Kornimate/medical-research-clean huggingface dataset:
medication dispenser to improve care at home for the elderly

Conditions: Medication Adherence; Cognitive Impairment

Summary: the purpose of this study is to investigate the efficacy of the karie automated medication delivery device in enhancing medication adherence among a group of elderly patients with mild to moderate cognitive decline.

given the risks associated with poor adherence and the apparent contribution of good adherence to reducing hospitalizations and emergency department (ed) visits, interventions for promoting good adherence should be pursued. to this end, a number of devices have been developed to promote medication adherence, though with limited success due to reliability, cost, etc. the purpose of this study is to investigate the efficacy of the karie automated medication delivery device in enhancing medication adherence among a group of community-dwelling patients immediately following discharge from inpatient rehabilitation. this study will utilize a multi-site randomized controlled trial design. one week prior to discharge from inpatient rehab, consenting patients will be randomly assigned to receive medication self-management education only (sme) or medication self-management education + karie (sme+k). both sites (west park healthcare centre, and capitalcare) will recruit 150 participants for the study. at each site, 75 patients will be in the intervention group (sme + karie) and 75 will be in the control group (sme only).

Eligibility criteria:
inclusion criteria: * need to manage medications independently at home * stabilized on medication, as per pharmacist/physician discretion; and * mild-moderate cognitive/physical impairments, as per ot assessment * montreal cognitive assessment (moca) score not less than 16 * english speaking exclusion criteria: * absent from community for more than one month during study * inability to access study site pharmacy following discharge

Keywords: medication adherence medication dispensing homecare elderly
treatment of postsphincterotomy bleeding with a novel self-assembling peptide hemostatic gel.

Conditions: Biliary Obstruction; Complication of Treatment

Summary: the aim of this observational study is to evaluate safety and efficacy of a novel self-assembling peptide hemostatic gel in reduction of bleeding after endoscopic sphincterotomy during ercp (endoscopic retrograde cholangiopancreatography )

ercp with sfincterotomy or precut is connected with procedural or/and postprocedural bleeding. estimated risk of bleeding is from 2% to 10%. procedural bleeding is usually managed by diluted epinephrine injection, balloon tamponade, hemoclip or fully covered metalic self-expanding stent placement. there is no standard preventive treatment for patients with higher risk of delayed post-sphincterotomy bleeding. purastat®, 3d matrix europe sas, caluire-et-cuire, france) is synthetic self-assembling peptide haemostatic gel indicated to stop bleeding from small blood vessel or oozing from capillaries. purastat® is easily aplicated through a catheter during the ercp procedure and it is not significantly prolonging the procedure. the transparent gel is not compromising the endoscopic view and enables to continue in procedure if necessary. all patients after ercp sfincterotomy or precut will recieve purastat® during the procedure adverse events (bleeding, cholangoitis, pancreatitis) will be monitored during following 4 weeks (ambulatory after hospital discharge) this cohort will be compared to historical control, when purastat® was not available tu use.

Eligibility criteria:
inclusion criteria: * . all patients indicated for ercp with papilosphincterotomy or precut. * participant is willing and able to give informed consent for participation in the study exclusion criteria: * known allergy to a novel hemostatic agent * gravidity * inability to sign informed consent

Keywords: ercp a novel haemostatic agent postsfincterothomy bleeding
consortium of early arthritis cohorts usa

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is the most common form of inflammatory arthritis. in the us, it is estimated that as many as 3 million adults may suffer from the disease. fortunately in the last few years, a shift in strategy toward the earlier institution of disease modifying drugs and the availability of new classes of medications have greatly improved the outcomes that can be expected by most patients. the goal of treatment now aims toward achieving the lowest possible level of arthritis disease activity and even remission, if possible as early on as possible. research has shown that this translates into minimized joint damage and enhanced physical function and quality of life for the ra patient. this also requires that a diagnosis of ra be made as early on as possible, and herein lies the challenge, i.e. identifying the ra patient early on in the course of their disease.

this is a study of usual care, a prospective cohort of all eligible and consenting patients referred to the inflammatory arthritis center of excellence and the division of rheumatology, department of medicine at hss as well as 3 consortium sites across the u.s. in order to study the effectiveness of recommended treatments in usual practice in different patients for short-term and long-term outcomes, and to determine factors that may predict how a patient's disease might progress over time, investigators will need to analyze and describe the strategies used to manage these patients and will need to understand: i. the frequency of single time-point and sustained (two or more time points) remission or low disease activity over time ii. factors that influence remission iii. which patients can achieve persistent sustained remission, and iv. who can undergo drug withdrawal and still sustain remission of low disease activity v. factors associated with treatment optimization or barriers to achieving this

Eligibility criteria:
inclusion criteria: * patient was 18 years of age or over at time of referral * joint symptoms for \< 12 months * 2+ swollen joints or 1 swollen joint with one of the following: rheumatoid factor \> 20 iu, (+) anti-ccp antibody, morning stiffness \> 45 minutes, responded to nsaids, (+) mtp squeeze test
interest of intravaginal electro-stimulation at home by gyneffik® compared to usual care in incontinent patients with prior perineal reeducation

Conditions: Urinary Stress Incontinence; Urinary Mixed Incontinence

Summary: the aim of this study is to assess the benefit of gyneffik®, a perineal electro-stimulator, during this home-care phase. women with stress urinary incontinence (ui) or with mixed ui (composed predominantly of stress ui), that responded to physiotherapy were included in this study in two parallel groups. the groups followed a self-reeducation program, with or without gyneffik® electro-stimulation sessions. the comparison of the two groups was based on the rate of women for whom the benefit of the initial perineal reeducation was maintained.


Eligibility criteria:
inclusion criteria: * out-patient over 18 years old, having understood and signed the informed consent form * seen for urinary stress incontinence or urinary mixed incontinence (with a major stress incontinence part) troubles * spontaneously asking for help * who can be followed for a long time exclusion criteria: * urinary incontinence (ui) found out during medical interviewing without spontaneous complaint * urinary troubles due to neurological pathology (stroke, multiple sclerosis, ...) * ui due to congenital malformation * ui having led to surgery * ui treated in the last 6 months * ui within 24 weeks of past partum * pelvic surgery within 12 months * on-going inflammatory or infectious neoplastic disease * perineal hypoesthesia * local conditions prohibiting the use of an intra-vaginal device (vaginal atrophia, continuous metrorrhagia, vaginal prolapse \> 2°, ...) * pacemaker use * women of child bearing potential without effective method of contraception or planning to get pregnant in the next 12 months * intravaginal contraception * mental impairment or inability to understand or follow study instructions * patient who may not come back to the study visits * patient already enrolled for another study or having been enrolled in another clinical study in the past 3 months

Keywords: urinary stress incontinence urinary mixed incontinence
pentoxifylline and systemic inflammation in hemodialysis patients

Conditions: Inflammation; End-stage Renal Disease; Hemodialysis

Summary: the aim of this study was to compare the effect of ptx vs placebo on serum concentrations of tnf-α, il-6, and crp in patients on hemodialysis.

patients were randomly selected from the total hd patients of our hospital. once included, patients were randomly allocated (by a computer-generated randomization list) to a study or control group. over a period of 4 months, patients of the study group received one ptx tablet (400 mg) orally once a day (at dinner time), whereas controls received one starch identical tablet on the same schedule. all patients had three hd sessions per week, with the same kind of single-use dialysis membrane and dialysate. monthly visits were scheduled for clinical and biochemical evaluations. a blood sample was taken at baseline and every month for measurement of complete blood count, urea, creatinine, glucose, albumin, lipids, and electrolytes (measured by usual methods). in serum samples at 0, 2 and 4 months, tnf-α and il-6 concentrations were measured by elisa using high sensitivity kits (amersham pharmacia biotech, buckinghamshire, uk). additionally, in the same serum samples, crp concentrations were measured by nephelometry using high sensitivity kits (dade behring, marburg, germany) in a nephelometry analyzer ii (dade behring, marburg, germany). all laboratory measurements, including inflammation markers, were performed in the central laboratory (hospital de especialidades, cmno), by the same personnel blinded to patient's details. treatment compliance was recorded by counting tablets left in the container at the end of each monthly visit.

Eligibility criteria:
inclusion criteria: * age ≥18 years, * ≥2 months on hd, * arteriovenous fistula as vascular access, and * endorsement of informed consent. exclusion criteria: * inflammatory cause of esrd, * liver disease, cancer, aids, * any infectious disease 2 months before the study, * failed kidney graft, * hypersensitivity to ptx or other methylxanthines, * hemorrhage/clotting disorders, * risk for worsening pre-existing cardiac arrhythmias or arterial hypotension, * treatment with antibiotics, non-steroidal anti-inflammatory drugs, steroids, immunosuppressives, statins or ptx 3 months previous to the study

Keywords: inflammation pentoxifylline hemodialysis
connecting through caregiving: reappraising intergeneration relationships

Conditions: Dementia

Summary: the purpose of the present study is to examine the effects of perspective-taking reappraisals on the well-being of adult-child dementia caregivers.

dementia caregiving presents a particular challenge wherein the adult child is parenting his or her parents. facilitating relational insights, the key components of the connecting through caregiving (ctc) intervention involves the following: 1) enhancing self-awareness of the caregiver, 2) developing interpersonal empathy of the care-recipient, 3) help-seeking, 4) balancing self-care and caring for others and 5) negotiating action plans. the ctc intervention is be evaluated against a basic skill training intervention consisting of scheduling pleasant events, communicating with the care recipient and other family members. dementia caregivers providing at least 14 hours of care per week to a parent living with dementia are recruited and randomized into one the two conditions. the intervention lasts for six weeks for both conditions. intervention in the first week consists of a home visit and a telephone follow-up. from the second to fifth week, there are weekly four telephone phone sessions. in the sixth week, there were two more telephone calls to consolidate the intervention and to review implementation plans.

Eligibility criteria:
inclusion criteria: * the study participants will be primary caregivers aged 18 or older and who have been caring for persons (aged 60 or above) with a physician diagnosis of alzheimer's disease in the mild to moderate range as determined by the clinical dementia rating scale. * primary caregivers are those who have been providing unpaid care for more than 14 hours a week for at least the past three months. * the care should involve day-to-day decision-making as well as any of the following: feeding, dressing, bathing, toileting, housework, preparing meals, medication and handling finances. * they can be daughter/son or daughter-/son-in-law of the care recipients. exclusion criteria: * exclusion criteria are as follows: signs of severe intellectual deficits, demonstrated suicidal ideation, exhibited evidence of psychotic disorders, hearing/ visual impairment or inability to read or speak chinese/cantonese fluently and severe.

Keywords: intergeneration reappraisal caregiving
a study of the in-space device for treatment of moderate spinal stenosis

Conditions: Spinal Stenosis

Summary: the purpose of this study is to evaluate the safety and effectiveness of the in-space compared to the x stop interspinous process distraction (ipd) device ("x stop") for the treatment of patients experiencing intermittent neurogenic claudication secondary to moderate degenerative lumbar stenosis at one or two lumbar levels.


Eligibility criteria:
inclusion criteria: * ≥ 50 years in age * leg/buttock/groin pain, with or without back pain, that can be completely relieved by flexion such as when sitting in a chair. * zurich claudication questionnaire score ≥ 2.0, * neurogenic intermittent claudication secondary to moderate lumbar spinal stenosis * has completed at least 6 months conservative therapy exclusion criteria: * axial back pain only without leg/buttock/groin pain * has had any prior lumbar spine surgery at any level * significant scoliosis, defined as cobb angle \> 10° * spondylolisthesis \> grade 1 or isthmic spondylolisthesis at affected level * osteoporosis * morbid obesity, defined as bmi \> 40 kg/m2
study of the glutaminase inhibitor cb-839 in leukemia

Conditions: Acute Myeloid Leukemia (AML); Acute Lymphocytic Leukemia (ALL)

Summary: many tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival. to exploit the dependence of tumors on glutamine, cb-839, a potent and selective inhibitor of the first enzyme in glutamine utilization, glutaminase, will be tested in this phase 1 study in patients with leukemia. this study is an open-label phase 1 evaluation of cb-839 in subjects with leukemia. part 1 is a dose escalation study to identify the recommended phase 2 dose as a single agent and in combination with azacitidine. patients enrolled into part 2 will be treated with the recommended phase 2 dose. as an extension of part 2, patients with relapsed/ refractory or newly diagnosed aml will be treated with cb-839 in combination with azacitidine. all patients will be assessed for safety, pharmacokinetics (plasma concentration of drug), pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that may predict responsiveness in later studies), and tumor response.


Eligibility criteria:
inclusion criteria * diagnosis of aml or all, relapsed or refractory after at least 1 prior treatment regimen. newly-diagnosed patients ≥ 60 years old who have refused or are considered unfit for standard chemotherapy regimens or stem cell transplantation are also eligible. * patients must have no available approved therapies that confer clinical benefit * all patients must have bone marrow involvement of their tumor, with documented blast percentage of \> 5%. * peripheral blood blast count must be ≤ 30,000 cells/µl. * eastern cooperative oncology group (ecog) performance status of 0-2 * adequate hepatic, renal, and cardiac function exclusion criteria * any other current malignancy * patients with acute promyelocytic leukemia (apl) * treatment with an unapproved, investigational agent within 21 days of the first dose of study drug * allogeneic hematopoietic stem cell transplant or donor lymphocyte infusion within 90 days prior to to the first dose of study drug * active gvhd * unable to receive medications by mouth * major surgery within 28 days before cycle 1 day 1 * uncontrolled, active infection; patients who are known to have hiv infection/ seropositivity, hepatitis a, b, or c, or cmv reactivation * significant neurotoxicity/neuropathy (grade 3 or higher) within 14 days prior to day 1 * refractory nausea and vomiting or other situation that may preclude adequate absorption * conditions that could interfere with treatment and procedures

Keywords: leukemia glutaminase glutamine
energy expenditure of people living with hiv/aids

Conditions: HIV/AIDS; HIV Lipodystrophy Syndrome

Summary: background: several studies have reported increased resting energy expenditure (ree) in people living with hiv/aids possibly due to changes in body composition that occurs in hiv lipodystrophy syndrome. the aim of this study was to evaluate the influence of the use of lipid-lowering drugs in resting energy expenditure (ree) and total energy expenditure (tee) in patients seropositive for hiv in treatment of lipodystrophy.

ree was measured by indirect calorimetry. tee was measured by doubly labeled water (dlw) technique and an activity monitor based on accelerometry (am).

Eligibility criteria:
inclusion criteria: * use of antiretroviral therapy for at least 4 months * a cluster of differentiation 4 (cd4) t-cell count of \>200 cells/mm3 * use of lipid-lowering drugs for at least 1 month (group hiv-seropositive with lipodystrophy and use of lipid-lowering) exclusion criteria: * signs or symptoms of opportunistic infections * thyroid disease

Keywords: energy expenditure doubly labeled water accelerometer hiv lipodystrophy syndrome.
safety study of pelvic and prostatic sib-imrt with long-term androgen deprivation for high risk localized prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate the incidence of urinary and rectal acute side effects of a pelvic and prostatic intensity-modulated arctherapy with simultaneous integrated boost (sib-imrt)combined with long-term androgen deprivation for patients with high risk localized prostate cancer


Eligibility criteria:
inclusion criteria: 1. histologically confirmed adenocarcinoma of the prostate 2. high risk localized adenocarcinoma defined by at least one of the following criteria: * clinical stage t2c, t3 or t4 * gleason score ≥ 8 * prostate-specific antigen (psa)≥ 20 ng/ml and ≤ 100 ng/ml 3. patient cn0, pn0 or nx (negative lymphadenectomy or no lymphadenectomy) 4. no pelvic adenopathy ≥ 15 mm on ct or mri, 5. absence of bone and/or visceral metastasis 6. androgen deprivation beginning no later than the day of radiotherapy and up to six months before irradiation 7. absence of prior pelvic radiotherapy, 8. absence of surgical treatment of prostate cancer except transurethral resection performed within 4 months minimum before radiotherapy, 9. age ≥ 18 years and ≤ 85 years 10. ecog performance status ≤ 1, 11. estimated life expectancy \> 5 years 12. membership of a social security system, 13. signed informed consent. exclusion criteria: 1. prostate cancer histology other than adenocarcinoma, 2. pn1 patients (lymph node dissection after histologically proven) 3. psa \> 100 ng/ml 4. history of cancer within 5 years prior to trial entry (with the exception of basal cell carcinoma skin) 5. patient with severe hypertension uncontrolled by appropriate treatment (≥ 160 mm hg systolic and / or ≥ 90 mm hg diastolic) 6. contra-indication for pelvic irradiation (eg scleroderma, chronic inflammatory disease of the digestive tract, etc ...) 7. contra-indication to agonists or antagonists of lh-rh 8. bilateral hip prosthesis, 9. patients already included in another clinical trial with an experimental molecule, 10. persons deprived of liberty or under guardianship 11. unable to undergo medical test for geographical, social or psychological.

Keywords: localized high risk
metabolic phenotypes in melanoma

Conditions: Melanoma

Summary: this is a single centre, correlative, longitudinal, biomarker study that aims to describe the metabolic features of human melanoma using mass spectrometry.

this is a single-centre, correlative study designed to investigate metabolic phenotypes in a longitudinal cohort of patients with melanoma. this study will involve the collection of tissue at the time of surgical excision or biopsy. the key intervention, in a subset of patients, will be to perform peri-operative infusions of a stable isotope, \[u13c\]glucose. patients will be intravenously administered sterile, pyrogen-free 13c-glucose, delivered as an 8g bolus followed by infusion of 4g/hour for 2-3 hours. blood samples will be obtained to monitor glucose and to analyse enrichment of labelled nutrients by gas-chromatography mass spectrometry (gc-ms). at the time of resection or biopsy, tumour samples will be divided and either immediately frozen in liquid nitrogen or processed to form patient-derived xenografts. frozen tumour samples will be subsequently processed for: isotope enrichment by gc-ms; global metabolomics by liquid-chromatography mass spectrometry (lc-ms); and genomic analyses. relevant clinical, histologic and genomic features will also be correlated with metabolic findings.

Eligibility criteria:
inclusion criteria: 1. patient has provided written informed consent 2. male or female aged 18 years or older at written informed consent 3. presence of a known melanoma lesion requiring surgical excision or biopsy 4. patient is willing and able to comply with the protocol for the duration of the study including undergoing biopsies and receiving a stable isotope infusion (where applicable) exclusion criteria: patients who meet any of the following criteria will be excluded from receiving a \[u-13c\]glucose infusion: 1. diabetes mellitus 2. pregnancy or breast feeding 3. patients unable to comply with study procedures and follow up in the opinion of the investigator

Keywords: metabolism