Kornimate/medical-research-clean huggingface dataset:
the intersection between loss of control eating and obesity: the role of restriction and food reinforcement

Conditions: Pediatric Obesity; Nutrition Disorders; Binge Eating; Body Weight

Summary: this study aims to determine the relationships among loss of control eating, restriction, relative reinforcing value of high energy-dense food, and obesity risk. in order to achieve this aim, the investigators will follow children over the course of a year, obtaining behavioral and observational measurements, in addition to a two-week restricted access and two week non-restricted access period.

the study will be mostly observational but will also include a randomized, cross-over design (the restricted access paradigm). the investigators will recruit children at risk for obesity in erie county, new york (n=100, 50 boys, 50 girls). the study will include 4 visits at baseline and follow-up visits at 6 and 12 months. at the first visit, the participants will complete consent, height/weight/body fat, questionnaires, and complete a delayed discount task and the relative reinforcing value task. the participants will be randomized to have two weeks of restricted access first or two weeks of non-restricted access first, and then will come into the laboratory to do the loss of control test meal. then they will have a one-week washout period, and will then complete the other two weeks of restricted/not restricted access. following this, they will complete the loss of control test meal again. at the follow-up visits, participants will come into the laboratory to have their height/weight/body fat measured, complete questionnaires, and complete the delayed discounting task, food reinforcement and loss of control test meals. participants will be compensated for their time after each visit. the details of the measures and procedures are outlined below.

Eligibility criteria:
inclusion criteria: * children (male and female) ages 8-11 * at risk for obesity or with obesity (defined as either having a bmi percentile that classifies the child as having overweight-bmi \>85th percentile but \ 25) * rating of neutral or higher for 50% of the study foods * consumption of one of the study foods at least twice/week exclusion criteria: * children below age 8 or above age 11 * not at risk for obesity (defined as having a bmi percentile that classifies the child as having normal weight-bmi \<85th percentile without having a parent with overweight or obesity) * allergic to study foods * dislike of study foods (less than 50% of the study foods rated neutral or higher) * does not consume at least one study food at least twice/week * current diagnosis of a clinical eating disorder (ed) * use of medications known to affect appetite (ritalin, adderall, concerta, wellbutrin, prednisone, etc) * unwillingness to complete study visits

Keywords: relative reinforcing value obesity risk children loss of control restriction
cryotherapy and tens on low back pain

Conditions: Low Back Pain, Mechanical

Summary: this study aim analyze the immediate effects of conventional transcutaneous electrical nerve stimulation (tens) and burst tens combined or not with cryotherapy in patients with non-specific low back pain. all subjects will be submitted to an evaluation of the painful sensation, through the numerical rating scale, and pain threshold, through algometry, before, immediately after the intervention and 25 minutes after.


Eligibility criteria:
inclusion criteria: * aged between 18 and 50 years; * have chronic non-specific low back pain. exclusion criteria: * serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as ankylosing spondylitis); * nerve root compromise (disc herniation and spondylolisthesis with neurological compromise, spinal stenosis, and others); * fibromyalgia * corticosteroid treatment in the previous two weeks; * antiinflammatory treatment in the previous 24 hours; * contraindications to the use of kinesio taping (allergy or intolerance); * score of three or less on visual analogue scale of the first day; * pregnancy; * ice allergy.
clinical study of migraine evolution

Conditions: Migraine Headache

Summary: understanding the speed at which migraine headaches develop is of importance to patients. determining the proportions in which different headache pain build-up occurs, may provide health care practitioners with valuable information with which to prescribe the most appropriate treatment. patients who experience a slow pain build-up may gain more benefit from medications which have a slow onset of effect, high tolerability and long action. conversely, medications with a rapid onset of effect may be of greater benefit to patients who experience rapid onset of migraine pain.


Eligibility criteria:
inclusion criteria: * subject is outpatient. * subject has a diagnosis of migraine with/without aura according to ihs criteria, of at least 1 years duration. * subject is able to comprehend the study procedures and to comply with study requirements. exclusion criteria: * subject has other chronic pain condition(s) not associated with migraine * subject is unable to understand the schedule/questionnaire.

Keywords: migraine headache observational
bladder exstrophy (fives fertility vesical exstrophy sexuality)

Conditions: Fertility

Summary: this analytical descriptive study aims to describe the fertility and sexuality male adult subjects carrying classic bladder exstrophy or epispadias and to highlight infertility risk factors. a questionnaire on paternity, urinary status, erections, ejaculations and sexual self-esteem and a semen analysis will be realized at first consultation, semen analysis results wil be explained at second consultation. it is assumed that fertility and sexuality exstrophic men are impaired.


Eligibility criteria:
inclusion criteria: * patients followed the hospices civils de lyon * consultant spontaneously in adult or pediatric urology, or neuroperineal rehabilitation and sexology * aged over 18 years * born with classic bladder exstrophy or epispadias. exclusion criteria: * refusal of participation * refusal to sign consent * minor patients or protected major, under guardianship * patients unable to understand the course of the study * cloacal exstrophy

Keywords: fertility sexuality male exstrophy-epispadias complex bladder exstrophy epispadias
dose-titration and open-label extension study of srp-4045 in advanced stage duchenne muscular dystrophy (dmd) patients

Conditions: Duchenne Muscular Dystrophy

Summary: this is a first-in-human dose-titration and open-label extension study to assess safety, tolerability, and pharmacokinetics of srp-4045 in advanced-stage duchenne muscular dystrophy (dmd) patients with deletions amenable to exon 45 skipping.

this is a randomized, placebo-controlled dose-titration study to assess safety, tolerability, and pharmacokinetics of 4 dose levels of srp-4045 in genotypically confirmed advanced-stage dmd patients with deletions amenable to exon 45 skipping. after completion of the dose-titration portion of the study and srp-4045 is determined to be safe, all patients will be evaluated on open-label srp-4045 for the duration of the study. safety, including adverse event monitoring, routine laboratory assessments, and cardiac testing will be monitored through the duration of the dose-titration and open-label portions of the study. clinical efficacy will be assessed at regularly scheduled study visits via quality of life questionnaires and tests of pulmonary and upper extremity function through the duration of the dose-titration and open-label portions of the trial.

Eligibility criteria:
inclusion criteria: * genotypically confirmed dmd (amenable to exon 45 skipping). * stable cardiac and pulmonary function. * limited or no ambulation. * on a stable dose of oral corticosteroids for at least 24 weeks or has not received corticosteroids for at least 24 weeks. exclusion criteria: * current or previous treatment with the experimental agents smt c1100 (bmn-195) or pro045. * other experimental treatment in the past 12 weeks. * if on cardiac medication, must be on a stable dose for the past 12 weeks. * major surgery within the past 3 months. other inclusion/exclusion criteria apply.

Keywords: duchenne muscular dystrophy exon skipping
pashto translation of leeds assessment of neuropathic symptoms and signs (lanss) pain scale

Conditions: Spinal Cord Injuries

Summary: there is a need for a culturally adapted screening tool to aid health care professionals or clinicians screen for the presence of neuropathic pain associated with spinal cord injuries in pashtoon population. . since paraplegic center hayatabad peshawar is a reputable institute for spinal cord injury patients' rehabilitation in khyber pakhtun khwa where most of pashto speaking sci patients are rehabilitated. while working there as a physical therapist i, my other colleagues and patients felt a need for a screening tool for pain in pashto language .so i decided to a conduct a tool validation study. this study will help the clinicians to assess their patient's pain type easily through the pashto version of lanss pain scale in pashtoon population and hence will help in timely management of the pain.

the leeds assessment of neuropathic symptoms and signs (lanss) pain scale, a screening questionnaire for identifying patients with neuropathic pain, was developed to identify patients with neuropathic mechanisms dominating their pain experience. the original english version of the lanss pain scale has been translated and validated in turkish, spanish, swedish, brazilian, portuguese, and chinese mandarin languages. however, no neuropathic pain questionnaire including the lanss has yet been established in pasto language in pakistan. although these screening tools are based on descriptors, their linguistic adaptation and validation into different languages are feasible and this ensures their reliability and validity in languages other than those in which they were initially developed.

Eligibility criteria:
inclusion criteria: * patients with traumatic spinal cord injury * both complete and incomplete sci patients * patients having pain history after spinal cord injury * patients having 3 or more than 3 months duration of sci * sci at or below thoracic spine exclusion criteria: * patients with other neurological disorders like multiple sclerosis, gbs, etc. * congenital conditions, tumor etc. * diabetic patients.

Keywords: pain
evaluation of blood biomarker-based diagnostic aid in outpatients suffering from depression

Conditions: Depressive Disorder; Bipolar Disorder; Bipolar Depression

Summary: this is an observational (non-interventional) study, carried out in an outpatient setting, which involves a blood sampling. the primary objective of this study is to confirm the association between the edit-b® editing signature and early unipolar or bipolar differentiation. results of this research may provide an aid to early diagnosis and guide clinical practice towards individualized treatment.


Eligibility criteria:
inclusion criteria: adult outpatients suffering from depression and/or bipolar disorders who gave their written informed consent to participate in the present study exclusion criteria: any patient without capacity of discernment or with harmful use of psychoactive substances
development of visual function evaluation method

Conditions: Retinitis Pigmentosa

Summary: the objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient

this study is a prospective observational study which consists of 4 parts; part 1a, 1b, 2 and 3. part 1a has been conducted on 6 subjects diagnosed with retinitis pigmentosa. additional examination will be performed using alternative devices imported outside japan on subjects who completed part 1a and re-consented (part 1b). based on the interim result of part 1a, part 2 will be conducted on another 6 subjects with retinitis pigmentosa with improved methodology and the devices used in part 1b. part 3 will be conducted in 6 healthy volunteers to obtain comparative data using devices used in part 1b.

Eligibility criteria:
inclusion criteria for patients with retinitis pigmentosa: * age: ≥ 20 years * subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent inclusion criteria for healthy volunteers: * age: ≥ 35 and ≤ 75 years * subjects with corrected visual acuity ≥ 1.0 with both eyes and without severe refractive error nor abnormal findings in slit-lamp microscopy, oct, fundoscopy and pupillary function test at screening exclusion criteria: * subjects who have participated in any other clinical trial or clinical study involving visual function evaluation within 6 months * subjects who have history of surgery, past history, and complications (cardiac/ hepatic/ renal/ respiratory/ hematological diseases, optic nerve diseases causing marked loss of visual field, and uveitis etc.) that potentially affect evaluation and safety of the study * pregnant women * subjects who are judged that continuation of the study is difficult during the study period * subjects who are employed by the company sponsoring this study, an organization or institution related to this study

Keywords: retinitis pigmentosa visual function evaluation
evaluation of a rapid microscopic diagnostic system for different vaginitis conditions

Conditions: Bacterial Vaginosis; Candida Albicans Vulvovaginitis; Candida Vulvovaginitis; Trichomonas Vaginitis; Atrophic Vaginitis; Desquamative Inflammatory Vaginitis

Summary: evaluate the diagnostic performance of the gyni™ device to detect different vaginitis conditions by comparison to microscopic diagnosis and related lab tests.

during gynecological exams, vaginal discharge samples will be are taken for testing the ph level, microscopic examination and laboratory examinations (vaginal cultures and sexually transmitted infections). one additional sample will be taken intended for the gyni™ system diagnosis. this additional examination will be performed in the clinic by pulling the cytobrush through a dedicated cartridge and scanning it in the gyni table-top scanner. the result diagnosis will be anonymously kept in the cloud. the diagnosis suggested by the gyni system will not be visible to the physician in order to prevent any bias. results from the physician, from the device and from the lab will be summarized and compared by the chief investigator

Eligibility criteria:
inclusion criteria: * women with vaginal complaints: discharge, malodor, itching, irritation, dyspareunia, pain * age \>= 18y exclusion criteria: * age \< 18y * not eligible to sign an informed consent * vaginal discharge samples found microscopically not interpret-able by the investigator due to patient using vaginal creams, ointments, lubricants or sperm presence. * during menstruation
combination of nebivolol and valsartan given as free tablets for stage 1 or stage 2 hypertension

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the safety and tolerability of nebivolol and valsartan given as a free tablet combination in patient with stage 1 or stage 2 essential hypertension.


Eligibility criteria:
inclusion criteria: * male or female outpatients of age 18 years or above * patients diagnosed with stage 1 or stage 2 essential hypertension * normal physical examination findings, electrocardiogram (ecg) results and chest x-ray; or abnormal findings judged by the investigator to be not clinically significant exclusion criteria: * secondary hypertension or severe hypertension * clinically significant cardiovascular disease or heart failure * a medical contraindication to discontinuing a current antihypertensive therapy * history of type 1 diabetes mellitus

Keywords: stage 1 stage 2 hypertension 1 year open label safety study
identification to elimination in hcv-infected individuals

Conditions: Hepatitis C

Summary: approximately 3.5 - 5 million americans are living with hepatitis c virus (hcv) in the united states. hcv significantly impacts rural pennsylvania. it is estimated that 160,000 adults in pennsylvania are living with hepatitis c. in 2010, center for rural pennsylvania estimated that 27% of population of pa live in one of pennsylvania's 48 rural counties. under this estimate, there are over 43,000 individuals affected with chronic hcv living in rural pennsylvania. rural county residents often experience barriers to health care by having fewer primary care providers and limited specialty care physicians available to them to address their healthcare needs. rq1: will the community based delivery system for hepatitis c screenings see an increase in positivity rates? ho1: there is no relationship between the community based delivery system with an increase in the hepatitis c screening positivity rates. ha1: there is a relationship between the community based delivery system with an increase in the hepatitis c screening positivity rates.

in rural pennsylvania, transportation is considered a socioeconomic barrier and social detriment to personal health. using an evidence-based model of population health by bringing the care into the high-risk population's community setting reduces the transportation and socioeconomic barriers of the most vulnerable at risk populations. it is estimated that 35% to 65% of opioid substitution treatment patients (ost), are infected with hcv. therefore, opt programs that are already operating will be engaged and will be a primary focus for patient screening and recruitment for these services. in addition, high volume venues attracting high-risk populations will also be targeted to encourage hcv screening, education, and treatment. primary objectives: to screen opioid substitution treatment patients (ost), high-risk individual at opioid treatment programs (otp), and/or all high-risk populations in outlying sites (anti-hcv prevalence) to initiate hcv treatment of ost patients and other high-risk individuals at otp facilities and/or high risk populations in outlying sites (linkage of care) to maintain the successful hcv therapy and cure \[sustained viral response (svr)\] in ost patients and other high-risk individuals at opt facility and/or high risk populations in outlying sites (retention) to facilitate the use of a patient navigator and nursing case management staff to reduce barriers to initial screening and patient education

Eligibility criteria:
inclusion criteria: subjects will be included in the study if the following criteria is met: 1. the subject must be an opioid substitution treatment patient. 2. the subject must fall into another high-risk population for the hcv. exclusion criteria: subjects may be excluded from the study if the subject falls into an exclusion category as identified as: 1. the subject cannot be or suspected of being pregnant 2. the subject cannot be under the age of 18 years. 3. no subjects requiring a legally authorized representative will be enrolled
role of adenosine in the release of vegf and cytokines

Conditions: Inflammation

Summary: the purpose of this study is to extend previous observations in animal models regarding the effects of adenosine in the release of cytokines to human subjects. we intend to accomplish this in two study protocols. in the first we will infuse intravenously adenosine and measure the plasma levels of inflammatory cytokines. in the second one, we will use a microdialysis technique to infuse intradermally small amounts of adenosine and will measure skin blood flow and will take a biopsy to measure levels of mrna for cytokines.

in protocol 1 we will infuse adenosine at a dose of 80 mcg/kg/min for 30 minutes while measuring plasma levels of adenosine at different time points, ranging from 30 minutes to 6 hours. because activation of a2b receptors also mediates the release of inflammatory cytokines, including il-6, samples will be taken to measure these and other inflammatory/angiogenic cytokines. in a second protocol, we will administer adenosine intradermically via a microdialysis probe for 30 minutes while we measure the local effect on skin blood flow using laser doppler techniques. one hour after the end of the infusion we will obtain a skin biopsy from the perfused area for measurement of mrna for vegf, il-8, il-6 and other cytokines. in addition, we foresee the possibility of further testing looking for and genetic association between angiogenesis and adenosine. these are proof-of-concept pilot studies. we will study up to 12 subjects in each protocol but an interim analysis will be performed after 6 subjects are studied. this will help us determine if a trend is observed, to perform power calculations, and determine if more extensive studies are warranted.

Eligibility criteria:
inclusion criteria: * age 18-60 yr. * all potential volunteers will have routine blood test to screen for hepatic, renal, and hematological abnormalities. * body mass index \< 27 kg/m2 . * female volunteers of childbearing potential will undergo hcg pregnancy test at screening and again on the study day. exclusion criteria: * pregnancy females * subjects unable to give voluntary informed consent * subjects on anticoagulant drugs or anemic * subjects with a recent medical illness * subjects with a history of coronary heart disease * subjects with known kidney or liver disease * subjects with history of asthma * recent (past three days) use of phosphodiesterase type 5 (pde5) inhibitors (sildenafil, tadalafil or vardenafil) * history of intolerance to adenosine or nitroprusside * history of methemoglobinemia * use of theophylline products * subjects with hematological abnormalities

Keywords: adenosine cytokines inflammation vegf
efficacy and safety of minimally invasive micro-sclerostomy (mims) in glaucoma surgery

Conditions: Glaucoma

Summary: the main objective is to evaluate the effectiveness of mims in patients with an indication for glaucoma surgery, compared to traditional surgery. the secondary objective is to assess safety. the investigating ophthalmologist will follow the patients and collect clinical data in order to identify the benefits and complications of mims. patients are expected to experience fewer complications compared to traditional glaucoma surgery.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years old who agree to participate in the study having signed informed consent * primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma with indication for glaucoma surgery (defined as uncontrolled intraocular pressure or worsening of visual fields, despite maximum tolerated medical therapy) and open iridocorneal angle ( trabecular meshwork visible on gonioscopy, shaffer classification grade 3-4) and healthy and mobile conjunctiva (without scars or adhesions). * chronic angle closure glaucoma with indication for combined glaucoma and cataract surgery exclusion criteria: * presence of other ophthalmological pathologies (except cataract) * history of intraocular surgery (unless cataract surgery), history of trauma, or conjunctival scarring in the quadrant planned for surgery * visual acuity lower than "counts fingers" ", closure of the iridocorneal angle (and angle-closure glaucoma unless associated cataract surgery), neovascular glaucoma or neovascularization of the iris, pachymetry \ 620 μm. * presence of severe systemic pathologies, pregnant or breastfeeding woman