Kornimate/medical-research-clean huggingface dataset:
effects of my diabetes care on patient outcomes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to conduct a two-arm, parallel-design, pragmatic randomized controlled trial of a patient portal intervention for diabetes, my diabetes care (mdc), to evaluate its effect on clinical outcomes.

484 adult patients with type 2 diabetes mellitus will be randomized to one of two arms. 242 will be assigned to the intervention (my diabetes care) embedded within an existing patient web portal, my health at vanderbilt at vanderbilt university medical center or patient gateway at brigham and women's hospital. 242 will be assigned to a usual care comparison arm with access currently available version of my health at vanderbilt or patient gateway without the my diabetes care (mdc) application. potentially eligible patients will be invited to be screened for enrollment in the study. interested patients will be able to complete an electronic consent form and enroll online via research electronic data capture (redcap). outcomes data will be collected from patients at four time points: baseline (t0), three-month follow-up (t1), three-month follow-up (t2), six-month follow-up (t3), and twelve-month follow-up (t4). at each time point, study participants will complete questionnaires electronically via email using redcap, participants' hemoglobin a1c level will be assess via home a1c test kits, and participants' diabetes health data will be abstracted from their electronic health record. participants will be randomized to the intervention or control arm after their baseline data is collected.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * age 18-75 years old * currently taking at least one medication for diabetes * be a patient at vanderbilt university medical center (vumc) or brigham and women's hospital (bwh) * able to speak and read in english or spanish * have reliable access to a smartphone, tablet, or computer with internet access * active patient web portal account (my health at vanderbilt at vumc or patient gateway at bwh) exclusion criteria: * receiving dialysis, * pregnant or planning to become pregnant within the next year, * living in a long-term care facility.

Keywords: diabetes patient web portals health information technology
bortezomib in treating patients with metastatic kidney cancer

Conditions: Kidney Cancer

Summary: rationale: bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. purpose: this phase ii trial is studying how well bortezomib works in treating patients with metastatic kidney cancer.

objectives: primary * determine, preliminarily, the efficacy of bortezomib in patients with metastatic non-clear cell renal cell carcinoma in terms of objective response rate after a minimum of 2 courses of treatment. secondary * correlate clinical response in these patients with baseline von hippel-lindau expression and nuclear factor-kb activity. outline: this is an open-label study. patients receive bortezomib iv over 3-5 seconds on days 1, 4, 8, and 11. treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed at 1 month and then periodically for 2 years. projected accrual: a total of 27 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * histologically confirmed pure non-clear cell renal cell carcinoma (rcc) * distant metastatic disease (tx, nx, m1) * tumor expresses wild-type von hippel-lindau tumor suppressor gene/protein * measurable disease on imaging scan (≥ 1 cm) * brain metastases allowed provided they have been treated with surgery and/or radiation therapy and show no evidence of progression on cerebral ct or mri scan 2 months following surgery and/or radiation therapy. * life expectancy ≥ 3 months * karnofsky performance status ≥ 60% * negative pregnancy test * fertile patients must use an acceptable method of contraception * no other major illnesses likely to limit survival * platelet count ≥ 100,000/mm\^3 * absolute neutrophil count ≥ 1, 000/mm\^3 * hemoglobin ≥ 10 g/dl (transfusion allowed) * creatinine clearance ≥ 30 ml/min or creatinine ≤ 2 mg/dl * alt or ast ≤ 2.5 times upper limit of normal * at least 4 weeks since prior radiotherapy and recovered * more than 30 days since any other prior investigational drugs exclusion criteria: * active cns metastases * pregnant or nursing * myocardial infarction within the past 6 months * new york heart association class iii or iv heart failure * uncontrolled angina * severe uncontrolled ventricular arrhythmias * electrocardiographic evidence of acute ischemia or active conduction system abnormalities * peripheral neuropathy ≤ grade 1 * hypersensitivity to bortezomib, boron, or mannitol * history of a non-rcc malignancy within the past 5 years except basal cell carcinoma of the skin * serious medical or psychiatric illness that would preclude study participation * prior cytotoxic chemotherapy for this cancer * other concurrent investigational therapy * concurrent chemotherapy, immunotherapy, or hormonal therapy

Keywords: stage iv renal cell cancer recurrent renal cell cancer papillary renal cell carcinoma
medico-economic evaluation comparing the use of ultrasonic scissors to the conventional techniques of haemostasis in thyroid surgery by cervicotomy

Conditions: Thyroid Tumor

Summary: the aim of our study is to evaluate the ultrasonic scissors (harmonic focus ethicon endo-surgery laboratory) as a device of hemostasis in thyroid surgery (total thyroidectomy) by cervicotomy, and to show a decrease in transient hypoparathyroidism compared to conventional techniques of haemostasis (clips, ligatures, and bipolar coagulation). secondary objectives of the study are the evaluation of (i) recurrent nerve morbidity, (ii) postoperative bleeding, (iii) postoperative pain, (iv) cost of both techniques (microcosting), (v) the overall cost of the techniques at six months, (vi) a linking of costs and medical outcomes and (vii) an estimation of the potential impact of new technology on the organization of operating rooms (operating time).


Eligibility criteria:
inclusion criteria: * age \> or = 18 yrs * with a toxic goiter or not, graves' disease or thyroid nodule requiring a total thyroidectomy * thyroidectomy under cervicotomy * no echographic criteria to suspect a cancer: poorly defined nodules, microcalcifications, cervical nodes * patient covered by social security * patient's informed and written consent * possible follow-up during 6 months exclusion criteria: * minors and adults under guardianship * preoperatively known thyroid cancer by cytology * planned partial thyroidectomy * peri-operatively antiplatelet intake * preoperatively ent examination (if performed) finding a vocal cords affection * diving goiter (\> 3 cm below the sternal notch) * surgery using videoscopy * lack of possible monitoring during the 6 months after surgery * history of anterior cervical surgery * pregnancy and breast-feeding * hypercalcemia (calcemia\> 2.6 mmol/l)

Keywords: ultrasonic scissors thyroidectomy
feasibility of expressive writing for body image distress and anxiety among adolescent and young adult cancer survivors

Conditions: Adolescent Cancer; Young Adult Cancer; Body Image

Summary: each year, about 89,500 adolescents and young adults (ayas; 15-39 years old) are diagnosed with cancer and up to 60% experience body image (bi) distress. bi is largely developed in adolescence and young adulthood and has implications for self-identity and quality of life. cancer itself and its associated treatments precipitate changes to appearance as well as body sensation and function, all of which can alter bi and lead to increased anxiety. an in-home bi-focused expressive writing (ew) program offers a promising outlet for addressing bi distress and anxiety in a way that eliminates constraints of clinical time and specialist availability. there are no recommended interventions to help aya cancer survivors cope with bi distress. to address this knowledge gap, the objective of this this pilot randomized-controlled trial is to determine the feasibility of a four-week bi-focused ew intervention to decrease bi distress and anxiety among aya cancer survivors with the hypothesis that this intervention will reduce bi distress and anxiety.

protocol was updated to make the previous secondary outcome measures now exploratory

Eligibility criteria:
inclusion criteria: * age 15-39 years * history of one or more cancer diagnoses with all treatment (surgery, chemotherapy, radiation) completed ≥ 3 months before enrollment) * bis ≥10 at time of screening * ability to provide consent or assent and parental consent if applicable. exclusion criteria: * plan to receive surgery, radiation, chemotherapy (including biologic agents, immunotherapy, and other targeted agents) for cancer treatment during the study period (from baseline assessment through post-four-week assessments and interview). participants may continue with surveillance (such as imaging or biopsies) during the study period. * initiation of new treatments for body image distress or anxiety (e.g., pharmacologic, psychotherapy) ≤8 weeks prior to study enrollment. although, participants may continue psychosocial or pharmacological treatments for anxiety or body image distress if the treatment were initiated at least eight weeks prior to study enrollment, the dose has not changed, and they report clinically relevant body image distress. * history of limb-altering surgery or amputation (surgical exclusions are based on the premise that significant appearance-altering surgeries may impact body image distress differently than other cancer therapies) * currently receiving end-of-life care

Keywords: expressive writing
a study to evaluate the effect of slimbiotics probiotic formula on weight management and metabolic health outcomes

Conditions: Metabolic Health; Weight Loss; Stress; Well-Being, Psychological; Sleep; Healthy Eating

Summary: this study is to evaluate the efficacy of a probiotic supplement on weight management and metabolic health. this study will be conducted as a hybrid trial consisting of both in-person visits and virtual assessments. two groups will be included: the intervention (slimbiotics probiotic) and placebo. the slimbiotics probiotic formula is the first plant-based probiotic targeting weight management and metabolic health. other competing probiotics are isolated from humans (feces) but the strains in slimbiotics were isolated from a fermented plant (millet porridge cereal). this product contains 3 probiotic strains: limosilactobacillus fermentum k7-lb1 limosilactobacillus fermentum k8-lb1 limosilactobacillus fermentum k11-lb3


Eligibility criteria:
inclusion criteria: * women \& men * 18+ * bmi between 25-32 * generally healthy - don't live with any uncontrolled chronic disease * own a sleep-tracking device (smart watch etc.) exclusion criteria: * any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders. * anyone with known severe allergic reactions. * women who are pregnant, breastfeeding or attempting to become pregnant * unwilling to follow the study protocol. * subjects currently enrolled in another clinical study * subjects having finished another clinical study within the last 4 weeks before inclusion * hypersensitivity, allergy or intolerance against any compound of the test products (e. g. acacia gum) * condition after implantation of a cardiac pacemaker or other active implants * sulfonylurea treatment * any disease or condition which might compromise significantly the hepatic (ascites), hematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system with the exception of the conditions defined by the inclusion criteria * history of or present liver deficiency as defined by quick \< 70% * regular medical treatment including over-the-counter, which may have an impact on the study aims (e.g. probiotics containing supplements, laxatives, steroids etc.) * history of hepatitis b, c, hiv * subjects who are scheduled to undergo any diagnostic intervention or hospitalization which may cause protocol deviations * simultaneous study participation by members of the same household * pregnancy and lactation * ascites as assessed by sonography * any diet to lose body weight * eating disorders or vegan diet * anorexia drugs * present drug abuse or alcoholism
a multi-center rct study on the efficacy and mechanism of multi-channel tdcs in rehabilitation of cognitive function after stroke

Conditions: Cognitive Dysfunction

Summary: this clinical rct study intends to combined different forms of multi-channel tdcs with the routine cognitive training process to treat patients with post-stroke cognitive dysfunction. the therapeutic effects among single-channel tdcs group, multi-channel tdcs and pseudo-multichannel tdcs group will be compared. brain magnetic resonance mechanism research will also be included to reveal the possible mechanism of multi-channel tdcs technology for psci brain network. thus, the efficacy and mechanism of multi-channel tdcs in post-stroke cognitive function rehabilitation will be researched both in the clinical and basic levels.


Eligibility criteria:
inclusion criteria: * 18-60 year-old * diagnosed cerebral apoplexy, meeting the diagnostic criteria of icd-10 * cognitive function, perceptual function decline after stroke * first onset and duration of 3-12 months * right-handed * mmse ≤25 * moca ≤25 * sign informed consent voluntarily and comply with the study plan exclusion criteria: * nihss ≥21 points * moca ≤18, or drs-2 ≤ 124, or ces-d ≥ 16 * taking drugs that affect central nervous activity, such as nerve antagonists * specific contraindication, such as electrode patch allergy, local skin injury or - - - - inflammation, and hyperalgesia in stimulated areas * patients use implantable electronic devices (such as cardiac pacemakers) or have - metal implants such as stents that affect mri examination * patients with a previous history of epilepsy, mental illness or skull injury * patients with dementia or obvious cognitive dysfunction before stroke * patients with aphasia or dysarthria and cannot complete the scale evaluation * pregnancy
antibody persistence, immune response and safety after doses of pentabio vaccine

Conditions: Healthy

Summary: measure antibody persistence prior to booster administration of pentabio vaccine.

number and percentage of children with anti diphtheria, titer and anti tetanus titer \>= 0.01 iu/ml, anti hbs \>=10miu/ml, anti hib \>=0.15ug/ml prior to booster administration.

Eligibility criteria:
inclusion criteria: * children, 18-24 months of age * subjects who had completed the primary series of pentabio vaccine in the previous trial * father, mother, or legally acceptable representative have been informed properly regarding the study and signed the informed consent form * subject's parents commit to comply with the instruction exclusion criteria: * subjects concomitantly enrolled or scheduled to be enrolled in another trial * evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature \>=37.5oc on day 0) * known history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection * known history of allergy to any component of the vaccines (e.f. formaldehyde) * known history of acquired immunodeficiency (including hiv infection) * subject who has received a treatment likely to alter immune response in the previous 4 weeks (e.g intravenous immunoglobulin, blood-derived products or long term corticotherapy (\>2 weeks) * subject receives other vaccination within 1 month prior to inclusion * any abnormality or chronic disease justified by investigator that might interfere assessment of the trial objectives * infant with a known history of diphtheria, tetanus, pertussis, hepatitis b and hib infection

Keywords: dtp-hb-hib pentavalen pentabio booster
effects of two modalities of non-invasive ventilation after extubation in very low birth weight neonates

Conditions: Preterm Infant

Summary: the objective of this study is to evaluate the effects of continuous positive airway pressure and nasal intermittent positive pressure ventilation on breathing pattern variables of very low birth weight neonates immediately after extubation.

the effects of non-invasive ventilation on the respiratory function of neonates have not been fully elucidated. currently, two modalities of non invasive ventilation are commonly used in brazilian neonatal intensive care units: continuous positive airway pressure (cpap) and nasal intermittent positive pressure ventilation (nippv). in this study, it was hypothesized that nippv will improve tidal volume when compared to cpap. the objective of this study is to evaluate the effects of continuous positive airway pressure and nasal intermittent positive pressure ventilation on breathing pattern variables of very low birth weight neonates immediately after extubation. soon after extubation, the neonates will be randomized into the cpap-nippv (sequence 1) or the nippv-cpap (sequence 2). the sequence will be assigned at random using sealed envelopes. respiratory inductive plethysmography will be used to evaluate the breathing pattern (tidal volume, respiratory rate, minute ventilation, mean inspiratory flow) and chest wall motion (labor breathing index, inspiratory phase relation, expiratory phase relation, total phase relation and phase angle). student t tests for paired samples will be used and the wilcoxon test according to the data distribution. a significance level of 5% will be adopted. the analyzes will be performed by statisticalpackage software for the social sciences® (spss, chicago, il, usa), version 17.0 for windows.

Eligibility criteria:
inclusion criteria: * presented gestational age less than or equal to 32 weeks and weight less than or equal to 1,500 g; * stability from an hemodynamic point of view (without use of amines); * have undergone invasive mechanical ventilation; * absence of congenital heart diseases and / or other congenital anomalies (myelomeningocele, gastroschisis and / or omphalocele) or chromosomal abnormalities; * absence of any condition that requires surgery in the neonatal period. exclusion criteria: * presented air leak syndrome (pneumothorax, pneumomediastinum); upper airway obstruction after extubation and non-scheduled extubation.

Keywords: non-invasive ventilation preterm infant breathing pattern
the efficacy of glucerna sr in chinese drug-naïve subjects with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of the study is to evaluate the effect of glucerna sr treating newly-diagnosed type 2 diabetes patients (ndm) on glycemic stability, with the application of cgms (continuous glucose monitoring system) and to further realize the safety and effect of glucerna sr on daily and day-to-day amplitude of blood glucose fluctuation.

glucerna sr (abbott laboratories, columbus, usa) is a nutritional product with lower glycemic response. about 24% of the total energy provided by glucerna sr is due to monounsaturated fatty acids, which can help keep good metabolic state in accordance with the recommendations of the american heart association. the aim of the study is to evaluate the effect of glucerna sr treating newly-diagnosed type 2 diabetes patients (ndm) on glycemic stability, with the application of cgms (continuous glucose monitoring system) and to further realize the safety and effect of glucerna sr consumed as a meal replacement at breakfast meal on daily and day-to-day amplitude of blood glucose fluctuation.

Eligibility criteria:
inclusion criteria: * newly diagnosed type 2 diabetes mellitus * fpg≤13mmol/l and/or 2hpg≤18mmol/l * hba1c≥7.0% * bmi (body mass index)≥18.5kg/m2 exclusion criteria: * patients taking any class of injectible or oral hypoglycemia agents to manage their hyperglycemia. * female patients are in gestation, lactation or intend to be pregnant in the study period. * patients are with type 1 diabetes, or other special types of diabetes, or gestational diabetes mellitus. * patients with drug hypersensitivity. * patients with obvious hepatic or renal diseases (alt, t-bil\>1.5 times of upper limit) * patients with severe or unstable angina, or heart failure (nyha class iii/iv) * patients having acute complications, or chronic complications maintained insulin therapy or insulin therapy under stress. * patients with chronic consumptive diseases like cerebrovascular disease, tumor, tuberculosis, or hematopathy, psychosis, autoimmune disease or severe digestive dysfunction.
transplantation of cultivated limbal epithelium on amniotic membrane for limbal stem cell deficiency

Conditions: Ocular Surface Disease

Summary: to evaluate the effectiveness of autologous (tissue from fellow eye) transplantation of cultivated limbal epithelium on amniotic membrane to treat severe surface irregularity and scarring of the corneal surface.

the corneal epithelium is under constant cell-turnover,and it has been shown that the limbus is the ultimate source of epithelial renewal. significant damage to limbal cells causes a disease state called limbal stem cell deficiency(lscd),characterized by different extents of conjunctival overgrowth onto cornea, vascularization, chronic inflammation, and poor epithelial integrity. in unilateral lscd, the damaged corneal surface may be reconstructed using two large segments of healthy limbal tissue (of approximately 6-8mm by 1mm) from the fellow eye in the procedure of conventional limbal transplantation.this may however compromise ocular surface integrity of the healthy eye depending on the amount of donated limbus. in more recent years, it has been possible to "save" limbal tissue by obtaining only a very small limbal biopsy (2mm by 1mm) from the fellow healthy eye which is "expanded" into a viable sheet of limbal cells via laboratory cultivation.this cultivated sheet of cells is transplanted to treat the damaged ocular surface. this study is a prospective nonrandomized trial which evaluates the efficacy of transplantation of autologous ex-vivo expanded limbal epithelium on intact amniotic membrane for unilateral total limbal stem cell deficiency.

Eligibility criteria:
inclusion criteria: * unilateral total limbal stem cell deficiency with normal fellow eye, or minimally damaged fellow eye (less than 1/3 limbus affected) exclusion criteria: * systemic disease affecting both eyes such as stevens-johnson syndrome

Keywords: autologous transplantation ex-vivo expanded limbal epithelium limbal deficiency
18 month prospective efficacy and safety study of bimatoprost intracameral implant (durysta)

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: study to collect effectiveness and safety data after administration of a bimatoprost intracameral implant in patients with open-angle glaucoma (oag) or ocular hypertension (oht).


Eligibility criteria:
inclusion criteria: - patient diagnosed with oag or oht who is scheduled to receive a bimatoprost intracameral implant in at least one eye. exclusion criteria: - a history of any of the following ocular surgeries in the eye due to receive a bimatoprost intracameral implant:ahmed glaucoma valve, baerveldt shunt, ex-press glaucoma shunt implantation, molteno shunt, trabeculectomy, vitrectomy, retinal surgery, cypass micro-stent or anterior chamber intraocular lens (ac iol) placement. * concurrent or anticipated enrollment in an interventional clinical trial involving either an investigational medicinal product or medical device. * previous enrollment in another allergan bimatoprost intracameral implant study.