Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of bonded versus banded space maintainers

Conditions: Tooth Loss

Summary: comparing bonded space maintainers to banded space maintainers

comparing bonded space maintainers to banded ones regarding clinical success in maintaining the space for the prematurely lost primary molar and radiographic space loss in both banded and bonded space maintainers. finally, patient satisfaction regarding both treatments.

Eligibility criteria:
inclusion criteria: patient and parent showing cooperation and compliance. medically free children. patients having mandibular first deciduous molar indicated for extraction due to extensive coronal caries beyond possible repair, root caries and/or failed pulp therapy. having all first permanent molars erupted and in class i molar relation. according to space analysis available space is less than or equal to needed space. having all their mandibular incisors erupted. with deciduous canines and second deciduous molars in the side of the extraction maintained throughout the entire follow-up period. caries free, non-restored buccal surfaces of the mandibular second primary molars and deciduous canines. 1/3 to less than 2/3 of the root of the permanent successor is formed to the prematurely lost primary molars. exclusion criteria: children with any parafunctional habits. children with previous allergies to stainless steel. crowned abutment teeth. permanent successors with 2/3 of its roots formed and space analysis does not indicate the fabrication of space maintainer.
enforced reduction in physical activity and recovery in older adults

Conditions: Muscle Degeneration; Body Weight Changes; Walking, Difficulty

Summary: apparently healthy and well-functioning community dwelling 70-80 year-olds will be recruited to the study. all subjects undergo pre-screening for suitability and a physicians examination, as well as 7-day habitual daily steps are measured to ascertain baseline physical activity. half of the recruited subjects (n=40) will be randomized into the intervention group and half (n=40) randomized into the control group. the intervention group is then required to reduce their daily steps to \<2000 for a 2-week period. thereafter, the intervention group participates to a 4-week strength+endurance training rehabilitation program and no longer has restricted daily step count. the control group continues their normal habitual physical activity level throughout the 6-week study period.


Eligibility criteria:
inclusion criteria: 1. aged 70-80 years, 2. community-dwelling, 3. able to walk 500 m without assistance or use of walking aid and regularly walking \>5000 steps per day, 4. mmse \>24, 5. bmi 20-35 kg·m2 (i.e. not underweight or severely obese), 6. no serious cardiovascular or musculoskeletal disease, 7. no risk factors for deep-vein thrombosis (e.g. blood clotting disorder, obesity, bowel diseases, personal or family history of dvt etc.), 8. non-smoker, 9. provision of informed consent. exclusion criteria: 1. underlying diseases likely to limit lifespan and/or intervention safety. contraindication for physical exercise or physical tests identified during physician's examination, 2. unwilling/unable to track daily step counts using accelerometer, 3. excessive and regular use of alcohol (more than 7 units per week for women and 14 for men) 4. difficulty in communication due to severe vision or hearing problems 5. unwilling to provide consent or accept randomization into either study group
clinical validation of the renischem l-fabp poc assay

Conditions: Acute Kidney Injury; Contrast-induced Nephropathy

Summary: this study will involve measurement of levels of a novel urinary biomarker of renal ischemia, l-fabp. the purpose of the study is to perform a clinical validation of the ability of l-fabp measurements in urine using the renischem l-fabp poc test to predict the development of aki within 2 days following cardiac and vascular catheterization procedures involving exposure to radiocontrast media.

this study will validate the ability of the renischem l-fabp poc test to predict aki risk in patients undergoing cardiac catheterization and receiving iodinated contrast medium. contrast medium is known to be both vasoconstrictive and chemotoxic, which can lead to renal ischemia and, ultimately, aki. infusion of radiographic contrast agents, with the associated increases in osmotic load and viscosity, increases hypoxia of the renal medulla and increases renal free radical production through post-ischemic oxidative stress. earlier identification of contrast medium-induced acute kidney injury (ci-aki) risk can facilitate improved management of patients to prevent aki, for example, through selection of alternative imaging methods or contrast agents. subjects will be recruited prospectively based on pre-specified enrollment criteria. blood and urine samples will be collected after enrollment and at several timepoints, and various tests will be performed, including point-of-care l-fabp measurements on urine samples.

Eligibility criteria:
inclusion criteria: * patients age 18 or older on the day of the procedure * undergoing cardiac or vascular interventional procedures for diagnostic angiography, coronary intervention, tavr or tavi, with planned use of radiocontrast media within the next 30 days * able to provide informed consent * available to participate in follow-up visits * egfr \< 45 within the last 90 days, or * egfr \< 60 within the last 90 days with at least one (1) of the following risk factors: * diabetes * heart failure (acute or chronic) * anemia (hemoglobin \< 12 g/dl for females and \< 13 g/dl for males) within the last 90 days * age \> 75 on the day of the procedure exclusion criteria: * patient on dialysis or with egfr \< 15 within the last 30 days * history of renal transplant * current use of immunosuppressive drugs other than prednisone \< 10 mg/day * current clinically significant infection (including hiv, hepatitis) * presence of kdigo stage 1, 2, or 3 aki within the last 7 days, according to kdigo criteria * known or suspected nephritic or nephrotic syndrome. * a current post-renal etiology of renal impairment * known allergy or hypersensitivity to radiographic contrast dye that cannot be pre-medicated * females that are known to be pregnant or nursing * participation within the last 30 days in another clinical trial involving use of any drug known to affect aki and/or device known to affect aki

Keywords: l-fabp point of care
hypothermia and the effect of ambient temperature 2

Conditions: Hypothermia; Neonatal Outcome; Cesarean Section

Summary: neonatal hypothermia is associated with increased risk of mortality as well as multiple morbidities. the prior heat study conducted at our institution showed a difference in neonatal hypothermia with a change in ambient operating room temperature. the investigator's objective is to determine if an increase in ambient operative room temperature decreases the rate of neonatal morbidity. operating room temperature will be randomized to the current institutional standard of 20°c (67°f) or a temperature of 24°c (75°f), on a weekly basis for a period of 1.2 years.

this is an open, prospective, randomized, single center trial that will address the primary research question: does an increase in ambient operating room temperature result in a lower rate of composite neonatal morbidities? during the 1.2 year study period, the operating room temperatures on labor and delivery will be adjusted to either the current standard of care with ambient operating room temperature of 20°c (67°f), or the maximum temperature allowable per hospital policy in the current operating rooms, which is 24°c (75°f), as determined by cluster randomization. composite neonatal morbidities will be recorded including hypoglycemia necessitating treatment; need for respiratory support within the first 24 hours; culture-proven sepsis; and mortality. association of outcomes with the types of passive and active warming performed will include these morbidities stratified by gestational age as well as maternal outcomes. in addition, an electronic survey will be administered to the operating resident physicians to assess their experience with the study conditions.

Eligibility criteria:
inclusion criteria: * all pregnant women and their neonates undergoing cesarean delivery by the parkland hospital obstetrics service on the labor and delivery unit during the study period. exclusion criteria: * exclusion criteria include cases where a cesarean delivery is planned but a precipitous vaginal delivery occurs, intrauterine fetal demise has been diagnosed prior to start of surgery, the neonate is noted to have a major congenital anomaly and resuscitative efforts are not performed ("comfort care only" provided), or a neonatal temperature is not available.
this study is designed to evaluate pd/pk and safety of replagal manufactured by two different processes.

Conditions: Fabry Disease

Summary: this study is designed to evaluate safety and pk/pd in canadian fabry patients.

in 2008, a change in the agalsidase alfa drug substance manufacturing process was made. there are no changes to the drug product formulation, manufacturing site, manufacturing process, or container closure. an agalsidase alfa bioreactor manufacturing process (agalaf1) utilizing animal component-free media replaced the previous roller bottle (rb) process. this study is designed to provide pd/pk and safety data. the assessment schedule is designed to capture the pk profile of drug uptake in the blood as well the pharmacologic effect which manifests over the course of weeks. each patient will serve as his own control.

Eligibility criteria:
inclusion criteria: 1. the patient must be diagnosed with fabry disease using the following criteria: the patient is a hemizygous male with fabry disease as confirmed by a deficiency of α-galactosidase a activity measured in serum, leukocytes, or fibroblasts or has a confirmed mutation of the α-galactosidase a gene. 2. patient is male and between 18 and 65 years of age, inclusive. 3. patient must be willing to remain in the clinic as required by the study and comply with the procedures and evaluations of the study. 4. at the time of confirmation of study eligibility visit, patients must have received at least 26 weeks of treatment with rb replagal at a dose of 0.2 mg/kg administered iv eow. 5. patient provides informed consent. patients who are naive to ert: 1. treatment naive patients must have a pretreatment plasma gb3 level above the normal range (if value is available). exclusion criteria: 1. patient is unable to be venipunctured and/or tolerate venous access. 2. patient has tested positive for anti-agalsidase alfa antibodies either at screening or confirmation of eligibility visit. 3. patient had pre-ert plasma gb3 levels within the normal range (if value is available). 4. patient is participating in any other shire hgt investigational study. 5. patient is currently on dialysis, is expected to begin dialysis during the study, has received a kidney transplant, or is on the renal transplant waiting list. 6. patient is unable to comply with the protocol (eg, clinical relevant medical condition making implementation of the protocol difficult, unstable social situation, or otherwise unlikely to complete the study) or is, in the opinion of the investigator, otherwise unsuited for the study. 7. the patient is enrolled in another clinical study that involves clinical investigations or use of any investigational product (drug or device), except for the canadian fabry disease initiative, within 6 months prior to receiving the first dose of af replagal in this study or at any time during the study. 8. the patient has previously received af replagal prior to study entry.

Keywords: replagal
velcade (bortezomib, ps-341) and rituximab in relapsed/refractory mantle cell and follicular non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma

Summary: this study will determine the overall response rate and toxicity of rituximab and velcade in combination in patients with relapsed or refractory mantle cell non-hodgkin's lymphoma.

rationale: previous studies testing bortezomib and rituximab separately indicate these agents have some efficacy against mantle cell lymphoma (mcl). bortezomib is a targeted cancer drug that blocks proteasomes. the proteasome is an enzyme complex existing in all cells that influences proteins controlling cellular processes. by blocking the proteasome, bortezomib disrupts biologic pathways such as those related to the growth and survival of cancer cells. rituximab is a monoclonal antibody that attaches to a protein called the cd20 antigen that is found almost exclusively on the surface of b-cells with leukemia. once rituximab attaches to the protein, the immune system activates to kill the malignant b-cells. the current study combines bortezomib and rituximab in patients with relapsed or refractory mcl. purpose: this study will evaluate the safety and efficacy of bortezomib and rituximab in patients with relapsed or refractory mcl. blood, molecular, and tumor analysis will be conducted to provide researchers with information about areas such as rituximab resistance, the effects of bortezomib on cells associated with immune function, and protein alterations related to the cellular growth and death of mcl. in addition, the role of maintenance therapy and timing of administration in mcl will be assessed. treatment: patients in this study will receive bortezomib and rituximab. both drugs will be administered through intravenous infusions. there are two treatment periods in this study. the first is considered induction therapy where patients will receive bortezomib and rituximab intermittently over an eighteen week period. lower dosages of rituximab will be given to patients at the beginning of the study to ensure no severe toxicity occurs. those patients without disease growth after the eighteen weeks of treatments will continue with maintenance therapy. during this time period, patients will be given bortezomib and rituximab for up to one year and a half. several tests and exams will be conducted throughout the study to closely monitor patients. treatments will be discontinued due to disease growth or unacceptable side effects.

Eligibility criteria:
inclusion criteria: * histologically confirmed mantle cell or follicular lymphoma * relapsed or refractory disease * ecog (eastern cooperative oncology group) performance status of 0, 1, 2 or 3 exclusion criteria: * pre-existing sensory or motor peripheral neuropathy * no active or untreated cns (central nervous system) lymphoma * history of severe, life-threatening hypersensitivity or infusion reactions prior rituximab treatment.

Keywords: relapsed/refractory nhl follicular mantle cell non-hodgkin's lymphoma
targeted α-synuclein pet imaging in the diagnosis of multiple system atrophy

Conditions: Multiple System Atrophy - Cerebellar Subtype (MSA-C); Multiple System Atrophy - Parkinsonian Subtype (MSA-P)

Summary: the aim of this study was to apply the targeted α-synuclein pet study technique to investigate the pathological load and spatial distribution characteristics of α-syn in msa patients, and to assess its value as a biomarker for diagnostic typing, disease severity, and prognosis in msa.


Eligibility criteria:
inclusion criteria: * age\> 35 years old, gender is not limited; * clinically confirmed msa and clinically probable msa according to the 2022 mds msa diagnostic criteria; * all patients had been ruled out of polyq disease by genetic testing; * voluntarily participate in this study and sign the informed consent form. exclusion criteria: * pregnancy or breastfeeding; * contraindications to mri examination or inability to cooperate in completing neuroimaging examination; * previous history of other neurological disorders or presence of other organic intracranial lesions on neuroimaging that cannot be interpreted by msa, such as epilepsy, trauma, tumors, or high-grade cerebral white matter degeneration (fazekas grade 2 and above); * history of alcohol or drug abuse

Keywords: multiple system atrophy petct α-synuclein
the effect of the modified simulation model on self-efficacy, anxiety, and academic motivation in episiotomy training

Conditions: Episiotomy; Anxiety; Simulation

Summary: it was planned as a randomized controlled study to determine the effect of the modified simulation model on self-efficacy, anxiety and academic motivation in episiotomy training. it will be held online with students from the midwifery department of osmaniye korkut ata university.


Eligibility criteria:
inclusion criteria: * midwifery student * volunteers exclusion criteria: * involuntary

Keywords: episiotomy anxiety simulation
comparison of flat colorectal lesion detection by artificial intelligence-assisted colonoscopy versus endoscopists

Conditions: Flat Colorectal Lesion

Summary: the development of artificial intelligence (ai) systems in the field of colorectal endoscopy is currently booming, colorectal cancer being, by its frequency and severity, a real public health problem. in terms of image analysis, ai is indeed able to perform many tasks simultaneously (lesion detection, classification, and segmentation) and to combine them. lesion detection is thus the starting point of the whole chain to choose at the end the most appropriate treatment for the patient. large-scale studies have demonstrated the superiority of artificial intelligence-assisted detection over the usual detection by gastroenterologists, mainly for the detection of sub-centimeter polyps. however, the investigators have shown that a recent computer-aided detection system (cade) such as the endo-aid software in combination with the evis x1 video column (olympus, tokyo, japan) may present difficulties in the detection of flat lesions such as sessile serrated lesions (ssls) and non-granular laterally spreading tumors (lst-ngs). this represents a major challenge because in addition to their shape being difficult to identify for the human eye in practice and where ai assistance would be of great value, these rare lesions are associated with advanced histology. in addition, the investigators recently described the case of a worrisome false negative of ai-assisted colonoscopy, which failed to detect a flat adenocarcinoma in the transverse colon. therefore, it is important to measure the false negative rate of ai detection based on the macroscopic shape of the lesion. comparing this rate to the human endoscopist's false negatives would improve the performance of ai for this specific lesion subtype in the future.


Eligibility criteria:
inclusion criteria: * both gender patients even or older than 18 years old * patient with french health insurance coverage * obtaining of oral non opposition to research after loyal, clear and complete delivery of information * patients addressed to our center for colorectal lesion resection * patients presenting a colorectal lesion discovered during a diagnostic colonoscopy exclusion criteria: * patients with health disorders needing short procedure times * patients with no colorectal lesion * difficulty continuing colonoscopy due to poor sedation * difficulty continuing colonoscopy due to a serious adverse event * inappropriate participation after colonoscopy is completed * unwillingness to participate after colonoscopy is completed

Keywords: detection ai cad colorectal cancer lst adenoma ssl
european survey of cardiovascular disease prevention, diabetes and chronic kidney disease (euroaspire vi)

Conditions: Coronary Disease; Acute Coronary Syndrome; Unstable Angina; ST Elevation Myocardial Infarction; Non-ST Elevation Myocardial Infarction

Summary: the goal of this observational study is to provide a unique european picture of preventive action by cardiologists, other specialists and primary care physicians looking after patients with coronary heart disease (chd), individuals at high cardiovascular disease risk and all those with hypertension, dyslipidaemia (including familial hypercholesterolaemia), diabetes and dysglycaemia and chronic kidney disease (ckd) and determine whether the european guidelines on cardiovascular disease prevention, hypertension, lipids, diabetes and chronic kidney disease are being followed.

euroaspire is a multicentre european study in coronary patients and individuals at high risk of developing cardiovascular disease (cvd), describing their management through lifestyle and use of drug therapies and providing an objective assessment of clinical implementation of current scientific knowledge. five euroaspire surveys have been carried out by the european society of cardiology so far: euroaspire i in 1995-1997 in nine countries, euroaspire ii in 1999- 2000 in 15 countries, euroaspire iii in 2006-2009 in 22 countries, euroaspire iv in 2012-2015 in 26 countries and euroaspire v in 2016-2018 in 27 countries. this sixth euroaspire survey will investigate the cardiometabolic and renal continuum in both secondary and primary cardiovascular disease prevention in 2023-2025 under the auspices of the european society of cardiology, global registries and surveys programme (grasp). as in the previous euroaspire surveys this survey will be focused on hospital patients with chd, with and without diabetes mellitus, and apparently healthy individuals in primary care at high risk (hypertension, dyslipidaemia, diabetes) of developing cvd.

Eligibility criteria:
inclusion criteria: * patients having signed an informed consent * patients aged from 18 years old at the time of identification * at least six and at most 24 months elapsed between the index event (the recruiting diagnostic or treatment criteria below) and the date of interview * patients meeting the recruiting diagnostic or treatment criteria: * coronary patients: acute coronary events (acute coronary syndrome {stemi or nstemi}, unstable angina) or an emergency or elective revascularisation for coronary artery disease (cabg, pci) * high cardiovascular disease (cvd) risk patients: patients free of cvd, who have been prescribed one or more of the following treatments: blood pressure and/or lipid-lowering and/or glucose lowering (diet and/or hypoglycaemic agents and/or insulin) exclusion criteria: * patients living outside defined geographical areas * patients admitted to hospital from outside the geographical area or under the care of cardiologists in hospitals that do not participate in euroaspire vi
resiliency training for adolescent neurofibromatosis patients via videoconferencing with skype

Conditions: Neurofibromatoses

Summary: the aim of this research is to adapt the nf-specific adult version of the skype 3rp for use with adolescents, and to test its feasibility, acceptability, and preliminary effect in improving quality of life, and in decreasing stress and psychological distress.


Eligibility criteria:
inclusion criteria: 1. must be between the ages of 12 and 17 2. can read and speak english at or above the 6th grade level 3. diagnosis of neurofibromatosis type 1 or neurofibromatosis type 2 by a specialized medical provider exclusion criteria: 1. severe active or untreated major mental illness that would interfere with study participation, to be determined at the discretion of the study investigator (e.g. untreated psychosis or suicidality) 2. recent (within past 3 months) change in antidepressant medication 3. use of formal relaxation training (including past participation in a mind-body program), currently or in the past 6 months 4. unable or unwilling to sign the informed consent documents 5. unable or unwilling to participate in an intervention delivered via videoconferencing with skype