Kornimate/medical-research-clean huggingface dataset:
pemetrexed plus cisplatin bi-weekly, in patients with urothelial cancer (metastatic, locally advanced or non-resectable)

Conditions: Urologic Neoplasms

Summary: to assess the anti-tumor activity, as measured by response rate to bi-weekly pemetrexed plus cisplatin, in chemo-naive patients with diagnosed metastatic or locally advanced (non-resectable) urothelial cancer.


Eligibility criteria:
inclusion criteria: * histologically proven locally advanced disease or metastatic transitional cell carcinoma of the urothelium including bladder, urethra, ureter, and renal pelvis. patients should not be suitable for surgery or radiation with curative intent. however patients whose pre-chemotherapy sites of disease are restricted to the primary or regional lymph node sites and who have a major response to chemotherapy will be evaluated for post-chemotherapy surgical resection of residual cancer if the tumor has become resectable at the end of chemotherapy. * measurable disease status, as defined in the response evaluation criteria in solid tumors (recist) criteria (therasse et al., 2000) * one course of prior radiation therapy is allowed. prior radiation must have been completed at least 4 weeks before enrolment into the study and the patients must have recovered from all toxic effects. exclusion criteria: * have central nervous system (cns) or leptomeningeal metastases (unless the patient has completed successful local therapy for cns metastases and has been off corticosteroids for at least 4 weeks before starting study therapy). a screening computed tomography (ct) or magnetic resonance imaging (mri) before enrollment in the absence of a clinical suspicion of brain metastases is not required. * inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents 2 days before, the day of, and 2 days after the dose of pemetrexed plus cisplatin or cisplatin alone. if a patient is taking a nonsteroidal anti-inflammatory drug (nsaid) or salicylate with a long half-life (for example, naproxen, piroxicam, diflunisal) it should not be taken 5 days before the dose of pemetrexed (8-day period for long-acting agents such as piroxicam), the day of, and 2 days after the dose of pemetrexed plus cisplatin.
dry eye under china's dynamic covid-zero strategy

Conditions: Dry Eye Symptoms

Summary: to compare the prevalence of dry eye symptoms and to investigate the association of the risk factors with the dry eye symptomatology among university students in the epidemic and non-epidemic areas of china under the covid-zero strategy.

as the covid-19 outbreak at the end of 2019 spread around the world, the world health organization declared it a public health emergency of international concern on 30th january, and a global pandemic on 1st march. in addition to the threat of coronavirus itself, anti-epidemic measures such as wearing masks, maintaining social distance, prohibiting group gathering, blockade, isolation, curfew, closure, working at home, online learning, etc., have also greatly changed people's daily life dynamics. unlike the previous regional blockade (city-wide) suspension of school and work, china has shifted to dynamic prevention and control in april 2020, and the basic life and activities in the epidemic area are not restricted. this study aims to compare the prevalence of dry eye symptoms and to investigate the association of the risk factors with dry eye symptoms among college students in the epidemic and non-epidemic areas of china under the dynamic covid-zero strategy.

Eligibility criteria:
inclusion criteria: * college students with age ≥18 years * no other medication history in recent 2 weeks; * have high compliance and are willing to fill in the questionnaire on time exclusion criteria: * routinely using artificial tears and other eye drops; * taking any medication that could interfere with the results of the study; * with any history of eye surgery

Keywords: dry eye symptoms anxiety depression
impact of hormonal contraception on hiv acquisition and transmission risk

Conditions: HIV; Contraception

Summary: this is a prospective cohort study focusing on hiv negative women. the investigators want to learn how the contraceptive methods of depot medroxyprogesterone acetate (dmpa), etonogestrel implant (eng-implant), levonorgestrel intrauterine device (lng-iud) and the paragard® t 380a intrauterine copper contraceptive impact the vaginal immune environment.

the three proposed aims will evaluate the effect of four contraceptive methods (depot medroxyprogesterone acetate (dmpa), etonogestrel implant (eng-implant), levonorgestrel intrauterine device (lng-iud) and paragard® t 380a intrauterine copper contraceptive) on: (1) hiv target immune cells within the female genital mucosa; (2) markers of t-cell activation and trafficking within the female genital mucosa; and (3) secreted cytokines and chemokines within the female genital mucosa.

Eligibility criteria:
inclusion criteria: * female * age 18-45 years * normal menses (22-35 day intervals) for at least 3 cycles * intact uterus and cervix * interested in to dmpa, eng-implant or lng-iud or paraguard * willing to delay initiation of hormonal contraception for up to 1 month * willing to use condoms or abstain from sexual intercourse for at least 48 hours before each genital tract sampling (condoms will be made available) * able and willing to provide informed consent, and undergo serial blood and cervicovaginal lavage (cvl) sampling * negative hiv screening exclusion criteria: * pregnant within the last 3 months * breastfeeding * history of loop electrosurgical excision procedure, conization, or cryosurgery within the past year * use of hormonal contraception or iud in the past 6 months * known history of medical condition that would interfere with the conduct of the study * symptomatic vaginal infection or genital ulcer disease at screening * taking medications that interact with selected contraceptive * contraindications to selected contraceptive per the centers for disease control and prevention (cdc) medical eligibility criteria or judgment of clinician

Keywords: hiv-negative
a study to evaluate the change in disease state and adverse events in adult participants with polymyalgia rheumatica (pmr) dependent on glucocorticoid treatment, receiving subcutaneous injections of abbv-154

Conditions: Polymyalgia Rheumatica

Summary: polymyalgia rheumatica (pmr) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older. this study evaluates how safe and effective abbv-154 is in participants with glucocorticoid-dependent pmr. adverse events and change in disease activity will be assessed. abbv-154 is an investigational drug being evaluated for the treatment of pmr. participants will be randomized into 1 of 4 treatment groups or arms, each arm receiving a different treatment. there is a 1 in 4 chance that a participant will be assigned to placebo. around 160 participants, of at least 50 years of age, with pmr will be enrolled in the study at approximately 95 sites worldwide. the study is compromised of a 52 week double-blind, placebo-controlled period and a follow-up visit 70 days after the last dose of the study drug. all participants will receive a glucocorticoid taper along with the assigned dose of abbv-154 or placebo, subcutaneously (sc) every other week (eow). there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of polymyalgia rheumatica (pmr) and fulfillment of the 2012 european league against rheumatism/american college of rheumatology (eular/acr) provisional classification criteria for pmr. * must have had at least 2 episodes of unequivocal pmr flare. * must be on a stable dose of prednisone. * must be willing to follow the protocol-defined glucocorticoid tapering regimen. exclusion criteria: * have been treated with a prior tnf antagonist. * current use of immunomodulators other than prednisone and hydroxychloroquine.

Keywords: polymyalgia rheumatica pmr abbv-154 glucocorticoid
cinacalcet versus parathyroidectomy in peritoneal dialysis patients

Conditions: Kidney Failure; Secondary Hyperparathyroidism; Vascular Diseases

Summary: this is a pilot, prospective randomized controlled study with the primary objective to evaluate and compare medical treatment of severe shpt, namely oral cinacalcet versus surgical treatment, that is, parathyroidectomy with forearm autografting, on the progression of coronary artery and valvular calcification and left ventricular mass index in endstage renal disease patients receiving peritoneal dialysis over 12 months. the change in arterial stiffening, left ventricular volume, aortic valve calcium score and bone mineral density, nutritional status and biochemical parameters, quality of life measures will be evaluated as secondary objectives of this study.

patients with severe secondary hyperparathyroidism (shpt) are frequently complicated with vascular calcification. there is some suggestion that subtotal parathyroidectomy may reduce or stabilize vascular calcium scores in dialysis patients. experimental data suggests that shpt plays an important role in mediating uraemic arterial disease and that parathyroidectomy largely prevented the development of calcification. cinacalcet has emerged as a novel therapy for the treatment of shpt and has been shown to reduce the need for surgical parathyroidectomy. however, their effects on vascular, cardiac, bone and nutrition status have not been evaluated and compared with parathyroidectomy.

Eligibility criteria:
inclusion criteria: 1. esrd patients on long-term peritoneal dialysis treatment, with elevated intact parathyroid hormone (ipth) levels \> 800pg/ml. 2. patients with parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan. 3. patients with age between 18 - 75 years. exclusion criteria: 1. patients with background valvular heart disease 2. patients who are unfit for general anaesthesia 3. patients with acute myocardial infarction within recent two months 4. patients with poor general condition 5. patients with plans for living related kidney transplant within 1 year 6. patients with previous history of parathyroidectomy 7. patients with underlying malignancy 8. patients with hepatic dysfunction

Keywords: chronic kidney disease peritoneal dialysis secondary hyperparathyroidism parathyroidectomy vascular calcification cinacalcet
near infrared fluorescence imaging with indocyanine green

Conditions: Solitary Pulmonary Nodules

Summary: this research study will evaluate how near infrared fluorescence imaging (nifi) with indocyanine green (icg) contrast dye can assist in the identification and diagnosis of lung nodules during surgery. nifi is an intraoperative imaging technology that utilizes a coupled camera/fluorophore (icg) system to fluoresce tissues of interest. intravenous icg is a fluorophore with a long-standing high safety profile.

this research study is a pilot test of the effectiveness of a near infrared fluorescence imaging (nifi) system in the detection and diagnosis of pulmonary nodules. patients selected for enrollment in this study will be adults (≥18 years) that have been scheduled for surgical biopsy and/or resection of a primary lung nodule identified by prior imaging. patients will receive an injection of indocyanine green (icg) contrast dye one day prior to their surgery. intraoperatively, the nifi system will be used to visualize and characterize the fluorescence patterns given off by these lung nodules, as well as look for additional undiagnosed nodules. these nodules will then be resected and receive histological characterization, as per standard of care. the nifi system will be evaluated for its ability to 1) visualize nodules and their margins 2) differentiate between benign and malignant nodules and 3) identify additional undiagnosed nodules.

Eligibility criteria:
inclusion criteria: * subjects must be willing to undergo surgical biopsy and/or resection of pulmonary nodule(s). * women and men at least 18 years of age * subjects must have a ct scan of the chest within 8 weeks of surgery exclusion criteria: * previous thoracic surgery * inoperable tumor/nodule * unable to tolerate surgery * history of allergies to iodides * breast feeding * pregnant

Keywords: indocyanine green fluorescence imaging
cement floors and child health (cradle)

Conditions: Ascaris Lumbricoides Infection; Necator Americanus Infection; Trichuris Trichiura; Infection; Diarrhea

Summary: this randomized trial in rural bangladesh will measure whether installing concrete floors in households with soil floors reduces child enteric infection. the trial will randomize eligible households to receive concrete household floors or to no intervention and measure effects on child soil-transmitted helminth infection, diarrhea, and other enteric infections. the study will collect longitudinal follow-up measurements at birth and when children are ages 3, 6, 12, 18, and 24 months.


Eligibility criteria:
inclusion criteria: * residence in chauhali upazila or adjacent upazilas in sirajganj or tangail districts in bangladesh * no plan to relocate in the next 2-3 years * reside in home with floors made entirely of soil * pregnant woman 13-30 weeks gestation resides in the home at the time of enrollment exclusion criteria: * home is not strictly residential (e.g., includes a business) * household with walls made of mud/soil * household floor size \> 500 square feet
effect of plantar vibration on static and dynamic balance

Conditions: Stroke Patients

Summary: the aim of this study is to have a positive effect on the static and dynamic balance of vibration applied to the foot base in stroke patients.

kırıkkale university faculty of medicine physical therapy will be hospitalized in the usa clinic and volunteers will be involved in stroke rehabilitation. the patients who meet the inclusion criteria and who are excluded from the exclusion criteria will be randomized according to the order of arrival and will be divided into two groups as the education group and the control group. patients will be taken to the control and study group respectively in order of arrival. if the next patient falls outside the inclusion criteria of the study, randomization will be applied to the next patient. patients in the control group will be given routine conventional physiotherapy in 4-week and 60-minute sessions. the training group will be given routine conventional physiotherapy in 4-week and 45-minute sessions.in addition, three sessions a week will be applied to the soles of the feet for 15 minutes with a 15-100 hz vibration device on both sides of the soles of the feet before conventional physical therapy. individuals before; age, gender, marital status, nutritional characteristics, habits, smoking and alcohol, auxiliary devices, background information, family history, educational status, social security, previous or current occupation, frequency of fall, cause of fall and drugs used will be questioned. static and dynamic equilibrium parameters will be evaluated at the beginning of the study and at the end of the 4th week.

Eligibility criteria:
inclusion criteria: * 45-70 years of age stroke areas * cognitive and non-communication problems * volunteer to join the work * those with less than 150 kilos * can walk 10 meters independently (with assistive device if available) * patients with a maximum level of 2-3 spasticity according to the modified ashworth scale * patients at least 8 weeks after stroke diagnosis exclusion criteria: * people who are not stable due to vital signs * those with coronary heart disease * open wounds under the soles of the feet * being spastic at the level that will block the base touch * pathological conditions affecting lower limb sense (diabetic peripheral neuropathy, post- fracture surgery) * 20 seconds independent standing * mini mental test score below 24 * multiple sclerosis, parkinson's disease, etc. * those with vision problems * patients with thoracolumbar surgery * patients with spinal canal stenosis

Keywords: static balanced dynamic balanced stroke rehabilitation vibration
early versus late enteral iron in infants less than 1301 grams

Conditions: Iron Deficiency; Anemia of Prematurity

Summary: background: preterm infants are at risk of iron deficiency. the smaller the infants are at birth, the smaller the iron stores at birth and the higher the risk of iron deficiency. hypothesis: preterm infants with a birth weight of less than 1301g require iron supplementation earlier than previously recommended. methods: prospective randomized controlled clinical trial (1996-1999). results: early iron supplementation may reduce the incidence of iron deficiency and the need for late blood transfusions.

objectives. to examine whether early enteral iron supplementation (ei) would improve serum ferritin as a measure of nutritional iron status at 2 months of age and would prevent definite iron deficiency (id) in infants with a birth weight of \ 100 ml/kg/day were tolerated (ei) or at 61 days of life (late enteral iron supplementation \[li\]). nutritional iron status was assessed: 1) at birth, 2) at 61 days of life, 3) when the infants reached a weight of 1.6 times birth weight, and 4) before blood was transfused at a hematocrit of \ 50% one week after the onset of enteral iron supplementation. restrictive red cell transfusion guidelines were followed and all transfusions were documented. erythropoietin was not administered. the primary outcome variables were: 1) ferritin at 61 days and 2) the number of infants with id. results. ferritin at 61 days was not different between the groups. infants in the li group were more often iron-deficient (26/65 vs 10/68) and received more blood transfusions after day 14 of life. no adverse effects of ei were noted. conclusions. ei is feasible and probably safe in infants with birth weight \<1301 g. ei may reduce the incidence of id and the number of late blood transfusions. id may occur in very low birth weight infants despite early supplementation with iron and should be considered in the case of progressive anemia. pediatrics 2000; 106:700 -706; preterm infant, iron supplementation, iron deficiency, blood transfusion.

Eligibility criteria:
inclusion criteria: * inborn infant * birth weight of \<1301 g * admitted between june 1996 and june 1999 exclusion criteria: * major anomalies * hemolytic disease * twin-to-twin transfusion syndrome * missing parental consent

Keywords: preterm infant iron supplementation iron deficiency blood transfusion
therapeutic exercise programme to improve the functional capacities, depression and anxiety of patients with chronic kidney disease during haemodialysis sessions.

Conditions: Exercise Therapy; Chronical Kidney Disease

Summary: therapeutic exercise during outpatient hemodialysis treatment for patients with chronic kidney disease


Eligibility criteria:
inclusion criteria: * aged 18 years or older * treated for a minimum of 3 months with hd * with clinical stability (good tolerance to sessions expressed as stable vital signs during the session) * voluntarily and with prior signed informed consent, have agreed to participate in the study exclusion criteria: * physical or cognitive limitations that prevent following the intervention program * cardiovascular problems (unstable angina, uncontrolled arrhythmia, decompensated heart failure, pericarditis or myocarditis, severe untreated mitral or aortic stenosis) * uncontrolled arterial hypertension (sbp \> 200 mmhg and dbp \> 120 mmhg) * uncontrolled diabetes * severe neuropathies * acute systemic infection * severe renal osteodystrophy * stroke (cerebrovascular accident, transient ischemic attack)
hypothyroidism, metabolism and quality of life - focus on qol, ree, cognitive function and body composition

Conditions: Hypothyroidism

Summary: this project has the following primary aims: the main objective is to delineate the association between changes in resting energy expenditure (ree) and qol in hypothyroid patients before and after one year of l-t4 treatment. to achieve this, the investigators plan to compare newly diagnosed hypothyroid patients soon after diagnosis before l-t4 therapy has been initiated after 6 months and after 1 year of treatment. primary endpoint is changes in ree compared to changes in qol secondary endpoint is changes in cognitive function and changes in body composition before and after one year of treatment and furthermore changes in insulin resistance following changes in body composition and free fatty acids (ffa).

subjects and methods: 74 newly diagnosed hypothyroid patients of both genders and age between 20 and 75 years will be recruited from the out-patients clinic in herlev and gentofte hospital and the general practitioners before start of substitution therapy. participants will get an appointment immediately after diagnosis to avoid unnecessary delay of treatment. shortly after diagnosis patients will undergo a test panel at the first experimental day, where patients arrives fasting. * psychological test using: * thypro a thyroid-specific quality of life questionnaire(18), * cognitive function by calcap® abbreviated test battery, * perceived cognitive deficit questionnaire (perceived deficits questionaire) * major depression inventory (mdi) questionnaire * ree will be measured by a ccm-express calorimeter, * dexa-scan * blood samples will be taken and patients will be characterized through basic information. * insulin resistance will be assess through an oral glucose tolerance test (ogtt) at end of the first experimental day patients will start l-t4 therapy following national guidelines, with regular control of thyroid hormones to ensure optimal treatment. when patients are euthyroid and tsh is below 4 \* 10-3 international units pr liter (mu/l) patients will have blood samples monitored every 3 months for the rest of the trial. after 6 and 12 months of treatment patients will undergo a similar experimental day and return to their general practitioner or outpatient clinic. a control group of 18 matched healthy persons will undergo the first experimental day in the same way as the hypothyroid patients, except they do not start any kind of therapy and they only participate in the first experimental day.

Eligibility criteria:
inclusion criteria: * tsh \> 10 mu/liter exclusion criteria: * serious competing illness * pregnancy or planning to become pregnant * thyroidectomized patients * unable to speak and understand danish

Keywords: basal metabolic rate quality of life resting energy expenditure insulin resistance cognitive function body composition