Kornimate/medical-research-clean huggingface dataset:
treatment protocol of replagal for patients with fabry disease

Conditions: Fabry Disease

Summary: the study will evaluate the safety and efficacy of replagal® (agalsidase alfa) at a dose of 0.2 mg/kg infused intravenously (iv) over 40 minutes, every other week. the study will monitor the course of disease in males and females with fabry disease who are naive to treatment or were previously treated with agalsidase beta (fabrazyme®).

this study will evaluate the safety and efficacy of replagal in patients with fabry disease who are either naive to treatment, who were previously treated with agalsidase beta, or who had previously received replagal. patients diagnosed with fabry disease who have not previously received treatment, who have received agalsidase beta, or who had previously received replagal will be eligible to enroll in the study and will receive replagal at a dose of 0.2 mg/kg body weight administered by an iv infusion over 40 minutes every other week. this study will be conducted in the united states. study visits will occur in 3 phases: * screening/baseline phase: a screening/baseline period (day -30 to day -1) to determine eligibility and obtain baseline measurements. patients who have previously received agalsidase beta will be tested for the presence of anti-agalsidase beta antibodies. * treatment phase: a 12-month treatment phase during which all patients will receive replagal administered iv every other week. clinical assessments will occur at months 1, 3, 6, 9, and 12. the study may be extended to continue giving patients access to treatment. * end-of-study phase: an end-of-study contact either as an office visit or follow-up telephone call will occur one month after the last infusion.

Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of fabry disease. 2. patient is willing and able to provide written informed consent, and assent if applicable. 3. females of childbearing potential must agree to use a method of birth control throughout the study and for at least 30 days after the final infusion. the method of contraception must be considered adequate and appropriate in the opinion of the investigator. exclusion criteria: 1. hypersensitivity to replagal, the active substance, or any of the excipients. 2. the patient is pregnant or breast feeding. 3. concomitant use of agalsidase beta (fabrazyme). 4. has received treatment with any investigation drug or device within the 30 days prior to study entry. 5. otherwise unsuitable for the study, in the opinion of the investigator.

Keywords: α galactosidase a glycosphingolipid storage disorder agalsidase alfa enzyme replacement therapy replagal agalsidase beta fabrazyme
safety and immunogenicity of the japanese encephalitis vaccine ic51 (ixiaro®) in a pediatric population

Conditions: Encephalitis

Summary: the primary objective is to assess the systemic and local safety profile of purified inactivated japanese encephalitis virus (jev) vaccine ic51 administered in two doses in a 28 days interval up to month 7 after the first ic51 vaccination in a pediatric population from endemic regions.

open-label, randomized, active controlled phase 3 study in children aged ≥ 2 months to \< 18 years. subjects aged ≥ 2 months to \< 12 months were randomized in a 2:1 ratio to receive ic51 (0.25 ml dose) or prevnar® as a safety comparator. children aged ≥ 12 months to \< 3 years and ≥ 12 years to \< 18 years were randomized in a 3:1 ratio to receive ic51 (0.25 ml dose \< 3 years, 0.5 ml ≥ 12 years) or havrix®720 as safety comparator. for subjects aged ≥ 3 years to \< 12 years, a dose finding run-in phase was performed. a total of 200 subjects were randomized 1:1 to receive either the 0.25 ml or the 0.5 ml dose of ic51, and the appropriate dose was determined based on an interim analysis. after this run-in phase, 300 further children in this age group were randomized 2:1 to receive either 0.5 ml of ic51 or havrix®720. immunogenicity was be studied in a subgroup of 30 children aged ≥ 2 months to \< 12 months; 125 children aged ≥ 12 months to \< 3 years and 140 children ≥ 12 years to \< 18 years. for the age group of ≥ 3 to \< 12 years immunogenicity was assessed in the 200 children enrolled during the dose-finding run-in phase.

Eligibility criteria:
inclusion criteria: * male or female healthy children and adolescents aged \> 2 months to \< 18 years at the time of first vaccination. * written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable. * female subjects: either no childbearing potential or negative pregnancy test, for females after menarche willingness to practice a reliable method of contraception. exclusion criteria: * clinical manifestation of japanese encephalitis * history of flavivirus vaccination (including any investigational vaccines) * history of vaccination with havrix®720 and/or prevnar® * history of immunodeficiency or immunosuppressive therapy * known hiv, hbv or hcv infection * history of hypersensitivity reactions to other vaccines * acute febrile infection at each visit during which the subject receives a vaccination * active or passive immunization within 2 weeks prior to the first ic51 vaccination and up to the second ic51 vaccination.

Keywords: pediatric japanese encephalitis vaccine endemic countries to assess the systemic and local safety profile of purified inactivated japanese encephalitis virus (jev) vaccine ic51
evaluation of cardiopulmonary parameters in individuals with asthma

Conditions: Asthma

Summary: the aim of the study compare the cardiopulmonary parameters of individuals with asthma with healthy subjects.

it is thought that aerobic capacity of asthmatic individuals decreases due to chronic respiratory disease, especially oxygen consumption. detailed investigation will be provided with this research.

Eligibility criteria:
inclusion criteria: * no respiratory, cardiovascular and metabolic diseases * regular non-smoker exclusion criteria: * non-consenting * pregnant women
diagnosic and pronostic values of kappa and lambda free light chains in central nervous system inflammatory diseases

Conditions: Central Nervous System Diseases; Multiple Sclerosis

Summary: numerous studies have shown the diagnostic interest of cerebrospinal fluid kappa free light chains and kappa index in multiple sclerosis. however, large cohort studies are lacking and little is known about the correlation between kappa and lambda indexes and multiple sclerosis evidence disease activity. therefore, this study plan to validate the kappa and lambda free light chains and indexes as diagnostic biomarker in multiple sclerosis and to correlate the concentration of kappa and lambda free light chains with clinical and radiological activity in a large cohort of patients.


Eligibility criteria:
inclusion criteria: * patients presenting with symptoms evocative of cns involvement for who serum and cerebrospinal fluid kappa free light chains and kappa index are available exclusion criteria: * infectious cns disease * tumor cns disease * active cns bleeding * monoclonal gammapathy * severe chronic renal failure (glomerular filtration rate \<30 ml/mn)

Keywords: multiple sclerosis kappa free light chains lambda free light chains
european pediatric catheter ablation registry

Conditions: Cardiac Arrhythmias

Summary: the main objective of the european pediatric catheter ablation registry is to collect data on ablation procedures in the european pediatric population in order to improve the management of this subset of patients.

catheter ablation has revolutionized the management of cardiac arrhythmias in patients and has become first-line therapy for managing many pediatric patients with atrioventricular accessory pathway or atrioventricular nodal-mediated supraventricular tachycardia. cardiac ablation in children is not a standardized procedure as in adults as evidence gaps still have to be filled. on a european perspective, lack of a dedicated scientific society has limited so far the collection and sharing of data among the most experienced centers. actually there are no sufficient data available about the management of pediatric patients undergoing ablation in clinical practice, in particular regarding indications, methodology and clinical follow-up.

Eligibility criteria:
inclusion criteria: * pediatric patients scheduled to any kind of an ablation procedure; * patient´s age between 0 and 18 years; * legal guardians understand the nature of the procedure, are willing to comply with study follow-up evaluations, and provide written informed consent prior to the procedure. exclusion criteria: * patient unable to comply with follow-up schedule; * patient has medical conditions that preclude protocol compliance or limit study participation; * legal guardian or patient unwilling or unable to provide informed consent.

Keywords: ablation procedure pediatric european cardiac arrhythmias registry observational prospective catheter cryoablation atrioventricular
a study of body fat distribution and airway mechanics in healthy adults

Conditions: Healthy Volunteers Only

Summary: this study investigates how body fat distribution affects airway closure and lung mechanics in healthy adults. using electrical impedance tomography (eit), esophageal manometry, and computed tomography (ct), we aim to characterize how varying bmi and fat topography influence regional ventilation and airway collapse in supine and prone positions. healthy volunteers with a range of bmis will undergo a 2-hour imaging session with noninvasive and minimally invasive monitoring.

this physiological research study explores the relationship between body habitus, fat distribution, and mechanical responses of the lung to the prone and supine position. in a prospective, single-center, physiological, crossover study, study subjects (n=20) will be recruited among healthy volunteers across bmi categories. lung function will be assessed in the supine and prone position (maintained for 15 min). intrathoracic pressure (itp) will be measured using esophageal manometry. airway opening pressure (aop) will be measured by as the airway pressure (non-invasively applied through a mask) needed to match itp. regional ventilation will be measured in both positions using electrical impedance tomography. subjects will then transfer to the computed tomography (ct) scanner, where supine and prone images will be acquired during breath holds after normal expiration and after full inspiration. ct scans will then be analyzed for the quantification of lung volumes, thoracic adipose mass and airway geometry.

Eligibility criteria:
inclusion criteria • healthy subjects older than 18 years and younger than 80. exclusion criteria * pre-existing cardiopulmonary disease * history of tobacco or ecigarette smoking

Keywords: obesity electrical impedance tomography computed tomography esophageal manometry airway geometry
visual function with bilateral acrysof® restor® aspheric sn6ad1

Conditions: Cataract

Summary: the objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the acrysof® restor® aspheric +3.0 intraocular lens (iol).


Eligibility criteria:
inclusion criteria: * prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (iol). subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal iol and be willing and able to complete all follow-up visits. exclusion criteria: * subjects with pre-existing conditions that could skew the results or are contraindications for the acrysof® restor® iol should be excluded from the study. please consult the acrysof® restor® aspheric product inserts under "precautions" for subject groups that should be excluded from this study. all subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by keratometry (k) readings. if the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.

Keywords: bilateral cataract iol restor aspheric
multicenter retrospective database on prognostic and predictive factors in patients with neuroendocrine tumors

Conditions: Neuroendocrine Tumors; Carcinoma;Endocrine

Summary: multicenter retrospective longitudinal analytical study of patients with neuroendocrine tumors.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older and with histologically confirmed neuroendocrine tumors; * metastatic or inoperable disease; * patients with clinical information about the therapies received, including exclusive palliative care. exclusion criteria: * lack of data on survival outcomes and/or details on treatments received.
social cognition in longstanding psychosis

Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder With Psychotic Features; Major Depression With Psychotic Features; Psychosis Not Otherwise Specified (NOS)

Summary: in the current study, the investigators propose to measure the five domains of social cognition identified by the national institute of mental health (nimh) as relevant to individuals with psychosis (i.e., theory of mind, attribution style, emotion recognition, social perception, and social knowledge). the investigators will also explore the association between different domains of social cognition and outcomes relevant to psychotic disorder (e.g., symptomatology, social functioning, and vocational functioning).

there is growing evidence that individuals with longstanding psychotic disorders suffer from deficits in social cognition (i.e., the cognitive skills needed to successfully navigate social interactions). however, to date, there have been few attempts to measure multiple components of social cognition within the same population of individuals with psychosis. thus, the interrelationships between various aspects of social cognition remain unclear. in the current study, the investigators propose to measure the five domains of social cognition identified by nimh as relevant to individuals with psychosis (i.e., theory of mind, attribution style, emotion recognition, social perception, and social knowledge). the investigators will also explore the association between different domains of social cognition and outcomes relevant to psychotic disorder (e.g., symptomatology, social functioning, and vocational functioning).

Eligibility criteria:
inclusion criteria: * diagnosis of a schizophrenia spectrum disorder or an affective disorder with psychotic features per the diagnostic and statistical manual of mental disorders-iv-text revised (dsm-iv-tr) criteria using the structured clinical interview for the dsm-iv. * duration of psychotic symptoms greater than or equal to 5 years determined using the symptom onset in schizophrenia inventory * age 18-75 * no evidence of mental retardation. * able to provide informed consent as evidenced by passing the informed consent quiz with a score of 80% or greater. * fluent in english as assessed per self-report from participant exclusion criteria: * unwilling or unable to complete study assessments (e.g., unable to read self-report questionnaires) * subject is currently pregnant per subject's report

Keywords: psychosis schizophrenia schizoaffective disorder bipolar disorder with psychotic features major depression with psychotic features psychosis nos social cognition
associations of vitamin d receptor apai and tru9i polymorphisms with the risk of primary open-angle glaucoma

Conditions: Primary Open- Angle Glaucoma

Summary: this study investigated whether vitamin d receptor gene polymorphism is altered in primary open-angle glaucoma subjects carrying the risk allele.primary open-angle glaucoma patients and age-matched people in the han population were enrolled. vitamin d receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment length polymorphism technique.


Eligibility criteria:
inclusion criteria: * intraocular pressure greater than 22 mmhg with two or more medications wide anterior chamber angle glaucomatous optic neuropathy (glaucomatous optic nerve damage was defined as cup-to-disc ratio higher than 0.7 or focal loss of the nerve fiber layer (notch) associated with a consistent glaucomatous visual field defect) visual field loss consistent with optic nerve damage and visual fields were performed by using standard automated perimetry exclusion criteria: * the presence of any secondary glaucoma including exfoliation syndrome or a history of ocular trauma high myopia macular degeneration other ocular diseases a known history of systemic diseases and administration of vitamin d3 or other analog
the effect of laughter yoga on tex anxiety and educational stress

Conditions: Laughter Therapy; Anxiety; Stress, Exam

Summary: the primary purpose of this study is to examine the effects of laughter therapy on tex anxiety and educational stress in 8th-grade students.


Eligibility criteria:
the inclusion criteria of the study were determined as being an 8th-grade student, speaking and understanding turkish, and being able to perform daily life activities. the exclusion criteria of the study were to have undergone a surgical operation in the last three months, and to have uncontrollable blood pressure, diabetes and asthma.
mri-guided stereotactic body radiation therapy (sbrt) for ovarian cancer

Conditions: Cancer of Ovary; Cancer of the Ovary; Neoplasms, Ovarian; Ovarian Cancer; Ovary Cancer; Ovary Neoplasms

Summary: the investigators propose to evaluate the feasibility, safety, and preliminary efficacy of delivering online, adaptive magnetic resonance imaging (mri)-guided and gated stereotactic body radiation therapy for patients with recurrent or metastatic ovarian cancer on a novel, integrated co-60 mri treatment machine. to best assess this technology, the investigators will focus on patients that have no more than three sites of progressive disease within the central thorax, liver, and/or non-liver abdominopelvis to receive adaptive, mri-guided and gated sbrt with mri simulation. patients will be treated in five fractions over one to two weeks. by adhering to strict normal tissue constraints, expected toxicity will be within the current standard of care but will allow adaptation based on daily anatomic changes. the prescription dose will be determined based on hard normal tissue constraints, and capped at 10gy per fraction. although the long term goal will be to achieve improved local control and disease-free survival with reduced toxicity, the present study will be driven by the short term goal of demonstrating the feasibility of this novel treatment approach for recurrent or metastatic ovarian cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed primary disease histology of solid ovarian, fallopian tube, or primary peritoneal tumor categorization. * deemed medically fit for stereotactic body radiation therapy by the treating physician. * at least 18 years old. * karnofsky performance status ≥ 70 * completed any systemic therapy (excluding endocrine therapy, which may be ongoing) at least one week prior to planned start of sbrt (two weeks preferred) and must have no plans to initiate systemic therapy for at least one week following end of sbrt (two weeks preferred). * able to understand and be willing to sign an irb approved written informed consent document (or legally authorized representative, if applicable). exclusion criteria: * past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by mri-guided, gated, and/or online adaptive sbrt * current central nervous systemic disease. * widespread progressive disease, i.e., more than three sites of progressive disease (note that more than three sites of disease are permitted provided there are no more than three sites of progressive disease). * actively receiving any investigational agents. * presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * pregnant and/or breastfeeding. patients of childbearing potential must have a negative pregnancy test within 14 days of study entry. * medical contraindication to undergoing mr imaging.
comparison of sms, ivr, and cati surveys in colombia

Conditions: Surveys and Questionnaires; Noncommunicable Diseases

Summary: the objective of the study is to adapt and assess the feasibility, quality, and validity of short message service or 'text message' (sms), interactive voice response (ivr), and computer assisted telephone interviews (cati) for collecting information on noncommunicable disease (ncd) risk factors

using random digit dialing (rdd) sampling technique, rdd participants will be randomized to one of the three arms: 1) sms or 2) ivr or 3) cati. participants in the first study arm will receive an sms survey. participants in the second study arm will receive a ivr survey. participants in the third study arm will receive a cati survey. the ivr, sms and cati questionnaires contain a set of demographic questions and one ncd module (alcohol, or tobacco, or diet, or physical activity, or blood pressure and diabetes). the investigators will examine contact, response, refusal and cooperation rates and demographic representativeness by each study arm.

Eligibility criteria:
inclusion criteria: * access to a mobile phone * greater or equal to 18 years of age * in colombia, conversant in the spanish language exclusion criteria: * less than 18 years of age

Keywords: mobile phone surveys interactive voice response computer assisted telephone interview short message service non-communicable diseases
treatment of adolescent idiopathic scoliosis patients using the ellipse magec system

Conditions: Adolescent Idiopathic Scoliosis

Summary: the purpose of this study is to collect data on the use of the ellipse magec system to treat patients with adolescent idiopathic scoliosis (ais) who have failed external brace therapy.


Eligibility criteria:
inclusion criteria: * diagnosis of adolescent idiopathic scoliosis * failed external brace therapy defined as either (a) progression of the curve greater than 5 degrees at any time while undergoing external brace therapy, or (b) inability or unwillingness to comply with at least 16 hours per day of external bracing * skeletally immature (risser sign 0, 1, 2, or 3) * in girls, either (a) pre-menarchal, or (b) post-menarchal by no more than 6 months * age between 10 and 15 * primary cobb angle greater than 25 degrees but not yet requiring spine fusion * candidate for surgical implantation of spinal instrumentation * patient resides locally with respect to the investigator's clinic and is willing and able to comply with the requirements of the protocol * must sign informed consent to permit the use of personal health data exclusion criteria: * patients with a pacemaker, implanted cardiac defibrillator, or any other electronic implant * patients who require an mri following implantation * skeletally mature (risser sign 4 or 5; or fused tri-radiate cartilage) * diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature * history of previous surgical treatment for ais