Kornimate/medical-research-clean huggingface dataset:
the influence of closing the gap on postoperative seroma and recurrences in laparoscopic ventral hernia repair

Conditions: Ventral Hernia

Summary: a multicenter prospective randomized controlled trial comparing closure versus non-closure of the hernia defect between 2 and 5 cm in width using a tissue separating mesh (physiomesh™) in laparoscopic ventral hernia repair.


Eligibility criteria:
inclusion criteria: * written informed consent from the patient or his/her legal representative * ventral or incisional hernia requiring elective surgical repair * diameter between 2 and 5cm in width * midline and flank hernias are eligible exclusion criteria: * no written informed consent * 'hostile' abdomen, open abdomen treatment * contraindication to pneumoperitoneum * emergency surgery (incarcerated hernia) * parastomal hernia * subxiphoidal hernia * subcostal hernia * suprapubic hernia * clean-contaminated or contaminated field * hernia diameter \>5cm in width * pregnancy * non-compliance

Keywords: ventral hernia
the impact of family financial support on cognition

Conditions: Impaired Cognition

Summary: the investigators have partnered with financial coaching organizations to establish what the investigators have termed a "medical-financial partnership (mfp)" that offers financial coaching to improve financial and mental health. the investigators will evaluate the mfp's impact on cognition using the patient reported outcomes measurement information system (promis) cognition short form 8a.

financial coaching is a new tool in the field of community development, but it has already demonstrated significant financial impact in a number of studies, including one randomized trial conducted by the urban institute. financial coaching improves participant financial literacy, budgeting, saving for financial emergencies, and debt level. the investigators' project will help clinicians and the field of community economic development understand health and well-being through a new economic lens and assess the health-related impacts of the emerging field of financial coaching. the investigators have partnered with financial coaching organizations to establish what they have termed a "medical-financial partnership (mfp)" that offers financial coaching to improve financial and mental health. the investigators will evaluate the mfp's impact on cognition using the patient reported outcomes measurement information system (promis) cognitive abilities short form. community-based participants will be recruited from south los angeles and randomized to receive either monthly financial coaching plus access to referral for social services (intervention) or access to referral for social services alone (control). inclusion criteria include having dependents under age 18, having some form of income, and having a tax identification number (social security number or individual tax identification number). participants will be surveyed quarterly regarding their cognition using the promis cognitive abilities short form 8-item survey.

Eligibility criteria:
inclusion criteria: * participants will be included if they are caregivers/parents of one or more dependents, have some form of income, and have a tax identification number. exclusion criteria: * inability to take part in financial coaching due to disability or primary language other than english or spanish.

Keywords: cognition financial coaching social determinants of health socioeconomic status
effects of transdermal nicotine on smoking, craving and withdrawal in people with schizophrenia

Conditions: Schizophrenia and Disorders With Psychotic Features; Tobacco Use Disorder; Schizophrenia

Summary: individuals with schizophrenia are three times as likely to smoke cigarettes as individuals without schizophrenia. while a great deal of research has been focused on smoking cessation programs for healthy individuals, little attention has been directed towards developing an effective smoking cessation treatment for schizophrenics. this project will evaluate the effects of 0, 21 and 42 mg transdermal nicotine on smoking, urge to smoke, and nicotine withdrawal symptoms after 5 hrs abstinence in smokers with schizophrenia and heavy-smoking non-psychiatric control smokers.

nicotine is the most commonly abused drug among individuals with schizophrenia; at least 60 percent of schizophrenics smoke cigarettes. nicotine withdrawal may cause a temporary worsening of schizophrenia symptoms, making it especially difficult for these individuals to quit smoking. little research has been done on the most effective way to control nicotine use in schizophrenic individuals. transdermal nicotine and bupropion reduce smoking in non-psychiatric smokers, but little is known about the effects of these medications in smokers with schizophrenia. this project examines the effects of 0, 21 and 42 mg transdermal nicotine on smoking behavior and related subjective effects (urge to smoke and nicotine withdrawal symptoms) in smokers with schizophrenia and non-psychiatric heavy smoking controls. participants come to the laboratory at 9 am, at which time placebo or nicotine patches are applied. after 5 hrs of smoking abstinence, participants undergo a smoking cue reactivity assessment in which craving and withdrawal symptoms are measured after viewing and handling neutral cues and smoking cues. this is followed by 90 min period in which participants can smoke freely, and smoking topography variables are measured.

Eligibility criteria:
inclusion criteria: * smokes between 20 and 50 cigarettes per day * diagnosis of schizophrenia or schizoaffective disorder exclusion criteria: * if enrolled in the control group, must not be diagnosed with a psychiatric disorder * currently dependent on alcohol or any drug (other than nicotine) * currently trying to quit smoking * currently taking bupropion, desipramine, clonidine, buspirone, or doxepin * history of liver disease * history of heart attacks or chest pain * allergic to adhesives * pregnant or breastfeeding

Keywords: nicotine dependence tobacco dependence
cardiac screening of middle aged and older women and men (master athletes)

Conditions: Heart Disease

Summary: in 2010 there was published new european recommendations for assessment of adult and elderly men and women, who want to start with physical activity and/or participate in endurance contests. in this study we want to test if a group of people with positive score on a self-reported questionnaire and/or high-risk score in a risk scoring system (norrisk) have more undetected heart diseases than a control group with no reported or detected risk factors.

forty senior athletes between 35 to approximately 80 yrs old with a positive score will be included in one group, and another forty seniors without positive score in a control group. each of them will be tested with an cardiorespiratory exercise test (cpet) with ecg and examined with echocardiography together with an usual medical examination and blood tests (cholesterol and hba1c-glucose). some with symptoms of arrhythmias will be examined by 24-hours holter-monitoring. the main purpose of the study is to assess if men and women with a positive score on the questionnaire og norrisk-screening (risk calculator for coronary heart disease) have more detectable heart diseases than the control group.

Eligibility criteria:
inclusion criteria: \> 35 yrs old master athletes positive score on symptom based questionnaire or high risk score no known heart disease participated in long-term endurance competitions exclusion criteria: \< 35 yrs old known heart disease

Keywords: heart screening master athletes cardiovascular disease
biomarker study to diagnose alzheimer's disease

Conditions: Alzheimer Disease; Mild Cognitive Impairment

Summary: the purpose of our study is to investigate csf and blood biomarkers among the subjects with mild cognitive impairment (mci) and alzheimer's disease (ad) as well as normal controls.

alzheimer's disease is the most prevalent cause of dementia. a biomarker is a variable that are measured in vivo and indicate specific features of disease related molecular mechanisms and pathologic changes, including amyloid processing and aggregation, tau hyperphosphorylation, accumulation of neurofibrillary tangles, synaptic dysfunction, neurodegeneration, and loss of brain tissue. we examine serum oligomeric beta-amyloid 42 and csf monomeric beta-amyloid 42, total tau and phosphorylated tau, as well as pib-pet, fdg-pet and brain mri in 90 participants (30 normal controls, 30 patients with mild cognitive impairment, 30 patients with alzheimer's disease).

Eligibility criteria:
inclusion criteria: 1. signed and dated written informed consent obtained from the subject or the subject's legally acceptable representative ( if applicable) in accordance with the local regularities. 2. both male and female, aged \> 50 and \<90, if women, must have no childbearing potential 3. controls did not have subjective memory complaints or any of 28 diseases and did not have a history suggestive of a decrease in cognitive function (stroke or transient ischemic attack, seizures, parkinson's disease, multiple sclerosis, cerebral palsy, huntington's disease, encephalitis, meningitis, brain surgery, vascular surgery of the brain, diabetes requiring insulin control, improperly managed hypertension, cancer diagnosed within the past 3 years excluding skin cancer, shortness of breath while sitting still, use of home oxygen, heart attack with changes in memory, walking, or solving problems lasting at least 24 hours afterwards, kidney dialysis, liver disease, hospitalization for mental or emotional problems in the past 5 years, current use of medications for mental or emotional problems, alcohol consumption greater than 3 drinks each day, drug abuse in the past 5 years, treatment for alcohol abuse in the past 5 years, unconsciousness for more than one hour other than during surgery, overnight hospitalization due to head injury, illness causing a permanent decrease in memory or other mental functions, trouble with vision that prevents reading ordinary print even with glasses, or difficulty understanding conversations because of hearing even with a hearing aid) 4. the controls also had scores that were at least one standard deviation above the mean scores of the respective age- and education-matched population on the k-mmse and an average score of 0.42 or less on the korean instrumental activities of daily living (k-iadl) exclusion criteria: -
effect of jkb-122 on prednisolone and azathioprine induced remission in autoimmune hepatitis (aih)

Conditions: Autoimmune Hepatitis

Summary: this is a phase 2 study. all patients will receive prednisolone and aza as standard of care (soc) during the study. at the end of the study, all data collected will be analyzed the efficacy and safety of jkb-122 on soc reduction and inflammation improvement in autoimmune hepatitis

jkb-122 has been demonstrated effective reducing aminotransferase in refractory aih patients with soc.this is a new phase 2 study to find an optimal dose for relevant phase 3 study in newly diagnostic aih patients. all patients will receive prednisolone and aza as standard of care (soc) during the study. subjects will be randomized to receive 5 mg jkb-122, 15 mg jkb-122, 35 mg jkb-122 or placebo in 1:1:1:1 ratio, adjunct to soc. this protocol with the primary endpoint being biochemical remission and evaluation of 3 different treatment doses. the histology will be explored as secondary to test long term benefit and to show similar trend with the biomarkers.

Eligibility criteria:
inclusion criteria: 1. male or female, 18 to 65 years old. 2. if female of childbearing potential, must not be pregnant or breastfeeding and either postmenopausal (no menses for previous 12 months) or using an effective method of birth control. 3. probable or definite diagnosis of autoimmune hepatitis according to the international autoimmune hepatitis study group criteria. 4. new diagnosis of aih that requires treatment according to the current easl guidelines. 5. has elevated liver test results (alt) at least 5x uln at screening. 6. is capable of understanding and signing the informed consent document. exclusion criteria: 1. overlap syndrome with primary sclerosing cholangitis (psc) or primary biliary cholangitis (pbc) 2. has cirrhosis on liver biopsy, or child-pugh score greater than 6 at screening. 3. has human immunodeficiency virus (hiv) or is hepatitis b virus or hcv positive. 4. has history of alcohol intake \> 25 g/day within the past six months. 5. severe anemia, leukopenia , or thrombocytopenia. 6. known intolerances to prednisolone or azathioprine. 7. current treatment with prednisone/prednisolone and/or immunosuppressive medication for an indication other than autoimmune hepatitis 8. has a known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold 9. has unstable and uncontrollable hypertension (\>180/110 mmhg) 10. has current malignancy or a history of malignancy (within the past 5 years), except basal or non-metastatic squamous cell carcinoma of the skin that has been treated successfully. 11. has any form of current substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.

Keywords: autoimmune hepatitis orphan disease aminotransferase steroid sparing alt
factor vii, prothrombin complex concentrate, and fresh frozen plasma in warfarin-related intracranial hemorrhage

Conditions: Intracranial Hemorrhage

Summary: the purpose of this dose-ranging pilot study is to compare recombinant activated factor vii, prothrombin complex concentrate and fresh frozen plasma (each starting at low doses with escalation if necessary) for the reversal of warfarin in the setting of acute intracranial hemorrhage.

both recombinant activated factor viia (rfviia) as well as prothrombin complex concentrate (pcc) are labeled for the treatment of bleeding episodes in patients with hemophilia. many hospitals are also using each for the following unlabeled indications: bleeding rescue in surgical patients, severe multiple trauma with ongoing bleeding, intracranial bleeding \< 4 hours since symptom onset, traumatic head injury with evidence of expanding bleed, retroperitoneal bleed, and life-threatening bleeding due to idiopathic coagulopathy. to our knowledge, these two products have never been clinically compared head to head for the reversal of warfarin in the setting of intracranial hemorrhage. the rfviia (novoseven) guidelines are based off of national data and utilize a dose range of 40-90 mcg/kg of ideal body weight (2.8-6.3 mg for a 70 kg. patient) with an additional dose if needed. the dose cited in the literature for the management of intracerebral bleeds ranges from 10 to 120 mcg/kg (0.7 - 8.4 mg for a 70 kg. patient,) with higher doses associated with increased risk of thromboembolic events. the recommended dosing of pcc is 30-50 i.u. per kilogram of ideal body weight with additional dosing if needed. pcc (profilnine®sd) is a mixture of the following vitamin k-dependent clotting factors: ii (prothrombin), vii (proconvertin), ix (plasma thromboplastin component; ptc; christmas factor), and x (stuart-prower factor). these factors are required for the conversion of prothrombin to thrombin and thus adequate hemostasis, and are synthesized in the liver. currently at the most hospitals around the country, fresh frozen plasma (ffp) is the mainstay for reversal of warfarin-related coagulopathy in intracranial hemorrhage at the discretion of the treating attending physician. we propose to study all the current reversal practices in the intracranial hemorrhage population here at the university of utah as part of a quality improvement project for both patient safety and cost. we will perform a safety and feasibility study comparing dosage regimens of rfviia, fixa and fresh frozen plasma (ffp) infusion in the normalization of coagulopathy in the context of warfarin-related intracerebral hemorrhage. our primary outcome is time to inr normalization defined as inr≤ 1.3 on two consecutive readings separated by 2 hours.

Eligibility criteria:
inclusion criteria: * non-traumatic intracranial hemorrhage (subdural or intraparenchymal) * known warfarin ingestion * inr ≥2.0 * gcs \<13 exclusion criteria: * pregnancy * history of venous thrombosis or pulmonary embolus * acute myocardial infarction * acute stroke

Keywords: intracranial hemorrhage warfarin anticoagulant factor vii prothrombin
first-sight refractive error correction in the developing world

Conditions: Vision Loss

Summary: the aim of this study is to test the efficacy of the first-sight refractive kit designed to provide refractive correction of simple hyperopia, myopia and astigmatism with autorefraction.

in remote and underserved areas, a patient may have limited or no access to eye specialists or healthcare facilities that offer equipment to provide standard refraction and purchase corrective lenses. first sight refracting system (fsr) is designed specifically to be used in remote and underserved areas. fsr is not considered the standard of care in the us. fsr is a portable refraction and lens-frame dispensing system with low cost of production. as a kit, it contains +/- 6.00 diopters of corrective lenses, color coordinated flipper, - 1.25 diopter astigmatism lens, visual acuity chart, astigmatic eye chart, measuring tape to measure the distance of the subject to the eye charts, pupillary distance ruler to measure for the frame size of the glasses to be dispensed, and lint free gloves. the kit comes with two standard frames. the corrective lenses are designed to be placed in the frames that can be readily dispensed to the patient after the refraction is done. the refraction technique is simple and straightforward and any healthcare worker in remote and underserved areas can provide the test and dispense glasses at no cost. this is the third phase of first sight refractive study to be done in haiti. adult and children subjects will be recruited during their routine examinations and/or visual acuity screenings at the justinien hospital. the proposed study will compare the visual acuity measurements obtained from the first sight refraction system (test procedure) with the visual acuity measurements obtained from the autorefraction (standard care). the international study will recruit 150 subjects which will test fsr's effectiveness as a refracting tool of choice to be used in remote and underserved areas. data from this study will be compared with the us studies.

Eligibility criteria:
inclusion criteria: * subjects must be 7 years of age and older * healthy subjects with no known ocular trauma, no surgery, ocular disease or pathology that would prevent obtainment of best correctable visual acuity to 20/30. exclusion criteria: * refractive error greater than (+)/(-) 6.00 diopter, or astigmatism greater than 1.50 diopters. * known ocular (corneal, lenticular, vitreal, or retinal) pathology that may limit best correctable visual acuity.

Keywords: vision nearsighted vision farsighted
nano-pulse stimulation (nps) in sebaceous hyperplasia optimization study

Conditions: Sebaceous Hyperplasia; Skin Abnormalities; Skin Lesion

Summary: primary study objective is to evaluate the optimization of nano-pulse stimulation (nps) energy settings for lesion clearance of sebaceous hyperplasia (sh) lesions from facial areas of healthy adult subjects.

* evaluate lesion clearance of treated facial sebaceous hyperplasia lesions using multiple sized treatment tips with microneedles. * evaluate lesion clearance of the treated sebaceous hyperplasia lesions using multiple energy settings levels at various time points. * evaluate skin effects and adverse event rate.

Eligibility criteria:
inclusion criteria: * male or female between 18 and 75 years of age * voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained. * understanding of the clinical investigation, agree to cooperate with the investigational procedures and are willing to return for all the required follow-up visits. * understands that shs are to be treated in a single treatment session is aware that they may receive a second treatment at their third study visit * must be able to visit clinic site at 7-, 30-, 60-days post-primary treatment of sh lesion and at 30- and 60-days post-retreatment. * clinically diagnosis of typical sebaceous hyperplasia. * minimum of four sh lesions. * undergo all study procedures including consent for photographs of the treated sh sites. * agrees to refrain from using all other sh lesion removal products or treatments (topical medication including over-the-counter medications) during the study period. exclusion criteria: * implantable electronic devices (i.e., pacemaker, implantable cardioverter defibrillator) * active infection or history of infection in designated test area within 90 days prior to first treatment. * not willing or able to sign the informed consent. * known to be immune-compromised. * known to be a keloid producer. * taking blood thinning medications. * insulin dependent, type i diabetics. * allergies to lidocaine or lidocaine-like products. * employed by the sponsor, clinic site, or entity associated with the conduct of the study. * have any condition or situation which, in the investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study. * known prior inability to complete required study visits during treatment period. * use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study.
a long term follow-up study for asian adult patients with attention deficit hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of this study is to assess long-term safety and tolerability in adult patients who have completed a previous atomoxetine study.


Eligibility criteria:
inclusion criteria: * patients who have completed the b4z-je-lyee study (nct00962104) and signed the informed consent document (icd). * patients must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture and examinations, required by the protocol. * patients must possess an educational level and degree of understanding of the language of their country that enables them to communicate suitably with the investigator and study coordinator. exclusion criteria: * patients who meet diagnostic and statistical manual of mental disorders, fourth edition, text revision criteria for current anxiety disorder and also patients who require anti-anxiety drug therapy within previous study except for those taking benzodiazepines analogs for anxiety. the dosage of diazepam equivalents should not be more than 5 milligrams/day (mg/day). * patients who, in the opinion of the investigator, are at serious suicidal risk or serious risk of harming others, or whose score for item 11 on the hamilton depression rating scale-17 items is equal or more than 2 at randomization or screening. * patients with significant medical conditions that are likely to become unstable during the trial or would likely be destabilized by treatment with atomoxetine or require treatment with excluded medications. * patients with a history of allergy to atomoxetine, severe allergies to more than 1 class of medications, or multiple adverse drug reactions. * patients who have received treatment within the past 30 days with a drug that has not received regulatory approval for any indication at the time the informed consent document is obtained.

Keywords: adhd