Kornimate/medical-research-clean huggingface dataset:
a prospective, contralateral, eye to eye comparison of smile surgery to lasik surgery

Conditions: Myopia

Summary: subjects will undergo smile surgery in one eye and lasik surgery in their other eye to correct myopia.

subjects will have a comprehensive eye examination once they express an interest in the study. this includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. if there is any pathology noted that would exclude the subject from the study, then we will inform the patient and make an appropriate referral. if the subject is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. subjects will undergo bilateral simultaneous eye surgery. which eye is treated with the wfg-lasik and which eye is treated with smile will be randomized so there is a 50% chance for either eye to receive one treatment. subjects will be seen on the day of surgery, post op day one, one week, one month, three months, six months and one year. subjects will receive topical antibiotics in each eye for one week following the procedure. subjects will receive topical steroid ophthalmic drops for one week after treatment. subjects will also receive topical antibiotic ophthalmic drops for four days after treatment. all of this is within the usual and customary standard of care for the treatment of subjects undergoing lasik and smile surgery.

Eligibility criteria:
inclusion criteria: * subjects age 22 and older with healthy eyes. nearsightedness between -0.75 diopters and -8.00 diopters. * subjects with up to 3.00 diopters of astigmatism. exclusion criteria: * subjects under the age of 22. * subjects with excessively thin corneas. * subjects with topographic evidence of keratoconus. * subjects with ectatic eye disorders. * subjects with autoimmune diseases. * subjects who are pregnant or nursing. * subjects must have similar levels of nearsightedness in each eye. they can not be more than 1.5 diopter of difference between eyes. * subjects with 3.25 or more diopters of astigmatism * subjects must have similar levels of astigmatism in each eye. they can not have more than 0.50 diopters of difference between eyes.

Keywords: smile lasik myopia wavefront-guided
a composite assay for her2-positive early-stage breast cancer management

Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3); HER2

Summary: the goal of this observational study is to assess the prognostic value of a genomic classifier (s18) and its refined version (s\*) in women with early-stage her2-positive breast cancer. the study aims to determine whether these tools can predict event-free (efs) and disease-free survival (dfs) in patients treated with neoadjuvant and/or adjuvant trastuzumab-based therapies.

the population includes women aged 18 or older with stage i-iii her2-positive breast cancer who received trastuzumab ± pertuzumab. data and tumor tissue samples from this population have been collected prospectively from istituto nazionale dei tumori irccs fondazione pascale, naples (cohort a), and from ospedale "di summa-perrino", brindisi (cohort b). the study integrates clinical-pathological and genomic data to refine and validate the prognostic capabilities of the s18 classifier.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. operable breast cancer (stage i-iii) 3. any status of hormone receptor in the primary tumor, according to institutional guidelines 4. her2-positive primary tumor, according to asco guidelines, i.e., her2-positive phenotype by immunohistochemistry (ihc) 3+ or 2+ with a positive result for erbb2 gene amplification analysis using ish techniques (cish, sish, fish) 5. neoadjuvant and/or adjuvant therapy based on trastuzumab ± pertuzumab 6. written informed consent from patients exclusion criteria: 1. patient in follow-up for less than 3 years after surgery 2. a prior diagnosis of invasive cancer before the diagnosis of breast cancer

Keywords: her2-positive operable breast cancer gene-expression based classifier prognosis
immunoglobulin g therapy dose optimization

Conditions: Obesity; Immune Deficiency

Summary: the overall goal of this proposal is to investigate effects of obesity on pharmacokinetics of immunoglobulin g (igg) and to develop strategies for optimization of dosing of igg in obese patients. there is an ongoing debate regarding the most appropriate dosing of igg formulations in obese patients. obesity poses significant health risks; and evidence supporting dosing strategies of igg in obese patients is inadequate. some of the adverse reactions have been attributed to a relative overdosing in these patients, due to a limited distribution of igg into fat tissue.

the estimated prevalence of overweight and obese individuals \>20 years in the us is 154.7 million (nearly double since the early 1960s), and over 1.6 billion people are considered overweight or obese worldwide. compounding the health risks associated with obesity is the insufficient data supporting dosing strategies for a variety of medication used to treat conditions encountered in obese patients. no consensus on the best dosing strategy for igg in obese patients has been established. total (tbw), ideal (ibw), and adjusted (adjbw) body weight-based dosing are being utilized by different institutions. thus, there is an urgent need to identify evidence supporting optimal dosing strategies for igg. it has been proposed that using tbw to dose igg in obese patients may increase the risk of thrombosis owing to increased blood viscosity, activation of platelets, or vasospasm; and the increase in blood viscosity has been reported as igg dose dependent. the use of using ibw or adjbw has been advocated to reduce the side effect and drug expenditures. it is currently unknown what the clinical impact is of using measures of body weight other than tbw to calculate igg doses, and the effect of obesity on igg pharmacokinetics has not been experimentally evaluated.

Eligibility criteria:
inclusion criteria: * aged 18 to 75 years * currently treated with ivig exclusion criteria: * liver impairment (elevations in liver enzymes of greater than 3 times the upper limit of normal) * reduced renal function (crcl \< 50 ml/min) * patients with a pacemaker or an automatic implantable cardioverter-defibrillator

Keywords: pharmacokinetics obesity primary immune deficiency chronic inflammatory demyelinating polyneuropathy
rigid corset immobilisation of patients suffering from spondylodiscitis: practice assessment

Conditions: Management of Spondylodiscitis

Summary: our study is a survey of the current management of patients suffering from spondylodiscitis.

our main objective was to describe the use of rigid corsets to immobilise patients with spondylodiscitis in hospital, by asking doctors about their practices. the secondary objectives are : * to describe the use of rigid corsets to immobilise patients suffering from spondylodiscitis in hospital by asking paramedical staff about the way in which medical prescriptions were implemented and patients about their compliance. * to measure the rate of satisfaction and understanding of patients treated with a corset. * to detail the different ways in which doctors and paramedical staff manage patients hospitalised for spondylodiscitis, depending on their age, training, speciality and the department in which they work.

Eligibility criteria:
inclusion criteria: for patients: * patients aged over 18, * patients hospitalised at clermont-ferrand university hospital with infectious spondylodiscitis, * patient willing to be interviewed. for care workers: - doctors, nurses or care assistants involved in the care of patients hospitalised with spondylodiscitis. exclusion criteria: for patients : * minor patients, * patients wearing a corset for a non-infectious spinal pathology, * patient refusing to take part in the study. for care workers: - doctor, nurse or nursing auxiliary refusing to take part in the study.

Keywords: spondylodiscitis corset spinal infection vertebral disc spinal bodies practical assessment
rizatriptan 5 mg and 10 mg, sumatriptan 100 mg, and placebo comparison study (0462-030)

Conditions: Migraine Headache

Summary: a study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine attacks and duration of relief provided. this study will also provide additional efficacy data on rizatriptan 5 mg and 10 mg for the treatment of migraine.


Eligibility criteria:
inclusion criteria: * patient had at least a 6-month history of migraine, with or without aura * patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions. * patient was judged to be in good health, apart from migraine exclusion criteria: * patient was pregnant or a nursing mother * patient had abused drugs or alcohol within 12 months prior to entering the study * patient had a history of cardiovascular disease * patient had clinically significant electrocardiography (ecg) abnormality * patient had a resting systolic blood pressure of greater than 145 mm hg or diastolic of less than 95 mm hg at screening * patient received treatment with an investigational device or compound within 30 days of the study start * patient typically suffered from less then 1 or more than 8 attacks of migraine per month * patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches * patient had hypersensitivity to sumatriptan * patient had participated in any previous study involving rizatriptan
effects of body position and recruiting maneuver on lung aeration assessed through ultrasound in patients intubated for acute respiratory failure related to novel coronavirus 19 disease

Conditions: Acute Respiratory Failure

Summary: second analysis of data prospectively collected during an investigation assessing the clinical characteristics of patients admitted for hypoxemic acute respiratory failure (harf) related to novel coronavirus 19 disease (covid-19). in particular, the primary aim of the present analysis is to assess the effects of recruiting maneuver and prone positioning on lung aeration evaluated through lung ultrasound in patients undergoing invasive mechanical ventilation


Eligibility criteria:
inclusion criteria: patients intubated for covid-19 harf - exclusion criteria: any contraindication to recruitment and lung ultrasound, pregnancy -
clinical trial evaluating low dose g-flip plus mitomycin c for stage iv pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the study focuses on advanced metastatic pancreatic cancer, testing a combination of low-dose anti-cancer drugs (g-flip: gemcitabine, fluorouracil, leucovorin, irinotecan, and oxaliplatin) with the addition of mitomycin c. the aim is to find a safer and more effective therapy for this devastating disease.

objective: evaluate the safety, tolerability, and efficacy of g-flip combined with mitomycin c for advanced pancreatic cancer. design: open-label study with 60 evaluable subjects. treatments: g-flip administered every 2 weeks, with mitomycin administered every 4 weeks. efficacy assessments: based on response criteria (complete response, partial response, stable disease, progressive disease), response rate, progression-free-survival, overall survival, and 12-month survival rate. safety assessments: include physical exams, symptom evaluation, vital signs, ecog performance status, clinical pathology, urinalysis, and quality of life assessments.

Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic (stage iv) pancreatic adenocarcinoma. * failed first-line chemotherapy. * ecog performance status of 0-2. * expected survival of more than 3 months. * adequate organ function as indicated by lab values. * age 18 or older. * signed informed consent. exclusion criteria: * • known brain metastases. * significant cardiovascular or other uncontrolled diseases. * pregnant or breastfeeding women

Keywords: pancreatic low dose
rasagiline in advanced parkinson's disease patients with motor fluctuations treated with levodopa/carbidopa therapy.

Conditions: Parkinson's Disease

Summary: study to look at the effectiveness, tolerability and safety of two doses of rasagiline (0.5 mg and 1mg) in advanced parkinson's disease (pd) patients who have been treated with levodopa/carbidopa therapy.


Eligibility criteria:
inclusion criteria: * patients must have completed the week 26 visit of tvp 1012/133 (visit 06) in accordance with the protocol. * women must be postmenopausal, surgically sterile, or using adequate birth control methods. women of childbearing potential must have a negative pregnancy test at baseline/month 0. * patients must be willing and able to give informed consent. exclusion criteria: * serious or severe, test drug-related (probable or definite) adverse reaction in study tvp 1012/133. * premature discontinuation from study tvp 1012/133 for any reason. * a clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. such conditions may include cardiovascular, pulmonary hepatic, renal, metabolic diseases or malignancies as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or ecg.
changes in sleep patterns and stress in infants entering child care

Conditions: Sudden Infant Death Syndrome

Summary: when babies start day care, they experience many changes, some of which may affect their risk for sudden infant death syndrome (sids). the investigators want to find out if stress or change in the baby's sleep patterns can be a reason for this increased risk for sids.

the overall aim of this study is to describe sleep patterns in infants as they transition from home to child care, including 24-hour sleep duration, changes in the timing of daytime naps, and changes in nocturnal sleep periods; to describe potential sleep disrupters, such as temperature, light and noise, in home and child care settings that may impact sleep quality and sleep patterns; to describe markers of parent and infant stress levels during the transition to child care; to describe markers of infant circadian rhythm during the transition to child care.

Eligibility criteria:
inclusion criteria: * infants who are less than 3 months of age from english-speaking families where one or both parents live in the household will be eligible to participate. if the infant will be entering child care, the infant must be entering a licensed child care center, and child care entry must be between 60 and 120 days of age. exclusion criteria: * s/he was born prematurely, with a gestational age less than 37 weeks at birth, or had a birth weight \<2500 grams (5-1/2 lbs) * s/he has any medical problems that require ongoing care by a subspecialty physician

Keywords: sudden infant death syndrome sids infant licensed day care sleep patterns stress levels
bay58-2667 dose finding trial investigating fixed doses in patients with acute decompensated chronic congestive heart failure (adhf)

Conditions: Acute Heart Failure

Summary: a placebo controlled, double-blind and randomized study to assess different doses of a new drug (bay58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.


Eligibility criteria:
inclusion criteria: * male and non-pregnant, non-lactating female subjects, age \>/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy * subjects must have the clinical diagnosis of chf made at least three months prior to enrollment * subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study: * dyspnea and * clinical evidence of volume overload exclusion criteria: * acute de-novo heart failure * acute myocardial infarction and/or myocardial infarction within 30 days * valvular heart disease requiring surgical intervention during the course of the study * heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease * primary hypertrophic cardiomyopathy * acute inflammatory heart disease, eg, acute myocarditis * unstable angina requiring angiography

Keywords: heart failure
cardiac resynchronisation therapy in patients with heart failure: mechanistic insights from cardiac mri and electroanatomical mapping

Conditions: Heart Failure

Summary: cardiac resynchronisation therapy (crt) is a specialist pacemaker procedure that aims to improve the efficiency of the heartbeat. this treatment is used routinely in patients with heart failure and a delay in electrical conduction across the heart seen on the surface ecg (heart tracing). the investigators aim to assess acute response to crt and compare different methods of delivering crt using hemodynamic data from invasive dp/dtmax and electroanatomical data from either invasive mapping or non-invasive body surface mapping.


Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * male or female, aged 18 years or above. * either 1) has crt system in situ or 2) has a planned crt system implant or 3) has a planned upgrade to crt from a standard pacemaker * nyha grade ii-iv heart failure * lvef\<35% * intrinsic qrs duration \>120ms * on optimum medical therapy for heart failure * female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter * able (in the investigators opinion) and willing to comply with all study requirements. * willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the study. exclusion criteria: * female participants who is pregnant, lactating or planning pregnancy during the course of the study. * scheduled elective surgery or other procedures requiring general anaesthesia during the study. * participant who is terminally ill or is inappropriate for placebo medication * any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. * rate uncontrolled atrial fibrillation precluding a cmr * significant peripheral vascular disease precluding an ep study * a contraindication to anticoagulation * a prosthetic aortic or tricuspid valve * significant aortic valve disease * known lv thrombus * insufficient capacity to consent to the study
a study of pertuzumab in addition to chemotherapy and trastuzumab as adjuvant therapy in participants with human epidermal growth receptor 2 (her2)-positive primary breast cancer

Conditions: Breast Cancer

Summary: this randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable her2-positive primary breast cancer. this study will be carried out in collaboration with the breast international group (big).


Eligibility criteria:
inclusion criteria: * non-metastatic operable primary invasive her2-positive carcinoma of the breast that is histologically confirmed, and adequately excised * eastern cooperative oncology group (ecog) performance status less than or equal to (\</=) 1 * known hormone receptor status (estrogen receptor and progesterone receptor) * the interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days). the first cycle of chemotherapy must be administered within 7 days of randomization or on day 56, whichever occurs first * baseline left ventricular ejection fraction (lvef) greater than or equal to (\>/=) 55 percent (%) measured by echocardiogram (echo) or multiple-gated acquisition (muga) scan * confirmed her2 positive status * completion of all necessary baseline laboratory and radiologic investigations prior to randomization * women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the participant and/or partner for the duration of the study treatment and for at least 7 months after the last dose of study drug exclusion criteria: * history of any prior (ipsi- and/or contralateral) invasive breast cancer * history of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin * any "clinical" t4 tumor as defined by primary tumor/regional lymph nodes/distant metastasis (tnm), including inflammatory breast cancer * any node-negative tumor * any previous systemic chemotherapy for cancer or radiotherapy for cancer * prior use of anti-her2 therapy for any reason or other prior biologic or immunotherapy for cancer * concurrent anti-cancer treatment in another investigational trial * serious cardiac or cardiovascular disease or condition * other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness * abnormal laboratory tests immediately prior to randomization * pregnant or lactating women * sensitivity to any of the study medications or any of the ingredients or excipients of these medications
effects of vitamin d and omega-3 supplementation on telomeres in vital

Conditions: Aging

Summary: the vitamin d and omega-3 trial (vital; nct 01169259) was a randomized clinical trial in 25,871 u.s. men and women investigating whether taking daily dietary supplements of vitamin d3 (2000 iu) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. this ancillary study is being conducted among participants in vital-ctsc cohort and will examine whether vitamin d or fish oil supplementation has beneficial effects on cellular aging.

this project is an ancillary study based on the parental study "the vitamin d and omega-3 trial (vital; nct 01169259)" at the harvard clinical and translational science centre (ctsc) and brigham and women's hospital. our research focuses on the separate and synergistic effects of vitamin d and omega -3 supplements on telomere length, a cellular aging marker, using de-identified samples from vital-ctsc cohort. aims: 1) to test the hypothesis that vitamin d supplementation decreases leukocyte telomere length attrition. the investigators will determine the effect of vitamin d supplementation on telomere length attrition over time (baseline, year 2, and year 4); 2) to test the hypothesis that marine omega-3 fatty acid supplementation decreases ltl attrition. the investigators will determine the effect of marine omega-3 fatty acid supplementation on telomere length attrition over time (baseline, year 2, and year 4); 3) to determine to what extent the effects of vitamin d or omega-3 supplementation on inflammatory cytokines and cvd risk factors are mediated by telomere length attrition over time; 4) to explore the synergistic effects vitamin d and omega-3 fatty acid supplementation.

Eligibility criteria:
inclusion criteria: the subcohort of 1,054 participants in vital (nct 01169259) who are receiving detailed health assessments at a clinical and translation science center at boston are eligible to participate in this ancillary study: - exclusion criteria: none -

Keywords: vitamin d, omega-3 fatty acid, telomere length, inflammation