Kornimate/medical-research-clean huggingface dataset:
a pre-market study to evaluate the performance and safety of a skin preparation device for removal of dry crusty skin

Conditions: Keratosis, Actinic; Actinic Lesion; Solar Keratosis/Sunburn; Hyperkeratosis; Hyperkeratotic Callus; Hyperkeratotic; Lesion; Hyperkeratotic Actinic Keratosis

Summary: in this clinical one-site investigation the performance and safety of a skin preparation device will be evaluated for removing hyperkeratotic skin prior to further medical treatment. comfort and pain during skin preparation, as well as performance and safety of device, will be compared to comparators on separate skin areas for every subject.


Eligibility criteria:
inclusion criteria: * attending the clinic for treatment of actinic keratosis using daylight photodynamic therapy * age: 18 - 100 years. * available for two follow-up visits: two weeks after treatment and 4 months after treatment * provision of informed consent i.e., subject must be able to understand and sign the patient information and consent form * subject have been informed on the nature, the scope and the relevance of the study exclusion criteria: * known or suspected allergy/hypersensitivity to phenol formaldehyde * wound at the skin site to be treated * documented skin disease at the time of enrollment, as judged by the investigator * previously enrolled in the present investigation * inclusion in other ongoing investigations simultaneously that would preclude the subject from participating in this investigation as judged by the investigator * actinic keratosis treatment obtained within last 6 months * involvement in the planning and conduct of the clinical investigation (applies to all investigation site staff and third party vendor) * any subject that according to medical research act, paragraphs 7-10, is deemed unsuitable for study enrolment. * complications that would increase wound risks if investigational product would be used.
rewarding adherence program - an intervention using small prizes allocated by a prize drawing to increase arv adherence

Conditions: HIV

Summary: the goal of this study is to identify ways for implementing small prizes allocated by a drawing to improve adherence to antiretroviral medication in an hiv clinic in kampala, uganda. the study is called rewarding adherence program (rap).

the proposed 3-year study will develop and test rap for incentivizing art clients to remain engaged in care and highly adherent to their medication. phase 1 of the project will consist of focus groups with patients, clinic providers and directors, and community leaders and will elicit information on barriers and facilitators of long-term retention and adherence maintenance, how to best implement the intervention to ensure acceptability and feasibility, and perceptions of the transportability of the planned intervention. parameters of the intervention that will be probed include the frequency, type, and value of the prizes, and award presentation. phase 2 will build on phase 1 to develop and pilot test the rap in a 20 months long randomized controlled trial (rct) among clients who have been on art for at least 2 years and have problems with missed clinic appointments or art doses. primary assessments will be administered at screening and months 4, 8, 14 and 20. in phase 3 some adjustments to the intervention will be made after reviewing phase 2 data, if needed, and then the intervention will be administered to the control group for 6 months to assess effects on adherence in this group (the original intervention group will not participate in this phase). finally, the investigators will conduct focus groups with providers, implementers, and study participants to learn about implementation difficulties and areas for future improvement. study findings will directly inform the design parameters of a larger, more rigorous evaluation in an r01 application that will focus on the cost-effectiveness and sustainability of the intervention.

Eligibility criteria:
inclusion criteria: * patient at mildmay kampala clinic * on antiretroviral medication (arv) for at least two years * shows recent adherence problems (missing a clinic visit or pharmacy refill in the last six months) exclusion criteria: * not able to understand study procedures and/or provide informed consent * not fluent in either english or luganda (the two main languages spoken around kampala)

Keywords: arv adherence
probiotics and hemodynamic changes in cirrhosis

Conditions: Cirrhosis

Summary: this is a single-center blinded randomized interventional placebo-controlled study of the effect of probiotics on hemodynamic parameters and liver function in cirrhosis.

forty patients with child-pugh class b and c cirrhosis will be randomized in a 1.5:1 ratio to test and control arms. patients in the test arm will receive probiotic saccharomyces boulardii (a07fa02 - saccharomyces (enterol) biocodex ltd, france, registration number lp-000622 from 21.09.2011) for 3 months, patients in the control arm will receive placebo for 3 months. all patients also will receive standard treatment: spironolactone 100 mg/day in ascites and carvedilol 12.5 mg/day in esophageal varices. the patients will be blinded. at inclusion and after 3 months after starting of probiotic/placebo treatment, systemic hemodynamics parameters (cardiac output and systemic vascular resistance), liver function (serum albumin and total bilirubin level, international normalized ratio, presence and degree of ascites or hepatic encephalopathy), the gut microbiome, biomarkers of bacterial translocation (presepsin, lipopolysaccharide), intestinal permeability (claudin 3), systemic inflammation (tumor necrosis factor alpha ) and endothelial dysfunction (nitrites, endothelin) will be assessed. after the end of the study, an interim analysis of the effect of the probiotic on aforementioned systemic hemodynamics and liver function indicators will be carried out. if there is a positive effect, a full analysis of all the aforementioned factors contributing to its development will be performed.

Eligibility criteria:
inclusion criteria: * cirrhosis * child-pugh class b or c; * age between 18 and 70 years; * signed informed consent. exclusion criteria: * use of lactulose, lactitol, or other prebiotics, probiotics, antibiotics, or metformin in the past 6 weeks before inclusion; * alcohol consumption in the past 6 weeks before inclusion; * inflammatory bowel disease; * cancer; * prematurely discontinuation of the consumption of tested probiotic/placebo; * started taking antibiotics, other probiotics, or prebiotics during the follow-up period; * refusal to participate during the follow-up period.

Keywords: gut-liver axis microbiota microbiome liver cirrhosis hemodynamics
validation of next generation cerebral and tissue oximeter

Conditions: Oxygen Deficiency

Summary: this is a validation study of a near-infrared spectroscopy (nirs) device designed to measure the cerebral tissue oxygen saturation.


Eligibility criteria:
inclusion criteria: 1. healthy, male or female subjects between the ages of 18 to ≤46 years; 2. completion of a health screening for a medical history by a licensed physician, nurse practitioner or physician assistant; 3. minimum weight 40kg; 4. bmi within range 18.0 - 30.0. exclusion criteria: 1. prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., novocain) \[self-reported\]; 2. prior known severe allergies to medical grade adhesive/tape (band-aid) \[self-reported\]; 3. taking any medication other than birth control \[self-reported\]; 4. is currently participating in, or has recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational drug, device, or biologic study \[self-reported\]; 5. has a negative allen's test to confirm non-patency of the collateral artery \[clinical assessment by pi or delegate\]; 6. has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure \[self-reported\]; 7. is female with a positive pregnancy test \[serum or urine\], or is female and is unwilling to use effective birth control between the time of screening and study procedure or is breastfeeding; 8. has anemia \[lab values specific for gender\]; 9. has a history of sickle cell trait or thalassemia \[self-reported\]; 10. has an abnormal hemoglobin electrophoresis test \[lab measurement\]; 11. has a positive urine cotinine test or urine drug screen or oral ethanol test \[poc testing\]; 12. has a room air saturation less than 95% by pulse oximetry \[measurement by pi or delegate\]; 13. has a clinically significant abnormal ecg \[assessment by pi or delegate\]; 14. has a clinically significant abnormal pulmonary function test via spirometry \[assessment by pi or delegate\]; 15. has a cohb greater than 3%, or methb greater than 2% \[measured by venous blood sample co-oximetry\]
clinical characteristics and surgical outcomes of the fellow eye in bilateral retinal detachments

Conditions: Retinal Detachment

Summary: to assess the clinical features and the surgical outcomes of rd repair surgery of the fellow eye in bilateral retinal detachments

bilateral retinal detachment is a rare but sight-threatening disease, that can cause blindness and poor quality of life. it has been proved that patients who suffer from rd in one eye have a considerably increased risk to subsequently develop an rd in the fellow eye. it can be expected that patients who experienced a rd in one eye, tend to present sooner when experiencing a rd in the fellow eye, and thus have a greater visual and/or anatomical prognosis. in this study, we aim to describe characteristics of bilateral rd and compare the initial and subsequent eye in terms of clinical preoperative features, surgical management, and anatomical and visual results.

Eligibility criteria:
inclusion criteria: * all patients that underwent retinal detachment repair surgery for bilateral sequential retinal detachment between january 2016 and december 2023 at the nancy regional and university hospital center (via pars plana vitrectomy or scleral buckling) and with a minimum of 6 month of post-operative follow-up after the last surgery. exclusion criteria: * patients that underwent surgery at another facility * patients with a history of previous vitrectomy or * patients with a history of trauma from a penetrating injury or ruptured globe, retinal neovascular condition, hereditary vitreo-retinopathy

Keywords: retinal detachment bilateral vitrectomy
flortaucipir 18f pet imaging in biocard study

Conditions: Cognitive Decline

Summary: this study is designed to assess the imaging characteristics of flortaucipir (18f-av-1451) in subjects who participated in the biomarkers of cognitive decline among normal individuals (biocard) study at johns hopkins university.


Eligibility criteria:
inclusion criteria: * males or females that have provided consent and are currently enrolled in biocard study * ability to tolerate pet scan procedures * ability to provide informed consent for study procedures exclusion criteria: * has condition(s) that could augment risk to participant or compromise ability to tolerate experimental procedures or interfere with analysis of the study data as determined by the investigator * has a history of risk factors for torsades de pointes or taking medications known to cause qt prolongation. * has electrocardiogram acquired prior to initial flortaucipir scan that clinically contradicts subject's participation in the study as determined by the investigator. bazett's corrected qt (qtcb) interval must be assessed and not exceed accepted values (458 msec in males, 474 msec in females). * females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraceptive methods. * has hypersensitivity to flortaucipir * has a currently clinically significant infectious disease, endocrine/metabolic disease, pulmonary/renal/hepatic impairment, or cancer that could impact study participation or scan results in the opinion of the investigator. * has a non-study related radiopharmaceutical imaging/treatment procedure within seven days prior to flortaucipir imaging visit. * is unsuitable for a study of this type in the opinion of the investigator.
safety and pharmacokinetics of ascending single oral doses of edp-322 in nonfasting and fasting healthy volunteers

Conditions: Skin and Soft Tissue Infections; Methicillin-resistant Staphylococcus Aureus

Summary: this was a randomized, double-blind, placebo-controlled, ascending single dose safety, tolerability, and pharmacokinetic study of orally administered edp-322. this study was conducted at a single site. edp-322 has a benefit to risk profile that supports testing in target patient populations.


Eligibility criteria:
inclusion criteria: * healthy adult males or females \[if documentation existed that they were surgically sterilized\]. * were in good general health as determined by medical history, physical exam and clinical laboratory tests, and without evidence of clinically significant abnormality, in the opinion of the investigator and medical monitor. * the resting 12-lead ecg obtained at screening shows no clinically significant abnormality and a qtc (bazett's correction) \<450 msec. * weight less than 132 pounds (60kg) with bmi between 18-32 kg/m3, inclusive. * subject has read, understood, and signed the written informed consent form. exclusion criteria: * history of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances. * history of gastric surgery, vagotomy, bowel resection, or any surgical procedure that might interfere with gastrointestinal motility, ph, or absorption. * any abnormal or screening clinical lab test results... * medication related exclusions... * lifestyle related...

Keywords: macrolides antibiotics safety tolerability pharmacokinetics phase i mrsa/ssti
non-interventional, retrospective cohort study to explore oac treatment in korea

Conditions: Atrial Fibrillation

Summary: the primary purpose of this study is to evaluate comparative effectiveness and safety outcomes of therapies to prevent thromboembolic events in patients with nonvalvular atrial fibrillation by using korean nationwide health claims database.


Eligibility criteria:
inclusion criteria: 1. patients aged 18 years or older on the index date 2. patients had ≥1 medical claim for af (refer to table 1) before or on the index date with at least one hospitalization or at least two outpatient visits: 3. patients prescribed aspirin, warfarin, or noacs during intake period (from july 1, 2015 to november 30, 2016) exclusion criteria: patients meeting any of the following criteria will not be included in the study. 1. medical claims indicating diagnosis or procedure for hip/knee replacement surgery within 6 weeks prior to index date 2. medical claims indicating a diagnosis code indicative of rheumatic mitral valvular heart disease, mitral valve stenosis during the 12-month baseline period (valvular af / prosthetic heart valves) 3. medical claims indicating a diagnosis code of vte (venous thromboembolism) during the 12-month baseline period 4. medical claims indicating a diagnosis or procedure code of transient af, or cardiac surgery during the 12-month baseline period (thyrotoxicosis, hypertrophic cardiomyopathy, elective defibrillation, radiofrequency ablation, or left atrial appendage occlusion) 5. medical claims indicating a diagnosis code of other conditions during the 12-month baseline period (end-stage chronic kidney disease / kidney transplant / dialysis / pericarditis) 6. for the comparison of "noac versus noac", and "noac versus warfarin", patients with any oacs (apixaban, dabigatran, rivaroxaban, or warfarin) in the pre-index period (from 1 year prior to the day before index date) 7. for the comparison of "noac versus aspirin", patients with following medications in the pre-index period (from 1 year prior to the day before index date) * noac user: oacs (apixaban, dabigatran, rivaroxaban, warfarin) * aspirin user: none
expanded access neoantigen vaccine in solid tumors

Conditions: Solid Tumor, Adult

Summary: this is an expanded access use study. safety data will be collected from participants.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of a solid tumor * pathology review demonstrates tumor cellularity of \>30% in quantities sufficient to complete dna and rna library construction * at least 18 years of age. * women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * able to understand and willing to sign an irb approved written informed consent document. exclusion criteria: * known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty. * acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, hepatic renal, and/or other functional abnormality that would jeopardize the health and safety of the participant as determined by the investigator based on medical history, physical examination, laboratory values, and/or diagnostic studies. * history of syncopal or vasovagal episode as determined by medical record and history in the 12 month period prior to first vaccination administration. * individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for eligible injection sites (left and right medial deltoid region) exceeds 40 mm. * individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art. * therapeutic or traumatic metal implant in the skin or muscle of either deltoid region. * any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child. * current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators. * pregnant and/or breastfeeding.
pegasys® plus ribavirin in hemophilic patients with hepatitis c virus infection

Conditions: Hepatitis C; Hemophilia

Summary: hemophilic patients are a known high risk groups for acquiring the hepatitis c. the surveillance data from ministry of health in ir.iran had shown that 60% of them are infected with hcv infection. we are trying the pegasys plus ribavirin in hemophilic patients with hcv.

the investigators enroll 400 patients into the study. the patients receive pegasys (peginterferon alpha-2a(40 kd)) 180 microgram per week plus copegus (ribavirin) 800 microgram for genotype 2 and 3 and 1000 milligram for weight less than 75 kg and 1200 milligram for more than 75 kg. the duration of protocol is depends on genotypes of virus. in genotype 1 and 4, for 48 week and in genotypes 2 and 3 , for 24 weeks. the patients are visited every 4 weeks with biochemistry lab tests. the patients are checked with quantitative hcv rna on the third months after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the six month after treatment completion for sustained response rate. the patients with undetectable hcv rna are considered as responders. we have omitted the liver biopsy in the patients.

Eligibility criteria:
inclusion criteria: * hcv rna positive * age older than 12 years exclusion criteria: * ongoing pregnancy or breast feeding * hx of hcc * hx of alcoholic liver disease * hx of bleeding from esophageal varices * hx of hemochromatosis * hx of autoimmune hepatitis * hx of suicidal attempt * hx of cerebrovascular dis * hx of severe retinopathy * hx of severe psoriasis * hx of scleroderma * hx of metabolic liver disease * hx of sle

Keywords: hepatitis c hemophilia pegasys ribavirin
treadmill training with functional electric stimulation after stroke

Conditions: Stroke

Summary: the purpose of this study was to investigate the effects of the treadmill training with functional electric stimulation on sensorimotor cortical reorganization and functional improvement in subjects with chronic stroke.


Eligibility criteria:
inclusion criteria: * diagnosis of unilateral hemiparesis secondary to cerebrovascular accident with post-onset duration of more than 6 months * ability to walk independently for at least 6 meters with or without use of walking aids * ability to follow simple verbal commands or instructions exclusion criteria: * unstable medical conditions * history of other diseases known to interfere with participation in the study * past history of a seizure * history of skin allergy to electrode * use of a cardiac pacemaker
which parameters of short-term blood pressure variability best predict early outcomes in acute ischemic stroke

Conditions: Stroke

Summary: previous studies on the association between blood pressure variation (bpv) in acute ischemic stroke and functional outcomes yield conflicting result. the obscured definition and measurement of bpv engenders considerable confounding factors, making it difficult to interpret. we aim to investigate the predictive role of 24-hour bpv on early outcomes in acute non-cardiogenic ischemic stroke.

this is a perspective registered cohort study. patients with acute non-cardiogenic ischemic stroke are included into the study. during the first 24 hours after admission, the 24 hours blood pressure monitoring is to be taken and used to calculate various parameters of hour-to-hour blood pressure variability, including standard deviation(sd), coefficient of variation (cv), variation independent of mean(vim) and average real variability (arv) of systolic blood pressure (sbp) and diastolic blood pressure (dbp). the demographic and clinical data are also recorded. this is an observational sturdy, thus the caring physician make clinical decisions according to individual patient's condition. the endpoints are defined as early neurological deterioration, functional outcome(modified rankin scale\<3 as good outcome) at discharge and 3 months.

Eligibility criteria:
inclusion criteria: * acute ischemic stroke exclusion criteria: * cardiogenic cerebral embolisms due to atrial fibrillation, pronounced heart valve diseases or valve replacement operation; * isolated sensory symptoms, isolated visual changes, isolated dizziness, or vertigo, without explicit mri-dwi evidence for acute cerebral infarcts; * coexisting severe systematic diseases on admission such as acute coronary syndrome, malignant tumor, plasma dialysis therapy for renal failure, cirrhosis, rheumatic disease which would influence patients' independent functions .

Keywords: stroke, blood pressure, prognosis