Kornimate/medical-research-clean huggingface dataset:
promoting the universal medication schedule via mobile and ehr technologies

Conditions: Type 2 Diabetes

Summary: the purpose of this study test the effectiveness of the universal medication schedule (ums), which was designed as a strategy to standardize and simplify medication instructions to support safe and effective prescription drug use among diabetic.

research has shown the ums (1) improves patients' understanding of how much to take of a medicine and when, and (2) reduces the number of times per day patients would take a multi-drug regimen. in this study, ums tools will be exported into a second electronic health record platform to demonstrate ease of dissemination. also, as patients may require assistance outside of clinic visits to adapt their prescription regimen to the ums, this study will test the potential benefit of daily short message service (sms) text reminders via cell phone. we will conduct a three-arm, provider-randomized controlled trial among english and spanish-speaking adults taking three or more prescription drugs to evaluate the effectiveness of the ums strategy, with and without sms text reminders, to improve patient understanding, consolidation, and adherence compared to usual care.we will conduct a three-arm, provider-randomized trial at two community health centers in chicago, il to evaluate the ums and ums+sms text reminder strategies compared to usual care. english and spanish-speaking patients who are prescribed three or more medications will be recruited and assessed by phone at baseline, three months, and six months.

Eligibility criteria:
inclusion criteria: * diagnosis of type ii diabetes * age 30 or older * taking 3 or more prescription medications for chronic conditions * english or spanish speaking exclusion criteria: * self-reported severe, uncorrectable vision * hearing impairment * cognitive impairment * not responsible for administering his/her own medications * not able to receive text messages on their cell phone

Keywords: ums medication schedule diabetes drug labeling
effect of gdc-0810 on the pharmacokinetics of pravastatin in healthy female subjects of non-childbearing potential

Conditions: Breast Cancer

Summary: this study is to assess the pharmacokinetics (pk) of a single dose of pravastatin with and without concomitant gdc-0810 administration in healthy female subjects of non-childbearing potential. during period 1 (day -1 to day 4) pk parameters of pravastatin will be determined in the absence of gdc-0810. during period 2 (days 5-28) pk parameters of pravastatin will be determined in the presence of gdc-0810.


Eligibility criteria:
inclusion criteria: * female subjects between 18 and 65 years of age, inclusive. * female subjects of non-childbearing potential including non-pregnant, non-lactating, and either postmenopausal or surgically sterile for at least 45 days post procedure. * within bmi range 18.5 to \</= 29.9 kg/m\^2, inclusive. * in good health, as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ecg), vital signs, and clinical laboratory evaluations. * receive an explanation of the mandatory pharmacogenomic (pgx) component of the study. exclusion criteria: * significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder. * previous history of adverse reaction to statins. * participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to check-in (day -1) in period 1. * use of systemic hormone replacement therapy within 1 year prior to check-in (day -1). * history of use of tamoxifen, aromatase inhibitor or any other endocrine agent for treatment of breast cancer. * female subject is pregnant lactating, or breast feeding.
study of gw823093 in japanese subjects with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: to investigate the preliminary pharmacokinetics, pharmacodynamics, safety and tolerability of gw823093 at doses of 15mg and 30mg given once daily for 7 days in japanese type 2 diabetes mellitus (t2dm) patients.


Eligibility criteria:
inclusion criteria: * t2dm diagnosed at least 3 months prior to screening and fasting plasma glucose (fpg) level \<280mg/dl at the screening visit. * concurrent t2dm therapy: must be diet controlled - or - not taking more than 2 oral anti-diabetic agents, and willing to withdraw from these treatments 2 weeks prior to the first dosing. exclusion criteria: * must not have any other major illness other than diabetes

Keywords: pharmacodynamics diabetes pharmacokinetics
evaluation of elexacaftor/tezacaftor/ivacaftor (elx/tez/iva) in cystic fibrosis (cf) participants 12 to less than 24 months of age

Conditions: Cystic Fibrosis

Summary: this study will evaluate the pharmacokinetics (pk), safety, tolerability, pharmacodynamics (pd), and efficacy of elx/tez/iva in cf subjects 12 to less than (\<) 24 months of age.


Eligibility criteria:
key inclusion criteria: participants who have at least 1 f508del mutation in the cf transmembrane conductance regulator (cftr) gene or another elx/tez/iva-responsive cftr mutation key exclusion criteria: history of any illness or any clinical condition that, in the opinion of the investigator, might either confound the results of the study or pose an additional risk in administering study drug(s) to the participant other protocol defined inclusion/exclusion criteria may apply.
radiodiagnostic properties of maxillary antroliths

Conditions: Antrolith; Maxillary Sinus

Summary: background: to evaluate the frequency and radiodiagnostic characteristics of maxillary antroliths using cone beam computed tomography. materials and methods: a review of 1166 patients aged 11-85 years was conducted to assess the frequency of maxillary antroliths, considering sex, age, and location. the relationship between antroliths and sex, location, dental treatment status, and sinus inflammation was evaluated. the shape, size, and volume of the antroliths were also analyzed. significance was set at p=0.05 for statistical analysis.


Eligibility criteria:
inclusion criteria: * dpr and cbct and also had a maximum of 3 months * image quality was sufficient * no artifacts cbct images exclusion criteria: * tomographic images that contained pathologies such as cysts/tumors in the * insufficient diagnostic quality * history of maxillofacial trauma or surgery, any syndrome/bone-related disease/metabolic disease * insufficient diagnostic quality or patient position-related artifacts

Keywords: cone beam computed tomography lithiasis maxillary sinus panoramic radiography
safety, tolerability, and immunogenicity of different combinations of trivalent influenza vaccine varying influenza antigen dose, adjuvant dose, and route of administration in healthy elderly individuals ages 65 years and older

Conditions: Influenza

Summary: the study will evaluate the safety, tolerability and immunogenicity of different doses and types of influenza vaccine in healthy elderly subjects.


Eligibility criteria:
inclusion criteria: * subjects 65 years or older generally in good health as determined by medical history, physical assessment and clinical judgment of the investigator. exclusion criteria: * subjects who have received influenza vaccine within the past 6 month and who have received adjuvanted vaccine in the past two years. * subjects with hypersensitivity to vaccine components. subjects who are on or were recently on immunosuppressive therapy.

Keywords: influenza flu vaccine intradermal adjuvant
effects of psyllium on niacin tolerability

Conditions: Flushing; Hyperlipidemias; Dyslipidemias

Summary: the purpose of this study is to determine whether psyllium is effective in reducing flushing due to niacin and also to measure the effect of niacin on cholesterol levels.


Eligibility criteria:
inclusion criteria: * patients who are starting er niacin for clinical indication by a healthcare provider * no prior use of psyllium for the past 2 months * no prior use of niacin for the past 3 months * ability to give informed consent * must be reachable by telephone exclusion criteria: * known contraindications to er niacin, aspirin or psyllium (including: presence of nausea, vomiting, abdominal pain, intestinal obstruction, or fecal impaction; known hypersensitivity to er niacin, aspirin or psyllium; severe hepatic dysfunction, transaminitis; history of gastrointestinal bleed attributable to aspirin induced gastritis) * patient who are unable to perform assessment of flushing using the standardized scales or questionnaires * patients who are pregnant

Keywords: niacin psyllium dietary fiber
a study of repetitive transcranial magnetic stimulation in bipolar patients

Conditions: Cognitive Impairment; Relapse; Bipolar Disorder

Summary: this study will investigate the effect of repetitive transcranial magnetic stimulation (rtms) on cognition and long-term clinical outcomes of bipolar patients.

cognitive deficits are core features of bipolar disorder. preliminary evidence shows that repetitive transcranial magnetic stimulation (rtms) might have positive effects in enhancing cognition and improving clinical symptoms in patients with depression. this study will investigate the effect of rtms on cognition and long-term outcomes (12 month) of bipolar patients.

Eligibility criteria:
inclusion criteria: * bipolar type i or ii subjects diagnosed according to the diagnostic and statistical manual of mental disorders (dsm-5) * age 18-60 years * rating on 24-items hamilton depression rating scale (hamd)\<18 * rating on the young mania rating scale (ymrs) \< 12 exclusion criteria: * history of any dsm-iv axis i diagnosis other than bd type i or ii * implanted medication pump or cardiac pacemaker; * have had prior brain surgery * any metal in the head (except in mouth) * any disease of increased intracranial pressure * suicide attempt * pharmacotherapy * unstable medical conditions * in the process of changing and redrawing withdrawing psychoactive medications within the past 4 weeks (except for sleeping medications such as benzodiazepines)
the renal safety of tenofovir alafenamide in hbv-related acute-on-chronic liver failure: real-world study

Conditions: Antiviral Drugs

Summary: tenofovir alafenamide (taf) and entecavir (etv) are the preferred agents in patients with predisposing factors for nephrotoxicity, but few studies to date have directly compared the renal safety of the two antiviral drugs in patients with acute-on-chronic liver failure (aclf). hence, the investigators compared the risk of kidney function decline among patients with hbv related acute-on-chronic liver failure (hbv-aclf) treated with etv or taf.from april 2020 to june 2021, a total of 272 hbv-related aclf hospitalized patients in the xiangya hospital of central south university were enrolled in this prospective study. chronic hepatitis b was diagnosed by hepatitis b surface antigen and/or hepatitis b virus deoxyribonucleic acid (hbv-dna) positivity for ≥6 months. aclf was diagnosed based on the criteria proposed by the apasl working party. all patients received antiviral therapy with taf (25 mg qd, n=100) or etv (0.5mg qd, n=172), and comprehensive medical treatments. clinical and laboratory data were collected to evaluate the progression of chronic kidney disease (ckd) .


Eligibility criteria:
inclusion criteria: * the presence of hepatitis b surface antigen (hbsag) in the serum for at least 6 months. * evidence of active viral replication as documented by measurable hbv dna in the serum (≥2000iu/ml). exclusion criteria: * less than 18 years old. * history of eskd or kidney transplantation. * unknown baseline estimated glomerular filtration rate (egfr). * coexistence with other liver diseases such as alcoholic liver disease, autoimmune hepatitis, drug-induced liver injury, or other viral infections(hepatitis a, c, and e virus or hiv infection). * concomitant with malignant tumor or other serious diseases affecting survival time. * patients with missing data. follow-up period of \<48 weeks.
a pilot study of the efficacy and program cost-effectiveness of prevention plus for childhood obesity

Conditions: Obesity

Summary: in 2007 the expert committee published recommendations on the prevention and treatment of childhood obesity. these recommendations outlined four interventions intended for advancement based on the child's age, body mass index (bmi), and response to treatment. the initial stage, prevention plus, is to be implemented in the primary care setting and focuses on primary care providers monitoring growth monthly and delivering intervention messages that target dietary and leisure-time behaviors that most contribute to energy imbalance in children. little research has evaluated the efficacy of these recommendations. thus the primary goal of the proposed pilot study is to test the feasibility of the prevention plus stage for treating childhood overweight and obesity in a primary care setting. as the cost of interventions is a large barrier to the translation of evidence-based research into primary care settings, a second goal of the project is to evaluate program cost-effectiveness.


Eligibility criteria:
inclusion criteria: * between 4 to 8 years of age at the start of the intervention * overweight or obese (≥85th bmi-for-age percentile) * have no medical conditions that effect growth, intake or physical activity (e.g., prader willi syndrome, type 2 diabetes, etc.) * not currently participating in a weight loss program and/or taking weight loss medication * have a primary caretaker willing to participate in the research study, receive monthly newsletters and be randomized to one of the three conditions * caretaker must be able to read, speak and understand english and the child speak english * have transportation to their child's primary care provider office * family does not plan to move out of the area before march 2012

Keywords: treatment of childhood obesity
a comparison of naropin and ketorolac for postoperative analgesia after total knee arthroplasty

Conditions: Postoperative Pain

Summary: the purpose of this study is to determine wether ketorolac is effective in the treatment of postoperative pain after total knee arthroplasty


Eligibility criteria:
inclusion criteria: * total knee arthroplasty * age \> 18 * tolerance for study drugs * written informed consent exclusion criteria: -

Keywords: total knee arthroplasty
multiple ascending dose study of tc-5619 in healthy elderly subjects and subjects with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this is a phase 1 study to examine the safety, tolerability and pharmacokinetics of tc-5619 in elderly subjects with and without alzheimer's disease. group 1 includes elderly subjects with alzheimer's disease to receive tc-5619 or placebo for 28 days to evaluate safety and tolerability. group 2 includes healthy elderly subjects in a dose escalation design to receive tc-5619 or placebo for 10 days to evaluate safety, tolerability and pharmacokinetics.


Eligibility criteria:
inclusion criteria (groups 1 \& 2): * normal body mass index (bmi) * non-smoking for a minimum of 3 months * subjects must be in reasonably good health, based on medical history, physical examination, vital signs, and ecg. group 1 only: * subjects a mini mental state examination score between 12-22, inclusive. * diagnosis of probable alzheimer's disease according to national institute of neurological and communicative disorders and stroke-alzheimer's disease and related disorders association (nincds-adrda) criteria * subjects must have a reliable caregiver. exclusion criteria (groups 1 \& 2): * subjects with clinically significant heart disease, pulmonary disease, diabetes, neurologic or psychiatric disease (group 1 subjects must have alzheimer's disease), or any other illness that could interfere with interpretation of study results. * subjects with a past or current history of seizures cannot participate. * current use of donepezil, rivastigmine or galantamine.

Keywords: alzheimer's disease
analysis of i-trace high order aberrations induced by wavefront optimized ablation profiles

Conditions: Myopia

Summary: this work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles wfo using i-trace aberrometer (ray -tracing)

the itrace (tracey technologies, houston, tx) is uniquely designed to combine placido corneal topography with a ray tracing aberrometer to measure quality of vision in a patient. this work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles wfo using i-trace aberrometer (ray -tracing)

Eligibility criteria:
inclusion criteria: 1. myopia up to -8.0 d and astigmatism up to -2.0d. 2. cases above 18 years of age with a stable refraction for at least one year. exclusion criteria: 1. keratoconus. 2. patients with collagen diseases. 3. previous lasik or any other refractive surgery. 4. severe dry eye syndrome.
a study of extended therapy of pegasys (peginterferon alfa-2a) in combination with copegus (ribavirin) in patients with chronic hepatitis c and slow response

Conditions: Hepatitis C, Chronic

Summary: this open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined pegasys and copegus extended therapy in patients with chronic hepatitis c with genotype 1, 2 and 3. patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with pegasys and copegus and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. pegasys 180 micrograms will be administered sc once weekly and copegus will be administered as 800 mg, or 1000-1200 mg daily oral doses. the anticipated time on study treatment is 24 weeks. the target sample size is 50-150 patients.


Eligibility criteria:
inclusion criteria: * adult patients \>/= 18 years of age * chronic hepatitis c, genotype 1, 2, 3 * compensated liver disease * patients who completed 48 weeks or 24 weeks of standard treatment with pegasys and copegus and were identified as slow virological responders exclusion criteria: * decompensated liver disease * signs or symptoms of hepatocellular carcinoma * uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus
uhcds a-tdcs + te in fibromyalgia patients

Conditions: Fibromyalgia

Summary: the present study aims to investigate the effect of a unihemispheric concurrent dual-site anodal transcranial direct current stimulation combined with therapeutic exercise on pain in subjects with fm.

fibromyalgia (fm) syndrome is characterized as a cardinal symptom of chronic pain. it is one of the rheumatic diseases with the greatest impact on quality of life. although the etiology and pathophysiology are not yet completely clear, fm is related to specific changes in brain activity, such as a decrease in blood flow in the thalamus, caudate nucleus and pons tegmentum. this could be related to the appearance of a disorder in pain regulation, characterized by an alteration of the sensory and pain process in the central nervous system, due to neuroplastic changes in the neural circuits related to pain. imaging studies have shown that fm could be associated with functional changes in the brain, such as a reduction in connectivity in efferent pain inhibitory pathways and central sensitization in afferent pain pathways, resulting in an increase in pain perception. the most common fm treatment guidelines recommend aerobic exercise as the only non-pharmacological therapy with level a recommendation in the treatment of fm. in the same way, it concludes that it is more than recommended to combine therapies assuming synergistic effects between them. neuromodulation treatments with transcranial direct current stimulation (tdcs) have been shown to induce significant analgesia in fm through the modification of sensory processing of pain by thalamic inhibitory circuits. to date, the few studies that have combined tdcs and therapeutic exercise in fm have applied tdcs to the primary motor cortex (m1) in isolation. currently, several studies conclude that unihemispheric concurrent dual-site anodal transcranial direct current stimulation (uhcds a-tdcs) on the dorsolateral prefrontal cortex (dlpfc) and m1 produces a 50% greater modulation of corticospinal excitability in healthy subjects. to date, there is no study that has evaluated the effectiveness of this novel application of tdcs in subjects with fm on pain.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years. * fulfilled the 2010 american colleague of rheumatology criteria for fibromyalgia. * usual pain intensity of 4 or more points on a visual analogue scale. * able to participated in a therapeutic exercise program. * understanding of spoken and written spanish. exclusion criteria: * pregnancy or breastfeeding. * metallic implants in the head. * tumor, trauma or surgery in the brain. * epilepsy or stroke. * history of substance abuse in the last 6 months. * use of carbamazepine in the last 6 months. * diagnosed psychiatric pathology. * rheumatic pathology not medically controlled. * coexisting autoimmune pathology. * chronic inflammatory disease (rheumatoid arthritis, erythematosus systemic lupus, inflammatory bowel disease).

Keywords: neuromodulation therapeutic exercise pain