Kornimate/medical-research-clean huggingface dataset:
pilot study of biomarkers and cardiac mri as early indicators of cardiac exposure following breast radiotherapy

Conditions: Breast Cancer

Summary: patients with breast cancer receive low doses to smaller volumes of the heart, but they also have an excellent long-term survival, so it is crucial to study the effects of low dose radiotherapy. indeed, a recent study suggests that these effects can be seen within the first 5 years after treatment, and that there is no dose threshold. the investigators wish to develop imaging and blood biomarkers of cardiac exposure, as a first step to identifying patients at increased risk for cardiac effects. these patients can then be targeted for close monitoring and early intervention, potentially with statins or ace inhibitors. additionally, by characterizing a time-course and radiation dose-volume relationship, potentially real-time modifications can be made to radiotherapy (rt) field design for patients sensitive to rt effects. finally, this information can be incorporated into better designs of treatment plans for future patients.

radiotherapy plays an integral role in breast cancer therapy. multiple randomized studies have demonstrated decreased local-regional recurrence rates and decreased breast-cancer mortality. however, balanced with this survival benefit is the potential toxicity of the treatment itself. in particular, cardiac effects of radiotherapy have been a concern and an area of research for the past 20 years. from long-term follow up of patients with lymphoma, it is known that radiotherapy can lead to increased risk of myocardial infarction, valvular dysfunction, systolic and diastolic function abnormalities, and heart failure among cancer-survivors. patients with breast cancer receive lower doses to smaller volumes of the heart, but they also have an excellent long-term survival, so it is crucial to study the effects of low dose radiotherapy. indeed, a recent study suggests that these effects can be seen within the first 5 years after treatment, and that there is no dose threshold. the investigators hypothesize that they can develop imaging and blood biomarkers of cardiac exposure, as a first step to identifying patients at increased risk for cardiac effects. these patients can then be targeted for close monitoring and early intervention, potentially with statins or ace inhibitors. additionally, by characterizing a time-course and radiation dose-volume relationship, potentially real-time modifications can be made to rt field design for patients sensitive to rt effects. finally, this information can be incorporated into better designs of treatment plans for future patients.

Eligibility criteria:
inclusion criteria: * patients who will receive radiotherapy as treatment for left-sided breast cancer * patients must understand and be willing to sign an informed consent form approved for this purpose by the institutional review board (irb) of the university of michigan medical center indicating that they are aware of the investigational aspects of the treatment and the potential risks. exclusion criteria: * patients with a contraindication to contrast-enhanced mri
pharmacists and pharmacy technicians to improve admission medication history accuracy

Conditions: Adverse Drug Events

Summary: we tested two interventions to improve the accuracy of medication histories obtained at hospital admission. the interventions target elderly and chronically ill patients prone to erroneous medication histories and resultant medication errors. for targeted patients, we tested the effect of using pharmacists and pharmacy technicians to obtain an initial medication history. this was studied using a randomized controlled trial of usual care (which involves nurses and physicians) vs usual care + pharmacists vs usual care + pharmacy technicians to obtain an admission medication history. the overarching hypothesis was that by leveraging pharmacists and pharmacy technicians we can minimize admission medication history errors and related downstream events.

importance: admission medication history (amh) errors frequently cause medication order errors and patient harm. objective: to quantify amh error reduction achieved when pharmacy staff obtain amhs before admission medication orders (amo) are placed. design: three-arm randomized clinical trial. setting: large hospital with community and trainee physicians. population: 306 enrolled patients with complex medical histories. interventions: in one intervention arm, pharmacists, and in the second intervention arm, pharmacy technicians obtained initial amhs prior to admission. they obtained and reconciled medication information from multiple sources. all arms, including the control arm, received usual amh care. this included common process variation occurring in: accuracy of pre-existing medication histories; nurses' ability to obtain amhs at hospital admission; and admitting physicians' efforts to verify and order from prior amhs. main outcomes and measures: the primary outcome was severity-weighted mean amh error score. to detect amh errors, all patients received reference standard amhs, which were compared with intervention and control group amhs. amh errors and resultant amo errors were independently identified and rated by ≥2 investigators as significant, serious or life-threatening. each error was assigned 1, 4 or 9 points, respectively, to calculate severity-weighted amh and amo error scores for each patient.

Eligibility criteria:
inclusion criteria: * accessed via ehr, were: \>=10 chronic prescription medications * history of acute myocardial infarction or congestive heart failure * admission from skilled nursing facility * history of transplant, or active anticoagulant, insulin, or narrow therapeutic index medications. exclusion criteria:(supersedes inclusion criteria) * admitted to pediatric, trauma or transplant services with pharmacists

Keywords: adverse drug events
lactoferrin versus ferrous sulfate in iron-deficiency during pregnancy

Conditions: Iron Deficiency Anemia

Summary: the main drawbacks with oral iron are side-effects, poor compliance, and limited absorption from the gut. it has become very apparent gastrointestinal intolerance with oral iron therapy is dose related and common (up to 20% of patients), and this frequently leads to poor compliance. lactoferrin (formerly known as lactotransferrin) is a glycoprotein, and a member of a transferrin family, thus belonging to those proteins capable of binding and transferring iron. it represents an attractive and promising alternative to ferrous sulphate oral administration as pregnant women receiving lactoferrin did not experience any adverse effects. this study aims to compare between lactoferrin and ferrous sulphate for therapy of iron deficiency in pregnant women.


Eligibility criteria:
inclusion criteria: * pregnant women with single fetus. * second trimester (14-20weeks of gestation). * normal hemoglobin level: more than10g\\dl. * serum ferritin less than 15 mcg / l exclusion criteria: * other type than iron-deficiency anemia (thalassemia, hemolytic anemia ... etc.) * any other chronic diseases (bronchial asthma, renal or hepatic, hematological or cardiovascular diseases ... etc.) * having hypersensitivity to iron preparations. * treatment with any other iron preparation in the last month. * history of peptic ulcer, oesophagitis or hiatal hernia. * medical disorders with pregnancy. * need for alternative parenteral route to blood transfusion when rapid increase is required (perioperative anemia-severe anemia in late pregnancy-postpartum anemia) . * bleeding in early pregnancy. * refusal to participate in the study. * family history of thalassemia-sickle cell anemia or malabsorption syndrome. * recent blood transfusion. * inflammatory bowel disease as intolerance of oral therapy but tolerated to parenteral route.
intervention for self-regulation to physical exercise in people with fibromyalgia

Conditions: Fibromyalgia

Summary: this work is part of a broader research with women with fibromyalgia. the aim of this study is to establish the effectiveness of implementation intentions to manage the preference for avoiding pain and fatigue and stop walking exercise, versus to maintain the approximate behavior (walking), taking into account high and low pain catastrophizing conditions.

fibromyalgia is a widespread and diffuse musculoskeletal chronic pain problem not associated with inflammatory or degenerative changes, often accompanied by fatigue and sleep problems, in addition to anxiety, depression and cognitive dysfunction. its prevalence in europe for adults is estimated at 2.5% with a higher proportion of women. the treatment incorporates physical activity and exercise as one of its therapeutic aims has shown positive effects on health outcomes.however, it has been reported that women with fibromyalgia are less active than others with similar socio-demographic characteristics.theories of behavioral self-regulation that taking into account motivational and volitional processes (implementation intentions) provide a conceptual framework to work with the incorporation and maintenance of the exercise, helping these people to create strong goals and handle the different self-regulation problems that can arise. these include the ones related to the preference for avoidance goals (pain or fatigue avoidance) against performing or keep doing an activity (walking exercise). this work searches to help women with fibromyalgia to manage the above mentioned inhibitors to incorporate and maintain long-term physical exercise walking. we consider the heterogeneity of people with fibromyalgia in pain catastrophizing, which makes necessary to adapt interventions aimed to promote physical exercise. we expect participants with high catastrophizing and implementation intentions to control the preference for avoiding pain or fatigue will walk more time than the other conditions.

Eligibility criteria:
inclusion criteria: * women with fibromyalgia attended the fibromyalgia unit of the valencian community (hospital of san vicente del raspeig, alicante) * within the age limits exclusion criteria: * comorbidity that prevents walking * those related to the 6mwt application protocol

Keywords: fibromyalgia walking exercise implementation intentions self-regulation pain catastrophizing women
prematurity prevalence among t1d patients and its characteristics compared with premature-born non-diabetic patients

Conditions: Type 1 Diabetes Mellitus

Summary: the aims of this study are: 1. to assess the prevalence of prematurity, especially early prematurity, among t1d patients, and compare it to the prematurity prevalence among the non-diabetic general population in israel. 2. to characterize epidemiological and clinical factors that differ between premature-born patients that developed t1d and those that have not, including the nutritional and therapeutic properties in nicu.

a national cohort study, including linkage of data from 13 pediatric diabetes centers and israeli national registries, including all patients with t1d born during 1990-2013. data collected includes: ethnicity, gestational age, birth season, age and season at t1dm diagnosis, and presence of autoimmunity in family. the prevalence of prematurity among t1d is compared to the non-diabetic general population registry of 2000-2013. additional comparisons are between t1d patients born term and preterm, aimed to unveil specific influencing clinical and epidemiological factors. in the latter part of the study, a multi-centered, paired case-control study is performed. preterm born t1d patients will be paired to matched non-diabetic children at a ratio of 3:1, according to medical center, sex, gestational week of birth, season and year of birth. data collected includes: ethnicity, family history of autoimmune diseases, age and type of first enteral nutrition, and pharmacological exposures.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with t1d 2. patients treated in one of the 13 participating centers 3. for the case-control portion of the study, all children born between 1.1.1990-31.12.2013 and admitted to nicu medical centers that have been included in the original cohort portion 4. patients for whom a complete medical record is available exclusion criteria: 1. lack of birth data 2. unknown type of diabetes 3. for case control portion, an incomplete medical record/inadequate documentation

Keywords: premature birth risk factor type 1 diabetes mellitus seasonality prevalence enteral feeding immunomodulating medications early onset
effect of short-term basal insulin initiation in newly diagnosed type 2 diabetes on 1-year glycemic control

Conditions: Type2diabetes

Summary: in this study, we aim to explore the beneficial effect of early short-term (two weeks), self-titrated, basal-only insulin therapy on the degree of glycemic control over 1-year follow through a prospective cohort.

despite the development of new drugs and therapeutic strategies for treating type 2 diabetes mellitus (t2dm), achieving long-term glycemic control remains a challenge. results from the united kingdom prospective diabetes study (ukpds) suggest that deterioration of glycemic control can be largely attributed to progressive β-cell loss, irrespective of the nature of pharmacological intervention. therefore, treatments that can preserve or improve β-cell function are of great interest in the field of t2dm therapeutics. some studies have shown that short-term intensive insulin therapy in patients newly diagnosed with t2dm produces beneficial effects on β-cell function, glycemic control, and rate of remission within 1 year. however, these studies applied complex regimes for insulin initiations that require frequent follow-up and are difficult to accept as initial therapy for t2dm.

Eligibility criteria:
inclusion criteria: (must have) * newly diagnosed type 2 diabetes mellitus on no glucose-lowering drugs and * either hemoglobin a1c equal to or more than 9% and/or random blood glucose equal to or more than 300 mg/dl. exclusion criteria: * patients with type 1 diabetes mellitus, * urine ketone dipstick + and above at baseline or anytime throughout the study. * pregnancy. * current or recent steroid use. * history of coronary heart disease and heart failure. * gfr less than 60 ml/min/1.73 m2.
effects of exercise intensity on adhd symptoms

Conditions: Attention Deficit Disorder with Hyperactivity; Attention Deficit Hyperactivity Disorder; ADHD

Summary: this project investigates the effects of a bicycling exercise at three levels of exercise intensity (low, moderate, and high) on attention deficit/hyperactivity disorder (adhd) in college students. specifically, the outcomes of interest in this study are self-reported executive functioning, self-reported functional impairment, and adhd symptom severity. the hypothesis is that exercise will improve executive functioning, while reducing functional impairment and adhd symptom severity, and that this response will be most pronounced in the high-intensity exercise group.


Eligibility criteria:
inclusion criteria: diagnosis of attention deficit/hyperactivity disorder (adhd) age 18-16 student at kent state university exclusion criteria: seizures/epilepsy syncope asthma chronic obstructive pulmonary disease (copd) restrictive lung disease adult respiratory distress syndrome (ards) heart problems/defects/heart failure/valve problems liver/kidney disease diabetes mellitus current pregnancy
the importance of ghrelin for glucose metabolism after sleeve gastrectomy

Conditions: Bariatric Surgery Candidate; Glucose Metabolism Disorders

Summary: the overall aim is to delineate the contribution of ghrelin to glucose tolerance after sleeve gastrectomy. the hypothesis is that decreased concentration of ghrelin after sg is of importance for improved insulin secretion and glucose tolerance seen after sg. the expectation is therefore that infusion of ghrelin will impair insulin secretion and glucose tolerance compared with a control day without ghrelin infusion.

roux-en-y gastric bypass (rygb) and sleeve gastrectomy (sg) are bariatric procedures. overwhelming evidence support bariatric surgery as the most effective treatment for severe obesity and related metabolic comorbidities, particularly type 2 diabetes mellitus. the mechanisms of improved glycaemic control after sg are not fully understood and differ from those of rygb. interestingly, there is demonstrated a markedly lower secretion of the orexigenic hormone ghrelin after sg compared with both rygb and unoperated obese controls. hence, the decreased level of ghrelin could be of major importance in relation to the improved glucose tolerance after sg. ghrelin is secreted from the gastric mucosa in the fasting state and decreases in response to food intake. administration of exogenous ghrelin reduces insulin sensitivity and glucose tolerance in healthy humans and contributes to hyperglycaemia. in accordance, ghrelin receptor knockout in mice improves glucose sensitivity and enhances glucose-stimulated insulin secretion. on this background the investigators hypothesize that the markedly reduced secretion of ghrelin after sg could therefore be of particularly importance for the improved glucose tolerance after this procedure. this present study is complementary to an on-going study in sg operated subjects, where the role of ghrelin for appetite and insulin secretion during a mixed meal followed by an ad libitum meal are investigated. in the present study the effect of ghrelin on insulin secretion and insulin sensitivity is thoroughly investigated using methods eliminating the effect of other hormones on glucose metabolism. ghrelin will be infused in physiological doses aiming for plasma concentration after sg resembling the pre-operative plasma concentrations. specific aim is to evaluate the effect of ghrelin on both alpha and beta cell function as well as on liver and peripheral insulin sensitivity in individuals with sg using matched controls. the subjects will be investigated with both glucose and glycerol tracers, ivgtt and a hyperinsulinemic euglycaemic clamp.

Eligibility criteria:
inclusion criteria: * sleeve gastrectomy-operated \> 12 months prior to inclusion * weight stable (+/- 3 kg during the last 3 months) * fasting glucose \< 7,0 mmol/l / hba1c \< 48 mmol/mol pre- and postoperative * signed written informed consent exclusion criteria: * pregnancy or breastfeeding. * haemoglobin \< 6,5 mm.

Keywords: ghrelin gastric sleeve glucose metabolism
comparison of two types of family therapy in the treatment of adolescent anorexia nervosa

Conditions: Anorexia Nervosa

Summary: this study will compare the effectiveness of two different family treatments for the treatment of adolescent anorexia nervosa.

the long-term objective of this study is to enhance the treatment and outcome of anorexia nervosa (an). research on the treatment of an has lagged that of other conditions, even other eating disorders such as bulimia nervosa. the focus of this study is on adolescent an. successful early treatment is likely to reduce the prevalence of chronic an with its high rates of morbidity and mortality and high health care costs. the most promising treatment for adolescent an is a specific form of family therapy called behavioral family therapy (bft). this treatment is focused on the disordered eating behavior that characterizes an and enables parents to refeed their child. although there have been several small scale studies of bft there has been no controlled comparison with another form of family therapy. therefore we propose to use systems family therapy (sft) which has been developed to represent the type of family therapy practiced in the community. one hundred and sixty adolescents of both genders aged 12-18 years meeting dsm-iv criteria for anorexia nervosa will be entered to the study. recruitment is projected to extend for 2 years. participants will be randomly allocated to one of the two types of family therapy. family therapy will be given for 36-weeks. for the purpose of the present study, patients will be followed for 12-months after the end of family treatment. hence, each family will participate for approximately 2-years, with a total participation time of some 40-hours. in a sub-study blood will be drawn from those volunteering for genetic analysis focusing on the subset of non-responders to treatments.

Eligibility criteria:
inclusion criteria:diagnosis of anorexia nervosa with ideal body weight \>75% exclusion criteria:current psychotic illness or mental retardation that would prohibit the use of psychotherapy medically unstable for outpatient treatment

Keywords: anorexia nervosa adolescents family therapy
bcma-cd19 ccar in multiple myeloma and plasmacytoid lymphoma

Conditions: Multiple Myeloma in Relapse; Refractory Multiple Myeloma; Plasmacytoid; Lymphoma

Summary: this is a phase i, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of bcma-cd19 ccar in patients with relapsed and/or refractory multiple myeloma and plasmacytoid lymphoma.

bcma-cd19 ccar is a compound chimeric antigen receptor (ccar) immunotherapy with two distinct functional car molecules expressing on a t-cell, directed against the surface proteins bcma and cd19. bcma-cd19 ccar is also aimed to treat multiple myeloma, a challenging disease due to the heterogeneity of myeloma cells, which renders single-antigen targeting car t-cell therapy ineffective. bcma-cd19 ccar is proposed to target both bulky myeloma cells expressing bcma, and myeloma stem cells expressing cd19 to effectively eradicate the disease. bcma-cd19 ccar is also aimed to treat heterogeneous plasmacytoid lymphoma bearing two types of lymphoma cells, regular lymphoma cells expressing cd19 and plasmacytoid lymphoma cells expressing bcma. the use of two different targets intends to increase coverage and eradicate cancerous cells before resistance develops in surviving cancer cells that have undergone selective pressures or antigen escape.

Eligibility criteria:
inclusion criteria: * signed written informed consent; patients volunteer to participate in the research * diagnosis is mainly based on the world health organization (who) 2008 * patients have exhausted standard therapeutic options * systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks * female must be not pregnant during the study exclusion criteria: * patients declining to consent for treatment * prior solid organ transplantation * potentially curative therapy including chemotherapy or hematopoietic cell transplant * prior treatment with bcmaxcd3 or cd19xcd3 bispecific agents

Keywords: bcma cd19 bcma-cd19 ccar t cells multiple myeloma plasmacytoid lymphoma
a study of experimental medication bms-986235 in healthy subjects

Conditions: Mediators of Inflammation

Summary: this is a study of experimental medication bms-986235 in healthy subjects.


Eligibility criteria:
inclusion criteria: * patients must be normal healthy volunteers as determined by no clinically significant deviations in medical history, physical examination, ecgs, vital signs, and clinical laboratory determinations * patients must have a body mass index (bmi) of 18 - 30 mg/kg2, inclusive exclusion criteria: * patients that are pregnant * patient with any significant acute or chronic medical illness * patient with a current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption * patient with any surgery within 12 weeks of study treatment administration * patient with any gastrointestinal surgery that could impact upon the absorption of study drug * patient who donated blood to a blood bank or in a clinical study (except a screening visit) within 12 weeks of study drug administration (within 2 weeks for plasma only) * patient who received a blood transfusion within 12 weeks of study drug administration other protocol defined inclusion/exclusion criteria apply