Kornimate/medical-research-clean huggingface dataset:
molecular features predicting response/resistance to trastuzumab in metastatic breast cancer patients

Conditions: Breast Cancer

Summary: aim of the study is to assess the impact on response to herceptin-based therapy in patients with advanced breast cancer. tumor specimens from primary breast cancer will be analized for several biological factors potentially involved in herceptin sensitivity. tests that will be performed include: fish analyses of egfr, her-2, her-3, c-myc, pten, met, igfr-1. immunofluorecence of p95her2. mutation analyses of egfr, her-2, met, c-myc, pten, kras, pik3ca, igfr-1. immunohistochemistry of the same biomarkers.


Eligibility criteria:
inclusion criteria: * hystological diagnosis of breast cancer * availability of tumor tissue * availability to assess the response to trastuzumab according to recist criteria * availability of clinical data exclusion criteria: * unavailability of tumor tissue * impossibility to assess the response to trastuzumab according to recist criteria

Keywords: egfr, her-2, her-3, met, kras
effects of vitamin d on beta cell function and insulin sensitivity in pre-diabetes and diabetes mellitus type 2

Conditions: Diabetes Mellitus, Type 2; Glucose Intolerance; Vitamin D Deficiency

Summary: the purpose of this study is to evaluate if treatment with vitamin d increase beta cell function and insulin sensitivity in subjects with pre-diabetes or newly diagnosed diabetes mellitus type 2.


Eligibility criteria:
inclusion criteria: * meeting criteria for ifg, igt, ifg+igt or diabetes mellitus at ogtt. * bmi ≤ 32 kg/m2. * hba1c ≤ 7.0 % (monos) or ≤ 63 mmol/mol (ifcc). * fasting plasma glucose \< 9 mmol/l * s-25-oh-vitamin d3 \< 75 nmol/l. exclusion criteria: * treatment with any vitamin d preparation. * regular sun-bathing in solarium. * hypercalcemia at screening, defined as free s-calcium \> 1.35 mmol/l. * hyperphosphatemia at screening, defined as s-phosphate \> 1.5 mmol/l. * sarcoidosis or other granulomatous disease. * treatment with phenytoin, barbiturates, rifampicin, isoniazid, cardiac glycosides, orlistat or colestyramin. * impaired hepatic function. * impaired renal function * cardiac disease defined as: * unstable angina pectoris * myocardial infarction within the last 6 months * congestive heart failure nyha class iii and iv * cerebral stroke within the last 6 months. * anti-diabetic medication of any kind. * females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
improvement of endothelial function by egcg

Conditions: Cardiovascular Diseases

Summary: cardiovascular diseases are a major cause of morbidity and mortality worldwide. impaired endothelial function (assessed as flow-mediated dilation) represents an early marker for later cardiovascular events. epidemiological and experimental studies suggest that consumption of tea is associated with lower progression of atherosclerosis and reduced cardiovascular mortality. tea contains high amounts of polyphenols with important biological activities. the green tea catechin epigallocatechin-3-gallate (egcg) is the most potent physiologically active compound in vitro. however, little is known about its contribution to beneficial effects of tea in vivo. in this crossover study the impact of a single dose of egcg applied in different forms (green tea beverage, green tea extract and egcg) on flow-mediated dilation is investigated in healthy volunteers two hours after ingestion. the amount of egcg (200 mg) corresponds to appr. 0.5 l of green tea. the results of the study will elucidate the contribution of egcg in cardiovascular protective effects of green tea in vivo. the outcomes will provide insights about the role of egcg in different application forms to improvements of endothelial function in humans.


Eligibility criteria:
inclusion criteria: * male healthy volunteers * 20-50 years * bmi \< 27 kg/m2 * cholesterol \< 240 mg/dl exclusion criteria: * diabetes mellitus * hypertension * conditions with impaired endothelial function * smoking * regular drug use * alcohol abuse * regular tea drinkers

Keywords: green tea egcg cardiovascular diseases endothelial function flow-mediated dilation
a study to evaluate the pharmacokinetics of bms-986141 in participants with hepatic impairment compared to healthy participants

Conditions: Hepatic Impairment

Summary: an oral dose of bms-986141 administered in hepatic impairment and healthy participants to evaluate pharmacokinetics in this patient population.


Eligibility criteria:
inclusion criteria: * women not of childbearing potential (wnocbp), and males, ages 18 to 70 years, inclusive. * bmi of 20.0 to 38.0 kg/m2 inclusive * participants who a history of normal renal function * subjects with hepatic impairment must be on a stable dose of medication and/or treatment regimen * healthy subjects to the extent possible matched to four subjects with hepatic impairment with regard to body weight, age and gender, as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations exclusion criteria: * any nonhepatic significant acute or chronic medical illness that could affect participant safety or data interpretation as determined by the investigator. * history of recurrent dizziness or fall risk within 4 weeks of study drug administration * history of primarily cholestatic liver diseases, autoimmune liver disease, metastatic liver disease or active alcoholic hepatitis * history of known bleeding diathesis or coagulation disorder (eg, thrombotic thrombocytopenic purpura) * other protocol defined exclusion criteria could apply
binding of foliglurax to regions in the brain in healthy participants and in patients with parkinson's disease (pd)

Conditions: Healthy; Parkinson Disease

Summary: a study to learn how foliglurax binds in regions of the brain

to study binding of foliglurax to mglu4 receptors in human brain, up to 9 healthy subjects (part a) and up to 8 patients with parkinson's disease (part b) will be injected with a liquid dose of a radiolabelled tracer that allows measurement of foliglurax binding in the brain to determine to which degree foliglurax binds to regions of the brain.

Eligibility criteria:
inclusion criteria: part a: * healthy subjects * the subject has a normal structural mri (smri) scan performed in the screening period, as judged by the investigator. * the subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, body weight, ecg, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests. * the subject can tolerate confined spaces for prolonged periods of time. * the subject is suitable for radial and/or brachial artery blood sampling and cannulation. part b: * patients with parkinson's disease * the subject has a normal smri scan performed in the screening period, as judged by the investigator. * the patient is, in the opinion of the investigator, fit for enrolment in the study based on the assessment of medical history, physical examination, vital signs, body weight, ecg, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests. * the patient has been diagnosed with idiopathic parkinson's disease for ≥3 years, with a current disease severity of 2 to 4 on the modified hoehn and yahr scale in the off state. * the patient has dyskinesia that is not too severe to cause discomfort for the patient during pet imaging and predictable off time * in addition to the above criteria, the patient must, in the opinion of the investigator, also be suitable for the study and the included pet imaging sessions. * the patient has been receiving a stable regimen of levodopa-containing therapy (total levodopa dose ≤1600 mg per day) (≥3 doses per day of standard levodopa or ≥3 doses per day of carbidopa and levodopa, sustained-release tablets or extended-release capsules of carbidopa and levodopa or benserazide and levodopa), and be on a stable regimen of permitted anti-parkinsonian drugs (peripheral decarboxylase inhibitors, dopamine agonists \[except apomorphine\], monoamine oxidase type b \[mao-b\] inhibitors \[except safinamide\], or catechol-o-methyl transferase \[comt\] inhibitors) for ≥4 weeks prior to foliglurax dosing * the patient can tolerate confined spaces for prolonged periods of time * the patient is suitable for radial and/or brachial artery blood sampling and cannulation exclusion criteria: * the subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the imp other inclusion and exclusion criteria may apply.
a study of quarterly intravenous bonviva (ibandronate) in women with post-menopausal osteoporosis.

Conditions: Postmenopausal Osteoporosis

Summary: this single arm study will assess the efficacy and safety of quarterly intravenous bonviva in women with post-menopausal osteoporosis. all patients will receive bonviva 3mg i.v. every 3 months. the anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.


Eligibility criteria:
inclusion criteria: * post-menopausal women with osteoporosis; * \<=80 years of age; * naive to oral bisphosphonates, or have discontinued daily and/or weekly bisphosphonate treatment for \>1 year. exclusion criteria: * metabolic bone disease other than post-menopausal osteoporosis; * treatment with other drugs affecting bone metabolism within last 6 months; * previous or current malignant disease (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer).
management of adrenal emergency in germany

Conditions: Adrenal Insufficiency

Summary: the management of adrenal crisis is often problematic and the time to adequate treatment is frequently delayed.the aim of the study is to evaluate the management of adrenal emergencies requiring parenteral glucocorticoid treatment by a prospective multicenter study in patients with chronic adrenal insufficiency.

despite established hormone replacement therapy, patients with chronic adrenal insufficiency (ai) are at risk of suffering from adrenal crisis (ac). further data suggests that the management of ac is often problematic and the time to adequate treatment is frequently delayed.the aim of the study is to evaluate the management of adrenal emergencies (ae) requiring parenteral glucocorticoid (gc) treatment by a prospective multicenter study. patients with chronic ai receive a questionnaire on the management of emergency situations, which had to be completed and sent back in case of an emergency requiring parenteral gc administration. furthermore, patients were contacted by phone in case of a missing response every six months.

Eligibility criteria:
inclusion criteria: * age ≥18 years * documented chronic adrenal insufficiency * established corticosteroid replacement therapy * written informed consent exclusion criteria: - age \<18 years

Keywords: adrenal insufficiency adrenal crisis adrenal emergency glucocorticoid injection
depression and cardiovascular risk markers: effects of rosuvastatin therapy

Conditions: Depression

Summary: the purpose of this study is to investigate whether rosuvastatin decreases measures of inflammation in depressive patients.

depression is associated with increased risk of cardiovascular disease, in which one possible mechanism is systemic inflammation. further, patients at high risk of cardiovascular disease, rosuvastatin decreases the risk, especially among patients with increased inflammation. this is a proof-of-concept study to investigate whether the antiinflammatory effect of rosuvastatin is similar in depressive as in patients with cardiovascular disease.

Eligibility criteria:
inclusion criteria: * persisting self-reported depressive symptoms \> 5 weeks * indications of aortic atherosclerosis on pet/ct exclusion criteria: * clinical indication of statin use. * contraindication of statins, or of pet/ct and mri. * established cardiovascular disease. * bipolar disorder og comorbid psychosis.

Keywords: inflammation atherosclerosis hydroxymethylglutaryl-coa reductase inhibitors
combined antagonistic muscle magnetic stimulation and selective periferal neurotomy to improve results on spasticity

Conditions: STROKE

Summary: the objective of the present trial is to demonstrate magnetic stimulation as an useful complementary treatment in order to improve patients' evolution without the need of extensive surgical lesion.

patients with refractory post stroke upper right limb spasticity will operated by median nerve or median/ cubital selective neurotomy depending upon more affected territories. some of them could be also also operated with posterioris tibialis neurotomy to treat equine's foot whenever also clinically present. preoperative motor blocks might be possitive in all cases. a week later, they will be treated by magnetic stimulation on selected antagonistic muscles, related to pre - operative affected ones, mostly deltoids, triceps and finger extensors with an equipment dipol zeta d5 (russian federation), with 1.5 tesla of intensity. trials will be repeated twice a week in sessions of 30 minutes during 6 months with simultaneous intensive classic rehabilitation. patients will be monthly evaluated by the mean score of modified ashworth scale, related to fingers, wrist, elbow and shoulder and also with barthel scale.

Eligibility criteria:
inclusion criteria: * severe and refractory right hemiparesia or hemiplegia, affecting hand function. * failure of kinesic treatment * 2 points or more improvement on modified ashworth scale after anestethic blockade exclusion criteria: * severe cardiovascular disease * severe pulmonary disease * neoplasia advanced disease * joint anchylosis * irreversible retraction for muscle fibrosis

Keywords: barthel scale disability modified ashworth scale right arm neuromodulation spasticity stroke
safety and efficacy evaluation of β-globin restored autologous hematopoietic stem cells in β-thalassemia major patients

Conditions: β-thalassemia

Summary: this is an open label study to evaluate the safety and efficacy of β-globin restored autologous hematopoietic stem cells in ß-thalassemia major patients

we will recruit ß-thalassaemia major patients and collect their autologous hematopoietic stem cells, which will be modified with the lentihbbt87q system to restore β-globin expression. after conditioning, the autologous hematopoietic stem cells with restored β-globin will be reinfused to the patients and followed up for two years to collect data.

Eligibility criteria:
inclusion criteria: * 8-16 years old. subject and/or subject's legal guardian fully understand and voluntarily sign informed consent; * clinically diagnosed as transfusion-dependent β-thalassemia major; * with sufficient rbc infusion, subjects must maintain hemoglobin ≥9g/dl, serum ferritin threshold ≤ 3000 ng/ml and the liver iron overload mild or absent for at least 3 months before mobilization of hematopoietic stem cell; * follow the arrangements for treatment and regular medical checks within two years post-transplantation exclusion criteria: * the physical condition does not meet the requirements for hematopoietic stem cell mobilization and transplantation myeloablation; * received gene therapy and allogeneic hsct in the past. * have an available hla matched donor. * enrolling in another clinical trial. * other unsuitable conditions identified by doctors.
feasibility study testing a sleep intervention in prostate cancer patients with insomnia

Conditions: Cancer of Prostate; Insomnia

Summary: this study of a randomized controlled trial aims to evaluate the feasibility of a 12-week sleep program and the randomized controlled trial research procedure. in total 20 participants will be recruited and randomized to the intervention or control group.

this feasibility study of a randomized controlled trial, aims to evaluate the feasibility of a 12-week sleep program consisting on aerobic exercise and cognitive-behavioral therapy. in this study the investigators wish to evaluate the program as well as the randomized controlled trial research procedure. in total 20 participants will be recruited and randomized to either the intervention group (n=10) or control group (n=10).the intervention group will participate in two exercise sessions each week and four sessions based on cognitive-behavioral therapy for insomnia.

Eligibility criteria:
inclusion criteria: * prostate cancer * receiving treatment with androgen deprivation therapy or in combination with chemotherapy * insomnia * over 18-yers old * understand oral and written danish * written informed consent exclusion criteria: * medical assessment that does not allow aerobic exercise * severe cognitive problems * night work during the interventions period * exercise training more than three times a week
effectiveness of pressure garment therapy after burns

Conditions: Hypertrophic Scarring After Burn Injury

Summary: purpose - to determine the effectiveness of custom-fit pressure garment therapy in the prevention of hypertrophic scarring in healed burns. background - approximately one million people are burned each year in the united states. the most devastating outcomes following burns is the ugly, itchy, hypertrophic scar that interferes with work and all other aspects of life. pressure garment therapy is routinely used to minimize hypertrophic scarring even though there is no scientifically valid data that this therapy is efficacious. pressure garments are extremely unattractive, expensive and uncomfortable and their use needs to be based upon valid data. goals and objectives - the investigators plan to determine the effectiveness of pressure garment therapy in the control of hypertrophic scarring in healed burns. methods - the i-scan® device was designed to measure pressure at the body/environment interface and allows clinicians to deal with pressure-related problems for at-risk patients. it has been widely used in rehabilitation medicine but not with burn survivors. the investigators will use this device to measure the pressure at the garment/skin interface. 2) furthermore, the few studies that have been attempted to determine efficacy have used between subjects designs. since burn depth is extremely variable from patient to patient and since hypertrophic scarring is greatly influenced by age and race/origin, the between subjects design requires very large numbers of subjects. the investigators will use a within wounds design studying forearm burns and applying pressure to half of the wound and no pressure to the other half. the investigators will then compare hardness, color, thickness and clinical appearance.


Eligibility criteria:
inclusion criteria: * treated from time of burn at the university of washington burn center during the first two years of the grant period * burns covering the majority of the forearm that healed spontaneously in three or more weeks. patients will be entered into the study within 4 weeks of injury. * age 7-65 years. patients younger than 7 years will be excluded given the cooperation required during follow-up evaluations. patients over 65 years will be excluded since the incidence of hypertrophic scarring in persons over 65 is too low to warrant pressure garment trials. * patients of any race, ethnicity, or skin color. * informed, written consent in accord with the rules of the human subjects committee of the university of washington and the health insurance portability and accountability act (hipaa). exclusion criteria: * incarcerated patients * homeless patients * patients with substance abuse * patients with psychiatric diagnosis * patients unavailable to return regularly for follow-up evaluations

Keywords: hypertrophic scar burn cicatrix pressure garment
dietary intervention and assessment of obesity-related gene methylation levels in overweight women

Conditions: Obesity

Summary: the clinical study aimed to study the effect of an intervention with foods containing folate and hazelnut oil to assess whether this diet could modulate the methylation levels of two obesity-related genes, lep and pomc, in addition to impacting body weight and values of lipid profile of overweight women. the hypothesis of the clinical study is that the intervention diet could reduce the methylation levels of the genes mentioned and this would impact on the reduction of body weight and improvement of the lipid profile of the women studied.

the intervention study was carried out with a sample selected by randomization, and n = 40 adult women classified as overweight were considered for the study. after assessing the eligibility criteria, women were instructed to have stable weight, eating habits and levels of physical activity constant to those found during the baseline, as well as receiving an individual diet plan one week before starting the dietary intervention. before the start of the intervention, the 40 women were allocated to four groups of 10 each, and three groups started the individual diet plan for weight maintenance with a focus on vegetables and legumes with antioxidant and folate-rich action, and were also invited to consume foods fortified with folic acid and foods naturally rich in folate to achieve a usual folate intake close to the ras (≥400 µg), this amount was for intervention group 1 and 2, group 3 received a lower amount (approximately half of the consumption of groups 1 and 2) and group 4 was the control group. still referring to the intervention, the participants of the three groups received advice from a nutritionist, responsible for this research and all the printed material free of charge, including pre-packaged foods, and also delivered hazelnut oil capsules, used as a source of monounsaturated fat. counseling sessions with the nutritionist were offered daily at the homes during the entire period of the intervention, except for group 4, where the monitoring was weekly, to maintain eating habits. after the end of the 8 weeks of the intervention, the third stage of the study began, which consisted of anthropometric assessment, analysis of the dietary intake of the 24-hour food record and blood collection for biochemical tests and dna methylation.

Eligibility criteria:
inclusion criteria: * adult women, aged between 20 and 59 years; * women with classification of overweight and obesity; * women who signed the informed consent form. exclusion criteria: * women who changed their lifestyle 3 months before the study started; * alcoholic women or smokers; * taking medications known to interfere with folic acid metabolism (in the past 3 months), such as antacids and anticonvulsants; * individuals who use supplements in general, such as fish oil or other fatty acids; * pregnant or planning to become pregnant during the study period.

Keywords: epigenetic obesity diet folate monounsaturated fat