Kornimate/medical-research-clean huggingface dataset:
feasibility study of stereotactic body radiotherapy for early breast cancer

Conditions: Breast Neoplasm

Summary: most women with early breast cancer are treated with breast conserving therapy (bct), consisting of breast conserving surgery (surgery to remove the cancer itself) followed by radiation to the breast. this treatment can take time and is associated with its own side effect profile. an innovative radiation technique called stereotactic body radiotherapy (sbrt) can deliver large doses of radiation precisely to the tumour while avoiding critical organs, therefore destroying the cancer and avoiding surgery altogether. sbrt has been successfully used for a number of cancers and it is proposed that it could be used to eradicate breast cancer. this feasibility study will investigate the feasibility and safety of treatment using sbrt in women with early stage breast cancer. thirty-two women age 70 years or older with early breast cancer will be treated with sbrt (5 treatments) followed by breast conserving surgery and hormonal therapy. an mri and breast conserving surgery will be performed at 8-12 weeks after radiation to assess response to treatment. the primary outcome of the study will be feasibility, meaning the ability to deliver radiation treatment as planned. secondary outcomes will include treatment related toxicity and pathological response. if this study shows that sbrt can be used to treat patients primarily, it will lead to further evaluation of sbrt for early breast cancer.


Eligibility criteria:
inclusion criteria: * women age ≥ 70 years; * new histological diagnosis of invasive carcinoma of the breast, grade i or ii, estrogen and progesterone receptor (er and pr) positive, her2 negative on needle biopsy and limited to stage i (t1 n0 m0) on clinical and radiological assessment with mri of the breasts and axillary ultrasound; * candidate for breast conserving surgery; * signed study consent form completed prior to study entry. exclusion criteria: * breast cancer with disease within 5 mm from skin or chest wall; * previous or concomitant invasive malignancies treated within 5 years of study entry; * serious non-malignant disease (cardiovascular, pulmonary, systemic lupus or scleroderma), which would preclude to definitive radiation therapy; * psychiatric disorders, which would preclude from obtaining informed consent * geographic inaccessibility for follow-up

Keywords: feasibility study early breast cancer stereotactic body radiotherapy cyberknife pre-operative radiotherapy
identification of cerebrospinal fluid with injeq iq-needle during paediatric lumbar puncture

Conditions: Pediatric Lumbar Puncture

Summary: this is clinical feasibility study on the device performance with paediatric patients. the main objective is to validate the performance of investigational device in distinguishing and identifying the cerebrospinal fluid (csf) inside the subarachnoid space during a lumbar puncture on paediatric patients.


Eligibility criteria:
inclusion criteria: * children whose diagnosis or treatment plan requires lumbar puncture to acquire a csf sample. * consent from the parents exclusion criteria: * being a high risk patient (as determined by the investigator) * any contraindication to a common lumbar puncture apply also in the investigation
levetiracetam for painful polyneuropathy

Conditions: Painful Polyneuropathy

Summary: polyneuropathy of different etiologies is often associated with pain. the standard treatment of this pain is anticonvulsants or antidepressants, but none of these treatment are effective or tolerable for all patients. levetiracetam is a newer anticonvulsant and it is the hypothesis is that it could relieve neuropathic pain in polyneuropathy. this is a randomised, double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3.000 mg/day on pain in polyneuropathy


Eligibility criteria:
inclusion criteria: * age 20 to 0 years * painful symptoms of polyneuropathy for at least 6 months * confirmed diagnosis of polyneuropathy * baseline pain score of 4 or more (0 to 10 point scale) * pain at least 4 days a week * adequate anticonceptive treatment for women with childbearing potential * informed consent exclusion criteria: * other cause of pain * previous allergic reactions towards levetiracetam * known adverse drug reactions on levetiracetam * pregnancy * severe disease * inability to follow study protocol * treatment with antidepressants, other anticonvulsants or opioids

Keywords: polyneuropathy neuropathic pain levetiracetam
macs and healthy volunteers bone study

Conditions: MACS Syndrome

Summary: adrenal adenoma is detected in 5-7% of adults and demonstrates mild autonomous cortisol secretion (macs, dexamethasone suppression test \>1.8 mcg/dl) in 50% of individuals with adenoma. published reports suggest a 48%-52% 2-year incidence of new vertebral fractures in patients with macs without any significant changes in bone density measurements. a disproportionate decrease in bone quality versus density or other factors such as sarcopenia potentially contribute to development of new vertebral fractures. determining which specific abnormalities in the steroid metabolome affect bone density, quality and strength as well as bone remodeling markers and body composition will potentially serve as a diagnostic biomarker of clinical significance.

in this study, we will determine whether patients with macs (versus healthy age and sex matched controls) demonstrate: 1) decreased bone strength and quality disproportionate to the decrease of bone density and 2) abnormalities in the steroid metabolome correlate with the degree of abnormalities in bone parameters. in a cross-sectional study of 75 patients with macs and 75 age- and sex-matched healthy controls, we will determine the relationship of the steroid metabolome to measurements of bone density, quality and strength, bone turnover markers, as well as body composition. all patients will be interviewed in regards to their health, to include questions on bone health, frailty, cognition (nih toolbox), and quality of life. we will measure 1) bmd (bone mineral density) at the lumbar spine, hip and radius and body composition using dual-energy x ray absorptiometry (dxa), 2) radial and tibial bone microstructure by high-resolution peripheral quantitative computed tomography (hr-pqct), 4) bone turnover markers (osteocalcin, pinp, ctx, sclerostin). 5) age reader measurement, 6) hand grip measurement, 7) 6 minute walk test. all patients will provide a 24 h urine for steroid metabolome analysis. for primary outcomes, we will determine if steroid metabolome profiling better predicts abnormal bone strength (as measured by trabecular bone volume/tissue volume \[bv/tv\] ratio).

Eligibility criteria:
inclusion criteria: * patients with macs * age 18-no maximum * exogenous steroids therapy within the last 5 years ( for more than 3 months , prednisone equivalent \>7.5 mg daily) * steroid hormone replacement therapy * any drug therapy affecting bone metabolism * recent fracture exclusion criteria: * exogenous steroids therapy within the last 5 years ( for more than 3 months , prednisone equivalent \>7.5 mg daily) * steroid hormone replacement therapy ( for adrenal insufficiency, hypogonadism, menopause) * therapy for osteoporosis * any drug therapy affecting bone metabolism * comorbidities affecting steroid metabolome or bone metabolism * recent fracture
dysphagia, qol and attitudes towards peg in als patients

Conditions: Amyotrophic Lateral Sclerosis

Summary: in amyotrophic lateral sclerosis, dysphagia has a high incidence. with deterioration of swallowing function, percutaneous endoscopic gastrostomy (peg) tube is recommended to ensure sufficient and safe oral intake. dysphagia and peg placement alter quality of life (qol). however, qol and attitudes toward peg remain largely unexplored. the purpose of this study is to monitor the swallowing function in relationship to qol and attitudes toward peg tube insertion and feeding.

the purpose of this study is to monitor the deterioration of swallowing function in als patient population, and to explore its impact on qol and attitudes toward peg tube insertion and feeding in the course of the disease. it will take maximum of 60 minutes to fully evaluate the swallowing function and complete the questionnaires. the evaluation procedure will be repeated every 3 months until peg tube insertion, which will allow us to closely monitor the swallowing function in a relation to attitudes toward peg and qol. the data obtained from this study should contribute significantly to the knowledge of qol in als patients with dysphagia, and it will allow for a comparison of qol in als patients with and without peg tube. this study will also expand the understanding of attitudes in als patients and their relatives toward peg, and the impact of those attitudes on the decision-making process.

Eligibility criteria:
inclusion criteria for patients: * 18 years of age or older * diagnosis of als * follow-up at university medical centre ljubljana, division of neurophysiology, every 3 months * be able to visit the study site for in-person procedures every 3 months inclusion criteria for relatives: * at least 18 years of age exclusion criteria for patients: * co-existing illness or disorder that could influence the swallowing function independently of the als diagnosis * clinically significant cognitive deterioration or dementia at enrollment, as determined by the als study neurologist exclusion criteria for relatives: * signs of probable cognitive deterioration or dementia at enrollment
one year outcome after robotic assisted laparoscopic sacral colpopexy, a case series review

Conditions: Pelvic Organ Prolapse; Urinary Incontinence

Summary: robotic approach to sacral colpopexy is a relatively new procedure. the literature is scarce in regard to its long-term outcomes. this advanced procedure is offered at mmh through the urogynecology division. the investigators setup to review the one year outcome of patients who underwent this procedure using a polypropylene mesh. these outcomes will include anatomical and quality of life measures.


Eligibility criteria:
inclusion criteria: * any robotic assisted laparoscopic sacral colpopexy with polypropylene mesh during the study period exclusion criteria: * other graft material than polypropylene. * enrollment in a different study.

Keywords: uterine prolapse vaginal prolapse mesh erosion urinary incontinence bowel symptoms
topical ruxolitinib lichen planus

Conditions: Lichen Planus

Summary: to evaluate the safety and efficacy of incb018424 phosphate cream in cutaneous lp as assessed by the change in physician global assessment (pga), body surface area (bsa), index treatment and control lesion by clinical assessment scale of severity for index lesion signs and symptoms (cails) score, pruritus numerical rating scale (nrs), and skindex-16. to predict responses through the identification of unique biomarkers of lp at week 0 and utilizing rna sequencing on responsive and non-responsive tissue at week 4.

this is a single center, exploratory, open-label, single-arm design study of 12 patients. treatment naïve and treatment refractory patients with lp will be treated with incb018424 phosphate cream. patients who are non-responders, to physician choice standard of care, will undergo a washout period and will be enrolled in the study. the study consists of 3 epochs: screening/washout period (of at least 1 week and up to 4 weeks), treatment epoch (of 8 weeks from screen/washout), and follow up epoch (of 4 weeks). the screening and washout period will allow for treatment naïve/ new diagnosis lp to undergo evaluation and diagnosis and for treatment refractory to undergo a washout. the total duration of the study will be 13-16 weeks.

Eligibility criteria:
subjects must be able to understand and comply with the requirements of the study and communicate with the investigator. subjects must give written, signed, and dated informed consent before any study related activity is performed. when appropriate, a legal representative will sign the informed consent according to local laws and regulation both men and women must be at least 18 years of age at the time of screening subjects must have clinical and histological features of lp lp must involve between 2 and 20% of the bsa subjects must have a minimum of 10 lesions of lp subjects must have treatment naive cutaneous lp or treatment refractory disease, as defined by failure of at least one established treatment for lp failure of prior therapy topical treatment systemic immunosuppressant oral metronidazole oral sulfasalazine oral retinoid
magnetic resonance imaging (mri) and decline of aging aviator performance

Conditions: Age-related Cognitive Decline

Summary: the primary purpose of this study is to apply state-of-the-art magnetic resonance imaging (mri) and magnetic resonance spectroscopic imaging (mrsi) techniques to measure changes over time in the brain.

we expect that mri and mrsi techniques will be a useful adjunct in research efforts to understand individual differences in performance of a complex attention-demanding task, such as flying a plane or driving a car. other predictors of change in performance of a complex task may include simple tests of processing speed and working memory, past training and recent practice of the task, and genetic risk factors for degenerative brain disease. in this project, we will examine whether baseline mr measures are as useful as longitudinal mr measures in predicting amount of change over time in task performance. this research is part of a long-term effort to achieve earlier identification of individuals at risk of decline and ultimately minimize loss of function.

Eligibility criteria:
inclusion criteria: * subjects will be included if they have participated in the protocol "age-related longitudinal changes in aviator performance" and agree to participate in this protocol. exclusion criteria: * subjects will be excluded if they currently have a major neurological disease, unstable/untreated medical disease (such as untreated hypertension). * in consideration of the magnetic fields in which subjects will be placed for the mr scanning, we will also exclude subjects who are unable to safely and comfortably complete the scanning session. this includes individuals who are wearing any metal prosthesis or who have cardiac pacemakers or any other nonremovable metal objects. * subjects reporting a history of severe claustrophobia or poorly controlled back pain will be excluded because it is unlikely they could comfortably remain still in the mri scanner for the duration of the scan. * in addition, subjects who do not fit in the apparatus will also be excluded.

Keywords: cognitive aging apolipoproteins e magnetic resonance imaging
a collection of vital status and pulmonary medication usage data for patients with chronic obstructive pulmonary disease (copd) who withdrew prematurely from tiotropium inhalation solution delivered by the respimat inhaler

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the objectives were to collect information on vital status and pulmonary medication use at the predicted exit date for patients who participated in two one-year trials and withdrew prematurely. the primary objective was to ascertain the vital status (dead or alive) of these patients in the time interval between the patients' withdrawal from the trial and their predicted exit date (i.e: 48 weeks from first intake of randomised treatment + 30 days). the secondary objective was to collect information on classes of pulmonary medication and some other specified pulmonary interventions used by these prematurely discontinued patients at the time of their predicted exit date (i.e 48 weeks from the first intake of randomised treatment + 30 days) or at date of death (if this occurred during the time interval of interest, i.e 48 weeks from the first intake of randomised treatment + 30 days).


Eligibility criteria:
inclusion criteria: * patients who withdrew prematurely from the randomised treatment phase of studies 205.254 and 205.255. exclusion criteria: * not applicable.
maternal omega-3 supplementation to reduce bronchopulmonary dysplasia

Conditions: Bronchopulmonary Dysplasia; Child Development; Neonatal and Perinatal Conditions

Summary: the aim of this randomized controlled trial is to determine whether docosahexaenoic acid (or dha, an omega-3 lipid) supplementation in lactating mothers providing breast-milk to their infant born below 29 0/7 weeks of gestational age (ga) improves bpd-free survival at 36 weeks post-menstrual age (pma). half of participants will receive docosahexaenoic acid (dha), an omega-3 lipid, while the other half will receive a placebo.

every year in canada, 1500 babies who are born early (prematurely) develop a serious lung disease called bronchopulmonary dysplasia (bpd). bpd causes major health problems in these infants, especially in their early childhood. in most situations, breast-milk is the ideal source of nutrition for growth and development of premature babies. however, diets of canadian mothers are generally deficient in omega-3 lipids (essential fats), resulting in lower protection from these omega-3 lipids in mother's milk-fed infants. previous research has shown that giving dha to mothers of premature babies is safe both for the mother and for their baby, and is an efficient way of helping babies meet their dietary requirements from breast-milk. furthermore, this previous research also suggests that this intervention may reduce the risk of bpd in premature babies receiving breast-milk.

Eligibility criteria:
inclusion criteria: 1. age more than or equal to 16 years 2. pre-term delivery (230/7- 286/7 weeks gestation) 3. no contraindication to breastfeeding 4. subject intends to provide own breast milk to infant 5. randomization before or at 72 hours post delivery exclusion criteria: mothers 1. mother is taking \> 250 mg of daily dha supplementation for last 3 months 2. mother who is currently enrolled or has participated in another clinical trial in which she had received an investigational drug or intervention within 3 months of the date of randomization (unless approved by the trial coordinating centre) 3. inability to comprehend and comply with study requirements 4. participation in this study in a previous pregnancy infants 1. significant congenital malformations in the infant (or one of the infants in case of multiple pregnancy) 2. infant (or one of the infants in case of multiple pregnancy) who is currently enrolled in another clinical trial (unless approved by the trial coordinating centre)

Keywords: neonatal prematurity omega-3 fatty acids breastfeeding
genetic and functional analysis of craniometaphyseal dysplasia (cmd)

Conditions: Craniometaphyseal Dysplasia

Summary: cmd can be inherited in an autosomal dominant or recessive trait. cmd may also be caused by de novo mutations. the goal of this study is to identify genes and regulatory elements on chromosomes that are the cause for cmd. the investigators also study blood samples and tissue samples from patients to learn about the processes that lead to this disorder. the investigators long-term goal is to find mechanisms to slow down bone deposition in cmd patients.

cmd is a very rare bone disorder that affects mostly bones of the head (=cranial bones) but also long (=tubular) bones. therefore, cmd has been added to the class of craniotubular bone disorders. there are a number of disorders in this group and sometimes they are difficult to distinguish. typical signs for cmd are the lifelong bone deposition in bones of the face and head (=progressive craniofacial hyperostosis) and the widening of the ends of long bones (=metaphyseal flaring). typical facial characteristics are wide-set eyes and a prominent jaw (=mandible). cmd is sometimes diagnosed in infants. the best way to confirm diagnosis is by molecular genetics.

Eligibility criteria:
inclusion criteria: * cmd; unaffected individuals only if part of a participating cmd family exclusion criteria: * no cmd; unaffected individuals only as part of a participating cmd family

Keywords: craniometaphyseal dysplasia bone hyperostosis osteoblast osteoclast
fetal st segment and t wave analysis in labor

Conditions: Pregnancy; Obstetric Labor; Parturition

Summary: the purpose of this research is to test a new instrument, called a fetal stan monitor, that may be used during labor to monitor the electrical activity of the baby's heart. this new instrument is designed to help the doctor determine how well the baby is doing during labor. it will be used along with the existing electronic fetal monitor used to measure the baby's heart rate and the mother's contractions during birth. the specific purpose of this research study is to see if this new instrument (fetal stan monitor) will have an impact on newborn health.

a randomized trial of fetal ecg st segment and t wave analysis as an adjunct to electronic fetal heart rate monitoring (stan): fetal ecg analysis of the st segment (stan) is now fda-approved and clinically available in the united states as an adjunct for the interpretation of electronic fetal heart rate patterns. there have been a number of randomized controlled trials as well as observational studies in europe documenting utility of this modality in terms of reducing fetal acidosis at birth, and decreasing the need for operative vaginal delivery. however, despite these endorsements, there remain concerns with the application of the technology to the united states. none of the randomized trials were performed in the united states where patient case-mix and obstetrical practice, such as the use of fetal scalp ph, differ from europe, which may affect the impact of this technology on perinatal outcomes. moreover, the results of the european studies are not uniformly positive. this protocol describes a randomized controlled trial of the stan technology as an adjunct to electronic fetal heart rate monitoring versus fetal heart rate monitoring alone.

Eligibility criteria:
inclusion criteria: * singleton, cephalic pregnancy * gestational age at least 36 weeks, 1 day * cervical dilation of at least 2 cm and no more than 7 cm * ruptured membranes exclusion criteria: * multifetal gestation * planned cesarean delivery * need for immediate delivery * absent variability or sinusoidal pattern at any time, or a category ii fetal heart rate pattern with absent variability in the last 20 minutes before randomization * inability to obtain or maintain an adequate signal within 3 trials of electrode placements * occurrence of any st event during attempt to obtain adequate signal * patient pushing in the first stage of labor * known major fetal anomaly or fetal demise * previous uterine surgery * placenta previa on admission * maternal fever greater than or equal to 38 c or 100.4 f * active hsv infection * known hiv or hepatitis infection * other maternal and fetal contraindications for using the stan monitor * enrollment in another labor study * participation in this trial in a previous pregnancy * no certified or authorized provider available

Keywords: stan fetal monitoring fetal acidosis fetal heart rate monitoring perinatology