Kornimate/medical-research-clean huggingface dataset:
cefepime vs. ceftriaxone to treat nursing home-acquired pneumonia

Conditions: Pneumonia

Summary: randomized trial of nursing home residents with pneumonia to assess if intramuscular cefepime is a safe, efficacious, and cost-effective alternative to once daily intramuscular ceftriaxone for the treatment of elderly nursing home residents who develop pneumonia and do not require hospitalization.

to compare the efficacy, safety, and pharmacoeconomics of cefepime versus ceftriaxone. double-blind study of nursing home residents \>60 years of age with pneumonia. patients were randomized to cefepime or ceftriaxone 1 gm q24h to be administered intramuscularly. after three days, responding patients could be switched to oral antibiotics. main outcome measures: clinical success, adverse events, and cost-effectiveness ratios.

Eligibility criteria:
inclusion criteria: residents of a nursing home for \>=30 days who were at least 60 years of age and developed pneumonia not amenable to oral antibiotics while not requiring hospitalization, a new infiltrate on chest xray, estimated clcr \<=60 ml/min, presence of standard clinical criteria, signed informed consent. exclusion criteria: allergy to cephalosporins, receipt of \>24 hours of an antibiotic (unless no improvement was evident), an existing infection due to a pathogen known resistant to either study drug; expected mortality within 48 hours, immunosuppression, hypotension or respiratory distress requiring ventilatory support, prior limited treatment or supportive care only directives, suspected or known pseudomonas aeruginosa or mrsa infections, primary lung cancer or another malignancy metastatic to the lungs, bronchial obstruction or a history of post-obstructive pneumonia, or patients receiving renal dialysis.

Keywords: intramuscular antibiotics nursing home acquired pneumonia nhap pharmacoeconomics cefepime ceftriaxone
urinary catheter 'fill and flush' valve: safety, effectiveness, acceptability and feasibility trial

Conditions: Indwelling Urinary Catheter Users

Summary: the fill and flush valve (valve) is an automated valve which is designed to open in response to rising bladder pressure which occurs as the bladder becomes full. the valve is situated between the idc and the drainage bag as a manual valve would be.

the objective of this study is to assess preliminary safety, effectiveness, reliability, comfort and user acceptability of the valve with adults who have a long-term idc and the feasibility of undertaking future community-based evaluation. to do this the investigators will * determine if the valve functions reliably i.e. automatically opens to drain urine within acceptable individual bladder volumes with a range of patients; * determine if the valve functions effectively i.e. allows for the complete bladder emptying (\< 100ml post void residual) during rest and daily activities; * determine if the process of filling and automatic draining is comfortable and acceptable for participants; * collect preliminary data on the potential for bioburden/biofilm following in human use of the valve; * assess the feasibility of undertaking a future randomised control trial of the valve. group 1 - the investigators will test the valve with participants (n=8) who currently use a standard manual valve (without leg-bag).this first group will include a safety cohort of participants (n=4). all safety data will be reviewed from the initial 4 participants before further participants can undergo the study investigation. group 2- the investigators will test the valve with participants (n=8) who currently use a drainage bag with free drainage. the data collection process and study procedures will be identical for both groups. after use(in both groups), the valves will be examined microbiologically in the university of southampton laboratory to detect bioburden and/or biofilm to ascertain a baseline for future studies.

Eligibility criteria:
inclusion criteria: * idc-users (urethral or suprapubic), over 18, who have had a catheter in situ for at least one month and use a manual valve or drainage bag to collect urine * independent with catheter care needs (e.g. bag emptying or valve opening) * able to transfer from bed to chair, stand and walk short distances unaided * able to drink moderate levels of fluid (500mls in the first 2 hours and 150mls per hour thereafter) * able to provide informed consent (self-report and research nurse assessment) * usual medical provider provides confirmation of suitability exclusion criteria: * end stages of a terminal illness * current treatment of urinary tract infection * has been advised by a urologist against using a valve on clinical grounds * lack of bladder sensation (e.g. unable to sense when bladder needs emptying) * previous bladder surgery that could affect the integrity of the bladder * at known risk of autonomic dysreflexia

Keywords: urinary catheter idc
real-world ruxolitinib experience in pv

Conditions: Polycythemia Vera

Summary: this is a multicentric, observational, retro-prospective study in adult pv patients - resistant or intolerant to hydroxyurea - who are going to receive or have already initiated treatment with ruxolitinib according to the approved local label. enrolment will last 9 months after the first enrolled patient. patients will be observed for a minimum of 3 months, in order to evaluate the primary endpoint for all patients.

this is a multicentric, observational, retro-prospective study in adult population who have been diagnosed with polycythemia vera according to the 2022 (who or icc) criteria, who are resistant or intolerant to hydroxyurea and who are going to be prescribed or have already initiated treatment with ruxolitinib according to the approved local label. patients who started treatment with ruxolitinib - according to clinical practice - will be enrolled. enrolment will last 9 months after the first enrolled patient. patients will be observed for a minimum of 3 months, in order to evaluate the primary endpoint for all patients.

Eligibility criteria:
inclusion criteria: 1. patients aged ≥ 18 years of age 2. subjects must be diagnosed with pv according to the 2022 world health organization (who) or international consensus classification (icc) criteria 3. subjects must have a treatment history for pv that meets the definition of resistance or intolerance to hydroxyurea (hu) in accordance with the indications of the italian medicines agency 4. patients already on ruxolitinib treatment (retrospective cohort) at the start date of the study or patients who will start ruxolitinib (prospective cohort) during the study enrollment 5. signed informed consent exclusion criteria: 1. different diagnosis from pv \[eg. other chronic myeloproliferative neoplasia such as essential thrombocythemia, myelofibrosis; or of congenital erythrocytosis or secondary erythrocytosis\]

Keywords: ruxolitinib
a study to evaluate the efficacy of enbrel (registered) etanercept over a period of 12 months in the routine treatment of patients with rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, or plaque psoriasis.

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Axial Spondyloarthritis; Plaque Psoriasis

Summary: the purpose of this non-interventional study is to evaluate the efficacy of etanercept during routine clinical use over a maximum of 12 months in patients with rheumatoid arthritis (ra), psoriatic arthritis(psa), axial spondyloarthritis(axspa) or plaque psoriasis (pso). in so doing, particular attention will be paid to the proportion of those patients who only attain the desired treatment goal after 12 weeks of treatment. the primary efficacy end point for the study is the proportion of patients who attain the desired treatment goal after 12 and 24 weeks,


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of ra, axspa, psa or pso * no prior treatment with etanercept and eligibility for treatment with etanercept according to the summary of product characteristics. exclusion criteria: * the contraindications, special warnings, and precautions according to the summary of product characteristics for etanercept shall apply. * the additional documentation of the patient in another post-marketing study with etanercept is not permitted.
a non interventional study with doce onkovis (docetaxel) utilized for the treatment of cancer

Conditions: Carcinoma

Summary: the main purpose of this observational study with docetaxel is to determine the number of treatment cycles and the quantity of doce onkovis needed therefore under the special circumstance of ambulant chemotherapy. onkovis aims an economical utilization of the chemotherapeutics.the provision with adapted packaging sizes as to decrease the excess quantity to be discarded follows also this objective. secondary objectives are the evaluation of the safety and tolerability of doce onkovis. to this purpose data regarding co medications and adverse events are also collected.


Eligibility criteria:
inclusion criteria: * indication for docetaxel according to the smpc and treating physician exclusion criteria: * according to the docetaxel smpc

Keywords: carcinoma breast cancer non-small cell lung cancer prostata cancer adenocarcinoma of the stomach squamous cell carcinoma of the head and neck region ambulant chemotherapy treatment cycles docetaxel doce onkovis quantity of docetaxel packaging sizes
preoperative hemogram parameters and braf molecular test detected by bethesda 3 cytology.

Conditions: Blood Platelet Disorder; BRAF V600E; Thyroid Nodule; Cytologic Atypia

Summary: the main hypothesis of this study is that preoperative hemogram parameters can be used as biomarkers for malignancy in patients with thyroid nodule bethesda 3 cytology. the secondary hypothesis is that braf molecular testing has a high predictive value in predicting malignancy in patients with thyroid nodule bethesda 3 cytology. primary outcome: preoperative hemogram parameters. secondary outcome: braf positivity.

the main hypothesis of this study is that preoperative hemogram parameters can be used as biomarkers for malignancy in patients with thyroid nodule bethesda 3 cytology. the secondary hypothesis is that braf molecular testing has a high predictive value in predicting malignancy in patients with thyroid nodule bethesda 3 cytology. primary outcome: preoperative hemogram parameters. secondary outcome: braf positivity. this study aims to reduce unnecessary thyroidectomies, thyroidectomy complications and treatment costs due to bethesda 3 cytology. the age and gender of all patients to be included in the study will be recorded. mean platelet volume (mpv), neutrophil/lymphocyte ratio (nlr), platelet/lymphocyte ratio (plr) and lymphocyte/monocyte ratio (lmr) will be recorded in preoperative hemograms. nodule sizes detected by preoperative bethesda iii cytology will be recorded. the sizes of nodules with preoperative aus cytology after thyroidectomy, determined as a result of pathological examination, will be recorded. patients with malignant cytology will be divided into papillary thyroid carcinoma (ptc), follicular thyroid carcinoma (ftc), and tumor sizes will be recorded. among the patients included in the study, braf molecular testing will be performed on the preoperative cytology of 25 patients whose thyroidectomy materials were reported to be malignant.

Eligibility criteria:
inclusion criteria: 1. patients between the ages of 18 -75 2. patients who were diagnosed with bethesda iii as a result of preoperative fnac and decided to undergo thyroidectomy exclusion criteria: 1. patients over 18 years old and under 75 years old 2. patients with malignancy detected in another focus with preoperative bethesda iii fnac 3. detection of malignancy in another focus other than the nodule with bethesda iii cytological result after thyroidectomy 4. failure to obtain preoperative hemogram results patients who do not agree to participate in scientific studies for braf testing

Keywords: thyroid carcinoma bethesda 3 braf
buffered lidocaine for reducing pain in patients undergoing prostate biopsy, burn trial

Conditions: Prostate Cancer

Summary: this phase i/ii trial examines if buffered lidocaine reduces the pain that patients may experience during prostate biopsy. prostate biopsies are typically performed awake, in the office, with only local anesthetic. as a result, many patients note considerable pain during these procedures. local anesthetics such as lidocaine are typically acidic, which is thought to cause pain and burning during infiltration (injection). as a result, buffered local anesthetic has become the standard of care (soc) in multiple specialties using awake local anesthetic. however, it has not been explored during prostate biopsies. adminstering buffered lidocaine may reduce pain in patients undergoing prostate biopsy.

outline: patients are randomized to 1 of 2 arms. arm a: patients receive soc lidocaine via injection during soc prostate biopsy on study. arm b: patients receive buffered lidocaine via injection during soc prostate biopsy on study. after completion of study intervention, patients are followed up 1-2 days post-biopsy.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * 18 years old or older * patients with prostates * those with and without a prior diagnosis of prostate cancer * recommended to undergo a prostate biopsy in the urology clinic. only patients that have been scheduled for a biopsy (for clinical purposes) will be enrolled. may include all of the following types of prostate biopsies: * transperineal or transrectal * systematic or targeted/fusion biopsy * 12 core biopsy or \> 12cores * biopsy naïve or prior biopsy exclusion criteria: * anorectal pathology precluding placement of a transrectal ultrasound * diagnosis of chronic prostatitis, interstitial cystitis, pelvic pain syndrome * concomitant chronic pain condition * neurological condition affecting pain or sensorium (ex. spinal cord injury, stroke, multiple sclerosis, etc.) * prostate biopsy performed with any anesthesia other than local anesthetic (monitored anesthesia care, general anesthesia) * prostate biopsy completed in the operating room * patients who ultimately require additional local anesthetic beyond what is allotted in the study intervention * patients taking anxiolytics in the 6-hours prior to the biopsy * those with a known hypersensitivity, allergic reaction, or contraindication to using sodium bicarbonate. this includes patients who are receiving diuretics known to produce a hypochloremic alkalosis

Keywords: prostate cancer prostate biopsy transperineal biopsy transrectal biopsy mri fusion biopsy buffered lidocaine sodium bicarbonate local anesthesia lidocaine
lung and melanoma cancer patients covid19 disease (gravid)

Conditions: Covid-19; Lung Cancer

Summary: this is a multi-centre study on lung cancer patients which experienced covid-19. information on clinical features, clinical course, management and outcomes will be collected for both, thoracic cancers and covid-19 infection. firstly, investigators will be registered in an online secure registry. after that, a protocol will be developed in order to collect clinical data for the research. it will also include i on the care organization or the perception of the patient and their family members. the final stage will consist on retrospective data collection from patients. so, it is a retrospective study data collection, preceded by prospective data registry.


Eligibility criteria:
inclusion criteria: * patients diagnosed with lung cancer * patients who have contracted covid-19 infection exclusion criteria: * patients diagnosed with lung cancer but no confirmation of covid-19 infection.

Keywords: covid-19 coronavirus lung cancer
actimetry monitoring of the paretic upper limb in chronic post stroke.

Conditions: Chronic Stroke; Non-use of the Paretic Upper Limb

Summary: after a stroke, 80% of patients continue to have difficulty using their paretic upper limb in activities of daily living (adl) despite post-stroke rehabilitation practices that aim to promote the use of the paretic upper limb. it is known that functional recovery depends on actual use (use it or loose it), but one-time measurements in the clinic do not allow quantification of the actual use of the paretic upper limb in daily life (in the person's living environment). the investigators hypothesize the feasibility of quantifying functional use of the paretic upper limb by actimetry in clinical routine.

after a stroke, 80% of patients continue to have difficulty using their paretic upper limb in activities of daily living (adl) despite post-stroke rehabilitation practices that aim to promote the use of the paretic upper limb. it is known that functional recovery depends on actual use (use it or loose it), but one-time measurements in the clinic do not allow quantification of the actual use of the paretic upper limb in daily life (in the person's living environment). project will monitor 30 chronic and 30 healthy subjects over one week period using two wrist worn sensors . the main objective is to objectively quantify by actimetry, over 7 days, the real functional use of the paretic upper limb in the activities of daily living of post-stroke hemiparetic subjects in chronic phase, by the functional use ratio between the two arms (useratio).

Eligibility criteria:
inclusion criteria: inclusion criteria common to all participants: * be between 18 and 90 years old post-stroke subjects should: * having a stroke with motor sequelae in the upper limb * be in the chronic phase (\>3 months post-stroke) of a stroke whatever the aetiology exclusion criteria: non inclusion criteria common to all participants: * absence of free, informed and express oral consent * no affiliation to a french social security system or beneficiary of such a system * patient protected by law * pregnant or breastfeeding women not eligible for inclusion, post-stroke subjects: * not understanding the constraints of the study * have cognitive impairments that prevent them from understanding the study * with a known hemigligence in the medical record (omission \> 8 on bells test)

Keywords: accelerometry stroke upper limb functional recovery home environment rehabilitation real use non use
a study of ly3041658 in adults with hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: the reason for this study is to see if the study drug ly3041658 is effective in participants with moderate-to-severe hidradenitis suppurativa (hs).


Eligibility criteria:
inclusion criteria: * have a diagnosis of hs for at least 6 months * have hs lesions in at least 2 different anatomic areas * have inadequate response or intolerance to a 28 day course of oral antibiotics * have a total count of abscesses and inflammatory nodules greater than or equal to 4 * agree to use a topical antiseptic daily * agree to stop using topical antibiotics during the study. in certain cases, oral antibiotics will be allowed exclusion criteria: * have more than 20 draining fistulae * have received any biologic medication (adalimumab, etc.) for the treatment of hs * plan to use oral opioids for hs-related pain during the study * uncontrolled depression or suicidal thoughts
phase i/ii trial of sodium stibogluconate in myelodysplastic syndrome

Conditions: Myelodysplastic Syndromes

Summary: sodium stibogluconate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. this was originally designed as a phase i/ii trial studying the side effects of sodium stibogluconate and how well it works in treating patients with myelodysplastic syndromes. unfortunately, due to funding issues, the phase ii portion was never conducted.

patients receive sodium stibogluconate iv over 30 minutes on days 1-5 and 15-19. treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. patients who respond to treatment may continue therapy until disease progression. patients undergo bone marrow aspiration, biopsy, and peripheral blood sample collection periodically for correlative laboratory studies. after completion of study treatment, patients are followed up at 8 weeks. the phase ii portion of this trial was never conducted due to lack of funding.

Eligibility criteria:
inclusion criteria: * documented myelodysplastic syndromes (mds), including therapy-related mds * meets 1 of the following criteria: * refractory to prior azacitidine or decitabine * did not tolerate treatment with azacitidine or decitabine due to cytopenias or other side effects * not a candidate for azacitidine or decitabine due to cytopenias or other medical conditions that would contraindicate nucleoside analogues * refused treatment with azacitidine or decitabine * life expectancy ≥ 16 weeks * not pregnant or nursing * no b12 deficiency, folate deficiency, or pyridoxine responsive anemia as confirmed by relevant laboratory testing * no prolongation of qtc or ventricular ectopic beats on ekg * no evidence of cardiac disease * no active infection and afebrile * more than 21 days since prior azacitidine or decitabine * more than 21 days since other prior treatment for mds (e.g., thalidomide, valproic acid, or other agents as part of a clinical trial) * prior cytokines (e.g., erythropoietin, g-csf, and gm-csf) allowed * prior chemotherapy and/or radiotherapy for solid tumors or lymphoma allowed provided there is no evidence of active disease from the prior malignancy exclusion criteria: * prior treatment for leukemia (e.g., acute myeloid leukemia, chronic myelogenous leukemia, acute lymphocytic leukemia, or chronic lymphocytic leukemia) * concurrent cytokines * concurrent antileukemic treatment, including bone marrow transplantation and radiotherapy
thalidomide in combination with capecitabine in patients with metastatic breast cancer

Conditions: Breast Cancer

Summary: the lack of non-overlapping toxicities between the two drugs, the ease of all oral drug administration, and the possibility for antitumor synergy make exploration of this combination regimen attractive in women with previously treated metastatic breast cancer. this phase ii trial will be performed in collaboration with the minnie pearl cancer research network, a multicenter, community-based clinical trials group.

upon determination of eligibility, patients will be receive: thalidomide + capecitebine

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * metastatic breast cancer confirmed by biopsy * measurable or evaluable disease * females \> 18 years * able to perform activities of daily living with minimal assistance * life expectancy \> 3 months * adequate bone marrow, liver and kidney function * all patients must give written informed consent in order to participate. exclusion criteria: you cannot participate in this study if any of the following apply to you: * women who are pregnant or lactating. * received more than 3 prior chemotherapy regimens in the metastatic setting. * received continuous infusion 5-fluorouracil lasting \> 120 hours. * received thalidomide or capecitabine as their last prior regimen. * preexisting moderate to severe neuropathy please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.