Kornimate/medical-research-clean huggingface dataset:
a real-world analysis of concomitant medication use among metastatic breast cancer patients treated with cdk4/6 inhibitors

Conditions: Metastatic Breast Cancer

Summary: this is a retrospective cohort study to assess the real-world analysis of concomitant medication use among metastatic breast cancer patients treated with cdk4/6 inhibitors utilizing the us optum research administrative claims database.

this is a retrospective cohort study utilizing the us optum research administrative claims database. adult female patients who had hr+/her2- mbc were identified and included in the study. these patients were stratified into three cohorts based on the first cdk4/6i received (ribociclib, palbociclib, or abemaciclib). * study period: period during which all relevant medical and pharmacy information in the database was retrieved * index event identification period: time frame during which index treatment was identified * first cdk4/6i: the date on which patients initiated their first treatment after being diagnosed with hr+/her2- mbc; this date was considered as the index date * baseline period: time frame during which patient characteristics, prior mbc treatments, and concomitant treatments received by cdk4/6i-naïve patients were evaluated * follow-up period: time frame on and after the index date during which patients' treatments and dosing patterns were observed establishment of baseline period health plan enrollment in the three months prior to the index treatment was included in the baseline period. patient demographics, clinical characteristics, national cancer institute (nci) comorbidity index, concomitant medication use that can potentially lead to a ddi, and other bc treatments prior to the index treatment were evaluated during this period. establishment of follow-up period patients were observed for ≥3 months starting from the index date until the end of the study period or continuous enrollment or until the time when patients switched to another therapy (including another cdk4/6i), whichever came first. dosing patterns for cdk4/6i were evaluated in the follow-up period. analyses were conducted at key time points of 3, 6, and 12 months

Eligibility criteria:
inclusion criteria: * treated with cdk4/6i from 2015-02-01 to 2019-06-30 * ≥2 claims with a bc diagnosis recorded ≥30 days apart from the index date * ≥2 claims with an mbc diagnosis, with a time interval between the first bc diagnosis date and the first mbc diagnosis date no longer than 30 days * female patients aged ≥18 years * continuous health plan enrollment for ≥3 months prior to the index date and ≥3 months post-index date exclusion criteria: * none

Keywords: concomitant medication, drug-drug interaction, cdk4/6 inihibitor, hr+/her2-metastatic breast cancer
study to examine the effect on glucose control and safety/tolerability of exenatide given two times a day to subjects with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this open label study is designed to assess long term glucose control, as measured by hemoglobin a1c (hba1c) and to evaluate long term safety and tolerability in subjects with type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a day.


Eligibility criteria:
inclusion criteria: * the subject has an hba1c value \<=11.0% * the subject has a body mass index (bmi) of 25 kg/m\^2 to 45 kg/m\^2, inclusive exclusion criteria: * is currently treated with certain medications, including exogenous insulin

Keywords: exenatide diabetes amylin exendin-4
evaluating pegasus - a group intervention for young people with an autism spectrum disorder

Conditions: Efficacy of PEGASUS

Summary: when a clinician gives an autism spectrum disorder (asd) diagnosis they hope this will be helpful to the person receiving it and their family. in reality children with an asd describe few benefits to receiving this diagnosis - they often report feeling confused and stigmatised by it. parents can also struggle to understand their child's diagnosis and report needing greater support from professionals in this respect (midence \& o'neill, 1999; osborne \& reed, 2008). little is known about how to help children and families integrate their asc 'label' in a positive way. whilst there is anecdotal evidence that psychoeducation after diagnosis can help, there has been no formal evaluation of this approach and no evidence-based programmes of this type are available. in the current study the investigators aim to test empirically a psychoeducational programme for children with an asd ('pegasus'), using a randomised controlled design. the investigators aim to evaluate whether this psychological and educational intervention impacts positively upon understanding of asc, self-esteem, functional adaption, well-being and family functioning.


Eligibility criteria:
inclusion criteria: 1. received an asd diagnosis from child and adolescent psychiatrist, clinical psychologist or paediatrician. 2. aware of asd diagnosis. 3. aged between 9 and 14 years. 4. able to function in group setting, as evidenced in educational context. 5. speaks english exclusion criteria: 1. no generalised intellectual disability as indicated by iq below 65. 2. not engaged in additional formal psychosocial intervention during study period. 3. not taking psychiatric medication at baseline assessment, or taking a stable dose of psychiatric medication expected to remain constant throughout study participation.

Keywords: autism spectrum disorder; psychoeducation
evaluation of functional mri and dti (imaging techniques) in children with epilepsy and focal brain lesions

Conditions: Epilepsy

Summary: this study is being done to look at the relationship between brain structure and brain function in patients with epilepsy or focal brain lesions (abnormal areas) that require surgery. this study will look at an imaging technique called magnetic resonance imaging (mri) for looking at the brain. specifically, the study will look at functional mri, which is an imaging technique that can map brain function by taking pictures of the brain as it performs different tasks such as reading, thinking, or moving a body part and diffusion tensor imaging (dti), which will look at brain structure. these types of imaging may help us learn more about different areas of the brain and how those areas of the brain are used in children with epilepsy. we plan to study 30 children with epilepsy.


Eligibility criteria:
inclusion criteria: * children with intractable epilepsy exclusion criteria: * children requiring sedation for scanning

Keywords: mri, fmri, epilepsy, pediatric
no3-rich beet juice and exercise on postmenopausal women cardiovascular health

Conditions: Arterial Hypertension; Postmenopausal; Menorrhagia; Cardiovascular Diseases

Summary: in the context of physical exercise, there is no evidence of the acute and continued use of beetroot juice with a previously recommended dose of nitrate (no3) (\>300mg) on the cardiovascular performance of hypertensive and postmenopausal women. we will investigate the effects of beetroot juice rich in no3 acutely (first day: 140ml/800mg) and during a week with daily doses (second to the seventh day: 70ml/400mg) on blood pressure, heart rate (hr), cardiac autonomic control, ef, inflammatory, hormonal, and stress biomarkers oxidative stress and enzymes involved in nitric oxide synthesis and mitochondrial regulation, under resting conditions, as well as mediated by submaximal aerobic exercise sessions. through a randomized, crossover, triple-blind, placebo-controlled clinical trial, 20 physically inactive hypertensive women will undergo an acute and 7-day trial, each with two intervention protocols: 1) placebo and 2) beetroot; in which will ingest beet juice with or without no3 in its composition with a 7-day washout interval. on collection days, exercise will be performed on a treadmill for 40 minutes at a speed corresponding to 65-70% of vo2peak. the collection of variables (cardiovascular, autonomic, and blood samples for molecular analyses) of the study will take place at rest (120 minutes after ingestion of the intervention), during exercise (40 minutes), and in the effort recovery stage (during 65 minutes) based on previously validated protocols. the collections were arranged so that the measurement of one variable does not interfere with the other and that they have adequate intervals between them.


Eligibility criteria:
inclusion criteria: * women with 50 to 65 old years; * physically inactive; * postmenopausal diagnosis (amenorrhea for 12 months or more); * arterial hypertension diagnosis (previously); * systolic blood pressure values \>120mmhg up to 159mmhg and diastolic blood pressure values \>80mmhg up to 99mmhg. exclusion criteria: * previous history of acute myocardial infarction and/or stroke; * allergy or intolerance to nitrate, gluten, or milk; * medications (proton pump inhibitors, beta-blockers, calcium channels antagonists).
exercise training effects on cognition and brain function in multiple sclerosis: project exact

Conditions: Multiple Sclerosis; Cognitive Impairment

Summary: cognitive impairment is highly prevalent, poorly-managed, and disabling in persons with ms and exercise training might represent a promising approach to manage this symptom of the disease. the proposed study aims to examine the effects of 3-months of supervised, progressive (both intensity and duration) treadmill walking exercise training (designed based on pilot work and american college of sports medicine guidelines) compared with an active control condition (i.e., stretching-and-toning activities) on cognitive processing speed and functional mri outcomes in 88 cognitively-impaired persons with ms. this study is critical for providing evidence supporting treadmill walking exercise training as a behavioral approach for managing slowed cognitive processing speed (i.e., the most common ms-related cognitive impairment) and improving brain health in persons with ms.


Eligibility criteria:
all participants will: * be between the ages of 18-65 * have a clinically definite ms diagnosis based on established criteria * be fully-ambulatory based on expanded disability status scale (edss) scores between 0-4.0 * demonstrate slowed cps based on initial sdmt scores at least 1 sd below the regression-based normative score for healthy controls (i.e., 16th percentile) * be relapse-free and will not have acutely taken corticosteroids for at least 30 days (i.e., relative neurologic stability) * not have a history of major depressive disorder, schizophrenia, bipolar disorder i or ii, or substance-abuse disorders. * not be taking medications that can affect cognition (e.g., antipsychotics, benzodiazepines). * be right-handed * have corrected vision better than 20/80 * not have known/diagnosed cardiovascular, metabolic, or renal disease. individuals with known/diagnosed cardiovascular, metabolic, or renal disease who are asymptomatic will be included only with a physician's approval. * demonstrate scores on the mini-mental state examination (mmse) of 21 or higher (no decisional impairment) * be on a stable disease-modifying therapy regimen (i.e., at least 6 months prior to study enrollment). * have a low risk for contraindications for mri based on not having metal (e.g., non-mri compatible aneurysm clips, metal shards in the body or eyes, or recently placed surgical hardware) or electronic devices (e.g., pacemaker, cochlear implant) within the body. * not be pregnant * not be engaging in ≥ 150 min of moderate-to-vigorous physical activity (i.e., not meeting public health guidelines for physical activity) per week * not be actively engaging in cognitive rehabilitation, or participating in regular brain fitness activities * demonstrate systolic blood pressure values of \< 200 mmhg or diastolic blood pressure values \< 110 mmhg at rest
a study that will evaluate ketogenesis and glucose-dependent insulin secretion methodologies in healthy male subjects (mk-0000-159)(completed)

Conditions: Obesity

Summary: this study will test the hypotheses that a single dose of oxyntomodulin (oxm) will be neutral or better than placebo in lowering ambient glucose levels during a graded glucose infusion (ggi) and that a single dose of oxm will lead to a statistically significant increase in the sum of the plasma βohb + acac levels compared to placebo.


Eligibility criteria:
inclusion criteria: * subject is judged to be in good health based on medical history, physical examination, and laboratory safety tests * subject has a body mass index of ≥27 kg/m\^2 and ≤35 kg/m\^2 and weighs ≥70 kg at the prestudy (screening) visit * subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months * subject is willing to avoid strenuous physical activity (weight lifting, running, bicycling, etc.) for the duration of the study exclusion criteria: * subject is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit * subject has a history of stroke, chronic seizures, or major neurological disorder * subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases * subject has irritable bowel disease, or recurrent occurrences of nausea, vomiting, diarrhea, or abdominal pain * subject has a history of hypertension requiring treatment * subject has a history of cancer * subject has history of diabetes, or family history of diabetes mellitus * subject has a history of hypersensitivity to oxm or hemaccel

Keywords: ketogenesis glucose-dependent insulin secretion graded glucose infusion oxyntomodulin
learning in stroke

Conditions: Stroke; Sensorimotor Impairment

Summary: after a stroke, plasticity occurs in the brain from microscopic to network level with positive but also negative consequences for functional recovery. why post-stroke plasticity takes a beneficial or a maladaptive direction is still incompletely understood. because the biological mechanisms underlying sensorimotor learning parallel those observed during recovery, learning mechanisms could be potential modifiers of post-stroke neuroplasticity and have a discrete mal-/adaptive impact on the recovery of sensorimotor function. this project seeks to further the understanding of the link between brain circuits that control the integration of new information during procedural learning in the injured brain and those circuits that are involved in adaptive plastic changes during recovery of sensorimotor function post-stroke. the project's methodological approach will allow the characterization of procedural learning-related neural network dynamics based on functional magnetic resonance imaging (mri) in human volunteers with and without neurologically impairment post-stroke. through multivariate integration of behavioral and biological descriptors of sensorimotor recovery, the project will investigate the association between motor learning-related network dynamics and descriptors of recovery.


Eligibility criteria:
inclusion criteria for all participants: * adult volunteers (age ≥18 years) * right-hand dominance as defined by the edinburgh handedness inventory stroke-specific inclusion criteria: * ischemic or hemorrhagic lesion * subcortical or cortical tissue involvement * chronic phase (\>6 months) after their index lesion * voluntary whole-hand grip force (mrc, medical research council scale for muscle force ≥2) * repeated release (standardized as a reduction of 50% of maximum voluntary contraction measured with a dynamometer) exclusion criteria for all participants: * presence of any mri risk factors * substance use disorder * psychotic disorders stroke-group specific exclusion criteria: * primary intracerebral hematoma * subarachnoid hemorrhage * bi-hemispheric or cerebellar strokes * other concomitant neurological disorders affecting upper extremity motor function * documented history of dementia before or after stroke * severe aphasia, particularly of receptive nature (nihss language subsection ≥2), affecting their ability to understand the purpose of the study and give informed consent * uncontrolled hypertension despite treatment * intake of tricyclic anti-depressants or neuroleptic medication.

Keywords: procedural learning maladaptive plasticity
the efficacy of auto-cross linked hyaluronic acid gel in the prevention of adhesion reformation after hysteroscopic resection of retained products of conception

Conditions: Retained Products of Conception

Summary: retained product of conception (rpoc) is defined by abnormal trophoblastic persistence or retained placenta inside the uterus cavity after a pregnancy independently of the outcome. untreated rpoc can compromise future fertility. rpoc are generally treated surgically, either by repeated evacuation or by hysteroscopy, which exposes the uterus to additional potential trauma.the combination of trauma to the gravid uterine cavity, hypoestrogenic state at the time of the operation or immediately afterward and local infection is considered to be the pathogenic mechanism of intrauterine adhesions (iua) , manifested clinically by menstrual abnormalities, infertility and recurrent pregnancy loss.to investigate the efficacy of auto-cross linked hyaluronic acid gel in the prevention of adhesion reformation after hysteroscopic resection of retained products of conception. after the completion of hysteroscopic resection of retained products of conception, patients will be randomized to one of the two groups by computer-generated numbers: \[1\] infusing auto-cross linked hyaluronic acid gel into intrauterine cavity in the experimental group; \[2\] no auto-cross linked hyaluronic acid gel into intrauterine cavity in the control group. second and third look outpatient hysteroscopy will be performed 4 and 8 weeks after the initial surgery. the patients will be followed up about menstrual pattern at 3 months after the surgery.the patients will be followed up about pregancy outcome at 12 months after the surgery.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of retained products of conception * written consent obtained exclusion criteria: * patients with severe complications of medicine and surgery * acute or chronic genital tract inflammation * no understanding or approving the randomized controlled trial

Keywords: retained products of conception hysteroscopy intrauterine adhesion auto-crossed-linked hyaluronic acid gel
l-leucine in diamond blackfan anemia patients

Conditions: Diamond Blackfan Anemia

Summary: diamond-blackfan anemia (dba) is a rare congenital syndrome associated with physical anomalies, short stature, red cell aplasia, and an increased risk of malignancy. mutations affecting genes encoding ribosomal proteins cause dba. genetic studies have identified heterozygous mutations in at least one of eight ribosomal protein genes in up to 50% of cases. 25% of patients carry a mutation in the ribosomal protein (rp)s19 gene, whereas mutations in rps24, rps17, rpl35a, rpl11, and rpl5 are rare. p53 activation has been identified as a key component in the pathophysiology of dba after cellular and molecular studies. other potential mechanisms that warrant further investigation include impaired translation as the result of ribosomal insufficiency, which may be ameliorated by leucine supplementation. despite significant improvements in understanding of the pathophysiology of diamond blackfan anemia (dba), there have been few advances in therapy. the cornerstones of treatment remain corticosteroids,chronic red blood cell transfusions, and hematopoietic stem cell transplantation, each of which is fraught with complications. other treatments have been shown to be effective in only a few patients or in individual case reports : il-3, cyclosporine (alone or in combination with steroids), metaclopramide. gene therapy is still a part of research programs. there are some indications that the amino acid (aa) l-leucine, a translation enhancer, may have some efficacy in dba and 5q-syndrome, which has the same altered ribosome functions as the dba. l-leucine is an essential aa that is unique among the branched-chain aa acting as a nutrient regulator of protein synthesis in skeletal muscle and adipose tissue. several preclinical studies with dba lymphocytes exposed to various l-leucine doses, have demonstrated that protein synthesis can be increased by using high doses l-leucine. recent clinical data on l-leucine therapeutic use have demonstrated increase the hemoglobin level and transfusion independence in patients with dba and 5q-syndrom. these data support the rationale for clinical trial on l-leucine use as a therapeutic agent for dba patients.

experimental: one arm l-leucine , dose- 700mg/m2 , per os, 3 time a day, 6 months

Eligibility criteria:
inclusion criteria: * signed informed consent form * diagnosed diamond blackfan anemia * transfusion dependenсe * adequate renal function * adequate liver function * negative b-hcg and adequate contraception exclusion criteria: * known hypersensitivity to branched chain amino acids * diagnosed aa metabolism disorder * prior hsct * pregnancy or planning to become pregnant
frailty index and geriatric assessment in predicting toxicity to front-line chemotherapy in treating patients with stage iv non-small cell lung cancer

Conditions: Recurrent Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Summary: this phase ii trial is studying how well a frailty index and geriatric assessment works in predicting toxicity to front-line chemotherapy in treating patients with stage iv non-small cell lung cancer. a frailty index and geriatric assessment prior to treatment may help identify a better treatment regimen

primary objective: i. to determine the correlation of the data from the frailty index and geriatric assessment tool with the level of toxicity encountered in the first two cycles of therapy. outline: patients complete a frailty index and geriatric assessment prior to beginning chemotherapy. patients receive standard-of-care chemotherapy comprising carboplatin intravenously (iv) and paclitaxel iv on day 1. treatment repeats every 21 days for up to 2 courses.

Eligibility criteria:
inclusion criteria: pathological documentation of non-small cell lung cancer stage iv disease prior adjuvant chemotherapy for the earlier stages of non-small cell lung cancer is allowed patients with brain metastases are allowed on protocol only if they have received brain irradiation and are neurologically stable patients with other malignancies are allowed on protocol unless they are receiving active treatment (surgery, radiation, chemotherapy or immunotherapy) for the other malignancy ability to understand and the willingness to sign a written informed consent document exclusion criteria: prior palliative chemotherapy pregnant and/or lactating women prior radiation therapy other than brain irradiation for brain metastases
participants preferences to disease modifying agents in relapsing remitting multiple sclerosis condition

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: this multi-center non-interventional, observational, cross-sectional study in adult participants with relapsing remitting multiple sclerosis (rrms) will evaluate the participants' preferences for disease modifying treatments (dmt) in routine clinical practice.


Eligibility criteria:
inclusion criteria: * participants aged greater than or equal to (\>/=) 18 years * participants who have a diagnosis of rrms as documented in their medical records * participants who have been prescribed a dmt for at least 3 months * participants who have an expanded disability status scale (edss) score of 1-6 points exclusion criteria: - participants with any personal or medical condition that in opinion of the investigator would interfere with or make impossible proper participation in the study