Kornimate/medical-research-clean huggingface dataset:
second line therapy to treat age-related macular degeneration (amd) for patients not responding well to lucentis therapy by itself

Conditions: Age Related Macular Degeneration

Summary: the purpose of this study is to demonstrate that visudyne-lucentis-dexamethasone (v-l-d) triple therapy will give similar efficacy and safety results as lucentis monotherapy.

study design: patients who have received 2-6 previous treatments with lucentis monotherapy and who have exudative activity associated with the choroidal neovascularization (cnv) lesion, as confirmed by fluorescein angiography (fa) or optical coherence tomography (oct), will be eligible. patients will be randomly assigned at 4-8 weeks after the previous lucentis treatment to either 1. continuation of lucentis monotherapy 2. triple therapy with half fluence visudyne (300 mw/cm2 for 83 seconds) followed within 2 hours by intravitreal lucentis 0.5 mg (first injection) and then dexamethasone 0.5 mg (second injection) (v-l-d). both groups will receive treatment at baseline and then as needed (prn), according to retreatment criteria, with monthly assessments thereafter for 12 months. in the triple therapy group, patients may only be retreated with the v-l-d combination at intervals of no less than 3 months; if retreatment is needed 1 or 2 months after a previous v-l-d treatment, the patient will receive a lucentis injection at that visit; however, if retreatment is needed and the previous v-l-d treatment was at least 3 months prior, then v-l-d treatment is mandatory. oct, visual acuity (va) testing, and possibly fa will be conducted at each assessment visit to define the need for retreatment.

Eligibility criteria:
main inclusion criteria: * patients with subfoveal cnv due to amd who, after 2-6 previous treatments with lucentis monotherapy, continue to have exudative activity associated with the cnv lesion 4-8 weeks after the last treatment. exudative activity is defined as one or more of: * cnv leakage confirmed by fa * new hemorrhage associated with the cnv lesion * subretinal fluid or cystoid macular edema by oct showing retinal thickness ≥ 230 μm * all lesion composition types with a lesion greatest linear dimension (gld) ≤ 5400 microns (approximately ≤ 9 disc areas \[da\]) * best corrected etdrs va score of 25-73 letters (approximate snellen equivalent of 20/40-20/320) main exclusion criteria: * subfoveal geographic atrophy or subfoveal fibrosis in the study eye * intraocular surgery within 3 months of enrollment * inability to attend the protocol-required visits * known allergies or hypersensitivity to any of the study treatments

Keywords: vision loss retina veg-f fovea amd
evaluation of d-chiro-inositol treatments

Conditions: Inositol; Testosterone; Insulin; Ovulation; Asprosin

Summary: healthy women will take tablets containing 600 mg d-chiro-inositol twice per day for one month. we will evaluate metabolic and hormonal.parameters, as insulienmia, glycemia, estradiol, testosterone.


Eligibility criteria:
inclusion criteria: * good state of health; * regular menstrual cycle. exclusion criteria: * pregnancy; * delivery in the previous 6 months; * currently breastfeeding; * menopause; * alcohol or drug abuse; * insulin resistance defined as homa-ir index greater than or equal to 2.5; * other medical morbidities, such as hypertension, pcos, or diabetes; * oligomenorrhea or amenorrhea; * current treatment with corticosteroids or hormones (oral contraceptives, estrogensic, progestogensin); * use of gnrh analogues, serms, or sprms within the previous 6 months.
musculoskeletal health in adult haematological cancer survivors

Conditions: Lymphoma; Leukemia; Cancer Survivors; Musculoskeletal Complication

Summary: haematological cancer treatment often includes use of high dose glucocorticoids (steroids), chemotherapy and radiotherapy and current evidence suggests that these patients may have lower bone mineral density after treatment when compared to the general population which can predispose them to increased risk of fragility fractures. evidence of the impact of these musculoskeletal burden to patients (e.g. quality of life) are not available. this study aims to describe musculoskeletal complications experienced by long-term haematological cancer survivors and examine the impact of the burden from the patient perspective. the study will be conducted in 2 parts; a questionnaire study and an interview study to help understand the extent of musculoskeletal problems experienced by this group of patients and the impact of this on quality of life.


Eligibility criteria:
questionnaire study inclusion criteria: 1. age 18 or above at diagnosis of haematological cancer 2. diagnosis of haematological cancers: lymphoma or leukaemia 3. cancer survivors as recorded in the local database of lymphoma and haematopoietic stem cell transplant database 4. able to give written informed consent 5. able to read and understand english exclusion criteria: 1.currently receiving any active cancer treatment interview study inclusion criteria: 1. age 18 or above at diagnosis of haematological cancer 2. diagnosis of haematological cancers: lymphoma or leukaemia 3. cancer survivors as recorded in the local database of lymphoma and haematopoietic stem cell transplant database 4. able to give written or verbal informed consent 5. able to read and understand english exclusion criteria: 1 .currently receiving any active cancer treatment
diagnostic accuracy of the madx multi array xplorer (max 45k) automated laboratory system and the madx allergy explorer version 2 (alex²) - ige multiplex test for the diagnosis of pre-defined groups of specific high-priority allergens

Conditions: Birch Pollen Allergy; Grass Pollen Allergy; House Dust Mite Allergy; Cat Allergy; Bee Venom Allergy; Vespid Venom Allergy

Summary: about 20% of the general population are affected by an allergy - with an upward trend. quite often, allergic people do not consider their disease as serious and suffer from subsequent complications, like allergic asthma, later in their life. the sooner the allergen source is identified, the sooner the therapeutic intervention (e.g. dietary recommendations, allergen avoidance, anti-inflammatory treatment or allergen immunotherapy) can be started. cross-reactivity may also play an important role. therefore, a comprehensive allergy test is essential for an optimal treatment of patients. modern multiplex testing is an individualized diagnostic approach, which may help to identify eligible patients for allergen immunotherapy and may identify risk groups by analyzing the sige profile. until now, published data on the clinical usability of multiplex allergy diagnostic test systems are often limited. even though, available studies show a good correlation between conventionally used multiplex or singleplex assays (isac or immunocap) and the new multiplex assay (alex and alex²), the results are often based on small sample sizes investigating many different allergens. therefore, this clinical performance study is conducted to evaluate the diagnostic accuracy of the alex² ige multiplex test using the multi array explorer (max 45k, macroarray diagnostics) automated laboratory system in comparison to a conventional ige singleplex test system as well as clinical symptoms and skin prick test results in a total of 826 patients. patients with the most common inhalant allergies (e.g. grass pollen, house dust mite or cat allergy) will be included as well as patients suffering from hymenoptera venom allergy, which is the major cause of anaphylaxis.


Eligibility criteria:
inclusion criteria: * male and female subjects with suspicion of allergy * written consent of the participant (and/or his/her parent or legal representative) after being informed exclusion criteria: * oral treatment with corticosteroids (\>5mg/day) * treatment with antihistamines (histamine (h1) receptor blockers) * hematological disease (coagulation disorders, anemia)
effect of neural mobilization on lumbosacral radiculopathy patients with peripheral sensitization

Conditions: Radiculopathy

Summary: the primary purpose of this study was to investigate the effects of slider and tensioner techniques on pain, hip and knee rom in lumbosacral radiculopathy patients with peripheral sensitization. a secondary purpose was to evaluate the correlation between these outcomes measurements.

study design: double-blind case-control trial. methods: fifty-one male lumbosacral radiculopathy patients with peripheral sensitization, were divided into one of the three groups: slider, tensioner, and control. the primary outcome measurements were visual analog scale (vas) for pain, hip range of motion (rom) during slr test, and knee flexion rom during slump test. the measurements were taken at baseline, after 1st, 3rd, and 6th session. statistical analysis: a two-way mixed design analysis of variance (manova) with post-hoc (bonferonni correction) was used to calculate the differences with time (baseline, 1st,3rd,6th sessions) as a within-group factor and group (control, slider, and tensioner) as a between-group factor. the effect size was calculated with cohen's d. pearson's correlation was used for correlation analysis.

Eligibility criteria:
inclusion criteria: * patients with lumbosacral radiculopathy with dominant peripheral sensitization * patients with unilateral leg pain. * patient s-lanss score \> 12, * negative sensory and motor examination. * positive neural tissue provocation tests (straight leg raising test, slump test). * adult. * pain duration of more than 3 months. exclusion criteria: * s-lanss score ≥ 12, * motor or sensory deficits, * history of back or lower extremity surgeries, * bilateral referred pain, * patients with pacemakers, cardiovascular problems, epilepsy, active malignancy, dermatological conditions, and diminished pain sensation.

Keywords: lumbosacral radiculopathy peripheral sensitization neural mobilization radicular lbp slider tensioner
a study to to assess the effect of dapagliflozin when administered once a day versus twice a day on blood glucose

Conditions: Healthy Volunteers

Summary: the primary objective of the study is to assess the effect of dapagliflozin on the amount of glucose in the blood and urine when dapagliflozin is administered once a day (10 mg) versus twice a day (5 mg every 12 hours) after five days of dosing.


Eligibility criteria:
inclusion criteria: * female healthy volunteers must be post-menopausal (cessation of menses \>1year, be surgically sterile (documented) or have undergone hysterectomy) or be sexually abstinent from enrolment until follow-up examination * have normal physical exam, vital signs ecg findings, and laboratory values exclusion criteria: * use of prescription medication for a chronic or acute medical condition within 3 weeks of randomization * history or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic or renal disease, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs as determined by the investigator * previous participation in an astrazeneca (az) or bristol-myers squibb (bms) dapagliflozin study

Keywords: healthy volunteers inhibition of glucose re-absorption diabetes dapagliflozin
pharmacokinetics/pharmacodynamics of argatroban injection in end-stage renal disease patients undergoing hemodialysis

Conditions: Kidney Failure, Chronic; Renal Disease, End-Stage

Summary: the primary goals of this investigation are to provide guidance on how to dose argatroban in patients undergoing hemodialysis and to assess the safety and tolerability of argatroban in hemodialysis patients. the secondary goal of the study will be to assess the adequacy of anticoagulation during hemodialysis.


Eligibility criteria:
basic inclusion criteria: 1. patients, adult men or women who are between 21 and 75 years of age who are on maintenance hemodialysis regimen for at least three (3) months prior to the study start. 2. patients who can tolerate a hemodialysis session lasting up to 9 hours. 3. patients who can tolerate a hemodialysis treatment with blood flow rates of 300 ml per minute. 4. female volunteers who are not documented to be surgically sterile must be willing to abstain from sexual intercourse during the study or be willing to use intrauterine devices or 2 forms of barrier contraception for at least 7 days prior to the initial dose of study medication and continuing through the completion of the study. basic exclusion criteria: 1. any clinically relevant abnormality identified per the investigator on the screening medical assessment or laboratory examination. 2. history of regular alcohol abuse. 3. treatment with an investigational drug within 30 days. 4. history of drug allergy of clinical significance in the opinion of the investigator. 5. currently taking warfarin or other anticoagulants. 6. currently taking nsaids (with the exception of aspirin). 7. individuals who are obese. 8. any history of bleeding disorder. 9. any subject with a screening resting systolic blood pressure \>180 mmhg and/or resting diastolic blood pressure of \>100 mmhg unless, in the opinion of the principal investigator, the blood pressures would not endanger the subject while participating in this trial. 10. concurrent uncontrolled cardiovascular, hematologic, respiratory, cns, gastrointestinal disease or chronic alcoholism. 11. anemia defined as a hematocrit of \< 30 and hemoglobin \< 10g/dl. 12. concurrently taking (within the past 30 days) phenytoin, cimetidine, rifampin, cyclosporin or tacrolimus. 13. known hypersensitivity to argatroban or related compounds. 14. significant hepatic insufficiency as defined by total bilirubin greater than 1.5 mg/dl or transaminase (alt, ast) elevations greater than 2 times the upper limit of the laboratory reference range.

Keywords: esrd end-stage renal disease hemodialysis
cgm - reimagine primary care

Conditions: Diabetes Mellitus, Type 2

Summary: to assess the impact of continuous glucose monitoring versus standard of care (e.g. a finger-prick protocol using a glucometer) on clinical outcomes, healthcare utilization, and cost in patients with type i or ii diabetes treated within the reimagine primary care clinics.

this is a parallel randomized controlled trial. eligible patients who consent will be randomized to one of two groups: (1) the intervention group who will be given a dexcom g6 for cgm, or (2) the control group who will follow their current standard finger-prick protocol via a provided contour next one glucometer. the cgm group must download the dexcom g6 and clarity mobile apps for data capture, whereas the standard of care group will use the contour next mobile app for their respective readings. the dexcom g6 captures real-time, dynamic glucose data every five minutes. devices used in this study are fda approved and commercially available.

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes mellitus with a hba1c ≥6.5% * patients that are currently managing their glucose levels for diabetes with a glucose meter (or will be prescribed one by their healthcare provider) * patients that are treated within the four reimagine primary care clinics (cottonwood family medicine, cottonwood senior, avenues internal medicine, and holladay internal medicine). • patients 18-80 years of age exclusion criteria: * patients that are not managing their glucose levels for diabetes (and not advised to use a glucose monitor by their physician) * patients that are not treated within the four reimagine primary care clinics * patients less than 18 years of age, and 81 years of age and older * patients with a diagnosis of dementia * if the patient is currently using a continuous glucose monitor * patients with previous hospitalization for hypoglycemia within the last 18 months * no access to a mobile phone to download the dexcom or contour next applications * patients who are pregnant or planning to become pregnant over the course of their six-month participation

Keywords: continuous glucose monitor (cgm) dexcom g6
the efficacy of influenza vaccine in reducing cardiovascular events in patients with coronary artery diseases

Conditions: Coronary Artery Diseases; Myocardial Infarction; Stable Angina

Summary: influenza vaccine reduces the cardiovascular events in post-myocardial infarction (mi) patients and in those with stable angina (sa).

a connection between infectious processes and atherosclerosis is repeatedly reported \[1\]. acute respiratory infection was found to be associated with myocardial infarction (mi) \[2,3\] and a number of epidemiological studies found that mortality attributable to cardiovascular diseases is increased during influenza epidemics \[4\]. naghavi et al \[5\] in a case-control study of patients with coronary artery disease (cad) found that vaccination against influenza was negatively associated with the development of new mi during the same influenza season. while some clinical trials found influenza vaccine effective in secondary prevention of cardiovascular adverse events \[6,7\], a large trial \[8\] failed to approve such an efficacy. furthermore, a recent review of published trials on the subject concluded that frailty selection bias and use of non-specific endpoints such as all cause mortality have led cohort studies to greatly exaggerate vaccine benefits and that the remaining evidence base is currently insufficient to indicate the magnitude of the mortality benefit of the vaccination program \[9\]. this study aims to assess the efficacy of vaccine in secondary prevention of cardiovascular events in mi and stable angina (sa) patients using specific endpoints including reliable quantitative tools.

Eligibility criteria:
inclusion criteria: * patients with the diagnosis of acute, evolving or recent mi (after recovered the acute phase) as defined by: 1. typical rise and gradual fall (troponin) or more rapid rise and fall (ck-mb) of biochemical markers of myocardial necrosis with at least one of the following: * ischemic symptoms * development of pathologic qwaves on the ecg * ecg changes indicative of ischemia (st segment elevation or depression); or * coronary artery intervention (e.g., coronary angioplasty). 2. pathologic findings of an acute mi \[12\] * patients with stable angina pectoris and documented coronary artery stenosis (angiography). exclusion criteria: * any acute disease * chronic liver or kidney diseases * conditions accompanied by immunosuppression (like organ transplantation, hiv) * diagnosed malignancy * incubation with influenza vaccine within the past 5 years * any psychological disease that interferes with regular follow-up * congestive heart failure (killip class iv) * unstable angina, and contradictions of vaccine incubation (like egg allergy).

Keywords: influenza vaccine
ketogenic diet adjunctive to salvage chemotherapy for recurrent glioblastoma:a pilot study

Conditions: Glioblastoma Multiforme

Summary: recently, ketogenic diet has been recognized a useful treatment strategy for glioblastoma in vitro. therefore, the purpose of the study is to evaluate the safety and efficacy of ketogenic adjuvant to salvage chemotherapy for recurrent glioblastoma.

diet change by limiting carbohydrates and increasing the proportion of fatty acids and proteins can lead to ketogenic metabolism and might limit energy production in tumor cells and inhibit tumor growth. in a pilot of recurrent glioblastoma, ketogenic diet adjuvant salvage chemotherapy was given as interventional group and standard diet adjuvant salvage chemotherapy was given as control group. the study examines whether a ketogenic diet adjunctive to salvage chemotherapy can be applied to the patients and may inhibit tumor growth and influence the quality of life of the patients.

Eligibility criteria:
inclusion criteria: 1. age 18-60 2. karnovsky performance score of 60 or more. 3. histologically confirmed glioblastoma multiforme, grade 4 4. ability and willingness to signed informed consent form. 5. documented recurrence or progression after surgical resection/debulking, radiation and temozolomide chemotherapy. 6. normal function of liver and kidney exclusion criteria: 1. any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, carnitine deficiency and pancreatitis 2. history of uncontrolled hyperlipidemia or hyperglycemia. 3. history of human immunodeficiency virus, or hepatitis c 4. pregnancy or breastfeeding 5. inability or unwillingness of subject to give written informed consent

Keywords: ketogenic diet recurrent glioblastoma chemotherapy
genetic identification (id) of segmental dysplastic nevi

Conditions: Segmental Dysplastic Nevi

Summary: the investigators' goal is to identify the mutation in the gene that is responsible for the development of segmental dysplastic nevi. to identify the gene the investigators may use a candidate gene approach (i.e. sequence specific genes that are thought to be involved: nras, braf, etc) or a genome-wide approach trying to implicate regions in the genome (loss-of-heterozygosity or copy number changes on comparative genomic hybridization).

dysplastic (atypical) melanocytic (dmn) nevi have been identified as being potential precursors of melanoma and markers for patients at risk of developing primary melanoma1. in addition, having an increased number of nevi is associated with increased risk1. dmn are present in 2-5% of white adults in the u.s. population and international studies have documented up to 18% prevalence2. these lesions may be present in at least 17% of white adults with melanoma and 20-50% of melanomas may arise in nevi and atypical nevi2. the exact gene(s) involved in the development of nevi have yet to be elucidated. segmental dysplastic nevi are nevi that are restricted to one area of the body3. this condition is much rarer than the occurrence of dysplastic nevi, but nonetheless, may involve the same genetic mutation. the pattern of distribution in sdn is thought to result from mosaicism, i.e. the part of the body that expresses the dysplastic nevi has a mutation in a gene, however, the rest of the body does not contain this same mutation. other mosaic disorders that have been studied in greater detail than sdn have been shown to be caused by a single gene mutation4. it appears that sdn is no different and that it too is caused by a mutation in a single gene, however, this gene is not yet known. in this study we will perform a genetic analysis of tissue from a patient known to have sdn. with the information we gather from this analysis, we may be able to find the gene responsible for the development of dysplastic nevi. primary research objective: to investigate the genetic mutation involved in the development of dysplastic nevi by examining a patient with sdn.

Eligibility criteria:
inclusion criteria: * patient with a positive history of segmental dysplastic nevi exclusion criteria: * none