Kornimate/medical-research-clean huggingface dataset:
influence of diabetes control on treatment of diabetic macular edema with ranibizumab

Conditions: Visual Acuity Reduced Transiently; Macular Edema, Cystoid

Summary: the aim of the prospective randomized study is to investigate whether a intensified diabetic control program leads to better final visual acuity and less frequent diabetic ocular complications in patients with diabetic retinopathy when compared with a normal diabetic treatment.

patients with diabetic macular edema (dme) will be treated with intravitreal ranibizumab injections and the effect of optimal control of internal factors (eg. glycemia, blood pressure etc) on final functional (best corrected visual acuity-cbva) and morphological (central retinal thickness-crt) will be investigated. patients will be randomized into two groups: group with intensified diabetic control will be follow and investigated monthly at department of diabetology, endocrinology and nutritional medicine (campus benjamin franklin) in berlin with aim to reach the optimal glycemic control defined as hba1c \< 6,5%. further, triglycerides values \< 140 mg/dl and blood pressure \< 140/90 mmhg will be pursued. second group of patients will be followed by their general practitioner and in the study center only blood samples will be taken quarterly without active medical intervention. bcva, crt and the number of required ranibizumab injections will we evaluated and compared between both study groups.

Eligibility criteria:
inclusion criteria: - patients with diabetic macular edema relevant to visual acuity * oct central retinal thickness ≥ 250µm * hba1c \> 6,5% at initial visit * bcva ≤0.8 and ≥0.05 * age ≥18 years * written patient informed consent given exclusion criteria: * previous treatment with intravitreal drugs in last 6 months * vitreous hemorrhage as a consequence of proliferative retinopathy * pregnancy * blood pressure of ≥ 180/100 (or uncontrolled pressures under pharmacological therapy) * chronic systemic or ocular inflammatory/autoimmune diseases (e.g. inflammatory bowel disease, addison´s disease, cushing syndrome, uveitis) * systemic cortisone or anti-vegf therapy * acute systemic or ocular infectious diseases

Keywords: diabetic macular edema, ranibizumab, visual acuity, diabetic control
implementation of an oral chemotherapy adherence intervention

Conditions: Solid Tumor; Hematologic Malignancy

Summary: the goal of this study is to evaluate the effectiveness and usability of a newly developed oral anticancer agent adherence program implemented across 6 cancer clinics (two academic, two urban, and two rural). the study will include 160 adult participants with either solid tumors or hematologic malignancies who have been taking oral anticancer agents for at least six months. this study will have two groups of participants, a pre- and post-implementation group. in the pre-implementation of the program group, investigators will administer a survey to the 80 participants and gather information about their medication prior to their enrollment of the program. similarly, 80 participants who have been enrolled into this program for at least 6 months will serve as the post-implementation group. these patients will be administered the same survey. the results from both groups will be analyzed to see how effective the medication adherence program is.

participants enrolled in this adherence program will have individualized counseling sessions with their clinical pharmacists regarding their oral anticancer agent. the pharmacists will review with all their patients, information including proper administration, side effects, symptom management, and treatment plans. participants will continue to have these counseling sessions with their pharmacists, until the patient becomes stable on the oral anticancer agent. once stable, the participant will be placed into one of three monitoring risk categories (low risk, medium risk, high risk), by the pharmacist, based on several factors. each of the three monitor categories will have different monitoring intervals where patients will interact with the pharmacists differently. additionally, each patient will have follow-up appointments and will have access to further education and will be reassessed each time. furthermore, additional help will be provided to each patient based on their needs. depending on the monitoring category, participants may meet with their pharmacist more and communicate either through electronic surveys or in-person visits.

Eligibility criteria:
inclusion criteria: * adult (age ≥21 years-old) patients * diagnosed with a solid or hematologic malignancy * monotherapy on oral anticancer agent on treatment for at least 6 months exclusion criteria: * patients on time-limited or intermittent therapy (non-continuous) * patients on comfort (end-of-life) care * patients enrolled on hospice

Keywords: oral anticancer agent oral chemotherapy adherence
safety, tolerability, and efficacy study of lfx453 in actinic keratosis patients

Conditions: Actinic Keratosis

Summary: this is a randomized, vehicle controlled, active comparator, parallel group, study with a total duration of 24 weeks including screening and follow-up. study drug is applied topically for 2 cycles of 4 week treatment, separated by 4 weeks off-treatment. assessors of study endpoints are blinded to treatment allocation.


Eligibility criteria:
key inclusion criteria: * male patients, and female patients of non-childbearing potential, age ≥ 18 to ≤ 75 years (at the time of the screening visit), and in general good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening * patients with at least five clinically typical, visible or palpable non-hyperkeratotic ak lesions within a contiguous area of 25 cm2, or within 2 areas for a maximum total of 25cm2, on the face (at least 2 cm from the periocular areas, lips, nares and ears) and/or balding scalp * presence of at least one additional visible or palpable non hyperkeratotic ak lesion outside of the selected area amenable to the collection of a skin biopsy, and located at least at 2 cm from the limits of the area to receive treatment * male patients had to agree to use adequate contraception for the duration of the study. key exclusion criteria: * known hypersensitivity to any constituents of the study drugs (including local anesthetics if consenting to biopsies) or known allergies to imiquimod or to drugs of similar chemical classes or history of serious allergic reaction. * presence of atopic dermatitis, eczema, psoriasis, rosacea or other possible confounding skin conditions on face or balding scalp even outside of the treatment area. * invasive tumors within the treatment area, e.g., merkel cell carcinoma, melanoma, squamous cell carcinoma (scc), basal cell carcinoma, the latter being accepted if completely surgically removed. * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. * history of hypertrophic scarring. * concurrent disease that suppresses the immune system.

Keywords: actinic keratosis, patients, topical, lesion count, clearance rate
facilitating catheter guidance to optimal site for vt ablation

Conditions: Post-myocardial Infarction Ventricular Tachycardia

Summary: each year in the uk, approximately 150,000 people have a heart attack when the blood supply to their heart is compromised. as a result, affected regions of the heart can become diseased and scarred. in a healthy person, electrical waves propagate across the heart in a regulated pattern which triggers contraction to pump blood around the body. the scar tissue that forms as a result of a heart attack can disrupt the propagation of the electrical waves. if significant disruptions occur, blood cannot be pumped out of the body effectively, leading to sudden death. ablation therapy aims to eliminate areas of diseased tissue that cause disruption to the heart rhythm, by applying radiofrequency using catheters inserted into the heart. the most accurate techniques used to locate the region to ablate require the induction of dangerous heart rhythms, which are only inducible in about 65% of people. pace mapping is a technique used to locate regions to ablate, which can be performed during normal heart rhythm. ecg data, which records electrical signals from the heart, is collected when the patient has an abnormal heart rhythm. from this template ecg, a clinician can tell the approximate location of the diseased tissue. a catheter is directed to that location, the heart stimulated, and another ecg, called the paced ecg is recorded. if the paced ecg matches the template ecg, it is assumed that the heart was paced in the location that requires ablation. current ablation techniques are difficult, time consuming, and inaccurate. as a result, the procedure may work in only half of all patients, and result in unnecessary damage to healthy tissue, leading to later impairment of heart function. the cps project's overall goal is to increase the success rates of ablation therapy by improving the accuracy and efficiency of locating the optimal region of tissue to eliminate during the pace mapping procedure. increasing ablation therapy success rates will mean that patients will be unlikely to suffer from future heart rhythm disorders as a result of their heart attack, increasing the life expectancy of heart attack patients. excess damage caused to the heart as a result of unnecessary ablation lesions will be limited, decreasing the likelihood of future complications. in addition, dangerous heart rhythms do not need to be induced in the patient, significantly decreasing the risk of death during the treatment.


Eligibility criteria:
inclusion criteria: * post-myocardial infarction ventricular tachycardia diagnosis * scheduled to undergo radiofrequency catheter ablation as either emergency or elective case exclusion criteria: * unable to perform pace mapping during ablation procedure * unable to terminate vt thus unable to provide data regarding successful ablation lesion sites * intracardiac thrombus
impact of rapid detection of mrsa

Conditions: Staphylococcus Aureus Infections

Summary: the objective of this study is to evaluate the impact of the alere\&#8482; pbp2a test combined with pharmacist review of antimicrobial therapy, on clinical outcomes and cost in hospitalized patients with sterile site s. aureus infection.


Eligibility criteria:
inclusion criteria: 1. inpatients (adults and children) at mayo clinic, rochester with sterile source s. aureus cultures (both control and intervention periods) 2. above, with rapid pbp2a testing (intervention period only). exclusion criteria: 1. patients with polymicrobial cultures (i.e., growth of s. aureus plus other organisms in the culture). 2. patients who have not provided mn authorization to use their medical records for research. 3. patients who have had the filmarray blood culture identification diagnostic test performed on an index s. aureus blood culture. 4. patients who have had a sterile source s. aureus culture within the prior 30 days.

Keywords: mssa, mrsa
diagnosis of laryngeal lesions using the probe-based confocal laser endomicroscopy

Conditions: Laryngeal Leiomyoma; Probe-based Confocal Laser Endomicroscopy

Summary: to evaluate the diagnosis of laryngeal lesions using the probe-based confocal laser endomicroscopy in vivo.

in this study, we will conduct in-vivo confocal laser endoscopic imaging studies of laryngeal and precancerous lesions to explore the value of pcle in the diagnosis of laryngeal cancers.

Eligibility criteria:
inclusion criteria: 1. 18≤male or female age ≤85 years old; 2. patients with vocal cord lesions founded by white light laryngoscope and needed to perform laryngeal microsurgery; 3. willing and able to comply with study procedures and provide written informed consent to participate in the study. exclusion criteria: 1. male or female \ 85 years; 2. the patient has abnormal blood or coagulation function, and there is a risk of bleeding during the examination; 3. the patient has severe cardiopulmonary function or liver and kidney dysfunction and cannot tolerate surgery. 4. the patient has a history of allergies to drugs or food. 5. the patient has a positive serotonin sodium allergy test and is allergic to sodium fluorescein; 6. lactation or pregnant women. 7. refusal to sign the informed consent form. 8. others who do not take this test.

Keywords: probe-based confocal laser endomicroscopy optical biopsy
hypofractionated image-guided radiotherapy (igrt) with organ motion mitigation and urethral sparing for prostate cancer

Conditions: Adenocarcinoma of the Prostate

Summary: the present study evaluates the clinical outcomes following definitive ultra-high dose per fraction external beam radiation therapy delivered in patients with organ-confined adenocarcinoma of the prostate. patients enrolled in the study will undergo image-guided, volumetric intensity-modulated arc radiotherapy (igrt-vmat) with state-of-the-art treatment-planning and quality assurance procedures with emphasis on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility. a rectal balloon with air filling will be used for prostate target immobilization and anatomical reproducibility, while a urethral catheter loaded with beacon transponders will be used to ensure set-up reproducibility and online target tracking. previously untreated patients with prostate cancer will be treated with 45 gy in five fractions of 9 gy over 5 consecutive days. patients will be followed at one month post-treatment and every 3 months for up to 12 months (+/- 4 weeks) and every 6 months (+/- 6 weeks) thereafter. acute and late toxicity evaluations will focus, though not exclusively, on urinary, rectal and sexual functions and will be assessed through validated expanded prostate cancer index composite (epic), international prostate symptom score (ipss) and international index of erectile function (iief) questionnaires. serum prostate specific antigen (psa) values will be drawn on the same schedule as clinical follow-up. patients will be continuously monitored for a minimum of 5 years.


Eligibility criteria:
inclusion criteria: * signed study specific informed consent form; * histologic confirmation of adenocarcinoma of the prostate by biopsy; * previous hormonal therapy is allowed (but not required); * no direct evidence of regional or distant metastases after appropriate staging studies; * age ≥ 40; * performance status 0-2; * american urological association (aua) score must be ≤ 20 (alpha blockers allowed); * computerized tomography (ct) or ultrasound-based volume estimation of prostate gland ≤ 150 grams. exclusion criteria: * metastatic disease from prostate cancer on imaging studies mri evidence of radiographic t3, t4; * previous pelvic radiotherapy; * previous surgery for prostate cancer; * previous hormonal therapy given for more than 6 months prior to therapy; * history of crohn's disease or ulcerative colitis; * previous significant obstructive symptoms; * significant psychiatric illness; * severe, active co-morbidity as defined in section 3.
study on the safety and effectiveness of risperidone treatment of acute psychotic patients

Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorders

Summary: the purpose of this study was to evaluate the safety of risperidone treatment in acute psychotic patients that require an admission into emergency department. the effectiveness of risperidone in controlling acute psychotic symptomatology and incidence, severity and risk of psychomotor agitation in acute psychotic patients was also studied.

antipsychotic drugs are key treatment for the acute psychotic symptoms experienced by schizophrenic, schizoaffective disorder and schizophreniform disorder patients. in the last years, atypical antipsychotics having fewer side effects than conventional neuroleptics, have been introduced into clinical practice. there is not an agreement about what type of drugs should be used in an emergency situation (acute psychotic patient). the aim of this observational, prospective study was to evaluate the impact of a treatment regimen with the atypical antipsychotic drug, risperidone, as first line treatment in acute psychotic patients that requested an admission into the hospital. effectiveness of risperidone treatment was measured by positive and negative syndrome scale (panss) agitation sub scale, brief psychotic rating scale and days of in-patient period. aggressive behavior was rated using staff observation aggression scale (soas) and visual analogic scale for agitation and anxiety. safety was evaluated collecting elicited adverse events. observational study - risperidone, 3-6 mg per day, orally, during the study period (in-patient period for each patient).

Eligibility criteria:
inclusion criteria: * acute psychotic symptoms in schizophrenia * schizoaffective disorder and schizophreniform disorders in patients that required an admission into a hospital and in which physicians considered the use of risperidone as treatment under clinical practice exclusion criteria: * pregnant or lactating patients * patients with psychiatry pathology other than schizophrenia or schizoaffective disorder * patients with neurology pathology except parkinsonism induced by neuroleptics * patients with other severe concomitant pathology * patients treated with risperidone in the last 30 days

Keywords: schizophrenia schizoaffective disorder schizophreniform disorders
novel gallium 68 citrate in orthopedic infections

Conditions: Joint Prosthesis

Summary: in the proposed study, our aim is to evaluate the uptake of 68gallium-citrate in patients with failed joint prosthesis and compare it with that of conventional 18fluorine-fluorodeoxyglucose (18f-fdg) positron emission tomography/computed tomography (pet/ct) scan. we will perform pet/ct scan with 68gallium citrate and 18f-fdg in subjects with failed hip or knee prosthesis. both 68gallium-citrate and 18f-fdg scans, done within 24-48 hours from each other, will be performed within 4 weeks before surgical evaluation/revision of the hardware.


Eligibility criteria:
inclusion criteria: * at least 6 months after hip replacement with complaint of joint pain. * radiographic studies compatible with prosthesis loosening (i.e. periprosthetic infection or aseptic loosening). * pending surgical evaluation and tissue sampling within the next few weeks to differentiate between infection and aseptic loosening. exclusion criteria: * inability to consent * pregnancy or known or suspected hypersensitivity to metals or gallium * joint replacement for any reason other than primary or secondary osteoarthritis * prior surgical therapy for prosthesis failure after initial hospital discharge * active inflammatory/infectious process at any location other than prosthetic joint (sarcoidosis, rheumatoid arthritis, hiv infection, sle)

Keywords: pet/ct 68gallium citrate orthopedic hardware infection
the acute effects of cocoa flavanols intake on overt and covert attention

Conditions: Healthy Young Adults

Summary: the present study aimed to examine whether a cocoa beverage containing 710 mg of flavanols enhances both overt and covert attention in healthy young adults, using a randomized, double-blind, baseline- and placebo-controlled crossover design.

cocoa flavanols (cf) have various physiological effects that may directly or indirectly enhance cognitive functions. following cf intake, a series of biochemical processes within vascular smooth muscle cells lead to the relaxation of smooth muscles, the dilation of blood vessels, and an increase in cerebral blood flow. for the brain to function optimally, cerebral blood flow must be maintained at a level that ensures a constant supply of oxygen and glucose to neurons. during periods of intense neuronal activity, neurons require more oxygen and nutrients, which is met by an increase in blood flow. given that cf has been shown to enhance blood flow and perfusion in brain regions associated with attention (e.g., the parietal cortex, anterior cingulate cortex, and dorsolateral prefrontal cortex), it was hypothesized that cf intake could acutely improve both overt and covert attention.

Eligibility criteria:
inclusion criteria: * normal or corrected-to-normal visual acuity exclusion criteria: * history of neurological, psychiatric, cardiovascular or metabolic disorders * following a medically restricted diet * taking antidepressant, anxiolytic, and antipsychotic drugs in the past three months * currently taking anticoagulant * taking herbal supplements in the past week * allergic or intolerant to cocoa, caffeine, sucrose, or fructose * color blindness

Keywords: cocoa flavanols overt attention covert attention
identifying biological markers of cardiovascular events in patients with aortic stenosis or tavi

Conditions: Aortic Stenosis

Summary: aortic stenosis, a common cardiovascular disease, is pathophysiologically associated with a chronic inflammatory myocardial reaction and fibrosis leading to cardiac dysfunction and impaired coronary perfusion. these elements may precede the onset of symptoms. the assessment of inflammatory and fibrosis factors (in particular by means of biomarkers) in patients with aortic stenosis will make it possible to identify asymptomatic patients at greater risk who could benefit from intervention earlier. this is part of a personalised medicine adapted to the patient. patients will be recruited during their tavi (transcatheter aortic valve implantation) assessment consultation. if the patient agrees to take part in the study, information relating to routine care procedures will be collected (patient history, clinical examinations, electrocardiogram, echography, coronary angiography, tavi procedure if applicable, biology). outside of routine care, a biocollection will be established (serum, plasma), quality of life questionnaires will be carried out and adverse events will be collected where present. patients will be divided into 3 groups according to the indication for tavi (group a - symptomatic severe aortic stenosis with indication for tavi, group b - asymptomatic severe aortic stenosis without indication for tavi, group c - asymptomatic moderate aortic stenosis without indication for tavi). the main objective is to compare the levels of biomarkers of inflammation and fibrosis between the 3 groups at each sampling time common to all three groups between inclusion and 1-year follow-up.


Eligibility criteria:
inclusion criteria: * patients \>=18 years of age * patient with symptomatic or asymptomatic severe or moderately severe aortic stenosis (according to the recommendations of the european society of cardiology - esc). * no opposition. exclusion criteria: * conjunctive heart disease (e.g. amyloidosis). * presence of a contraindication to tavi. * impossibility of giving the subject informed information. * privation of civil rights (curatorship, tutorship, protection of justice).

Keywords: aortic stenosis tavi cardiology biomarkers
retrospective evaluation of patient failure to follow-up at a community based headache clinic

Conditions: Headache

Summary: this is a retrospective review of the records of patients seen at the kilgo headache clinic in alabama between 7/1/05 and 6/30/07. the goal of the study is to identify factors at the time of the initial office visit that can be used to predict failure to follow-up.


Eligibility criteria:
inclusion criteria: * headache * initial office visit between 7/1/05 and 6/30/07 exclusion criteria: * none

Keywords: headache adherence followup