Kornimate/medical-research-clean huggingface dataset:
moving well for total knee arthroplasty (tka)

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to assess the efficacy of a behavioral intervention, moving well, in improving levels of anxiety and depression for patients undergoing total knee arthroplasty (tka).

moving well is a behavioral intervention, guided by peer coaches, that aims to improve mental and physical preparation for patients planning to undergo total knee arthroplasty (tka) and improve postoperative recovery and outcomes. peer coaches are patients who themselves have had tka due to advanced osteoarthritis (oa) of the knee and have been trained and certified to become peer coaches.

Eligibility criteria:
inclusion criteria: * subjects must have their primary tkr (one knee or both knees) scheduled in 8 weeks or more * be willing to participate in the moving well (intervention) arm or staying well (attention control) arm * are willing to work with a coach * ≥ 50 years of age * speak english * have access to the internet, computer, and a working phone * we will prioritize the recruitment of subjects with low socioeconomic status defined as being a beneficiary of medicaid or no insurance and an underrepresented racial/ethnic group (hispanic/black). exclusion criteria: * non-english speakers * the intervention will first be delivered in english to ensure feasibility with the content before adapting the material for patients who speak other languages. * tkr was a result of a septic joint or revision (implant malfunction) * unable to exercise (e.g., bed bound or wheelchair bound) * have had contralateral tkr or other joint replacement surgery (hip, shoulder) within the past 5 years * if they have ra or other connective tissue disease: lupus, ankylosing spondylitis, psoriatic arthritis, scleroderma, infectious arthritis, polymyalgia rheumatica.

Keywords: arthroplasty replacement peer coach
efficacy and safety of oral roflumilast taken once daily in patients older than 40 years with chronic obstructive pulmonary disease (by217/m2-119)

Conditions: COPD

Summary: the aim of the study is to compare the effect of roflumilast on lung function in patients with copd. roflumilast will be administered orally once daily in the morning at one dose level. the study duration consists of a baseline period (4 weeks) and a treatment period (12 weeks). the study will provide further data on safety and tolerability of roflumilast.


Eligibility criteria:
main inclusion criteria: * written informed consent * patients with a history of chronic obstructive pulmonary disease (copd) as defined by the gold criteria (2003) * fev1/fvc ratio (post bronchodilator) smaller or equal 70% * fev1 (post bronchodilator) 30-80% of predicted * fixed airway obstruction * current smoker or former smoker (smoking cessation at least one year ago) with a smoking history of at least 10 pack years * clinically stable copd within 4 weeks prior to baseline visit * availability of a chest x-ray main exclusion criteria: * copd exacerbation indicated by a treatment with systemic glucocorticosteroids * lower respiratory tract infection * diagnosis of asthma * known alpha-1-antitrypsin deficiency * need for long term oxygen therapy defined as longer or equal 16 hours/day * clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator) * known infection with hiv, active hepatitis and/or liver insufficiency (according to the child pugh score a or worse) * diagnosis or history of cancer * clinically significant cardiopulmonary abnormalities * pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial * female patients of childbearing potential, not using reliable method of contraception for the entire study duration, post-menopausal \> 1 year or who are not using any other method considered sufficiently reliable by the investigator in individual cases * participation in another study (use of investigational product) within 30 days preceding the baseline visit or re-entry of patients already enroled in this trial * alcohol or drug abuse * inability to follow the study procedures due to e.g., language problems, physiological disorders * use of not allowed drugs * suspected hypersensitivity to the study medication or rescue medication

Keywords: copd chronic obstructive pulmonary disease roflumilast
evaluate protective efficacy of diff strengths of human rotavirus vaccine after admn of 2 doses to infants aged 2 months

Conditions: Infections, Rotavirus

Summary: the purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.


Eligibility criteria:
inclusion criteria: * healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks or a birth weight of \>2000g. * written informed consent obtained from the parent or guardian of the subject. exclusion criteria: * planned administration of oral polio vaccine during the period starting from 2 weeks before each dose of study vaccine(s) and ending 2 weeks after. * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection * history of diphtheria, tetanus, pertussis, hib disease and/ or hepatitis b. * previous vaccination against diphtheria, tetanus, pertussis, and/or haemophilus influenzae type b. * history of allergic disease * any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gi tract or other serious medical condition as determined by the investigator. * gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination) * previous confirmed occurrence of rv ge. * household contact with an immunosuppressed individual or pregnant women. * administration of immunoglobulins and/or blood products since birth or planned administration during the study period
the effect of uv-c enriched foods on vitamin d deficiency

Conditions: Vitamin d Deficiency

Summary: this study is an experimental design study in which demographic characteristics, food consumption, biochemical parameters and anthropometric measurements of individuals with low vitamin d levels before and after consuming uv-enriched foods will be examined.

it was designed to be applied to individuals with low vitamin d levels working in fatih sultan mehmet training and research hospital who meet the research conditions. n the first phase of the study, demographic information will be recorded by asking demographic information from the people who volunteered to participate in the study and who meet the study criteria by using a questionnaire form and 3-day food consumption record information by face-to-face interview technique; anthropometric measurements of the participants will be taken and baseline blood values will be recorded. at the beginning of the experimental study, individuals will be randomized by computer-assisted randomization into four different groups. biochemical analyses will be analyzed every two weeks, analyses will be repeated 1 month after the study and the effects of vitamin d enrichment on biochemical parameters will be determined.

Eligibility criteria:
inclusion criteria: 1. working in the hospital 2. being between the ages of 18 and 65 3. not being pregnant or lactating 4. not taking vitamin d supplements or fish oil in the last 1 month 5. serum 25(oh)vitamin d value below 30 μg/l 6. no kidney disease, kidney stones, cortisone use, blood thinners 7. not being in a solarium 8. not eating fish more than once a week 9. volunteering to participate in the research exclusion criteria:
prevention of p. vivax malaria during pregnancy in bolivia

Conditions: Malaria

Summary: the purpose of this study is to determine which, between weekly prophylaxis or malaria attack treatment, both by chloroquine, is the most appropriate way to protect women and foetus from p. vivax malaria infection during pregnancy.

it has been demonstrated that malaria is responsible for anaemia during pregnancy and reduces birth weight among newborns. in bolivia, malaria is mostly caused by p. vivax. maternal and foetal consequences of p. vivax infections have been poorly investigated until now, over all in south america. in fact, recommendations for the protection of pregnant women from malaria in bolivia have not been clearly established. prophylaxis by chloroquine is still recommended in other continents than africa, mainly because chloroquine resistances are still uncommon in p. vivax species. the alternative way to protect women during pregnancy is to treat malaria attacks during antenatal visits. for this purpose, we will realize a study in order to assess the most appropriate way to protect women and foetus from malaria infection, i.e. weekly prophylaxis or mild malaria attack treatment, both by chloroquine. by realizing a randomized and multicentric clinical trial on 800 women in each group, we will compare the impact on maternal malaria attack incidence rates, on proportions of mothers with anaemia, on low-birth weight and on positive parasitaemias during pregnancy and at delivery, of weekly prophylaxis and mild malaria attack diagnosis and treatment. the study will be undertaken during 18 months in the region of santa cruz and will give important information to the bolivian ministry of health for establishing national recommendations.

Eligibility criteria:
inclusion criteria: * pregnancy between 4 to 36 weeks of gestation * intention to deliver at the maternity clinics * residence near the maternity clinics * written informed consent (parents or tutors if aged\<18 years) exclusion criteria: * pregnancy prior to 4 weeks or after 36 weeks of gestation * allergy to chloroquine * clinical signs of hepatic or renal alteration * inability to take drugs by oral route * presence of effective uterine contractions

Keywords: malaria plasmodium vivax pregnancy chemoprophylaxis
chronic insomnia and csf markers of dementia

Conditions: Insomnia Chronic

Summary: the longstanding view has been that insomnia, and other forms of sleep disturbance, emerge as a consequence of dementia and are the result of progressive neuronal damage. however, there is growing evidence that the direction of causation may go both ways, with sleep disturbance potentially increasing vulnerability to dementia. longitudinal studies have found that sleep disturbance often precedes and increases risk for dementia by several years.the purpose of this study is to examine the relationship between chronic insomnia and dementia biomarkers and orexin levels found in cerebrospinal fluid (csf). fifteen adults age 30-50 with chronic insomnia and age- and gender-matched good sleepers will undergo overnight polysomnography and csf sampling in the morning.


Eligibility criteria:
inclusion criteria: * age 30-50 * men and women * to be included in the insomnia group, subjects must meet the following dsm5 diagnostic criteria for insomnia disorder: dissatisfaction with sleep quantity or quality (difficulty initiating or maintaining sleep, or waking up too early) despite adequate opportunity for sleep; sleep disturbance causes clinical significant distress or impairment in functioning; present at least 3 times per week for at least 3 months; sleep disturbance is not better explained by a medical or psychiatric condition or based on the effects of a substance exclusion criteria: * diagnosis or evidence of sleep disorders other than insomnia as determined by the screening questionnaires and clinical history * women who have been pregnant or lactating within the past six months * non-fluency in spoken or written english * current or past month shiftwork defined as working during the evening or night shift * current use of medications or otc products that impact sleep * evidence of neurological abnormalities that could include the risks associated with lumbar puncture (e.g.papilledema, mass lesion, chiari malformation).
root canal treatment outcome in patients under bisphosphonate therapy

Conditions: Root Canal Infection; Bisphosphonate-Associated Osteonecrosis; Periapical Abscess; Endodontically Treated Teeth

Summary: the aim of this study was to evaluate the survival rate and healing time of compromised teeth and seriously compromised teeth that were endodontically treated in patients which received bisphosphonate therapy . clinical complications, success and survival rate was reported. mean clinical parameters, clinical symptoms and presence of periapical radilucency were recorded.

the study was conducted in one university endodontic clinical department - dental school between january 2009 and december 2017. root canal treatment was performed according previously reported operative protocols.

Eligibility criteria:
inclusion criteria: * patients affected by endodontic disease and able to attend a hygiene recall program exclusion criteria: * inability to attend a recall hygien program

Keywords: success rate survival rate endodontic treatment
efficacy and safety of insulin detemir in combination with insulin aspart and biphasic insulin aspart 30 in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to investigate the efficacy and safety of an intensified treatment regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more convenient regimen with biphasic insulin aspart 30 twice daily on blood glucose control in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * duration of type 2 diabetes for at least 6 months since diagnosis * current treatment with one or two oral antidiabetic drugs for at least 3 months or with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily * bmi below 40 kg/m2 * hba1c between 7-12% * able and willing to perform self-monitoring of capillary blood glucose exclusion criteria: * current antidiabetic treatment with combination of three or more oral antidiabetic drugs * previous treatment with short-acting human insulin, short-acting insulin analogue or biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed) * known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the investigator * known or suspected allergy to trial product or related products * pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures * receipt of any investigational drug within 4 weeks prior to this trial * previous participation in this trial
atrial fibrillation and diabetes mellitus

Conditions: Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes

Summary: single center prospective study to analyze the impact of diabetes mellitus on patients' outcome following radiofrequency-guided catheter ablation for atrial fibrillation.

a total number of 50 patients with diabetes mellitus will undergo radiofrequency-guided catheter ablation for atrial fibrillation. pre-procedural cardiac mri will be performed with late-gadolinium enhancement to visualize the individual amount and distribution of fibrosis in the right and left atrium. the relationship between diabetes mellitus and individual atrial arrhythmia substrates as well as patients' outcome following catheter ablation will be analyzed.

Eligibility criteria:
inclusion criteria: * patients undergoing their 1st radiofrequency-guided catheter ablation for atrial fibrillation * diabetes mellitus * able to understand and willing to sign the informed consent form. * age ≥18 years. exclusion criteria: * contraindication for de-mri with a full dose of gadolinium-based contrast agent. * previous left atrial ablation or surgical procedure * women currently pregnant, breastfeeding, or of childbearing age not currently taking or not willing to use a reliable form of contraception * mental or physical inability to take part in the study * morbid obesity (bmi \> 35), or inability to be placed in mri due to body mass.
outcomes after hypotensive neuraxial anesthesia in total hip arthroplasty

Conditions: Total Hip Arthroplasty; Primary Total Hip Arthroplasty; Hypotension; Database

Summary: this is a retrospective chart review to determine if neuraxial anesthesia is associated with worse outcomes after primary total hip arthroplasty.

the goal of this study is to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in primary total hip arthroplasty. the plan to analyze the outcomes is listed below: primary outcomes: multiple logistic regression will be used to compute the adjusted odds ratios of any postoperative complications (mi, cva, death) , adjusting for covariates including duration of intraoperative mean arterial pressure of less than pre-defined threshold, such as 55, or 60 mmhg mean blood pressure. sensitivity analyses will also consider the effects of intra-operative hypotension (ioh) defined as mean blood pressure of less than 40, 45, 50, 55, 60, and 65 mm hg. secondary outcomes: multiple logistic regression will be to compute the adjusted odds ratios of individual postoperative complications, (such as mi, cva, stroke) , adjusting for covariates including duration of intraoperative mean blood pressure of less than pre-defined threshold, such as 55, or 60 mmhg mean blood pressure. sensitivity analyses will also be conducted to test the effects of extend of ioh on complications.

Eligibility criteria:
inclusion criteria: * all primary total hip arthroplasty patient data with sufficiently complete intraoperative vital signs exclusion criteria: * revision primary total hip arthroplasty * incomplete intraoperative vital signs * anterior total hip arthroplasty
stroke rehabilitation using brain-computer interface (bci) technology

Conditions: Stroke

Summary: the purpose of this research is to determine if functional muscle stimulation, directed by electroencephalogram (eeg) output, can increase the extent of stroke recovery on behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fmri). participants will include stroke patients with upper-limb hemiparesis and can expect to be on study for approximately 4 months.

ongoing research (nct02098265) suggests that noninvasive eeg driven brain computer interface (bci) systems hold the potential for facilitating recovery in the chronic phase after stroke by synchronizing central or brain activity with peripheral movements and thereby harnessing brain plasticity. the specific aims of this study are: aim 1: to investigate the efficacy of active fes vs. passive fes, as measured by changes in behavioral measures. the investigators hypothesize that improvements in motor function will be significantly greater using the active fes therapy than the passive fes therapy. aim 2: to investigate the relationship between brain functional activation patterns and behavior changes induced by active vs. passive fes intervention. the investigators hypothesize that changes induced by active fes (as measured by brain fmri and eeg measures) will show greater adaptive brain reorganization changes (i.e. brain changes that correlate with improved outcomes) than that induced by the passive fes. aim 3: to investigate the relationship between brain white matter integrity and behavior changes induced by active vs. passive fes intervention. the investigators hypothesize that changes induced by active fes (as measured by brain dti measures) will show greater adaptive brain reorganization changes (i.e. brain changes that correlate with improved outcomes) than that induced by the passive fes.

Eligibility criteria:
inclusion criteria: * new-onset ischemic stroke 12 months prior - chronic time frame; * right hand dominant - affected arm; * mild to moderate unilateral upper extremity impairment or severe unilateral upper extremity impairment; * no upper extremity injury or conditions that limited use prior to the stroke; * must be able to provide informed consent on their own behalf. exclusion criteria: * inability to competently participate in study procedures * concurrent upper extremity therapy, other neurological or psychiatric disorders

Keywords: aneurysm transient ischemic attack
an open label, phase ii trial of continuous low-irradiance photodynamic therapy (clipt) using verteporfin (visudyne®) for the treatment of cutaneous metastases of breast cancer

Conditions: Metastatic Breast Cancer

Summary: the purpose of this phase ii study is to evaluate the efficacy and safety of continuous low- irradiance photodynamic therapy (clipt) when used with verteporfin in the treatment of cutaneous metastases of breast cancer for which no curative or significantly palliative therapy exists, including chest wall therapy.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed stage iiib or iv breast cancer with cutaneous metastases. exclusion criteria: * participants receiving any medications or substances that are known to cause photosensitivity (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, fluoroquinolones, st. johns' wort, amiodarone) are ineligible. * participants who have received prior systemic therapy (chemotherapy or targeted therapy) within 7 days of study day 1 or those who have not recovered from clinically significant adverse events due to agents administered more than 7 days earlier. (continuation of the same regimen of her-2 antibody targeted therapy agents, hormonal therapy and treatment with bisphosphonates or denosumab are permitted) * participants who are receiving any other investigational agents during the proposed treatment cycle.
open-label extension to evaluate the longer term efficacy and safety of lib003

Conditions: Hypercholesterolemia

Summary: to assess the longer term safety, tolerability, and ldl c lowering efficacy after 52 weeks of additional treatment with lib003 with subcutaneous (sc) dosing every 4 weeks (q4w)

to assess the longer term safety, tolerability, immunogenicity, pk, pd and ldl c lowering efficacy after 52 weeks of additional treatment with lib003 with subcutaneous (sc) dosing every 4 weeks (q4w) in patients on stable maximally tolerated statins with or without ezetimibe who completed the phase 2 dose ranging trial lib003-002

Eligibility criteria:
inclusion criteria: 1. men and women 18 years or older 2. elevated ldl-c on current lipid lowering therapy and; prior atherosclerotic cardiovascular disease (cvd) event or evidence of cvd or without cvd but at high risk for cvd based on american heart association/american college of cardiology (aha/acc) cvd risk calculator, or aged 40 years and older with diabetes and moderate- to high-intensity statin, or pre-treatment ldl-c 190 mg/dl or greater or heterozygous familial hypercholesterolemia (hefh) 3. patients who met original entry criteria in, and completed, the double-blind, placebo-controlled 16-week phase 2 study (lib003-002) exclusion criteria: 1. patients who did not who complete the double-blind, placebo-controlled 16-week phase 2 study (lib003-002) 2. \<18 years of age 3. pregnant or women of childbearing potential not using acceptable birth control