Kornimate/medical-research-clean huggingface dataset:
a phase 1 study to assess the safety,tolerability, and pharmacokinetics of gs-6615 in healthy subjects

Conditions: Ischemic Heart Disease

Summary: this is a phase 1, single-blind, randomized, placebo-controlled, multiple ascending dose study aimed to assess the safety, tolerability, and pharmacokinetics of gs-6615 in healthy subjects.


Eligibility criteria:
inclusion criteria: * weight of at least 50 kg with body mass index (bmi) between 18 and 30 kg/m2 * female subjects must be of non-childbearing potential as defined per the protocol * male subjects with female partners of childbearing potential must be using protocol acceptable methods of contraception * willing and able to comply with the requirements of the protocol and directions * willing to avoid consumption of grapefruit, grapefruit juice and seville oranges * willing to avoid consumption of nicotine (including nicotine gum) and alcoholic beverages exclusion criteria: * ongoing or history of any medical or surgical condition that, in the judgment of the investigator, might jeopardize the subject's safety or interfere with the study objectives * history of meningitis or encephalitis, seizures, migraines, tremors, myoclonic jerks, sleep disorder, anxiety, syncope, head injuries or a family history of seizures * any abnormal ecg findings, abnormal laboratory value, or physical examination findings at screening judged to be clinically significant * any abnormal neurological examination findings at screening that is judged as clinically significant * hemoglobin \< 12 g/dl * serology test positive for hiv, or hepatitis b or c * positive urine drug test (including cotinine or ethanol) * use of systemic prescription medications or over the counter (otc) medication, including multivitamins, and dietary and herbal supplement * use of any experimental or investigational drug or device within 30 days * female subjects who are of childbearing potential, pregnant or lactating * donation or loss of blood within 8 weeks and/or donation of plasma within 7 days * history of drug or alcohol abuse * psychosocial or addictive disorders

Keywords: ischemic heart disease heart disease
use of virtual reality for pain control in dermatological bedside procedures

Conditions: Pain

Summary: the purpose of this research study is to explore the impact of virtual reality (vr) on pain perception during out-patient procedures such as wart removal, wound debridement, and lidocaine injections.


Eligibility criteria:
inclusion criteria: * patients 13 years and older. * patient (or health care proxy when applicable) must sign an icf. * patient requiring any painful dermatological bedside procedure including: wound debridement, injections and liquid nitrogen application. * patients willing to participate and parents able to consent. exclusion criteria: * subjects with a diagnosis of vertigo, inner ear diseases or seizures are excluded due to the uncertainty of performance under vr conditions. * subjects requiring procedures on the head are also excluded to the interference of the vr headset.
psychological mechanisms linking food insecurity and obesity

Conditions: Obesity; Psychological

Summary: the current pilot study will examine emergent hypotheses by investigating the role of psychological mechanisms in the relationship between food insecurity and obesity. this objective will be achieved via a cross-sectional, observational pilot study collecting quantitative and qualitative data.

this pilot study will investigate an emergent risk factor for obesity: food insecurity, which is defined as the limited or uncertain availability of nutritionally adequate and safe foods. while paradoxically linked, numerous studies have shown a significant association between food insecurity and obesity. moreover, recent narrative works have developed new, untested hypotheses linking food insecurity and obesity positing the causal role of psychological mechanisms. given this, this mixed method pilot study will collect new psychological data in a sample of food secure and food insecure adults with and without obesity to examine the connections between food insecurity, body weight, and psychological constructs. the overarching objective of the study is to gather pilot data to identify potentially new intervention targets that will be used in future studies to more rigorously investigate the relationship between food insecurity and obesity.

Eligibility criteria:
inclusion criteria: * age 18-49 years * bmi ≥ 20.0 kg/m2 * able to read and write using the english language * willing to provide written informed consent exclusion criteria: * pregnancy

Keywords: food insecurity
assessing the quality of life and social support in age-related macular degeneration patients

Conditions: Age-Related Macular Degeneration

Summary: the aim of this study is to evaluate the quality of life of amd patients related to vision using the short version of the national eye institute visual function questionnaire (nei-vfq-25), patients' social support, and their relationship with demographic and clinical variables.

background and study aims. age-related macular degeneration (amd) is the most prevalent chronic progressive ocular disease. it has been shown in several studies that amd affects the quality of life of patients. the aim of this study is to evaluate the quality of life of amd patients related to vision using the short version of the national eye institute visual function questionnaire (nei-vfq-25), patients' social support, and their relationship with demographic and clinical variables. who can participate? patients with amd, who wish to participate, will be recruited. patients will be recruited from three locations of the kazakh scientific - research institute of eye diseases in almaty, nur-sultan and shymkent. what does the study involve? the study involves collecting demographic data of the participants, collecting baseline visual testing data from medical records, filling out of the nei-vfq-25, and answering two yes/no questions related to the social support and reliability of social support. what are possible benefits and risks of participating? assessment of quality of life and social support of the amd patients is a first step of developing targeted psycho-social support programs for amd patients. where is the study run from? patients will be recruited from three locations of the kazakh scientific - research institute of eye diseases in almaty, nur-sultan and shymkent. when is the study starting and how long it is expected to run for? start date 03/02/2020. end date 27/08/2022. who is funding the study? no funding for this study. who is the main contact? principal investigator: inara ismailova; +380 73 200 0688; i.ismayilova@gmail.com

Eligibility criteria:
inclusion criteria: * age-related macular degeneration; ability to speak and understand russian and/or kazakh language; willingness to participate exclusion criteria: * presence of glaucoma, cataracts of grade 2 or more according to the lens opacities classification system (locs) iii, and the presence of corneal opacities or any other retinal diseases

Keywords: age-related macular degeneration quality of life social support reliability of social support vision related quality of life
prostacox : metastatic prostate chemotherapy

Conditions: Metastatic Prostate Cancer

Summary: clinical response to chemotherapy. biological parameter (psa) and recist evaluation. association of docetaxel (j 15) and celecoxib.

association docetaxel (j 15) and celecoxib patient survival biological parameter : psa clinical status recist evaluation

Eligibility criteria:
inclusion criteria: * metastatic prostate cancer * asco progression criteria exclusion criteria: * other prostate chemotherapy
gut permeability-related inflammation and cardiovascular disease risk in normal-weight and metabolically healthy obesity

Conditions: Obesity

Summary: the investigators are examining the extent gut permeability explains observed inflammation in normal-weight and metabolically healthy obesity (and potentially cardiovascular disease risk).

cardiovascular disease (cvd) is responsible for 25% of deaths in the united states, and chronic inflammation contributes to risk. a growing body of evidence suggests that gut-derived bacterial components (e.g., lipopolysaccharide or lps) entering the bloodstream when the gut barrier fails (i.e., intestinal permeability) are a prominent source of inflammation in cardiometabolic conditions such as metabolic syndrome, coronary artery disease, and type 2 diabetes. two groups that are at \> 2x the risk for cvd, but largely still free of overt disease, are those with metabolically healthy obesity and normal-weight obesity. those with metabolically healthy obesity - defined as having an obese body mass index (bmi) but other clinical risk factors in the normal range (e.g., blood lipids) - and normal-weight obesity - defined as having a normal bmi yet high percent body fat - generally display little evidence of clinical risk, but present with elevated inflammatory markers including c-reactive protein (crp), tumor necrosis factor (tnf)-a, and interleukin (il)-6). therefore, it is likely that chronic inflammation is largely driving cvd risk in metabolically healthy and normal-weight obesity, but the source of this inflammation remains unclear. the primary aim of the proposed project is to determine the extent that markers of intestinal permeability are elevated in metabolically healthy obesity and normal-weight obesity compared to healthy controls and individuals with metabolic syndrome.

Eligibility criteria:
inclusion criteria: * control group: normal bmi, body fat percentage \ 130/85 mmhg, fasting glucose \>100 mg/dl, fasting triglycerides \>150 mg/dl, hdl cholesterol \< 40 mg/dl (men) or \< 50 mg/dl (women). * normal-weight obesity group: normal bmi, body fat percentage \> 25% for men and \> 35% for women. * metabolically healthy obesity: bmi \> 30, body fat percentage \> 25% for men and \> 35% for women, and \ 130/85 mmhg, fasting glucose \>100 mg/dl, fasting triglycerides \>150 mg/dl, hdl cholesterol \< 40 mg/dl (men) or \< 50 mg/dl (women). * metabolic syndrome group: bmi \> 30, body fat percentage \> 25% for men and \> 35% for women, and 2 or more of the following: blood pressure \>130/85 mmhg, fasting glucose \>100 mg/dl, fasting triglycerides \>150 mg/dl, hdl cholesterol \< 40 mg/dl (men) or \< 50 mg/dl (women). exclusion criteria: * presence of pacemaker * pregnant * cardiometabolic disease (e.g., diabetes, cardiovascular disease) * disease that is inflammatory in nature (e.g., inflammatory bowel disease, rheumatoid arthritis) * postmenopausal status * use of tobacco products * using illicit drugs * using lipid lowering drugs
the effect of intensive insulin therapy in the surgical critical care unit

Conditions: Sepsis; Respiratory Failure; Renal Failure; Surgical Site Infection

Summary: we sought to determine if there is a benefit to using an insulin drip to control hyperglycemia in the surgical critical care unit for patients who undergo general and vascular surgery.

while evidence exists for using tight glycemic control in the critically ill cardiac surgical patient, other patient populations have yet to be studied. we performed a prospective randomized trial for using intensive insulin therapy in the general and vascular critically ill surgical patient population. we will compare tight glycemic control versus conventional glycemic control to determine if there is a benefit to the normalization of blood glucose levels in this patient population

Eligibility criteria:
inclusion criteria: patients undergoing a general or vascular surgical procedure requiring admission to the surgical intensive care unit as a result of ventilatory requirement, vasopressor support, or physiologic instability - exclusion criteria: * under age 18

Keywords: intensive insulin therapy general surgical vascular surgical tight glycemic control
tegafur-uracil and leucovorin or s-1 in treating patients with stage iii colon cancer that has been completely removed by surgery

Conditions: Colorectal Cancer

Summary: rationale: drugs used in chemotherapy, such as tegafur-uracil, leucovorin, and s-1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. it is not yet known whether giving tegafur-uracil together with leucovorin is more effective than giving s-1 in treating patients with stage iii colon cancer. purpose: this randomized phase iii trial is studying giving tegafur-uracil together with leucovorin to see how well it works compared with giving s-1 in treating patients with stage iii colon cancer that has been completely removed by surgery.

objectives: * compare the disease-free survival of patients with stage iii colon cancer treated with s-1 or tegafur-uracil and leucovorin after curative surgery . outline: patients are randomized to 1 of 2 treatment arms. * arm i: patients receive oral tegafur-uracil and oral leucovorin 3 times daily on days 1-21. the treatment repeats 5 times every 5 weeks. * arm ii: patients receive oral s-1 twice daily on days 1-28. the treatment repeats 4 times every 6 weeks. biological samples are collected for gene expression analysis for identification of predictive markers.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of colon * stage iii (t1-4, n1-3, m0) disease * has undergone surgical resection of the tumor within the past 8 weeks patient characteristics: * ecog performance status 0-1 * able to take medications orally * wbc ≥ 3,500/mm³ and \< 12,000/mm³ * anc ≥ 1,500/mm³ * platelet count ≥ 100,000/mm³ * hemoglobin ≥ 9.0 g/dl * total bilirubin ≤ 2.0 mg/dl * ast/alt ≤ 100 iu/l * creatinine ≤ 1.2 mg/dl * no other active malignancies * must have none of the following comorbidities: * severe postoperative complications * uncontrollable diabetes mellitus * uncontrollable hypertension * myocardial infraction within 6 months * unstable angina pectoris * hepatocirrhosis * interstitial pneumonia, pulmonary fibrosis, or severe emphysema prior concurrent therapy: * no prior chemotherapy or radiotherapy for colon cancer * no concurrent radiotherapy * no concurrent biological response modifiers

Keywords: adenocarcinoma of the colon stage iii colon cancer
the effects of polyunsaturated fatty acids (pufa) on allergic/atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this clinical trial will study the effects of pufa supplementation during pregnancy and lactation period on fatty acid composition in human milk and plasma of the mothers and the clinical outcome of atopic dermatitis in infants at increased risk.


Eligibility criteria:
inclusion criteria: * woman is pregnant between 16 and 20 weeks * mother delivers after 36 weeks * mother is willing to breast-feed for four months * mother has potential to deliver a child with increased risk of atopic dermatitis * signed informed consent exclusion criteria: * mother is smoking * disease with influence on breast feeding * complicated pregnancy * allergic to seafood * allergic to soy * allergic to marine fish * mother has more than two salmon or tuna meals per week * mother is undergoing treatment with anticoagulants
safety and efficacy study of eculizumab in patients with refractory generalized myasthenia gravis

Conditions: Myasthenia Gravis

Summary: the purpose of this study is to determine whether eculizumab is safe and effective in the treatment of patients with generalized myasthenia gravis despite treatment with various immunosuppressants, such as prednisone, methotrexate, cellcept, cyclosporine, and cyclophosphamide, that are currently available.


Eligibility criteria:
inclusion criteria: * generalized mg * mgfa clinical classification class ii, iii or iva. * qmg total score ≥12 * minimum score of two (2) in four (4) or more test items in the qmg * able to give informed consent. * have failed at least two immunosuppressants after one year of treatment * a positive serologic test for binding anti-acetylcholine receptor abs at screening and one of the following a) history of abnormal neuromuscular transmission test demonstrated by single-fiber electromyography or repetitive nerve stimulation, or b) history of positive anticholinesterase test, eg, edrophonium chloride test, or c) patient has demonstrated improvement in mg signs on acetylcholinesterase inhibitors as assessed by treating physician. exclusion criteria: * history of thymoma or other neoplasms of the thymus. * history of thymectomy within 12 months prior to screening. * pregnancy or lactation * current or chronic use of plasmapheresis/plasma exchange * ivig treatment within 8 weeks prior to screening. * use of etanercept within 2 months prior to screening. * use of rituximab (rituxan®) within 6 months prior to screening. * mgfa class i, ivb, and v * crisis or impending crisis
study evaluating effexor® (venlafaxine) in achieving response and maintaining remission

Conditions: Depression

Summary: this is a study to determine the utility of effexor® (venlafaxine) in achieving response, including time to response, maintaining remission, and time to remission as measured by the 17-item hamilton rating scale for depression (ham-d) and to determine the utility of effexor® (venlafxine) on the various cluster of symptom scales in the 17-item ham-d.


Eligibility criteria:
inclusion criteria: * patients meeting criteria for a diagnosis of major depression, single or recurrent episode as described by the dsm-iv manual (appendix 1). * a ham-d 17 total score of at least 16 at baseline (dsm-iv manual, appendix 2). * patients above 18 years of age who meet the eligibility requirements. exclusion criteria: * patients taking maoi's within 2 weeks prior to the survey. * patients known to be suffering from bipolar disorder or schizophrenia. * patients who are treatment-resistant, i.e., in the past 3 years have failed (a) three previous adequate trials of greater than or equal to 2 classes of antidepressant medication, or (b) electroconvulsive therapy. * drug or alcohol dependence or abuse in the past 6 months per dsm iv criteria.
the omega study: use of eye drops to treat geographic atrophy associated with age-related macular degeneration (dry amd)

Conditions: Age-Related Macular Degeneration

Summary: the purpose of this trial is to compare the ability of two doses of ot-551 ophthalmic solution and drug-free solution to safely and effectively treat geographic atrophy associated with age-related macular degeneration.

age-related macular degeneration (amd) results in severe, irreversible central vision loss and is the leading cause of blindness in individuals older than 50 years in the western world. the vast majority of amd patients have the 'dry' (non-exudative) form that is characterized by the presence of drusen and atrophic changes in the retinal pigment epithelium (rpe). dry amd may remain static or progress slowly to produce areas of geographic atrophy (ga), the advanced or late-stage form of dry amd. ga is a severe vision-threatening lesion of the macula that may impair visual function, impact daily life activities, and result in blindness. currently, there is no approved treatment for dry amd or ga. pre-clinical results have shown that ot-551 may protect rpe cells and photoreceptors from oxidative damage and block angiogenesis stimulated by vegf and other growth factors, and therefore is a therapeutic candidate for treating ga.

Eligibility criteria:
inclusion criteria: * have a clinical diagnosis of ga in one or both eyes; * be of non-childbearing potential exclusion criteria: * have ga secondary to any condition other than amd in the study eye; * have a bcva of 20/200 or worse in the non-study eye; * have a history of or current choroidal neovascularization in either eye, or the need for any study eye anti-angiogenic therapy; * have any ocular condition in the study eye that would progress during the course of the study and could affect central vision or other ocular conditions that may be a confounding factor in this study; * need to wear contact lenses in the study eye during the study; * had confounding ocular surgery in the study eye; * have concomitant treatment with any systemic or ocular medication that is known to be toxic to the lens, retina, or optic nerve;

Keywords: amd age-related macular degeneration geographic atrophy ga
a study of progenta (cdb-4124) in pre-menopausal women with symptomatic leiomyomata

Conditions: Uterine Leiomyomata

Summary: a study of 3 doses of progenta versus placebo versus lucron depot for treatment of leiomyomata.

three doses of progenta (cdb4124 - 12.5, 25, 50 mg) versus placebo versus lucron depot (leuprolide acetate for depot suspension) was initiated in females with symptomatic leiomyomata. a single dose pk visit was conducted only for subjects randomized to the progenta arm, between screening and visit 1. a second pk assessment was conducted at visit 3 (one month on drug) to collect steady state data. treatment period lasted for 3 months.

Eligibility criteria:
inclusion criteria: * had at least one leiomyomata lesion that was identifiable and measurable by transvaginal ultrasound. * had a regular or steady menstrual cycle lasting from 24 to 36 days. exclusion criteria: * post-menopausal * subject with documented endometriosis

Keywords: uterine fibroids
topical everolimus in patients with tuberous sclerosis complex

Conditions: Facial Angiofibromas

Summary: tuberous sclerosis complex (tsc) is a rare genetic multisystem disorder characterized by the development of hamartomas in several organs (e.g. brain, heart, kidney, liver, lung), and skin in more than 90% of cases. facial angiofibromas (fa), present in about 80% of patients, are a stigmatizing hallmark of the disease. everolimus could be a candidate for use as a topical formulation to treat fa. this adaptive seamless phase ii/iii study primary objective is to determine the dose of topical everolimus for treatment of fa and evaluate the efficacy and safety of topical everolimus versus placebo in patients with angiofibromas.


Eligibility criteria:
inclusion criteria: * patients over the age of 2 years * with definite or possible diagnosis of tsc * with at least 3 fa, diagnosed by a dermatologist * patients (or parents or legal guardians) who have provided written informed consent prior to participation in the study * willing and able to comply with study requirements * with negative blood pregnancy test at the screening visit and using effective contraceptive methods for women of childbearing potential, up to 12 weeks after treatment discontinuation * covered by national health insurance exclusion criteria: * systemic treatment by sirolimus, everolimus, or any other immunosuppressive drug, during the previous 6 months * use of topical tacrolimus or sirolimus on the face, during the previous 6 months * destructive treatment (laser therapy, surgery, cryotherapy) of facial angiofibromas during the previous 6 months * concomitant use of topical treatments that could affect facial erythema (e.g. brimonidine) * known internal organ involvement requiring systemic mtor inhibitor in the next 6 months * immunosuppression (immunosuppressive disease or immunosuppressive treatment) * known chronic infectious disease known hypersensitivity to mtor inhibitor * neutropenia \< 1000/mm3 * thrombopenia \< 75,000/mm3 * chronic renal insufficiency (estimated glomerular filtration rate \< 60 mls/min) * chronic liver disease (sgot or sgpt \> 3 times upper normal limit) * uncontrolled dyslipidaemia * uncontrolled diabetes * brest feeding or pregnant women, or women on childbearing age without any effective method of contraception during treatment and up to 12 weeks after treatment discontinuation * subjects who, in the investigator's opinion, are unable or unwilling to comply with the protocol.

Keywords: tuberous sclerosis complex (tsc) topical everolimus seamless design dose-escalation study m-tor inhibitor