Kornimate/medical-research-clean huggingface dataset:
insulin action: role of skeletal muscle and insulin-mediated blood flow

Conditions: Hypertension

Summary: the overall objective of this proposal is to examine the contribution of changes in total body fat, enhancement in insulin-mediated vasodilatation and enhancement in endothelium-derived nitric oxide production to the improvements in metabolic insulin action. in addition, the study will track whether these improvements are related to changes in blood pressure.


Eligibility criteria:
age 50 - 75 years, elevated blood pressure, bmi greater than 25 but less than 40 kg/m2

Keywords: blood pressure insulin sensitivity blood flow
the impact of first aid blended learning training on learning outcomes and helping behaviour of adult laypeople in rwanda

Conditions: Emergencies; Injuries; Illness Physical

Summary: the goal of this study is to assess the impact of a first aid training delivered through a blended learning approach on learning outcomes and helping behaviour in adult laypeople in rwanda. participants will be randomly assigned to either: * a first aid training with blended learning approach; * a first aid training with conventional face-to-face approach; * no first aid training. all participants will be asked before, immediately after, and 6 months after the first aid trainings to complete * a questionnaire on first aid-related knowledge, self-efficacy, and willingness to help; * a practical test on first aid-related skills. the helping behaviour of the participants will be surveyed before and 6 months after the first aid trainings have been completed. researchers will compare the effects in learning outcomes and helping behaviour after 6 months between: * the first aid training with blended learning approach and no first aid training; * the first aid training with blended learning approach and first aid training with conventional face-to-face approach.


Eligibility criteria:
inclusion criteria: * adult (≥ 18 years) laypeople * access to a smartphone or tablet, which is able to install and run a mobile application exclusion criteria: * having attended a first aid training in the past * having an academic or professional background in the (para)medical field

Keywords: first aid blended learning laypeople
depression treatment in general medical settings

Conditions: Major Depression

Summary: the purpose of this study was to examine the effect of a new disease management model for depression, the collaborative depression management program (cdmp), designed to improve clinical outcomes and increase depression treatment in general medical settings.

clinically depressed individuals that could benefit from newer treatments for depression often do not receive care. low treatment rates are of particular concern since depression is projected to be the second leading cause of disability worldwide by 2010. major depression has been the focus of numerous intervention studies with primary care patients during recent years. however, despite advances in the development and testing of quality intervention models for depression treatment, very little is known about the effectiveness of interventions with latinos. this is important because latinos are less likely than whites to receive depression treatment, even though the rates of depression are similar for both groups. a major public health challenge is to make available the benefits of intervention developments in depression treatment for all groups in society. as a first step, we examined the impact of a quality depression intervention with puerto ricans. the specific aims were: 1. to examine the effect of a collaborative depression management program in reducing depressive symptoms, improving quality of life, and decreasing health-related functional impairment among puerto rican patients in general medical settings. 2. to determine whether a collaborative depression management program is effective in improving satisfaction with care and reducing barriers to depression treatment among puerto rican patients in general medical settings. this study employed a randomized experimental design. depressed patients receiving general medical care were assigned to one of two conditions: 80 to the depression management program and 80 to treatment as usual. all subjects completed assessments at baseline, week 8, week 16 and week 24. our overall programmatic goals were to increase the likelihood that depressed patients receive care and to make available for the puerto rican community advances in the treatment of major depression.

Eligibility criteria:
inclusion criteria: * patients ages 18 or older that meet the clinical criteria for major depression. exclusion criteria: * pregnancy, planning a pregnancy, breastfeeding or less than 3 months post-partum * severe cognitive impairment * ongoing psychiatric treatment * do not plan to use the study clinic as a main source of medical care during the next six months * a history of bipolar disorder or psychosis * those clinically judged to have a high acute suicidal risk * unstable or life-threatening medical condition
use of migraineboxtm head and neck cooling bath for treatment of primary headache in the emergency department

Conditions: Primary Headache

Summary: migraineboxtm is a simple, contoured cooling bath for the head and neck. effectiveness of migraineboxtm will be studied in primary headaches in the emergency department. the user simply reclines his/her head and neck into this device that has contours that support the head and neck. luke warm water is filled into the migraineboxtm before use and then a frozen insert is placed inside. this will gradually cool the water surrounding the patient's head and theoretically provide headache relief.


Eligibility criteria:
inclusion criteria: * 18-85 years old * benign headache * physician intends to treat headache pain in the ed with either droperidol, prochlorperazine, or a parenteral narcotic exclusion criteria: * unable to provide informed consent * headache due to trauma, subarachnoid hemorrhage, meningitis, intracerebral bleed, cranial tumor, sinusitis, dental pathology, temporomandibular joint dysfunction, glaucoma, or systemic infection * known renal impairment * known hepatic impairment * a history of coronary artery disease, peripheral vascular disease, or cerebrovascular disease * perforated ear drum * pregnant

Keywords: primary headache headache migrainebox
effect of dexmedetomidine on sevoflurane requirements and emergence agitation in children undergoing ambulatory surgery

Conditions: Ambulation Difficulty

Summary: although the aetiology of emergence agitation (ea) derives from multiple factors, it is a frequent side effect of sevoflurane anaesthesia in children. dexmedetomidine, a potent selective α2-adrenergic agonist, can reduce the doses of hypnotics, opioids, analgesics, and anaesthetics that must be concomitantly administered. this study was conducted to assess the effect of dexmedetomidine infusion on sevoflurane requirements and recovery profiles with ea in children undergoing ambulatory surgery.


Eligibility criteria:
inclusion criteria: * asa class i * obtaining written informed consent from the parents * aged 1-5 years, and weighing \<20 kg who were undergoing ambulatory hernioplasty or orchiopexy exclusion criteria: * mental retardation * developmental delays * neurological or psychiatric illnesses * coagulation disorder * spinal anomalies * bilateral procedures
internet-based and established dyspnea self-management programs in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the overall goal of this study is to compare the impact of a new internet dyspnea self-management program (edsmp) with an established face-to-face dyspnea self-management program (dsmp) in patients with copd. the primary aim of the study is to test the following two hypotheses: 1. the edsmp and the dsmp will have comparable improvements in the primary outcomes of shortness of breath (dyspnea) with activities of daily living (adl), exercise adherence and performance, and pulmonary exacerbations (frequency and duration) at 3 and 6 months. 2. the edsmp and the dsmp will have comparable improvements in the secondary outcomes of perception of support, self-efficacy for exercise and managing dyspnea, and health resource utilization at 3 and 6 months. this study is a randomized, longitudinal, repeated measures design with measurement times at 0, 3, and 6 months.

despite optimal medical treatment, people with chronic obstructive pulmonary disease (copd) continue to experience dyspnea or shortness of breath. this study will evaluate two different ways to provide education and support to help patients manage their shortness of breath. one program will be conducted in a face-to-face setting and a second through the internet. the main difference between the two programs is the way they are administered. the education, exercise, and monitoring components are the same. the overall goal of this study is to find out whether the two programs are comparable in their effect on shortness of breath (dyspnea) with activities of daily living, exercise adherence and performance, and pulmonary exacerbations (frequency and duration) at 3 and 6 months. perception of support, self-efficacy for exercise and managing dyspnea, and health resource utilization will also be measured at 3 and 6 months. this study is a randomized, longitudinal, repeated measures design with measurement times at 0, 3, and 6 months.

Eligibility criteria:
inclusion criteria: * diagnosis of copd, clinically stable for 1 month; * spirometry results showing at least mild disease (fev1/fvc \< 70% and fev1 \< 80% predicted after bronchodilator); * adl limited by dyspnea; * ability to speak english and sign consent form; * actively use computer and the internet; * maintain o2 saturation \> 85% on \< 6 l/min of nasal oxygen during the six minute walk; * understands and is able to rate shortness of breath during exercise exclusion criteria: * active symptomatic illness other than copd; * formal pulmonary rehabilitation training in the past 6 months

Keywords: chronic obstructive pulmonary disease pulmonary disease, chronic obstructive lung disease, obstructive self-care self-management patient education
long term follow-up of bone mineral density in hormone treated turner syndrome

Conditions: Turner Syndrome

Summary: turner syndrome (ts) is associated with osteopenia and osteoporosis. reduced bone mineral density (bmd) and increased risk of fractures are present in many younger and middle-aged women with ts. the objective is therefore to describe longitudinal changes in bmd in ts. the study is an observational follow-up study. examinations at baseline, after 5 and 10 years. bone mineral density is measured by dual energy x-ray absorptiometry (dexa) and bone turnover by bone markers. main outcome measures: bone mineral density (bmd; grams/ square centimetre) were measured at lumbar spine, hip and the non-dominant forearm.


Eligibility criteria:
inclusion criteria: * turner syndrome verified by karyotyping exclusion criteria: * untreated hypothyroidism or hyperthyroidism * present or past malignant diseases * clinical liver disease * treatment with drugs known to interfere with bone metabolism (e.g. glucocorticoids)

Keywords: turner syndrome bone mineral density estrogen replacement therapy dual energy x-ray absorptiometry
association of insulin resistance and fgf21 on cardiac function in pediatric dilated cardiomyopathy

Conditions: Cardiomyopathy, Dilated; Cardiomyopathy, Hypertrophic; Insulin Resistance

Summary: this study will investigate whether there is an association between insulin resistance and cardiac function in children with dilated or hypertrophic cardiomyopathy. this study will also investigate whether there is an association between fgf21 and cardiac function in children with dilated or hypertrophic cardiomyopathy and whether this is mediated through greater insulin resistance and/or through independent effects.

although pediatric cardiomyopathy is rare, the condition is severe and life-threatening. the main focus of this proposed study will examine whether insulin resistance is correlated with decreased cardiac function which will hopefully pave the way for future clinical trials using medications that sensitize insulin such as metformin or glucagon-like peptide-1 (glp-1 agonists) as possible therapeutic agents. the exploratory piece of this study will investigate a novel therapeutic target by determining whether fgf21 has any direct effects on cardiac function and whether it interacts with insulin resistance in altering cardiac function. patients with cardiomyopathy normally undergo echo as part of routine evaluation and follow up and is standard of care. at this time, there are no official guidelines for pediatric patients with cardiomyopathy to undergo oral glucose tolerance testing (ogtt) and thus it is not part of the standard of care. based on findings from this study, the investigators hope to justify performing an ogtt on pediatric patients with dilated or hypertrophic cardiomyopathy and incorporate the procedure in future practice guidelines.

Eligibility criteria:
inclusion criteria: * diagnosis of dilated or hypertrophic cardiomyopathy * pubertal (tanner 2 breast in females or testicular volume ≥ 4ml in males) * permission by the primary cardiologist of the patient for enrollment in the study exclusion criteria: * prior diagnosis of diabetes and treatment with anti-diabetes medication * neuromuscular disorder * inborn error of metabolism * malformation syndrome * clinically unstable based on the assessment of the primary cardiologist caring for the patient * inability of parent/legal guardian to provide informed consent * non-english speaking

Keywords: pediatrics
a clinical pharmacology of khk4827 in healthy volunteers and subject with moderate to severe psoriasis

Conditions: Psoriasis

Summary: this is a randomized, placebo-controlled, ascending single dose study of khk4827 to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous or intravenous administration of khk4827 in healthy male subjects or moderate to severe psoriasis patients.


Eligibility criteria:
inclusion criteria: health volunteers * able to provide written informed consent * healthy male between 20 to 45 years of age, inclusive at the time of screening * additional inclusion criteria apply psoriasis subjects * 20 to 70 years of age, inclusive at the time of screening * active but clinically stable, plaque psoriasis * psoriasis involving ≥10% of the body surface area * a minimum pasi score of ≥10 obtained during the screening period * additional inclusion criteria apply

Keywords: psoriasis
evaluating behavioral treatments to improve adherence to cpap in people with obstructive sleep apnea

Conditions: Adherence to CPAP in Obstructive Sleep Apnea

Summary: obstructive sleep apnea (osa) is a serious sleep disorder in which a person repeatedly stops breathing or experiences shallow breathing for short periods of time during sleep. the most common treatment for osa is the use of a continuous positive airway pressure (cpap) machine, but many people have trouble adhering to the treatment schedule. this study will evaluate the effectiveness of two behavioral therapy programs used in combination with cpap for improving treatment adherence in people with osa.


Eligibility criteria:
inclusion criteria: * osa confirmed by polysomnography (psg) * cpap is the prescribed form of treatment for osa * judged by sleep physician to respond to cpap exclusion criteria: * apnea/hypoxia index (ahi) less than 15 * diagnosis of another sleep disorder that causes arousals from sleep * past treatment for osa * current substance abuse problem * diagnosis of a serious medical condition that would interfere with involvement in the study * history of a major psychiatric disorder, other than depression * change in antidepressant medication in the 3 months before study entry

Keywords: obstructive sleep apnea osa adherence cpap cognition
special drug use investigation of eylea for diabetic macular edema

Conditions: Macular Edema

Summary: the objectives of this study are to investigate the safety and effectiveness of eylea

this is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of myopic choroidal neovascularization. the investigator will have made the choice of treatment (eylea) as well as the decision to use eylea according the japanese package insert prior to enrolling the patient in this study. the observation period for each patient starts when therapy with eylea is initiated. the enrollment period is 2 years. patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years. in total, 600 patients will be recruited. for each patient, data are collected as defined in the electronic case report form (ecrf) at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice).

Eligibility criteria:
inclusion criteria: * patients who start eylea treatment for diabetic macular edema (dme) exclusion criteria: * patients who have already received eylea treatment

Keywords: aflibercept anti-vegf
prevalence of anal high-risk human papilloma virus infection and abnormal anal cytology in men who have sex with men using pre exposure prophylaxis

Conditions: Human Papilloma Virus

Summary: the aim of the study is to determine the prevalence of anal high-risk hpv infection and abnormal cytology in hiv uninfected men who have sex with men (msm) using prep and hiv infected msm followed-up at the s-kliniek or hrc of the uz brussel. 200 participants will be preferably included in the study. the data will be collected using a self-administered questionnaire where socio-demographic characteristics, health-related issues and sexual behavior will be questioned. also anal canal sampling will be performed for cytological analysis. for the hiv infected msm, additional information will be extracted from the patient files: cd4+ t-cell count and nadir and duration of combination antiretroviral therapy.


Eligibility criteria:
inclusion criteria: * hiv uninfected msm of 18 years or older using prep since at least 3 months * hiv-infected msm of 18 years or older exclusion criteria for msm using prep: * any intervention in the (peri-) anal region in the past 3 months * enema within 24h before sampling * receptive anal sex within 24h before sampling * current/ongoing peri-anal topical hpv-treatment exclusion criteria for msm infected with hpv: * none
efficacy and safety of fenofibrate added on to atorvastatin compared with atorvastatin

Conditions: Mixed Hyperlipidemia

Summary: the purpose of this study is to evaluate the efficacy and safety of atorvastatin and fenofibrate compared with atorvastatin monotherapy in mixed hypercholesterolemic patients.

multi center, randomized, double-blind, parallel-group, therapeutic confirmatory study primary outcome measure: the mean percent change of non-hdl cholesterol \[time frame: from baseline at week 8\] secondary outcome measures: the achievement rate of ldl-c\<100mg/dl, non-hdl-c\<130mg/dl \[time frame: from baseline at week 8\] the mean percent change of ldl-c, hdl-c, tg, tc, apo-ai, apo-b \[time frame: from baseline at week 4, 8\] the mean percent change of non-ldl-c/hdl-c, tc/hdl-c, ldl-c/hdl-c, apo-b/apo-ai \[time frame: from baseline at week 4, 8\] the mean percent change of fibrinogen, hs-crp \[time frame: from baseline at week 4, 8\] safety evaluation \[time frame: treatment period and extension period\]

Eligibility criteria:
inclusion criteria: * \>19 years old * high risk patient to coronary heart disease (applied to 1 or more chd risk factor listed below) 1. patient with coronary heart disease 2. patient with carotid artery disease, peripheral blood vessel disease, abdominal aneurysm 3. patient with diabetes(hba1c≤9.0%) 4. 10-year risk of chd \>20%(by framingham 10-year risk score calculation) * at visit 1(screening) 1. 100mg/dl≥ldl-c, 150mg/dl≤tg≤500mg/dl * 4weeks of atorvastatin 20mg monotherapy run-in period 2. ldl-c\<100mg/dl, 150mg/dl≤tg≤500mg/dl * if treated with atorvastatin 20mg monotherapy 4weeks prior to this study * at visit 2(after 4weeks of atorvastatin monotherapy run-in period) * ldl\<100mg/dl, 150mg/dl≤tg≤500mg/dl exclusion criteria: * patients with acute artery disease within 3 months * patients with congestive heart failure(nyha class iii\~iv) or uncontrolled arrhythmia within 6 months * patients with uncontrolled hypertension(sbp\>160mmhg or dbp\>95mmhg) * tsh\>1.5x uln * patients with myopathy, rhabdomyolysis or ck\>2x uln * hypersensitive to atorvastatin and/or fenofibrate or had photoallergy or phototoxicity during fibrate and/or ketoprofen treatment * serum creatinine\>2.5mg/dl, ast or alt \> 2x uln * history of drug or alcohol abuse within 6 months * history of gi tract surgery or disability to drug absorption * women with pregnant, breast-feeding * patients with gallbladder disease * patients with biliary cirrhosis * patients with pancreatitis(acute pancreatitis is excluded due to severe hypertriglyceridemia) * patients treated with any investigational drugs within 4 weeks at the time consents are obtained * history of malignant tumor including leukemia, lymphoma within 5 years * patients must be treated with medications prohibited for concomitant use during study period * not eligible to participate for the study at the discretion of investigator
a study of car-t cells targeting both bcma and gprc5d in treatment of relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: an open-label, dose finding study to investigate the safety, pharmacokinetics, and preliminary efficacy of bmca and gprc5d dual target car-t cells therapy in patients with relapsed or refractory multiple myeloma


Eligibility criteria:
inclusion criteria: * signed and dated, written informed consent prior to any study specific procedures; * estimated life expectancy of minimum of 12 weeks; * ecog 0-2; * diagnosed as multiple myeloma according to the imwg criteria; * evidence of cell membrane gprc5d and/or bcma expression, as determined by a validated immunohistochemistry (ihc) or flow cytometry of tumor tissue; subjects should have measurable disease. at least meet one of the following criteria: 1. if igg type mm, serum m protein ≥10g/l; if iga, igd, ige or igm type mm, serum m protein ≥5g/l; 2. urine m protein level ≥0.2g(200mg/24h); 3. light chain type mm, serum free light chain (sflc) ≥ 100mg / l and k/ λ flc ratio is abnormal; 4. there are extramedullary lesions; * subjects have had at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (pis) and immunomodulatory agents (imids); * adequate organ functions exclusion criteria: * active smoldering multiple myeloma; * active plasma cell leukemia; * with organ amyloidosis; * central nervous system (cns) involvement; * pregnant or breastfeeding; * hepatitis b virus (hbv) surface antigen (hbsag) or hepatitis b core antibody-positive and detectable hbv dna in peripheral blood; hepatitis c virus (hcv) antibody and hepatitis c virus rna in peripheral blood; human immunodeficiency virus (hiv) antibody * uncontrolled hypertension hypertension defined as a blood pressure (bp) ≥150/95 mmhg; symptomatic heart failure per new york heart association classification class ii, iii or iv), mean resting corrected qt interval corrected by fridericia's formula (qtcf) \> 470 msec (female), 450 msec (male) obtained from ecg; baseline left ventricular ejection fraction (lvef) below institution's lower limit of normal (lln) or \<50%; * have a history of another primary malignancy within 5 years prior to starting study treatment. exceptions here are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ.