Kornimate/medical-research-clean huggingface dataset:
acetylcholine iontophoresis as a new challenge with type 2 diabetic peripheral neuropathy: a possible new therapy

Conditions: Type 2 Diabetes Mellitus; Peripheral Neuropathy

Summary: the investigators initial study opened the way for randomized trials that monitor the effects of acetylcholine (ach) iontophoresis vasodilators on endothelial nitric oxide synthetase (nos) to develop a transdermal treatment that is effective, free from systemic adverse effects.

the investigators studied endothelial-mediated microvascular blood flow in neuropathic diabetic patients to determine the association between endothelial regulation of the microcirculation and the expression of endothelial constitutive nitric oxide synthetase (nos). as a result, the nerve fibers can become damaged. once the nerves have been damaged they cannot repair themselves. material and methods: a group of 80 patients (male and female) diagnosed as type 2 diabetes mellitus, will be included in the study their age ranged from 40-60 years. patients randomly will be divided into two groups: study groups (a) 40 patients type 2 diabetes mellitus with clinically proved peripheral neuropathy. and control group (b) 40 patients with asymptomatic type 2 diabetes mellitus. they were selected from south valley university hospitals. group (a) receive iontophoresis by acetylcholine with (15) min for three sessions per week for four weeks. also the investigators followed up study group (a) one month of aerobic exercises in form of 15 minute walking, bicycling, or swimming, and the investigators reevaluated nitric oxide level. group (b) received shame iontophoresis with (15) min for three sessions per week for four weeks.

Eligibility criteria:
inclusion criteria: * patients have to be symptomatically stable with type 2 diabetes mellitus complicated with peripheral neuropathy. * optimized pharmacological treatment that will be remained unchanged throughout the study. exclusion criteria: * implanted cardiac pacemakers. * patients with known skin allergies. * presence of skin inflammations. * peripheral vascular disease.

Keywords: acetylcholine iontophoresis diabetic neuropathy electrophysiological investigations nitric oxide type2 diabetes mellitus aerobic exercises
artificial intelligence to improve cardiometabolic risk evaluation using ct scans

Conditions: Pre-diabetes; Diabetes Mellitus

Summary: to validate the ability of the fathealth algorithm to identify individuals with pre-diabetes and with type 2 diabetes mellitus

this multicentre prospective study will evaluate the ability of the fathealth technology to correctly identify individuals with pre-diabetes and diabetes, validating the technology against the current gold-standard diagnostic method, oral glucose tolerance testing. participants will be individuals who have undergone a ct scan of the chest (coronary ct angiogram \[ccta\] or ct chest) as part of observational cohort studies. participants will be invited for an oral glucose tolerance test (ogtt), which is the current gold-standard method for detecting pre-diabetes and diabetes mellitus. all patients must have an evaluable ogtt. the study population will include: 1. approximately 90 individuals who had a ccta as part of their clinical care (45 identified as having an abnormal fathealth algorithm calculation and 45 with a normal fathealth algorithm calculation) will undergo ogtt which is evaluable; and 2. approximately 90 individuals who had a chest ct as part of their clinical care (45 identified as having an abnormal fathealth algorithm calculation and 45 with a normal fathealth algorithm calculation) will undergo ogtt which is evaluable.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. male or female, aged 18 to 80 years. * body mass index (bmi) ≥ 25kg/m2 * fathealth status assessed as the following: * elevated fathealth status (50% of participants) * non-elevated fathealth status (50% of participants) exclusion criteria: * participant is unable or unwilling to give informed consent * participant is unable to understand english language * confirmed diagnosis of diabetes mellitus treated with oral medication or insulin
refining the role of mid-induction bone marrow biopsy in acute myeloid leukemia: a pilot study

Conditions: Acute Myeloid Leukemia

Summary: the purpose of the study is to observe the outcomes of patients with acute myeloid leukemia who do not receive an immediate second round of chemotherapy after undergoing a standard mid-induction bone marrow biopsy.

this will be a pilot study that will include patients with aml receiving intensive induction therapy with 7+3 +/- a third agent (for any actionable cytogenetics or mutations). all patients will have a planned mid-induction bone marrow assessment as standard of care. all patients will subsequently be observed for count recovery, regardless of bone marrow results and in the absence of peripheral blood disease proliferation, and an end of induction bone marrow biopsy will be performed either at count recovery or between days 28 and 42 in the absence of count recovery. patients with complete remission (cr) will proceed to consolidation chemotherapy as determined by the treating investigator. patients with refractory disease will proceed to further therapy as determined by the treating investigator. all patients will be followed for long-term outcomes.

Eligibility criteria:
inclusion criteria: 1. adult male or female, age ≥18 2. patients with newly diagnosed aml (de novo or secondary), treated with intensive induction chemotherapy (7+3+/-3rd agent). the 3rd agent will be midostaurin for flt3-mutant aml or gemtuzumab ozogamicin for core-binding factor aml. patients on clinical trial with an investigational agent added to 7+3, may be enrolled on the protocol after discussion between the investigators and medical monitors. 3. prior use of hypomethylating agents, lenalidomide, erythropoiesis stimulating agents and growth factors as allowed for treatment of myelodysplastic syndrome. prior treatment for aml is not allowed. 4. cardiac function: ejection fraction \>50-55% 5. adequate organ function for receipt for induction chemotherapy 6. patients with hiv and hepatitis b or c should have controlled disease. 7. females of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment. exclusion criteria: 1. any other active malignancy requiring treatment or with expected survival ≤1 year. 2. recipients of prior allogeneic stem cell transplant. 3. patients with psychiatric illness or social situation that would limit compliance with the study requirements. 4. patients with active cns disease 5. patients with apl 6. received any investigational drugs within the 14 days prior to the first day of induction 7. pregnant and/or breastfeeding
clinic-based financial coaching and family health and development

Conditions: Economic Problems; Development, Child; Quality of Life

Summary: this study will examine the impact of clinic-based financial coaching on parent health-related quality of life and child development measures, as well as family social needs for families with young children receiving pediatric care at a primary care practice in the los angeles county safety net.

with an expert group of researchers, financial coaches, and implementation scientists, we will study the impact of clinic-based financial coaching on parent health-related quality of life, child developmental risk, and social needs.we will conduct a clinical randomized controlled trial of financial coaching for low-income families. parents of infants in a large pediatric primary care safety-net clinic will receive either 1) financial coaching from trained coaches plus social needs screening and resource navigation at all well child visits (intervention) or 2) social needs screening and navigation alone (active control) and will be followed for two years. aims include: 1a) examine parent outcomes of overall health-related quality of life (primary parent outcome); 1b) examine child outcomes of developmental risk scores (primary child outcome) and well-child visit adherence; 1c) examine family social needs outcomes including incidence of any food insecurity, housing instability, transportation or utilities interruptions (primary family outcome any one or more); and financial metrics.

Eligibility criteria:
inclusion criteria: * parents/caregivers in families with children 4 months or under at enrollment receiving care at harbor-ucla medical center clinic. exclusion criteria: * cognitive impairment or not speaking english or spanish.
an effectiveness and safety study of elmiron (pentosan polysulfate sodium) for the treatment of chronic non-bacterial inflammation of the prostate gland

Conditions: Prostatitis

Summary: the purpose of this study is to evaluate the safety and effectiveness of elmironâ® in the treatment of chronic non-bacterial inflammation of the prostate gland.

the objective of this randomized, double-blind, placebo-controlled study is to determine the effectiveness and safety of elmiron® 100 mg three times per day for 12 weeks, as compared with placebo, in patients with chronic non-bacterial inflammation of the prostate gland. safety evaluations will be assessed throughout the study. the hypothesis of the study is that elmiron® will be more effective than placebo, as based on the change in the total national institutes of health chronic prostatitis symptom index (nih-cpsi) score from baseline to the final visit (week 12) and is generally well-tolerated. patients will receive oral elmiron® 100 mg three times per day orally or matching placebo three times per day for 12 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic non-bacterial prostatitis/chronic pelvic pain syndrome * symptoms of discomfort or pain in the perineal and/or pelvic region (lower abdomen) for at least three of the last six months for which there is no recognized cause * symptoms persist despite treatment with antibiotics for non-bacterial prostatitis in the past six months. exclusion criteria: * clinically significant medical problems or other organ abnormalities * psychiatric disorders * urinary tract infection during the last three months * history of bladder, urethral or prostate cancer * prostate specific antigen (psa) greater than or equal to 4 ng/ml * diagnosis or treatment for genital herpes or herpes flare within the last year.

Keywords: prostatitis elmiron pentosan polysulfate sodium
precise treatment of prediabetes and stage 1 hypertension

Conditions: Diabetes

Summary: to identify the occurrence of diabetes, hypertension, cardiovascular and cerebrovascular events and all-cause death in patients with baseline prediabetes and stage1 hypertension after 18 years follow up. to identify whether one or several metabolites can be used as serum markers to judge the prognosis of patients with prediabetes and stage1 hypertension, and to establish the evaluation model of metabolites for the prognosis.

to identify the occurrence of diabetes, hypertension, cardiovascular and cerebrovascular events and all-cause death in patients with baseline prediabetes and stage1 hypertension after18 years follow up, then explore the role of risk factors. after assessing the association between bp categories and all-cause mortality and cardiovascular mortality, to analyze the risk for all-cause and cardiovascular mortality by blood glucose categories and bp categories combined by using multiple cox regression analysis. to analyze the corresponding incidence of all-cause mortality per 1,000 person-years for the bp\<130/80 mmhg, 130-139/80-89 mmhg, and ≥140/90 mmhg or treated groups respectively after adjusting for age, sex, and other factors. to identify the associations between cardiovascular mortality and bp categories alone or combined with blood glucose categories were consistent with that of all-cause mortality. to identify relative metabolic molecular biomarker panel detected by mass spectrometry in blood samples correlating with efficacy in prediabetes and stage 1 hypertension among chinese adults. compare the plasma metabolic profiles of different groups and the metabolic markers were screened and optimized by multivariate statistical analysis, logistic regression analysis and receiver operating characteristic (roc) curve analysis. to determine whether one or several metabolites can be used as serum markers to judge the prognosis of patients with prediabetes and stage1 hypertension, and to establish the evaluation model of metabolites for the prognosis.

Eligibility criteria:
inclusion criteria: 1. aged from 18-76 years old 2. lived in shanghai pingliang community for 20 years 3. all participants' blood pressures are at baseline exclusion criteria: 1. aged \ 76 years old 2. with second primary malignant diseases. 3. other situations assessed by investigator can disturb quality control of the investigation.

Keywords: 130-139/80-89 mmhg all-cause mortality cardiovascular mortality glucose metabolism chinese
transplant-related mortality in patients undergoing a peripheral blood stem cell transplantation or an umbilical cord blood transplantation

Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome

Summary: study cr-air-006 is a part of the atir clinical development plan and will provide control data for patients treated with atir in clinical studies (e.g. study cr-air-007).


Eligibility criteria:
inclusion criteria: * any of the following hematologic malignancies: * acute myeloid leukemia (aml) in remission at the time of the transplantation * acute lymphoblastic leukemia (all) in remission at the time of the transplantation * myelodysplastic syndrome (mds) * patient received any of the following transplantations: * allogeneic t-cell depleted hsct without atir administration from a haploidentical donor between 1 january 2006 and 30 june 2013 (haplo group) * allogeneic hsct from a fully matched or 1-locus mismatched unrelated donor between 1 january 2010 and 31 december 2012 (mud/mmud groups) * double umbilical cord blood transplantation between 1 january 2010 and 31 december 2012 with no more than 2 human leukocyte antigen (hla)-mismatches at hla-a, b, and/or -dr between each of the units and the recipient (ucb group) * male or female, age ≥ 18, ≤ 65 years. exclusion criteria: * allogeneic stem cell transplantation prior to the transplantation qualifying for the study.

Keywords: haploidentical donor unrelated donor umbilical cord blood graft versus host disease transplant-related mortality hematologic malignancy hematopoietic stem cell transplantation
impact of a multidisciplinary intensive management clinic on outcomes in multi-ethnic asian incident hemodialysis patients

Conditions: Stage 5 Chronic Kidney Disease

Summary: patients with end-stage renal disease are most vulnerable in the early months following hemodialysis (hd) initiation. data from the united states renal data system and singapore renal registry showed high mortality rates in the first 3-12 months of dialysis. comprehensive multidisciplinary intervention programs implemented in the initial 3-4 months of dialysis showed reduction in mortality and morbidity in incident dialysis patients in the united states. based on these models, the hemodialysis initiation and transition (hit) clinic involving a renal physician, clinical pharmacist and coordinator was set up. the main aim of the clinic is to provide multidisciplinary, intensive and consistent care to patients in the first 3 to 4 months after hd initiation to focus on and streamline the management of dialysis issues and complications. these interventions would help patients achieve goal therapeutic targets, as well as reduce hospitalization rates and mortality, thereby improving their clinical outcomes and self-reported quality of life, and could result in economic and cost savings for the patients and healthcare system. the purpose of this study is to determine if the multidisciplinary, intensive and collaborative management of our multiethnic asian patients newly-initiated on hd improves laboratory, clinical, economic and patient-reported outcomes. adult incident hd patients from nuh will be randomized to the hit clinic or to conventional management. information on demographics, medical/medication histories, laboratory data (dialysis adequacy, iron-deficiency anemia, mineral/bone disorder, malnutrition and diabetes), hospitalizations, deaths and medical costs will be obtained and compared between the 2 groups. patient-reported outcomes will be measured using the kidney disease quality of life-short form, euroqol 5 dimensions, family functioning measure, oslo-3 social support scale and health services utilization questionnaires. data collection will take place at baseline, 3 to 4 months and 12 months after the first visit, with a total study duration and follow-up period of 1 year.


Eligibility criteria:
inclusion criteria: * all patients who are newly-initiated on hd and who meet the following criteria will be included in the study: * male or female 21 years of age or older with stage 5 ckd (egfr \< 15 ml/min/1.73m2) * newly-initiated on hd within the past 4-8 weeks of being seen in the nuh outpatient renal clinic exclusion criteria: * transient hd patients * patients with poor cognitive function or are not able to complete the pro questionnaires.

Keywords: incident hemodialysis
bioequivalence study of saxagliptin and glucophage combination formulations in healthy subjects (b)

Conditions: Type 2 Diabetes Mellitus

Summary: to demonstrate bioequivalence of a 2.5 mg saxagliptin/1000 mg metformin (glucophage) immediate release (ir) fixed dose combination (fdc) tablet to the 2.5 mg saxagliptin tablet and 1000 mg metformin ir tablet co-administered to healthy subjects in a fasted and in a fed state.


Eligibility criteria:
inclusion criteria: * men and women ages 19 to 45 inclusive * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ecgs), and clinical laboratory determinations * body mass index (bmi) of 18 to 32 kg/m2, inclusive. bmi = weight (kg)/ \[height (m)\]2 exclusion criteria: * women of child-bearing potential (wocbp) who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product * any significant acute or chronic medical illness * current or recent (within 3 months) gastrointestinal disease * any major surgery within 4 weeks of study drug administration * history of allergy to dipeptidyl peptidase 4 (dpp4) inhibitor or related compounds * history of allergy or intolerance to metformin or other similar acting agents * prior exposure to saxagliptin * prior exposure to metformin within 3 months of study drug administration * estimated creatinine clearance (clcr) of \< 80ml/min using the cockcroft gault formula
study evaluating single ascending doses of ils-920

Conditions: Acute Ischemic Stroke

Summary: this is a first-in-human study of ils-920. this study will provide an initial assessment of the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of ils-920 after administration of ascending single intravenous (iv) doses to healthy adult subjects.


Eligibility criteria:
inclusion criteria: * men or women of nonchildbearing potential * aged 18 to 50 years inclusive at screening. exclusion criteria: * any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. * history of drug abuse within 1 year before study day 1.

Keywords: acute ischemic stroke
effect of injectable anticoagulants on research for a circulating lupus-type anticoagulant

Conditions: Antiphospholipid Syndrome; Anticoagulant Drugs

Summary: the aim is to assess the effect of injectable anticoagulants (unfractionated heparin (ufh), low molecular weight heparins (lmwh), fondaparinux, danaparoid, argatroban) on lupus anticoagulant testing assays over broad anti-xa activity ranges and to establish their potential for causing false-positive or false-negative results.

citrated whole blood was collected from subjects with positive lupus anticoagulant (la) testing and from subjects with negative la testing. injectable anticoagulants were prepared in demineralized water and added to plasma samples la+ and la- to obtain broad anti-xa activity ranges. anti-xa measurement and la testing were performed in neat and spiked plasma samples. la testing was performed with 4 different analyzer-reagent combinations to represent almost all hemostasis manufacturers currently available. there will be no direct comparison between the la+ and la- groups, the objective is to evaluate the effect of increasing concentrations of injectable anticoagulants on these 2 distinct populations.

Eligibility criteria:
inclusion criteria: * for all subjects: * adult male or female subject. * in capacity to give informed consent to participate in the research. * affiliated to a social security system. for the la- group: * without a previous thrombosis and considered healthy on the basis of the interview and clinical examination. * without coagulation disease for the la+ group: - notion of the presence of lupus anticoagulant (according to isth criteria) and whose last test was positive. exclusion criteria: for all subjects: * medical history considered by the investigator to be incompatible with the trial * refused participation * recent administration of oral or injectable anticoagulants * inr \> 1.5 * pregnant women, nursing mothers * guardianship, curatorship, deprived of liberty, safeguard of justice

Keywords: lupus coagulation inhibitor anticoagulant drugs
a study to describe treatment patterns of advanced breast cancer in poland in the real-world data setting

Conditions: Breast Neoplasms

Summary: the study is descriptive and aims to characterize the treatment patterns of advanced breast cancer in poland in the real-world data setting. the main goals are to assess the current treatment patterns of hormone receptor-positive (hr+) human epidermal growth factor receptor 2 negative (her2-) advanced breast cancer and their changes in clinical practice and relate them to patients' demographics, disease characteristics, type of other therapies used in patients as well as disease progression and visceral crisis occurrence.


Eligibility criteria:
inclusion criteria: * adult patients with histologically diagnosed advanced breast cancer (with locoregional recurrence not eligible for radical local treatment or with distant metastases) * patient has a documented hormone (estrogen and/or progesterone) receptor expression and lack of her2 receptor overexpression or lack of her2 gene amplification (hr+/her2- breast cancer subtype) * patient had no prior treatment for advanced breast cancer * patient has no symptomatic metastases to the central nervous system * there is no other malignancies in patient requiring active treatment * patient is without co-occurring other malignancies treated with palliative assumption exclusion criteria: * parallel patient's participation in any other clinical trial at the time when the decision over the advanced breast cancer treatment was made or up to 30 days before it.

Keywords: hormone receptor-positive human epidermal growth factor receptor 2 negative (hr+ her2-) advanced breast cancer