Kornimate/medical-research-clean huggingface dataset:
arginine-stimulated indication of early outcome after islet transplantation

Conditions: Islets of Langerhans Transplantation; Diabetes Mellitus; Chronic Pancreatitis

Summary: through islet transplantation, functional β-cell mass can be restored. allogeneic islet transplantation is a treatment modality for a select group of patients with complicated type 1 diabetes mellitus. for patients undergoing (partial) pancreas resection, autologous islet transplantation may help prevent complicated diabetes. up until now, no studies have been performed on early islet graft function in the first week after transplantation. early graft function may be a predictor for estimating long-term islet graft success. arginine can excite β-cells to release insulin. it can thus provide an estimate of β-cell secretory capacity and can be used as an alternative to (oral) glucose tolerance tests. in this study, we aim to find a predictor model for islet graft function by assessing peak c-peptide after arginine stimulus in the early post-transplantation phase.


Eligibility criteria:
inclusion criteria: * age 16 years or older * currently on the lumc waiting list for allogeneic or autologous islet transplantation * willing to use a flash glucose monitoring (fgm) system in the two weeks prior to transplantation exclusion criteria: * patients who are pregnant * patients with known hypersensitivity to arginine

Keywords: total pancreatectomy autologous islet transplantation tpiat beta-cell function c-peptide arginine mixed meal tolerance test allogeneic islet transplantation islet function ibmir
autologous bone marrow stem cells in ischemic stroke.

Conditions: Stroke, Acute; Infarction, Middle Cerebral Artery

Summary: the aim of the study is to determine the safety and tolerability of an autologous cd34+ subset bone marrow stem cell infusion into the middle cerebral artery in patients who have suffered acute total or partial anterior circulation syndrome (tacs/pacs).

the proposed trial will involve the recruitment of a total of 10 patients. the cells will be collected from each subject recruited, via bone marrow sampling. cd34+ stem cells will then be isolated and harvested during a process of immuno-selection in accordance with the principles of good manufacturing practice. the cd34+ cells will then be directly infused into the area of the stroke intra-arterially using the middle cerebral artery. initially, the investigator will monitor each patient for a period of 6 months post-stem cell infusion. thereafter, they will revert to their previous treatment regime in the clinic. assessment of adverse events will be by physical examination and measurement of laboratory parameters. assessment of efficacy will be by physical examination and the measurement of laboratory, ct and mri parameters.

Eligibility criteria:
inclusion criteria: * symptoms and signs of clinically definite acute stroke * time of stroke onset is known and treatment can be started within 7 days of onset * ct or mri brain scanning has reliably excluded both intracranial haemorrhage and structural brain lesions which can mimic stroke (e.g. cerebral tumour) * the stroke is severe and conforming to the tacs phenotype (weakness, homonymous hemianopia and a focal cognitive deficit (e.g. aphasia) or reduction in consciousness) or pacs phenotype (two out of the three tacs criteria) * an age range of 30-80 years old * stroke confined to mca territory on ct or mri brain imaging * nihss score \>/= 8 exclusion criteria: * known defect of clotting or platelet function (but patients on anti-platelet agents can enrol) * haematological causes of stroke * severe co-morbidity * hepatic or renal dysfunction * the patient is female and of childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding * hypo- or hyperglycaemia sufficient to account for the neurological symptoms; the patient should be excluded if their blood glucose is \ 20.0mmol/l * patient is likely to be unavailable for follow-up e.g. no fixed home address * patients with evidence of life threatening infection (e.g. hiv) or life threatening illness (e.g. advanced cancer) * patient was already dependent in activities of daily living before the present acute stroke * patients who have been included in any other clinical trial within the previous month

Keywords: stroke middle cerebral artery
phase 2 study of azacitidine (vidaza) vs mgcd0103 vs combination in elderly subjects with newly diagnosed acute myeloid leukemia (aml) or myelodysplastic syndrome (mds)

Conditions: Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome (MDS)

Summary: the purpose of the study is to determine how effective azacitidine, mgcd0103, and the combination of azacitidine and mgcd0103 are in treating aml or mds in people over 60 years of age.

this randomized, 3-arm phase 2 study will compare the safety and efficacy of single-agent azacitidine (currently 1 of 3 approved treatments for myelodysplastic syndrome \[mds\]) to that of single-agent mgcd0103 and to that of combination therapy with mgcd0103 and azacitidine in elderly patients with acute myelogenous leukemia (aml) or intermediate-2 (int-2) or high-risk mds, for whom no standard of care exists. the goal of the study is to determine which of the 3 treatment arms are worthy of further investigation in a subsequent phase 3 study of elderly subjects with aml or int-2 or high-risk mds.

Eligibility criteria:
inclusion criteria: * able to provide written informed consent, and be willing and able to comply with all the study procedures * must be 60 years of age or older * must have a pathologic confirmation of newly diagnosed (de novo or untreated secondary) aml or newly diagnosed int-2 or high-risk mds (ipss classification) according to who criteria * must have a eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 * must have adequate organ function, including total bilirubin ≤ 1.5 x upper limit of normal (uln); ast \& alt ≤ 2.5 x uln; and serum creatinine ≤ 2.0 x uln. exclusion criteria: * considered fit for intensive chemotherapy and opt to be treated with intensive chemotherapy * prior transplantation or any prior anticancer therapy (standard or investigational, including chemotherapy, treatment with hdac inhibitors, or combination hdac and azacitidine) administered to treat aml or mds. * clinical evidence of central nervous system (cns) involvement by leukemia * a diagnosis of promyelocytic leukemia * previous or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry * active and uncontrolled clinically significant infection * known positive serology for hepatitis b surface antigen (hbsag), hepatitis c antibody (hcv ab) or human immunodeficiency virus (hiv) * less than 4 weeks elapsed since any major surgery * any prior or active disease that may interfere with the procedures or evaluations to be conducted in the study

Keywords: acute myeloid leukemia myelodysplastic syndrome azacitidine vidaza mgcd0103 histone deacetylase inhibitor dna methyltransferase inhibitor epigenetic therapy
improving implementation of lung cancer screening in diverse populations ii

Conditions: Early Detection of Cancer; Lung Cancer

Summary: this project assesses the feasibility, appropriateness, and acceptability of a "commonly asked questions after lung cancer screening" (caq) informational document that the investigators created, resulting from patient and provider discussion in focus groups and interviews. if effective, the caq may be a new tool to help improve patient understanding of lcs results and adherence to follow-up recommendations.

barriers to optimal implementation of lung cancer screening (lcs) include low levels of patient knowledge. patient understanding of lcs results may alleviate distress and improve understanding of recommendations. the investigators developed a "commonly asked questions after lcs" (caq) information sheet based on gaps in knowledge identified by patient focus groups and provider interviews. the study objective was to assess caq appropriateness and acceptability, and preliminary impact on patient understanding and distress after receiving lcs results. the investigators conducted a pilot alternating intervention controlled trial of the caq. all patients in the university of washington/seattle cancer care alliance lcs program who underwent baseline or annual lcs were received a mailing within one week of their scan, either: 1) usual care: a brief form letter with screening results; or 2) usual care plus the caq (intervention). the mailing assignment was alternated weekly. mailed follow-up surveys assessed appropriateness and acceptability of caq as well as lcs knowledge in the intervention group. primary outcomes include: 1) ratings of "i understand the results of my most recent lcs ct scan" on a likert scale; 2) correct self-report of next step based on lung-rads standardized follow-up; 3) symptoms of distress (measured by ies); as well as 4) measures of acceptability and appropriateness. secondary outcomes include responses to 6 questions regarding lung cancer screening knowledge.

Eligibility criteria:
inclusion criteria: * has undergone lcs or is referred for lcs * able to give informed consent exclusion criteria: * cognitive or language limitations (i.e., expressive language limitations, non-english speaking * known malignancy other than non-melanoma skin cancer

Keywords: lung cancer screening low-dose chest ct scan
a single-center prospective interventional study on fpg500 in non-metastatic prostate cancer patients

Conditions: Prostate Cancer

Summary: the search for clinically actionable alterations within the non-metastatic prostate cancer setting has been an overlooked issue so far. genomic alterations predicting tumor progression or representative of micrometastatic spread could be crucial to prompt the correct treatment strategy, sequencing and possible intensification in the high-risk and locally advanced settings. similarly, the definition of the genomic landscape in low-risk patients progressing to more aggressive disease could be of importance to prompt an immediate active treatment to those patients otherwise eligible to active surveillance. a cgp program has been launched by the fondazione policlinico universitario agostino gemelli irccs (fpg), a leading italian research hospital (id: fpg500, ethical approval number 3837) and it convers 10 cancer types. this program offers genomic testing of over 500 genes through an efficient in-house process. to now, a cgp from fpg 500 has been applied to cholangiocarcinoma, endometrial cancer, non-small cell lung cancer. investigators propose a prospective interventional single center study whose aim is to implement a comprehensive genome profiling (cgp) through this next generation sequencing (ngs) program for non-metastatic pca and to define actionable mutations that correlate with tumor progression. the actionability relies on the opportunity to intensify treatment in non metastatic cases at risk of progression or to identify distant spread before it becomes biochemically and/or radiographically evident for high risk non metastatic cancers. from previous research, a genomic profiling may reveal distinct mutations or gene expression patterns linked to metastasis, biochemical recurrence, and psa persistence. some of these genomics alterations may be associated with poorer outcomes in high-risk and locally advanced patients. conversely, patients under active surveillance might exhibit a more stable genomic profile, with fewer mutations representative of aggressive disease. expected outcomes will include the development of accurate prognostic tools, allowing for better-tailored treatment plans and early intervention strategies to manage disease progression.


Eligibility criteria:
inclusion criteria: * histologically proven diagnosis of low-risk, or high-risk or locally advanced prostate cancer * high-risk and locally advanced prostate cancer undergoing surgery * low-risk prostate cancer undergoing active surveillance or surgery exclusion criteria: * previous or concomitant malignancies * patients already undergoing androgen suppression or other medical treatments for prostate cancer
vascular reactivity assessment by the angiodefender device -- a precision study

Conditions: Cardiovascular Diseases

Summary: the objective of this study is to define the repeatability and reproducibility of quantifying flow-mediated dilation (fmd) of the brachial artery (ba) using the angiodefender (ad) methodology. repeatability will be assessed by repeat ad testing of the same subject 1 hour apart, using the same ad device and operator. reproducibility will be assessed by comparing fmd scores obtained for the same subject, but using different ad devices and operators.


Eligibility criteria:
inclusion criteria: 1. men and women, ≥18 years old 2. eastern cooperative oncology group/zubrod score performance status of 0, 1, or 2, determined within 7 days prior to fmd testing on study day 1 (visit 1) 3. written informed consent understood and signed; understanding of study procedures and ability to comply with them for the length of the study exclusion criteria: 1. body mass index (bmi) \>50 kg/m2 2. mid-upper arm circumference of arm selected for fmd testing \ 42 cm 3. sinus arrhythmia, atrial fibrillation, atrial flutter, multifocal atrial tachycardia, frequent (\>1 per 10-sec strip) premature atrial or ventricular contractions (isolated, non-isolated, or alternating), documented by 12-lead ecg with rhythm strip at the time of subject screening. 4. clinical signs and/or symptoms of active viral or bacterial infections 5. resting muscle tremor or inability to remain still for the duration of the testing period 6. systolic blood pressure (sbp) at rest of \>170 mmhg or diastolic blood pressure (dbp) at rest of ≥110 mmhg. 7. diabetic subjects - type i or ii 8. previous intolerable adverse reaction(s) to vascular testing using an upper extremity occlusive pneumatic cuff

Keywords: flow-mediated dilation angiodefender device precision repeatability reproducibility cardiovascular diseases
study of biostate for treatment of children with hemophilia a complicated by antibody development

Conditions: Hemophilia A

Summary: this is a clinical study to investigate how well biostate works in treatment of male patients below the age of 12 years who have a clotting factor deficiency that is aggravated by the development of antibodies. the antibodies are directed against the clotting factor that is given for replacement therapy and usually make therapy unsuccessful. the treatment used in this study is called immune tolerance therapy.


Eligibility criteria:
inclusion criteria: * male subjects diagnosed with haemophilia a (≤ 2% fviii level in the absence of factor replacement, according to their medical history). * age 28 days to \<12 years. * subject is eligible for immune tolerance induction (iti) therapy exclusion criteria: * the subject has received iti previously. * subjects with a historical peak inhibitor titre of ≥ 200 bu/ml. * concomitant treatment with drugs with immunosuppressive side effects (eg, systemic corticosteroids), azathioprine, cyclophosphamide, high dose immunoglobulin or the use of a protein a column or plasmapheresis and interferons. * high risk of cardiovascular, cerebrovascular, or other thromboembolic events (excluding catheter thrombosis) as judged by the investigator. * subjects who are human immunodeficiency virus (hiv)-1 or hiv-2 positive (as reported in the medical records or determined at screening).
pediatric obesity related metabolite profile and gut microbiota

Conditions: Obesity, Childhood

Summary: in this study, the investigators aimed to observe changes in the gut microbial composition before and after the weight-loss intervention, including dietary control and exercise, in obese children. the main metabolites produced by gut microbiome, short chain fatty acids (scfas) will be also analysed. the investigators will analyse the change of gut microbiome composition and metabolites related with weight-loss intervention and the relationship between microbiome composition and metabolites.

many recent studies have suggested that dysbiosis of the gut microbiome might related to obesity. there is growing evidence that the composition of gut microbiome changes in childhood obesity compared to normal-weight children, and it is attracting attention as an adjustable environmental factor in obesity treatment. it has been reported that gut microbiome could be changed due to environmental influences such as diet and exercise. in this study, the investigators aimed to observe changes in the gut microbial composition before and after the weight-loss intervention, including dietary control and exercise, in obese children. the main metabolites produced by gut microbiome, short chain fatty acids (scfas) would be also analysed to investigate the relationship with gut microbiome and with weight-loss intervention. intervention is not performed for normal-weight children, and samples from normal-weight children will be used as a control for gut microbiome and biochemical tests.

Eligibility criteria:
inclusion criteria: * obese children: children ≥95 ‰ * non-obese children: 5‰\<bmi \<85 ‰ exclusion criteria: * taking antibiotics, probiotics, or steroids for a month before visit * taking probiotics-like products including yogurt for seven days before visit * having enteritis symptoms including diarrhea for a month before visit * chronic heart disease, chronic bowel disease, chronic liver disease, chronic kidney disease, endocrine disease, genetic diseases or congenital metabolic disorder

Keywords: microbiome metabolome
comparison of carvedilol and atenolol on anti-anginal and metabolic effects in patients with stable angina pectoris

Conditions: Stable Angina Pectoris

Summary: there are few data regarding anti-anginal effects between beta-blockers with and without vasodilating property. beta-blocker without vasodilating property is generally known to have unfavorable effects on glucose and lipid metabolism. therefore, the investigators compared carvedilol and atenolol on anti-anginal and metabolic effects in patient with stable angina pectoris.

previous studies have demonstrated that beta-blockers are effective in reducing not only ischemia but also cardiovascular mortality following myocardial infarction. and, recent guidelines have suggested the potential for use of beta-blockers as first-line agents in chronic stable angina. however, beta-blockers are a diverse class with different mechanisms of action and physiological effects. various pharmacologic properties that characterize beta-blockers include cardioselectivity, intrinsic sympathomimetic activity, and concomitant vasodilating alpha-adrenoceptor blockade, which might exhibit differential anti-anginal efficacies. in addition, traditional beta-blockers, particularly nonvasodilating beta-blockers, have been reported to have negative metabolic effects, including hyperglycemia, insulin resistance, and dyslipidemia. these unfavorable effects of beta-blockers should be considered in patients with stable angina pectoris, because the pathophysiology of coronary artery disease is associated with abnormalities in glucose and lipid metabolism. carvedilol, a newer vasodilating beta-blocker, has been shown to differ from traditional beta-blockers in terms of metabolic effects in patients with hypertension and diabetes. however, few data regarding comparative anti-anginal and metabolic effects between beta-blockers with and without vasodilating property have been reported, particularly in patients with angina pectoris. in this study, we simultaneously compared anti-anginal and metabolic effects of carvedilol and atenolol in patients with stable angina pectoris.

Eligibility criteria:
inclusion criteria: * stable angina pectoris who had a positive exercise treadmill test according to the american college of cardiology foundation and the american heart association guidelines exclusion criteria: * acute coronary syndrome * coronary revascularization within the past 3 months * asthma or chronic obstructive lung disease * bradycardia (heart rate \< 55 beat/min) * history of severe adverse reaction to beta-blockers * symptomatic arrhythmia requiring anti-arrhythmia therapy * heart failure * severe renal or hepatic failure

Keywords: beta-blockers anti-anginal effect lipid metabolism glucose metabolism
tms for improving response inhibition in adolescents with ocd

Conditions: Obsessive-Compulsive Disorder

Summary: the study will examine whether inhibition of the pre-supplementary motor area (psma) using transcranial magnetic stimulation (tms) normalizes activity in psma-connected circuits, improves response inhibition, and reduces compulsions in adolescents with ocd.


Eligibility criteria:
inclusion criteria: * age 13-18 years * presence of ocd, as indicated by score on the children's yale-brown obsessive-compulsive scale * patient and one parent speak english fluently (to ensure comprehension of study measures and instructions * right-handed * if taking psychotropic medications, these have been stable for \> 6 weeks and are expected to remain stable for the approximately 3-week study protocol * if currently in psychotherapy, symptom improvement has plateaued (no improvement in the past 6 weeks and symptoms expected to remain stable for the approximately 3-week study protocol) exclusion criteria: * • medical conditions contraindicated for tms or eeg, including history of intracranial pathology, increased intracranial pressure, epilepsy or seizures, traumatic brain injury, brain tumor, stroke, implanted medical devices, possible pregnancy (female of childbearing age not using effective contraception), or any other serious medical condition (note that medical history will be reviewed by a study physician prior to tms administration) * metal in the head, except mouth (e.g., cochlear implant, implanted brain stimulators, aneurysm clips) * active suicidality or psychosis * existing diagnosis of bipolar disorder, autism spectrum disorder, mental retardation, or cognitive disability * substance abuse or dependence * taking a stimulant medication (and unwilling to forgo on study visit days) * taking medication with the potential to lower seizure threshold (e.g., neuroleptics, antipsychotics) * patient is a ward of the state * family history of epilepsy * history of syncope