Kornimate/medical-research-clean huggingface dataset:
pharmacokinetic study of once daily pmr compared to twice daily cilostazol ir tablets in healthy volunteers

Conditions: Intermittent Claudication

Summary: the study is designed to evaluate the bioequivalency between the test formulations of extended-release tablet of cilostazol (pmr) administered once-daily and the reference formulation of immediate-release tablet of cilostazol (cilostazol) administered twice-daily in normal healthy male and female subjects under fasting conditions.


Eligibility criteria:
inclusion criteria: * must be 18 to 45 years of age, inclusive. * absence of diseases, such as heart failure, significant kidney impairment or a history of restricted blood flow to the heart, that could affect the study outcomes. * having a body mass index (bmi) within normal standard limits (18.5\~24.9, inclusive). * willing and able to give informed consent to participate in the clinical study and comply with all study procedures, restrictions and attend all visits. exclusion criteria: * history of bleeding tendency. * use of anticoagulant agent(s) within 1 month prior to screening. * use of tobacco or nicotine products within 6 months of screening. * intake of over the counter or prescription drugs (other than hormonal contraceptives) within 2 weeks prior to randomization. * on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening; or anticipating use of any of these therapies during the course of the study (other than the study products). * history of substance abuse, such as alcohol, iv drugs, and inhaled drugs, within 1 year prior to screening. * known history of having acquired immunodeficiency syndrome (aids) or positive pre-study result of infection with human immunodeficiency virus (hiv); history or positive pre-study hepatitis b surface antigen or positive hepatitis c antibody result within 3 months of screening. * pregnant or breast feeding. * women of child-bearing potential not using an effective birth control method. women of child-bearing potential are defined as women physiologically capable of becoming pregnant, unless they meet the following criteria: 1. post-menopausal: 12 months of natural (spontaneous) amenorrhea or less than 12 months of spontaneous amenorrhea with serum follicle stimulating hormone (fsh) levels \> 40iu/l, or; 2. 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, or; 3. using one or more of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation), hormonal contraception (e.g. implantable, injectable, vaginal patch, and oral), and double-barrier methods. reliable contraception should be maintained throughout the study and for 7 days after study discontinuation. * known or suspected hypersensitivity to any ingredient of study drug(s). * donated blood or lost more than 150 ml of blood within 3 months prior to randomization or plans to donate blood or plasma within 4 weeks after completion of the study.

Keywords: peripheral artery disease cilostazol pmr extended-release tablet of cilostazol
fish, polyunsaturated fatty acids intake and type 2 diabetes

Conditions: Type2 Diabetes

Summary: the role of fishery diet and polyunsaturated fatty acids (pufa) in the development of type 2 diabetes (t2d) is heavily debated but evidence from large populations in china is scant. the investigators aim to use data from the china health and nutrition survey (chns) to assess the long-term association between fish, pufa intake and t2d risk.

the role of fishery diet and polyunsaturated fatty acids (pufa) in the development of t2d is heavily debated but evidence from large populations in china is still lacking. the investigators aim to utilize data from china health and nutrition survey (chns, 1997-2011). the investigators will calculate cumulative means of fish and pufa intake based on 3-day food records in each wave. sex-specific cox regression models will be used to estimate relative risk of t2d. results from this work will provide epidemiological evidence for improving recommendations on fish and pufa intake for chinese in dietary guidelines.

Eligibility criteria:
inclusion criteria: * adults aged ≥20 with complete data on diet and follow-up time exclusion criteria: * missing information for type 2 diabetes * type 2 diabetes * cardiovascular disease

Keywords: fish polyunsaturated fatty acids chns
a phase 3 efficacy and safety study of fosmanogepix for the treatment of adult patients with invasive mold infections.

Conditions: Invasive Mold Infections

Summary: the purpose of this study is to evaluate the efficacy and safety of fosmanogepix (administered iv or oral) for the treatment of adult patients with invasive mold infections. the study is looking for patients who have been diagnosed with invasive mold infections. the maximum study duration will be approximately 8 months, including a target study treatment duration of 84 days which can be extended up to 180 days and follow-up period. the patient will be assigned to one of two treatment cohorts: cohort a (primary therapy): patients will receive either the study drug or institutional standard of care antifungal treatment. cohort b (salvage treatment; i.e. treatment given after patients did not respond to previous treatments or did not tolerate them): patients will receive the study drug the primary aim is to compare the all cause mortality with a fixed threshold at day 42.


Eligibility criteria:
main inclusion criteria: 1. diagnosis of proven or probable invasive mold infection (imi) defined in accordance with the revision and update of the consensus definitions of invasive fungal disease from the eortc/msgerc as adapted for this study and caused by aspergillus spp. (in patients with limited treatment options), fusarium spp., lomentospora prolificans, mucorales fungi, or other multi-drug resistant molds. 2. patient's condition allows for appropriate infection source control measures. main exclusion critera: 1. refractory hematologic malignancy. 2. chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis. 3. covid-19 associated mucormycosis. 4. invasive fungal disease caused by more than one fungal pathogen is not permitted in cohort a but is permitted in cohort b. 5. patients with a karnofsky performance status \< 20 at screening. 6. requirement, or anticipated requirement, for hemodialysis, peritoneal dialysis, or hemofiltration. 7. patients with known human immunodeficiency virus infection. 8. ongoing neurological disorders. 9. patients receiving hospice/comfort care only. 10. other medical or psychiatric condition. 11. current use of any prohibited concomitant medication(s). 12. current/ previous administration of an investigational drug within 30 days. 13. prior enrollment in this or any previous study of fosmanogepix. 14. moderate or severe hepatic impairment. 15. patient who is pregnant or lactating. 16. known hypersensitivity to fosmanogepix, manogepix, or any of their excipients.

Keywords: fungal infection antifungal mold infection rare molds multidrug resistant mold aspergillus spp. fusarium spp. lomentospora prolificans mucorales fungi scedosporium spp.
trial comparing care in multiple clinics versus care in a cardiac, diabetes and kidney care clinic

Conditions: Kidney Diseases; Heart Diseases; Diabetes Mellitus

Summary: the purpose of this study is to assess the benefits of a combined cardiac, kidney, and diabetes clinic versus multiple clinics. hypothesis: attendance at multiple clinics by one individual patient has multiple problems which may be overcome by the introduction of a combined care clinic.

this is a randomized control trial to compare health care resource utilization, and achievement of stated targets of therapy (bp, hgb, glucose control, use of preventive medications) as well as patient and health care team satisfaction, and longer term patient outcomes in patients with kidney disease who have either or both diabetes and heart disease, and currently attend either a diabetic or heart function clinic (or both) in addition to a kidney care clinic. in addition, we will also establish and refine the specialized cross-disciplinary care model, within a framework in vancouver, and evaluate its functioning from the perspectives of allied health and medical professionals. this is a systematic evaluation of health care delivery methods to a complex group of patients, which will serve as a nidus for ongoing research in both health outcomes research, and biomedical research. the creation of this multifaceted clinic in an organized manner would permit evaluation of all of the components of it, and also demonstrate the importance of collaboration between disciplines and between public health care initiatives and industry partners, who would fund this clinic infrastructure and research components in the initial phase.

Eligibility criteria:
inclusion criteria: * all patients currently attending or who would be eligible to attend 2 or more of the following clinics: cardiac, diabetic or kidney exclusion criteria: * those patients currently attending the diabetic, cardiac or kidney clinics who do not have more than one condition (i.e. who have only one of the diagnoses) or who refuse to sign informed consent

Keywords: combined clinic chronic kidney disease diabetes
ventrassisttm lvad for the treatment of advanced heart failure - destination therapy

Conditions: End-stage Heart Failure; Cardiomyopathies

Summary: the purpose of this study is to evaluate the safety and effectiveness of lvads in providing long-term circulatory support for patients who have chronic stage d heart failure and are ineligible for a heart transplant. this is a multi-center, prospective, randomized, controlled clinical trial, which is comprised of two independent modules.

currently, patients with stage d heart failure who are not transplant candidates are treated with a spectrum of therapies, including specialized medical management as well as mechanical support with an lvad approved by fda for destination therapy. however, there is substantial variation in the therapeutic approaches employed to treat these patients, with relatively low numbers of patients receiving dt lvad therapy to date. therefore, the ventrassist dt trial is designed to provide maximal flexibility to the investigators/clinicians to incorporate their clinical judgment in managing these complex patients.

Eligibility criteria:
inclusion criteria (the following are general criteria; detailed criteria are included in the study protocol): * eligible for either the ventrassist or an fda-approved dt lvad * lvef \<=25% * stage d heart failure * ineligible for cardiac transplantation * treated with standard heart failure therapy exclusion criteria (the following are general criteria; detailed criteria are included in the study protocol): * contraindication to lvad implantation * contraindication to anticoagulant or anti-platelet agents. * pre-existing mechanical circulatory support other than intra-aortic balloon pump * therapy with an investigational intervention at the time of screening * a condition, other than heart failure, which would limit survival to less than 2 years

Keywords: ventrassisttm lvad end-stage heart failure cardiomyopathy
yt90 zevalin and combination chemotherapy (z-chop)in treating patients with stage ii, stage iii, or stage iv diffuse large b-cell lymphoma

Conditions: Diffuse Large B-cell Lymphoma

Summary: the purpose of this study is to determine whether the treatment of yt90 zevalin in combination with chop (cyclophosphamide, doxorubicin, vincristine, and prednisolone)are effective as first line treatment in patients with bulky stage ii or stage iii or iv diffuse large b-cell lymphoma

radioimmunotherapy represents a significant advance over unlabeled immunotherapy for the treatment of patients with b-cell non-hodgkin's lymphoma. the radiobiological effects associated with yt90-labelled ibritumomab tiuxetan (zevalin) include the induction of apoptosis and cell-cycle redistribution. the response rate tend to be higher in patients who have been treated with fewer prior therapies and yt90-labelled ibritumomab tiuxetan may be suitable for use early in the course of therapy. yt90-labelled ibritumomab tiuxetan has less non hematologic toxicity than chemotherapy, with only minimal alopecia, mucositis, nausea, or vomiting, and a lower incidence of infections. yt90-labelled ibritumomab tiuxetan regimen is routinely and safely given in an outpatient setting and is completed in 7-9 days and is thus more convenient to be used.

Eligibility criteria:
inclusion criteria: * histologically confirmed cd20 positive diffuse large b-cell lymphoma with bulky stage ii or stage iii or stage iv * bidimensionally measurable disease * performance status zubrod 0-2 * less than 20,000/mcl circulating lymphoid cells on wbc differential count * no clinical evidence of cns involvement, no prior diagnosis of indolent lymphoma, no histologic transformation * ejection fraction more than or equal to 45% by muga or no significant abnormality by echocardiogram * fertile patients with effective contraception method * no other malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, stage i or ii cancer in complete remission, or carcinoma in situ of cervix * no hiv positive, no prior solid organ transplantation * no prior antibody therapy, chemotherapy, radiotherapy for lymphoma exclusion criteria: * serum creatinine ot bilirubin more than 2.5 x uln unless due to lymphoma * active uncontrolled infection * concurrent severe and/or uncontrolled medical disease which could compromise participation in the study * patients with more than 25% infiltrated bone marrow * patients with platelet counts less than 100,000/mcl or neutrophil counts less than 1,500/mcl

Keywords: zevalin zevalin plus chop diffuse large b-cell lymphoma first line diffuse large b-cell lymphoma
olif25™ /olif51™ study

Conditions: Degenerative Disc Disease; Scoliosis

Summary: the purpose of this single-arm observational study is to observe and document clinical outcomes of the olif25™ and olif51™ procedures in patients diagnosed with degenerative disc disease or degenerative scoliosis, and report the rate of adverse events of interest through the 24 months follow-up visit.


Eligibility criteria:
inclusion criteria: 1. patient is 18 years of age or older. 2. patient agrees to participate in the study and is able to sign the informed consent/data release form. 3. patient is undergoing surgery from l2-l5 for olif25™ and/or from l5-s1 for olif51™ for degenerative disc disease or degenerative scoliosis. exclusion criteria: 1. illiterate or vulnerable patients (e.g. minors, participants incapable of judgment).
pharmacogenomics study on il28b genetic variants in chinese children with hepatitis c virus infection

Conditions: Chronic Hepatitis C

Summary: the aim of this study is to investigate the relationships between interleukin 28b genetic variants and the response to treatment of chronic hepatitis c in chinese children.

hepatitis c affects thousands of children throughout the world. most children acquire the virus through vertical transmission, although parenteral routes of acquisition are also common. affected children are usually asymptomatic and histological findings are mild with a low risk of progression, about 5% develop significant liver disease in childhood. the use of combination treatment with interferon-alpha and ribavirin were recommended in the treatment of chronic hepatitis c in children, svr in children with genotype 1 ranged from 44% to 59%. svr in children with genotype 2 and 3 was more than 90%. but both interferon and ribavirin have significant side effects which affect compliance, such as: repeated flu like symptoms, leukopenia and anemia, moderate weight loss, behavioural problems, thyroid dysfunction and transient deceleration of the growth rate. in addition, approximately 50% of children infected with genotype 1 do not respond to therapy. recent work has highlighted that single nucleotide polymorphisms (snps) around the il28b gene have been identified as strong predictors of spontaneous and treatment-induced hcv clearance in adults, especially rs 12979860 and rs 8099917. a recent article in hepatology also reported that interleukin (il)-28b c/c genotype in the child was associated with spontaneous clearance of hepatitis c virus (hcv) genotype 1 infection. all this reports show that genetic variation in interleukin-28b locus is associated with the procession of chc. the aim of this study was to study the association between genetic variation in il-28b and the development of chc in chinese children, such as: hcv viral load, serum alanine aminotransferase, histological change and the response to the treatment with interferon-alpha and ribavirin.

Eligibility criteria:
inclusion criteria: * aged 1-18 years * patients with chronic hcv infection exclusion criteria: * hcv infected patients previously treated with antiviral drugs * co-infected patients with hiv or hepatitis b virus (hbsag positive) * hepatocellular carcinoma or other malignancies * anticipated with difficulty of follow-up observation

Keywords: chronic hepatitis c interleukin 28 children
a pilot study of triple ntrti/nsrti therapy in antiretroviral naive hiv-1 infected patients

Conditions: HIV

Summary: the purpose of this study is to evaluate the antiviral effect and durability of antiviral response (hiv-1 rna pcr) and safety of a triple ntrti/nsrti therapy in antiretroviral naive patients. patients will receive tdf plus ftc plus azt for at least 48 weeks. further objectives are to evaluate resistance pathways in failing patients treated with tdf/ftc/azt and to evaluate a treatment strategy of sparing pis and nnrtis for later treatment.


Eligibility criteria:
inclusion criteria: * 18 years and older * hiv-1 positive * antiretroviral treatment naive * one cd4 count \>200/ul within 14d prior to study drug administration * one hiv-1 rna pcr value \>5000 and \<100.000 cop/ml within 14d prior to study drug administration * women of child bearing potential: negative serum pregnancy test within 14d of study * ability to understand and provide written informed consent * overall stable disease * absence of clinical signs of lipodystrophy exclusion criteria: * alcohol or illicit drug use * malabsorption syndrome or other gastrointestinal dysfunction * clinically relevant pancreatitis/hepatitis within the last 6 months * receiving other investigational drugs * abnormal hemoglobin, neutrophil, platelet, ast/alt, pancreatic amylase, creatinine clearance, total bilirubine levels within 14d prior to study * pregnancy/breast-feeding * radiation therapy or cytotoxic chemotherapeutic agents within 30d of study * prior antiretroviral therapy at any time, investigational antiretrovirals trial at any time, hiv vaccine within 90d prior to study * immunomodulating agents * serious medical condition (diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction) * active diagnosis of aids (except for cutaneous kaposi sarcoma) * foscarnet therapy or other agent with documented activity against hiv-1
effect of an aural rehabilitation program in hearing-impaired older adults

Conditions: Older Adults; Hearing Impairment; Nursing

Summary: hearing impairment in older adults is becoming a common health problem as the population ages. the impact of hearing impairment in older adults includes not only physical function and cognitive performance, but also depression, loneliness and social isolation, as well as having a negative impact on quality of life and financial status. therefore, an audiological rehabilitation program intervention is recommended. the purposes of this study are to examine the effects of an audiological rehabilitation program (hear-talk-activity audiological rehabilitation program) intervention on communication abilities, depression, loneliness and quality of life outcomes in older adults with hearing impairment. the single-blind, randomized control trial will include older adults aged 65 years or older with hearing impairment and aid user. participants will be randomized to either intervention groups or control groups.

the study will be an experimental design featuring repeated measures, with data collected from a pretest, a posttest and a follow-up test. an estimated total of 96 participants will be randomly assigned to experimental and control groups. the experimental group will participate in a 10-week aural rehabilitation program (hear-talk-activity audiological rehabilitation program), including provide information, hearing aids and assistive listening devices, communication strategies and skills, personal coping and adjustment, psychosocial support and stress management, consisting of 60-minute sessions once per week, while the control group will be put on a waiting-list group. each group will be assessed of the outcomes at 3 time points: baseline (t0), three months following the intervention (t1) and again at six months following the intervention (t2). the investigators will use the hearing handicap inventory for the elderly-screening version (hhie-s), the 10-item version of the center for epidemiological studies depression scale (10-item ces-d), the short-form university of california, los angeles (ucla) loneliness scale-8 item (uls-8) and the short form-12 health survey (sf-12) as the outcome indicators. the principle of intention-to-treat (itt) analysis will be used, and the result will be analyzed mainly by generalized estimating equation (gee).

Eligibility criteria:
inclusion criteria: * being 65 or older * pure-tone average (pta) more than 40 decibel (db) hearing level (hl) and aid users less than half a year * living in the community * having normal cognitive * articulate in the mandarin chinese language * signing a consent form to participate exclusion criteria: * severe psychiatric disorders * acoustic neuroma lead to hearing impairment * chronic otitis media lead to hearing impairment

Keywords: audiological rehabilitation hearing impairment quality of life older adults communication ability depression loneliness
e-pat neuromod evaluation of personalized rtms for resistant depression

Conditions: Depressive Disorder; Treatment-Resistant

Summary: although repetitive trans-cranial magnetic stimulation (rtms) is an effective therapy for resistant depression, it still fail to remit up to 70% of these patients. we hypothesize that personalizing the procedure using functional mri to better select dysfunctional regions and robotic coil placement to stimulate these regions homogeneously, will increase its efficacy. individualized rtms will be compared to traditional rtms procedure and to trans-cranial direct current stimulation (tdcs). in this small proof of principle study our primary outcome measure will be the correction of the mri anomalies. symptoms reduction and the proportion of remitters will be secondary outcome measurements.


Eligibility criteria:
inclusion criteria: * aged from 18 to 65 y * affiliated to the health insurance * having signed an informed consent * suffering from major depression according to the dsm5 * unresponsive or incomplete remission after at least one trial of antidepressant (\> 6 weeks at efficient dose or side effects) * treatment stable for \> 6 weeks exclusion criteria: * contraindication for mri, rtms or tdcs: non-removable ferromagnetic body, prosthesis, pacemaker, medication delivered by an implanted pump clip or vascular stent, heart valve or ventricular shunt, seizure disorders, skin pathology in the region of tdcs electrode placement. * pregnancy * severe and non-stabilized somatic pathology * patients deprived of liberty or hospitalized without their consent

Keywords: individualized medicine functional neuroimaging robotic proceedure transcranial magnetic stimulation, repetitive transcranial direct current stimulation monocentric compariative cross-over 3 arms study randomized, single-blind method