Kornimate/medical-research-clean huggingface dataset:
bi 10773 add-on to metformin in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of bi 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with t2dm with insufficient glycemic control. in addition, there will be an open-label treatment arm with sitagliptin (januviatm) as add-on therapy to metformin.


Eligibility criteria:
inclusion criteria: 1. male and female patients with a diagnosis of type 2 diabetes mellitus and previously treated with metformin alone or with metformin and one other oral antidiabetic drug 2. stable metformin therapy of at least 1500 mg/day, or less if that is a maximum tolerated dose. 3. hba1c at screening 6.5% to 9.0% for patients on metformin and one other antidiabetic drug, and hba1c \>7.0% to 10% for patients on metformin only 4. hba1c \>7.0% to 10.0% at visit 2 (start of run-in) 5. age \>=18 and \<80years 6. body mass index (bmi) \<=40 kg/m2 7. signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (gcp) and local legislation exclusion criteria: 1. myocardial infarction, stroke or transient ischemic attack (tia) within 6 months prior to informed consent 2. impaired hepatic function 3. renal insufficiency or impaired renal function 4. diseases of the central nervous system or psychiatric disorders or clinically relevant neurological disorders that may interfere with participation in the trial 5. chronic or clinically relevant acute infections 6. current or chronic urogenital tract infection 7. history of clinically relevant allergy/hypersensitivity 8. treatment with glitazones (e.g., rosiglitazone, pioglitazone), glucagon-like peptide (glp-1) analogues, or insulin within 3 months prior to informed consent 9. treatment with anti-obesity drugs within 3 months prior to informed consent 10. treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to informed consent 11. alcohol abuse or drug abuse 12. treatment with an investigational drug within 2 months prior to informed consent 13. women of child-bearing potential who are nursing or pregnant, or who are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to periodic pregnancy testing during participation in the trial
biological therapy in previously treated patients with non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: interleukin-2 may stimulate a person's white blood cells to kill non-small cell lung cancer cells. purpose: phase ii trial to study the effect of biological therapy with interleukin-2 in patients with previously treated non-small cell lung cancer.

objectives: i. determine the response rate and median duration of response of interleukin-2 (il-2) in patients with previously treated non-small cell lung cancer. ii. determine the median survival of patients treated with il-2. iii. further delineate the toxicity of il-2 in these patients. outline: this is an open label study. patients receive bolus interleukin-2 on days 1-5 and 8-12. the cycle repeats every 3 weeks. patient response is evaluated after 2 cycles. patients with stable disease, partial, or complete response may be treated with maintenance il-2 for up to 4 additional cycles. patient evaluation is performed after every 2 cycles. at this point, patients with stable or responding disease may be treated with il-2 every 6 weeks until disease progression, intolerable toxic effects, or 2 cycles beyond complete response. projected accrual: a maximum of 30 patients will be accrued.

Eligibility criteria:
disease characteristics: histologically proven recurrent or refractory non-small cell lung cancer at least one prior systemic therapy or prior radiation therapy must have measurable disease previously irradiated sites of disease are not considered evaluable unless there is radiologic documentation of progression patient characteristics: age: not specified performance status: ecog 0-2 life expectancy: at least 3 months hematopoietic: wbc at least 3,000/mm3 hemoglobin greater than 10 g/dl platelet count greater than 100,000/mm3 hepatic: bilirubin less than 2.0 mg/dl renal: creatinine less than 2.0 mg/dl cardiovascular: no prior history of myocardial infarction within previous 6 months no uncompensated congestive heart failure no primary (not due to electrolytes or drugs) cardiac arrhythmias besides premature ventricular contractions pulmonary: no dyspnea at rest or need for supplemental oxygen patients with symptomatic lung disease or extensive lung metastases must have oxygen saturation greater than 90% other: not pregnant or nursing negative pregnancy test patients with elevated temperatures greater than 100.5 f must have no occult infection prior concurrent therapy: biologic therapy: no concurrent cyclosporin chemotherapy: at least 3 weeks since chemotherapy and recovered no concurrent methotrexate see disease characteristics endocrine therapy: no concurrent systemic corticosteroids radiotherapy: at least 3 weeks since radiotherapy see disease characteristics surgery: not specified

Keywords: recurrent non-small cell lung cancer
choice of optimal transcatheter treatment for mitral insufficiency registry

Conditions: Mitral Regurgitation

Summary: this multinational, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent transcatheter mitral valve implantation (tmvi), in comparison to those screened for tmvi but deemed ineligible, who subsequently underwent interventional mitral valve edge-to-edge repair, mitral valve surgery or medical/conservative therapy.


Eligibility criteria:
inclusion criteria: * clinically significant mitral insufficiency * patient underwent screening for tmvi * echocardiography data at baseline (and after tmvi, e2e and surgery) * follow-up of at least 30 days exclusion criteria: - age under 18 years
evoked responses as pharmacodynamic biomarkers in healthy and schizophrenic participants (mk-4334-007)

Conditions: Cognitive Impairment Associated With Schizophrenia

Summary: the primary purpose of this randomized, double-blind, placebo-controlled cross-over study was to record and measure 40 hz-auditory steady-state response (assr) in healthy controls (hc) and participants with mild-to-moderate schizophrenia (sz) to determine if the mean inter-trial coherence (itc) magnitude derived from the 40 hz-assr is lower in sz than in hc at baseline.

this is a 2-part study. part 1 was a 2-period study in which participants received either 21 mg nicotine patches and then placebo patches or vice versa, with each patch co-administered with placebo capsules, in a counterbalanced order. in part 2, participants were randomized to receive either mk-4334 250 mg capsule or placebo capsule, each with placebo patches.

Eligibility criteria:
inclusion criteria: hc participants: * is in generally good health * has no history of clinically relevant neuropsychiatric illness * is a mild-to-moderate tobacco user of ≥1-year duration, smoking the equivalent of \~10-15 cigarettes/day participants with mild-to-moderate sz: * has a current diagnosis of sz with a duration ≥1 year * is clinically stable and in the residual (non-acute) phase of illness for ≥12 weeks prior to the study * is stably maintained on a regimen of up to 2 first- or second-generation antipsychotics with no dose changes \>50% in combination with concomitant medication commonly prescribed to this population for ≥8 weeks prior to screening and during the study * is a mild-to-moderate tobacco user of ≥1-year duration, smoking the equivalent of \~10-15 cigarettes/day all participants: * for males, agrees to be abstinent from heterosexual intercourse, or use an approved contraception method, during the study and for 90 days after the last dose of study drug * for females, is not of childbearing potential * is willing to comply with restrictions on the use of nicotine or nicotine-containing products during the study exclusion criteria: hc participants: * has known biological family history of psychotic disorder in a first or second degree relative participants with mild-to-moderate sz: * may be excluded from participation by the investigator based on treatment history and/or performance on various screening tests all participants: * is positive for hepatitis b surface antigen, hepatitis c antibodies, or human immunodeficiency virus (hiv) * is at imminent risk of self-harm * has had major surgery or donated blood within 4 weeks prior to screening * has evidence of cognitive impairment or significant mental disability * has a history of clinically significant abnormality or disease * has a history of cancer (malignancy) * is unable to refrain, or anticipates use, of any non-prescription drugs or herbal remedies * has participated in another clinical study within 6 weeks or 5 half-lives (whichever is greater) prior to screening
study to evaluate the pharmacokinetic interaction between fimasartan and atorvastatin in healthy male volunteers

Conditions: Hypertension

Summary: a phase i clinical trial to compare the pharmacokinetics and safety of fimasartan/atorvastatin combination tablet and coadministration of fimasartan and atorvastatin in healthy male volunteers.

after subjects have signed informed consent voluntarily, they go through screening period for within 21 days. group 1 period 2 period 3 period a f a f+a b f f+a a c a f+a f d a f f+a e f+a f a f f+a a f at each period taking fimasartan, subjects of this group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times in each period). at each period taking atorvastatin, subjects of this group have blood sampling 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hour after medication(12 times in each period). at each period taking fimasartan and atorvastatin, subjects of this group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times in each period).

Eligibility criteria:
inclusion criteria: 1. healthy male subject, aged 19- 50 years at screening. 2. body weight between 19.0 and 28.0 of ideal body weight (ibw)(kg) = {height (cm) - 100} \* 0.9 exclusion criteria: 1. history of any illness that may affect the absorption, distribution, metabolism or excretion (hepatobiliary, renal, cardiovascular, endocrine (e.g., hypothyroidism), respiratory, gastrointestinal, hemato-oncology, central nervous system, psychiatric and musculoskeletal system) 2. hypotension (systolic ≤ 100 mmhg or diastolic ≤ 65 mmhg) or hypertension (systolic ≥ 140 mmhg or diastolic ≥ 90 mmhg), measured at screening 3. evidence of hereditary disease, including galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption. 4. history of gastrointestinal disease (i.g., crohn's disease, active peptic ulcer) or resection operation that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy)\] 5. participation in any other study within 2 months prior to the first administration of study drug (the finish time of previous study is the day of the last administration of study drug)

Keywords: fimasartan
c677t and a1298c mthfr polymorphisms and fluoropyrimidine effectiveness in metastatic colon cancer

Conditions: Colon Cancer; MTHFR Gene Mutation; Chemotherapeutic Toxicity; Chemotherapy Effect

Summary: fluoropyrimidines are the backbone of chemotherapy regimes used to treat metastatic colorectal cancer (crc). these drugs act in different pathways of folate metabolism altering dna synthesis mainly by inhibition of the tymidylate synthase. for this reaction the 5,10-methylenetetrahydrofolate acts as cofactor. it has been demonstrated that a1298c and c677t polymorphisms in the methylenetetrahydrofolate reductase (mthfr) gene result in reduced enzyme activity that leads to reduced availability of this important cofactor. hence, we hypothesized that the presence of these polymorphisms are related to the efficacy and toxicity of fluoropyrimidines in patients with crc.

patients with metastatic colorectal cancer are invited to join this study at the start of treatment with any fluoropyrimidine used alone or in combination with oxaliplatin and/or irinotecan +/- bevacizumab, panitumumab or cetuximab. dna extraction will be done from blood and tissue samples to determine the c677t (rs1801133) and 1298 a\>c (rs18011131) polymorphisms of the mthfr gene. the patient will be followed at least for one year during treatment to determine any toxicity related to the therapy and to determine the overall survival, progression-free survival and response rate. patients will be categorized into different categories according to the genetic status of each polymorphism.

Eligibility criteria:
inclusion criteria: * patients with metastatic colorectal cancer receiving first line therapy with any fluoropyrimidine (capecitabine or 5-fluorouracil) alone or in association with oxaliplatin, and/or irinotecan, plus either bevacizumab or cetuximab/panitumumab. exclusion criteria: * any other malignant condition

Keywords: colon cancer fluoropyrimidine
diode laser treatment of onychomycosis

Conditions: Onychomycosis

Summary: the purpose of this study is to evaluate the v-raser diode laser system with investigational nail fungus handpiece in the treatment of onychomycosis.


Eligibility criteria:
inclusion criteria: * confirmed subungual onychomycosis in a great toe that does not extend to the eponychium * fitzpatrick skin type i-iv * written and verbal informed consent * able to comply with study instructions and to return to the clinic for required visits * agrees to refrain from other active topical, laser or light-based treatment to the great toes * agrees to the use of naftin gel between the toes to prevent/control tinea pedis exclusion criteria: * pregnancy, breastfeeding or planning to become pregnant * history of cutaneous photosensitivity, porphyria and hypersensitivity to porphyrins or photodermatoses * any skin pathology or condition that could interfere with the evaluation or that requires the use of interfering topical or systemic therapy * coagulation disorder or current use of anti-coagulation medication (including aspirin use of greater than 81 mg per day) * any condition which, in the investigator's opinion, would make it unsafe for the subject to participate * enrolled in an investigational drug or device trial, or has been treated with an investigational device or received an investigational drug within 30 days * oral lamisil within 1 year, sporanox or over-the-counter topicals within 1 month, or other prescription anti-fungal medications or topicals within 6 months * evidence of diabetic neuropathy or peripheral vascular disease related to diabetes, or a loss of protective sensation in the affected foot * psoriasis, lichen planus, infection involving the lunula, prior surgical treatment of the affected great toe within 1 year, or a history of trauma to the affected great toe * immunocompromised status, or with existing (or history of) cancer/skin malignancy * distal nail thickness of greater than 2mm in the affected great toenail

Keywords: onychomycosis toenail fungus
presentation, patterns of myocardial damage, and clinical course of viral myocarditis

Conditions: Myocarditis Viral

Summary: viral myocarditis has been recognized as a cause of congestive heart failure, however diagnosis and treatment represents a challenging process. recently, there is an increasing frequency of different cardiotropic viruses in the clinical setting of myocarditis. the introduction of the new molecular techniques in analysing the etiologic agent of acute myocarditis has enhanced significantly the knowledge on the molecular epidemiology of these viruses. the etiology of patients admitted to our university hospital remains unclear. it is therefore important to identify the aetiology associated with myocardial infections. the purpose of the present study is to analyze the prevalence of a broad spectrum of cardiotropic viruses, including enteroviruses, adenoviruses and parvo b19 virus, in adults with suspected myocarditis with special reference to b19 virus due to its increasing prevalence nowadays. the results of this study will provide a very important information for the prevalent infectious viral agents in our university hospital which will guide treatment protocol.

objectives 1. there are almost no data regarding the relative prevalence of viral pathogens associated with myocarditis and the demographic and clinical features related to these infections in egypt. therefore, our main interest is to determine the prevalence of the most common viruses in clinically relevant (i.e., hospitalization- requiring) patients with acute or chronic myocarditis, using highly sensitive molecular techniques as the diagnostic tool. 2. our second aim is to determine the distribution of mono- and coinfections between these viral agents. 3. finally, to correlate between the microbiological findings in this study and patient characteristics including age, sex, clinical features, regional distribution, and degree of urbanization (determined on the basis of the size of the city and the density of the population) of the patients.

Eligibility criteria:
inclusion criteria: * all patients with recent unexplained heart failure in last 3 months and diagnosed as myocarditis by cardiac magnetic resonance (cmr) after exclusion of ischemic (by coronary angio) or valvular (by detailed echo) causes. exclusion criteria: * ischemic cardiomyopathy. * peripartum cardiomyopathy * valvular etiology of heart failure

Keywords: viral myocarditis
prospective study to observe and manage progression of pulmonary nodules

Conditions: Lung Nodules

Summary: based on the previous review and research, we would like to further observe the nodule changes in patients with pulmonary nodules. these changes include factors such as the reason for the further enlargement or deterioration of the nodule, time, lifestyle, the patient's region, and hereditary medical history. at the same time, we will further look at the corresponding characteristics of a population that does not change the size and nature of the nodule, including age, gender, and all the factors discussed above. on this basis, we can propose more scientific methods for the treatment and management of pulmonary nodules, and provide a more reliable clinical reference for the clinical treatment of pulmonary nodules.


Eligibility criteria:
inclusion criteria: lns patients aged 18 years and older who were previously treated in guang'anmen hospital. exclusion criteria: (1) had the lns removed; (2) lns less than or equal to 3 mm in size; (3) had not undergone thorax ct; (4) had failed to complete treatment; (5) had incomplete medical records or was lost to follow-up.
macular pigment and glare disability

Conditions: Vision, Entoptic

Summary: the purpose of this study is: i. to measure mp optical density (mpod) in two groups (experimental and placebo) of 50 subjects each (n = 100), during an lutein + zeaxanthin supplementation period of 12 months. ii. to test the hypothesis that increases in mp (via 12 mg daily lutein + zeaxanthin supplementation) will result in significantly improved visual performance under disability glare conditions. iii. to test the hypothesis that increases in mp (via 12 mg daily l + z supplementation) will result in significantly reduced photostress recovery times. iv. to test the hypothesis that increases in mp (via 12 mg daily l + z supplementation) will result in improved contrast enhancement.

the following measurements will be taken, before and after supplementation with lutein and zeaxanthin: macular pigment optical density (mpod) visual performance under glare conditions photostress recovery times chromatic contrast sensitivity.

Eligibility criteria:
inclusion criteria: * gender: male or female * age: 18 - 40 years * bmi: 20-30 * no anticipated changes in dieting habits (as relevant to xanthophyll intake). * no anticipated surgical procedures. * assessed as healthy, based on a pre-study examination including medical history, physical examination, and clinical laboratory. the examination will be performed by an md or a nurse practitioner. * willingness and ability to give written informed consent and willingness and ability to comply with the study requirements. * corrected visual acuity (etdrs): better than 20/60 exclusion criteria: * bmi \ 30 * age \ 40 years * smokers * current or history of relevant diseases (such as amd) * corrected visual acuity worse than 20/60 * inability to reliably perform mpod measurements by heterochromatic flicker photometry or any of the other ophthalmic tests of the study. * any condition likely to interfere with normal gastro-intestinal absorption of xanthophylls. * current use of xanthophyll containing supplements * use of xanthophyll containing supplements in the past 6 months * participation in any other study during last 1 month. * blood donation during the last 3 months. * known hypersensitivity or allergy to xanthophylls. * regular intake of medications or supplements, which the principal investigator deems likely to confound the study outcomes. * suspected lack of compliance with any requirements of the study. * childbearing potential and unwillingness to refrain from acceptable anticonceptive measures (not including abstinence). * current pregnancy or breast feeding * any relevant abnormalities in the routine laboratory tests

Keywords: macular pigment glare disability lutein photostress chromatic contrast sensitivity
answer als: individualized initiative for als discovery

Conditions: Amyotrophic Lateral Sclerosis; Primary Lateral Sclerosis; Flail Arm ALS; Progressive Muscular Atrophy; Monomelic Amyotrophy; Motor Neuron Disease; Asymptomatic ALS Gene Carriers; Healthy Controls

Summary: creation of a large repository of induced pluripotent stem cells (ipsc), bio-fluid samples (blood and spinal fluid (optional)), and cell lines for als gene identification. this will be combined carefully with collected measures of the pattern of the symptoms people with als have and how these change over time. people with other motor neuron diseases and healthy controls will be included as comparisons

patients will have 5 study visits; screening, 3, 6, 9 and 12 months. there will be a one year post-participation follow-up period, during which they will receive an email or phone call interview once every 3 months. during the first year, samples will be collected, breathing, muscle strength, spasticity, general function and cognitive behavior will be assessed. healthy controls will have 2 study visits during which blood samples will be collected and questionnaires given.

Eligibility criteria:
inclusion criteria: * participants with familial or sporadic als diagnosed as possible, laboratory-supported probable, probable or definite according to the world federation of neurology (wfn) el escorial criteria, primary lateral sclerosis flail arm als, progressive muscular atrophy, monomelic amyotrophy, motor neuron disease, asymptomatic als gene carriers * participants who are ages 18-100, inclusive. exclusion criteria: * participants with spinal-bulbar muscular atrophy * known diagnosis of hiv/aids, hepatitis b, or hepatitis c.

Keywords: als stem cell biomarker disease progression