Kornimate/medical-research-clean huggingface dataset:
special investigation in patients with psoriasis vulgaris and psoriatic arthritis (all patients investigation)

Conditions: Psoriasis

Summary: the survey will be conducted with regard to the following aspects of treatment with humira (adalimumab) in patients with psoriasis vulgaris and psoriatic arthritis receiving this drug: * unknown adverse drug reactions, especially clinically significant adverse reactions * incidence and conditions of occurrence of adverse reactions in the clinical setting * factors that may affect the safety and effectiveness of humira.

this study was non-interventional, open-labeled, all-cases, central registration method, post marketing observational study in which humira was prescribed for patients with psoriasis vulgaris and/or psoriatic arthritis in routine medical practice. when investigators prescribed humira to an eligible patient who provided informed consent, they filled out a registration form and send it to the registration center via postal mail. at the end of the 24-week observation period, an investigator filled out a case report form for each patient to describe the findings during the study period, and provided the completed form to medical representatives. even if humira treatment was for any reason discontinued, the investigators followed each such participant for 24 weeks after the first administration of humira, and filled out a case report form for the participant at the end of the 24-week period. some participants entered this study from study nct00647400 (m04-702), a phase iii extension study of humira (adalimumab) in japan.

Eligibility criteria:
inclusion criteria: all patients who receive humira for the treatment of psoriasis vulgaris or psoriatic arthritis not responding to conventional treatment will be evaluated. eligible patients should be * those not responding to at least one type of conventional systemic treatment (including ultraviolet therapy) who have skin lesions involving 10% of body surface area or * patients with intractable eruptions of joint signs/symptoms. exclusion criteria: contraindications according to the package insert include patients who have any of the following: * serious infections * tuberculosis * a history of hypersensitivity to any ingredient of humira * demyelinating disease or a history of demyelinating disease * congestive cardiac failure.

Keywords: psoriasis
n-3 polyunsaturated fatty acids (pufas) in the prevention of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to determine the effect of n-3 pufas in addition to amiodarone and renin-angiotensin-aldosterone system (raas) inhibitors on the maintenance of sinus rhythm after electrical conversion in patients with persistent atrial fibrillation (af).

atrial fibrillation (af) is the most common sustained arrhythmia and represents an increasing burden on the healthcare system. treatment of af remains controversial. in patients on antiarrhythmic therapy, the one-year relapse rates of af after cardioversion ranges from 44% to 77% at one year and amiodarone appears to the be the most effective in maintaining sinus rhythm.over the last few years, a growing amount of evidences has supported the protective effects of n-3 pufas in preventing ventricular arrhythmias and reducing the risk of sudden cardiac death. furthermore, in the last years, the interest for their possible beneficial role in af prevention has been increasing.we hypothesized that the administration of n-3 pufas could reduce the af recurrence rate more than amiodarone plus raas inhibitors in patients with persistent af. therefore the present study aims to evaluate the role of n-3 pufas in the prophylaxis of af recurrences after dccv in addition to amiodarone and ras blockers therapy in patients with persistent af.

Eligibility criteria:
inclusion criteria: * persistent atrial fibrillation (af) lasting \> one month * history of at least one af relapse after previous electrical or pharmacological cardioversion exclusion criteria: * left atrium size \> 6 cm * severe valvulopathy * myocardial infarction during the previous 6 months * unstable angina * nyha heart failure class iv or hemodynamic instability * cardiac surgery during the previous 3 months * significant pulmonary thyroid and hepatic disease * contraindications to treatment with amiodarone or rass inhibitors * chronic renal dysfunction * qt \> 480 msec in the absence of bundle-branch block * bradycardia \< 50 b/min * diagnosis of paroxysmal af * hyperkalemia * pregnancy * any disease or other medical treatment that, in the opinion of the investigators, could interfere with the study.

Keywords: pufa atrial fibrillation
study to evaluate the efficacy of ezc pak in adults with upper respiratory infection (uri)

Conditions: Common Cold

Summary: a randomized-controlled interventional clinical trial to evaluate the effectiveness of ezc pak \& ezc pak+d for the treatment of the common cold and/or a uri.

this is a randomized-controlled interventional treatment study with three arms of comparable demographics to evaluate the efficacy of ppc pharmaceuticals ezc pak (\& ezc pak+d) to improve the severity and duration of the common cold or a uri in individuals. it is hypothesized that study participants will experience a positive impact on the duration and severity of their cold/uri while using ezc pak (\&ezc pak+d). the second study objective is to examine if patients are accepting the test product as an alternative to antibiotics.

Eligibility criteria:
inclusion criteria: * male or female over 18 years old * must be in good health (don't report any medical conditions asked in the screening questionnaire) * seeking otc remedies to reduce the severity and duration of their common cold symptoms, when they arise * must have a thermometer at home * must have a blood pressure monitor at home * ideally, uses one of the following devices: apple watch, oura ring, fitbit, other fitness trackers exclusion criteria: * unwilling to try the test product for their cold * has any of the following medical conditions: * ragweed or daisy allergy * chronic seasonal allergies * liver disease * autoimmune or connective tissue disorder (e.g., rheumatoid arthritis, lupus, multiples sclerosis, hiv) * alcohol consumption more than 7 drinks per week, or more than 3 drinks per occasion * iv drug use * renal disease * females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
the effect of different oxaliplatin dose in transarterial infusion (tai) in unresectable hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: evaluate the effect of different oxaliplatin dose in tai in treating unresectable hcc.


Eligibility criteria:
inclusion criteria: * older than 18 years old and younger than 75 years; * ecog ps≤1; * proven hepatocellular carcinoma according patological examination or easl/aasld diagnostic criteria; * not previous treated for tumor; * unresectable; * the lab test could meet: neutrophil count≥2.0×109/l; hemoglobin≥100g/l; platelet count≥75×109/l; serum albumin≥35g/l; total bilirubin\<2-times upper limit of normal; alt\<3-times upper limit of normal; ast\<3-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; pt≤upper limit of normal plus 4 seconds; inr≤2.2; * sign up consent exclusion criteria: * cannot tolerate tai or surgery; * known history of other malignancy; * be allergic to related drugs; * underwent organ transplantation before; * be treated before (interferon included); * known history of hiv infection; * known history of drug or alcohol abuse; * have gi hemorrhage or cardiac/brain vascular events within 30 days; * pregnancy
evaluation of wear experience with daily disposable and monthly replacement toric contact lenses

Conditions: Astigmatism Bilateral

Summary: comparison of wear experience with daily disposable and monthly replacement soft contact lenses in contact lens wearers who have astigmatism.


Eligibility criteria:
inclusion criteria: * subjects must be current soft lens wearers in both eyes. * subjects must have 20/25 or better distance visual acuity with current lenses (entering acuity). * good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the pi) * ability to give informed consent * willing to spend time for the study. subjects will be required to attend two study visits and wear contact lenses on days between study visits. * either gender * any racial or ethnic origin exclusion criteria: * participants cannot be pregnant or lactating. * participants cannot be current wearers of the study lenses * no current ocular inflammation or infection as assessed by the study investigator

Keywords: contact lenses astigmatism
added value of o-rads in evaluation of ovarian lesions

Conditions: Ovarian Diseases

Summary: to detect added value of o-rads in evaluation of ovarian lesions and compare o-rads with gi-rads regarding malignancy rate, the validity and reliability through pathological results and other modalities

ultrasound (us) continues to be the initial imaging modality of choice for the identification and characterization of adnexal masses (am) . structured reporting of am findings was identified by a society of radiologists in ultrasound consensus working group as a target for the investigation to improve the management of women with am . many established guidelines and structured reporting have been developed using sonography to characterize am, including subjective assessment, simple scoring systems, and statistically derived scoring systems . in 2008, the international ovarian tumor analysis (iota) group proposed the use of us simple rules for the diagnosis of ovarian malignancy. these are based on a set of five us features indicative for a benign tumor (b features), and five us features indicative for a malignant tumor (m features) . in 2009, the gynecology imaging reporting and data system (gi-rads) was designed as an attempt allowing standardized reporting of am. this system is based on recognition patterns and criteria provided by the iota. the american college of radiology (acr) published the ovarian-adnexal reporting and data system (o-rads), which provides an up-to-date suggestion to stratify the am according to sonographic features. the o-rads offers a comprehensive algorithm that categorizes am by their possibility of being normal (o-rads 1), to high risk of malignancy (o-rads 5) . for the application of the us classification system of am in clinical settings, it is essential to evaluate their validity and reproducibility. several studies have investigated the validity of these risk stratification systems in the assessment of am. however, data on the comparability and reproducibility of the systems are limited. the purpose of this study is to detect added value of o-rads in evaluation of ovarian lesions and compare o-rads with gi-rads regarding malignancy rate , the validity and reliability through pathological results.

Eligibility criteria:
inclusion criteria: * all newly diagnosed patients with ovarian lesions referred to the radiology department. * must be able to be examined. exclusion criteria: * patients younger than 17 years old * patient who refused to be a part of the study and undergo examination.
intra-operative uterosacral ligament bupivacaine injection during minimally invasive hysterectomy

Conditions: Pain, Postoperative; Opioid Use

Summary: this is proof of concept, phase i randomized controlled trial studying a short acting non-opioid anesthetic, bupivacaine to improve post-operative pain in gynecologic surgery patients. patients who are undergoing minimally invasive (laparoscopic or robotic) hysterectomy will be randomized to receive no uterosacral injection, normal saline uterosacral injection, or 0.25% bupivacaine uterosacral injection just prior to colpotomy (incision around the cervix and removal of uterus) during minimally invasive hysterectomy.


Eligibility criteria:
inclusion criteria: * women over the age of 18 years old * undergoing benign minimally invasive hysterectomy with minimally invasive gyn surgeon at johns hopkins hospital * patients must be english speaking. exclusion criteria: * pregnancy * allergy, contraindication, or intolerance to bupivacaine, opioids, tylenol, or nsaid drugs * pre-operative daily opioid consumption * peri-operative transverse abdominis plane block * recent history of drug or alcohol abuse (in last year) * severe cardiovascular, hepatic or renal disease.
observational study of cardiovascular disease.

Conditions: Cardiovascular Diseases; Cardiovascular Morbidity; Coronary Heart Disease; Low-density-lipoprotein-type

Summary: this observational study will follow participants who completed follow-up in the fourier outcomes trial to evaluate the long-term effects of evolocumab treatment. long-term post-trial (legacy) beneficial effects have been reported with statins, niacin, hypoglycemic therapy and fibrates. whether similar effects are seen after ldl cholesterol (ldl-c) lowering by pcsk9 inhibition is currently unknown. evolocumab therapy causes a profound reduction in ldl cholesterol of approximately 60%. statins have shown legacy effects over 5 years post-trial, including a 7% reduction in total mortality in meta-analysis and 12% reduction in coronary mortality. it would therefore be hypothesized that additional effects beyond the trial period would be conferred by previous evolocumab treatment. it is also important to assess the long-term safety of prior evolocumab treatment.


Eligibility criteria:
subjects who completed the fourier outcomes trial (defined as attendance at close-out visit irrespective of treatment compliance) will be approached by fourier outcomes site investigators and asked about their interest in taking part in this trial.

Keywords: cardiovascular events coronary heart disease cardiovascular death low density lipoprotein cholesterol (ldl-c) evolocumab fourier outcomes
cocoa supplementation, inflammaging, and epigenetic aging

Conditions: Aging; Inflammation; Cardiovascular Diseases

Summary: the cocoa supplement and multivitamin outcomes study (cosmos; nct02422745) is a randomized clinical trial of cocoa extract supplement (containing a total of 500 mg/d flavanols, including 80 mg. (-)-epicatechins), and a standard multivitamin supplement to reduce the risk of cardiovascular disease and cancer among men aged 60 years and older and women aged 65 years and older. this ancillary study is being conducted among participants in cosmos and will examine whether the cocoa extract supplement or the multivitamin supplement has an anti-aging effect (epigenetic aging and inflammaging) and examining these findings in the context of cvd risk factors and outcomes.


Eligibility criteria:
participants in cosmos (nct02422745) who meet the following criteria are eligible to participate in this ancillary study: inclusion criteria: * provided blood samples at baseline, year 1, and year 2 of follow-up. * opted to use emsi for longitudinal blood collections, during which seated bps were additionally measured. exclusion criteria: • did not collect blood samples at baseline, year 1, or year 2 of follow-up.
comparing sonovue with sonazoid using ceus-lirads in hcc

Conditions: Hepatocellular Carcinoma; Cirrhosis

Summary: the new version of ceus li-rads published at 2018(version 2017). in this study, the investigators aim to investigate the diagnosing performance of ceus li-rads by administrating different contrast agents (sonovue/ sonazoid).

independent radiologists from department of ultrasound will report their diagnosing results according to ceus li-rads version 2017 without getting any information about patients. the researcher of this subject will collect all results and evaluated the sensitivity and specificity of ceus li-rads and the diagnosing performance with different contrast agents.

Eligibility criteria:
inclusion criteria: * patients at risk for hcc with focal liver lesion on conventional ultrasound. * history of cirrhosis. * historty of hbv infection. exclusion criteria: * systemic therapy with sorafenib * pretreat lesion * patients don't sign the informed consent.

Keywords: hepatocellular carcinoma cirhossi contrast-enhanced ultrasound li-rads
effectiveness of varenicline: testing individual differences

Conditions: Smoking Addiction

Summary: the study will evaluate the effectiveness of smoking cessation using varenicline versus placebo. effectiveness will be measured by the average number of cigarettes smoked per smoking day for up to 36 weeks.


Eligibility criteria:
inclusion criteria: * 18 yrs to 55 yrs * smoker exclusion criteria: * medical contraindications
palliative radiofrequency ablation in metastatic renal cell carcinoma patients

Conditions: Carcinoma, Renal Cell

Summary: the purpose of this study is to evaluate efficacy and safety of radiofrequency ablation in metastatic renal cell carcinoma patients with primary tumor less than 5 cm before medical treatment. ablation may allow for reduced morbidity and may increase the likelihood of patients receiving systemic therapy.

nephrectomy has become an integral part of the management of patients with metastatic kidney cancer. performing nephrectomy in these patients is not without risk, however. the very real chance of significant metastatic disease progression during the postoperative period or complication before or during surgery that may prolong postoperative recovery could potentially delay or prevent the administration of systemic therapy in the postoperative period. patient selection for surgery remains critical for success. radiofrequency ablation (rfa) is a medical procedure where tumor is ablated using microwave energy to treat a medical disorder. the benefits of rfa in selected metastatic renal cell carcinoma patients with small primary tumor (\<5 cm) will be evaluated in this phase i/ii study.

Eligibility criteria:
inclusion criteria: * histologically proven renal cell carcinoma before rfa; * primary tumor no grater than 5 cm; * ct-confirmed metastatic measurable sites; * good prognosis by adapted mskcc criteria; * no treatment for rcc;

Keywords: metastatic renal cell carcinoma radiofrequency ablation
a randomized, single center pilot study comparing hyaluronic acid to vaginal estrogen for treatment of genitourinary syndrome of menopause

Conditions: Genitourinary Syndrome of Menopause (GSM)

Summary: non-hormonal alternatives for the treatment of genitourinary syndrome of menopause (gsm) are needed. in this proposed trial, patients who are diagnosed with gsm will be randomized to receive either a hyaluronic acid (hla) vaginal insert or vaginal estrogen topical cream for 12 weeks. there will be a baseline visit and an 12 week follow up visit, at which points the patient will undergo a detailed history and physical examination including a pelvic exam, vaginal ph sampling, vaginal cell sample for microscopic analysis, and will fill out a vulvovaginal symptom questionnaire (vsq). these study arms will be analyzed to assess the efficacy of hla as compared to the gold standard of vaginal estrogen to treat gsm symptoms.


Eligibility criteria:
inclusion criteria: 1. postmenopausal status as defined by amenorrhea for \>12 months or history of bilateral salpingo-oophrectomy or if the patient has had a hysterectomy and menopausal symptoms for \>1 year or fsh \> 40 2. symptoms of gsm 3. negative pap smear as per asccp guidelines 4. capable of giving informed consent 5. ambulatory 6. capable and willing to follow all study-relation procedures exclusion criteria: 1. use of any hrt (systemic or local) or raloxifene within six weeks of proposed start date 2. history of estrogen-sensitive tumor 3. undiagnosed vaginal bleeding in the past 12 months 4. history of thromboembolic event 5. currently have or have had liver problem 6. bleeding disorder 7. impaired mental status 8. prior pelvic irradiation 9. active vaginal infection 10. any medical reason the investigator deems incompatible with treatment with vaginal estrogen
effect of physician peer coaching on burnout in hospital-based physicians: a pilot randomized clinical trial

Conditions: Burn Out

Summary: the prevalence of burnout symptoms among physicians is high, especially for acute care physicians. physician burn out is a long-term stress reaction marked by emotional exhaustion, depersonalization, and a lack of sense of personal accomplishment. the healthcare environment, due to its demanding pace and emotional intensity, puts physicians at high risk for burnout.

physician-led professional coaching is a one-on-one intervention between a physician coach and an individual physician that is systematic, collaborative, future-focused, goal-oriented and is meant to help coaches attain valued professional or personal development. the trial will be conducted with 25 participants in an intervention cohort and 25 participants in a control. the intervention cohort will receive 6 individual coaching sessions over 6 months. coaching sessions will use the cheer acronym for conducting the coaching sessions: celebrate, hear, executive coaching, engage, and recharge. the control group will be eligible for coaching sessions after the completing of the interventional arm. physicians randomized to the control arm will be offered the same individualized coaching sessions as those that were in the intervention group. te maslach burnout inventory survey will be used to measure burnout and will be collected at baseline, 3 months, 6 months, and 9 months. the physician coach will be blinded to all survey data as it is being collected.

Eligibility criteria:
inclusion criteria: * geisinger physician * practicing medicine at least 6 months in the geisinger system exclusion criteria: * currently seeking professional coaching sessions * planning to leave the geisinger system within 1 year
neomatrix wound matrix collagen dressing skin prick test

Conditions: Allergy Skin; Allergy; Dermatitis, Allergic Contact

Summary: the objective of this study is to investigate the potential of neomatrixtm wound matrix to cause an allergic response to healthy volunteers using a skin prick test.

using a minimally invasive skin prick test, the test material, positive control, and negative control are applied to the forearm using a prick test. the test area is observed after 15 minutes, 6 hours, and again at 1-2 days after the initial prick test. the skin will be examined for a reaction such as a wheal and/or a flare, a flare alone is not clinically significant.

Eligibility criteria:
inclusion criteria: * healthy volunteers aged at least 18 years. * completed written informed consent and receive a copy of their executed icf. * volunteers must be capable of understanding and following directions in english. exclusion criteria: * pregnancy or lactation; * inadequate or non-existent contraception (women of child bearing potential only); * a current skin disease; * heavy alcohol consumption; * current use or history of repeated use of recreational drugs; * recent illness prior to test; * significant past medical history of diseases to potentially effect study results; * current treatment of allergy; * a history of multiple drug hypersensitivity; * concurrent medication likely to affect the response to the test articles or confuse the results of the study; * known sensitivity to the test articles; * participation in a repeat insult patch test (ript), skin prick test (spt) or follow-up work within the last month; * sensitization or questionable sensitization in a skin test; * recent immunization.