Kornimate/medical-research-clean huggingface dataset:
impact of caregiver depression on asthma in the child

Conditions: Depressive Disorder, Major; Asthma

Summary: this study will examine if depression in a primary caregiver is associated with more hospitalization or er visits in children with asthma. this study will also explore whether treatment for depression in the primary caregivers is associated with improvement in asthma in school-aged children. asthma is a very common childhood disorder of airway inflammation. the causes include environmental irritants, cold temperature, and infection in the respiratory tract, and emotional factors can contribute to symptom exacerbation. however, asthma is a disease that can be well controlled if there is proper medication compliance and careful control of environmental conditions. data suggests that psychiatric symptoms in the mothers of children with asthma are associated with more asthma related hospitalizations in children. thus, we want to explore this question further using more specific diagnostic instruments in order to detect what types of symptoms are associated with increased asthma related service utilization. also, we want to explore if effective treatment of the caregivers' symptoms is associated with decreased hospitalization and emergency room visits for the child.


Eligibility criteria:
inclusion criteria: * primary caregiver of a child currently hospitalized at children's medical center of dallas for an asthma exacerbation and between the ages of 5 and 16 years old * male and female * english or spanish speaking * between the ages of 18 and 70 years old * caregivers with major depressive disorder will be offered treatment exclusion criteria: * at risk for suicide defined by multiple suicide attempts (greater than or equal to 3 in the past), and/or current suicidal ideation with a well-formed plan or intent * unlikely to attend follow-up appointments * mentally retarded or suffer from other severe cognitive impairment * pregnant or nursing, or women of childbearing age who will not use methods of birth control or abstinence during the study * suffering from a severe or life-threatening medical illness which would make completion of the study unlikely * suffering from treatment refractory depression defined by failing three adequate trials of antidepressants * depression as part of bipolar disorder or schizophrenia or schizoaffective disorder, or current depression secondary to a medication or general medical condition, or with psychotic features
vascular impact of omega-3 in metabolic syndrome

Conditions: Essential Hypertension; Metabolic Syndrome

Summary: the overall aims of the present project are to investigate the impact of a nutritional approach based on omega-3 from vegetal origin on vascular function in hypertension associated with metabolic syndrome.


Eligibility criteria:
inclusion criteria: * female and male patients with treated essential hypertension (blood pressure values\<140/90 mmhg under antihypertensive treatment). * presence of at least two of the following criteria of the metabolic syndrome: abdominal girth \>102 cm in men or \>88 cm in women, hdl-c\ 1.5 g/l (or specific treatment for these lipid abnormalities), fasting glucose \>1.10 g/l. exclusion criteria: * secondary hypertension, myocardial infarction, coronary artery disease, cerebrovascular disease, stroke or transient ischemia, cardiac failure, diabetes (or fasting glucose\>1.26 g/l) or renal failure (mdrd \< 50 ml/min) * severe hypercholesterolemia (total cholesterol \> 2.5 g/l), alcohol or drug abuse, toxicomania, or clinically significant abnormalities in other current biological parameters.
non-interventional observational study on who-5 questionnaire application in parkinson's disease

Conditions: Parkinson Disease

Summary: to assess the predictive value of sequential administration of who-5 and mdi (major depression inventory) for the clinical management of parkinson disease (pd) patients by * determination of the prevalence of depression in pd patients, based on mdi severity categories and the self-rating scale who-5, where poor well being was indicated. * exploration of influencing factors (pd status, therapeutic status) on the prevalence of mdi depression categories.


Eligibility criteria:
inclusion criteria: 1. pd patients attending one of the participating neurologist practices during 2 fixed weeks in november 2008 2. idiopathic pd with or without fluctuations 3. male or female pd patients aged at least 30 4. ability to reliably complete self-rating scales (who-5, mdi) ), according to the physician's judgement. 5. written informed consent by the patient for study participation. exclusion criteria: 1. pd patients who only attend the practice to get a prescription and are not seen by the doctor on that day 2. patients who are not able to understand the questionnaires (e.g. due to mental impairment or language problems).
a post-marketing surveillance to assess safety and efficacy of rosuvatatin/ezetimibe

Conditions: Mixed Dyslipidemia

Summary: post-marketing surveillance of rosuvastatin/ezetimibe

this study will collect clinical data, mainly focused on safety, in korean population as per the requirement of mfds for market authorization.

Eligibility criteria:
inclusion criteria: * the patient who is first prescribed and administered rosuvastatin/ezetimibe exclusion criteria: * the patients who are overreacting to this drug or its components * the patients with severe renal impairment
value of penile elastography in diagnosis of patients with erectile dysfunction and non-responders to intra-corporal injection

Conditions: To Investigate the Value of Penile Elastography in the Diagnosis of Fibrosis of CC

Summary: penile erection is a neurovascular response that induces penile arterial dilatation, increased blood flow, and cavernous smooth muscles (csm) relaxation; the enlarging corpora cavernosa compress the subtunical veins, against a rigid tunica albuginea, and entrap blood within the penis. impaired csm function can result in corporo veno-occlusive dysfunction (cvod) and erectile dysfunction. nevertheless, diagnostic tests, which can evaluate the status of csm, are not clinically applicable. penile elastography is a new promising tool that can assess the stiffness of the corpora cavernosa. accordingly penile elastography can assess the status of the cavernous tissue and can distinguish patient with corporal fibrosis.


Eligibility criteria:
inclusion criteria: * for group 1: patients (age ≥ 21) have established sexual relationship for at least 3 months. these patients are complaining of ed and not responding to intracorporal injections (ici). * for group 2: men (age ≥ 21) have an established sexual relationship for at least 3 months. these men have normal erectile function. exclusion criteria: * peyronnie's disease, post-priapism corporal fibrosis, and clinically detected post traumatic corporal fibrosis, previous ici therapy, history of penile and/or urethral surgery, liver cell failure, renal failure, heart failure, endocrinal diseases (e.g. thyroid- adrenal), medications that may cause ed, and neurologic and psychotic disorders.
lifestyle modification for obesity-related type 2 diabetes

Conditions: Type 2 Diabetes Mellitus; Overweight; Obesity

Summary: dietary carbohydrate is the major determinant of postprandial glucose levels, and preliminary evidence suggests that low carbohydrate diets improve glycemic control when accompanied by weight loss. to determine if glycemic control can be improved by varying dietary carbohydrate during weight loss, we compared two weight loss diets with different carbohydrate levels for the treatment of obesity-related type 2 diabetes over 24 weeks in the outpatient setting.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus for at least one year * hgba1c \> 6.0 * bmi from 27-50 kg/m2 exclusion criteria: * unstable medical condition * serious medical condition * ast or alt \> 100 * serum creatinine \> 1.5

Keywords: lifestyle modification weight loss hyperglycemia hypoglycemic agents
evolut pro china clinical study

Conditions: Severe, Symptomatic Aortic Stenosis

Summary: interventional study to evaluate the safety and efficacy of the medtronic corevalve™ evolut™ pro system when used by china implanting centers in chinese patients with severe symptomatic aortic stenosis (as) who are at high risk for surgical aortic valve replacement (savr).

the study is targeting 6 centers with a maximum of 8 centers in china and estimating 65 subjects with a maximum of up to 70 subjects with attempted implants including 50 subjects with an attempted implant in primary study population and the first two attempted subjects at each site for roll-in population. the subjects will follow the assessment with pre and post-procedure, discharge, 30 days(primary endpoint), 6 months, 1 year, and annually through 5 years.

Eligibility criteria:
inclusion criteria: 1. aortic valve area (ava) \ 40 mmhg, or max aortic velocity \> 4.0 m/sec 2. high risk for savr defined as sts-prom score ≥ 8% and ≤ 15%, or documented heart team agreement of high risk for avr due to frailty or comorbidities 3. symptoms of aortic stenosis and nyha ≥ ii exclusion criteria: 1. age is less than 65 years old 2. non-calcified aortic valve 3. bicuspid aortic valve with no raphe or 2 raphes (sievers classification type 0 or type 2) 4. ascending aortic diameter \> 4.5 cm
antisocial behavior: passing from parent to child to grandchild

Conditions: Dyssocial Behavior; Antisocial Personality Disorder

Summary: antisocial behavior often occurs in different generations within the same family. however, it is not known what factors contribute to this passing of antisocial behavior from parent to child to grandchild. this study is part of a project evaluating antisocial behavior in families; it focuses on the passage of such behavior from one generation to the next.

while it is well-known that antisocial behavior runs in families, little is known about the specific mechanisms by which it is transmitted from one generation to the next. this prospective study will examine biological influences on transgenerational continuity and change, and how biology interacts with social factors in modulating the transmission of antisocial behavior. the study is unique in that it includes both mothers and fathers, focuses on early mechanisms, and addresses female as well as male antisocial behavior. this study is part of the continuing mauritius child health project. the project began by testing 1,795 children age 3 years old on psychophysiological, behavioral, nutritional, and cognitive measures. both male and female children were tested. their parents were also assessed for psychosocial influences. one hundred children then participated in a nutritional, exercise, and educational enrichment intervention from ages 3 to 5 years old. the intervention has been shown to increase physiological arousal and attention at age 11 years and to reduce conduct disorder at age 17 years. these 3-year-old children are now 30-year-old adults. this study will retest these adults on psychophysiological, psychosocial, cognitive, behavioral, parenting, and antisocial behavior measures. their previously untested spouses will also be assessed. finally, many of these adults now have 3-year-old children of their own; these children will be evaluated as well. measures of life stress, daily hassles, family conflict, mental illness, and criminal behavior will be assessed. data from the enrichment cohort will be evaluated to determine if the intervention disrupted the intergenerational transmission of antisocial behavior from the second to third generations.

Eligibility criteria:
inclusion criteria: * child of a participant tested in previous mauritius child health project studies

Keywords: antisocial behavior mauritius child health project intergenerational transmission
18f-naf uptake and aortic stenosis progression

Conditions: Aortic Stenosis

Summary: this study aims to evaluate whether baseline 18f-sodium fluoride uptake activity at aortic valve could predict aortic stenosis progression in moderate aortic stenosis. patients with moderate aortic stenosis are enrolled and underwent baseline evaluation including 18f-sodium fluoride pet/ct. after 1 year, all the participants underwent follow-up echocardiography. the study design is an observational trial. primary endpoint was a change in mean pressure gradient along the aortic valve as assessed by echocardiography at 1 year. secondary endpoints include changes in aortic valve area, and symptom occurrence.

recent studies demonstrated 18f-sodium fluoride (naf) uptake activity as a marker of early-stage calcification. although valve calcification could be visualized either by echocardiography or coronary computed tomography, they only reflect the current burden of calcium deposit not the activity of calcium deposit. limited studies exist regarding the usefulness of 18f-naf uptake at aortic valve for prediction of stenosis progression. patients with moderate aortic stenosis - diagnosed by echocardiography - will be enrolled. enrolled participants will undergo baseline 18f-naf pet/ct within 6 weeks of baseline echocardiography and followed up for 1 year. after 1 year, all the participants are required to evaluate the aortic stenosis progression by performing echocardiography. the objective of the study is to test whether baseline 18f-naf uptake activity predict as progression.

Eligibility criteria:
inclusion criteria: * over 20 years old * moderate aortic stenosis exclusion criteria: * age \< 20 yrs * pregnant women
study of vp301 in patients with multiple myeloma, lymphoma, or solid tumors

Conditions: Solid Tumors, Adult; Multiple Myeloma; Lymphoma

Summary: this study will test the safety, tolerability, and pharmacokinetics of vp301 in patients with relapsed or refractory multiple myeloma, lymphoma, or solid tumors.

this study will test the safety, tolerability, and pharmacokinetics of vp301 in patients with relapsed or refractory multiple myeloma, lymphoma, or solid tumors. this study will be conducted in two parts: dose escalation - this part will evaluate increasing doses of vp301 to identify the maximum tolerated dose (mtd) or recommended phase 2 dose (rp2d). the first patient enrolled on the study will receive the lowest dose of vp301. once this dose is shown to be safe, an additional patient will be enrolled at the next higher dose. patients will continue to be enrolled into either single or multiple patient groups receiving increasing doses until the mtd or rp2d is reached. dose expansion - patients with relapsed myeloma and lymphoma will be enrolled and treated with vp301 at the mtd or rp2d.

Eligibility criteria:
inclusion criteria: * histologic diagnosis of a refractory solid tumor, refractory myeloma or lymphoma with measurable or evaluable disease * patients must have progressed following all therapies of known, potential clinical benefit, or for whom treatments of known clinical benefit are contraindicated. * adequate kidney, liver, and hematologic function * eastern cooperative oncology group (ecog) performance status 0 to 2 exclusion criteria: * active brain metastases and history of leptomeningeal metastases. * myeloma patients with plasmacytoma as only measurable disease * non-secretory myeloma * patients with advanced metastatic, symptomatic, visceral spread who are at risk of life-threatening complications * active or chronic, uncontrolled bacterial, viral, or fungal infection(s) * abnormal ecg * has clinically significant cardiovascular disease * additional active malignancy that may confound the assessment of the study endpoints * pregnancy or lactation * known seropositivity for hiv (human immunodeficiency virus) or active hepatitis b or hepatitis c
feasibility study of the effect of intra-dermal insulin injection on blood glucose levels after eating

Conditions: Diabetes Mellitus, Type 1

Summary: this study is to determine the effect of intra-dermal (id) administration of regular and of rapid-acting insulin, before eating, on blood glucose levels for several hours after a standard meal (a mixed, liquid meal). insulin will also be given normally, subcutaneously, for control or comparison purposes. the hypothesis or expectation is that id insulin will work more quickly and control blood glucose levels better than sc injection.

previous studies have shown that intra-dermal (id) insulin administration results in a more rapid onset of action in comparison to subcutaneous (sc) administration as measured by glucose infusion rate (gir) under glucose clamp conditions.the aim of this study is to investigate whether id administration of regular human insulin or rapid-acting insulin analogue leads to reduced postprandial glycemic excursions in comparison to sc application under highly standardized experimental conditions. effects on the occurrence of hypoglycemia will also be investigated, as well as pk and pd comparisons between different insulin formulations administered id. this is a mono-center, open-label, randomized, 5-period crossover study in patients with type 1 diabetes

Eligibility criteria:
inclusion criteria: * type 1 diabetes for 1-15 years, on multiple daily injections (mdi) or insulin pump (csii) in stable control with hba1c \<= 9.0%. * able to attend clinic for 5 different days exclusion criteria: * bmi \> 32 kg/m2 * evidence of gastroparesis or impaired renal function or lipodystrophy

Keywords: diabetes insulin subcutaneous intra-dermal blood glucose
ombitasvir/abt-450/ritonavir and dasabuvir with or without ribavirin in hcv genotype 1-infected adults with chronic kidney disease

Conditions: Chronic Hepatitis C; Hepatitis C Virus; Compensated Cirrhosis; Severe Renal Impairment; End-stage Renal Disease

Summary: this open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in hcv-genotype 1-infected subjects with an estimated glomerular filtration rate (egfr) \<30, including those on hemodialysis or peritoneal dialysis.


Eligibility criteria:
inclusion criteria: 1. positive for anti-hcv ab (antibody) and hcv rna \>1,000 iu/ml at screening. 2. screening laboratory result indicating hcv genotype 1 infection. 3. subject has never received antiviral treatment for hepatitis c infection (treatment-naive subject) or subject has received previous treatment with peginterferon with or without rbv with non-response (hcv rna quantifiable at end of treatment or relapsed after end of treatment). 4. estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73 m\^2 as estimated by the modification of diet in renal disease (mdrd) method. exclusion criteria: 1. women who are pregnant or breastfeeding. 2. positive test result for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus (hiv ab). 3. any current or past clinical evidence of child-pugh b or c classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.

Keywords: chronic hepatitis c hepatitis c end-stage renal disease hepatitis c genotype 1 severe renal impairment renal disease compensated cirrhosis renal impairment dialysis hepatitis c virus cirrhosis
determinism of the mechanism of action of specific immunotherapy in hymenoptera venom allergy

Conditions: Hymenoptera Allergy

Summary: currently, most of the protocols used for desensitization to hymenoptera venoms consist of a very rapid increase in doses of venom extracts administered during the sit in a day without systemic reaction of the patient which is not yet explained. the hypothesis is that this good tolerance is due to a rapid decrease in the response of mast cells and basophils to the allergen.. the main objective is to study basophil activation in response to the allergen during the first day of desensitization, measured by basophil activation test. the initiation of desensitization follow a protocol of rapid growth rates. the basophil activation level in the course of desensitization will be analyzed by flow cytometry after in vitro stimulation by allergen. changes in t cell polarization is also analyzed by flow cytometry. evolution of the expression of different proteins in blood basophils will be studied by measuring their messenger rnas


Eligibility criteria:
inclusion criteria: * patients over 18 years and below 75 years age * patient who presented a generalized allergic reaction after an puncture of a hymenoptera * patient with positive skin tests against the venom of a hymenoptera * patient with positive specific ige against the venom of a hymenoptera • to which an indication of accelerated desensitization was chosen in day hospitalization * information and consent signed by the patient * patient affiliated to french social security system * for women of childbearing age, taking an effective contraceptive. exclusion criteria: * patients with the following diseases: mastocytosis, systemic infection or hospitalization within 4 weeks before inclusion, chronic inflammatory disease, cancer, unbalanced asthma, immune deficiency * patients on beta-blocker, following another specific immunotherapy, or ongoing immunosuppressive therapy. * pregnant or lactating * people placed under judicial protection * patient participating or having participated in another biomedical research within six months

Keywords: hymenoptera puncture
safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of bi 1021958 tablets in healthy male volunteers

Conditions: Healthy

Summary: safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of bi 1021958 tablets in healthy male volunteers (first-in-human trial)


Eligibility criteria:
inclusion criteria: 1. healthy male subjects exclusion criteria: 1. any relevant deviation from healthy conditions
a study of mirikizumab (ly3074828) in participants with moderate to severe plaque psoriasis

Conditions: Plaque Psoriasis

Summary: the main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in participants with moderate to severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: * present with chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline and meet the following criteria: * plaque psoriasis involving ≥10% body surface area (bsa) and absolute pasi score ≥12 in affected skin at screening and baseline * spga score of ≥3 at screening and baseline * candidate for biologic treatment for psoriasis. exclusion criteria: * have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data. * breastfeeding or nursing (lactating) women. * have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening. * have received live vaccine(s) (included attenuated live vaccines) within 1 month of screening or intend to during the study. * have any other skin conditions (excluding psoriasis) that would affect interpretation of the results. * have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days prior to baseline. * have received topical psoriasis treatment within 14 days prior to baseline. * have received anti-tumor necrosis factor (tnf) biologics, or anti-interleukin (il)-17 targeting biologics within 8 weeks prior to baseline. * have previous exposure to any biologic therapy targeting il-23 (including ustekinumab), either licensed or investigational (previous briakinumab use is permitted).

Keywords: il-23 dermatology