Kornimate/medical-research-clean huggingface dataset:
study in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of vm-1500

Conditions: HIV-infection

Summary: a randomized single dose, drug-drug interaction study in healthy volunteers for vm - 1500 given alone or in combination with raltegravir or darunavir in a 3 arm approach. the parallel design is used due to the long half life for vm-1500.

this drug-drug interaction study will not be done as a cross-over study due to the extreme long half life of the drug. the 24 healthy subjects participating will be randomized to vm-1500 alone or vm-1500 in combination with raltegravir or darunavir in parallel arms. for the cohort taking vm-1500 40 mg only just 4 subject will be enrolled as 6 subjects have been already on the same regimen in the trial before. based on the parallel design it seems appropriate not to expose more healthy subjects than necessary. this means the available data of 6 subjects dosed with 40 mg vm-1500 alone will be matched. three groups of healthy subjects will be randomized to vm-1500 alone or vm-1500 in combination with raltegravir or darunavir (4:10:10). the healthy subjects will stay at the unit and receive 40 mg vm-1500 alone or vm1500 in combination with raltegravir or darunavir one time and pk blood samples at several time points will be collected. pk (trough level) blood samples will also be collected at visits on days 2, 4,7, 14, 21, and on day 36.

Eligibility criteria:
inclusion criteria: 1. male subjects age between 18-45 years 2. has been determined healthy by physical examination, assessment of drug abuse, medical history and vital signs 3. has normal or acceptable results for the following screening tests: complete blood count (cbc), blood urea nitrogen (bun), serum creatinine (cr), fasting blood sugar (fbs), total bilirubin, aspartate aminotransferase (ast or sgot), alanine aminotransferase (alt or sgpt), alkaline phosphatase (alp) and urinalysis. 4. negative result for hepatitis a, hepatitis b, hepatitis c and hiv antibodies 5. willing to participate and signed the informed consent form exclusion criteria: 1. hepatic or kidney disorders or any other disease or disorder which may in the opinion of the investigator interfere with the results of the study or threaten the health of volunteers; 2. drug intake (including herbal drugs) during the last month; 3. active alcohol and/or drug abuse that, in the opinion of the site investigator, would interfere with adherence to study requirements; 4. volunteers have taken any investigational drug at least 3 month prior to the start of the study; 5. inability to understand the protocol or follow its instructions.
development and assessment of a spanish-language hearing loss toolkit for self-management

Conditions: Hearing Loss

Summary: the objective of this application is to develop and evaluate spanish-language hearing education materials for adults. our hypothesis is that participants will demonstrate better understanding of their hearing loss and associated difficulties, and will be better able to identify options for self-management following delivery of culturally and linguistically appropriate patient education materials.

there are documented disparities in hearing healthcare use between hispanic/latino adults and non-hispanic/latino whites, despite similar hearing loss prevalence rates. it has been suggested that a lack of culturally competent interventions contributes to poor healthcare delivery and outcomes for those with limited english proficiency. the objective of this application is to develop and evaluate spanish-language hearing education materials for adults. our hypothesis is that participants will demonstrate better understanding of their hearing loss and associated difficulties, and will be better able to identify options for self-management following delivery of culturally and linguistically appropriate patient education materials. the rationale for the proposed research is that findings will contribute to the development and testing of novel interventions aimed at increasing hearing healthcare access and utilization in vulnerable populations in a subsequent r01 application.

Eligibility criteria:
inclusion criteria: 1. participants will include community-dwelling, spanish-speaking (monolingual or bilingual) adults over age 50 who self-identify as hispanic/latino 2. clinically-significant hearing loss defined as either greater than 25 decibels hearing leve (db hl) thresholds at 2 or more frequencies from 250 - 8000 hertz (hz) and/or significant self-reported hearing difficulties as defined by a score of greater than 8 on the hearing handicap inventory - screening measure for adults/elderly. exclusion criteria: * individuals who are not fluent spanish-speakers or who do not self-identify as hispanic/latino are not eligible to participate in this study.
pacritinib versus best available therapy to treat myelofibrosis

Conditions: Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis

Summary: phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to best available therapy (bat) in patients with primary or secondary myelofibrosis.

multicenter, randomized, controlled, phase 3 trial comparing the safety and efficacy of pacritinib with that of bat in patients with primary or secondary myelofibrosis. approximately 322 eligible patients will be randomized in a 2:1 allocation to pacritinib (400mg qd) or bat (includes any physician-selected treatment for myelofibrosis with the exclusion of jak inhibitors (inhibitors of janus kinases)). spleen volume will be measured by mri or ct at baseline and every 12 weeks thereafter. an independent radiology facility (irf), blind to treatment assignments, will measure spleen volumes. patients will also be followed for safety, leukemia free survival (lfs), overall survival (os), frequency of red blood cell (rbc) and platelet transfusions, and other exploratory endpoints. an independent data monitoring committee (idmc) will evaluate the safety of pacritinib.

Eligibility criteria:
inclusion criteria: * intermediate -1 or -2 or high-risk myelofibrosis (per passamonti et al 2010) * palpable splenomegaly ≥ 5 cm on physical examination * total symptom score \>13 on the mpn-saf tss 2.0, not including the inactivity question * patients who are platelet or red blood cell transfusion-dependent are eligible * adequate white blood cell counts (with low blast counts), liver function, and renal function * no spleen radiation therapy for 6-12 months * last therapy for myelofibrosis was 2-4 weeks ago, including any erythropoietic or thrombopoietic agent * not pregnant, not lactating, and agree to use effective birth control exclusion criteria: * prior treatment with a jak2 inhibitor * history of (or plans to undergo) spleen removal surgery or allogeneic stem cell transplant * ongoing gastrointestinal medical condition such as crohn's disease, inflammatory bowel disease, chronic diarrhea, or constipation * cardiovascular disease, including recent history or currently clinically symptomatic and uncontrolled: congestive heart failure, arrhythmia, angina, qtc prolongation or other qtc risk factors, myocardial infarction * other malignancy within last 3 years other than certain limited skin, cervical, prostate, breast, or bladder cancers * other ongoing, uncontrolled illnesses (including hiv infection and active hepatitis a, b, or c), psychiatric disorder, or social situation that would prevent good care on this study * life expectancy \< 6 months

Keywords: myelofibrosis post-polycythemia vera myelofibrosis post-essential thrombocythemia myelofibrosis primary myelofibrosis polycythemia vera essential thrombocythemia bone marrow disease hematologic disease splenomegaly pacritinib mpn-saf mpn-saf tss anemia myeloproliferative neoplasm spleen volume thrombocytopenia sb1518
assessing antibody responsiveness to hepatitis b vaccine in aged lymphoma patients undergoing treatment with rituximab

Conditions: Lymphoma

Summary: background: the ability of the immune system to function declines with aging. this is reflected by a marked decrease in the responsiveness to vaccinations and to infectious agents. consequentially, there is a profound reduction in the quality of live and an increased dependency on the health systems. studies have shown that the production of b lymphocytes in the bone marrow declines with aging and long-lived b cells accumulate in the periphery. thus, instead of a juvenile repertoire of b cells that is capable to recognize any new pathogen, the repertoire of the elderly becomes more restricted and fails to respond to new antigens. working hypothesis and aims: we hypothesize that the dramatic change in the cellular composition in aging reflects homeostasis pressures that are set by long-lived peripheral b cells. here, the investigators hypothesize that altering the homeostasis, by active depletion of the peripheral b cells, will revive b lymphopoiesis in the bm and rejuvenate the peripheral repertoire of b cells in aging. consequentially, this will significantly improve immune responsiveness of aged individuals to new antigenic challenges. methods: the investigators propose a parallel study in human and mouse. for our clinical study we will use old lymphoma patients that were treated with the b cell depleting therapy, rituximab, for transient b cell depletion and established full b cell reconstitution. we will test the responsiveness of these patients to hepatitis b vaccine and compare it to aged-matched control group. the investigators will also use old human cd20 transgenic mice where b cell depletion is imposed by anti human cd20 antibodies. in these experiments we will study physiological and immunological changes to understand aging mechanisms in the b lineage. expected results: we expect that old patients treated for b cell depletion will have an increased responsiveness to the hepatitis b vaccine relative to the control group. importance: the investigators propose an efficient approach to improve immune response in the elderly population. this will increase efficacy of vaccination, reduce morbidity and improve quality of life. it will also reduce the cost of medical treatment. in addition, this study will show that senescence in the b lineage can be reversed, which is in contrast to the general concepts of aging. probable implications to the welfare and health of the aged population medicine: improving the immune competence will increase efficacy of vaccination, reduce morbidity, and reduce dependency on health systems. this will significantly improve the quality of life.


Eligibility criteria:
inclusion criteria: * 55 years and older * lymphoma * rituximab exclusion criteria: * disease remission
dietary effects on circulating lipoprotein-associated phospholipase a2 (lp-pla2) activity and enzyme activity in peripheral blood mononuclear cells (pbmcs) in patients with prediabetes or newly diagnosed type 2 diabetes

Conditions: Impaired Fasting Glucose; Newly Diagnosed Type 2 Diabetes

Summary: we determined the effects of dietary intervention (replacement of refined rice with whole grains and legumes and a high intake of vegetables) on circulating lp-pla2 activity and enzyme activity in peripheral blood mononuclear cells (pbmcs) in patients with impaired fasting glucose (ifg), impaired glucose tolerance (igt) or newly-diagnosed type 2 diabetes.

ninety-nine patients with impaired fasting glucose (ifg), impaired glucose tolerance (igt) or newly-diagnosed type 2 diabetes were randomly assigned to either a control group (usual diet with refined rice) or the whole grain group.

Eligibility criteria:
inclusion criteria: * subjects who were in in impaired fasting glucose (ifg, 100≤ fasting glucose \<126 mg/dl) * or newly diagnosed type 2 diabetes (fasting glucose ≥126 mg/dl) exclusion criteria: * current and/or past history of cardiovascular disease including angina * liver or kidney dysfunction * thyroid or pituitary disease * unstable weight loss/gain (≥2 kg) over the previous 12 months * pregnancy or lactation * taking medications or supplements
effect on quality of life after prostatectomy

Conditions: PROSTATECTOMY; URINARY INCONTINENCE

Summary: aim: this study was conducted to determine the effect of pelvic floor exercises (pte) on urinary incontinence and quality of life (qol) after radical prostatectomy (rp). methods: this randomized controlled, single-blind, experimental study was completed with a total of 33 rp patients, 18 of whom were interventions, and 15 were controls. the intervention group was given pelvic floor exercises (pte) training in the preoperative period, regular pte was performed three times a day for six months in the postoperative period, and the continuity of the exercises was checked by telephone. on the other hand, no intervention was applied to the control group other than routine treatment.


Eligibility criteria:
inclusion criteria: * being literate, * having the mental competence to understand the questions, * radical prostatectomy was performed due to the diagnosis of localized prostate cancer, * continuing post-operative follow-up, * no incontinence problem before surgery, * anatomically free of genito-urinary system pathology, * those who volunteered to participate in the study were recruited. exclusion criteria: - with bladder insufficiency (dysfunction), • individuals with a different type of incontinence problem such as stress incontinence, neurogenic bladder were not included in the study.

Keywords: radical prostatectomy pelvic floor exercises urinary incontinence quality of life
copeptin in differentiation of polyuria and polydipsia

Conditions: Polyuria; Polydipsia

Summary: the differential diagnosis of patients with polyuria/ polydipsia is often complex, but important for the therapeutic strategy. challenging is in particular the clinical differentiation between patients with a partial diabetes insipidus centralis and patients with primary polydipsia as underlying disease, because both groups are associated with similar urinary osmolalities. the determination of plasma arginine vasopressin is unusual in this context, since measurement of avp is not reliably. c-terminal provasopressin (copeptin) is secreted stoichiometrically with avp from the neurohypophysis, but has a longer half life in the circulation, and is thus easier to measure. therefore, the investigators will analyze in that study the diagnostic utility of plasma copeptin in the differential diagnosis of polyuria and polydipsia.


Eligibility criteria:
inclusion criteria: * patients with polydipsia/ polyuria, with indication for performing a deprivation test * \> 18 years exclusion criteria: * ddavp during the last 14d * pregnancy

Keywords: diabetes insipidus primary polydipsia copeptin utility of plasma copeptin in differential diagnosis of polyuria/ polydipsia while performing a traditional deprivation test
switching from fondaparinux to bivalirudin or unfractionated heparin in acs patients undergoing pci

Conditions: Acute Coronary Syndromes

Summary: the primary objective of this clinical trial is to evaluate safety of switching from fondaparinux to either unfractionated heparin or bivalirudin for patients experiencing acute coronary syndrome undergoing percutaneous coronary angioplasty.

this is a prospective open label, randomized, multi-center registry. one hundred patients who received fondaparinux within the 24 hours prior to presentation to the coronary catheterization lab and who are suitable for percutaneous coronary intervention. the patients will be randomized in a 1:1 fashion to either unfractionated heparin or bivalirudin during the angioplasty. all patients will be followed throughout the duration of the hospital stay.

Eligibility criteria:
inclusion criteria: 1. the patient is, male or female, \> 18 years of age; 2. the patient presents with coronary syndrome, unstable angina or non st segment elevated myocardial infarction (nstemi) defined as at least one of the following criteria: * elevated creatine kinase mb or troponin i or t (above uln) * ecg changes indicative of ischemia 3. the patient is scheduled for angiography, with possible angioplasty, evaluation of their coronary disease; 4. the patient is able and willing to conform to the requirements of the study and voluntarily signs an informed consent. 1. st elevated myocardial infarction within the preceding 48 hours; 2. patient weighs more than 400 lbs (181.2 kg) or less than 110 lbs (50 kg); 3. patients presenting on or received bivalirudin, gp iib/iiia inhibitors or low-molecular weight heparin within the preceding 24 hours; 4. patients that received unfractionated heparin less than or equal to 90 minutes prior to fondaparinux administration. 5. patients with known conditions of bleeding diathesis or actively bleeding within the previous 6 months (gi bleed etc.); 6. known diagnosis of acute bacterial endocarditis; 7. patients with cardiogenic shock or required intra-aortic balloon pump (iabp) 8. if patient is on warfarin (coumadin) therapy; 9. patients who had a major or minor stroke (cva or tia) or major surgery within the past 6 months; 10. known impaired renal function (creatinine ≥ 3.0 mg/dl (265.2 μmol/l),) status post renal transplant, patients on chronic dialysis or creatinine clearance ≤ 30 ml/min; 11. a platelet count of less than 100,000 cells/mm3; 12. known allergies to fondaparinux, aspirin, clopidogrel bisulfate (plavixr), ticlopidine (ticlidr), heparin, bivalirudin, or contrast that cannot be medically managed; 13. prior angioplasty within the previous 30 days; 14. contraindication to low-molecular weight heparin, unfractionated heparin or bivalirudin; 15. pregnant or lactating women; 16. any significant medical condition, which in the investigator's opinion, may interfere with the patient's optimal participation in the study; 17. currently participating in an investigational drug or another device study.
a phase 2 exploratory pharmacodynamic study of hp802-247 in venous leg ulcers

Conditions: Venous Leg Ulcers

Summary: assess the influence of hp802-247 on biochemical and cellular markers of inflammation in chronic venous leg ulcers


Eligibility criteria:
inclusion criteria: * provide informed consent * age ≥ 18 years and of either sex * willing to comply with protocol instructions, including allowing all study assessments * have a venous leg ulcer (vlu) between the knee and ankle (at or above the malleolus), with a surface area ≥ 4.0 cm x cm and ≤ 15.0 cm x cm * venous insufficiency confirmed by duplex doppler ultrasound examination for valvular or venous incompetence * arterial supply adequacy confirmed * target ulcer involves a full thickness skin loss, but without exposure of tendon, muscle, or bone * target ulcer duration ≥ 12 weeks but ≤ 104 weeks (24 months). * acceptable state of health and nutrition exclusion criteria: * history of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin b or any other component of hp802-247,or known sensitivity to iodine * prior diagnosis of systemic lupus erythematosus with elevated anti-dna antibody titers, buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication * therapy with another investigational agent within thirty (30) days of screening, or during the study, or any participation in a previous hp802-247 trial * a target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic) * documented history of osteomyelitis at the target wound location within 6 months preceding the screening visit * refusal of or inability to tolerate compression therapy * therapy of the target ulcer with collagenase santyl® ointment, autologous skin graft, biological dressings or living cell products (e.g., oasis®, apligraf™, dermagraft™) within 30 days preceding the screening visit * therapy of the target ulcer with topical growth factors within 1 week preceding the screening visit * current therapy with systemic antibiotics * current systemic therapy with cytotoxic drugs * current therapy with chronic (\> 10 days) oral corticosteroids * current therapy with tnfα inhibitors * history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers)

Keywords: venous leg ulcer ulcer venous stasis compression
visualase visualization database (vivid-1)

Conditions: Epilepsy; Tumor; Other

Summary: the purpose of the vivid-1 data collection study is to establish a database of clinical images and associated technical files from commercial cases using the visualase thermal therapy system (vtts). all data collected will be de-identified. no safety or effectiveness assessments will be completed.


Eligibility criteria:
inclusion criteria: 1. patient correlating with the de-identified data set to be collected received standard of care treatment using the visualase system prior to the date of site activation. exclusion criteria: 1. patient correlating with the de-identified data set to be collected is a minor (less than 18 years old, or as defined by local policy) that is not allowed to participate in this type of research project (eg, irb approval with waiver of consent) per irb policy 2. patient correlating with the de-identified data set to be collected is enrolled in the medtronic slate trial
comparison of surgical interventions for lateral epicondylitis: a prospective study

Conditions: Lateral Epicondylitis; Tennis Elbow

Summary: the investigator hopes to determine if one of three current standard of care surgeries for lateral epicondylitis (tennis elbow) is more effective than others. the three surgeries are: arthroscopic tenotomy, open tenotomy, and debridement and repair.


Eligibility criteria:
inclusion criteria: * 18-65 yrs old * pain over the lateral epicondyle (via palpitation over the lateral epicondyle, resisted wrist extension, resisted finger extension of the middle finger) for a duration of greater than 6 months prior to enrollment * conservative treatment has failed and surgical intervention is recommend as standard of care * ability to give informed consent exclusion criteria: * had surgery by a physician or specialist within the last 2 years as treatment for lateral epicondylitis * congenital deformities, tendon ruptures or elbow fractures within the past year * co-existing elbow diagnosis (i.e. osteoarthritis or instability) * pregnant women, women trying to get pregnant, or breastfeeding mothers * under the age of 18 or over 65 * incapable of giving informed consent

Keywords: tennis elbow lateral epicondylitis