Kornimate/medical-research-clean huggingface dataset:
study to evaluate the efficacy and safety of fexuclue tablet

Conditions: Gastroesophageal Reflux Disease

Summary: this observational study is a large-scale, prospective, and multi-institutional observational study. patients from 19 to 75 years of age, will take a self-assessment (pro) during the study period before and after administration of pexuclue tablet.

data will be collected based on patient's medical records from daily visit. enrolled subjects will take a patient reported outcome (pro) survey including quality of life evaluation (gerd-hrql) and self-awareness symptom (rdq). the survey will be done twice (before and after the administration of fexuclue tablet) electronically through an application (e-pro).

Eligibility criteria:
inclusion criteria: 1. adult aged 19 years to 75 years (on registration date) 2. patient scheduled to administer fexuclue tablet based on the medical judgment of investigator. 3. patient who has not taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit. 4. patient who agreed to participate in this observation study and signed informed consent form exclusion criteria: 1. a person who falls under the prohibition of administration according to the permission for fexuclue tablet * patients with hypersensitivity to the components of fexuclue tablet or fexuclue tablet and a history thereof * patients undergoing atazanavir, nelfinavir or lilpivirin-containing preparations * pregnant and lactating women * patients with genetic problems such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabortion 2. a person who has taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit. 3. in addition to the above, a person who has determined that the researcher (the doctor in charge) is not suitable for participation in this observation study
prospective, assessment of vitamin d and calcium supplementation, improvement of nutritional status and preoperative rehabilitation in patients before knee arthroplasty.

Conditions: Knee Osteoarthritis; Vitamin D Deficiency; Pain, Postoperative; Arthropathy of Knee

Summary: prospective randomized study of 150 patients qualified for knee arthroplasty between 2015 and 2017. patients were randomized into 3 groups receiving vitamin d and calcium supplementation, increased protein supply and preoperative rehabilitation, respectively. following factors were analyzed: changes in vitamin d3, calcium, total protein, albumin and crp levels during preparation for surgery, nutritional status on the subjective global assessment (sga) scale, osteoporosis risk assessment according to the osteoporosis risk score, level of pain felt on the scale vas and the number of analgesics used, the result of the duke activity status index, the result of the following scales: cardiac risk index for orthopedic surgery (lee), knee injury and osteoarthritis outcome score (koos), fear avoidance beliefs questionnaire (fabq) about physical activity, the quality of life scale (qols). additionally, the occurrence of perioperative complications was analyzed (e.g. venous thrombosis and pulmonary embolism, wound or joint infection, excessive bleeding, loosening of the implant, bone fracture or fracture, pain).


Eligibility criteria:
inclusion criteria: * with a disease lasting more than 5 years and without total limitation of physical fitness, * reporting pain\> 5 on the vas scale (visual analogue scale) * general fitness according to the asa (amercican society of anestesiology) scale up to 3 exclusion criteria: * patients with metabolic and systemic disorders with contraindications for calcium substitution, vitamin d3 and protein supply, * intolerance of physical effort\> 2, 5 met (metabolic equivalent of task) * limitation of the degree overall efficiency\> 3 in the asa classification
rehabilitation of working memory and brain plasticity after traumatic brain injury: plastim-mdtc

Conditions: Traumatic Brain Injury; Cognitive Impairment

Summary: the aim of this study is to assess the brain correlates, as assessed with multimodal mri, of working memory training in patients with severe traumatic brain injury (tbi)

this is a pilot feasibility study. patients with subacute/chronic (\> 6 months) severe tbi will be included if they suffer from a deficit in working memory. they will receive a specific hierarchical training of working memory (3 sessions per week during three months), according to a previously described methodology. a multimodal mri will be performed at neurospin center (cea, orsay, france) before and after cognitive training, including: structural imaging (t1, flair and diffusion tensor imaging, dti); functional connectivity at rest; and functional activation during a working memory task (n-back). behavioral and imaging changes after training will be analysed individually and compared to a group of healthy controls matched for age, gender and education.

Eligibility criteria:
inclusion criteria: * moderate to severe traumatic brain injury * 6 months or more after the injury * working memory deficit on cognitive testing exclusion criteria: * previous neurological or psychiatric condition * severe behavioral troubles * contra-indication to mri * pregnancy

Keywords: working memory cognitive rehabilitation functional neuroimaging
the effect of sodium alginate on appetite sensation

Conditions: Obesity; Overweight

Summary: the aim of the study is to investigate the effects of a low-calorie alginate containing fruit flavored beverage on appetite and body weight development.

the project consists of two different studies: study i: a randomised controled meal test study aimed at studying the acute effect of the alginate-containing beverage on appetite sensation and spontaneous calorie intake (and safety i.e. nausea, well-being etc) in normal to overweight healthy subjects. here, a placebo beverage or the alginate-containing beverage will be administered as a pre-load before a standardised breakfast meal. subjective appetite sensation will be measured with visual analogue scale (vas) every 30 minutes four up to 5 hours. an additional beverage will be administered prior to an ad libitum lunch meal, where spontaneous water and energy intake will be registered. study ii: secondly the aim is to study the effects of a daily intake of a placebo or alginate-containing beverage on body weight and composition in a randomised parallel intervention study of 12 weeks duration. a total of app. 50 obese healthy adults will receive a hypocaloric diet and be randomised to consume either placebo or alginate-containing beverage before each of the three main meals every day. the development in body weight and composition and blood pressure will be monitored and blood samples will be analysed for markers related to the risk of cvd and type 2 diabetes.

Eligibility criteria:
inclusion criteria: * healthy men and women * normal to slight overweight (bmi: 22-28 kg/m2) * 20-45 years of age exclusion criteria: * smoking * daily medicine use (oral contraceptives excluded) * use of dietary supplements * blood donation 3 months prior to the study * hb\<7.5 mmol/l * chronic illnesses such as hyperlipidemia, diabetes and inflammatory diseases * pregnancy or breastfeeding * elite athletes (\>10 hours hard exercise/week) * vegetarians

Keywords: appetite energy intake gastric emptying well being body weight
efficacy of nevirapine compared to zdv + 3tc administered in labor and again at postdelivery in hiv positive women

Conditions: HIV Infections

Summary: the primary objective of the study was to evaluate the efficacy of nevirapine versus zdv+3tc (zidovudine + lamivudine), when administered in labor and again at postdelivery, in reducing peripartum mother to child transmission of hiv (human immunodeficiency virus). the secondary objective was to assess the overall hiv transmission rate between the 2 groups (intrauterine, intrapartum and postpartum up to 6 weeks) as well as to explore the relationship between infection and timing of maternal dose relative to birth, infant feeding method, maternal peripheral blood viral load, and other potential risk factors for transmission. following the introduction of the second and third amendments to the protocol, 2 substudies were added. the objectives of these substudies were to evaluate the frequency of resistance-conferring mutations to nevirapine (amendment 2) and to zdv+3tc (amendment 3); to determine whether there was a reversion of any resistant virus to the wild type; and to determine if the resistant virus was transmitted from the mother to the child.


Eligibility criteria:
inclusion criteria: * pregnant women who present after 38 weeks gestation or in labour after 35 weeks gestation who are tested hiv positive. estimated gestational age will be determined by one or more of the following: * reliable menstrual history, which corresponds with uterine size * physical examination * estimated fetal weight * a consent form for the mother and neonate will be signed by either the mother or the guardian prior to inclusion exclusion criteria: * mothers who have taken any antiretrovirals in the last 12 months * mothers who are not able to take oral medication * mothers who present with ards (acute respiratory distress syndrome), septic shock or eclampsia * mothers presenting in discomfort, i.e. regular painful uterine contractions, or other factors that may contribute to her not being able to understand and sign the informed consent for hiv testing and study participation * use of another investigational drug or concurrent participation in another investigational protocol during the current pregnancy * unwillingness or inability to reasonably comply with the protocol (i.e., mother and neonate/infant could not be followed for the full 6 weeks of the trial) * grade 4 sgpt (serum glutamate pyruvate transaminase) (\>10 times the upper limit of normal value), if known prior to delivery * a recent history (6 months preceding the study) or current evidence of drug abuse and/or alcoholism * mothers with fetuses with anomalies incompatible with life, if known prior to delivery * decision to deliver the infant by elective cesarean section * amniocentesis was indicated * infants with severe growth retardation diagnosed before birth infants who fall into the following groups will not receive treatment, but the mother-infant pair will remain in the trial * infants with malformations incompatible with life * life-threatening perinatal conditions which do not allow oral therapy (e.g., sepsis)
novel imaging markers in spms

Conditions: Secondary Progressive Multiple Sclerosis; Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis

Summary: this pilot study takes the innovative approach of using ultrasmall superparamagnetic iron oxide (uspio) nanoparticle enhanced mri to measure activity of the innate immune system within ms lesions. activity of innate immunity has been hypothesized as one of the critical pathologic processes underpinning neurologic worsening in progressive ms. as such, in the short term this project proposes to investigate uspio uptake in spms lesions as a promising in vivo imaging biomarker for chronic-active lesions, as distinguished from chronic-inactive lesions.


Eligibility criteria:
inclusion criteria: 1. adults age 35 to 65 years 2. clinically diagnosed with secondary progressive multiple sclerosis (spms) (2017 mcdonald criteria) 3. worsening 25 foot walk time (worsening spms cohort) over the preceding 2 years. 4. ambulatory with ability to walk at least 20 meters without rest, with or without aid 5. ability and willingness to attend study visits and complete the study exclusion criteria: 1. clinically diagnosed with relapsing remitting multiple sclerosis (rrms), primary progressive multiple sclerosis (ppms), clinical isolated syndrome (cis), or radiologically isolated syndrome (ris) 2. clinical ms relapse and/or new mri lesion(s) within the preceding 2 years 3. positive pregnancy test 4. gadolinium contrast allergy 5. acute or chronic kidney disease with egfr \<30 ml/min/1.73m2 6. pacemaker or other mri contraindications per american college of radiology guidelines 7. intravenous iron sensitivity 8. serum ferritin and transferrin saturation above age-adjusted upper limit of normal (if serum ferritin is above normal, but transferrin saturation is normal, the subject is not excluded)

Keywords: perilesional microglia ferumoxytol uspio utrasmall superparamagnetic iron oxide nanoparticles infiltrating macrophages activated microglia uspio enhancement
real life use of ravulizumab in italian patients with paroxysmal nocturnal hemoglobinuria

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: this study will collect clinical response data on participants who were already treated with eculizumab for at least 26 weeks and who started ravulizumab treatment as a specific therapeutic strategy as per ordinary clinical practice.

this study is an italian multi-center, observational (non-interventional), cohort study composed of both retrospective and prospective observation periods on the same paroxysmal nocturnal hemoglobinuria (pnh) participants. after the first participant in from different italian study centers, participants will be consecutively enrolled for 9 months and they will be observed for 52 weeks after the start of ravulizumab.

Eligibility criteria:
inclusion criteria: * body weight of 10 kilogram or above * hemolysis with clinical symptom(s) indicative of high disease activity * documented diagnoses of pnh confirmed by high-sensitivity flow cytometry evaluation of red blood cells and white blood cells with granulocyte or monocyte clone size of ≥ 5% * clinically stable after having been treated with eculizumab for at least the past 6 months * participant already assigned to ravulizumab treatment as a specific therapeutic strategy within the current routine clinical practice (this decision has to be made independently and before the enrolment of the participant in the study) * vaccinated against neisseria meningitidis (according to summary of product characteristics) \< 3 years before dosing or at least 2 weeks prior to initiating ravulizumab unless the risk of delaying ravulizumab therapy outweighs the risk of developing a meningococcal infection * signed written informed and privacy consent prior to study participation exclusion criteria: * history of hematopoietic stem cell transplantation (evaluated at baseline) * known pregnant or breastfeeding participant (evaluated at baseline) * participant unable to read and write in italian language and to autonomously fill in questionnaires and scales (evaluated at enrolment) * participants enrolled in any clinical study receiving experimental treatments for pnh (evaluated at baseline) * hypersensitivity to the active substance or to any of the excipient of the study drug. * participants with unresolved n. meningitidis infection at treatment initiation * participants who are not currently vaccinated against n. meningitidis unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination

Keywords: piga gene complement-inhibitor protein cd55 cd59 efficacy safety patient registry
tdcs with cognitive training to reduce impulsivity and weight in veterans with obesity

Conditions: Obesity

Summary: the purpose of this study is to investigate if transcranial direct current stimulation (tdcs) can increase the effectiveness of cognitive training to reduce impulsivity in individuals with obesity, and to evaluate weight change with these individuals. the long-term goal of this research is to develop new treatment approaches for individuals with obesity.

two-hundred forty individuals will be screened with the goal of consenting and enrolling 124 patients and 88 patients completing the study. participants completing the study will concurrently complete a structured weight loss program. the investigators' study protocol will consist of 13 study visits including four testing days, one before (v1), one on the day of the tenth session of tdcs (v11), another test visit (v12) 6 weeks later, and a final test visit approximately 4 months after beginning stimulation (v13).

Eligibility criteria:
inclusion criteria: * veteran enrolled in a move! weight management program (group or individual) at the minneapolis va health care system * obese (bmi\>30 or bmi\>27 plus at least one weight-related comorbidity) * adults, ages 18 years or older (up to age 80) * able to understand english, self-consent and follow study-related procedures * willing to use a reliable form of birth control if they are of females of child-bearing potential exclusion criteria: * history of any of the following: seizures, severe or moderate head injury, head surgery, significant neurological disorder (significance based on principal investigator's judgment) * frequent severe headaches * history of scalp conditions such as eczema or seborrheic dermatitis * metal in head (other than in mouth) including shrapnel/surgical clips/welding fragments * implanted medical devices (including pumps and cardiac pacemakers) * pregnancy * acute substance dependence or withdrawal that would affect ability to complete cognitive training * moderately severe to severe depression (as identified on phq-9 scale during baseline screening) * other psychological or medical disorders requiring inpatient treatment (as identified during chart review) * presence of a known metabolic or hormonal disorder (such as cushing's, untreated thyroid dysfunction, or uncontrolled diabetes mellitus defined as a hemoglobin a1c \> 8.0), or significant edema/volume overload - all of which would affect weight * uncontrolled hypothyroidism that would affect weight

Keywords: transcranial direct current stimulation neuromodulation
augmenting virtual reality exposure therapy for acrophobia

Conditions: Specific Phobia; Anxiety Disorders; Fear of Heights; Acrophobia

Summary: this study will examine whether tactile feedback and point-based rewards can be used to improve outcomes from virtual reality exposure therapy for acrophobia.

exposure therapy is one of the most potent techniques available for treating anxiety-related disorders, including specific phobia. however, estimates suggest that 10-48% of anxiety patients do not fully respond to exposure therapy. meta-analyses demonstrate that virtual reality exposure therapy (vret) is equally effective as traditional, in vivo ('in life') exposure therapy. furthermore, individuals with anxiety disorders report greater preference (and lower likelihood of treatment refusal) for vr, rather than in vivo, exposure therapy. although vret has well-established efficacy and is rapidly growing in popularity, there has been very little research evaluating how specific elements of vr game design might be used to improve outcomes from vret. this study evaluates two game design elements that we hypothesize will improve vret outcomes: tactile feedback and a point-based reward system. tactile feedback (tf; i.e., touching a real object that matches an element in the vr environment) enhances sense of presence in vr. higher presence activates anxiety during vret, which is essential for promoting the active mechanisms of exposure therapy and may also improve treatment retention. on the other hand, point-based rewards (pr) in games enhance sense of competence (i.e., sense of progress and achievement), and increase both enjoyment and likelihood of future use of games. furthermore, several studies demonstrate that pr improves traditionally difficult-to-change health behaviors, such as increasing exercise frequency and reducing misuse of pain medications. although this research is promising, the impact of pr on vret is unknown. to test the influence of tf and pr on vret outcomes, we will randomize participants with acrophobia to receive (a) standard virtual reality exposure therapy, (b) vret with tactile feedback, (c) vret with a point-based reward system, or (d) vret with tactile feedback and a point-based reward system. participants' fear reactivity will be assessed with behavioral, physiological, and subjective/self-report measures at baseline, post-treatment, and follow-up.

Eligibility criteria:
inclusion criteria: * fluent in english * indicates sufficient fear of heights based on responses (a) on a self-report questionnaire (the acrophobia questionnaire) administered at prescreening, and (b) on behavioral avoidance tests administered at baseline. exclusion criteria: * already receiving exposure therapy for height phobia

Keywords: exposure therapy virtual reality acrophobia fear of heights
self operating of the personal wheezometer by intended users - a usability study

Conditions: Asthma

Summary: the naepp (national asthma education and prevention program) guidelines recommend that spirometry be performed on patients with asthma because they serve as an objective measure of airway obstruction. unfortunately, most children under 5 years of age are unable to perform a forced expiratory maneuver making conventional spirometry unavailable in this age group in most venues. furthermore, other population groups such as retarded people, elderly or physically handicapped share the same difficulty. karmel sonix ltd has developed the personal wheezometer a hand-held pulmonary sounds analyzer that utilizes contact sensors to acquire, amplify, filter, record and quantify the presence of wheezing. this usability study was designed to test independent home use and device interface effectiveness of the personal wheezometer in order to validate its safe and effective use by intended users.


Eligibility criteria:
inclusion criteria: * male/female age 18 years and up. * subject is diagnosed as an asthmatic, or subject is parent/guardian of an asthmatic child age under 18 years. * subject understands the study procedure. * subject is able to read the user manual. * signed informed consent form * compliance with study requirements. exclusion criteria: * major physical, motor, mental, behavioral, or psychiatric limitations. * concurrent additional major illness. * subject objects to the study protocol.

Keywords: asthma wheeze rate respiratory function tests