Kornimate/medical-research-clean huggingface dataset:
intervention with vitamin d and omega-3 supplements and incident heart failure

Conditions: Heart Failure

Summary: this study will examine whether an intervention with vitamin d or fish oil supplements can reduce the risk of heart failure among adult men and women during a follow up period of up to five years (starting from the time of randomization into the parent vital trial). the investigators hypotheses are that both vitamin d and fish oil supplements will each reduce the risk of heart failure.

for this ancillary study of the ongoing parent vital trial, we will adjudicate incident heart failure cases occurring during a time period of up to five years starting from randomization of subjects in the parent vital study. intention-to-treat analysis will be used to assess the efficacy of vitamin d as well as omega-3 fatty acids.

Eligibility criteria:
inclusion criteria: * men aged 50 or older or women aged 55 or older * be consuming no more than 800 iu of vitamin d from all supplemental sources combined (individual vitamin d supplements, calcium+vitamin d supplements, medications with vitamin d \[e.g., fosamax plus d\], and multivitamins), or, if taking, willing to decrease or forego such use during the trial; * be consuming no more than 1200 mg/d of calcium from all supplemental sources combined, or, if taking, willing to decrease or forego such use during the trial; * not be taking fish oil supplements, or, if taking, willing to forego their use during the trial exclusion criteria: * prevalent heart failure * history of cancer (except non-melanoma skin cancer), heart attack, stroke, transient ischemic attack, angina pectoris, cabg, or pci * history of renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or wegener's granulomatosis; * allergy to fish or soy
pharmacokinetic and pharmacodynamic study of idn-6556 in aclf

Conditions: Acute on Chronic Hepatic Failure; Acute Liver Failure; Liver Cirrhosis; Acute Alcoholic Hepatitis

Summary: the study will evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of idn-6556 in subjects with cirrhosis of the liver who are hospitalized for more than 24 hours due to acute deterioration of liver function.


Eligibility criteria:
inclusion criteria: * male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study * subjects with a clinical, radiological and/or histological diagnosis of cirrhosis * subjects having not required hospital admission within 4 weeks of screening for a complication of cirrhosis * subjects with an acute deterioration of liver function * subjects who meet one of the following criteria: 1. subjects with renal failure (defined as creatinine ≥ 2.0 to ≤ 3.4 mg/dl) 2. subjects with other single organ failure with i. renal impairment (defined as an increase in creatinine of \> 0.3 mg/dl from either an established prior baseline level or if applicable, upon admission to hospital if prior level is unavailable; for inclusion, the creatinine level must be raised above normal levels), and/or ii. hepatic encephalopathy grade i or ii 3. subjects with two organ failures * if a subject received steroids for alcohol-induced acute liver failure, he/she must be unresponsive to steroid therapy. responsiveness is based on investigator discretion. * willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to one month after the last dose of study drug exclusion criteria: * known infection with hiv * subjects with cirrhosis who develop decompensation at any time in the postoperative period following partial hepatectomy * subjects with evidence of uncontrolled infection defined as persistent bacterial culture positivity despite adequate antibiotic therapy * subjects with clinical evidence of disseminated intravascular coagulation * subjects with chronic and/or pre-existing kidney disease defined as egfr (estimated glomerular filtration rate) of less than 30 ml/min for 3 months or longer * subjects who are hypotensive (defined as mean arterial pressure \<70 mmhg) or require the use of inotropic support * subjects with evidence of significant and/or uncontrolled bleeding * subjects requiring mechanical ventilation * subjects with active or history of malignancies other than hepatocellular carcinoma (hcc) within milan criteria or curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for five or more years * subjects previously exposed to idn-6556 * history or presence of clinically concerning cardiac arrhythmias, or prolongation of screening (pre-treatment) qt or qtc interval of \> 480 milliseconds (msec)

Keywords: liver failure cirrhosis alcoholic hepatitis
lipoarabinomannan (lam) enzyme-linked immunosorbent assay (elisa) in diagnostics of childhood tuberculosis (tb)

Conditions: Tuberculosis

Summary: in children, it remains quite difficult even in developed countries, to prove a diagnosis of tuberculosis (tb). new means for diagnosis of this disease are currently being researched. one candidate test is lipoarabinomannan elisa from urine, which has shown good sensitivity of up to 80% in adults. our study aims to evaluate this test in the diagnosis of children with tb.

among candidate new diagnostics for tb, a test for mycobacterial lipoarabinomannan (lam) excretion in urine has shown promising results in one tanzanian study: the sensitivity for detecting tb culture-positive patients was 80.3%. of 103 healthy volunteers, only one gave a false positive result (boehme, 2005). until now, there are only data concerning this test for diagnosis of adult disease. for evaluation of routine use in children in countries like malawi, we are starting a prospective study. children 0-14 years of age with suspected tb will be investigated using tb culture as the gold standard. in sputum samples, microscopy will be done. simultaneously, lam elisa from the patient´s urine will be done.

Eligibility criteria:
inclusion criteria: * age 0-14 years * suspicion of active tb or tb contact exclusion criteria: * no informed consent

Keywords: childhood tuberculosis diagnostic lipoarabinomannan elisa tuberculosis in childhood
evaluate three methods for diagnosis of invasive fungal infection in chinese patients after hsct

Conditions: Invasive Fungal Infection; Aspergillosis; Fungemia; Hematopoietic Stem Cell Transplantation

Summary: the purpose of this study is to assess the cut-off value of gm/g test in chinese patients after hematopoietic stem cell transplantation, and evaluate gm/g test and real-time pcr for diagnosis of ifi in chinese patients.

invasive fungal infection is one of the major complications of hsct recipients, and the incidence is increased rapidly in recent years. ifi also commonly occurs in chinese hsct recipients, and there is no formal report on the mortality and morbidity of ifi in chinese patients, so this study could supply these data. galactomannan(gm) is a cell wall component of aspergillus only, which is released to the blood stream when the aspergillus grows. while the β-d-glucan(bg) is in the most fungal cell wall, and the high level of bg in body fluid is also an evidence of fungal infection. in this study, the serum level of gm and bg would be detected by the commercial available kit. we will assess the cut-off value of gm/g test by proven/probable ifi patients and negative controls. then, we could calculate the sensitivity, specificity, positive and negative predict value of the gm/g test. meanwhile, we may find out the genus of the fungus by comparison of the two methods. for example, both positive of gm and g-test may suggest that the pathogen is aspergillus, while the positive g-test and negative gm-test implies the candida may be the pathogen. rt-pcr is also a helpful method for the ifi diagnosis, which is more sensitive than gm and g-test and encompassing multiple fungal genera. the small-subunit rrna gene sequence is relatively conserved among members of fungal kingdom, including the aspergillus and candida species, the dimorphic fungi, the agents of zygomycosis, and pneumocystis. so we will amplify that part of dna and using gene specific probe to detect whether the sample is positive for fungus or not. until now, there is no report about real-time pcr assay for diagnosis of ifi in chinese hsct recipients, so we want to carry out this study. at the same time, the result of real-time pcr assay could help us to estimate the coincidence of gm and g-test with the ifi patients. after performing the above three diagnostic test, we could identify the hsct recipients whether they have the ifi more accurately, so that we could evaluate the antifungal therapy and find out the risk factors for ifi in those patients more accurately.

Eligibility criteria:
inclusion criteria: * persistent fever(\>38.0℃) after three days broad-spectrum anti-bacteria or virus therapy * chinese patients after hematopoietic stem cell transplantation exclusion criteria: * severe hemolysis patients

Keywords: diagnosis galactomannan glucan real-time pcr invasive fungal infection aspergillosis chinese patients
leg muscle activity measured via electromyography in back squat variations

Conditions: Surface Electromyography; Muscular Fatigue

Summary: the purpose of the study is to see how different forms of the squat exercise change my body's leg muscle activity. four forms of the traditional back squat will be used: traditional back squat, barefoot squat, box squat, and traditional back squat with chains.

resistance exercise has various benefits that promote health and reduce the chance of chronic disease, but the biggest benefit may be found in the effects on maintaining muscle mass throughout the aging process. the implications resistance training has on an individual's ability to function throughout the day with less fatigue whilst performing tasks at an easier level can all be related to improved strength and endurance that comes with resistance training. furthermore, how the nervous system adapts and sends signals to the working muscles are of great interest as neuromuscular adaptations help in coordination, balance, and agility. variations of the same style of exercise have been theorized to improve and/or change the adaptations that can occur. thus, the purpose of this study would be to assess surface electromyography (semg) activations on 4 anatomical sites simultaneously during the squat exercise under varying conditions.

Eligibility criteria:
inclusion criteria: * participants will be males and females between the ages of 18 - 30 years * participant has provided written and dated informed consent to participate * participant is willing and able to comply with the protocol * participant is apparently healthy and free from disease, as determined by a health history questionnaire * participant agrees to abstain from lower body exercise 3 days prior to each testing visit * participant has completed at least 1 lower body workout every week for the past 6 months exclusion criteria: * participant reports any unusual adverse events associated with this study that in consultation with their physician recommends removal from the study * participant begins consumption of new supplement during the timeline of this study * participant is unable to refrain from consuming pre-workout supplement prior to testing sessions * participant is unwilling to refrain from lower body exercise at least 3 days prior to each testing session

Keywords: electromyography resistance trained
study where pharmaco magnetic resonance imaging (mri) effects of azd6765 will be compared to placebo in depressive male and female subjects

Conditions: Depression

Summary: the purpose of this study is to determine the effect of a single dose infusion of azd 6765 compared with placebo and ketamine on the blood oxygen level dependent signal using fmri (functional magnetic resonance imaging) in depressed subjects.


Eligibility criteria:
inclusion criteria: * documented clinical diagnosis meeting criteria from the dsm-iv by structured clinical interview,major depressive disorder, single episode or recurrent * outpatient status at screening and at randomisation exclusion criteria: * a major depression disorder which has a major impact on the subjects current psychiatric status * subjects not allowed to use mood stabilizers, antidepressants or other antipsychotic or psychoactive drugs * subjects with lifetime history of schizophrenia, bi-polar, psychosis and psychotic depression

Keywords: phase i bold signal fmri azd6765 bold signal measured by fmri
an open, uncontrolled study of gk567 in the deodorization of malodorous fungating neoplastic tumours

Conditions: Malodorous Infected Cutaneous Ulcer

Summary: this clinical trial objective is to investigate the safety and efficacy of gk567 to alleviate malodour of foul smelling, anaerobically infected fungating neoplastic tumours, over 14 days of treatment. the clinical hypothesis is that the success rate is no worse than 70% in the population of interest, where success for a patient is defined as a smell score of 0 or 1 at day 14/end of treatment, as assessed by the study investigator.


Eligibility criteria:
inclusion criteria: * the subject is a male or female aged between 20 years or older. * the subject has a cutaneous fungating neoplastic tumour with a smell that suggests established or early infection, with a minimum score of 2 (i.e. mildly offensive smell) on a 0-4 smell scale, (based on the study investigator's assessment) exclusion criteria: * the subject is currently receiving systemic antibiotics or received in the last 2 weeks, * the subject is currently receiving systemic or topical metronidazole or received in the last week, * the subject is currently receiving topical antibiotics or received such treatment applied on cutaneous fungating neoplastic tumour in the last 1 week, * the subject already receives any topical treatment on the cutaneous fungating neoplastic tumour
clinical and cost effectiveness of ace inhibitor, ramipril, in intermittent claudicants

Conditions: Intermittent Claudicants

Summary: the investigators are conducting a randomised controlled trial to investigate the clinical and cost effectiveness of ramipril which is an anti-hypertensive medication in patients with intermittent claudication. the investigators aim to recruit 78 participants in total. the investigators will randomise the 78 participants into two groups: ramipril group with 39 participants and placebo group with 39 participants. the investigators will measure ramipril's effect on walking by doing a simple treadmill test and measuring the maximum walking distance the participant can walk. the investigators also want to examine ramipril's effect on arterial function, cardiovascular prognosis, quality of life and cost effectiveness.


Eligibility criteria:
inclusion criteria: * patients with unilateral or bilateral intermittent leg claudication which was stable for the last 6 months. * patients with abpi \< 0.9 at rest at least in one leg. * bp ≤ 160/90 and a stable medication regimen for the last 6 months. * able to give informed consent * able to comply with study protocol exclusion criteria: * documented bilateral renal artery stenosis * unlikely to be compliant with medication or follow up as determined by the recruiting institution. * pregnancy * patients with critical limb ischemia (this includes patients with ischaemic rest pain and ulceration \> 2 weeks and/or a resting ankle pressure \< 50mmhg- grades ii and iii according to rutherford et al 1997.\[56\]. * patients who had a recent (less than 3 months) angioplasty or bypass surgery * patients who are unable to perform a treadmill test due to a limiting heart, respiratory or arthritic disease * history of angioneurotic oedema * currently taking ace inhibitor or angiotensin receptor blocker * contraindication to ace inhibitor * history of ace inhibitor intolerance * a creatinine rise of \> 30% from baseline and/or potassium \> 5.9 mmol/l * unwillingness to participate. * level 1 evidence for ace inhibitor treatment, including: * documented heart failure, left ventricular dysfunction or ejection fraction \<35% on previous echocardiography * uncontrolled hypertension, bp \> 160mmhg systolic or 100mmhg diastolic on 3 separate readings measured after 10 minutes rest on 2 separate occasions * recent (\< 3months) myocardial infarction or stroke * chronic renal impairment (serum creatinine \> 250 micromol/l)

Keywords: ace inhibitors intermittent claudication ramipril
a study of avastin (bevacizumab) and xeloda (capecitabine) in patients with advanced or metastatic liver cancer

Conditions: Liver Cancer

Summary: this study will evaluate the efficacy and safety of oral xeloda (capecitabine) plus intravenous avastin (bevacizumab) in patients with advanced or metastatic liver cancer. the anticipated time on study treatment is 3-12 months.


Eligibility criteria:
inclusion criteria: * adult patients \>=18 years of age; * advanced or metastatic liver cancer; * \>=1 measurable lesion. exclusion criteria: * current radiotherapy, chemotherapy, or other experimental therapies; * prior cytotoxic chemotherapy; * major surgery, open biopsy, or traumatic injury within 28 days of study entry; * history of a malignancy during the last 5 years, other than cutaneous basal cell cancer or in situ cervical cancer.
the effects of antecedent hypoglycemia or exercise on the response of the brain to subsequent hypoglycemia

Conditions: Type 1 Diabetes

Summary: the studies proposed in this application seek to use non-invasive techniques to examine the impact of repeated hypoglycemia on the brain.

the studies proposed in this application seek to use non-invasive techniques to examine the impact of repeated hypoglycemia on the brain. during the past decade many studies have shown that appropriate magnetic resonance imaging (mri) methods may be used to assess alterations in brain regional activation in response to external stimuli or tasks. thus, this non-invasive technique will enhance our ability to learn more about brain function, during hypoglycemia and may delineate information about the role of the brain in hypoglycemia associated autonomic dysfunction.

Eligibility criteria:
inclusion criteria: * healthy male and female subjects aged 18-45 * type 1 diabetes mellitus patients aged 18-45 * body mass index 21-38 kg/m2 * normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities and an ekg stress test. * female volunteers of childbearing potential will undergo hcg pregnancy test. only women who are not pregnant will participate in the study. diabetic subjects: * hba1c= 5.5-11.0% * duration of type 1 diabetes \> 3 yr * normal bedside autonomic function exclusion criteria: all subjects * prior or current history of poor health * abnormal results following screening tests * pregnancy * subjects unable to give voluntary informed consent * subjects with a recent medical illness * subjects with a history of hypertension, heart disease or cerebrovascular disease * subjects with known liver or kidney disease * subjects with recent weight loss or consuming a low carbohydrate diet * subjects taking steroids * subjects taking beta-blockers * subjects on anticoagulant drugs, anemic or with known bleeding diatheses * evidence of diabetic neuropathy, autonomic neuropathy, proteinuria, extensive background or proliferative retinopathy, hypertension, or cardiovascular disease

Keywords: fmri hypoglycemia
bioequivalence study of 500 mg and 1000 mg glucophage (metformin) tablets in healthy subjects

Conditions: Type 2 Diabetes Mellitus

Summary: to demonstrate the bioequivalence of 500 mg and 1000 mg glucophage tablets manufactured by bms relative to the respective strengths of 500 mg and 1000 mg diabex tablets marketed in australia by alphapharm in the fed state


Eligibility criteria:
inclusion criteria: * men and women ages 18 to 55 inclusive * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ecgs), and clinical laboratory determinations * body mass index (bmi) of 18 to 32 kg/m², inclusive. bmi = weight (kg)/ \[height (m)\]² exclusion criteria: * any significant acute or chronic medical illness * current or recent (within 3 months) gastrointestinal disease * any major surgery within 4 weeks of study drug administration * history of allergy or intolerance to metformin or other similar acting agents * prior exposure to metformin within 3 months of study drug administration * estimated creatinine clearance (clcr) of \< 80ml/min using the cockcroft gault formula
effect of automated insulin delivery on early-stage diabetic complications

Conditions: Type 1 Diabetes

Summary: aim of this study is to verify the effects of an advanced hcl (medtronic minimed™ 780g) compared to sap with plgs on metabolic outcomes and markers of early microvascular damage in a population of adults with t1d previously treated with csii. evaluation of endothelial disfunction and autonomic neuropathy will also be performed.

new algorithms for the automation of insulin delivery (aid) are showing great benefit on glucose control in people with type 1 diabetes. indeed, hybrid closed loop (hcl) systems can improve hba1c levels, percentage of time in defined glucose range, time below range and time over range, according to rct and observational studies results. however, scientific evidences demonstrating potential benefits on the reduction of diabetes complications are limited regarding csii or sap with demonstrated reduction of cardiovascular mortality, improvement of albuminuria and peripheral nerve damage. data on aid effects on complications of diabetes are missing. in this study intermediate damage markers will be measured to assess potential effects of aid in comparison to sensor augmented pumps.

Eligibility criteria:
inclusion criteria: * male and female patients * t1d patients above 18 years in csii treatment for at least 3 months * hba1c values between 6.0% and 9.5% * disease duration ≥ 2 years * written informed consent obtained from the patient exclusion criteria: * pregnancy * participation to other clinical trials * a history of alcohol or drug abuse * advanced diabetic nephropathy defined as presence of albuminuria ≥ 300 mg/g or egfr \< 60 ml/min/1,73m2 * proliferative diabetic retinopathy or macular edema * established atherosclerotic cardiovascular disease (ascvd) or history of heart failure * presence of serious diseases or conditions which in the opinion of the investigator makes patient non-eligible for the study * hypoglycemia unawareness (clarke score \> 4) * patients unable to understand spoken and written italian language

Keywords: automated insulin delivery type 1 diabetes complications