visit 2) to confirm subject eligibility. * Subject has taken another investigational product or has taken part in a clinical study within 30 days prior to the Screening Visit (Visit 1). * Subject has previously completed, discontinued, or was withdrawn from this study. * Subject is taking any medication that is excluded or has not been appropriately washed out according to the protocol requirements. * Subject is required to take or anticipates the need to take medications that have central nervous system effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors. Stable use of bronchodilator inhalers is not exclusionary. * Subject is female and is pregnant or lactating Sex : ALL Ages : - Minimum Age : 6 Years - Maximum Age : 17 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	337
Target Study Title: Characteristics of Patients Diagnosed With NSAID Sensitivity in Thailand Target Study Description: #Study Description Brief Summary Study clinical characteristics and phenotypes of patients diagnosed with NSAID sensitivity in Thailand #Intervention - DRUG : aspirin, NSAIDs, paracetamol - Perform skin test and/or provocation test with aspirin, paracetmol, or suspected NSAIDs in questionable cases Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Thai patients with a history of an immediate reaction to aspirin/paracetamol, or NSAIDs visiting King Chulalongkorn memorial Hospital Exclusion Criteria: * None Sex : ALL Ages : - Minimum Age : 15 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	338
Target Study Title: Assessment of the Reducting Effect of Dexmedetomidine on the Morphine Use for Severe Burned Patients Target Study Description: #Study Description Brief Summary The new progresses relative to sedation-analgesia for resuscitation unit lead to perform a light and cooperative sedation as soon as possible in order to decrease the period of mechanical ventilation. Dexmedetomidine (DEX), which is a central alpha-2 agonist, is the referential hypnotic in this case with a reduction of the morphine-type use. DEX was mainly studied in the bandage procedures for the burned adult. The aim of this study is to evaluate the reducing effect of DEX on the morphine use in case of severe burnings for adults, to describe the receivers of DEX and to report the procedure of this new molecule. Detailed Description The new progresses relative to sedation-analgesia for resuscitation unit lead to perform a light and cooperative sedation as soon as possible in order to decrease the period of mechanical ventilation. Dexmedetomidine (DEX), which is a central alpha-2 agonist, is the referential hypnotic in this case with a reduction of the morphine-type use. DEX was mainly studied in the bandage procedures for the burned adult. The aim of this study is to evaluate the reducing effect of DEX on the morphine use in case of severe burnings for adults, to describe the receivers of DEX and to report the procedure of this new molecule. This study would manage to develop a protocol using dexmedetomidine to reduce the use of morphine for the sedation-analgesia. It expects a sensitization of physicians about the need to form the nurse crew for the autonomous use of a protocol before performing a new evaluation of sedation-analgesia. Task Instruction: 1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from): <FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * Inclusion Criteria 1 * Inclusion Criteria 2 * Inclusion Criteria 3 * ... Exclusion Criteria: * Exclusion Criteria 1 * Exclusion Criteria 2 * Exclusion Criteria 3 * ... ##Sex : [MALE\|FEMALE\|ALL] ##Ages : - Minimum Age : ... Years - Maximum Age : ... Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT\|CHILD\|OLDER ADULT] comma separated ##Accepts Healthy Volunteers: [YES\|NO] </FORMATTED_CRITERIA>	<FORMATTED_CRITERIA> #Eligibility Criteria: Inclusion Criteria: * More than 18 years * Hospitalised for severe burning (total burned skin surface higher than 20% and/or smoke inhalation and/or severe comorbidities) * Having received a continued dexmedetomidine administration of at least 24 hours for the case group and having received no dexmedetomidine administration for the control group Exclusion Criteria: * Inability to communicate (language barrier, major cognitive disorders) * Medical contraindication for dexmedetomidine (hepatocellular insufficiency, hypersensibility, grade II or III atrio-ventricular blocks without device, acute brain vascular pathology). * For the control group, pregnancy is a non-inclusion criterion Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT Accepts Healthy Volunteers: No </FORMATTED_CRITERIA>	339