Kornimate/medical-research-clean huggingface dataset:
videoocular assessment of eye movement activity in an ataxia telangiectasia

Conditions: Ataxia Telangiectasia; Dysmetria

Summary: ataxia-telangiectasia (a-t) is a multisystem auto-somal recessive disorder linked to the a-t mutated gene (atm) on chromosome 11q22-23, and characterized by progressive neural degeneration, immunodeficiency, and progressive ocular motor dysfunction. in previous studies, the quantitative description of the ocular motor deficits from clinical examination was limited to various defects in saccade and gaze control, dysmetric saccades, impairments of smooth pursuit, gaze holding, convergence, vestibular and optokinetic nystagmus slow phases, and cancellation of the vestibulo-ocular reflex. the aim of our research is to add existing findings with quantitative description of oculomotor patterns in a-t patients using videooculography (vog).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of ataxia telangiectasia, * informed consent, * stay at the clinical research rehabilitation center "russkoe pole" for 14 days. exclusion criteria: * epilepsy, * poor visual acuity, inability to percept from a computer monitor, * inability to hold head and posture satisfactory to perform the tasks, * difficulty to obtain adequate recordings due to corrective lenses, * visual field defects.

Keywords: eye movements saccades unstable gaze holding rehabilitation
the impact of a colonoscopy monitoring program on endoscopists' performance

Conditions: Adenoma Colon Polyp; Sessile Serrated Adenoma

Summary: the goal of this clinical trial is to learn if colonoscopy monitoring program works to adenoma detection rate in endoscopists. it will also learn about the impact on sessile serrated lesion detection rate, adenomas per colonoscopy, sessile serrated lesions per colonoscopy, advanced adenoma detection rate. the main questions it aims to answer are: does colonoscopy monitoring program effect on adenoma detection rate in endoscopists? participants will: receive result of colonoscopy monitoring program or not every 3 months for 1 year


Eligibility criteria:
inclusion criteria: * endoscopists with at least 1 year of colonoscopy experience exclusion criteria: * endoscopists with less than 1 year of colonoscopy experience

Keywords: adenoma sessile serrated adenoma colonoscopy
phase 3 study of immunotherapy to treat advanced prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine if asymptomatic or minimally symptomatic patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * metastatic prostate cancer * asymptomatic or minimally symptomatic * progression during hormonal therapy * eastern cooperative oncology group (ecog) performance status 0-1 exclusion criteria: * liver, lung or brain metastases * prior immunotherapy or chemotherapy for metastatic prostate cancer * autoimmune disease * hiv, hepatitis b, or hepatitis c infection
pioglitazone on pancreatic steatosis and bone health

Conditions: Obesity; Type 2 Diabetes

Summary: randomized, double blind, placebo controlled trial evaluating the effect of pioglitazone on pancreatic fat content and bone turnover markers.


Eligibility criteria:
inclusion criteria: * fat level in the pancreas above 4% (measurement done by us with an mri) * english speaker * over 21 years old exclusion criteria: * contraindication to mri * anemia * pregnancy or desire to conceive * use of unapproved medications * prior pancreatic disease * use of more then 2 alcoholic drinks every day

Keywords: pioglitazone prediabetes diabetes obesity pancreatic fat
a comparison of 122-0551 foam versus vehicle foam in subjects with plaque psoriasis (study 306)

Conditions: Plaque Psoriasis

Summary: this phase 3 study (study 306) has been designed to determine and compare the efficacy and safety of 122-0551 foam and vehicle foam applied twice daily for two weeks in subjects with plaque psoriasis.


Eligibility criteria:
inclusion criteria: * subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 12% affected body surface area. * subject has an investigator's global assessment (iga) score of at least three (moderate) at study start. * if subject is a woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control for the duration of the study. exclusion criteria: * subject has spontaneously improving or rapidly deteriorating plaque psoriasis. * subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis. * subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk by study participation. * subject has used any phototherapy (including laser), photo-chemotherapy or other forms of photo based therapy for the treatment of their psoriasis within 30 days prior to study start. * subject has used any systemic methotrexate, retinoids, systemic corticosteroids \[including intralesional, intra-articular, and intramuscular corticosteroids\], cyclosporine or analogous products within 90 days prior to study start. * subject has used any systemic biologic therapy (i.e., fda-approved or experimental therapy) within five half-lives of the biologic prior to study start. * subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to study start or is intending to have such exposure during the study.
alcohol expert system intervention for problematic alcohol use

Conditions: Alcohol-related Disorders; Alcohol Drinking

Summary: in a randomized controlled trial, patients recruited in a general hospital and fulfilling criteria for alcohol dependence, alcohol abuse or at-risk drinking will be randomly allocated to two conditions:(1) transtheoretical model (ttm)-based expert system group, patients receive an individualized feedback on drinking norms, health-related risks and core constructs of the ttm, augmented by a ttm-based manual, (2) control group,receiving a booklet on health behavior. outcome assessment will be conducted after 12 months. the hypothesis is that individualized feedback leads to greater reduction in alcohol consumption and elevated readiness to change at follow-up.

background: a promising approach in secondary prevention of problem drinking is to provide brief interventions in medical settings. however, brief interventions have not become implemented in general practices (gps) due to insufficient role security and therapeutic commitment of physicians. computerized expert systems can provide very cost-effective means of intervention and have been effective in the field of smoking cessation. however, in the alcohol field, research on this issue is scarce. objectives: comparing an expert system based on the transtheoretical model of behavior change for patients with at-risk drinking, alcohol abuse or alcohol dependence to a control condition. methods: about 2,500 screenings among consecutive general hospital patients aged 18 to 64 will be conducted. subjects fulfilling inclusion criteria (severe alcohol dependence excluded) will be randomly assigned to one of two conditions with 150 patients each: (1) in the ttm-based expert system group, patients receive an individualized feedback on drinking norms, health-related risks and core constructs of the ttm, augmented by a ttm-based manual. (2) in the control group, participants receive a booklet on health behavior. outcome assessment will be conducted after 12 months. outcome variables are alcohol consumption, stages of change progress and utilization of formal help. expected impact: findings are expected to provide evidence for a computerized ttm based expert system to be used in primary care. this would be the first international results confirming such an approach in the alcohol field. if a ttm-based expert system would be effective, this could significantly save resources and enhance secondary prevention. therefore, data are of great public health interest. relationship to the objective of the collaboration: as in the other studies, empirical data on new proactive approaches to reach underserved populations in the addiction field will be provided. the project will add knowledge on the economical use of interventions.

Eligibility criteria:
inclusion criteria: * alcohol abuse * alcohol dependence * at-risk drinking exclusion criteria: * current treatment for alcohol problems * terminal illness

Keywords: expert system transtheoretical model of behavior change brief intervention general hospital
elevating voices, addressing depression, toxic stress and equity in group prenatal care

Conditions: Pregnancy Related; Perinatal Depression

Summary: this study will provide high-quality, representative data on the capacity of elevating voices, addressing depression, toxic stress and equity in group prenatal care (elevate gc) to reduce perinatal depression, preterm birth, and low birthweight in african-american women. if findings from this study indicate that elevate gc is feasible and effective, this model could be implemented nationwide to help achieve mental and obstetric health parity for low-income women of color in the united states.


Eligibility criteria:
inclusion criteria: * english or spanish speaking * ≤18 weeks' gestation * established prenatal care at elevate site * high-risk for postpartum depression by ≥1 risk factor (personal/family history, baseline epds≥10, low-income, 13-19 years old, single, history of physical/sexual abuse, unplanned/undesired pregnancy, history of pregnancy loss) * ability to attend group prenatal visits at specified days/times * willingness to be randomized * ability to give informed consent * any patient that has received prenatal care in a group setting previously exclusion criteria: * multiple gestation * major fetal anomaly * serious medical co-morbidity/psychiatric illness necessitating more care than can be safely provided in group setting * serious medical co-morbidity necessitating more care than can be safely provided in group setting
assessment of the effectiveness of low-level laser therapy on the hands of patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of the present study was to assess the effectiveness of low-level laser therapy on the reduction in pain and improvement in function in the hands of patients with rheumatoid arthritis

rheumatoid arthritis (ra) is a chronic inflammatory disease of unknown etiology that basically compromises the joints in a generalized, symmetrical, additive and usually progressive manner. this clinical condition includes pain and altered functionality. low-level laser therapy (lllt) has been studied since the 1970s with regard to its therapeutic effects. the literature suggests that it offers analgesic as well as anti-inflammatory benefits. a number of studies carried out in the laboratory and on animals have shown that lllt contributes toward the treatment of inflammatory joint disease. however, studies on humans with ra have yielded controversial results. a large part of the authors researched state that further randomized double-blind controlled studies should be carried out to prove the effectiveness of lllt on ra. thus, the aim of the present study was to assess the effectiveness of lllt on the reduction in pain and improvement in function in the hands of patients with ra.

Eligibility criteria:
inclusion criteria: * patients with ra * inflammatory condition of at least two hand joints among the wrists, proximal interphalangeal (pip) joint and metacarpophalangeal (mcp) joint * visual analogue scale (vas) for pain between 3 and 8 cm during activities of daily living * and being of either gender exclusion criteria: * skin lesions at the application site * other illnesses affecting the hands; physiotherapy for the hands in the previous three months * joint injections in the previous three months * change in disease-modifying anti-rheumatic drugs in the previous three months * and change in corticosteroids in the previous month.

Keywords: rheumatoid arthritis hands randomized controlled low level laser
perspective on thoughts and feelings as a predictor of psychological well-being in daily life, in a community sample

Conditions: Mental Health; Mindfulness

Summary: this project examines the psychological construct of decentering - a mindfulness-related construct marked by an observer perspective on one's ongoing mental processes. specifically, this project seeks to explore the extent to which decentering modulates the relationship between people's affective states and their momentary mental health and well-being, and to test the psychological processes by which decentering might exert these effects. this study includes a baseline assessment followed by a 7-day study completed from home where participants respond to brief surveys about their current experiences six times per day (i.e., an ecological momentary assessment \[ema\] design). the investigators hypothesize that decentering moderates the association of extreme affect with related symptoms (i.e., elevated negative affect with depression and anxiety; elevated positive affect with mania, narcissism, and histrionic traits) and well-being, such that the association is attenuated at high levels of decentering. this will be examined using the ema data, analyzing between-person levels (i.e., trait) as well as momentary within-person processes (i.e., concurrent and prospective states). further, the investigators predict that broadened attentional focus and improved self-regulation are mechanisms that contribute to the beneficial effects of decentering in daily life. this hypothesis will be examined in two ways: 1. as individual differences, wherein greater self-regulatory abilities (e.g., higher heart rate variability) and less attentional biases towards emotional stimuli mediate the association between trait decentering and subsequent daily well-being/symptoms, and 2. as within-person momentary levels, wherein broader attentional processes and greater self-regulation in daily life mediate the concurrent and prospective association between momentary decentering and well-being/symptoms. note that the study uses a multimodal assessment of each of the proposed processes. for attentional processes, a variety of parameters extracted from an emotional eye tracking paradigm will be examined. for self-regulatory abilities, assessments will include self-report, physiological (heart rate variability), and behavioral ("go / no-go" task) measures of such abilities.


Eligibility criteria:
inclusion criteria: * age 18-65, fluency in english exclusion criteria: * current cognitive impairments (i.e., intellectual disability, dementia, current psychotic symptoms) that preclude giving informed consent and accurately answering study questions

Keywords: self-control ecological momentary assessment attentional bias respiratory sinus arrhythmia affect emotion regulation well-being decentering affective disorders
impact of hpv on a cohort of southern italian women: epidemiological, clinical, morphological and microbiological features

Conditions: Cervix Cancer

Summary: hpv is known to be the causal agent in the majority of cervical cancers. however, the role of the cervical bacterial microbiome in cervical cancer is not clear


Eligibility criteria:
inclusion criteria: * women in fertile age exclusion criteria: * severe comorbidities

Keywords: hpv cervical cancer microbiome
a dispensing comparison of a test daily 1 day lens against a control 1 day lens.

Conditions: Myopia

Summary: the purpose of this study is to compare the dispensing performance of somofilcon a test 1 day contact lens against somofilcon a control 1 day contact lens.

the purpose of this study is to evaluate the clinical performance of a silicone-hydrogel test contact lens compared to the commercially available silicone-hydrogel (control) contact lens when worn over one week for each lens type in a randomized, bilateral, cross-over, dispensing study on a daily disposable basis.

Eligibility criteria:
inclusion criteria: * has had a self-reported oculo-visual examination in the last two years. * is at least 18 years of age and has full legal capacity to volunteer. * has read and understood the information consent letter. * is willing and able to follow instructions and maintain the appointment schedule. * is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected. * currently wears soft contact lenses (average wearing of 8 hours/day and 5 days/week) without the need of using rewetting drops * requires spectacle lens spherical powers between -1.00 to -5.75 diopters sphere (0.25d steps). * has no more than 0.75 diopters of refractive astigmatism. * has clear corneas and no active ocular disease. * has not worn lenses for at least 12 hours before the examination. * has a usable pair of spectacle lenses if required for transportation to the site for the initial visit exclusion criteria: * is presently participating in any other clinical or research study including eye related clinical or research study. * has never worn contact lenses before. * has any systemic disease affecting ocular health. * has any active ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. * is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health. * has any known sensitivity to fluorescein dye or products to be used in the study. * has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. * has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * is aphakic. * has undergone corneal refractive surgery. * is pregnant, lactating, or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit).
percutaneous endoscopic gastrostomy in hands of orl-hn surgeon

Conditions: Head and Neck Cancer; Percutaneous Endoscopic Gastrostomy; Complication

Summary: peg tubes are commonly used to provide nutritional support to patients with head and neck cancer. peg insertions are typically carried out by gastroenterologists, but also otorhinolaryngologist - head and neck surgeons perform the procedure in some countries. prospective studies on peg tube placements in an orl - hns service are lacking. the investigators aim was to prospectively evaluate the preformance of orl - hn surgeons in peg tube insertions, and analyze the time gains and cost effectiveness achieved of the independency from other specialities.


Eligibility criteria:
inclusion criteria: * head and neck cancer as a underlying disease exclusion criteria: -
pharmacokinetics of raltegravir during third trimester pregnancy and post-partum

Conditions: HIV Infections

Summary: this study will evaluate the pharmacokinetic disposition of raltegravir in pregnant hiv-1 infected women. these results will be compared to pharmacokinetic data obtained following pregnancy as well as to studies previously carried out in nonpregnant women and male patients. by determining the disposition characteristics for this specific patient population, antiretroviral (arv) dosing can be optimized during pregnancy. appropriate dosing is necessary to minimize adverse effects, slow progression of disease, and further reduce the risk for vertical transmission. data will also be obtained on genital tract penetration and placenta transfer of raltegravir to the newborn. the subjects enrolled in this study will take an antiretroviral based regimen containing raltegravir twice daily both during and after their pregnancy. the specific regimen will be chosen by their own primary care provider based on their antiretroviral history and resistance testing. they will undergo a series of blood sampling for pharmacokinetic analysis over 12 hours on two occasions; a) during their 3rd trimester and b) approximately 3 months postpartum. concentrations of raltegravir in the infant will be assessed by cord and infant blood sample at delivery and a blood sample at approximately 3 months of age. hypothesis: the pharmacokinetic exposure of raltegravir as measured by the 12 hour area under the plasma concentration versus time curve (auc0-12h) during third trimester pregnancy is similar to the auc0-12h estimated three months post-partum.


Eligibility criteria:
inclusion criteria: * female, 16 years old or older * pregnant, at least 14 weeks gestation in order to initiate raltegravir treatment if decided by their pregnancy health care provider. the first pharmacokinetic study visit occurs no sooner than 26 weeks gestation (3rd trimester) * normal fetal heart motion by ultrasound, vital signs and brief physical exam as conducted by their primary pregnancy health care provider within two weeks of study entry (part of their standard prenatal care) * intolerance or resistance to at least two classes of antiretroviral agents * availability of a raltegravir-optimized background regimen based on referring provider's selection and resistance testing * english or spanish speaking exclusion criteria: * inability to follow study protocol or drug administration * women who are planning to breastfeed (this is not recommended for hiv-infected women to reduce hiv transmission to the baby) * women unable to sign informed consent * women with a history of anaphylaxis or other life threatening adverse event associated with antiretroviral therapy

Keywords: pharmacokinetics pregnancy raltegravir hiv antiretroviral treatment of hiv in pregnant women with raltegravir
oscillation and lung expansion (ole) for treatment of neuromuscular disease patients

Conditions: Neuromuscular Diseases

Summary: the study will be a non-randomized open label pilot study using an observational design comparing a retrospective control period to an active treatment period with oscillation and lung expansion (ole) therapy.

the study is a decentralized trial. all data will be collected in the patients' homes. the primary objective of the study is to evaluate the impact of ole to treat respiratory complications of neuromuscular disease patients. the frequency of pulmonary exacerbations and other clinical outcome measures will be assessed to determine the effect of consistent ole therapy.

Eligibility criteria:
inclusion criteria: * documented diagnosis of neuromuscular disease (nmd) * age 5-80 years * history of one or more respiratory exacerbations in the past 6 months or two or more respiratory exacerbations in the past 12 months, which required unplanned or unscheduled medical intervention. * ability to perform ole therapy as directed * signed informed consent (and assent if minor subject) exclusion criteria: * diagnosis with rapidly progressing nmd such as certain types of motor neuron disease (mnd) * anticipated requirement for hospitalization within the next six months * history of pneumothorax within past 6 months * history of hemoptysis requiring embolization within past 12 months * pregnancy * use of ole therapy within the past 12 months * inability or unwillingness to perform ole therapy or study procedures as required