Kornimate/medical-research-clean huggingface dataset:
physiologic assessment of coronary stenosis following pci

Conditions: Coronary Artery Disease; Coronary Stenosis; Angina, Unstable; Angina, Stable

Summary: this is a pilot study designed to assess the relationship between ifr (instantaneous wave-free ratio) pullback and the distribution of coronary atheroma/stenoses as assessed by quantitative coronary angiography (qca) post angiographically successful pci (percutaneous coronary intervention).

define-pci is a multi-center, prospective, non-significant risk study in up to 25 centers in usa and internationally. consented subjects with cad (coronary artery disease) who undergo physiologic lesion assessment with ifr\<0.90 in at least 1 coronary artery are eligible for participation. after successful pci to all culprit lesions based on angiographic assessment of the treating physician, a blinded post-pci ifr and ifr pullback will be performed. the proportion of patients with impaired post-pci ifr will be assessed, and the number of patients in whom ischemia could theoretically be normalized with further pci determined. additionally, the association between the post-pci ifr results and cardiovascular events and clinical symptoms will be assessed. follow-up will be at 1, 6 and 12 months, including administration of quality of life questionnaires.

Eligibility criteria:
inclusion criteria: 1. subject must be \> 18 years old 2. subjects presenting with stable angina, silent ischemia or non-st-elevation acs (acute coronary syndrome) (unstable angina or biomarker positive) 3. single vessel cad with at least 2 separate lesions (≥10 mm apart) of ≥40% stenosis or a single long lesion of ≥20mm or multi-vessel cad, defined as at least 2 vessels with ≥40% stenosis 4. pre-pci ifr performed in all vessels intended for pci 5. pre-pci ifr of \<0.90 of at least 1 stenosis 6. subjects are able and willing to comply with scheduled visits and tests and to provide informed consent. exclusion criteria: 1. pregnant or planning to become pregnant for the duration of the study 2. acute stemi (st-elevated myocardial infarction) within the past 7 days 3. cardiogenic shock (sustained (\>10 min) systolic blood pressure \< 90 mmhg in absence of inotropic support or the presence of an intra-aortic balloon pump). 4. ionotropic or temporary pacing requirement 5. sustained ventricular arrhythmias 6. prior cabg (coronary artery bypass graft) 7. known ejection fraction ≤30% 8. chronic total occlusion (cto) 9. known severe mitral or aortic stenosis. 10. any known medical comorbidity resulting in life expectancy \< 12 months. 11. participation in any investigational study that has not yet reached its primary endpoint. 12. known severe renal insufficiency (egfr \<30 ml/min/1.72 m2). 13. timi flow \<3 at baseline 14. intra-coronary thrombus on baseline angiography
evaluation of mhealth for serious mental illness

Conditions: Schizophrenia; Schizoaffective Disorder; Major Depressive Disorder; Bipolar Disorder

Summary: this study is a waitlist control trial evaluating the acceptability and preliminary efficacy of a smartphone application with people with mental illness.


Eligibility criteria:
inclusion criteria: * 18 years or older * owns an android or iphone smartphone with wifi or 3g/4g capabilities (required for data transmission) * has diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or major depression * english speaker exclusion criteria: * does not live in the u.s. * has already participated in the study * unavailable for 60 days * currently incarcerated or hospitalized

Keywords: schizophrenia schizoaffective disorder mobile application smi ehealth e-health health technology mhealth m-health mobile health serious mental illness electronic health
mt-8554 for reduction of vasomotor symptoms in postmenopausal women

Conditions: Menopause Hot Flashes

Summary: the purpose of this study is to assess the efficacy and safety of mt-8554 for treatment of vasomotor symptoms (vms) associated with menopause.

this is a phase ii randomized, double-blind, placebo-controlled study for dose selection in postmenopausal women with moderate to severe vms, defined as follows: * moderate: sensation of heat with sweating, able to continue activity * severe: sensation of heat with sweating, causing cessation of activity this study is comprised of a screening period, a run-in period and a 12-week double-blind treatment period.

Eligibility criteria:
inclusion criteria: additional screening criteria check may apply for qualification: * provide written informed consent to participate in this study * spontaneous amenorrhea for ≥12 months; or spontaneous amenorrhea for at least 6 months and with follicle stimulating hormone (fsh) levels \>40 miu/ml; or documented bilateral salpingo oophorectomy ≥6 weeks, with or without hysterectomy * 7 or more moderate to severe vms per day, or 50 or more moderate to severe vms per week * have a consistent bedtime on at least 5 nights per week * mean vms frequency during the placebo run in period does not drop by more than 50% from the mean level reported for 2 weeks during the screening period * vms diary compliance \>50% * in the investigator's opinion, subject is able to understand the nature of the study and any risk involved in participation, and is willing to cooperate and comply with the protocol restrictions and requirements exclusion criteria: additional screening criteria check may apply for qualification: * history of any cancer within 5 years except for basal cell carcinoma * history of undiagnosed abnormal vaginal bleeding * history of hepatitis b, hepatitis c or hiv * history of psychiatric illness, excessive alcohol intake or use of recreational drugs who are unsuitable for study enrollment and compliance * presence or history of severe adverse reaction or allergy to any drug * peripheral vascular disease or disorders with associated vasculopathies * clinically significant conditions which could interfere with the objectives of the study or the safety of the subject, as judged by the investigator * endometrial thickness of \>=5 mm as measured by transvaginal ultrasound * abnormal result from baseline endometrial biopsy (i.e., endometrial hyperplasia or endometrial cancer) * aspartate aminotransferase (ast), alanine aminotransferase (alt), or total bilirubin ≥2.0 × upper limit of normal (uln) above the reference range * subjects of childbearing potential
effects of angiotensin converting enzyme (ace) inhibitors versus candesartan in reducing cardiovascular events in primary treatment of hypertension

Conditions: Hypertension; Cardiovascular Disease

Summary: the planned study will be a retrospective study on the effect of ace's vs. candesartan on cardiovascular events and on health economic effects in a "real life" setting in sweden.


Eligibility criteria:
inclusion criteria: * all patients found in electronic patient journals at the participating centres, who were prescribed either aceis (atc-c09a-b) or arbs (c09c-d) for hypertension from 1 january 1999 - 31 december 2007. the first date of such a prescription starts the observation time and is called the index prescription. exclusion criteria: * no history of cardiovascular disease. * ongoing malignancy

Keywords: hypertension ace arb real life data cvd cost effectiveness
the metabolic effects of a high fructose versus a high glucose diet in overweight men

Conditions: Hepatic Fatty Acid Metabolism; Systemic Insulin Resistance; Oxidative Stress; Cardiovascular Status

Summary: dietary consumption of fructose has increased by nearly 50% since 1960. a high fructose diet (hfrd) results in greater visceral adiposity and systemic insulin resistance than a high glucose diet. the effects of fructose on liver fatty acid and atp stores, systemic oxidative stress and cardiovascular status are not fully known.

the protocol will assess the following outcomes: 1. the ultimate fate of this increased hepatic fatty acid production following a high fructose vs. glucose diet 2. the effect of a high fructose vs. glucose diet on liver atp stores 3. the effect of a high fructose vs. glucose diet on markers of oxidative stress 4. the effect of a high fructose vs. glucose diet on cardiovascular status factors critical to carbohydrate metabolism such as systemic insulin resistance, body composition, energy expenditure, physical activity will also be assessed. 32 centrally overweight healthy males with a low baseline fructose intake will be recruited. they will be randomised double blindly to receive 25% of their dietary energy requirements from either fructose or glucose for 14 days. the sugars will first be taken in an energy balanced and then an overfeeding setting.

Eligibility criteria:
inclusion criteria: 1. body mass index 25-32 2. waist \> hip circumference 3. age 18-50 years 4. male exclusion criteria: 1. reported weight change \> 3 kg in prior 3/12 2. active health problems 3. contraindications to mri scanning 4. symptoms of functional bloating or irritable bowel syndrome 5. abnormal liver or renal function tests 6. random glucose greater than 11.0 mmol/l 7. evidence of metabolic or viral liver disease as screened for by hepatitis b and c serology, and ferritin. 8. alcohol intake \> 21 units per week 9. vegetarianism 10. normal daily fructose intake from drinks greater than that in 500ml of coca cola 11. abnormal carbohydrate energy contribution to baseline diet - defined as greater than 2 standard deviations from the mean of the national diet and nutrition survey 2002 data

Keywords: fructose fatty liver disease diet
mindfulness-based program for children with disruptive behavior disorder

Conditions: Disruptive Behavior Disorder; Oppositional Defiant Disorder; Attention Deficit and Disruptive Behavior Disorders

Summary: the present rct study investigates whether combined mindfulness program for children and their parents was beneficial for italian children, aged 8-12, with disruptive behavior diagnosis (dbd). the study tests the program effects on children's behavioral difficulties in school and home contexts; children's and parents' mindfulness abilities; children's impulsiveness; and parents' stress. the study include a sample of 50 children randomly allocate to the intervention or to the control condition (wait-list control sample). repeated measures of children's and parents' and teachers' reported measures will be used.


Eligibility criteria:
inclusion criteria: * disruptive behavior primary diagnosis exclusion criteria: * iq \< 80 * asd diagnosis * ongoing other interventions

Keywords: mindfulness adhd oppositional defiant disorder
efficacy and safety of telmisartan/rosuvastatin co-administration in hypertensive patients with hyperlipidemia

Conditions: Hypertension; Hyperlipidemia

Summary: to identify efficacy and safety of telmisartan/rosuvastatin co-administration in hyperlipidemia control in hypertensive patients with hyperlipidemia compared to each monotherapy.


Eligibility criteria:
inclusion criteria: * signed informed consent * men and women \>18 years of age * subject who has one of 3 conditions classifed by cardiovascular risk factors, 10-year risk, blood pressure, ldl-c, coronary artery disease and equivalent exclusion criteria: * female who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study,. * other exclusions applied
a study to assess the tolerability of a single dose of stx107 in adults with fragile x syndrome

Conditions: Fragile X Syndrome

Summary: the study will consist of a screening period (up to 14 days), a treatment period, and a follow-up period. sixteen subjects will be enrolled into two sequential dose cohorts - 10 or 30 mg (or matching placebo) across four study centers.


Eligibility criteria:
inclusion criteria: * male subjects 18 to 50 years of age, inclusive. * molecular documentation of the full fragile x mutation. exclusion criteria: * subjects with a history of seizure disorder who are, in the opinion of the investigator and medical monitor, not currently considered to be well controlled. * subjects currently being treated with psychoactive medications (including stimulants and anxiolytics). * subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. 4. subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study. * subjects who, in the investigator's opinion, might not be suitable for the study
feasibility of high levels of energy expenditure from physical activity for breast cancer survivors

Conditions: Breast Cancer Female

Summary: the purpose of the study is to demonstrate that breast cancer survivors who need to lose weight are able to follow a weight loss program which combines modest calorie restriction with a graduated activity program..

feasibility will be assessed by 1) the number of women that complete the 3--month program; 2) the number of women that can achieve the targeted amount of physical activity per week by the end of the program; and 3) the median amount of physical activity achieved group by all subjects that complete the program.

Eligibility criteria:
inclusion criteria: * women \< age 71 in good general health. * prior diagnosis of breast cancer. * at least 3 months from completion of any cytotoxic chemotherapy or radiation or surgery. may continue to take endocrine therapy and/or maintenance trastuzumab. * body mass index (bmi) 30-45 kg/m2. * by self-assessment, currently performing 60 minutes or less of purposeful exercise per week but able to walk at least 30 minutes on a level surface. * access to a smart phone capable of running myfitnesspal and garmin connect apps and willing to have diet and exercise data from these apps viewed by study personnel. * live in the greater kansas city metropolitan area * willing and able to perform moderate intensity exercise at least 5 days per week for 3 months. * willing to perform unsupervised home exercise for the entire 3 months. * willing to participate in a weekly behavioral modification group phone call for 3 months. * willing to participate in a controlled dietary intervention with portion controlled meals and partial meal and track food intake and exercise. exclusion criteria: * use of metformin, insulin, steroids or weight loss or anti-psychotic drugs within the prior 3 weeks * individuals with prior bariatric surgery procedures * need for chronic immunosuppressive drugs * participation within the past 6 months on a structured weight loss program such as weight watchers® * physical impairments (bad hip, knees, feet, peripheral neuropathy) that would prohibit performing moderate intensity exercise at least 5 days per week. * any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for participation in the trial such as recent cardiac event. * currently receiving investigational agents in a clinical trial.

Keywords: breast cancer survivor weight loss program
investigate the effect of ezetimibe, simvastatin, and omega 3- fatty acids on dyslipidemia patients: a pharmacokinetics based study

Conditions: Hyperlipidemia; Mixed

Summary: this randomized controlled pharmacokinetic based study will be carried out on patients with both sexes and various ages, plasma triglycerides levels, clinical health disorders and using different agents for treatment of their hyperlipidemia in order to access the optimal drug therapy with best cost effectiveness in the elderly cases under investigation.


Eligibility criteria:
inclusion criteria: * patients of dyslipidemia with high triglyceride level (200 to 499 mg/100 ml). * total cholesterol level more than 200 mg/100 ml * male and female * age 35 - 70 years exclusion criteria: * - hypersensitivity of drugs * liver toxicity * -patients suffering from renal dysfunction
short-term metabolic effects of mirtazapine in healthy subjects

Conditions: Healthy

Summary: the purpose of this study is to determine metabolic changes upon a 7 day medication of 30 mg mirtazapine per day in healthy subjects.


Eligibility criteria:
inclusion criteria: * male sex * age 20-25 years * somatically and mentally healthy * normal body weight (body mass index (bmi)18.5-25) exclusion criteria: * smoking within the last 6 months * medication within last 6 months * current or former psychiatric illness * positive family history (first grade relatives) for metabolic diseases * alcohol abuse * current or former illicit drug abuse * current or former drug abuse * known intolerance to, or former prescription of study medication * participation in other clinical trials at the same time or participation in clinical trials associated with administration of a drug within the last 6 months * homelessness * shift work within last 12 months * known hypersensitivity to mirtazapine or other components of the drug given * known epilepsy; glaucoma; liver, kidney, or heart disease; urinary dysfunction; hypotonia; diabetes or any other metabolic disease * known hematologic disease, especially agranulocytosis or leukopenia * blood donation within last 6 months prior to the begin of the study * hemoglobin below 13.5 mg/dl

Keywords: mirtazapine metabolism depression healthy males
a study to investigate the efficacy and safety of different doses of losartan potassium (mk0954-011)

Conditions: Hypertension

Summary: the purpose of this study was to compare the antihypertensive efficacy of different doses of losartan compared to placebo and enalapril, in patients with supine diastolic blood pressure of 100-115 mmhg.


Eligibility criteria:
inclusion criteria: * patient has been diagnosed with mild to moderate hypertension, with supine diastolic blood pressure of 100 to 115 mmhg * patient has no active medical problems other than essential hypertension that might affect blood pressure * patient has received no drug therapy that might affect blood pressure exclusion criteria: * prior exposure to losartan * history of stroke * history of myocardial infarction * atrial flutter or atrial fibrillation * history of congestive heart failure * known sensitivity to ace inhibitors * known positive test for hiv/aids or hepatitis b * patient is being treated for acute ulcer disease * history of chronic liver disease * actively treated diabetes mellitis * any known bleeding or platelet disorder * absence of one kidney * women of childbearing potential or who are breastfeeding * patient is abusing or has a history of alcoholism or drug addiction
amino acid feed children's study

Conditions: Milk Hypersensitivity

Summary: this study of the tolerance and acceptability of an amino acid based feed will assess gastrointestinal (gi) tolerance, product intake and acceptability in relation to taste, smell, texture in 20 patients between 1-10 years currently using or requiring an amino acid based feed for the dietary management of cows' milk allergy and food-allergy-associated conditions, over 4 weeks.

dietary management of cows' milk allergy (cma) involves avoiding cow's milk protein in the diet, whilst ensuring that an adequate nutritional intake is achieved with suitable alternative foods or prescribable feeds. a number of studies and clinical insights indicate that cma is persisting longer than infancy, into later childhood and becoming more complex. if a child has cma, eliminating the offending allergens whilst maintaining an intake of food that meets their nutritional requirements for growth and development is challenging due to the significant nutritional contribution these foods make to a child's diet, particularly milk and dairy products. this supports the need for alternatives to cow's milk to be available for children \>1year of age to help meet their nutritional needs. aminoacid based feeds are already widely used in clinical practice to meet this need. a new nutritionally complete amino acid based powdered feed for the dietary management of cma, or other conditions where an amino acid based is recommended, in children aged 1-10yrs old, has been developed. this study is to support the use of this new amino acid based feed in clinical practice. the study will evaluate the tolerance and acceptability of the amino acid based powdered feed in 20 children aged 1-10yrs of age receiving or requiring an amino acid based feed for the dietary management of cma and food allergy associated conditions, over 4 weeks. the primary outcome will be gastrointestinal tolerance, with secondary outcomes of compliance, acceptability, nutrient intake and anthropometry.

Eligibility criteria:
inclusion criteria: * male or female * age 1-10 years * currently using or requiring an amino acid based feed * expected to receive at least 30% of their energy intake from the study product * written informed consent from parents / carer exclusion criteria: * parenteral nutrition contributing more than 70% of total energy intake * children with major hepatic or renal dysfunction * participation in other studies within 2 weeks prior to entry of this study * investigator concern around willingness/ability of parent/carer to comply with protocol requirements
effects of osteopathic treatment in patients with tension type headache

Conditions: Tension-Type Headache

Summary: the aim of this study is to evaluate the effects of the suboccipital muscles inhibition technique on patients suffering from tension-type headaches.

the tension-type headache is a recurrent condition with a high financial repercussion in portugal. their side effects often impact daily activities, reducing the quality of life of the patients. in several studies, the excessive tension of the suboccipital muscles are usually referred as a cause of tension-type headache, since they can exert tension on the dura mater through the myodural bridge.

Eligibility criteria:
inclusion criteria: they must have tension-type headache, that is, a headache with: * a duration of at least 30 min to days, with or without an break; * must have at least two of the following four characteristics: 1. bilateral location 2. pressure or squeezing quality (non throbbing) 3. weak or moderate intensity 4. not aggravated by routine physical activity such as walking or climbing stairs; * must have both of the following criteria: 1. only one of the following: photophobia, phonophobia, or mild nausea 2. absence of moderate or severe nausea or vomiting. exclusion criteria: * they can't be on antibiotics, antivirals, or antidepressants; * they can't have neurological problems; * they shouldn't have any absolute contraindication for the osteopathic maneuvers; * they can't have acute pathologies (ex: infection) or serious (ex: cancer); * they can't have fractures in the skull, cervical spine or high dorsal spine (up to d4); * they can't be pregnant.
infant microbiome in diaper rash

Conditions: Diaper Rash

Summary: the objective of this study is to evaluate the microbiome composition of infant's (9-12 month) skin experiencing diaper rash in order to determine if the onset and severity of erythema associated with diaper rash is influenced by the type of bacteria colonizing the skin.


Eligibility criteria:
inclusion criteria: * infants aged 9-12 months with mild to moderate diaper rash exclusion criteria: * use of topical or oral antibiotics or antifungals within the past 4 weeks. * use of zinc-containing diaper rash creams within 48 hours first sample * immunocompromised