Kornimate/medical-research-clean huggingface dataset:
everlinq endovascular access systems enhancements (ease-2) study

Conditions: Chronic Kidney Diseases

Summary: prospective, single-center study to evaluate the everlinq endoavf system when used to create an endoavf in hemodialysis patients. this study aims to investigate expansion of the percutaneous venous access location to the superficial system which may provide additional procedural benefit.

a total of up to 50 subjects will be enrolled and will undergo an endoavf creation procedure using the everlinq system. all subjects may be followed for up to 12 months post index procedure based on investigator's discretion. the duration of the study is expected to be approximately two (2) years.

Eligibility criteria:
inclusion criteria: 1. eligible for a native arteriovenous fistula. 2. adult (age \>18 years old). 3. established, non-reversible kidney failure requiring hemodialysis (including pre-dialysis patients). 4. target vein diameter(s) at fistula site ≥ 2.0 mm. 5. target artery diameter at fistula site ≥ 2.0 mm. 6. procedural access site artery and vein diameter ≥ 2.0 mm. 7. at least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the perforating vein. 8. estimated life expectancy \> 1 year. 9. patient is free of clinically significant conditions or illness within 30 days prior to the av fistula that may compromise the procedure. 10. presence of an antecubital perforating vein diameter ≥ 2.0 mm. exclusion criteria: 1. known central venous stenosis or central vein narrowing \> 50% based on imaging on the same side as the planned avf creation. 2. upper extremity venous occlusion(s) and/or vessel abnormality(ies) on the same side as the planned avf creation that precludes endovascular avf creation by the everlinq system as deemed by the interventionalists' clinical judgment. 3. prior surgically created access in the planned treatment location. 4. functioning surgical access in the planned treatment arm. 5. pregnant women. 6. new york heart association (nyha) class iii or iv heart failure. 7. hypercoagulable state. 8. known bleeding diathesis. 9. immunosuppression, defined as use of immunosuppressive medications used to treat an active condition. 10. documented history of drug abuse including intravenous drugs within six months of avf creation. 11. "planned" concomitant major surgical procedure within 6 months of enrollment or previous major surgery within 30 days of enrollment. 12. currently being treated with another investigational device or drug. 13. known allergy to contrast dye which cannot be adequately pre-medicated. 14. known adverse effects to sedation and/or anesthesia which cannot be adequately pre- medicated. 15. patients who do not have an ulnar or radial artery. 16. distance between target artery and vein or other anatomical abnormality will not permit catheters to be introduced, navigated to fistula site, or allow magnets to align vessels sufficiently to create the fistula. 17. evidence of calcification in vessels at the fistula site. 18. evidence of active infections on the day of the index procedure. 19. written informed consent not obtained.
concurrent nimotuzumab versus cisplatin with radiotherapy for locoregionally advanced npc

Conditions: Nasopharyngeal Carcinoma

Summary: the study is to evaluate whether concurrent nimotuzumab could decrease the severe acute treatment-related toxicities compared with concurrent chemoradiotherapy for locoregionally advanced npc. three hundreds and twenty patients will be recruited into this study.

scheme: eligible stage iii and iva/b npc patients will first be stratified by institution, then randomized to 2 arms at 1:1 ratio. - arm cisplatin: neoadjuvant tpf chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-fu 2500 mg/m2 every 3 weeks for 3 cycles), followed by cisplatin 40 mg/m2/week in concurrent with imrt - arm nimotuzumab: neoadjuvant tpf chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2, 5-fu 2500 mg/m2 every 3 weeks for 3 cycles), followed by weekly nimotuzumab 200mg in concurrent with imrt

Eligibility criteria:
inclusion criteria: * histologically proven poorly differentiated or undifferentiated carcinoma of the nasopharynx. * stage iii and iva/b npc patients * kps \>70 * age between 18-70 * agc \> 2000, platelets \> 100,000, ast or alt\ 50ml/min exclusion criteria: * histology other than poorly differentiated or undifferentiated carcinoma, including keratinized squamous cell carcinoma. * evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations. * initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease. * patients with simultaneous or prior malignancy (not include basal cell carcinoma of skin) * prior radiation treatment to the head and neck or any prior chemotherapy

Keywords: nasopharyngeal carcinoma neoadjuvant chemotherapy concurrent chemotherapy nimotuzumab
a 6-month study to evaluate sulforaphane add-on effects in treatment of schizophrenia

Conditions: Schizophrenia

Summary: the goal of the study is to investigate whether adding different doses of sulforaphane will benefit the clinical symptoms and cognitive function in individuals who have schizophrenia. this study will compare the sulforaphane with placebo. there is a thirty percent change (less than half) of receiving the placebo. the purpose of including placebo is to judge if the outcome is related to the study medication rather than other reasons.

this study will be carried out in six mental health institutes in china and total of 180 patients with first-episode or early onset schizophrenia will be enrolled into the study. the mental health institute at the second xiangya hospital, central south university. individuals who participate in the study will be followed for 24 weeks. the changes in clinical symptoms and neurocognitive function will be assessed from baseline (week-2) to week-6 (acute phase), and week-12 to week-24 (maintenance phase).

Eligibility criteria:
inclusion criteria: 1. meet the diagnostic and statistical manual (dsm-v) diagnostic criteria for schizophrenia 2. first onset or duration of illness less than 3 years with current symptoms exacerbation 3. hospitalized in an acute episode (first hospitalization), or subsequent hospitalization or acute relapse) 4. male and female with aged 18 to 50 years 5. panss total \>=75 at 2 weeks. . 6. signed the study consent for participation exclusion criteria: 1. having history of substance dependence or abuse or whose symptoms are caused by the other diagnosable mental disorders; 2. having history of traumatic brain injury, seizures or other known neurological or organic diseases of the central nervous system; 3. taking antidepressants, stimulants, mood stabilizer or accepts electricity shock treatment; 4. having current suicidal or homicidal thoughts or any safety concern by research staff that cannot be manage in an inpatient setting; 5. the routine blood tests showing abnormal renal, liver function or other metabolic results . 6. pregnant or lactating women

Keywords: schizophrenia sulforaphane
correlation of menstrual cycle phase at time of primary surgery with 5-year disease-free survival in women with stage i or stage ii breast cancer

Conditions: Breast Cancer; Perioperative/Postoperative Complications

Summary: rationale: timing of breast cancer surgery may improve effectiveness of treatment and may help patients live longer. purpose: clinical trial to determine whether timing of primary surgery in relation to menstrual cycle is associated with disease-free survival 5 years after surgery in women who have stage i or stage ii breast cancer.

objectives: * document menstrual phase (follicular vs luteal) by circulating hormones and menstrual history at the time of primary surgery in premenopausal women with stage i or ii breast cancer. * correlate menstrual phase at primary surgery with 5-year disease-free survival in these patients. * compare the menstrual cycle data obtained by hormone levels and study-specific menstrual cycle history with information recorded in the general written record. * compare the menstrual cycle data (e.g., hormone levels and cycle history) for these women with the data for the general population. * estimate the disease-free survival of women who undergo a 2-stage surgical procedure with cancer found at both stages when the surgery is not confined to the same menstrual cycle phase. premenopausal women age 18 to 55 years, who were interviewed for menstrual history and who were surgically treated for stages i to ii breast cancer, had serum drawn within 1 day of surgery for estradiol, progesterone, and luteinizing hormone levels. menstrual history and hormone levels were used to determine menstrual phase: luteal, follicular, and other. disease-free survival (dfs) and overall survival (os) rates were determined by kaplan-meier method and were compared by using the log-rank test and cox proportional hazard modeling.

Eligibility criteria:
inclusion criteria: 1. women age 18 to 55 years 2. regular menstrual cycles of 21- to 35-days duration 3. pathologic stages i to ii breast cancer, in whom all gross disease-including ductal carcinoma in situ-was surgically removed either in a one-stage or two-stage procedure. 4. required serum be drawn within 1 calendar day of the lumpectomy/mastectomy for women who underwent a one-stage procedure and within 1 calendar day of each stage for women who underwent a two-stage procedure. exclusion criteria: 1. lactation within the past 3 months 2. galactorrhea 3. neoadjuvant therapy 4. previous breast cancer, and history of any cancer (except squamous or basal cell skin carcinoma) in which the patient was not disease-free for at least 10 years

Keywords: stage i breast cancer stage ii breast cancer perioperative/postoperative complications
impact of health literacy on outcomes and effectiveness of shared decision making programs in patients with chronic diseases

Conditions: Coronary Artery Disease

Summary: study objective was to explore the impact of health literacy on effectiveness of an educational intervention describing life-style and behavior modification for patients "living with coronary artery disease." our hypothesis was that a vhs/dvd version of this educational program would be "superior" to printed material alone in its impact on patients' knowledge about coronary artery disease and important life-style changes. furthermore, we believed this effect would be most notable among patients with low health literacy. we also were interested in the impact of the interventions on secondary outcomes including - health behaviors, health outcomes and patients' subjective experiences.

187 patients with coronary artery disease (cad) were randomized to one of two educational interventions prior to scheduled ambulatory visit: vhs/dvd plus printed booklet; or booklet alone. main measures included health literacy, cad knowledge assessment; clinical outcomes and health behaviors including - blood pressure, weight, smoking status, exercise and dietary habits.

Eligibility criteria:
inclusion criteria: * age \>= 18, * diagnosis of ischemic heart disease. exclusion criteria: * nursing home resident, * did not speak english, or * had a significant visual impairment that precluded their ability to read or watch television.

Keywords: health literacy patient education health behaviors chronic disease management shared decision-making patient-centered decision making
tuc3pii-01_tu2670 phase iia clinical study

Conditions: Endometriosis

Summary: this protocol for tu2670 is to investigate the efficacy, safety, pharmacokinetics (pk), and pharmacodynamics (pd) of multiple doses of tu2670 in subjects with moderate to severe endometriosis-associated pain.

treatment groups and duration: following a washout period of up to 12 weeks, subjects will enter a screening period of up to 12 weeks including an observation period consisting of a complete menstrual cycle. subjects will be randomly assigned in a 1:1:1:1 ratio to receive either 12 weeks of tu2670 320 mg qd, tu2670 240 mg qd, tu2670 120 mg qd, or matching placebo. tu2670 or a matching placebo will be administered in the clinic on day 1. subjects in the pk subset population will also receive the following additional doses in the clinic: day 2 (after collection of the 24-hour pk sample); the dose on the day scheduled for subsequent serial pk sample collection (week 4 or week 5); and the next scheduled dose (after collection of the 24-hour pk sample). all other doses can be taken by the subject at home. following the end of treatment, subjects will be followed up for safety for 12 weeks. statistical methods: all formal statistical tests will be done at the 5% 2-sided significance level. point estimates will have 2 sided 95% confidence intervals (cis) where applicable. where appropriate, variables will be summarized descriptively (frequency and percent will be summarized for categorical variables; n (number of available subjects), mean, standard deviation \[sd\], median, minimum, and maximum will be presented for continuous variables) by study visit and by treatment group. statistical summaries will be presented for the changes from baseline to each time point in efficacy endpoints that it is applicable.

Eligibility criteria:
inclusion criteria: * independent ethics committee (iec)-approved written informed consent/assent and privacy language as per national regulations must be voluntarily obtained from the subject. * premenopausal female subject, 18 to 45 years, inclusive * subject has moderate to severe endometriosis-related pain exclusion criteria: * subject has used hormonal contraceptives or other drugs with effects on gynecological endocrinology within 12 weeks * subject has been nonresponsive to gnrh-agonist or antagonist therapy for the management of endometriosis.
home biofeedback or pelvic floor physical therapy for postpartum urinary incontinence.

Conditions: Urinary Incontinence; Pelvic Floor Disorders

Summary: pelvic floor dysfunction is commonly seen in the postpartum women with symptoms including urinary urgency and frequency, urinary incontinence and fecal incontinence. pelvic floor physical therapy (pfpt) and home biofeedback devices have been shown to improve pelvic floor symptoms in postpartum and non-postpartum populations, respectively. this randomized noninferiority clinical trial will assess urinary incontinence-related quality of life in postpartum women with self-reported urinary incontinence who are randomized to a program of home biofeedback or pelvic floor physical therapy.

the objective of this proposal is to determine if home biofeedback devices are noninferior to pelvic floor physical therapy for the treatment of postpartum urinary incontinence through a randomized noninferiority clinical trial. the hypothesis is that both interventions will improve incontinence-related quality of life and that home biofeedback will be noninferior to pfpt. two specific aims will be investigated: 1) determine the impact of both interventions on urinary incontinence-related quality of life measured by the change in score at 3-months on the international consultation on incontinence questionnaire short form (iciq-sf); 2) determine patient impression of symptoms improvement (measured by the change in score at 3-months and 1-year on the patient global impression of improvement scale or pgi-i), overall pelvic floor symptoms (measured by the change in score at 3-months and 1-year on the pelvic floor distress inventory of pfdi) and changes in sexual function (measured by a change in score at 3-months and 1-year in the female sexual function index or fsfi). an additional exploratory aim will be to observe the change in pelvic floor symptoms in the postpartum period at 3-months and 1-year among a cohort of women who elect for the standard of care without pfpt or biofeedback.

Eligibility criteria:
inclusion criteria: * following a vaginal delivery (primiparous or multiparous, spontaneous, forceps, or vacuum assisted) * willingness to participate in pfpt or home biofeedback exercises * access to a smartphone with bluetooth capabilities * positive screen for urinary incontinence between 4 and 8 weeks postpartum defined as patient report of any urinary leakage within the prior two weeks exclusion criteria: * multiple births or deliver at ≤34 weeks * previous urinary incontinence or pelvic organ prolapse surgery * self-identified pre-pregnancy pelvic floor disorder such as urinary incontinence * fecal incontinence or chronic pelvic pain or if they have a history of prior pfpt
long-term follow up study

Conditions: Major Depressive Disorder

Summary: the ltfu study will conduct a naturalistic follow up of the well characterized can-bind study population of patients every six months and continuing over a five-year period. this will provide information on the longitudinal progress in mood, functioning, and quality of life of the can-bind sample with a view towards long-term outcome and treatment.

this is a long-term follow up study of the 'canadian biomarker integration network in depression' (can-bind) study. the can-bind study examines biological markers of antidepressant treatment response. the examined biomarkers included clinical, imaging, and genetic components. the long term follow up (ltfu) study will continue to follow the patients in this study each six months over a five year period. by doing so, a comprehensive clinical outcome data on a well characterized cohort of depressed patients will be obtained. the research team will conduct a naturalistic study of can-bind participants and will monitor the longitudinal progress in mood, functioning, and quality of life, with a view towards advising future treatment options. each patient completing can-bind will be asked to participate in the ltfu study.

Eligibility criteria:
inclusion criteria: * each patient completing the 16 weeks of can-bind who have previously met dsm-iv-tr criteria for major depressive episode (mde) in mdd as determined by mini. exclusion criteria: * any axis i diagnosis, other than mdd, that is considered the primary diagnosis. * bipolar i or bipolar ii diagnosis (lifetime), mdd with psychotic features (lifetime), schizophrenia or schizoaffective disorder. * presence of a significant axis ii diagnosis (borderline, antisocial). * high suicidal risk, defined by clinician judgement. * history of drug or alcohol use, with a severity of at least moderate or severe, according to dsm criteria, within the previous 6 months. * presence of significant neurologic disorder, head trauma, or other unstable medical conditions. * subject has any condition, for which in the opinion of the investigator, participation would not be in the interest of the subject (e.g. compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

Keywords: major depression major depressive disorder biomarkers mdd long term follow up
prevention of pressure ulcers in patients under non-invasive mechanical ventilation

Conditions: Respiratory Failure

Summary: this study aims to test direct application of the non-invasive mechanical ventilation -nivm- mask or interface as the most efficient intervention to prevent pressure ulcers (pu), compared with other three usual preventive measures which consist in the use of three different medical devices.

non-invasive mechanical ventilation (nivm) has turned into a standard in the care of patients with acute respiratory failure. defined as a support modality to the patient's spontaneous ventilation, it does not use invasive techniques to ventilate, working as an external device named interface or mask, avoiding so the complications associated to the invasive ventilation. nivm had been restricted to icu and pneumology services, but in the last years it has been extended to er with good results and it is being also used in the pre-hospital attention and in the home care of chronic patient. often, the preferred interface is the oronasal, worst tolerated but associated to best treatment of the acute pathology. in most cases to avoid air leaks, its proper placement generates high pressure on the skin, being able to harm patient's tissues, so that this therapy as intervention for the acute patient has pressure ulcers -pu- as main iatrogenic effect - although 95% of the pu are considered as preventable-. to diminish the pressure of the mask on the points of the face, nurses protect the most exposed zones with dressings of hydrogel-foam, polyurethane and/or hyperoxygenated fatty acids, trying to prevent pu. reviewed studies present a big variability in these practices as well as high dispersion of the results achieved. preventive measures are different and even none, as applying the mask or the interface directly could be the most effective treatment in the prevention of pu, avoiding not justified increase of fungible and other resources consumption. the aim of this study is to test direct application of the mask or interface, as the most efficient intervention, compared with other three usual preventive measures which consist in the use of three different medical devices: autoadhesive polyurethane dressing (allevyn thin®), semi-permeable hydrogel-foams adhesive dressing (askina transorbent border®) or hyperoxygenated fatty acids (linovera®)

Eligibility criteria:
inclusion criteria: * adults (≥18 years). * not tissue injury in face. * not structural deformation of the facial anatomy. exclusion criteria: * rejects informed consent

Keywords: noninvasive mechanical ventilation (nivm) continuous positive airway pressure (cpap) ventilation bilevel positive airway pressure (bipap) ventilation pressure ulcer (pu) nursing assessment
the baltimore experience corps study

Conditions: Aging; Generativity

Summary: the purpose of this study is to examine the effectiveness of the experience corps program in preventing or delaying physical disability in older adults, by studying the effects of volunteerism on physical, social and cognitive well-being.

the baltimore experience corps study is a randomized, controlled, community-based trial of the effectiveness of experience corps (ec) to determine if participation for adults 60 years and older, over two years of follow-up, results in better outcomes in the ec versus control arm in terms of mobility, strength, balance, and cognitive functioning. the experience corps is a community-based model for health promotion for older adults embedded within a social engagement program. the program places older adult volunteers in meaningful roles in public elementary schools, bringing the time, experience, and wisdom of older adults to bear in improving academic and behavioral outcomes of children. the experience corps incorporates health promotion preventing disability and dependency associated with aging, into new, generative roles for older adults. this program was initially designed by dr. linda fried of this application, along with marc freedman of civic ventures, inc. it has gone through two national demonstrations, neither of which evaluated the impact on older adults.

Eligibility criteria:
inclusion criteria: * 60 years or older * agree to commit to at least 1 year of participation in the ec and to participate at least 15 hours per week for the full school year, if randomized to the intervention group * meet minimum criteria for cognitive functioning necessary to function successfully in a school setting * functionally literate, using a nationally recognized and standardized evaluation which provides grade level equivalency in reading and spelling * ability to travel to the schools, if randomized to the intervention group * agree to accept randomization and to participate in evaluations * clearance on the baltimore city public school's criminal background check, if randomized to intervention group * complete training, if randomized to intervention group exclusion criteria: * under 60 years of age

Keywords: quality of life cognitive functioning activities of daily living disability prevention