Kornimate/medical-research-clean huggingface dataset:
adaptations to breast cancer and exercise

Conditions: Breast Cancer

Summary: this study aims to investigate the effects of different volumes of combined training on fatigue, neuromuscular variables, morphological, cardiorespiratory capacity, functionality, and quality of life, in breast cancer (bca) women undergoing primary treatment. two thirds will be the intervention group that will perform combined training, while the other third will be the control group that will have physiotherapy sessions.

although chemotherapy and radiation are mainstream treatment modalities, patients will often experience treatment-related side effects such as impairments to the neuromuscular and cardiovascular systems and reduction in quality of life (qol).to date, numerous positive effects on neuromuscular and aerobic parameters in response to resistance and aerobic training have been reported when both training modalities were simultaneously performed (i.e. combined training - comb) in bca patients. however, there is a lack of data regarding the prescription of this modality in bca patients, as the necessary dose of resistance training for significant improve in fatigue, neuromuscular, and quality of life. in this sense, no previous studies investigate the effect of different volumes of resistance training in bca patients, providing important informations about the prescription in this clinical population.

Eligibility criteria:
inclusion criteria: * breast cancer diagnostic at i and ii stages; * adjuvant or neoadjuvant chemotherapy (≤50% of sessions completed); * more than 18 years. exclusion criteria: * current smoking * diabetic neuropathy; * hypertension uncontrolled; * heart failure; * clinical depression; * skeletal muscle impairment which not allow physical exercise.

Keywords: breast cancer combined training fatigue
functional assessment in liver transplantation

Conditions: Cirrhosis; End Stage Liver Disease

Summary: in order to ensure the equity of the liver allocation process, it is important to create objective, scientifically validated markers of frailty in patients with end-stage liver disease that accurately predict patient outcomes. many measures have been developed to assess this clinical state in elderly patients, but none have been applied to patients with cirrhosis, a population at increased risk for accelerated functional decline. this protocol is designed to learn more about the effects of functional status (also known as "frailty") in liver transplant patients and patient outcomes both before and after liver transplant.

subjects in this study will be asked questions regarding functional status and ability to do activities at home. subjects will also be asked to complete several physical tests to assess functional status. for example, subjects will be asked to stand up from a chair several times, balance with their feet together, and walk down a hall as quickly as possible. subjects will also be asked to perform a hand grip strength test. subjects will be assessed at baseline and at every clinic visit in the pre-transplant setting. subjects will again be assessed at 3, 6, and 12 months post-transplant.

Eligibility criteria:
inclusion criteria: * adults (≥18 years old) * listed for liver transplantation, or are "listable" - i.e, have undergone formal evaluation and been approved for listing if/when patients achieve high enough priority * are seen in the outpatient clinic setting exclusion criteria: * have severe hepatic encephalopathy at enrollment (defined by the time to complete the numbers connection test (nct) \> 120 seconds, which is the first test that the participants complete upon enrollment).

Keywords: frailty liver transplantation functional status
methotrexate infusion and intrasilicone injection during diabetic vitrectomy

Conditions: Diabetic Retinopathy; Vitreomacular Traction

Summary: the goal of this interventional clinical trial is to assess anatomical and functional outcomes of methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery in patients with advanced proliferative diabetic retinopathy. the main questions it aims to answer are: 1. does methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery decrease the post operative vitreoretinal proliferation after vitrectomy in patients with advanced proliferative diabetic retinopathy? 2. does methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery improve post operative functional outcome after vitrectomy in patients with advanced proliferative diabetic retinopathy? researchers will compare the anatomical and functional outcomes after vitrectomy in patients with advanced proliferative diabetic retinopathy without using methotrexate.

tractional macular detachment (tmd) or macula threatening tractional retinal detachment (trd) and combined tractional-rhegmatogenous retinal detachment (trd/rrd) are considered as important indications for vitreoretinal intervention. although a growing number of eyes with tmd and trd/rrd are successfully treated with a single procedure, retinal re-detachment associated with fibrovascular proliferation or proliferative vitreoretinopathy (pvr) is still a major cause of failure of the surgery. previous studies have shown increased expression of inflammatory cytokines and growth factors in both proliferative diabetic retinopathy (pdr) and pvr. methotrexate (mtx) is an anti-neoplastic and anti-inflammatory agent used to treat a variety of malignancies and rheumatologic diseases. in ophthalmology, systemic and intraocular mtx has been successfully used for indeterminate uveitis, sarcoid uveitis and intraocular lymphoma. mtx has been recently found to inhibit pvr by stopping cellular proliferation and promoting organized apoptosis. mtx has also been found to be effective in lowering the incidence of pvr when used as an adjunct in irrigation fluid during vitrectomy for retinal detachment.

Eligibility criteria:
inclusion criteria: - patients with diabetic tractional macular detachment or combined tractional- rhegmatogenous retinal detachment exclusion criteria: * previous vitreoretinal surgery. * pregnant or lactating female. * co-existing pathology that might induce pvr such as penetrating ocular trauma or uveitis, co-existing congenital anomalies or hereditary vitreoretinopathies

Keywords: methotrexate proliferative diabetic retinopathy
collaboration to reduce disparities in hypertension

Conditions: Hypertension

Summary: a large number of african-american and low socioeconomic patients have poorly controlled high blood pressure because of not being able to take their high blood pressure medications. this puts these patients at higher risk of heart and kidney disease, stroke and death. this study is designed to reduce the barriers that prevent patients from taking their high blood pressure medications.

the objective of this study is to determine the effectiveness and cost-effectiveness of two interventions aimed at reducing barriers to blood pressure (bp) control in an indigent and african-american population. specifically, we will conduct a randomized controlled trial comparing bp control using either: (1) reimbursing patients for filling prescriptions (reimbursement arm); (2) a computer-based behavioral intervention (behavioral arm); (3) both the reimbursement and behavioral arms (combined arms); or (4) neither. the ultimate goal of this study is to reduce the incidence of htn-related cvd among these populations thereby reducing cardiovascular health disparities. specific aims of the study are to: 1. test whether receiving money each time the patient fills a prescription for medications improves bp control by a clinically significant amount. h1: reimbursing patients for filling prescriptions will significantly improve bp control. 2. test whether a computer-based behavioral intervention improves bp control by a clinically significant amount. h2: a computer-based behavioral intervention will significantly improve bp control. 3. test whether the two interventions are more effective in improving bp control than either alone. h3: the effect of improving bp control of administering both interventions together will be greater than the sum of the individual effects of each intervention alone. 4. examine the relative cost effectiveness of reimbursement for filling prescriptions, a computer-based behavioral intervention, and the combination of the two. h4: both interventions will be cost-effective relative to other commonly-covered services.

Eligibility criteria:
inclusion criteria: * patients of the philadelphia veterans administration hospital primary care clinic, pinnaclehealth adult outpatient clinics and the va pittsburgh healthcare system who have a diagnosis of hypertension; are currently taking antihypertensive medications; and have elevated blood pressure. exclusion criteria: * under 21 years of age * have a diagnosis of: * atrial fibrillation; * metastatic cancer; * end stage renal disease (esrd) with dialysis; * dementia; * new york heart association (nyha) class iv congestive heart failure (chf); * blind or deaf; * other reason for life expectancy of less than 1 year. * are currently participating in another experimental study

Keywords: high blood pressure health behaviors patient compliance
efficacy and safety of t2762 and vismed® in dry eye syndrome

Conditions: Dry Eye Syndrome

Summary: comparison of the efficacy and safety of t2762 and vismed® in the treatment of moderate to severe dry eye syndrome


Eligibility criteria:
inclusion criteria: * signed and dated informed consent * male or female aged from ≥ 18 years old. * known dry eye syndrome requiring artificial tears within the last 3 months prior to study selection. exclusion criteria: * best far corrected visual acuity \< 1/10 * severe blepharitis * severe dry eye
neoadjuvant dose-dense chemotherapy for hr+/her2- breast cancer patients with high proliferation index

Conditions: Breast Cancer

Summary: studies have shown that dose-dense chemotherapy reduces the risk of recurrence and death of breast cancer patients comparing with standard-schedule chemotherapy. but some research data indicate that hr+/her2- breast cancer patients benefit from dose-dense chemotherapy while some have negative results. how to identify hr+/her2 breast cancer patients who are more likely to benefit from dose-dense chemotherapy is strongly necessary. ki67 is a marker reflecting the proliferation of tumor cells. breast cancer patients with high ki67 are more likely to benefit from dose-dense chemotherapy. the purpose of this project is to investigate the efficacy and safety of neoadjuvant dose-dense chemotherapy for hr+/her2- breast cancer patients with high proliferation index. at the same time, we will explore biomarkers, such as mammaprint and blueprint, to further identify patients who benefit more from neoadjuvant dose-dense chemotherapy.


Eligibility criteria:
inclusion criteria: * females with age of 18 to 70 years old. * newly diagnosed breast cancer patients. * planned neoadjuvant chemotherapy. * hormone receptor status: estrogen receptor (er)-positive or progesterone receptor (pr)- positive. * her2/neu-negative. * ki67≥30%. * clinical stage iib-iiic. * informed consent form understood and signed. * patient agrees to all follow-up visits. * eastern cooperative oncology group (ecog) performance status 0 to 1. * women of childbearing potential must have a negative serum pregnancy test. exclusion criteria: * metastatic disease * pregnancy. * nursing mothers. * active or uncontrolled infection. * presence of another malignancies. * granulocyte count \< 1.5\*10\^9/l. * platelet count \< 100\*10\^9/l. * hemoglobin \< 90g/l. * serum creatinine more than 1.5 upper limit. * ast and alt more than 2.5 upper limit. * lvef\< 50%.
evaluation of therapeutic effect of 0.5 mg colchicine and 5 mg prednisolone on oral aphthae

Conditions: Oral Aphthae

Summary: the purpose of this study is to determine whether low doses of prednisolone, or colchicine are effective in the treatment of oral aphthae.

treatment of recurrent aphthous stomatitis (ras) remains, to date, empirical and non-specific. the main goals of therapy are to minimize pain and functional disabilities as well as decrease inflammatory reactions and frequency of recurrences.

Eligibility criteria:
inclusion criteria: * confirmation of clinical diagnosis of aphthae * having the experience of oral aphthae at least once in a month * two weeks wash out periods after the last treatment exclusion criteria: * history of any systemic disease * using drugs which affect immune system * pregnancy and breast feeding * aphthous related syndromes

Keywords: oral ulcers
a first-in-human, double blind, single dose study in healthy subjects and subjects with mild atopic asthma.

Conditions: Asthma

Summary: the purpose of this study is to determine if a single dose of amg 282 is safe in healthy subjects and subjects with mild atopic asthma.

a single sc or iv dose administration of amg 282 to healthy subjects and subjects with mild atopic asthma will exhibit an acceptable safety and tolerability profile within the dose ranges studied.

Eligibility criteria:
inclusion criteria (all subjects) * is a current non-smoker, has not used any nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) within the last 6 months, and cumulative smoking history is ≤10 pack years. * females must be of documented non-reproductive potential (ie, postmenopausal \[see definition below\]; or history of hysterectomy; or history of bilateral salpingectomy; or history of bilateral oophorectomy). * body mass index (bmi) between ≥ 18.0 and ≤ 32.0 kg/m2 at screening. (subjects with mild atopic asthma only) * documented history of mild, stable atopic asthma within 2 years of screening. * has used only inhaled short-acting β2-agonists (less than twice weekly) to treat asthma. * pre-bronchodilator forced expiratory volume in 1 second (fev1) \> 70% predicted at screening. exclusion criteria (all subjects) * history or evidence of a clinically significant disorder, condition or disease that, in the opinion of the principal investigator or amgen medical monitor would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion. * subject has a history of residential exposure to tuberculosis without a documented history of prophylactic treatment of tuberculosis or subject has a positive purified protein derivative (ppd) or quantiferon test at screening. subjects with a documented negative ppd or quantiferon test within 4 weeks prior to screening who have no known tuberculosis exposure and have not traveled to an area with tuberculosis do not need to have a test performed at screening. * has donated or lost ≥ 500 ml of blood or plasma within 8 weeks of administration of the first dose of ip. other criteria may apply.

Keywords: mild asthma atopic asthma healthy volunteers first-in-human
feasibility testing of a hospice family caregiver intervention to improve patient dyspnea care

Conditions: Dyspnea

Summary: this study is a pilot test of an intervention to train family caregivers of home hospice patients about recognizing and treating shortness of breath.

shortness of breath is a prevalent symptom causing distress among patients at the end of life. in home hospice care family caregivers are expected to assist their family member with symptom management. this is often accomplished with little or no training. the investigators have developed a bundle of training materials targeted for family caregivers of home hospice patients at risk for shortness of breath. the investigators will pilot test the intervention in this clinical trial. a future randomized clinical trial is planned and the evidence from this pilot will enhance the planning of that future trial.

Eligibility criteria:
inclusion criteria: * patient in home hospice care with an estimated survival of 3-4 weeks, at risk for dyspnea secondary to lung cancer, copd, or heart failure. * family caregiver in patient's home must speak and read english. exclusion criteria: * patients with bulbar als or quadriplegia.
quantitative end tidal co2 monitoring in the delivery room (dr)

Conditions: Delivery Room Resuscitation

Summary: this is a trial evaluating the use of an end tidal co2 monitor during ventilation in the delivery room. the use of the monitor is compared with clinical assessment of ventilation. the hypothesis is that using the monitor would results in a decrease in the incidence of hypo- or hypercapnia on admission to the nicu.


Eligibility criteria:
inclusion criteria: * need for ventilation in the delivery room exclusion criteria: * tracheal suctioning for meconium * congenital diaphragmatic hernia * suspected hypoplasia of the lungs * oligohydramnios \<28 weeks gestation or afi\<5 * known or suspected airway anomaly * mother not speaking english or spanish * refusal of consent

Keywords: ventilation end tidal carbon dioxide hypercapnia hypocapnia positive pressure ventilation neonates delivery room resuscitation
impact of yoga on cognitive function

Conditions: Heart Failure; Mild Cognitive Impairment

Summary: mild cognitive impairment is highly prevalent in patients with heart failure and results in poor well-being and quality of life. while yoga has proven effective in promoting cognitive health in older adults through its gentle movements, controlled breathing, and meditation, its effects on patients with heart failure remain unknown. therefore, this feasibility and pilot study plans to deliver a 12-week yoga intervention and test its effects on cognitive function in patients with heart failure and mild cognitive impairment.

a prospective, 2-arm comparative feasibility design will be used. the investigators will enroll 24 patients with a confirmed heart failure diagnosis with mild cognitive impairment. patients will be randomized equally into yoga intervention or control group. patients in the yoga intervention group will receive a 60-minute yoga session twice per week for 12-week. survey, cognitive function data, mri scans, and blood samples will be collected at baseline and at 3 months (after completion of yoga intervention).

Eligibility criteria:
inclusion criteria: * aged 55 years and older * confirmed heart failure diagnosis with mild cognitive impairment * new york heart association functional class ii-iv exclusion criteria: * co-existing neurological disorders, traumatic brain injury, psychiatric disorders, or terminal illnesses * have implanted defibrillator, left ventricular assist device placement or cardiac transplant * have any other implanted metals that interfere with the mri magnetic field for patient safety * substance abuse * pregnant * unable to perform yoga due to physical limitations or severity of illness

Keywords: yoga intervention cognitive function
strawberries and risk of diabetes in adults

Conditions: PreDiabetes; Metabolic Syndrome

Summary: strawberries can be categorized as a functional food based on results from several clinical trials in improving cardiometabolic health beyond providing nutrition. recent studies identify the role of strawberries in improving insulin resistance and risks of type 2 diabetes which urgently warrants further investigation, keeping in view the huge public health burden of diabetes in the us. in this study, the investigators propose to investigate the effects of a dietary achievable dose of strawberries on glycemic control, insulin resistance, and hba1c (primary variables) and biomarkers of inflammation and endothelial function in a 28- week controlled crossover study.

strawberries are popularly consumed fruits in the us and are a rich source of several bioactive compounds with demonstrated health benefits in t2d and cardiovascular disease (cvd). based on previously reported studies, strawberries have been shown to improve elevated lipid profiles/dyslipidemia, oxidative stress and inflammation in adults with the metabolic syndrome or prediabetes. in a recently reported study, strawberries at a dose of two-and-a-half servings per day for four weeks was shown to significantly reduce insulin resistance and serum adipokines in obese adults. these results conform to only a few reported trials using strawberries in adults with cardiometabolic risks. while these study findings are clinically meaningful, these warrant urgent investigation in trials of longer duration specifically targeting adults with impaired fasting glucose (vs. other features of the metabolic syndrome) as well as adults with diagnosed t2d with poor glycemic control despite taking medications. furthermore, to the best of our knowledge, only one clinical trial has been reported on the role of strawberries in improving glycemic control, oxidative stress, and inflammation in adults with t2d. while these results are encouraging, they lack generalizability due to the short duration of the study (six weeks) that precludes accurate changes in glycated hemoglobin (hba1c) as a stable biomarker of glucose control. based on these gaps in the existing literature, the investigators will examine the effects of strawberry supplementation at a dose of 2.5 servings/day for 12 weeks on glycemic control and related cardiometabolic profiles in prediabetes in a randomized controlled crossover trial.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * waist size greater than 40 inches in men or 35 inches in women * blood glucose greater than 100mg/dl but less than 126 mg/dl or glycated hemoglobin less than 6.5% * insulin resistance \>1.0 * not on diabetes medications * normal liver and kidney function tests exclusion criteria: * allergy to strawberries * smoke or drink alcohol on a regular basis * pregnant or lactating
magnesium and riboflavin treatment for post-concussion headache

Conditions: Concussion, Intermediate

Summary: this clinical trial will try to determine if the supplements magnesium and riboflavin will reduce the pain and duration of headaches in persons diagnosed with a concussion. the participant will be randomized to either active magnesium and riboflavin capsules or placebo (inert) capsules. the capsules will be taken once a day for 14 days. the participant will also complete a short diary form for the 14 days and will have 3 follow up visits either by telephone or in person.


Eligibility criteria:
inclusion criteria: * seen at university of virginia student health and wellness center or emergency department for initial visit for concussion; * less than 3 days have elapsed since their injury; * able to swallow capsules exclusion criteria: * concussion complicated by cranial bleed, skull fracture, additional severe injury; * kidney disfunction or failure; * significant gastro-intestinal dysfunction; * varsity athlete; * two or more previous concussions; * women who are pregnant or breast feeding; * taking tetracycline, fluoroquinolone, iron digoxin, chlorpromazine or penicillamine

Keywords: concussion; headache
polycystic kidney disease 1 (pkd1) gene variant groups in autosomal dominant polycystic kidney disease

Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Summary: the purpose of this study is to estimate the prevalence, demographic, and clinical characteristics of pkd1/2 gene variant groups in the adpkd population.


Eligibility criteria:
key inclusion criteria: * estimated glomerular filtration rate (egfr) greater than or equal to (≥) 30 milliliter per minute (ml/min)/1.73 m\^2 * willing and able to comply with scheduled visits and other study procedures * a pre-existing diagnosis of adpkd as defined in the protocol key exclusion criteria: * history of kidney disease other than adpkd that in the opinion of the investigator would independently impact the natural history of adpkd * history of solid organ or bone marrow transplantation or nephrectomy * ongoing renal replacement therapy or planning to start renal replacement therapy less than or equal to (≤)12 months from the genotyping visit in part a other protocol defined inclusion/exclusion criteria will apply.