Kornimate/medical-research-clean huggingface dataset:
treatment of apomorphine-induced skin reactions: a pilot study

Conditions: Parkinson's Disease; Apomorphine-induced Skin Reactions

Summary: skin reactions as a result of continuous subcutaneous apomorphine infusion occur frequently and interfere with the absorption of apomorphine. the histopathology of apomorphine-induced skin reactions is poorly understood. therefore treatment options are limited and suggestive. objective: to investigate the efficacy of four treatments including massage, dilution of apomorphine, treatment with topical hydrocortisone and pre-treatment with subcutaneous administered hydrocortisone, in parkinson's disease patients with apomorphine-induced skin reactions.


Eligibility criteria:
inclusion criteria: * female and male subjects aged ≥30; * diagnosis of idiopathic parkinson's disease of \>3 years' duration, defined by the united kingdom (uk) brain bank criteria, with the exception of \>1 affected relative being allowed, without any other known or suspected cause of parkinsonism (gibb \& lees, 1988); * treatment with continuous subcutaneous apomorphine infusion; * having apomorphine-induced skin reactions (i.e. erythema, swelling and/or nodule formation); * male and female patients must be compliant with a highly effective contraceptive method (oral hormonal contraception alone is not considered highly effective and must be used in combination with a barrier method) during the study, if sexually active; * subjects considered reliable and capable of adhering to the protocol, visit schedule, and medication intake according to the judgement of the investigator. exclusion criteria: * high suspicion of other parkinsonian syndromes; * history of respiratory depression; * hypersensitivity to hydrocortisone or any excipients of the medicinal product; * concomitant therapy with histamine antagonist; * known with cushing's disease or hypercortisolism * any medical condition that is likely to interfere with an adequate participation in the study including e.g. current diagnosis of unstable epilepsy; clinically relevant cardiac dysfunction and/or myocardial infarction or stroke within the last 12 months; * pregnant and breastfeeding women; * current infectious disease with fever at the time of investigation.

Keywords: parkinson's disease apomorphine infusion skin reactions subcutaneous nodules hydrocortisone massage dilution
natural history, genetic bases and phenotype-genotype correlations in autosomal dominant spinocerebellar degenerations

Conditions: Spinocerebellar Ataxias; Spastic Paraplegias

Summary: the autosomal dominant spinocerebellar degenerations are a highly heterogeneous, clinically and genetically, group of rare diseases and of severe evolution. so far, the responsible genes for less than 50% of the cases are known and because of their rarity, there are no phenotype-genotype correlations and well-defined disease history. the aims of the project are to develop and validate quantitative tools of the cerebellar syndrome and of the spasticity, to establish links between the phenotype and the result of the molecular analysis, to identify new loci/genes responsible for these disorders, and to establish the natural history of the disease according to the genotype. to this end, a prospective and multicentric study is proposed for recruiting and evaluating, clinically, a cohort of 225 patients; 150 of them are already followed-up in the centers involved. a dna collection will be set up in order to search for the implication of new loci and genes. a clinico-genetic database will be set up combining data from successive clinical evaluations and those of genotyping. this strategy will allow access to genetic counselling and molecular diagnosis (positive, presymptomatic or prenatal diagnoses), based on a rational strategy from phenotype-genotype correlations and the information concerning the relative frequency of the genes. the detailed description, with the help of new evaluation tools and of the follow-up of the natural history of the disease according to the genotype, constitutes a crucial step in the design of therapeutical trials in these orphan disorders. furthermore, the regular follow-up by specialized centers will allow better care of the patients.


Eligibility criteria:
inclusion criteria: * progressive ataxia or paraplegia, * familial history of the disease (patients), * over 18 years of age * no presentation of neurological or osteoarticular disorders exclusion criteria: * refusal to participate in the protocol, * an unknown familial history, * presenting with an interrecurrent disorder making the evaluation of the disease (stroke, dementia) impossible

Keywords: dominant spinocerebellar degenerations new rate scales natural history molecular biology candidate genes
retrospective data collection study in patients with macular oedema receiving ozurdex®

Conditions: Macular Edema; Retinal Vein Occlusion

Summary: this study will use retrospective data to evaluate the safety and efficacy of ozurdex® (dexamethasone intravitreal implant 0.7 mg) in the treatment of macular oedema due to retinal vein occlusion (rvo) in clinical practice. no intervention will be administered as part of this study.


Eligibility criteria:
inclusion criteria: * macular oedema in at least one eye due to branch retinal vein occlusion (brvo) or central vein occlusion (crvo) * received at least one injection of ozurdex® in the study eye exclusion criteria: * none
study of oral vinorelbine plus capecitabine versus taxane-gemcitabine combinations as 1st line chemotherapy in metastatic breast cancer

Conditions: Breast Cancer

Summary: the aim of this international open-label randomized phase ii trial is to evaluate the efficacy and safety of an all-oral combination and two all-intravenous combinations as first-line therapy for her2-negative mbc patients.


Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the breast; * documented metastatic disease previously untreated by chemotherapy; * her2 negative (assessed by 0-1+ ihc or 2+ ihc with fish-) on the primary tumor or on metastatic site; * karnofsky performance status 70%. exclusion criteria: * local relapse alone after conservative treatment or contra-lateral tumor; * patients with symptoms suggesting cns involvement or leptomeningeal metastases; * concomitant hormonal therapy for metastatic breast cancer; * prior chemotherapy in the metastatic setting; * patients previously treated with a vinca-alkaloid, capecitabine, gemcitabine or taxanes; * prior severe and unexpected reaction to fluoropyrimidine therapy (with or without documented dpd deficiency) or known hypersensitivity to 5-fluorouracil.

Keywords: breast cancer
comparison of lisdexamfetamine dimesylate with atomoxetine hcl in attention-deficit/hyperactivity disorder (adhd) subjects with an inadequate response to methylphenidate

Conditions: Attention-Deficit/Hyperactivity Disorder

Summary: this study will evaluate how long it takes for adhd symptoms to improve in subjects who are judged by the investigator to have had an inadequate response to methylphenidate therapy. the study will also test the safety of lisdexamfetamine dimesylate and how well it works.


Eligibility criteria:
inclusion criteria: * subject has had an historical or current inadequate response to methylphenidate (mph) treatment. inadequate response includes but is not limited to the presence of some residual symptoms, with associated impairment inadequate duration of action and/or variability of symptom control, and/or investigator feels that the subject may derive benefit from an alternative drug treatment to mph therapy. * subject is a male or female aged 6-17 years inclusive at the time of consent * subject must meet diagnostic and statistical manual of mental disorders, fourth edition. - text revision (dsm iv tr) criteria for a primary diagnosis of adhd based on a detailed psychiatric evaluation * subject must have a baseline adhd-rs-iv total score 28. exclusion criteria: * subject has taken more than 1 mph treatment (for example, 2 or more different mph treatments). examples include but are not limited to ritalin immediate release (ir) and equasym ir; medikinet ir and concerta; ritalin long-acting la and concerta. note: this does not include subjects who have taken ir mph for dose titration on a short-term basis (for example, £4 weeks) with an adequate response * in the investigator's judgement, subject has failed to respond to more than 1 previous course(s) of mph treatment. failure to respond includes worsening of symptoms or no change/minimal improvement of symptoms. * subject has previously been exposed to strattera or to amphetamine therapy * subject has previously demonstrated intolerable side effects to 1 mph treatment which limited titration to acceptable efficacy or that required a decrease in dose resulting in unacceptable tolerability and/or efficacy * subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid axis ii disorder or severe axis i disorder or other symptomatic manifestations, such as agitated states, marked anxiety, or tension that, in the opinion of the examining physician, will contraindicate treatment with spd489 or strattera or confound efficacy or safety assessments. * subject has a conduct disorder. oppositional defiant disorder is not exclusionary.

Keywords: adhd
comparative study of efficacy and safety of oral ibuprofen and intravenous ibuprofen in closure of patent ductus arteriosus in very low birth weight infants

Conditions: Patent Ductus Arteriosus

Summary: it is a prospective randomized simple-blinded pilot trial with the principal aim to compare efficacy and tolerance between oral ibuprofen and intravenous ibuprofen in early curative closure of pda in very low birth weight infants. the likelihood of ductal closure with only one or two doses of treatment is a secondary objective.

we calculated that a study group of 62 patients would be necessary for the study to be able to detect a difference of at least 25 percentage points in the closure rate between the oral ibuprofen and intravenous ibuprofen groups, assuming a closure rate of 65 percent with intravenous ibuprofen, with a p value of 0, 05 and a power of 80 percent.patients (gestational age, 25 to 32 weeks) with echocardiographically confirmed patent ductus arteriosus and respiratory distress will randomly be assigned to receive one (10 mg / kg), two (10 mg / kg followed 24 hours after by 5 mg /kg) or three (10 mg / kg followed at 24-hour intervals by two doses of 5 mg /kg each) doses of either intravenous ibuprofen (group i, n = 32) or oral ibuprofen (group o, n = 32), starting on the third day of life. the rate of ductal closure, side effects, complications, and the patients' clinical course will be recorded.

Eligibility criteria:
inclusion criteria: * a gestational age \< 32 weeks * a birth weight \< 1500g * a postnatal age between 48 and 96 hours, a respiratory distress requiring more than 25 % of oxygen supplementation * an echocardiographic evidence of left to right significant shunting pda exclusion criteria: * a right-to-left shunting * major congenital anomalies * ivh grade 3-4 * a tendency to bleed (defined by the presence of blood in the endotracheal aspirate, gastric aspirate, stools or urines and / or oozing from puncture sites) * a serum creatinine level \>140µmol/l, a serum urea nitrogen \> 14 µmol/l and a platelet count \< 60000/mm3.

Keywords: patent ductus arteriosus ibuprofen premature infant
thoracic fluid content by electric bioimpedance versus lung ultrasound in preterm neonates with respiratory distress

Conditions: Respiratory Distress Syndrome, Newborn

Summary: a prospective cohort study aims to evaluate the predictive value of thoracic fluid content measured by electric bioimpedance for detecting the need for surfactant administration or positive pressure ventilation requirement; whether invasive or non-invasive; in preterm neonates with respiratory distress and to compare it to lung ultrasound.

electrical cardiometry (bioimpedance) is an impedance-based method that has been recently introduced for continuous noninvasive hemodynamic monitoring for cardiac output (co) and tfc in both term and preterm infants. tfc is the sum of the total fluid volume found in the chest cavity; it is measured as the baseline resistance (bioimpedance) to the passage of a small electrical current through all chest tissues. larger tfc indicates a higher total thoracic fluid volume. tfc measurement has been correlated with heart failure symptoms, net fluid balance, and chest radiographic findings of abnormal pulmonary fluid content in adults. lung ultrasound (lus) is a reliable technique for physicians to complement physical examination findings and has emerged as an alternative option to overcome the limitations of chest x rays (cxrs). moreover, lus shows better diagnostic accuracy than cxr in some critical conditions and has been successfully adapted in nicus for the diagnosis of several diseases. we thought that tfc monitoring may be able to predict the need for surfactant administration or positive pressure ventilation requirement; whether invasive or non-invasive; in preterm neonates with respiratory distress comparable to lus.

Eligibility criteria:
inclusion criteria: * preterm neonates with gestational age ≤ 34 weeks, admitted with respiratory distress: defined as the presence of at least two of the following clinical symptoms: tachypnea, grunting, retractions (subcostal, intercostal, suprasternal), nasal flaring and other symptoms include apnea, bradypnea, irregular (seesaw) breathing, inspiratory stridor, wheezes and hypoxia exclusion criteria: * preterm neonates with evidence of any of the following: chromosomal anomalies mechanical ventilation or received endotracheal surfactant before first assessment

Keywords: preterm, respiratory distress, lus, tfc
lifestyle changes in patients with type 2 diabetes mellitus and hypertension

Conditions: Blood Pressure

Summary: data obtained in hypertensive patients without diabetes suggest that increased association of non-pharmacological treatment in patients with diabetes and hypertension may be associated with an improvement in blood pressure control. despite the beneficial results found, is not yet known the magnitude of the effect of a dash diet associated with the stimulus of physical activity on bp in patients with type 2 diabetes. the beneficial effects on blood pressure of an additional non-pharmacological intervention to drug therapy may have an even greater impact in patients with treatment-resistant hypertension the aim of this study is to evaluate the effect of changes in lifestyle on blood pressure in patients with type 2 diabetes and hypertension resistant to treatment.

the aim of this study is to evaluate the effect of changes in lifestyle on blood pressure in patients with type 2 diabetes and hypertension. secondary objectives are: assess whether the prescription of a dash-type diet and encouragement for physical activity through use of pedometers, can improve blood pressure control in patients with type 2 diabetes and hypertension resistant to treatment. forty type 2 diabetic with resistant hypertension outpatients were included in a randomized clinical trial: treatment 1- dash diet + encouragement for physical activity through use of pedometer; treatment 2- ada diet + usual exercises. the duration of each treatment are four weeks. the patients included should have performed ambulatory blood pressure monitoring (abpm) to exclude white-coat effect, ie when there are abnormal in the measurement of office blood pressure (equal to or above 140/90 mm hg) and normal blood pressure by abpm during the awake period (equal to or below 135/85 mm hg). twenty-four hour records with concurrent 24h urinary collections (protein intake estimative), clinical and laboratory evaluation were performed at baseline and after 4 weeks. serum fatty acids were measured in total lipids by gas chromatography.

Eligibility criteria:
patients inclusion criteria: * type 2 diabetes * blood pressure ≥140/90 mm hg * abmp ≥ 135/85 mm hg exclusion criteria: * digestive disease with malabsorption * diabetic neuropathy with gastroparesis * bmi ≥ 40 kg/m²

Keywords: diabetes exercise dash diet abpm
parameters of acceptability, compliance and efficacy of fulvestrant in post-menopausal patients with advance breast cancer

Conditions: Breast Cancer

Summary: the objectives of this study is to obtain information of faslodex use in the treatment of breast cancer in the clinical practice in argentina.

in argentina, faslodex is indicated for treating postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-oestrogen therapy or disease progression during anti-oestrogen treatment. this study will provide information regarding the acceptability and compliance of argentina patients to faslodex and will provide information regarding the efficacy of this treatment in local population.

Eligibility criteria:
inclusion criteria: * postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-estrogen therapy or disease progression during anti-estrogen treatment, currently receiving faslodex * signature of the informed consent exclusion criteria: * any contraindication to faslodex administration

Keywords: breast cancer fulvestrant faslodex acceptability compliance efficacy
elect trial - embolization of the lumbar arteries before evar

Conditions: Aortic Aneurysm

Summary: prospective, randomized, single-center study for the treatment of subjects with abdominal aortic aneurysm: embolization of the lumbar arteries before evar: a prospectively randomized trial comparing platinum-fibered microcoils (control arm) with the mvp® microvascular plug (study arm)"

this study is a prospective, single-center, 1:1 randomized trial to investigate the difference in radiation dose and intervention time between the embolization with fcp and mvp-plug.

Eligibility criteria:
inclusion criteria: 1. subject age ≥ 18 2. subject has been informed of the nature of the study, agrees to participate, and has signed a medical ethics committee approved consent form. 3. indication for the occlusion of lumbar arteries due to: 1. subject has an abdominal aortic aneurysm and 2. at least 2 patent lumbar arteries in the diseased area 4. subject understands the duration of the study, agrees to attend the stentgraft implantation 5. a microcatheter is successfully placed the target lumbar artery. exclusion criteria: 1. any surgical procedure or intervention performed within 30 days prior to or post index procedure 2. aortic aneurysm requires treatment with alternative therapies such as operation 3. any other aortic pathology 4. major untreated cardio-pulmonary disease 5. life-expectancy of less than one year 6. expected lack of compliance (e.g. if the patient may not be willing to have several sessions and the following repair done) 7. pregnant or nursing women 8. impaired thyroid function, if not under stable treatment 9. women of child-bearing potential without highly effective contraceptive measures 10. enrolled in another investigational drug, device or biologic study 11. failure to successfully intubate an lumbar artery 12. stroke or heart attack within 3 months prior to enrollment 13. known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure 14. significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy. 15. platelet count \ 600,000 mm3 16. receiving dialysis or immunosuppressant therapy 17. chronic kidney disease (serum creatinine \> 2.5 mg/dl)
comparison of mechanical bowel preparation versus enema for candidates to colorectal resection for adenocarcinoma

Conditions: Colorectal Cancer

Summary: the purpose of this study is to evaluate mechanical bowel preparation (mbp) with polyethylene glycol plus bowel enema versus bowel enema alone in patients candidates to colorectal resection for malignancy.

surgical site infections (ssi) in colorectal surgery (anastomotic leakage, wound infection, intraabdominal abscess) are associated with increased mortality, postoperative hospital stay and costs. from a recent metanalysis and randomized clinical trial there is the emerging evidence that mechanical bowel preparation (mbp) before elective colorectal surgery is not associated with reduction of sis, although it causes high discomfort for patients. on the same way other more recent studies show that mbp may cause an higher incidence of sis, and that mbp may alter the bowel mucosa morphology. other authors report an increased incidence of anastomotic leakage requiring surgery for patients undergoing a single preoperative phosphate enema whereas but an higher cardiovascular mortality for patients undergoing mbp. two recent studies do not clarify the usefulness of mbp for reducing sis after colorectal surgery and one stage anastomosis. for these reasons a more precise understanding of the relationship between mbp and sis could increase patients satisfaction and decrease unnecessary procedures and costs. at this point mbp represent the clinical standard for patients undergoing elective colorectal surgery at the european institute of oncology.

Eligibility criteria:
inclusion criteria: * patients candidates to colorectal surgery for histologically confirmed colorectal cancer * age 18-80 years * obtained written consent exclusion criteria: * patients at high risk for receiving a stoma (e. g. patients affected by distal rectal cancer \ 5 cm from the anal verge who underwent neoadjuvant ct-rt without downstaging or tumour shrinkage * intestinal obstruction * emergency procedures * patients who underwent colonoscopy within 7 day from surgery * asa 4-5 patients * patients unable to give informed consent * renal failure (serum creatinine \>3 mg/dl) * pregnant women * breast feeding women

Keywords: mechanical bowel preparation (mbp) enema
evaluation of absorption, metabolism, and excretion and estimation of the absolute bioavailability of k-312

Conditions: Dyslipidemia

Summary: the purpose of this study is to evaluation of absorption, metabolism, and excretion of \[14c\]-k-312 and estimation of the absolute bioavailability of k-312 in healthy male subjects


Eligibility criteria:
inclusion criteria: * subject provides written informed consent before any study-specific evaluation is performed. * subject is a healthy adult male between the ages of 25 and 45 years, inclusive. * subject has a body mass index (bmi) of 18.5 to 30 kg/m2, inclusive. exclusion criteria: * presence of active or recurring clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal, or metabolic disease requiring medical treatment. * any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of k-312. * clinically relevant abnormalities in clinical laboratory parameters, as judged by the investigator.