Kornimate/medical-research-clean huggingface dataset:
study in adult and pediatric patients with hsct-tma

Conditions: Stem Cell Transplant Complications; Thrombotic Microangiopathies

Summary: this is an observational, retrospective study designed to assess outcomes in patients diagnosed with hematopoietic stem cell transplant-associated thrombotic microangiopathy (hsct-tma) who were not treated with complement component (c5) inhibitor therapy. data required to evaluate study outcomes will be abstracted from the medical records of all patients who meet study eligibility criteria.


Eligibility criteria:
inclusion criteria: * body weight ≥ 5 kg at the time of hsct-tma diagnosis * documented tma diagnosis within 6 months from the hsct * evidence of renal dysfunction * presence of hypertension exclusion criteria: * history or presence of familial or acquired 'a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13' (adamts13) deficiency (activity \< 5%) * shiga toxin-related hemolytic uremic syndrome (st-hus) * positive direct coombs test * diagnosis of disseminated intravascular coagulation * history or presence of bone marrow/graft failure * diagnosis of veno-occlusive disease * received a complement inhibitor (eg, eculizumab) post-hsct through 12 months post tma diagnosis

Keywords: hematopoietic stem cell transplant transplant-associated tma thrombotic microangiopathy (tma)
effect of self regulation with mindfulness training on body mass index and cardiovascular risk markers in obese adults

Conditions: Obesity

Summary: this study is designed to assess the effect of a mindfulness training program with special focus on diet and nutrition vs. dietary counseling in 40 obese adults (bmi range 30-40) and their partner/spouses (irrespective of their bmi), in a 6-month pilot randomized controlled trial.

obesity is associated with deficits in self regulation. approaches that foster increased non-judgmental present moment awareness and increased acceptance have been demonstrated to enhance self regulation. one commonly used approach that synthesizes these concepts is mindfulness training. this study is designed to assess the effect of a mindfulness training program with special focus on diet and nutrition, on body mass index, cardiovascular risk markers, peripheral blood telomere length and telomerase levels in obese adults. the mindfulness training program is adapted from the attention and interpretation therapy developed by study investigators at mayo clinic. the study is designed as a 6-month pilot randomized controlled trial involving 40 obese adults and their partners/spouses with standard dietary counseling as the control intervention. promising feasibility and efficacy data from the study will prompt us to pursue a larger, multi-center trial to more definitively test this program as well as apply this intervention in clinical practice.

Eligibility criteria:
primary participant inclusion criteria: * obese adults (bmi ≥ 30) * currently working at mayo clinic rochester * able to provide informed consent * stable weight (within + 10 pounds) during the three months prior to enrolling in the study exclusion criteria: * currently (in the past six months) attending a weight loss program * underlying genetic or endocrine cause for weight gain * current cancer * medications known to affect weight (corticosteroids, antidepressants, anti psychotics, mood stabilizers, and anti-epileptic medications) * musculoskeletal conditions affecting the ability to adequately perform general physical activity * active smoking * substance abuse * quitting smoking within 6 months of enrolling in the study * have clinically significant acute unstable neurological, psychiatric, hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study * have an established practice of meditation for three or more months * not willing to complete study outcome measures. partner/spouse inclusion criteria: * able to provide informed consent exclusion criteria: * have clinically significant acute unstable neurological,psychiatric, hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study * have an established practice of meditation for three or more months

Keywords: obesity body mass index mindfulness training attention and interpretation therapy
correlation of optic disk morphology and ocular perfusion parameters in patients with primary open angle glaucoma

Conditions: Primary Open Angle Glaucoma

Summary: glaucoma is one of the most common causes of blindness in the industrialized nations. for a long time glaucoma has been defined as a disease in which high intraocular pressure (iop) leads to irreversible optic disc damage and subsequent visual field loss. however, recent investigations show that iop is not the only factor that is involved in the glaucomatous process leading to retinal ganglion cell death. the role of vascular factors in the pathogenesis of glaucoma has recently received much attention based on animal experiments and epidemiological studies. it is, however, assumed that vascular factors do not contribute to same degree in all glaucoma patients. generally, it is believed that a vascular component is more important in normal tension glaucoma patients and patients with underlying cardiovascular disease. little is, however, known about a potential association between optic nerve head morphology and ocular perfusion in poag patients. the current study seeks to gain insight into this association by assessing ocular blood flow parameters with a number of noninvasive technologies.


Eligibility criteria:
inclusion criteria: * men and women over 18 years * unilateral or bilateral primary open angle glaucoma * at least 3 reliable visual field tests showing cpsd \>= 2.0 in the eye that will be studied exclusion criteria: * history of acute angle closure * closed or barely open anterior chamber angle * standard deviation of visual field testing \> 10 * intraocular surgery or argon laser trabeculoplasty within the last six months * ocular inflammation or infection within the last three months * topical or systemically/oral therapy with steroids

Keywords: optic disc morphology ocular blood flow retina ocular physiology
effects of voluven on hemodynamics and tolerability of enteral nutrition in patients with severe sepsis

Conditions: Sepsis

Summary: the rapidity and the quality of fluid resuscitation in patients with severe sepsis are important factors for the prevention of secondary multi-organ failure. vascular filling may also have an impact on tolerability of enteral nutrition. the earliness and quantity of calories provided by enteral nutrition may have an impact on morbidity and mortality. this study will asses the effects of volume expansion on hemodynamics and tolerability of enteral nutrition in patients with severe sepsis. a data monitoring committee will review regularly safety data of the study.


Eligibility criteria:
inclusion criteria: * severe sepsis * requirement for fluid resuscitation exclusion criteria: * serum creatinine \> 300µmol/l * chronic renal failure * anuria lasting more than 4 hours * requirement for renal support
improving quality of life of children with cancer through psychosocial screening

Conditions: Cancer

Summary: in canada, approximately 1450 children are diagnosed with cancer annually. diagnosis of childhood cancer and its aggressive treatment can have devastating psychosocial effects on the whole family (e.g. unpleasant feelings or emotions that impact your daily activities). it is not known whether health care providers who treat these children use and value psychosocial tools or how beneficial the use of these tools is for these families. this research team will test the benefits of using psychosocial screening on the quality of life of treated children, parents and siblings.

in canada approximately 1450 children are diagnosed with cancer annually. childhood cancer diagnosis and treatment can have devastating psychosocial effects on the family. tools to screen for psychosocial risks (psr) in pediatric oncology are rare. our preliminary work adapted the psychosocial assessment tool (pat) for the canadian population, patrevised (patrev), and developed the psychosocial care checklist (pccl). the patrev is completed by parents of children with cancer, and yields a summary of the psychosocial needs of the patient, parents, and siblings. the pccl assesses hcps knowledge of family's psychosocial needs and services. importantly, psychosocial screening is associated with reduced parental anxiety and improved child's quality of life (qol). demonstration of the tool's ability to maximize patient and family psychosocial outcomes is needed. participants will be parents of children newly diagnosed with cancer, (patients and siblings (\> 8 years), if available). design: rct with concealed allocation to experimental group (eg) and control group (cg), with repeated measures (after diagnosis= t1, 6 months later=t2). the eg treating team will receive a summary of patrev risk information based on parent report. no risk information will be provided in the cg. parents in both groups will complete the patrev, family environment questionnaire, self--report and proxy reported qol, distress and mood measures for the patient and one sibling. patients and siblings will self-report on qol, distress and mood. patient charts will be reviewed (t2) to determine treatment intensity and documented psychosocial services for each family.

Eligibility criteria:
inclusion criteria: * parents of children newly diagnosed with cancer, within 2 to 4 weeks post-diagnosis. * siblings of children newly diagnosed with cancer, within 2-4 weeks post-diagnosis, between the ages of 8 years and 16 years, able to complete outcome measures, without a physical chronic condition. * children with cancer, newly diagnosed, within 2 to 4 weeks post-diagnosis, between the ages of 8 and 16 years, able to complete outcome measures. exclusion criteria: * parents of children not diagnosed with cancer. * sibling of children not diagnosed with cancer * children not diagnosed with cancer.

Keywords: psychosocial screening, quality of life
viral infections in chronic obstructive pulmonary disease (copd) exacerbations

Conditions: Pulmonary Disease, Chronic Obstructive; Respiratory Tract Infections; Virus Diseases; Lung Diseases, Obstructive

Summary: the objectives of the study are * to determine the prevalence of respiratory virus infections in copd patients, during and outside acute exacerbation * to explore the impact of these viral infections on the outcome of these patients * to explore the association between blood procalcitonin levels and viral infections in this population.

background chronic obstructive pulmonary disease (copd) is a leading cause of morbidity due to repeated exacerbations. the impact of viral infections during and outside copd exacerbations is poorly understood and there is only scarce data on the role of new biological markers of infection for the management of copd exacerbations. objectives of the project the investigators aim to 1. describe the epidemiology of viral infections in patients admitted with an exacerbation of their copd; 2. explore the evolution of viral infections outside exacerbations; 3. analyze the impact of viral infections on clinical outcomes; 4. explore the role of biological markers (crp, procalcitonin) for the diagnosis and prognosis of viral infections. methods the investigators will prospectively follow-up 100 patients admitted with an acute exacerbation of their copd. virological samples will be obtained at admission and at 3 months, to explore the evolution outside episodes of acute exacerbation. clinical information will be obtained after one-year follow-up. samples will be tested by rt-pcr for 15 respiratory viruses. the impact of viral infections and the role of biological markers will be explored using univariate and multivariate cox proportional hazard models.

Eligibility criteria:
inclusion criteria: * all consecutive patients known or suspected for moderate to very severe copd and admitted in the emergency center for an acute exacerbation of their copd * age above 18 years * we plan to include 100 patients with a complete work-up and follow-up * written informed consent will be obtained from every participant exclusion criteria: * patients requiring oro-tracheal intubation * patients unable to give their informed consent due to their clinical condition * other obvious cause of dyspnea (pulmonary embolism, acute pulmonary edema, lobar pneumonia) * patients suffering from bronchiectasis, asthma, pulmonary fibrosis and mineral dust pneumoconiosis * patients with a history of active tuberculosis * patients with a history of ischemic cerebral stroke and subsequent deglutition dysfunction

Keywords: procalcitonin acute exacerbation rt-pcr biological markers
a study of the safety and efficacy of pimavanserin in patients with parkinson's disease psychosis

Conditions: Parkinson's Disease Psychosis

Summary: the purpose of this study is to evaluate the safety and efficacy of 40 mg pimavanserin compared to placebo in patients with parkinson's disease psychosis (pdp).


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of parkinson's disease with a minimum duration of 1 year * presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening * psychotic symptoms must have developed after parkinson's disease diagnosis was established * subjects that are on anti-parkinson's medication must be on a stable dose for 1 month prior to study day 1 (baseline) and during the trial * subject that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 1 month prior to study day 1 (baseline) and must remain stable during the trial * the subject is willing and able to provide consent * caregiver is willing and able to accompany the subject to all visits * subject and caregiver are willing and able to adequately communicate in english for the purposes of the primary assessment exclusion criteria: * subject has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of parkinson's disease including, but not limited to, schizophrenia or bipolar disorder * subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat parkinson's disease * subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder * subject has had a myocardial infarction in last six months * subject has any surgery planned during the screening, treatment or follow-up periods patients will be evaluated at screening to ensure that all criteria for study participation are met. these evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).
japan statin treatment against recurrent stroke (j-stars)

Conditions: Ischemic Stroke

Summary: although hyperlipidemia is not always the risk factor of stroke, inhibition of 3-hydroxy-3-methylglutaryl-coenzyme a(hmg-coa) reductase can decrease the incidence of stroke in the patient with ischemic heart disease. the neuroprotective mechanism beyond cholesterol lowering should be expected to attenuate inflammation and atherosclerosis. the present study hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with safety.


Eligibility criteria:
inclusion criteria: * ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset * hyperlipidemia and total cholesterol level of 180-240mg/dl without the prescription of statin within previous 30 days * able to visit outpatient department * informed consent on the form. exclusion criteria: * ischemic stroke of other determined cause according to the toast classification * ischemic heart disease and necessary to use statin * hemorrhagic disorders * platelet count \<=100,000/ul within 3 months prior to study start * alanine aminotransferase (alt) or aspartate aminotransferase (ast)\>= 100iu/l within 3 months prior to study start * serum creatinine \>=2.0mg/dl within 3 months prior to study start * a scheduled operation * the presence of malignant disorder

Keywords: stroke brain ischemia cerebrovascular accident statin hydroxymethylglutaryl-coa reductase inhibitors cholesterol hypercholesterolemia hyperlipidemia multicenter studies prospective studies endpoint determination randomized controlled trials recurrence pravastatin
phase i : cediranib in combination with lomustine chemotherapy in recurrent malignant brain tumour

Conditions: Recurrent Glioblastoma; Brain Tumor

Summary: this is a phase i, open-label, multi-centre study designed to assess the safety and tolerability of cediranib in combination with lomustine in patients with primary recurrent malignant brain tumour.


Eligibility criteria:
inclusion criteria: * primary recurrent malignant brain tumour for whom lomustine would be standard therapy - diagnosis \& stage * patients received no more than 2 previous systemic chemotherapy regimes * life expectancy \> 12 weeks * patients must be at least 3 months from the completion of cranial radiation therapy exclusion criteria: * history of poorly controlled high blood pressure * recent major surgery prior to entry into the study

Keywords: cancer tumor advance solid tumour glioblastoma malignant brain tumour
tanezumab in osteoarthritis of the hip or knee (2)

Conditions: Osteoarthritis

Summary: test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis


Eligibility criteria:
inclusion criteria: * osteoarthritis of the hip or knee according to kellgren-lawrence x-ray grade of 2 exclusion criteria: * pregnancy or intent to become pregnant * bmi greater than 39 * other severe pain, significant cardiac, neurological or psychiatric disease

Keywords: monoclonal antibody rn624 pf-04383119 nerve growth factor anti-nerve growth factor oa pain arthritis
epidemiologic registry pethema lma 2013

Conditions: AML

Summary: epidemiologic and retrospective multicenter registry of all patients diagnosed with de novo or secondary aml in the pethema group institutions. this study is a non-interventional research regarding diagnosis and therapeutic approach

to perform this registry, every patient diagnosed with aml in the participant institutions, regardless type of aml and treatment administered, must be reported. it will be required to registry the main characteristics of the patients and aml at diagnosis, as cytomorphologic, immunophenotypic, and cytogenetic results, according to the habitual practice of the centers. the treatment which has been administered by every center of the pethema group, even when it is considered as supportive care, and evolution of the disease will also be reported (relapse o death). pethema group will input all the reported information in data bases with the appropriate security.

Eligibility criteria:
inclusion criteria: patients diagnosed with acute myeloid leukemia exclusion criteria: no exclusion criteria

Keywords: aml
the effect of dbcare, a food supplement on diabetes control

Conditions: Diabetes Mellitus, Non-insulin Dependant; Diabetes Mellitus Type 2; Diabetes Mellitus, on Oral Hypoglycemic Treatment; Adult Type Diabetes Mellitus

Summary: dbcare is a herbal food supplement that has been used over the years in india as a "traditional"anti-diabetic formula.dbcare was not tested controlled trials in humans, yet.we intend to test the ability of dbcare to improve blood sugar level control in patients with uncontrolled diabetes.

study design: prospective, randomized, single-blind, placebo-controlled trial inclusion criteria: men and women (older than 18 years old) with type 2 diabetes and inadequate glycemic control, defined by hba1c 8% ³ £10%. previous medications include any oral hypoglycemic agents, as monotherapy or in combination. concurrent lipid-lowering, anti-hypertensive and other medications are allowed exclusion criteria (before the study): type 1 diabetes mellitus pregnant or lactating women insulin treatment 3 months prior to study entry creatinine \>2 mg/dl abnormal liver function tests got\>x2 or gpt\>x2 the upper normal limit unstable anginal syndrome congestive heart failure (nyha class i-iv) inability to follow study instructions including low compliance exclusion criteria (during the study): severe hypoglycemia (less than 50 mg%) or any hypoglycemic event requiring intravenous glucose infusion number of patients: 30 patients (drug) 30 patients (placebo) design: four out-patient visits, at enrollment and every month thereafter at enrollment (visit 1) physical examination will be performed and a full set of blood tests will be withdrawn at 1 week (visit 2) adjustment of hypoglycemic medications will be done and full chemistry and blood count will be taken at 6 weeks (visit 3) adjustment of hypoglycemic medications will be done and full chemistry and blood count will be taken at 12 weeks (visit 4), the end of the study, physical examination will be performed and a full set of blood tests will be withdrawn on the 2nd 3rd and 4th visits pill-count will be performed glucose monitoring: patients will be asked to monitor fasting glucose levels at home, in the morning, on a daily basis drugs: identical drug containing/ placebo capsules drugs for a month will be given in each monthly visit dose: 2 tablets three times daily

Eligibility criteria:
inclusion criteria: * adults \>18y * with type 2 diabetes mellitus and inadequate glycemic control * hba1c \>8 \<10 * previous medications include oral hypoglycemic medications,as monotherapy or in combination exclusion criteria: * type 1 diabetes mellitus * pregnant or lactating women * insulin treatment 3 months prior to study entry * creatinine \>2 * abnormal liver function test got\>2 or gpt\>2 the upper limit of norm * unstable anginal syndrome * congestive heart failure nyha 1-4 * inability to follow study instructions

Keywords: diabetes mellitus herbal treatment food supplement
factors predicting postoperative cesarean section pain

Conditions: Postoperative Pain

Summary: in spite of identical analgesic protocols, parturients suffer different levels of pain postoperative lay. in this study we hope to identify factors which influence the perception of pain including preoperative anxiety, sleep quality and local anesthesia injection pain.


Eligibility criteria:
inclusion criteria: * women undergoing spinal anesthesia exclusion criteria: * women unable to cooperate * women undergoing general anesthesia

Keywords: cesarean section pain wound hyperalgesia
pharmacogenomic study (adjuvant chemotherapy)

Conditions: Gastric Cancer

Summary: to assess the role of germline polymorphisms in xenobiotic metabolism genes in toxicity profile. to assess the role of germline polymorphisms in genes associated with dna repair, p53 tumor suppressor gene and angiogenesis pathway in predicting recurrence and survival in gastric cancer patients treated with adjuvant chemotherapy.


Eligibility criteria:
inclusion criteria: * gastric cancer patients treated with adjuvant chemotherapy exclusion criteria: