Kornimate/medical-research-clean huggingface dataset:
randomized diagnostic trial comparing ethylglucuronide and ethanol

Conditions: Alcohol Use Disorder

Summary: background: alcohol use disorders represent a major health burden. efforts aiming at reducing alcohol-related harm include early detection of those with risky drinking habits as well detection of early relapse in patients with alcohol dependence who are detoxified and committed to abstinence. recently, ethyl glucuronide has been proved to be a good biomarker for the detection of recent drinking. however, to date, no randomized diagnostic trial has tested its impact on drinking outcomes. the aim of this study was to assess, with a randomized design, the implications of ethyl glucuronide screening on alcohol outcomes, compared to screening with a low-sensitivity biomarker such as ethanol. methods: alcohol dependent outpatients were randomized to either 24 weeks of continuous screening with ethyl glucuronide or ethanol. patients were aware of screening methods and results. after 24 weeks, all participants were screened with ethyl glucuronide. self-reports were also gathered. a logistic regression model was performed comparing the rate of ethyl glucuronide positive results at study end between groups. generalized estimating equations were performed to evaluate the descending rate of etg positive patients in the etg group, measured month to month.


Eligibility criteria:
inclusion criteria: * subjects had to be diagnosed of alcohol dependence according to dsm-iv, they had to undergo regular urine screening as part of their treatment and be willing to give informed written consent. exclusion criteria: * conditions rendering patients unable to complete study procedures

Keywords: ethyl glucuronide, biomarker, diagnostic randomized trial
treatment of aggressive prostate cancer in real life: initiation, schedule and management of triptorelin treatment.

Conditions: Prostate Cancer

Summary: the purpose of the protocol is to describe the proportion of subjects treated continuously with triptorelin during 12 months following treatment initiation. this study will take place at 187 locations (approximately) in france.


Eligibility criteria:
inclusion criteria: * at least 18 years old * histologically confirmed prostate cancer * triptorelin to be initiated in its labelled indication for a planned total duration of at least 12 months; decision to start triptorelin was made voluntarily by the physician as part of routine medical practice, prior to the inclusion in the study * ability to understand and complete questionnaire, exclusion criteria: * previously received a hormonal therapy during the last 6 months before inclusion, * simultaneously participates in a clinical trial.
promoting medication adherence among older adults with hypertension

Conditions: Hypertension

Summary: over 70% of us adults 65 or older are diagnosed with hypertension, the leading cause of cardiovascular disease and premature deaths in the world. despite availability of effective drugs to control blood pressure, uncontrolled blood pressure and low adherence to antihypertensive drugs persist as major public health and clinical challenges. on average, 50% of adults adhere to chronic disease medications and lower levels of adherence are associated with worse blood pressure control and adverse outcomes. many barriers to adherence are well known and have been targeted in interventions to improve medication adherence. as of yet, no single intervention has emerged as superior or even particularly effective in improving adherence. the investigators have recently identified unconscious, self-protective 'hidden motives' that contribute to nonadherence to chronic disease medications. there is a critical need to expand on this insight to test the potential for targeting individuals' 'hidden motives' for low adherence using an innovative learning process called immunity-to-change. as a critical step in testing this intervention to target these 'hidden motives', the investigators will undertake a pilot study to assess the feasibility and acceptability of the overcoming immunity-to-change intervention and determine effect sizes of the intervention on adherence, blood pressure (bp) control, and quality of life (qol). the investigators will test the immunity-to-change intervention in a sample of nonadherent older adults with hypertension (n=18). another sample of nonadherent older adults with hypertension will be monitored for comparison (n=18).


Eligibility criteria:
inclusion criteria: * men and women ages 55 and older, with the goal of a sex- and race-balanced sample * diagnosis of essential hypertension * uncontrolled hypertension * current treatment with antihypertensive medication * low antihypertensive pharmacy refill * english speaking * telephone access * ability to read print on a computer screen and use the computer keyboard * written consent to participate and hipaa authorization * written acceptance of study contract * approval of health care provider exclusion criteria: * cognitive impairment * enrollment in another clinical trial

Keywords: medication adherence middle aged 45-64 aged 65-79 aged, 80 and over
diabetic retinopathy candesartan trials.

Conditions: Type 1 Diabetes

Summary: the primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normotensive, normoalbuminuric type 1 diabetic patients with retinopathy. the secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (csme) and/or proliferative diabetic retinopathy (pdr) and beneficially influences the rate of change in urinary albumin excretion rate (uaer). this study is part of the direct programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 2 diabetes. the primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: * male or female aged 18 - 55 years with type 1 diabetes diagnosed before age of 36 years and in need for continuous insulin treatment within 1 year of diagnosis of diabetes are included. * duration of diabetes for \> 1 year and \< 20 years with stable diabetic therapy within last 6 months. * patients with untreated resting mean sitting sbp \ 20/10 up to \< 47/47 (on etdrs severity scale). exclusion criteria: * patients with the following conditions are excluded from participation on the study: * cataract or media opacity of a degree which precludes taking gradable retinal photographs * angle closure glaucoma, which precludes pharmacological dilatation of the pupil * history or presence of proliferative retinopathy * history or presence of clinical significant macular oedema (csme) * history or evidence of photocoagulation of the retina * other retinal conditions which may mask assessment, eg, retinal vein occlusion * positive micral dipstick test * presence of secondary diabetes * pregnant or lactating women or women of child bearing potential not practicing an adequate method of contraception * need of treatment with ace-inhibitor * haemodynamically significant aortic or mitral valve stenosis * known renal artery stenosis or kidney transplantation * hypersensitivity to study drug * severe concomitant disease which may interfere with the assessment of the patient, eg, malignancy, as judged by the investigator

Keywords: diabetes mellitus type 1
a study of combination treatment with pegasys (peginterferon alfa) and copegus (ribavirin)in patients with chronic hepatitis c

Conditions: Hepatitis C, Chronic

Summary: this 2 arm open-label study will assess the safety and tolerability of combination treatment with peginterferon alfa (pegasys) and ribavirin (copegus) in patients with chronic hepatitis c. patients will be assigned to receive peginterferon alfa (pegasys) 180 mcg sc once a week and ribavirin (copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. allocation to the treatment arms is to the discretion of the investigator (mainly according to genotype). adverse events will be monitored throughout the study and hematologic parameters every 2 weeks and twice during the 24-week follow-up.


Eligibility criteria:
inclusion criteria: * adult patients \>/= 18 years of age * serologic evidence of chronic hepatitis c infection * compensated liver disease * negative pregnancy test and in both males and females use of 2 forms of contraception during study and 6 months after treatment exclusion criteria: * history or other evidence of a medical condition associated with chronic liver disease other than hcv * hepatitis a, hepatitis b or hiv infection * hepatocellular carcinoma * severe concomitant disease
effect of atorvastatin and lifestyle intervention on progression of pre-clinical atherosclerosis

Conditions: Atherosclerosis

Summary: the purpose of this study is to determine whether atorvastatin, aggressive lifestyle intervention, and their interaction are effective in delaying the progress of pre-clinical atherosclerosis.

primary prevention of atherosclerotic disease remains a big challenge. currently, it is not clear how to treat those subjects with evidence of pre-clinical atherosclerosis but without obvious conventional risk factors. this randomized, placebo controlled, double blind study is to evaluate the effect of atorvastatin 10 mg daily, therapeutic lifestyle change, and their combination, on the progression of cimt in those with higher baseline cimt value but are not belong to 'high risk' category, according to the conventional risk factors.

Eligibility criteria:
inclusion criteria: * cimt is not less than 0.9 mm * without clinical diagnosis of atherosclerotic disease * without diabetes

Keywords: atherosclerosis atorvastatin therapeutic lifestyle change cimt abi pwv
phase2a primaquine dose escalation study

Conditions: Malaria

Summary: the purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of low single-dose primaquine for gametocidal activity against p.falciparum among adult glucose-6-phosphate dehydrogenase (g6pd)-normal malaria patients.


Eligibility criteria:
inclusion criteria: * male * age \>= 18 years and \< 50 years * malaria blood thick film positive * presence of gametocytes on thick blood film * agrees to admission to study ward for 26 hours post diagnosis and available for follow up visits * no allergies to study drugs * hemoglobin \>= 8 g/dl * no evidence of severe or chronic disease * written, informed consent
inspiratory resistive loading and proprioceptive postural control

Conditions: Low Back Pain; Respiratory Loading; Proprioceptive Impairment

Summary: proprioceptive weighting changes may explain differences in postural control performance. in addition, the respiratory movement has a disturbing effect on postural balance. postural balance seems to be impaired in individuals with respiratory disorders. besides the essential role of respiration, the diaphragm may also play an important role in the control of the trunk and postural balance. deficits in proprioception are found in a subgroup of patients with low back pain. in addition, disorders of respiration have been identified as strongly related to low back pain. the aim of the study is to clarify whether loading of the inspiratory muscles has a negative effect upon proprioceptive postural control in healthy individuals and individuals with recurrent low back pain.


Eligibility criteria:
inclusion criteria individuals with low back pain: * age: 18-45 years old * at least 1 year of low back pain with/without referred pain in buttock/thigh * at least 3 episodes of disabling low back pain * at least a score of 20% on the oswestry disability index * willingness to sign the informed consent inclusion criteria healthy individuals: * age: 18-45 years old * no history of low back pain * a score of 0% on the oswestry disability index * willingness to sign the informed consent exclusion criteria: * history of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant * one of the following conditions: parkinson, multiple sclerosis, stroke, history of vestibular disorder, respiratory disease, pregnancy * radicular symptoms * not dutch-speaking * strong opioids * neck pain * smoking history
use of consent language and mode to improve interactive voice response survey in colombia and uganda

Conditions: Surveys and Questionnaires; Noncommunicable Diseases

Summary: this study evaluates the effect of one new form of introduction language and three new modes of providing consent on interactive voice response (ivr) survey cooperation, response, refusal and contact rates, as compared to control group, in colombia and uganda.

using random digit dialing (rdd) sampling technique, rdd participants will be randomized to one of five introduction and consent combinations and then have them complete noncommunicable disease risk factor survey with an additional module regarding their understanding of the survey and of its voluntariness. this mobile phone survey will be sent as an interactive voice response (ivr). in ivr surveys, participants use their touch tone key pad to answer pre-recorded questions. (i.e. if you are male, press 1; if you are female, press 2). this study will be conducted in both colombia and uganda.

Eligibility criteria:
inclusion criteria: * access to a mobile phone * greater or equal to 18 years of age * in colombia, conversant in the spanish language. in uganda, conversant in luo, luganda, runyakitara or english languages. exclusion criteria: * less than 18 years of age

Keywords: mobile phone surveys interactive voice response consent
biobehavioral correlates of cancer-related cognitive dysfunction and its co-occurring symptoms

Conditions: Survivorship; Cognitive Dysfunction; Pain; Depression; Anxiety; Fatigue; Sleep Disturbance

Summary: this descriptive, cross-sectional study will evaulate and fully characterize factors associated with cognitive dysfunction in breast cancer (bcs) and colorectal cancer (crc) survivors that have cognitive concerns, and factors associated with psychoneurological symptom cluster in bcs and crc survivors.

primary aim: to identify demographic factors (age and education), medical and cancer treatment-related factors (comorbidities and treatment type), psychosocial factors (perceived stress, affect, optimism, coping, emotional support), cancer-related symptoms (pain, depression, anxiety, fatigue and sleep disturbance), and genetic factors (apoe, comt, bdnf) associated with the level of subjective or the level of objective cognitive dysfunction in breast cancer and colorectal cancer survivors. secondary aim: to identify demographic factors (age and education), medical and cancer treatment-related factors (comorbidities and treatment type), psychosocial factors (perceived stress, affect, optimism, coping, emotional support), and genetic factors (apoe, comt, bdnf) associated with psychoneurological symptom cluster using either subjective or objective cognitive dysfunction in breast cancer and colorectal cancer survivors.

Eligibility criteria:
inclusion criteria: inclusion criteria for breast cancer survivors: 1. female bcs 2. ≥ 21 years of age and older 3. ability to provide written consent and hipaa authorization 4. ≥6 months post-adjuvant therapy and neo-adjuvant therapy for early stage (stage i-iiia) breast cancer. current aromatase inhibitors or tamoxifen treatment at time of enrollment is allowed. 5. identify cognitive concerns (select yes) inclusion criteria for colorectal cancer survivors: 1. male or female crc survivors 2. ability to provide written consent and hipaa authorization 3. ≥ 21 years of age and older 4. ≥6 months post-adjuvant therapy and neo-adjuvant therapy for early stage (stage i-iii) crc 5. identify cognitive concerns (select yes) exclusion criteria: 1. report metastatic breast or colorectal cancer (stage iv) at time of consenting. 2. unable to read and understand english to complete survey questionnaires.

Keywords: breast cancer and colorectal cancer co-occurring symptoms
study of alirocumab (regn727/sar236553) in patients with heterozygous familial hypercholesterolemia (hefh) undergoing low-density lipoprotein (ldl) apheresis therapy

Conditions: Heterozygous Familial Hypercholesterolemia

Summary: the primary objective of the study is to evaluate the effect of alirocumab 150 mg every 2 weeks (q2w) in comparison with placebo on the frequency of low-density lipoprotein (ldl) apheresis treatments in participants with heterozygous familial hypercholesterolemia (hefh) undergoing weekly or bi-weekly ldl apheresis therapy.

ldl apheresis removes low-density lipoproteins (ldl) that transport cholesterol in the plasma portion of the blood. this treatment is mainly used for familial hypercholesterolemia, but can be used in other rare diseases. familial hypercholesterolemia (hefh) is an inherited genetic condition that causes accumulation of cholesterol in the blood, which can lead to atherosclerosis and heart disease. this treatment is recommended for patients who do not respond to dietary and/or medication control of ldl cholesterol.

Eligibility criteria:
inclusion criteria: 1. men and women ≥18 years of age at the time of the screening visit 2. diagnosis of hefh (heterozygous familial hypercholesterolemia) 3. currently undergoing ldl (low-density lipoprotein) apheresis therapy qw (weekly) or q2w (every 2 weeks) or at least 8 weeks prior to the screening visit exclusion criteria: 1. homozygous fh (familial hypercholesterolemia) 2. background medical lmt (lipid-modifying therapy) (if applicable) that has not been stable for at least 8 weeks prior to the screening visit 3. ldl apheresis schedule/ apheresis settings that have not been stable for at least 8 weeks prior to the screening visit 4. an ldl apheresis schedule other than qw to q2w 5. initiation of a new exercise program or exercise that has not remained stable within 8 weeks prior to the screening visit (week -2) 6. initiation of a new diet or a diet that has not been stable within 8 weeks prior to the screening visit (week -2) 7. use of nutraceuticals or over-the-counter therapies known to affect lipids, at a dose/amount that has not been stable for at least 8 weeks prior to the screening visit (week -2), or between the screening and randomization visit 8. presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins 9. known history of a positive test for human immunodeficiency virus 10. use of any active investigational drugs within 1 month or 5 half-lives of screening, whichever is longer 11. patients who have been treated with at least 1 dose of alirocumab or any other anti-pcsk9 monoclonal antibody in any other clinical studies 12. pregnant or breastfeeding women
study examining stress during pregnancy

Conditions: Stress

Summary: researchers at uva health system are interested in how women experience and deal with stress during pregnancy. participants will be randomly assigned either to engage in coping strategies on one's own or to receive 6 weeks of relaxation training. researchers will examine how coping strategies affect the course of the pregnancy and the health of the infant

participants will be asked to fill out questionnaires and complete some tasks that require concentration as heart rate and other biological signals are monitored. participants will also be asked to provide samples of saliva a few times during 1 day. these tasks will be repeated 3 times during pregnancy and participants will be asked to complete questionnaires at 6 months postpartum a stress-reduction workshop will be offered to all participants at the completion of the study. participants will be paid for study completion

Eligibility criteria:
inclusion criteria: * beginning of the 2nd trimester of pregnancy * feel stressed or overwhelmed * do not yet have any children exclusion criteria: * more than 1 miscarriage * currently receiving medication for anxiety or depression

Keywords: pregnancy stress anxiety
inpatient obesity intervention with phone follow-up

Conditions: Obesity

Summary: in this study we sought to determine whether inpatient weight loss counseling with post discharge phone follow-up would result in weight loss at six months. secondary endpoints included weight change from baseline, changes in waist-to-hip ratios, assessment of weight perceptions and changes in patient reported health outcome measures. to our knowledge, this is the first randomized trial designed to evaluate the effects of an obesity intervention with post-discharge follow-up in an inpatient general medicine population.


Eligibility criteria:
inclusion criteria: * adults ages 18-65 years old * body mass index between 30-50 kg/m2 * admitted to an internal medicine service exclusion criteria: * acute medical conditions known to affect weight (heart failure, cirrhosis, end-stage renal disease on dialysis, nephrotic syndrome, or pregnancy) * charlson comorbidity index \>3 * moderate to severe major depression * prolonged steroid use (\>2 weeks) * initiation of medications known to affect weight * non-english speaking * precontemplation stage of change

Keywords: obesity, inpatient, intervention, weight loss
the efficacy and safety of different phlebotonic drugs in children with venous malformations

Conditions: Drug Effect; Children, Only; Vascular Malformations; Surgery

Summary: the aim of this study is to evaluate the efficacy and safety of different phlebotonic drugs in children and to assess patient satisfaction after treatment.


Eligibility criteria:
inclusion criteria: venous malformation * venous malformation exclusion criteria: * allergy
coronary artery disease management using multislice computed tomography and magnetic resonance imaging

Conditions: Coronary Artery Disease

Summary: the primary objective of this study is to analyze the clinical value of a therapeutic management strategy based on the results of coronary ct angiography and functional mri. the clinical value of ct and mri will be analyzed in patients with suspected coronary artery disease.


Eligibility criteria:
inclusion criteria: * suspected coronary artery disease and planned conventional coronary angiography based on atypical angina pectoris exclusion criteria: * known coronary artery disease * st elevation * age below 30 years * women of child-bearing potential without a negative pregnancy test * inclusion in another study * heart rate above 70 beats per min and contraindications to beta blockers * atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block * inability to hold the breath for 10 s

Keywords: suspected coronary artery disease
effect of the active cycle of breathing technique on coronary artery bypass graft patients' outcomes

Conditions: Coronary Artery Bypass; Coronary Arterial Disease (CAD)

Summary: following cabg surgery, patients are at risk for several complications. one of the most common complications is postoperative pulmonary complications, which include atelectasis and dyspnea. these complications cause prolonged icu length of stay and increased health care costs. several studies recommended the active cycle of breathing technique as a method that increases secretion removal and improves lung functions, thus reducing the incidence of postoperative pulmonary complications. our study aims to investigate the effect of the active cycle of breathing technique on coronary artery bypass graft patients' outcomes.


Eligibility criteria:
inclusion criteria: * any adult patient who will undergo cabg exclusion criteria: * mechanically ventilated patients on the first postoperative day. * patients with preoperative lung collapse or pleural effusion.

Keywords: cabg acbt postoperative pulmonary complications chest tube duration hemodynamic parameters chest expansion