Kornimate/medical-research-clean huggingface dataset:
an efficacy and safety study of fentanyl transdermal patch in filipino participants with osteoarthritis and chronic low back pain

Conditions: Osteoarthritis; Low Back Pain

Summary: the purpose of this study is to evaluate the efficacy and safety of fentanyl among filipino participants with osteoarthritis (disorder which is seen mostly in older persons in which the joints become painful and stiff) and chronic (lasting a long time) low back pain.

this is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded") single-arm and prospective study (study following participants forward in time) of fentanyl in participants with osteoarthritis and chronic low back pain with moderate (medium level of seriousness) and severe (very serious, life threatening) pain levels. participants will be treated with fentanyl transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) starting with 12.5 microgram (mcg) dose of fentanyl. the dose will be increased on day 3, if needed, by 12.5 mcg. dose adjustments will be done every 3 days. maximum of 50 mcg dose of fentanyl will be allowed. participants will be evaluated for pain levels and quality of life using brief pain inventory (bpi) score and clinical global impression-severity (cgi-s) score. tramadol 50 milligram tablet at a maximum of 6 tablets per day will be used as supplemental doses of analgesic (drug used to control pain). participants' safety will be monitored through out the study.

Eligibility criteria:
inclusion criteria: * participants diagnosed with osteoarthritis and chronic low back pain * 3 months of persistent moderate to severe pain levels * more than 3 times a week frequency or daily moderate to severe pain * moderate to severe pain at baseline (at least a score of 4 in the 11-point numerical pain scale) exclusion criteria * history of allergy to fentanyl transdermal patch or its components and history of illicit drug use for the past 3 months * active skin disease preventing application of the transdermal system * chronic pulmonary disease (lung disorder) * participants susceptible to intracranial (inside the skull) effects of carbon dioxide retention * pregnant and breastfeeding mothers

Keywords: osteoarthritis low back pain fentanyl transdermal patch durogesic-d-trans
uromodulin in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the aim of the present study was to evaluate the levels of uromodulin in rheumatoid arthritis (ra) and to investigate whether it was correlated with baseline clinical characteristics. in addition ckd epi,mdrd,urine microalbuminuria,ph,serum urea, creatinine,crp (c-reactive protein) were measured.the participants consist of ; %68 patients,% 32 control group.

uromodulin, also known as tamm-horsfall protein, is a protein abundantly excreted in the urine in healthy individuals. it is synthesized in the thick ascending limb of henle (talh) and the early distal convoluted tubule. its biologic function is still obscure; however, some experimental studies indicated that it might serve as an important urinary defense factor against bacterial colonization and stone formation. there are controversial publications on the frequencies of urinary tract infections and nephrolithiasis in patients with mutations of uromodulin gene. deposition of mutated uromodulin in the urinary system may lead to tubular cell dysfunction and apoptosis. these alterations may subsequently cause tubular atrophy and interstitial fibrosis . moreover, the release of abnormal uromodulin after apoptosis through basolateral secretion may elicit an immune response which may give rise to an immune-mediated tubulointerstitial nephritis . uromodulin can activate the other components of the immune system and may modulate the inflammatory and immune responses through different mechanisms . experimental studies yielded that uromodulin negative mice displayed splenomegaly with infiltration of white pulp by macrophages and increased levels of tnf-α and interleukin-1 . rheumatoid arthritis is a systemic autoimmune condition that may eventually result in the joint damage, disability and premature mortality.

Eligibility criteria:
inclusion criteria: * patients who diagnosed of rheumatoid arthritis as criteria of acr/eular 2010. * all patients age range is 18-80 years. exclusion criteria : * renal failure * hepatic insufficiency * diabetes mellitus * other collagen vascular diseases, * history of smoking and consumption of alcohol

Keywords: uromodulin
effects on glutamine on the outcome of allogeneic bone marrow transplant recipients

Conditions: Pulmonary Veno-Occlusive Disease; Hepatic Veno-Occlusive Disease; Mucositis

Summary: the primary purpose of this project is to investigate if addition of glutamine, an amino acid, to standard parenteral nutrition, may improve the clinical outcome of the bone marrrow transplantation reducing the occurrence of veno-occlusive disease and severity of mucositis.


Eligibility criteria:
inclusion criteria: * allogeneic bone marrow transplant recipients using busulfan and cyclophosphamide as conditioning.

Keywords: veno-occlusive disease mucositis
evaluation of a metabolic preparation by a low-carbohydrate diet as atkins-diet to help in detecting infective endocarditis by 18f-fdg pet

Conditions: Infective Endocarditis

Summary: infectious endocarditis (ie) is a pathology where the mortality rate of between 20 and 25%, but a higher morbidity since 50% of the patients are treated by a valvular surgical procedure. the diagnosis of ie is often difficult and therefore too late. in 2015, the european society of cardiology recommendations published by the integrate positron emission tomography with computed tomography (pet/ct) with 18f-fluorodeoxyglucose (18f-fdg) in the diagnostic management of ie. however, during conventional examinations, with 12 hours fasting and low carb dieting, myocardial uptake of 18f-fdg may be intense and interfere with results. the purpose of this study is to assess a strict low carbohydrate diet as atkins (\<3gram/day of carbohydrate) diet to facilitate the infective endocarditis diagnosis by 18f-fdg pet/ct primary objective is to assess a strict low carbohydrate diet during 12h and 12h fasting for enhancing the contrast between infect area and surrounding structures and improve the detectability of infective endocarditis by pet/ct secondary objectives: 1. comparison of the detection sensitivity of ie outbreaks between 18f-fdg pet/ct performed with the low carbohydrate diet and conventional diet performed 2. to assess the strict low carbohydrate diet effects on the uptake 18f-fdg distribution , particularly in the myocardium, circulating blood, skeletal muscles, brain and liver. 3. characterization of metabolic changes generated by the low carbohydrate diet using plasma bioassays (blood glucose, insulinemia, free fatty acid concentration, ß-hydroxybutyrate).


Eligibility criteria:
inclusion criteria: * hospitalized patients with certainly infective endocarditis (95%) such duke and li criteria * patients with a social protection system * no impossibility of performing (18)f-fdg pet (agitated, confused patient, etc) * stable clinically * adaptive antibiotic therapy for at least 8 days * no known allergy to making impossible to follow strict carbohydrate diet exclusion criteria: * pregnancy, breastfeeding and woman of childbearing age without effective contraception * patients under guardianship or curators. * no treatment with corticoids, valproate, carbamazepine, phenytoin, phenobarbital, catecholamines * unbalanced diabetes (fasting capillary blood glucose \> 1,8 g/l ou 10 mmol/l) * patients with known hypersensitivity to 18f-fdg or any component of this product

Keywords: infective endocarditis pet/ct 18f-fdg low carbohydrate diet as atkins diet
study of admission versus discharge after transient ischemic attack (tia)

Conditions: Transient Ischemic Attack (TIA); Stroke

Summary: evaluate for difference in outcome between hospital admission versus discharge after recent tia, and evaluate feasibility of a larger study.

20 patients will be randomized within 24 hours of a tia to be admitted to the hospital or discharged to home, and the investigator will compare outcomes, cost, and evaluate the feasibility of a larger study.

Eligibility criteria:
inclusion criteria: * age 18 and older. * clinical diagnosis of tia within 24 hours of consent. exclusion criteria: * crescendo tias, defined as multiple within 24 hours of presentation. * posterior circulation tias diagnosed clinically by a member of the stroke team. * high grade carotid stenosis. * any compelling medical reason they should or should not be admitted or discharged (for example decompensated congestive heart failure, unstable angina, new ekg changes, pneumonia, sepsis). patients will only be enrolled if the only consideration for admission is the tia, and they otherwise meet appropriate standard of care criteria for discharge to home. * patients will be excluded if no one can be with them for the next 12 hours to ensure a rapid call to 911 should problems arise, specifically stroke.

Keywords: transient ischemic attack (tia). stroke. hospital admission.
urinary t lymphocytes predict renal flares in patients with inactive anca-associated glomerulonephritis

Conditions: Glomerulonephritis Acute

Summary: urinary cd4+ and cd8+ t lymphocytes may predict renal flares in patients with inactive anca-associated vasculitis and thus serve as early non-invasive biomarkers. urine samples of patients with inactive renal anca-vasculitis will be analysed by flow cytometry and compared to clinical outcome after 6 months.

data of previous studies have shown that counts of urinary t lymphocyte subsets correlate with disease activity in several immunological renal diseases, e.g. anca-associated glomerulonephritis. thus, study authors hypothesise that cd4+, respectively cd8+, t effector memory lymphocytes found in urine samples of patients with inactive anca-vasculitis predict subsequent renal flares. therefore, quantification of these cellular subsets might reliably predict relapse of anca associated glomerulonephritis at an early stage. in a prospective experimental study urine of patients with anca-vasculitis and no renal involvement or patients in renal remission will be analysed by flow cytometry. after 6 months of observation, clinical outcome and potential renal relapse will be determined and correlated to initial t lymphocyte count.

Eligibility criteria:
inclusion criteria: * diagnosed anca-associated vasculitis (clinical diagnosis of granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis or microscopic polyangiitis consistent with the chapel-hill consensus definitions and positive test for proteinase 3-anca or myeloperoxidase-anca) * no currently active renal involvement (defined as bvas = 0 with exception of hematuria or proteinuria as signs of renal scars) * written and informed consent exclusion criteria: * urinary tract infection * active menstrual bleeding * active renal involvement * other active renal disease (e.g. diabetic nephropathy) initially, we defined treatment with rituximab as exclusion criteria. however, upon closer examination, we recognized that this exclusion criterion was overly restrictive and may have inadvertently excluded eligible participants who met our other inclusion criteria. as a result of this reassessment, we have revised our exclusion criteria to no longer exclude individuals solely on the basis of receiving rituximab treatment.

Keywords: anti-neutrophil cytoplasmic antibody-associated vasculitis pauci-immune glomerulonephritis urinary biomarker churg-strauss syndrome microscopic polyangiitis granulomatosis with polyangiitis effector memory t lymphocytes prediction
conquering hypertension in urban vietnam

Conditions: Hypertension

Summary: the htn-urban project aims to improve hypertension (htn) control for adults in a large northern vietnamese city via a cluster-randomized trial design.

a cluster-randomized, type ii hybrid effectiveness implementation trial will take place in 14 urban communities in 7 urban districts in hai phong city in northern vietnam. community eligibility criteria: (1) located in urban hai phong city; (2) distance between 2 communities will be at least 10 km; (3) no other research studies/ health programs currently being implemented; and (4) key community and clinical leaders are willing to participate in the study. recruitment residents from participating sites will be invited to attend the community screening events run by local community health center (chc) staff and community health workers (chws). those meeting our pre-defined eligibility criteria will be invited to their chcs to learn more about the study. patients with elevated blood pressure (bp) will be invited for re-measurement over the next two weeks (at least 1 week apart). after the second bp measurement, patients with elevated bp will be invited to participate in the study. randomization fourteen communities in urban hai phong (700 patients with uncontrolled hypertension - htn) will be randomly assigned either to an intervention (7 communities- 50 patients per community) or comparison group (7 communities- 50 patients per community) by a computer procedure. patients with uncontrolled htn will be assigned to intervention versus comparison status based on the communities in which they reside. intervention group: the intervention group will receive 3 components including digital storytelling delivered via computerized intervention authoring system (cias), home blood pressure self-monitoring and expanded chw services (frequent contacts, visits and consultations). comparison group: patients in the comparison group will receive only "learn more" module - didactic material without htn related stories via cias. patients in both groups will be followed up at 3, 6 and 12 months.

Eligibility criteria:
inclusion criteria: * aged ≥18 years old; * presence of uncontrolled htn (systolic bp ≥ 140 mmhg or diastolic bp ≥ 90 mmhg) according to jnc-8; * willing to provide informed consent. exclusion criteria: * participation in another study on hypertension; * pregnant; * advanced cognitive impairment; * previous exposure to storytelling modules; * participant family member; * participant in intervention development.

Keywords: storytelling intervention home blood pressure monitoring community health workers urban hypertension vietnam htn-urban intervention
a study of pinatuzumab vedotin (dcdt2980s) combined with rituximab or polatuzumab vedotin (dcds4501a) combined with rituximab or obinutuzumab in participants with relapsed or refractory b-cell non-hodgkin's lymphoma (nhl)

Conditions: Follicular Lymphoma; Diffuse Large B-Cell Lymphoma

Summary: this multicenter, open-label study will evaluate the safety and efficacy of pinatuzumab vedotin (dcdt2980s) or polatuzumab vedotin (dcds4501a) in combination with rituximab (rtx), as well as of polatuzumab vedotin in combination with obinutuzumab in participants with relapsed or refractory (r/r) follicular lymphoma (fl) and r/r diffuse large b-cell lymphoma (dlbcl).


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 * life expectancy of at least 12 weeks * history of histologically documented r/r grades 1 to 3a fl, or r/r dlbcl * availability of an archival or freshly biopsied tumor tissue sample must be confirmed for study enrollment * have a clinical indication for treatment as determined by the investigator * must have at least one bi-dimensionally measurable lesion (greater than \[\>\] 1.5 centimeters \[cm\] in its largest dimension by ct scan or magnetic resonance imaging \[mri\]) exclusion criteria: * prior use of any monoclonal antibody, radio-immuno-conjugate or antibody drug conjugate within 4 weeks before study start * treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational anti-cancer agent within 2 weeks prior study start * adverse events except for sensory neuropathy from any previous treatments must be resolved or stabilized to grade less than equal to (\</=) 2 prior study start * completion of autologous stem cell transplant (sct) within 100 days prior study start * prior allogeneic sct * eligibility for autologous sct (participants with r/r dlbcl) * history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) * history of other malignancy that could affect compliance with the protocol or interpretation of results * current or past history of central nervous system lymphoma * current grade \>1 peripheral neuropathy * vaccination with a live vaccine within 28 days prior to treatment
swedish mammography cohort

Conditions: Cancers; Cardiovascular Diseases; Cataract; Gastrointestinal Diseases; Osteoporosis; Fractures

Summary: the swedish mammography cohort began in 1987-1990, when 66,651 women living in two counties in central sweden completed a mailed questionnaire that included items about their diet, parity, age at first child's birth, history of breast cancer in family, weight, height, and education. follow-up questionnaires have been sent out in 1997 and in 2008-09.

from 1987 to 1990 a population-based mammography screening program was introduced in two counties in central sweden. in västmanland county all women born between 1917 and 1948 received a mailed invitation to be screened by mammography between march 1987 and march 1989 (n=41,786) together with a 6-page questionnaire; 31,735 women (76%) returned the completed questionnaires. in uppsala county all women born between 1914 and 1948 were invited to the screening and received the same questionnaire between january 1988 and december 1990 (n=48517); 34916 women (72%) returned the completed questionnaires. hence, questionnaires completed before undergoing mammography were obtained from 66,651 women (74%) in the source population. these questionnaires included items about diet, parity, age at first child's birth, history of breast cancer in family, weight, height, and education. in 1997 a second questionnaire was sent to all cohort members who were still living in the study area. the questionnaire updated information about diet and was extended to include information on physical activity, medical history, age at menarche, history of oral contraceptive use, age at menopause, postmenopausal hormone use and lifestyle factors such as cigarette smoking history and use of dietary supplements. majority of questions in the questionnaires have been validated. during 2008-09, the exposure information was updated and extended by sending out two new questionnaires - one questionnaire on health including several signs of symptoms, sleeping, social relations etc (2008) and one on diet, dietary supplement use, and lifestyle factors (2009). incident cases of cancer are ascertained by record linkages of the study population with the national swedish cancer register and the regional cancer registers. cardiovascular and other diseases as well as surgeries and causes of death are identified by linkage to the national inpatient and other registries at the swedish board of health and welfare. ascertainment of cancer cases and other diseases is almost 100% complete. dates of deaths are ascertained through the swedish death register (100% complete), and information on date of moving out of the study area is obtained by linkage with the swedish population register.

Eligibility criteria:
inclusion criteria: * all women born between 1914 and 1948, living in central sweden exclusion criteria: * none
clinical validation of the molecular-based genepoc carba assay for the detection and differentiation of carbapenemase genes in rectal swab samples.

Conditions: Carbapenem-Resistant Enterobacteriaceae

Summary: the primary purpose of this clinical investigation is to establish the performance of the genepoc carba assay on the revogene. this will be achieved by comparing the test to a conventional method for detection of carbapenemase producing organisms (cpos) in rectal swab samples.

the genepoc carba assay will be performed using the revogene instrument. the revogene instrument, used in conjunction with appropriate reagents, is capable of automated cell lysis, dilution of nucleic acids from multiple sample types as well as automated amplification and detection of target nucleic acid sequences. the genepoc carba assay reagents kits consist of: 1. sample buffer tube (sbt) 2. disposable transfer tool (dtt) 3. disposable microfluidic cartridges (pie) the test is performed using the revogene™. the revogene automates sample homogenization, sample dilution, cells lysis, dna amplification, and detection of the amplified pcr products. user intervention is only required for discharging the patient sample into the sample buffer tube (sbt), transferring the sample into the pie, and loading/unloading the pies into the revogene carousel. a dual swab sample is collected when icf is signed by patient. one of the swab is transferred into the sbt and vortexed. sample is then transferred to the genepoc carba pie. the pie is then automatically processed by the revogene. on completion of a run, the user removes the processed pies from the instrument and discards them according to local biological waste management procedures. one revogene will be allocated per site. the purpose of this clinical trial is to enroll sufficient patients from up to 14 clinical centers to meet regulatory requirements, based on the reference method final results.

Eligibility criteria:
inclusion criteria: * samples from patients who were previously diagnosed to be infected with cpos, or were identified per hospital policies as being suspected or are at risk for cpo infection; * patient that signed the approved informed consent form (if applicable) * patient older than 2 years of age (\>24.0 months) * only one (1) compliant sample per patient is allowed exclusion criteria: * patient/sample not meeting inclusion criteria above

Keywords: carbapenem rectal swab infectious disease infection