Kornimate/medical-research-clean huggingface dataset:
use of sitagliptin to decrease microalbuminuria

Conditions: Type 2 Diabetes; Microalbuminuria

Summary: the people being asked to participate in this study have type 2 diabetes and abnormal levels of protein in their urine. this indicates that they are starting to develop diabetic kidney disease. the standard treatment for this is the use of one of two blood pressure medicines, either an angiotensin converting enzyme (ace) inhibitor or angiotensin receptor blocker (arb). however, these medicines are not always completely effective in stopping/reversing the kidney disease. some studies have previously suggested that another type of medicine, called sitagliptin, normal used to treat diabetes may also help prevent diabetic kidney disease from getting worse. this study is being performed to test the effectiveness of sitagliptin as compared to a placebo, along with a stable dose of an ace inhibitor or arb, to determine whether or not it will reduce protein levels in their urine. protein levels in the urine are a marker of the severity of kidney disease.

the people being asked to participate in this study have type 2 diabetes and abnormal levels of protein in their urine. this indicates that they are starting to develop diabetic kidney disease. the standard treatment for this is the use of one of two blood pressure medicines, either an ace inhibitor or arb. however, these medicines are not always completely effective in stopping/reversing the kidney disease. some studies have previously suggested that another type of medicine, called sitagliptin, normal used to treat diabetes may also help prevent diabetic kidney disease from getting worse.

Eligibility criteria:
inclusion criteria: * albumin/creatinine ratio between 30-299 mg/dl. * type 2 diabetes mellitus (t2dm) with hemoglobin a1c between 7 and 9%. * stable bp control of less than 145/90 on treatment with ace or arb for more than three months prior and during the trial. * glomerular filtration rate (gfr) of 60 ml/min/1.73m2 or more. * age between 18-75 years old. * for women: at least two years postmenopausal, surgically sterile, or using an acceptable contraceptive regiment to include oral contraceptive pill (ocp), intrauterine device (iud), double barrier, depo-provera, or subcutaneous progestin implant and negative urine pregnancy test at trial start. exclusion criteria: * pregnancy. * gfr less than 60 ml/min/73m2. * have a history of malignancy other than basal cell or squamous cell skin cancer and have not yet been treated, are currently being treated, or were diagnosed less than 5 years prior to visit 1. * advanced liver disease. * subjects cannot be on dpp-4 inhibitor or glycolipoprotein (glp-1) agonist for at least 4 months before the study start. * psychiatric condition that would prevent subject from following directions. per pi discretion.

Keywords: microalbuminuria type 2 diabetes
patients with relapse remitting multiple sclerosis (rrms): candidates for ms therapy change

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: the purpose of this study is to evaluate the change in patient-reported treatment satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. dmt standard of care, using the global satisfaction subscale of the treatment satisfaction questionnaire for medication (tsqm-9).


Eligibility criteria:
inclusion criteria: * patients must be diagnosed with relapsing remitting ms (rrms) as defined by 2005 revised mcdonald criteria. * patients who explicitly agree to be assigned to a treatment group that may receive fingolimod or dmt after having been informed about their respective benefits and possible adverse events by the investigator. * an expanded disability status scale (edss) score of 0-5.5 inclusive. * must have received continuous treatment with a single approved and indicated ms dmt for a minimum of 6 months prior to the screening visit. patients must continue with this ms dmt until the randomization visit. * naïve to treatment with fingolimod. exclusion criteria: * a manifestation of ms other than those defined in the inclusion criteria. * a history of chronic disease of the immune system other than ms or a known immunodeficiency syndrome. * history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. * patients with uncontrolled diabetes mellitus (hba1c \> 7%). * diagnosis of macular edema during screening phase. other protocol-defined inclusion/exclusion criteria may apply

Keywords: multiple sclerosis fingolimod disease modifying therapy tsqm-9
evaluating aranesp® in subjects with end stage renal disease onchronic hemodialysis

Conditions: End Stage Renal Disease

Summary: the purpose of this study is to assess the aranesp® dose administered intravenously (iv) once weekly to maintain hemoglobin (hgb) levels in hemodialysis subjects who are either recombinant human erythropoietin (rhuepo) naïve or subjects converted from rhuepo therapy administered iv thrice weekly (tiw).


Eligibility criteria:
inclusion criteria: - subjects with end stage renal disease (esrd) on hemodialysis exclusion criteria: - known hypersensitivity to aranesp® (darbepoetin alfa) or any of its excipients - participating in an investigational drug or device trial - patient will not be available for follow-up assessment - patient has any disorder that compromises the ability of the patient to give written informed consent and/or to comply with study procedures

Keywords: end stage renal disease (esrd) kidney disease, dialysis aranesp®, rhuepo anemia, hemoglobin dosing, amgen
normative database for pattern electroretinogram (perg) and flash electroretinogram (ferg)

Conditions: Glaucoma

Summary: the main goal of the study is to compile a normative database for the neuro optic vision assessment (novatm) pattern electroretinogram (perg) and flash electroretinogram (ferg) modules. this normalization intends to be included in a probabilistic analysis protocol to allow novatm perg/ferg users to identify patients with results outside the normal ranges.

investigators plan to enroll 50 subjects at wills eye hospital without any eye diseases. participants will undergo a complete eye examination to determine eligibility, including visual acuity testing, intraocular pressure (iop) in millimeters of mercury (mmhg), and visual field (vf) testing. participants will then be tested with diopsys nova™ perg \& ferg systems. for both tests, two electrodes are placed on the skin underneath each eye below the eyelashes. participants' skin will be cleaned before electrodes are placed. a small amount of gel will be placed on skin where electrodes are placed for testing. electrical responses are recorded with electrodes in response to visual stimuli.

Eligibility criteria:
inclusion criteria: * healthy volunteers age 18 years * older with normal eye exam exclusion criteria: * spherical refraction outside + 5.0 diopters and cylinder correction outside + 3.0 diopters. * iop (intraocular pressure) ≥ 22 mm hg (millimeters of mercury) * history of any type of glaucoma in either eye. * intraocular surgery in study eye (except non-complicated cataract or refractive surgery performed more than 1 year before enrollment). * best corrected visual acuity worse than 20/40. * evidence of diabetic retinopathy, diabetic macular edema, or other vitreo-retinal disease in either eye. * evidence of optic nerve, macula and/or retinal nerve fiber layer abnormality in either eye. * evidence of reproducible (false positives, fixation losses and false negatives ≤ 25% with no observable testing artifacts). * standard automatic perimetry (sap) abnormality in either eye, defined as pattern standard deviation \< 5% level, and/or abnormal glaucoma hemifield test result, and/or any other pattern of loss which is consistent with a neurologic and/or ocular disease. * current or recent (within the past 30 days) use of an agent (by any administering method) known to affect visual function. * inability to obtain reliable perg/ferg (pattern electroretinogram/flash electroretinogram) results.

Keywords: pattern electroretinogram (perg) flash electroretinogram (ferg)
efficacy and safety of asenapine with placebo and haloperidol (41023)(p05926)(completed)

Conditions: Schizophrenia

Summary: schizophrenia is a brain disease. the primary features of schizophrenia are characterized by positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. the symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. asenapine is an investigational drug that may help to correct the inbalance in dopamine and serotonin. this is a 6-week trial to test the efficacy and safety of asenapine, compared with placebo, using an active comparator agent (haloperidol) in the treatment of patients with an acute exacerbation of schizophrenia. patients who complete the 6-week trial will have the option of continuing in an additional one year extension trial.


Eligibility criteria:
inclusion criteria: * currently suffering from an acute exacerbation of schizophrenia. caregiver required. exclusion criteria: * have an uncontrolled, unstable medical condition. have any other pyschiatric disorder other than schizophrenia as a primary diagnosis.
electrophysiological biomarkers in mtle patients.

Conditions: Mesial Temporal Lobe Epilepsy

Summary: the investigators plan to enroll individuals with medical temporal lobe epilepsy who are undergoing surgical workup with clinically implanted intracranial electrodes. the study intends to administer computerized memory tasks and stimulation during the intracranial electroencephalography (eeg) monitoring period.

this is a nonrandomized interventional trial that will apply brain stimulation via clinically implanted intracranial electrodes to subjects with medial temporal lobe epilepsy with the purpose of identifying biomarkers related to the pre-ictal state; to perform an acute parameter search to determine the stimulation pattern that most effectively modifies these biomarkers and to identify changes in memory (free recall) during asynchronous distributed multi-electrode stimulation (admes).

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. male or female, aged 18-65 3. diagnosed with lesional or non-lesional mesial temporal (hippocampal) seizure onset confirmed on seeg monitoring 4. implanted with depth electrodes for localization of seizure onset with multiple hippocampal electrode arrays exclusion criteria: 1. any patient who is unwilling or unable to provide consent 2. women who are pregnant 3. patients under 18 years 4. incarcerated persons

Keywords: epilepsy biomarkers
stroke recovery and music or no music

Conditions: Ischemic Stroke

Summary: the primary outcome of this study is to determine the quantitative increase in connectivity, as measured by fmri brain and calculated as a percent increase from baseline in patients with ischemic stroke. eligible patients will receive a listening session of music or spoken word listening, 30 days to 5 years following ischemic stroke. assessments will include modified rankin scale, national institute of health stroke scale, functional magnetic resonance imaging, motor function tests, and neuropsychological evaluations. assessments occur at baseline, day 45, and day 90 after starting listening sessions.

this is a prospective, investigator-blinded and outcome assessor-blinded, randomized, single-center study in subjects 18-90 years old who have sustained an ischemic stroke within 30 days to 5 years. study subjects will be randomized 1:1 to receive one of two types of listening sessions: music or spoken word (language) listening. each arm will enroll a total of ten subjects, with a total study population of 20 subjects. subjects will follow a 90-day listening schedule. subjects will complete a baseline montreal cognitive assessment (moca), national institute of health stroke scale (nihss), modified rankin score (mrs), motor function tests, neuropsychological evaluations and functional magnetic resonance imaging (fmri) brain evaluation. follow-up evaluations on day 45 (+/- 7 days) and on day 90 (+/-7days) and will include nihss/mrs, motor function tests, neuropsychological evaluations and fmri brain evaluation. all subjects will continue to receive standard of care treatment for stroke as directed by their physician(s) regardless of study enrollment. the primary objective is to determine the quantitative increase in connectivity, as measured by fmri brain and calculated as a percent increase from baseline. the secondary objectives include the effect of music and language listening in improving motor function and neuropsychological development in patients with an ischemic stroke.

Eligibility criteria:
inclusion criteria: 1. ischemic stroke 30 days to 5 years days prior to enrollment 2. age 18-90 3. modified rankin score (mrs) 1-3, inclusive, post-qualifying event (for a history of multiple strokes, baseline mrs is 0-1 and a lower value than the qualifying mrs) 4. a measureable deficit either in motor or speech/cognition that can be assessed using standardized testing 5. fluency in english (written and verbal) 6. demonstrates willingness to participate in study and complete all schedule of events exclusion criteria: 1. severe cognitive impairment, as determined by investigator using the baseline moca score 2. comorbid neurological disease that may interfere with rehabilitation 3. psychiatric disorder or taking psychoactive medication that may interfere with completing study 4. inability to complete music listening exercises 5. alcohol or drug abuse 6. hearing impairment 7. contraindication to scheduled fmri brain evaluations 8. pregnant women

Keywords: stroke music ischemic stroke fmri functional mri
metabolic phenotypes of obesity and diabetic kidney disease in patients with type 2 diabetes mellitus

Conditions: Diabetic Kidney Disease; Obesity; Metabolic Syndrome; Diabetes Mellitus, Type 2

Summary: 1. comparison between the 4 groups of metabolic phenotypes of obesity as regard the presence and frequency of dkd 2. relation between dkd , obesity (bmi) and metabolic risk factors in patients with type 2 dm

diabetes is the major cause of chronic kidney disease in industrialized countries. individuals with diabetes and ckd are at a higher risk of developing end stage renal disease and experiencing cardiovascular death. type 2 dm complications are predicted by low estimated glomerular filtration rate and high urine albumin excretion(1). diabetic kidney disease is the primary cause of kidney failure globally, affecting 25% to 40% of persons with diabetes mellitus . early diagnosis of high-risk patients is crucial due to the high-risk of progressive deterioration of kidney function leading to end-stage kidney disease, which ultimately requires kidney replacement therapy (2). dkd risk factors include non modifiable factors like age , gender , race , genetics and modifiable factors like obesity and lifestyle. obesity is typically associated with metabolic diseases such as hyperglycemia, dyslipidemia, and high blood pressure. obesity's impact on renal insufficiency is debated ,and may be influenced by other metabolic abnormalities(3). metabolic phenotypes of obesity based on the bmi-based categories (non-obesity, obesity) and metabolic status (metabolically healthy status or metabolically unhealthy status): metabolically healthy non-obesity (mhno), metabolically healthy obesity (mho), metabolically unhealthy non-obesity (muno) and metabolically unhealthy obesity (muo)(3). there is a strong correlation between obesity and the onset and course of chronic kidney disease, according to a number of population-based studies. the investigators think there are still unsolved issues about the connection between obesity and ckd(4). so the study is concerned about detection of the relation between metabolic phenotypes of obesity and diabetic kidney disease

Eligibility criteria:
inclusion criteria: * type 2 diabetic adult patients admitted at assiut university hospital divided into 4 groups of metabolic phenotypes according to obesity and metabolic status . exclusion criteria: 1. age less than 18 2. type 1 diabetes 3. those with a bmi \&lt;18.5 kg/m2 4. co-existing non-diabetic renal disease 5. pregnancy and patients with malignancy 6. urinary tract infection
tricalm hydrogel® in the treatment of immunotherapy-related pruritus

Conditions: Immunotherapy-related Pruritus

Summary: this is a phase 2, randomized, open-label, single-center study that will assess the efficacy of tricalm hydrogel®, a topical gel containing strontium, for treating pruritus related to immune checkpoint inhibitors (icis).

pruritus is a common immune-related adverse event of immune checkpoint inhibitors (ici). this is a phase 2, randomized, open-label, single-center study that will assess the efficacy of tricalm hydrogel®, a topical gel containing strontium, for treating pruritus related to icis. topical strontium salts have been found to reduce the duration and severity of histaminergic and nonhistaminergic pruritus. the investigators hypothesize that tricalm hydrogel® will be effective in reducing the severity of immunotherapy-related pruritus and improve quality of life.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 years or older. 2. patients receiving icis for hematologic or oncologic malignancies at the moores cancer center infusion center at uc san diego. icis include ctla-4 inhibitors (ipilimumab), pd-1 inhibitors (cemiplimab, nivolumab, pembrolizumab) and pd-l1 inhibitors (atezolizumab, avelumab, durvalumab). 3. patients who develop grade 1-3 pruritus at any time after receiving at least one dose of ici. 4. preexisting use of oral antihistamines and/or gaba analogs more than 7 days prior to study entry are allowed. exclusion criteria: 1. diagnosis of primary skin disorders with pruritus symptoms (e.g., atopic dermatitis, psoriasis). 2. initiation of any new oral or topical antipruritic medications and/or systemic corticosteroids within 7 days prior to study entry. 3. presence of open wounds on the skin. 4. presence of pruritus on the face.

Keywords: immunotherapy pruritus
ips/peer support intervention in the dtes

Conditions: Behavior, Adaptive; Mental Illness; Substance Use

Summary: individual placement support (ips) is an evidence-based supported employment model for people with severe mental illness, designed to achieve employment in mainstream competitive jobs, either part-time or full-time. the aim of this study is to assess the (i) effectiveness of embedding the (ips)/peer support intervention as part of the primary care centre in securing employment of adults living in the downtown eastside in comparison to the usual treatment workbc (control group). (ii) effectiveness of ips/peer support versus the usual treatment (workbc) in improving mental illness, quality of life and personal recovery through participation in employment.

this 18-month mixed methods study consists of an effectiveness multi-site randomized controlled trial of the ips/peer support intervention plus an embedded qualitative exploration of participants' experiences. all clients receiving primary care services from one dtes clinical site who are employment ready and are not receiving mental health services will be randomly assigned to ips \& peer support (experimental group) or workbc (control group). clients are required to participate in the intervention for 16 weeks and will be assessed at baseline, 1-, 3-, and 6-months post study intervention start-date for both groups. assessments will include the 5 questionnaires administered at baseline which cover the following: employment quality, employment sustainability, education quality and quantity, quality of life, community engagement and clinical significant levels of depression and anxiety.

Eligibility criteria:
inclusion criteria: * adults, age 19 and over, accessing primary care services at the primary care centre listed in this study (ch pender community health centre) * at least one visit to vch pender community health centre * currently unemployed and not in school or post-secondary training. * able to provide informed consent and fluent in english (intervention is currently offered in english only). * not hospitalized at the time of recruitment. exclusion criteria: • adults, age 19 and over who have access to mental health services

Keywords: homeless employment
100% vs 80% of pegasys in koreans with chronic hepatitis c (chc)

Conditions: Sustained Virologic Response; IL28B Polymorphism

Summary: 1. randomized controlled multicenter study 2. the response of reducing dose of peginterferon alfa-2a in koreans with chronic hepatitis c genotype 1 3. il28b polymorphism in koreans with chc

the virologic response of koreans to combination therapy for chronic hepatitis c is similar to non-asians; however, dose modification occurs more frequently in koreans. -when we evaluated the rates of peginterferon α-2a and ribavirin dose modifications and their effect on the virologic response in koreans, we suggested that using at least 80% of the peginterferon α-2a dose in koreans not only maintains svr but also reduces drug side effects during the entire treatment period and a lower dose of ribavirin may be as efficacious as a standard dose(korean j intern med 2009;24:203-211). so we investigate whether the group of 80% use dosage of peginterferon alfa-2a did not show inferior response rather than that of 100 % use dosage group and minimize the adverse events. there are recently reports that koreans have favorable il28b snp for chc treatment. -we investigate the il28b polymorphism in koreans with chc and this result can effect on the svr depending on the dosage of peginterferon alfa 2a

Eligibility criteria:
inclusion criteria: * chronic hepatitis c (anti hcv+, hcv rna +) * genotype 1 * over 18 year-old * pregnancy test negative if women of childbearing age exclusion criteria: * pregnant women or breast feeding women * systemic chemotherapy or steroid therapy before 6 months of trial * coinfection with hav, hbv, and hiv * other liver disease such as hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxic hepatitis * hepatocellular carcinoma * evidence of decompensation such as variceal bleeding,ascites, encephalopathy * anc less than 1500, platelet less than 90k * cr more than 1.5 of unl * severe psychiatric problem * poorly controlled thyroid disease * severe retinopathy

Keywords: reducing dose of peginterferon chronic hepatitis c koreans il28b polymorphism
interstitial brachytherapy boost for treatment of anal canal cancers, comparison of two dose rates

Conditions: Anal Canal Cancer

Summary: comparative retrospective study of two anal canal brachytherapy techniques aimed at boosting \[low dose rate (ldr) and high dose rate (hdr)\]

efficacy of anal canal interstitial brachytherapy evaluated by local relapse rate, tolerance of interstitial brachytherapy of the anal canal evaluated by the rate of chronic toxicities.

Eligibility criteria:
inclusion criteria: * patients treated by brachytherapy anal canal to boost. exclusion criteria: * patients below age of 18 years

Keywords: anal canal cancer brachytherapy