Kornimate/medical-research-clean huggingface dataset:
the impact of hyaluronic acid injections on osteoarthritic knee mechanics

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to determine the impact of a regular course of treatment with hyaluronic acid (ha) injections on gait in knee osteoarthritis (oa) patients. three consecutive ha injections will be compared to three consecutive placebo injections to determine whether ha's analgesic effect is greater than that of a placebo injection, and to observe whether ha's viscoelastic properties are manifested in a human knee oa population. we hypothesize that ha injections will relieve pain to a greater extent than placebo injections in knee oa patients, and will afford them with improved walking characteristics, such as increased walking speed, and step length.

knee osteoarthritis (oa) is a severely debilitating disease associated with stiffness and pain in the knee joint, and with a loss of function. hyaluronic acid (ha) injections are incorporated into non-surgical standard of care for knee oa patients and have been proven to relieve pain in patients who have not received symptomatic relief with other knee oa interventions. ha allows synovial fluid to act as a lubricant and shock absorber for joints, and although this is encouraging ground to advocate for the use of ha treatment in knee oa patients, these properties have yet to be proven in a controlled clinical trial setting. therefore, we are undertaking this study to observe whether the physiological adaptation in the oa knee joint, initiated by ha injection, will result in biomechanical improvements in human knee oa patients, specifically walking mechanics.

Eligibility criteria:
inclusion criteria: * 60 - 80 years old. * mild to moderate knee osteoarthritis: * clinical diagnosis (symptoms). * radiographic diagnosis (kellgren-lawrence grade i - iii). * must provide provide informed consent and knowledge of all possible benefits and possible adverse events. * available for duration of the study. * not taking any other knee osteoarthritis medications during the study. exclusion criteria: * non - oa arthritides. * hip, ankle, or foot oa. * end stage oa. * lower back/extremity pathology. * previous surgery on knee affected by oa (except arthroscopy within the past 12 - 18 months). * neurological/cardiovascular gait impairment. * pregnant. * cognitively impaired. * not available for duration of study. * taking other knee oa medications at time of study. * gastro-intestinal disturbance. * avian allergy or any other contraindication to intra-articular injections with hyaluronic acid.

Keywords: knee oa, hyaluronic acid, gait, pain, synovial fluid
data analysis of adult and pediatric participants with acid sphingomyelinase deficiency (asmd) on early access to olipudase alfa in france

Conditions: Acid Sphingomyelinase Deficiency (ASMD)

Summary: primary objective: to describe the lung, spleen and liver outcomes of olipudase alfa secondary objectives: * to describe the patient's characteristics * to describe conditions of olipudase alfa use * to describe safety data related to the use of olipudase alfa * to describe complementary effectiveness outcomes parameters

approximate duration of enrollment: 30 months total study duration: approximately 30 months this is a national, multicenter observational retrospective and prospective cohort data collection study. retrospective is defined as collection of data from all patients, including deceased patients, who were already on early access olipudase alfa in france before the start of this study.

Eligibility criteria:
inclusion criteria: * the patient, or the patient's parent(s)/guardian(s), has signed written informed consent. * patients with a confirmed diagnosis of asmd under early access to olipudase alfa in france (ie, nominative compassionate use, pre marketing authorization early access, post marketing authorization early access). * the patient has documented deficiency of acid sphingomyelinase in peripheral leukocytes, lymphocytes, or cultured fibroblasts. * male and female patients of all ages. exclusion criteria: * the patient or legal guardian(s) who has not received information notice or who opposes to data collection. * patient who died before study initiation and who was opposed to data collection for research purpose when he/she was alive. the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
back school efficacy on low back pain and quality of life of workers. copcord study (stage ii)

Conditions: Low Back Pain

Summary: the study is an intervention, phase ii copcord study. (copcord= community oriented program to control rheumatic diseases). the purpose of this study is to find if back school training has any benefit on low back pain of the workers in a pharmaceutical factory in tehran suburbs.

a back school will be held on at the modava pharmaceutical factory, in tehran suburbs. we estimate that this prospective study will include almost one third of the 70 workers in the factory. the study provides objective data and subjective information from patients. the clinical benefits of back school on low back pain and quality of life will be reported at the beginning and the end of intervention and after a period of 6 months follow up.

Eligibility criteria:
inclusion criteria: * history of mechanical low back pain in the last six months exclusion criteria: * history of inflammatory spinal diseases * severe scoliosis * history of spinal surgery * history of spinal malignancy

Keywords: low back pain
validation of non-invasive intracranial pressure (icp) monitoring device

Conditions: Intracranial Hypertension; Abnormality of Intracranial Pressure

Summary: for purposes of validation, this study compares intracranial pressure measurements obtained with a novel self-calibrating, non-invasive, intracranial pressure measuring (icp) device, with the values obtained from (a) patients in an intensive care unit (icu) whose meet standard clinical indications for icp measurement and whose icp is measured using gold-standard implanted intracranial instrumentation and in (b) ambulatory subjects who meet clinical indications for lumbar puncture.

this study is designed to validate intracranial pressure measurements obtained with a novel, self-calibrating, non-invasive, intracranial pressure measuring (icp) device based on trans-cranial doppler technology. the ophthalmic artery is utilized as a natural icp sensor. up to 80 subjects will be recruited in 4 centers to achieve a power of 90% and a p\<0.05 compared to the values obtained from (a) patients in an icu whose meet standard clinical indications for icp measurement and whose icp is measured using gold-standard implanted intracranial instrumentation and in (b) ambulatory subjects who meet clinical indications for lumbar puncture. at least two comparative readings, separated by an hour or more, will be obtained from each subject.

Eligibility criteria:
inclusion criteria: * icu patients suspected of having an abnormality of icp undergoing monitoring with commercially-available, fda-approved instrumentation. exclusion criteria: history of: * glaucoma or optic hypertension * severe orbital or ophthalmic injury * orbital or intraocular surgery that might interfere with orbital compliance * congenital malformations of the eye and/or orbit that might interfere with orbital compliance or orbital vascular anatomy

Keywords: icp papilledema neurological intensive care
respiratory pattern during neurally adjusted ventilator assist (nava) in preterm infants

Conditions: Respiratory Distress Syndrome In Premature Infants; Preterm Infants

Summary: this study is to investigate the effect of a wide range of assistance levels on respiratory pattern, breathing variability including tidal volume and peak inspiratory pressure during neurally adjusted ventilatory assist (nava) in preterm infants. the investigators also aim to explore whether the effects of nava on the electrical activity of diaphragm (edi) signal amplitude, work of breathing and comfort of preterm infants.


Eligibility criteria:
inclusion criteria: * preterm infants born before 36 weeks of gestational age * who received mechanical ventilatory care through the endotracheal tube at least 24 hours for respiratory distress * no use of anesthetics or analgetics exclusion criteria: * with major congenital anomalies (facial, gastrointestinal tract, cardiac, etc) * with phrenic nerve palsy or injuries
comparison between "conventional monitoring" versus "monitoring via vitaphone" in the detection of post ablation atrial arrhythmias of paroxysmal atrial fibrillation

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) is the most common atrial arrhythmia. ablation of af is a recent technique, nevertheless, the success rates of ablation vary between 50% and 70% depending on the paroxysmal or persistent nature of af. these rates are difficult to assess in routine practice because they are based on the recurrence of fibrillation. the vitaphone is a non-invasive device, with which the patient can record a single-track ecg as his or her symptoms take place. the plot is then transmitted via the internet to the centre, which can thus diagnose a relapse of af. the aim of our study is to correlate the rhythm and symptoms of 20 patients with vitaphone 6 months after af ablation and to compare them with 20 other patients receiving conventional monitoring.

atrial fibrillation (af) is the most common atrial arrhythmia in the population and its incidence will increase in the coming years. ablation of af is a recent technique, the efficiency of which has considerably increased in recent years. nevertheless, the success rates of ablation vary between 50% and 70% depending on the paroxysmal or persistent nature of af. these rates are difficult to assess in routine practice because they are based on the recurrence of fibrillation. this definition of recurrence based on symptoms (palpitations, asthenia, fatigue, shortness of breath, malaise, precordialgia) is widely debated because some patients have asymptomatic af recidivism, while others experience palpitations that are not due to af. in this context, studies have been carried out with electrocardiographic recording devices implanted subcutaneously. given the invasiveness of this monitoring, it is not feasible in current practice. the vitaphone is a non-invasive device, with which the patient can record a single-track ecg as his or her symptoms take place. the plot is then transmitted via the internet to the centre, which can thus diagnose a relapse of af. the aim of our study is to correlate the rhythm and symptoms of 20 patients with vitaphone 6 months after af ablation and to compare them with 20 other patients receiving conventional monitoring. this is, to our knowledge, the first non-invasive french study using the vitaphone.

Eligibility criteria:
inclusion criteria: * af ablated patient * patient with paroxysmal af before the procedure * patient with health insurance or beneficiary of a social security scheme * unprotected adult patient * patient having given their consent exclusion criteria: * patient having undergone an af ablation due to persistent af * unable to understand or handle the vitaphone alone * failure to participate * minors * pregnant, lactating or parturient women * adult receiving psychiatric care, under legal protection, trusteeship or guardianship, or deprived of liberty by judicial or administrative decision
the effect of instrument assisted soft tissue mobilization on respiratory functions in chronic obstructive pulmonary disease

Conditions: COPD; Pulmonary Function; Soft Tissue Mobilization

Summary: the aim of this study is to investigate the effect of instrument-assisted soft tissue mobilization applied to the hamstring muscle on respiratory function in patients with copdthe patients to be included in the study will be divided into two groups by simple randomization. a group will be given breathing exercises (pursed lip breathing, diaphragmatic breathing and thoracic expansion exercises) as a home program. the other group will be given breathing exercises in the form of a home program in addition to 1 session of edym per week. both groups will be evaluated before and 4 weeks after treatment.


Eligibility criteria:
inclusion criteria: * diagnosed with gold stage i-ii copd * between the ages of 40-65 * copd in stable period * no other respiratory disease that impairs respiratory functions such as asthma * knee flexion angle of 15 degrees and above in the hamstring muscle shortness test, * individuals without musculoskeletal problems in their lower extremities were included. exclusion criteria: * copd patients who receive home oxygen therapy or who need oxygen therapy frequently * copd exacerbation, hospitalization with acute exacerbation in the last 15 days * pregnancy * kyphoscoliosis, advanced postural disorder * prior thoracic surgery * advanced heart failure * patients with primary pulmonary hypertension or have had a pulmonary embolism, * having serious neurological diseases such as parkinson's, hemiplegia, multiple sclerosis, * neuromuscular disease * having dementia, alzheimer's or advanced cognitive problems, * diagnosed with lung cancer or other malignancy, * people with morbid obesity will not be included in the study.
neural correlates of compulsivity

Conditions: Obsessive-Compulsive Disorder

Summary: this study aims to collect data from individuals with obsessive-compulsive disorder (ocd) and healthy controls in order to clarify how learning strategies are employed differently by individuals with compulsive psychopathology and healthy individuals. behavioral and electroencephalogram (eeg) data will be collected during one experimental reinforcement learning tasks from participants diagnosed with ocd (n = 30) and healthy controls (n = 30). computational modeling, an advanced data analytic approach that can directly link neural measures with behavior, will be used to quantify learning processes. these parameters then will be related to measures of neural events obtained using eeg, a neuroimaging method that has high temporal resolution, to test for evidence of neurocognitive alterations.

learning and decisions making are thought to be directed by multiple parallel cognitive systems. these systems account for automatic, inflexible responding to stimuli, as well as more deliberate, effortful representations of relationships in an environment. it has long been suggested than an imbalance in these cognitive control systems explains the emergence of compulsivity, a trait in which behaviors persist despite adverse outcomes. compulsivity is a characteristic of a number of psychological disorders, however, current theories of how abnormalities in cognitive systems involved in learning and decision making lead to the onset of these disorders remain incomplete.

Eligibility criteria:
inclusion criteria: * between 18-50 years of age * english-speaking * capacity to provide informed consent * primary diagnosis of ocd with at least moderate severity exclusion criteria: * current or lifetime history of psychiatric disorders other than ocd that may increase the risk of participation * history of any significant medical condition that may increase the risk of participation * alcohol or substance use disorder in the past year * exposure and response prevention for ocd within the last six weeks * currently taking psychotropic medication

Keywords: compulsivity obsessive-compulsive disorder exposure and response prevention electroencephalogram
high-protein oral supplement with liposomal curcumin in adults undergoing hemodialysis.

Conditions: Chronic Kidney Disease 5D

Summary: a 12-week double-blind randomized control trial will be conducted among adults on hemodialysis (n=15) to determine the impact of liposomal curcumin in a high-protein product on inflammation markers and oxidative stress. participants will be randomized via a computer-generator into either the control or intervention group. participants in each group will be given a total of 38 g of a high protein product with or without 7 mls of liposomal curcumin for a total of 8 weeks. at baseline, weeks 8 and 12, participants will have blood sampled and complete a 3-day 24-hour recalls (2 non-dialysis days and 1 dialysis day) and a quality of life survey.

this is a 12-week double-blind randomized controlled trial to evaluate the impact of liposomal curcumin in a high-protein product on inflammation markers for adults undergoing hemodialysis. crp and oxidative stress will be assessed from monthly blood samples using elisa kits. quality of life will be measured using the standard 36-item kidney disease quality of life instrument. there will be a 2-month recruitment period prior to the start of the trial to ensure the potential participants are familiarized with the clinical trial. eligible participants will sign the consent form to participate in the study. once the expected number of participants has been reached, they will be randomized 1:1 using block randomization. randomization will be done using a computer-generated program. the intervention will take place over an 8-week period. participants will have their blood drawn at the beginning of the study by the dialysis practitioner and start receiving the product on their next scheduled dialysis appointment. participants will be receiving the product three times a week in accordance with their dialysis schedule (m-w-f or t-th-s), for a total of 24 treatments. blood will be collected at baseline, at the end of the study and a month after to assess any carryover effects. additionally, participants will complete 3-day 24-hour recalls (2 non-dialysis days and 1 dialysis day), a spice-consumption survey, and a quality-of-life assessment at the beginning and end of the study.

Eligibility criteria:
inclusion criteria: * 18 years old or older * diagnosed with stage 5 ckd. * receiving hemodialysis at least three months before the trial start date * all participants can provide signed informed consent, have no dietary restrictions, no food allergies, nor chewing/swallowing difficulties. exclusion criteria: * adults with ckd stages 1-4. * adults undergoing peritoneal dialysis. * pregnant and/or lactating for the duration of the study as confirmed by the dialysis medical staff. * use of other ip within 3 months of the initiation of the study.
development of a newborn screening assay for angelman syndrome and prader-willi syndrome

Conditions: Angelman Syndrome; Prader-Willi Syndrome

Summary: the overall purpose of this project is to establish the capability of screening for angelman syndrome (as) and prader-willi syndrome (pws) in public health newborn screening (nbs) programs, with an aim of developing and validating a screening test for as and pws.

this project will have an assay development phase and an assay validation phase. in the assay development phase, the investigators will develop a method of assessing snrpn promoter (located in chromosome 15 q11-q13) methylation status using methylation-specific pcr coupled with a melting curve analysis with de-identified leftover dna from routine newborn screening dried blood samples for severe combined immunodeficiency and spinal muscular atrophy. in the assay validation phase, the investigators plan to assess the assay sensitivity and specificity using a set of dna samples extracted from dried blood spots in each following group: 1. healthy individuals 2. as patients with genetic testing confirmation that the maternal copy of chromosome 15 q11-q13 is deleted, or that there are two paternal copies of chromosome 15 q11-q13 or imprinting center defect. 3. pws patients with genetic testing confirmation that the paternal copy of chromosome 15 q11-q13 is deleted, or that there are two maternal copies of chromosome 15 q11-q13 or imprinting center defect. for participants with as or pws, blood samples will be obtained via a self-administered finger prick performed in the participant's home. the participant will mail the sample to the researchers using a provided envelope. if the team is not able to reach the participant after two phone call attempts, the study team may approach them at their next clinic visit to assess interest in study participation. if participants opt to join the study at this clinic visit, the blood sample may be obtained in clinic. for healthy controls, blood samples will be obtained via a self-administered finger prick, and participants will verbally respond to a brief demographic questionnaire.

Eligibility criteria:
inclusion criteria: * diagnosed with angelman syndrome, confirmed by molecular testing (deletion of maternal allele of chromosome 15q11-q13, paternal uniparental disomy, and imprinting center defects) * diagnosed with prader-willi syndrome, confirmed by molecular testing (deletion of paternal allele of chromosome 15q11-q13, maternal uniparental disomy, and imprinting center defects) * angelman syndrome or prader willi syndrome: current patient at uw health in the madison, wisconsin metropolitan area * healthy controls 18 years old or older and have not received a diagnosis of angelman syndrome or prader willi syndrome exclusion criteria: * angelman syndrome/prader willi syndrome: family requires a translator for medical visits * healthy controls: participants are unable to consent and complete study procedures in english.

Keywords: newborn screening assay public health
study to evaluate the safety and immunogenicity of gsk biological pandemic candidate influenza vaccine (h1n1) in children

Conditions: Influenza

Summary: the objective of this study is to evaluate the safety and immunogenicity study of gsk biologicals' pandemic influenza candidate vaccine (gsk2340272a) in children aged 3 to 9 years.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parent(s)/legally acceptable representative(s) (lar) can and will comply with the requirements of the protocol. * children, male or female, aged between 3 and 9 years at the time of first study vaccination. * written informed consent obtained from the parent(s) or lar(s) of the subject. * healthy children, as established by medical history and clinical examination when entering the study. exclusion criteria: * use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. * clinically or virologically confirmed influenza infection within six months preceding the study start. * planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration. * have received any seasonal flu vaccine since last year. * previous administration of any h1n1 a/california-like vaccine * chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. for corticosteroids, this will mean prednisone \>= 0.5 mg/kg/day, or equivalent. inhaled and topical steroids are allowed. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination. * history of hypersensitivity to vaccines. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * history of any neurological disorders or seizures. * acute disease and/or fever at the time of enrolment: * fever is defined as temperature \>= 37.5°c on oral, axillary or tympanic setting, or \>= 38°c on rectal setting. * subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. * administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study. * any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study. * child in care.

Keywords: influenza infection gsk bio's influenza vaccine gsk2340272a