Kornimate/medical-research-clean huggingface dataset:
improving care for nursing home pneumonia in nhcus and veterans' homes

Conditions: Pneumonia

Summary: nursing home acquired pneumonia (nhap) causes excessive morbidity, mortality, hospitalization, and loss of function. at any given time, 1.1-2.5% of veterans who reside at nursing home care units (nhcus) and state veterans homes (svhs) are ill with pneumonia. multi-faceted implementation of evidence-based guidelines has been shown to be feasible in the private sector. retrospective studies demonstrate an association between guideline adherence and improved survival.

background: nursing home acquired pneumonia (nhap) causes excessive morbidity, mortality, hospitalization, and loss of function. at any given time, 1.1-2.5% of veterans who reside at nursing home care units (nhcus) and state veterans homes (svhs) are ill with pneumonia. multi-faceted implementation of evidence-based guidelines has been shown to be feasible in the private sector. retrospective studies demonstrate an association between guideline adherence and improved survival. objectives: assess the feasibility of a queri-like strategy to translate the guidelines into practice at va-affiliated nursing homes through focus groups, interviews, and a small intervention trial. methods: nursing staff focus groups, key informant interviews, and tests of academic detailing (educational outreach) scripts were conducted at five facilities. based on the information gathered, the queri-like intervention was modified and tested at the florence, colorado svh during one influenza season compared to no intervention at a nearby svh. forty random svh nursing staff took an anonymous telephone survey of knowledge and attitudes about nhap twice prior to the intervention. a second randomly selected group of cnas and nurses took the survey after the intervention. research assistants enrolled residents with nhap, interviewed them and their nurses about their quality of life, assessed their function and reviewed their medical records. the intervention was multifaceted, including (1) a formative phase to tailor implementation and foster staff investment in process and outcomes, (2) institutional level change to facilitate immunization and use of appropriate antibiotics and tests; (3) interactive educational sessions to improve nursing assessment; and (4) academic detailing to physicians to impact diagnostic and prescribing practices. data were analyzed by template analysis technique for qualitative data; test-retest reliability of the knowledge and attitude survey; exploratory bivariate comparison of intervention delivery and uptake, process of care and outcomes between the intervention and control facilities. status: project work is ongoing.

Eligibility criteria:
inclusion criteria: residents of florence and walsenburg, colorado state veterans homes exclusion criteria: residents within 48 hours of death or if in facility \< 5 days
treating comorbid insomnia in transdiagnostic internet-delivered cognitive behaviour therapy

Conditions: Insomnia; Anxiety; Depression

Summary: transdiagnostic internet-delivered cognitive behaviour therapy (icbt) is an efficacious treatment option for anxiety and depression; however, not all patients benefit equally and some leave treatment before program completion. comorbid symptoms of insomnia are extremely common among individuals seeking icbt, yet sleep problems are rarely a primary focus of treatment in transdiagnostic icbt despite insomnia being a known risk factor for anxiety and depression. this trial is designed to test whether an icbt program for anxiety and depression can be improved by providing therapy for insomnia alongside the standard transdiagnostic program. for this randomized controlled trial, patients will be randomly assigned to receive either the standard icbt program for anxiety and depression, which includes only brief supplementary information about sleep (n = 68), or a modified version that includes a lesson specifically on sleep (n = 132). the sleep lesson will introduce patients to two key behavioural strategies: sleep restriction and stimulus control, which previous research has demonstrated are effective at reducing insomnia. patients will monitor their sleep throughout treatment and will complete measures of insomnia, anxiety and depression before treatment, at the end of the 8-week program, and 3 months after program conclusion to allow for a comparison of patient outcomes and completion rates between conditions. the acceptability of the new intervention will also be assessed by asking participants to provide feedback on the new materials and to complete measures of treatment satisfaction and working alliance.


Eligibility criteria:
inclusion criteria: * participants must reside in saskatchewan * participants must have access to a computer and feel comfortable using the internet * participants must be willing to provide a medical contact (e.g., family doctor) in case of medical emergency * participants must endorse some symptoms of anxiety or depression * participants must also endorse significant symptoms of insomnia (insomnia severity index score of 10 or above) exclusion criteria: * high risk of suicide * unmanaged severe psychiatric illness (e.g., psychosis, mania) * severe alcohol or addictions problems that require referral * high probability that another sleep disorder for which sleep restriction may be contraindicated is present (e.g., restless leg syndrome, sleep apnea, or sleep problems that are exclusively related to shift work)

Keywords: internet-delivered cognitive behaviour therapy insomnia depression anxiety transdiagnostic
no opioids prescriptions on discharge after surgery

Conditions: Opioid Use; Prescription Drug Abuse and Dependency; Surgery; Postoperative Pain

Summary: opioid analgesics are routinely prescribed for these patients for post-operative pain control. even a short exposure to opioids in opioid-naïve patients following minor or major surgery has been associated with de novo habitual or persistent use of opioids in 5-30% of patients. the goal of the study to eliminate the use of outpatient opioids prescriptions after major urologic surgery.

nearly 200 million opioid prescriptions are dispensed per year in the united states. opioid prescriptions given by medical providers are a major contributor to the opioid abuse epidemic. nearly 40% of opioid overdose-related deaths occur due to prescribed opioids. among patients diagnosed with opiate dependence, 80% had received an opioid prescription prior to their abuse diagnosis and 51% had a family member who had an opioid prescription, thus, opioids prescriptions, which are often in excess of the need by the patient, are a major contributor to this public health crisis. the investigators devised a prospective intervention study to eliminate or significantly reduced the use of opioids prescribed at hospital discharge after major urologic surgery.

Eligibility criteria:
inclusion criteria: * all patients undergoing major urologic cancer surgery, either open or laparoscopic, will be included in the study. * this will include all open or laparoscopic or robotic surgery including radical prostatectomy, radical cystectomy, radical nephrectomy, partial nephrectomy, nephron-ureterectomy, and similar procedures. exclusion criteria: * those with allergy or intolerance to nsaids may be excluded.

Keywords: opioids prescriptions surgery recovery pain score
high-density lipoprotein (hdl) cholesterol in women taking tibolone

Conditions: HDL Cholesterol

Summary: tibolone (livial) has been shown in previous studies to lower hdl cholesterol by up to 40%. this study aims to study the effects of fenofibrate on hdl and subfractions in women taking tibolone.

tibolone decreases plasma concentrations of hdl cholesterol and hdl-apoa1 and pre-beta hdl, consistent with a pro-atherogenic effect. the mechanism of tibolone on hdl cholesterol has been suggested to result from an acceleration of the catabolism of hdl by stimulation of hepatic lipase with no effect on cellular cholesterol efflux. ppar-a agonists, in particular fenofibrate, improve hdl metabolism by increasing the expression and hepatic secretion of hdl apoai and apoaii. we hypothesise that fenofibrate will rectify the perturbations on hdl metabolism wrought by tibolone.

Eligibility criteria:
inclusion criteria: * post-menopausal women * more than 6 months of amenorrhoea * raised fsh and low oestradiol level * if hysterectomised, raised fsh and low oestradiol level exclusion criteria: * diabetes * renal failure * proteinuria * high alcohol intake * regular endurance exercise * active weight loss of dieting * smokers * agents known to influence lipid metabolism * major systemic illness * intolerance to tibolone and fenofibrate * cholelithiasis * ck and alt \> 2uln * bleeding disorders * peptic ulcer disease.

Keywords: menopause menopausal symptoms tibolone hdl-c fenofibrate
the use of plasmajet during operative laparoscopy for endometriosis

Conditions: Endometriosis

Summary: endometriosis is a condition where functional endometrial tissue is present outside the uterus. it usually locates in the pelvis, which often includes the ovaries. one of the main concerns when performing surgery is to maintain fertility. nevertheless, a disadvantage of using monopolar and bipolar instruments for laparoscopic excision or coagulation of endometriosis lesions is the energy / thermal distribution that can cause damage to the surrounding healthy tissue. therefore, the use of ultrasound, laser or plasma energy can potentially reduce damage to surrounding tissues and prevent adhesion formation. in addition, ablation of the internal surface of endometriomas can be an effective alternative to cystectomy. the plasmajet system uses argon plasma which is released as kinetic, light and / or thermal energy. in this way the instrument can be applied within three functions, namely cutting, vaporizing and coagulating. moreover, plasma will dissipate very quickly upon contact with tissue which consequently allows a controlled depth of tissue penetration. thirdly, pure plasma energy differs from conventional electrosurgery since no electrical current will be spread through the tissue and therefore the thermal effect at surrounding tissues remains minimal. the aim of this pilot study is to investigate the feasibility, effectiveness and safety of plasma energy in the treatment of endometriosis.


Eligibility criteria:
inclusion criteria: * women between 18 and 45 years old. * the presence of endometriosis; requiring surgical laparoscopy. exclusion criteria: * women younger than 18 years. * women older than 45 years. * women who are scheduled for surgical laparoscopy where the removal of the uterus and / or ovaries is needed. * women who do not give written permission to participate.
contact force guided ablation versus conventional pulmonary vein isolation for paroxysmal atrial fibrillation

Conditions: Improving Outcome After Pulmonary Vein Isolation

Summary: the investigators prospectively investigate the differences between contact-force guided pulmonary vein isolation (pvi) and conventional pulmonary vein isolation in patients with paroxysmal atrial fibrillation (paf) with respect to adenosine guided unmasking of dormant conduction, procedural and clinical outcome.


Eligibility criteria:
inclusion criteria: * patients (\>=18 und \< 80 years) with symptomatic paroxysmal af * at least one unsuccessful attempt of antiarrhythmic drug (betablocker or class i oder iii). * oral anticoagulation with phenprocoumone, warfarine or doaks for at least 4 weeks prior to ablation with weekly documented inr \> 2.. * withdrawal of antiarrhythmic drugs at least 3 half times prior to ablation except amiodarone. exclusion criteria: * left atrial thrombus * contraindications for oral anticoagulation or adenosin
a long-term administration study of opc-41061 in patients with autosomal dominant polycystic kidney disease (adpkd) [extension of study 156-04-001]

Conditions: Autosomal Dominant Polycystic Kidney Disease

Summary: investigation into the long-term safety and efficacy of opc-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with adpkd who completed the preceding dose-finding study (156-04-001).

investigation into the long-term safety and efficacy of opc-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with adpkd who completed the preceding dose-finding study (156-04-001).

Eligibility criteria:
inclusion criteria: * patients who completed 5-day repeated administrations and the follow-up observation in the preceding study (156-04-001) * patients in whom the safety of repeated administration was confirmed based on the investigator's reports from the preceding study (156-04-001) exclusion criteria: * patients with serum creatinine concentration of 2.5 mg/dl or higher at the screening examination * patients with any of the following complications * uncontrolled hypertension * serious cardiovascular disease (eg. heart failure) or hepatic disease (eg. cirrhosis)" * patients with any of the following complications or history thereof * clinically significant drug allergies (anaphylaxis) or hypersensitivity (especially, hypersensitivity to benzazepine derivatives or suspected hypersensitivity thereto) * inability to personally give consent due to a mental disease " * patients with sbp (in sitting position) \<90 mm hg (at screening examination) * patients with history of massive bleeding or bleeding tendency * patients with a history of drug or alcohol abuse within 6 months prior to the screening examination * pregnant women, lactating women, or women who may become or plan to become pregnant * patients who received any investigational drug other than opc-41061 within 30 days prior to commencement of administration of opc-41061 * any patient who, in the opinion of the principle investigator or attending investigators, should not participate in the study

Keywords: adpkd tolvaptan
study of safety, tolerability and efficacy of dfv890 in participants with familial cold auto-inflammatory syndrome (fcas)

Conditions: Familial Cold Autoinflammatory Syndrome

Summary: the purpose of this phase ii study was to assess the safety, tolerability and efficacy of dfv890 in participants with fcas.

this was an open-label, single-arm, multiple dose, phase ii study to assess safety, tolerability and clinical efficacy of dfv890 in participants with fcas who showed evidence of inflammatory activity after the cold challenge performed during screening. the study included a screening period, a treatment period and a follow-up period.

Eligibility criteria:
inclusion criteria: * written informed consent must be obtained before any study-specific assessment is performed * body mass index within the range of 18-35 kg/m2 * patients with a genetic diagnosis of fcas * patients with a clinical history and investigations consistent with fcas exclusion criteria: * anti-rejection and/or immunomodulatory drugs must be discontinued (please, see protocol for further details) * clinically significant, suspected active or chronic bacterial (including mycobacterium tuberculosis), viral or fungal infection within 30 days prior to day 1. * patients with innate (e.g. tlr immunodeficiencies, defects in ifn-γ signaling) or acquired immune deficiencies (e.g. aids). * presence of human immunodeficiency virus (hiv) infection, hepatitis b surface antigen (hbsag) or hepatitis b core antibody (anti-hbc), or hepatitis c antibodies at screening. * live vaccines within 4 weeks of day 1 * pregnant or nursing (lactating) women. * women of child-bearing potential unless they are using highly effective methods of contraception. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: familial cold auto-inflammatory syndrome fcas dfv890 nlrp3 inhibitor, inflammasome inhibition cryopyrin-associated periodic syndromes caps
a study of the effect of renal impairment on the activity of gk activator (2) in patients with type 2 diabetes.

Conditions: Diabetes Mellitus Type 2

Summary: this study will investigate the effect of renal impairment on the pharmacokinetics/pharmacodynamics of gk activator (2) in patients with type 2 diabetes, and will evaluate the effect of renal function on the safety of the drug. patients will be assigned to treatment groups according to their renal function (normal, moderate renal impairment, or severe renal impairment). after a 1 week washout period from current oral anti-diabetic treatment, all patients will receive a single oral dose of 100mg gk activator (2), and blood and urine samples will be taken up to 96h post-dose. the anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-75 years of age; * type 2 diabetes, taken off current sulfonylureas and/or metformin therapy for \>=1 week prior to dosing with gk activator (2); * normal renal function, or moderate or severe impairment. exclusion criteria: * type 1 diabetes; * treatment with insulin or ppar gamma agonist within 6 months of screening.
ptx-200 and carboplatin in ovarian cancer

Conditions: Ovarian Cancer

Summary: the main purpose of this study is to determine if triciribine (tcn) and carboplatin are safe and tolerable when given together, and to determine if this combination of drugs can help people with recurrent ovarian cancer.

the purpose of this study is to investigate the safety and tolerability, and determine the maximum tolerated dose of triciribine when combined with carboplatin in women with platinum-resistant, recurrent or persistent ovarian cancer. the secondary objectives are to evaluate the clinical activity of carboplatin plus triciribine in women with recurrent/persistent, platinum-resistant ovarian cancer by assessing response rate, progression-free survival, and duration of stable disease.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * histologically confirmed, measurable or non-measurable, recurrent or persistent, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma. by standard gynecologic oncology group (gog) criteria, platinum-resistant disease is defined by a disease-free interval of less than 6 months following treatment with a platinum-based regimen, or the progression of disease during platinum-based therapy. * at least one prior regimen of chemotherapy, with no maximum number of chemotherapy cycles * a serum creatinine ≤ 1.5 mg% obtained ≤ 2 weeks prior to entry * adequate hematologic reserve obtained ≤ 2 weeks prior to entry: leukocytes ≥ 3,000 mm\^3; absolute neutrophil count ≥ 1500 mm\^3; platelets ≥ 100,000 mm\^3 * adequate hepatocellular function: aspartate aminotransferase (ast) and alanine transaminase (alt) ≤ 3x upper limit of normal within institutional limits; bilirubin ≤ 1.5 mg/dl * gynecologic oncology group (gog) performance status of 0, 1, or 2 * life expectancy of at least 90 days * the patient should be off chemotherapy, biologic therapy and radiation for 28 days. * neuropathy (sensory and motor) less than or equal to grade 1 per common toxicity criteria (ctc) version 4 exclusion criteria: * prior tcn-pm therapy * history of allergic reactions attributed to compounds of similar chemical or biologic composition to tcn-pm * patients must be disease-free of prior invasive malignancies for \>2 years with the exception of basal cell or squamous cell carcinoma of the skin. * inability to give informed consent * pregnancy * corrected qt interval (qtc) prolongation \> 450 milliseconds (msec)
a study to determine the absorption, distribution, metabolism, and excretion of lbh589

Conditions: Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies

Summary: this single center study will help determine the absorption, metabolism, and excretion of lbh589 and to assess the safety and efficacy of lbh589 in advanced cancer patients for whom no standard therapy exists.


Eligibility criteria:
inclusion criteria * histologically or cytologically confirmed cancer patients including solid tumors, lymphoma, or chronic hematological malignancies with progression on prior standard therapies. * eastern cooperative oncology group (ecog) performance status of \< 2 * normal renal and hepatic function exclusion criteria * patients with central nervous system (cns) involvement or brain metastases * patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago * patients with congenital long qt syndrome or uncontrolled hypertension * patients with a myocardial infarction or unstable angina within 6 months * congestive heart failure * impairment of gastrointestinal (gi) function * use of any anti-cancer therapy * female patients who are pregnant or breast feeding other protocol inclusion/exclusion criteria may apply.

Keywords: advanced cancer lymphoma chronic hematological malignancies adult
safety and efficacy of different oral doses of bay94-8862 in japanese subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic nephropathy (arts-dn japan)

Conditions: Diabetic Nephropathies

Summary: this study will be conducted in japanese subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic nephropathy( dn) using a multi-center, randomized, adaptive, double-blind, placebo-controlled, parallel-group design. primary objective of the study is investigate the change of urinary albumin to creatine ratio (uacr) after treatment with different oral doses of bay94-8862 given once daily from baseline to visit 8 (day 90)


Eligibility criteria:
inclusion criteria: * japanese subjects with type 2 diabetes mellitus and a clinical diagnosis of dn (diabetic nephropathy) treated with at least the minimal recommended dose of an angiotensin converting enzyme inhibitor (acei) and/or angiotensin receptor blocker (arb) * subjects with a clinical diagnosis of diabetic nephropathy (dn) based on at least 1 of the following criteria: * persistent very high albuminuria defined as urinary albumin to creatine ratio (uacr) of \>/=300 mg/g (\>/=34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (egfr) \>/=30 ml/min/1.73 m2 but \<90 ml/min/1.73 m2 chronic kidney disease-epidemiology collaboration (ckd-epi) or * persistent high albuminuria defined as uacr of \>/=30 mg/g but \ /=3.4 mg/mmol but \ /=30 ml/min/1.73 m2 but \<90 ml/min/1.73 m2 (ckd-epi) * serum potassium \</=4.8 mmol/l at both the run-in visit and the screening visit exclusion criteria: * non-diabetic renal disease (confirmed by biopsy) * known bilateral clinically relevant renal artery stenosis (\>75%) * glycated hemoglobin(hba1c) \>12% at the run-in visit or the screening visit * uacr \>3000 mg/g (339 mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit * hypertension with mean sitting systolic blood pressure (sbp) \>/=180 mmhg or mean sitting diastolic blood pressure (dbp) \>/=110 mmhg at the run-in visit or mean sitting sbp \>/=160 mmhg or mean sitting dbp \>/=100 mmhg at the screening visit * subjects with a clinical diagnosis of heart failure with reduced ejection fraction (hfref) and persistent symptoms (new york heart association class ii-iv) at the run-in visit * concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic

Keywords: bay94-8862 mr antagonist diabetic nephropathy japanese patients