Kornimate/medical-research-clean huggingface dataset:
post-marketing use of ct-p13 (infliximab) for standard of care treatment of inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn's Disease

Summary: this is a post-marketing observational study of patients with inflammatory bowel disease (specifically, crohn's disease or ulcerative colitis) who have been prescribed ct-p13 (infliximab) or remicade (infliximab) for treatment. ct-p13 (brand names inflectra and remsima) is a biosimilar medicine to remicade, meaning it is a biologic medicine that contains the same active substance as remicade (infliximab). the key study objectives are as follows: * to characterize the population and drug utilization patterns of patients treated with ct-p13 for crohn's disease (cd) or ulcerative colitis (uc) in the context of standard of care remicade * to explore the long-term safety profile of ct-p13 in the treatment of patients with cd or uc in the context of standard of care remicade * to assess the effectiveness of ct-p13 in the treatment of patients with cd or uc in the context of standard of care remicade

the study will be conducted in accordance with legal and regulatory requirements with scientific purpose, value and rigor following generally accepted research practices described in guidelines for good pharmacoepidemiology practices (gpp), good epidemiological practice (gep), good practices for outcomes research, international ethical guidelines for epidemiological research, european medicines agency (ema) european network of centres for pharmacoepidemiology and pharmacovigilance (encepp) guide on methodological standards in pharmacoepidemiology, and fda guidance for industry. data sources will be validated and will consist of the hospital medical records and monitoring will be organized on a regular basis. data for the study will be entered into a web based electronic data capture (edc) system at enrolment and then approximately every 3 months (at a minimum) thereafter up to 2 years. adverse events will be encoded according to meddra 17.1 or later. the sample size will be approximately 2500 patients recruited over a 30 month period and followed up to 2 years. no inferential analyses are planned. statistical analysis will be descriptive in nature.

Eligibility criteria:
inclusion criteria: 1. at least 12 years of age at the time of initial confirmed diagnosis of cd or uc and at least 18 years of age at the time of enrolment to the study. 2. patients who are prescribed ct-p13 or remicade for the treatment of cd or uc prescribed according to the corresponding summary of product characteristics (smpc) as determined by the investigator. patients with stomas or surgery/pouch will be included. exclusion criteria: 1. any reported contraindications for ct-p13 or remicade, according to the smpc. 2. known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrolment. 3. prior history of failure to respond to remicade or ct-p13.

Keywords: ct-p13 inflectra remicade infliximab observational follow-up safety effectiveness
effects of continuous anterior chest compression

Conditions: Evaluable

Summary: the aim is to test the physiological effects of continuous anterior chest compression in patients with severe to moderate ards.

acute respiratory distress syndrome (ards) is usually characterized by inhomogeneous lesions, leading to an inhomogeneous distribution of the mechanical ventilation with the following several deleterious effects: atelectrauma of dependent posterior areas and overdistension in the anterior ones. therefore, the gold standard treatment is to prevent vili with lung protective ventilation : low tidal volume, high positive end expiratory pressure and prone positioning which is a technique that reduces mortality. prone positioning has several beneficial effects : it relieves cardiac compression of the supporting lung, it stiffens the anterior chest wall thus limiting the risk of overdistension of anterior areas and promotes recruitment of non-dependent posterior pulmonary units. the overall effect is a more uniform distribution of transpulmonary pressures and improved ventilation to perfusion ratios. similar to prone positioning, continuous anterior chest wall compression stiffens the anterior chest wall. the investigators hypothesize that such reduction in anterior chest wall compliance may protect against overdistension and promote the redistribution of the ventilation in posterior areas.

Eligibility criteria:
inclusion criteria: * age ≥ 18 ans * intubated moderate and severe ards according to the berlin definition (pao2/fio2 ratio \<= 200 mmhg) * the patent must be sedated and paralyzed * informed consent from patient or family members exclusion criteria: * extracorporeal membrane oxygenation (ecmo) * pneumothorax * thoracic trauma during the last 3 months * refractory shock * contraindication to eit monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement) * pregnancy * any contra-indication to esophageal manometry (less than one month esophagus surgery, bronchopleural or esotracheal fistula, latex allergy) * no social care * adults under guardianship, curatorship or protection of the court

Keywords: ards : acute respiratory distress syndrome cacc : continuous anterior chest compression vili : ventilator-induced lung injury ards,human: adult respiratory distress syndrome
microarray analysis of gene expression in prostate tissues

Conditions: Prostate Cancer

Summary: the purpose of this study is to investigate gene expression profiles and biologic features of prostate tissue and how they relate to prostate cancer development and growth.


Eligibility criteria:
inclusion criteria: - patient scheduled to undergo either a biopsy or surgery for a prostate condition. exclusion criteria: - patients without a prostate condition

Keywords: prostate cancer gene expression tumor markers microarray analysis
accelerated transcranial magnetic stimulation (tms) for depression

Conditions: Depression

Summary: the purpose of this study is to determinate if accelerated rtms treatment over 1.5 days is effective for ameliorating depression in parkinson's disease.

objective: the goal of this study is to investigate a new approach to administering repetitive transcranial magnetic stimulation (rtms) in patients with refractory depression. (please note: the original requirement for comorbid parkinson's disease has been dropped from this study). research plan: this inpatient study will provide an initial test for the hypothesis that accelerated rtms is an effective treatment for depression. followup testing will help delineate the time course of response. methods: the rtms treatment site over left dorsolateral prefrontal cortex will be 5.5cm anterior to the hand motor area. treatments consisting of 1000 total pulses at 10 hz and 100% motor threshold will be administered hourly for 1.5 days, totaling 15 sessions. a comprehensive test battery will be administered just before and after treatment, at 3 weeks, and at 6 weeks after treatment. clinical relevance: we expect that accelerated rtms treatments will lessen the degree of depression to the same extent as rtms treatments of longer duration, but far more rapidly. a much shorter hospitalization would be more easily tolerated. in addition, reducing the duration of hospitalization substantially reduces burdens and costs to hospital, staff, and caregivers, while more rapidly enhancing function and quality of life.

Eligibility criteria:
inclusion criteria: * age 18-80 years. * patients who meet dsm-iv criteria for major depressive episode, severe, treatment resistant, with or without psychotic features. * consent to treatment with rtms. exclusion criteria: * patients with delirium or substance dependence within the last 6 months. patients will be screened initially with the michigan alcohol screening test (mast) and mini-mental status examination and further evaluated if clinically indicated. * patients with other significant central neurological disorders including increased intracranial pressure, brain mass, epileptic seizures, stroke, transient ischemic attack within two years, cerebral aneurysm, dementia, multiple sclerosis or other major cns dysfunction. * pregnant women. * patients with cardiac pacemakers, other intracardiac lines, cochlear implants, aneurism clips, or other intracranial implants with the exception of dental fillings. * patients with significant heart disease or with acute, unstable medical conditions that require stabilization (e.g., uncontrolled hypertension, bleeding) prior to treatment. * patients who require continued treatment with antipsychotics including clozapine and risperidone, benzodiazepines, lithium or anticonvulsants. patients will be allowed to continue on a stable dose of antidepressants and use zolpidem, since the latter is not felt to affect seizure threshold. * patients who are unable to ambulate independently and complete the assessment protocol.

Keywords: depression parkinson disease transcranial magnetic stimulation
customizing myopia control with multifocal toric contact lens

Conditions: Refractive Errors; Myopia

Summary: this study will evaluate the ability of toric multifocal contact lens to reduce the change of myopia progression in children (aged 8-12) with myopic astigmatism.

the purpose of this study is to assess if a center distance toric multifocal contact lenses can slow the amount of change of myopia progression in children with myopia plus astigmatism. multifocal contact lenses have been theorized to influence the peripheral optics of the eye such that they slow the rate of myopia progression in nearsighted children. this outcome is yet to be evaluated in children with myopia plus astigmatism.the secondary outcome is to measure the change in peripheral optics caused by the contact lens. this information is key to understanding the mechanism of multifocal contact lens optics on the eye. ultimately this information would be used to create a software that can estimate the effect of multifocal contact lenses on the peripheral optics of the child's eye. this software can potentially be used by practitioners worldwide to better customize multifocal contact lenses to slow myopia progression.

Eligibility criteria:
inclusion criteria: * 8 to 12 years, inclusive, at baseline examination * -0.50 to -6.00 d, inclusive, spherical component, cycloplegic autorefraction * ≥0.75 dc, cycloplegic autorefraction * 0.1 logmar or better best-corrected visual acuity in each eye exclusion criteria: * eye disease or refractive error conditions (e.g., keratoconus, retinal abnormalities, retinopathy of prematurity, etc.) * ocular surgery, severe ocular trauma, active ocular infection or inflammation * subjects with a condition or in a situation, which in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study.

Keywords: myopia multifocal contact lens refractive error myopia treatment myopia control myopia management
combining accelerometer, gyroscope, sound, electrocardiography and photoplethysmography data in cardiac monitoring

Conditions: Atrial Fibrillation

Summary: the goal of this interventional clinical trial is to investigate whether combining photoplethysmography (ppg) signals with accelerometer (acc), gyroscope (gyr), sound, and electrocardiography (ecg) derived smartphone data provides additional insights into the cardiac condition of individuals with and without atrial fibrillation (af).


Eligibility criteria:
inclusion criteria: inclusion criteria applicable for all groups: * at least 18 years old * participants must have the ability to understand and provide written informed consent * participants must have the ability to understand dutch group specific inclusion criteria: group 1: healthy volunteers * no cardiac conditions based on medical history. group 2: cardiology patients * patients at the consultation or ambulatory unit of cardiology (pre- cardioversion, pre-pulmonary vein isolation) with af. * patients without af but with a current cardiac condition (e.g. heart failure with a reduced or preserved ejection fraction) or a history of a cardiac condition (e.g. history of myocardial infarction). exclusion criteria: * individuals with unnaturally coloured fingers (i.e. tattoos, ink); this may weaken the signal and may interfere with the effectiveness of the device * persons with conditions causing tremors or the inability to hold their hand still for at least 60 seconds (e.g. parkinson or dementia) as, in this case, the device may not be able to accurately process a measurement * persons with reduced blood flow in the fingertips (e.g. perniosis or severe callus formation) as the device may not be able to detect the intensity variations induced by the blood flow * persons that have a disability to perform the measurements according to the instructions for use * persons with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can control the natural heart rhythm

Keywords: photoplethysmography single-lead electrocardiography
wald outreach for wellness: blood pressure outreach

Conditions: Pre-hypertension; Hypertension

Summary: the wald outreach center will partner with medicine for the greater good (mgg) to implement this pilot project called wald outreach for wellness (wow), a blood pressure outreach wellness intervention in a retail setting.

wow aims to provide community members with a digital blood pressure monitor, health education, and health care navigation as practical strategies to improve community members' management of pre-hypertension, and to reduce associated burdens and risks related to hypertension health disparities. this approach to reaching populations who use retail settings has the potential to implement a health promotion and wellness strategy aimed at populations with increased risk for hypertension related health disparities. the outreach strategy is aimed at reaching community members where community members gather for health care, provide the community members with practical, low-cost strategies for promoting health and wellness, increase community members' knowledge in hypertension management, help the community members navigate health care options and get the community members engaged in a medical home thereby reducing the burdens of hypertension health disparities. this research is important to continue to assess the best ways to reach and reduce hypertension health disparities in underserved communities with limited access to health care.

Eligibility criteria:
inclusion criteria: * community residents who participate in day at the market * adult individuals 18 years and older whose recorded bp reading is within the pre-hypertensive range 120-139 systolic; 80-89 diastolic * able to read and understand english exclusion criteria: * 17 years or younger * bp reading above pre-hypertensive range * unable to read and understand english

Keywords: health disparities outreach health behavior under-served communities
measurement of patient reported gastrointestinal (gi) and health-related quality of life (hrql) outcomes in renal transplant recipients (mylife)

Conditions: Renal Transplantation; Gastrointestinal Problems

Summary: the purpose of this study is to assess whether a switch from mycophenolate mofetil (mmf) to enteric-coated mycophenolate sodium (ec-mps) results in improved gi- and/or health-related quality of life outcomes, and to determine the proportion of renal transplant recipients who are experiencing any gi complaints under mmf-based immunosuppressive treatment.


Eligibility criteria:
inclusion criteria: * received kidney transplant at least 3 months prior to study enrollment * receiving immunosuppressive regimen that includes mmf in combination with other immunosuppressive drugs * receiving mmf for at least 1 month prior to enrollment exclusion criteria: * patients with any known hypersensitivity against mycophenolic acid, mycophenolate sodium, mycophenolate mofetil or other components of the formulations (e.g. lactose; see also summary of product characteristics of ec-mps) * if applicable, gi symptoms assumed or known not to be caused by mpa therapy (e.g. oral biphosphonates induced, infectious diarrhea) * acute rejection \< 1 week prior to study enrollment other protocol-defined inclusion/exclusion criteria may apply.

Keywords: renal transplantation mmf ec-mps gi problems
drug elution and distal protection during percutaneous coronary intervention in st elevation myocardial infarction

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to evaluate the clinical, echocardiographic and angiographic outcome of distal protection in the infarct related coronary artery and implantation of drug eluting versus bare metal stents in patients with st-elevation myocardial infarctions treated acutely with percutaneous coronary intervention.


Eligibility criteria:
inclusion criteria: * acute onset typical chest pain of \< 12 hours' duration * st-elevation of \> 4 mm (1mm = 0.1 mv) in contiguous leads of the electrocardiogram * high grade stenosis or occlusion of a native major coronary artery that can be crossed with a soft or intermediate tip guidewire * possibility to perform distal protection of the infarct-related artery exclusion criteria: * history of previous myocardial infarction * use of fibrinolytic agents for the index infarction * left main stenosis * heavily calcification of abdominal aorta or occlusive iliofemoral disease hampering access to the coronary ostias by the femoral route * known renal failure * other significant cardiac disease * other severe disease with an expected survival \< 1 year * known allergy against clopidogrel or contrast media that can not be avoided/limited by medication * linguistic difficulties needing an interpreter * gastrointestinal bleeding within 1 month * childbearing potential or pregnancy * participation in another study

Keywords: primary pci distal protection drug eluting stent restenosis
reducing caregiver stress and sleep disturbances in patients with progressive dementia

Conditions: Sleep Disorders

Summary: people under stress, such as those caring for an ill family member, often have trouble with their sleep. the aim of this study is to see if reducing stress and changing a caregiver's sleep and wake patterns will improve his/her sleep. the investigators also will see whether improvements in sleep result in improved mood, health, and general functioning.

the general aim of this study is to characterize stress-related sleep disturbances in spousal caregivers of patients with progressive dementia and to test the efficacy of an intervention designed to reduce stress and sleep disturbances. we will compare the efficacy of a stress management plus health sleep practices (sm+hsp) intervention to an attention-only control condition in spousal caregivers of patients with progressive dementia. specific aims for this study are: aim 1: to characterize stress-related sleep disruptions in spousal caregivers of patients with progressive dementia. aim 2: to test the short-term efficacy of a stress management plus healthy sleep practices (sm+hsp) intervention versus an attention-only control for improving sleep and health outcomes in caregivers of patients with progressive dementia. aim 3: to test the durability of the sm+hsp intervention among spousal caregivers of patients with progressive dementia. aim 4: to characterize: 1. the impact of stress-related sleep disruptions on health in older adults, and 2. the effects of sleep interventions on health and functioning.

Eligibility criteria:
inclusion criteria: * ages 60 or older * spousal caregivers of patients with progressive dementia * patients have a diagnosis of possible or probable alzheimer's disease or other progressive dementia * affirm that it is a physical and emotional strain to care for spouse * pittsburgh sleep quality index score of 5 or above or a polysomnographically determined sleep efficiency of 90% or worse. exclusion criteria: * psychotic disorder or substance abuse disorder * apnea-hypopnea index of greater than 30 * score of less than 24 on mini-mental state exam

Keywords: caregiving spousal sleep disturbances progressive dementia stress health outcomes intervention affective self-management caregivers m01.526.485.200 spouses f01.829.263.500.660 alzheimer's disease c10.574.945.249 parkinson's disease c10.574.812 sleep disorder c10.886.425.800.800
a prospective study of early mechanical stabilization and bleeding in disruption of the pelvic ring

Conditions: Pelvic Fracture

Summary: the objective of this study is to evaluate the effect of earlier placement of circumferential pelvic compression (cpc) on resuscitative measures required for life-threatening pelvic ring injuries and to guide the development of future efficacy trials of three advanced resuscitation techniques (surgical pelvic packing, angioembolization, reboa).


Eligibility criteria:
inclusion criteria: * patient age between 18 and 64 years, inclusive; * severe blunt or blast traumatic injury; * young-burgess apc-2 and 3, lc-3, vertical shear, and combined mechanism of injury (cmi) (tile b and c patterns; ota codes 61-b and 61-c); * circumferential pelvic compression (cpc) device used at any time within 24 hours of injury. * patient must speak either english or spanish exclusion criteria: * arrival to hospital of definitive care more than 6 hours after injury; * ballistic pelvic injury, other than from a blast mechanism; * time of cpc placement not recorded; * time of injury and time of ems dispatch unknown; * use of medical anti-shock trousers (mast); * confirmed dead on arrival to hospital
virtual reality (vr) to improve quality of life in patients diagnosed with neurological disorders

Conditions: Multiple Sclerosis; Chronic Pain; Neurological Disorder

Summary: participants with neurological disorders will be recruited to complete sessions of virtual reality (vr) immersion. vr has been shown to have therapeutic benefit in certain patient populations and requires further clinical study to determine the extent to which vr can be used to rehabilitate and reduce symptom burden. this study seeks to pilot newly developed vr methods and collect preliminary data in order to support research grants and inform larger clinical trials. additionally, this proposed study will explore the tolerability and preliminary efficacy of virtual reality (vr), specifically to determine whether vr can acutely reduce the severity of symptom burden caused by neurological disorders.


Eligibility criteria:
inclusion criteria: * 18-79 years of age * has been diagnosed by a clinician as having ms * able to commit to the designated period of testing * able to understand the informed consent process and provide consent to participate in the study * capacity to complete study procedures as determined by screening personnel * a brief pain inventory interference score of at least 3 or more. * sdmt z-score \> -3.0 * wrat4 standard score \> or = 85 exclusion criteria: * visual, auditory, and motor deficits that would prevent full ability to understand study * visual, auditory, and motor deficits that would prevent full ability to operate vr equipment * uncontrolled epilepsy * current diagnosis of vertigo * uncontrolled mood disorders * history of psychosis or schizophrenia * expanded disability status scale (edss) score greater than 6.5 * unable to tolerate or manipulate vr treatment procedures (as evidenced by vr capability assessment)