Kornimate/medical-research-clean huggingface dataset:
scan-rescan reproducibility of myelin sensitive mri techniques

Conditions: Myelin Integrity

Summary: this study is to assess the variation in the measurements of myelin sensitive mri techniques in both white and grey matter in the brain.

magnetization transfer imaging (mti) permits the assessment of the integrity of macromolecules in brain tissue, such as myelin and cellular/axonal membrane components. multi-echo susceptibility-based imaging (sbi) provides quantitative susceptibility maps and t2\* maps that - when combined - permit the disentanglement of myelin from iron and various phases of myelin degradation. myelin water imaging (mwi) quantifies the water trapped between myelin layers by separating the multiple water components in t2 relaxometry data. in fact, the presence of myelin on water pools bound to it provokes a loss in magnetic resonance (mr)-signal coherence, which is more rapid than the one characterizing the water pools located within the axons or in the cytoplasm. a method based on a spiral acquisition that achieves a myelin-specific signal in clinically compatible scan times is currently applied: t1 relaxometry (quantitative t1, qt1) - which measures the time that a perturbed nuclear spin distribution needs to get back to equilibrium in the longitudinal plane- is sensitive to a number of components of the brain tissue such as myelin, axonal diameter and the overall architectural organization of the brain tissue. finally, multi-shell diffusion allows the application of mathematical models of diffusion compartments, which in part are influenced by myelin integrity. the goal of this study is to assess the stability of these techniques in scan-rescan experiment on 20 healthy subjects.

Eligibility criteria:
inclusion criteria: * no neurological or psychiatric disorder exclusion criteria: * pregnancy * contraindication to mri (eg, claustrophobia, metallic implants, pacemaker etc). * inability to give consent.

Keywords: magnetization transfer imaging (mti) multi-echo susceptibility-based imaging (sbi) myelin water imaging (mwi) t1 relaxometry (quantitative t1, qt1) multi-shell diffusion myelin sensitive mri techniques
surveillance imaging modalities for breast cancer assessment

Conditions: Breast Cancer

Summary: the purpose of this study is to determine the effectiveness of surveillance breast mri compared to mammography alone in women with a personal history of breast cancer

our overall aim is to find out how well mri works compared with mammography for surveillance in women who have previously had breast cancer. specifically, our goals are to: 1. understand doctors' and patients' experiences with surveillance mammography and mri 2. provide evidence on which outcomes are more or less likely to occur 3. develop patient decision aids to help women and their doctors choose the surveillance method that is right for them how we will conduct the study: we will work with patients, doctors, policy makers, advocacy groups, and researchers to improve surveillance for women who have a personal history of breast cancer. through focus groups with patients and interviews with doctors, we will gain insights into women's experience with surveillance mammography and mri. we will also compare mammography to mri using data from the breast cancer surveillance consortium-the largest collection of breast cancer surveillance data in the nation. we will use data from more than 13,000 women diagnosed with breast cancer between 2005 and 2012 to determine how well each test works. we will measure the tests' effectiveness at finding second cancers, and estimate the likelihood of different outcomes. we will also determine whether one test appears to work better than the other to detect second breast cancers among different groups of women. we will then develop patient decision aids to help women and their doctors make more-informed choices about surveillance. what we hope to achieve: we hope this study will improve medical decision making and care for the 3 million women in the united states who have a history of breast cancer. specifically, our results will help women and their doctors make clearer, better choices about the surveillance method that is right for them.

Eligibility criteria:
inclusion criteria: surveillance imaging exams in women included in the breast cancer surveillance consortium who are 18+ years of age at the the of a stage 0-iii incident breast cancer diagnosis between january 1, 2005 and december 31, 2012. - exclusion criteria: * women with a diagnosis of lobular carcinoma in situ * women with missing cancer staging data from surveillance, epidemiology and end results (seer) program records * women with stage 4 breast cancer at time of diagnosis * women with a diagnosis of a second breast cancer event within six months of the primary diagnosis * women who die within six months of primary diagnosis * women who have had a double mastectomy

Keywords: breast cancer surveillance imaging comparative effectiveness
postoperative safety outcomes of intraoperative intracameral preservative-free moxifloxacin versus levofloxacin

Conditions: Cataract Senile; Endophthalmitis; Antibiotic Side Effect; Safety Issues

Summary: comparative safety study of intracameral levofloxacin versus moxifloxacin for postoperative infection prophylaxis

randomized clinical trial comparing corneal and retinal changes after intracameral levofloxacin or moxifloxacin administered at the end of surgery among eyes undergoing uncomplicated phacoemulsification.

Eligibility criteria:
inclusion criteria: * eyes undergoing uncomplicated cataract surgery by phacoemulsification exclusion criteria: * corneal opacities, corneal dystrophies, glaucoma, uveitis, retinopathy, optic neuropathy, concomitant infection (blepharitis, hordeolum, or conjunctivitis) or uncontrolled systemic disease and intraoperative complications that may affect visual outcomes were excluded from the study

Keywords: levofloxacin moxifloxacin prophylaxis endophthalmitis cataract surgery
gastropexy in the repair of patients with paraesophageal hernias

Conditions: Paraesophageal Hernia

Summary: patients scheduled for surgery for primary paraesophageal herniation are randomized to either conventional surgical hernia repair or with the addition of gastropexy.

patients scheduled for surgery due to primary paraesophageal herniation are randomized into either the control group or the interventional group. control group: patients undergo a crural repair combined with a short and floppy nissen fundoplication. interventional group: in addition to the crural repair and nissen fundoplication, patients receive a gastropexy. this involves the fixation of the posterior part of the wrap the right crus, the left portion of the wrap to the diaphragm, and the minor curvature of the stomach to the abdominal wall. follow-up assessments: imaging: computed tomography (ct) scans are performed before surgery and at 1 and 3 years postoperatively to evaluate anatomical outcomes. patient-reported outcomes: the following questionnaires are completed before surgery, as well as at 3 months, 1 year, and 3 years after surgery: sf-36: a global quality of life instrument. gsrs: the gastrointestinal symptoms rating scale. reflux frequency questionnaire: a measure reflux disease-related symptoms. dakkak's dysphagia score: an assessment of swallowing difficulties.

Eligibility criteria:
inclusion criteria: - patients diagnosed with a primary paraesophageal hernia (hiatal hernia types ii-iv) who are scheduled for elective or emergency surgical repair at participating centers exclusion criteria: * previous major upper gastrointestinal (gi) surgery, including prior hiatal hernia repair. * diagnosis of achalasia or any other significant esophageal motility disorder. * inability to understand the purpose of the study and/or inability or unwillingness to provide informed consent. * severe comorbidities, defined by an american society of anesthesiologists (asa) physical status score of greater than iii.
safety and pharmacokinetics study of hrs-1893 tablets in healthy subjects and those with impaired kidney function

Conditions: Hypertrophic Cardiomyopathy

Summary: the primary objective is to evaluate pharmacokinetics of hrs-1893 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.


Eligibility criteria:
inclusion criteria: 1. sign the informed consent before the trial, and fully understand the content, process and possible adverse reactions of the trial; 2. male or female subjects aged 18 to 65 (including 18 and 65); 3. body mass index (bmi) ranges from 19 kg/m2 to 28 kg/m2 (including 18 and 28); 4. the glomerular filtration rate should meet the following criteria (gfr, ml/min): subjects with mild renal impairment: 60-89 ml/min; subjects with moderate renal impairment: 30-59 ml/min. exclusion criteria: 1. suspected allergy to the study drug or any component of the study drug; 2. patients with cardiogenic shock, severe conduction block, sick sinus syndrome, heart failure, sustained tachyarrhythmia, torsades de pointes (tdp) or ventricular tachycardia, history of clinically significant t wave changes, myocardial infarction, angina pectoris; 3. people with conditions associated with reduced neuromuscular transmission (myasthenia gravis, lambert-eaton syndrome, duchenne muscular dystrophy); 4. patients with a history of gastric or intestinal surgery that may affect drug absorption; 5. participants with renal insufficiency who were judged by the investigator to be ineligible for the study; 6. patients with large fluctuations or rapid deterioration of renal function within 2 weeks before administration, as judged by the investigator; 7. subjects receiving renal replacement therapy within 3 months of the screening period or during the expected trial period; 8. within 3 months before screening, patients with underlying diseases that induced chronic kidney disease and were poorly controlled according to the investigator's evaluation.
trial of intravenous azithromycin to eradicate ureaplasma respiratory tract infection in preterm infants

Conditions: Ureaplasma Infections

Summary: the purpose of this study is to determine whether intravenous azithromycin is effective in eradicating ureaplasma respiratory tract infection in preterm infants born at 24 to 28 weeks gestation.

the study design will be a double-blind, placebo-controlled clinical trial to test the efficacy and safety of azithromycin 20 mg/kg x 3 days to eradicate ureaplasma spp from the respiratory tract of preterm infants 24 weeks 0 days to 28 weeks 6 days gestation exposed to positive pressure ventilation. the primary outcome will be survival with microbiological eradication of ureaplasma defined as survival to discharge or transfer with 3 negative cultures obtained post-therapy. secondary outcomes will include physiologic bpd at 36 weeks post-menstrual age (pma), overall mortality, incidence of co-morbidities of prematurity such as intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, bacterial and fungal nosocomial infection, pulmonary air leak, patent ductus arteriosus, retinopathy of prematurity, number of days of positive pressure ventilation, number of days of oxygen supplementation, use of postnatal steroids, and use of non-study antibiotics. at 6 and 18 months adjusted age, a pulmonary outcome questionnaire will be administered by phone or in person interview. at 18-22 months adjusted age, neurodevelopmental outcomes will be assessed by 1) bayley scale of infant and toddler development, 3rd edition (bsid-iii); 2) amiel-tison neurologic examination; 3) gross motor function classification system; and 4) medical record review for hearing impairment with or without amplification and vision impairment (vision \<20/200).

Eligibility criteria:
inclusion criteria: * gestational age 24 weeks 0 days-28weeks 6 days by best obstetrical estimate * \<72 h age * positive pressure ventilation for at least 1 hour duration during the first 72 hours of life * presence of indwelling intravenous line for drug administration exclusion criteria: * any patient judged to be non-viable or for whom withdrawal of life support is planned * patients with major lethal congenital anomalies * triplets or higher order multiples * patients delivered for maternal indications (low risk of ureaplasma colonization) * patients with ekg qt interval corrected for heart rate (qtc) ≥ 450 ms * patients with significant hepatic impairment (direct bilirubin \>1.5 mg/dl) * patients exposed to other systemic macrolide * patients with clinically suspected ureaplasma central nervous system (cns) infection or other confirmed bacterial/viral infection * patients participating in other clinical trials involving investigational products.

Keywords: ureaplasma parvum ureaplasma urealyticum prematurity bronchopulmonary dysplasia azithromycin
safety evaluation of clopidogrel sulfate in patients with stable angina/old myocardial infarction to whom percutaneous coronary intervention is being planned

Conditions: Stable Angina; Myocardial Infarction

Summary: primary objective: * to evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interest in patients with stable angina (sa) or old myocardial infarction (omi) to which percutaneous coronary intervention (pci) is being planned. secondary objectives: * to compare the incidence of adverse events, adverse drug reactions and bleeding events in patients treated with clopidogrel versus ticlopidine. * to compare the incidence of major adverse cardiac events (mace) and major adverse cardiac and cerebrovascular events (macce) in patients treated with clopidogrel versus ticlopidine. * to evaluate the long-term safety (adverse drug reactions, adverse events, safety events of interest and bleeding events) of clopidogrel for a total of 52 weeks; * to evaluate mace and macce of clopidogrel for a total of 52 weeks.

the study consisted of two periods: * a double blind treatment period of 12 weeks followed by, * an open label clopidogrel treatment period in a subset of patients. all patients should receive aspirin (81-100 mg once daily) as a background therapy during investigational product administration.

Eligibility criteria:
inclusion criteria: stable angina / old myocardial infarction patients who met all of the following criteria: * myocardial ischemic finding was proven within 2 months before randomization, * either ≥ 75% stenosis documented by cag or severe stenosis confirmed by multi-slice computerized tomography (msct) angiography within 1 month before randomization, * pci was being planned. exclusion criteria: * planned coronary artery bypass graft (cabg), emergent/urgent pci, or staged pci, * 3-vessel coronary artery disease with significant lesions in each vessel, * planned pci associated with 6 or more stent placements, * not less than 50% stenosis of the left main coronary artery, * chronic total occlusion (cto), * saphenous vein graft (svg). the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: old myocardial infarction platelet aggregation inhibitors angioplasty transluminal percutaneous coronary stents
effect of physical rehabilitation in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: this is a prospective study. the aim of this study is to investigate the effect of exercise retraining on cardiorespiratory parameters, postural balance, sociopsychological variables, and cognitive function in subjects with parkinson's disease. there will be two measurement sessions, one pre-intervention and one post-intervention (measuring cardiorespiratory parameters, evaluating dynamic and static postural balance, and assessing cognitive function).

this is a 12-week prospective study with the theme that i wish to develop in this context entitled "the effect of exercise retraining on cardiorespiratory parameters, postural balance, sociopsychological variables, and cognitive function in subjects with parkinson's disease". there will be two measurement sessions, one pre-intervention and one post-intervention (measuring cardiorespiratory parameters, evaluating dynamic and static postural balance, and assessing cognitive function). the recruited subjects will be randomly assigned to two groups: a control group and an experimental group. the subjects will be invited to attend the program three times per week. the control group will engage in an endurance training program, while the experimental group will participate in a combined endurance training and cognitive training program

Eligibility criteria:
inclusion criteria: * diagnosed with parkinson's disease according to the movement disorder society (mds) 2015 criteria. * mild to moderate stage according to the hoehn and yahr scale. * no hearing or visual impairments that could hinder the integration and implementation of the rehabilitation protocol. * has the ability to communicate and walk. * patient has been stable on treatment for 3 months. exclusion criteria: * a contraindication to engaging in cardiovascular physical activity * a montreal cognitive assessment score (moca ) of less than 24. * a current psychiatric disorder that could make it difficult or dangerous to adhere to the research protocol. * musculoskeletal impairments or excessive pain in any joint that could limit participation in an exercise program. * treatment with sedative medications

Keywords: "parkinson disease" "cognitive function" "postural balance" "physical rehabilitation"
movement disorders analysis using a deep learning approach

Conditions: Bradykinesia; Parkinson Disease; Hypokinesia; Akinesia; Parkinsonian Syndrome; Parkinsonian Disorders

Summary: bradykinesia is a key parkinsonian feature yet subjectively assessed by the mds-updrs score, making reproducible measurements and follow-up challenging. in a movement disorder unit, the investigators acquired a large database of videos showing parkinsonian patients performing movement disorder society-unified parkinson's disease rating scale (mds-updrs) part iii protocols. using a deep learning approach on these videos, the investigators aimed to develop a tool to compute an objective score of bradykinesia from the three upper limb tests described in the movement disorder society-unified parkinson's disease rating scale (mds-updrs) part iii.


Eligibility criteria:
inclusion criteria: * age \> 18 years exclusion criteria: * refusal of participation

Keywords: deep learning bradykinesia parkinson disease
care after resuscitation

Conditions: Cardiac Arrest

Summary: the purpose of this study is to investigate whether simple psychological interventions can be implemented at the essex cardiothoracic centre (ctc) with a view to supporting the psychological wellbeing of survivors of cardiac arrest during their recovery.

at the essex cardiothoracic centre (ctc) the follow up of patients surviving cardiac arrest demonstrated that standard psychological support arrangements for patients and their families/relatives were inadequate. the purpose of this study is to investigate simple psychological interventions can be implemented here at the essex ctc with a view to supporting the psychological wellbeing of survivors of cardiac arrest during their recovery. the investigators propose to recruit 2 groups of patients. the first group will be chosen from patients who have already survived a cardiac arrest \> 3 months prior to the start of the study. participants in this group (patient and a relative/friend) will be invited to attend an outpatient clinic at the essex ctc with members of the research team. the investigators will record general physical health condition and psychological wellbeing, using recommended questionnaires. a referral to onsite consultant psychiatrist will be offered to anyone expressing signs of severe depression. the second group will be recruited from patients who survive cardiac arrest from the start of study date. participants in this group (patient and a relative/friend) will be approached by a member of the research team whilst in hospital and an informed consent will be obtained. baseline data will be acquired using the recommended questionnaires and a supportive psychological intervention will be offered in the form of a dedicated telephone helpline, attendance at a cardiac arrest clinic and early referral to clinical psychiatrist if appropriate for psychological help. at around 6 months from the date of cardiac arrest, participants will be invited to attend a clinic to reevaluate post cardiac arrest care using the same recommended questionnaires. at the end of the study, the data between the 2 groups will be analysed.

Eligibility criteria:
inclusion criteria: * anyone surviving cardiac arrest * age greater than or equal to 18 yrs * cerebral performance category (cpc) 1-2 at the time of discharge from hospital * english speaking * able to give informed consent exclusion criteria: * age less than 18yrs * cpc 3-5 at the time of discharge from hospital * non-english speaking * unable to give informed consent

Keywords: cardiac arrest psychological intervention
the additive anti-inflammatory effect of simvastatin in combination with inhaled corticosteroids on p38 mapk in asthma

Conditions: Asthma

Summary: to test whether simvastatin has an additional anti-inflammatory effects on p38 mapk, a signaling molecule for inflammation in inhaled steroid-treated asthmatics.


Eligibility criteria:
inclusion criteria: * mild-to-moderate persistent asthmatics * fev1 = or \> 50% of predicted exclusion criteria: * previous history of renal disease or serum creatinine is more than 2 mg/dl. * previous history of liver disease. * pregnancy or lactation. * are already receiving or are known to be allergic to statins or to have developed myositis. * have an asthma exacerbation requiring treatment with oral corticosteroids during the 3 months prior to the commencement of study entry. * being treated with immunosuppressive agents. * unwilling to cooperate the study.

Keywords: moderate persistent asthma inhaled corticosteroids