Kornimate/medical-research-clean huggingface dataset:
tocilizumab for the treatment of cytokine release syndrome in patients with covid-19 (sars-cov-2 infection)

Conditions: Cerebrovascular Accident; Chronic Obstructive Pulmonary Disease; Chronic Renal Failure; Coronary Artery Disease; Diabetes Mellitus; Malignant Neoplasm; SARS Coronavirus 2 Infection

Summary: this phase iii trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (crs) in patients with sars-cov-2 infection. crs is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. tocilizumab is used to decrease the body's immune response. adding tocilizumab to standard of care may work better in treating crs in patients with sars-cov-2 infection compared to standard of care alone.

primary objective: i. to decrease the length of invasive mechanical ventilation (mv) and rate of 30-day mortality from crs due to sars-cov-2. secondary objectives: i. to decrease the rates of intensive care unit (icu) transfer. ii. to decrease the rate of invasive mechanical ventilation (mv). iii. to decrease the length of icu stay. iv. to decrease the rate of tracheostomy. v. safety and efficacy of tociluzumab. vi. biomarker assessment for response. outline: patients are randomized to 1 of 2 arms. arm i: patients receive tocilizumab intravenously (iv) every 12 hours for up to 3 doses in the absence of disease progression or unacceptable toxicity. patients also receive standard of care. arm ii: patients receive standard of care.

Eligibility criteria:
inclusion criteria: * diagnosis with sars-cov-2 by the currently available assays (food and drug administration \[fda\] approved) * should be hospitalized and exhibit at least one of the following predictors of mortality * age \>= 65 years * current smoker (smoked \>= 100 cigarettes in life and actively smoking) * chronic obstructive pulmonary disease (copd) * diabetes * hypertension * coronary artery disease * cerebrovascular accident (cva) * chronic renal disease (creatinine of \>= 2 mg/dl) * cancer * patients that have c-reactive protein (crp) \>= 10 mg/l * d-dimer \>= 0.5 mg/l * procalcitonin \>= 0.5 mg/l * lactate dehydrogenase (ldh) \>= upper limit of normal (uln) * patients or authorized family member willing to sign informed consent to participate in this study exclusion criteria: * pregnant or lactating women * hypersensitivity to tocilizumab * patients or authorized family member unwilling to sign informed consent to participate in this study * uncontrolled tuberculosis, or any uncontrolled fungal infection (eg: candidemia)
is ibrutinib-related atrial fibrillation dose dependent

Conditions: Hematological Malignancy; Atrial Fibrillation

Summary: ibrutinib, an oral inhibitor of bruton tyrosine kinase (btk), has recently revolutionized the treatment of various chronic b-cell malignancies and particularly chronic lymphocytic leukemia (cll). atrial fibrillation (af) has early emerged as a cardiovascular adverse effect (cvae) of ibrutinib but underlying mechanisms of iraf are not fully understood. while a dose-reduction or an interruption of ibrutinib is mentioned in the summary of product characteristics of ibrutinib, any beneficial effect on iraf management of such a management is unclear. the main aim of this study is to determine if iraf is a dose-dependent cvae in chronic b-cell malignancies patients by studying the association between ibrutinib dose and iraf reporting in vigibase®, the world health organization (who) pharmacovigilance database.

ibrutinib, an oral inhibitor of bruton tyrosine kinase (btk), has recently revolutionized the treatment of various chronic b-cell malignancies and particularly chronic lymphocytic leukemia (cll). atrial fibrillation (af) has early emerged as a cardiovascular adverse effect (cvae) of ibrutinib. in phase 3 randomized clinical trials (rct), ibrutinib exhibits a ≈4-fold increase-risk of af compared with controls (pooled relative-risk (rr) 3.9; 95% confidence interval (ci): (2.0-7.5); p\<0.0001). the annualized incidence rate of ibrutinib-related af (iraf) reporting in clinical trials is estimated to 4.9 (95% ci: 2.9-8.3) per 100 person-years. iraf risk persists throughout ibrutinib exposition and seems to be cumulative with the extension of follow-up and cardiac monitoring. underlying mechanisms of iraf are not fully understood. ibrutinib potently inhibits multiple off-target kinases at therapeutic concentrations. while a dose-reduction or an interruption of ibrutinib is mentioned in the summary of product characteristics of ibrutinib, any beneficial effect on iraf management of such a management is unclear. the main aim of this study is to determine if iraf is a dose-dependent cvae in chronic b-cell malignancies patients by studying the association between ibrutinib dose and iraf reporting in vigibase®, the world health organization (who) pharmacovigilance database.

Eligibility criteria:
inclusion criteria: * ibrutinib-related atrial fibrillation reports in vigibase at the time of data extraction * involving adult patients * with an available ibrutinib daily dose exclusion criteria: * minors * no ibrutinib dose available
a study to detect hyperkalemia using smartphone-enabled electrocardiogram (ekg)

Conditions: Hyperkalemia

Summary: the purpose of this study is to validate the real-world performance of a previously developed artificial intelligence - electrocardiogram (ai-ecg) algorithm for identification of hyperkalemia with a six-lead mobile-enhanced device .

1. ambulatory adult patients in the emergency department (ed) at increased risk for hyperkalemia (due to age ≥ 50 years, and one or more criteria including estimated glomerular filtration rate (egfr) (from serum creatinine) \ 5.2 milliequivalents per liter (meq/l) who present to the emergency department will be approached to consent for the rapid screening process. 2. those who consent will undergo 30 second 6 l ecg recording with a portable, mobile-enhanced device (alivecor kardia). 3. this ecg data is subsequently evaluated by our artificial intelligence algorithm to detect hyperkalemia, and the estimated probability of hyperkalemia is recorded. 4. the research team notifies supervising emergency department staff of patients whose probability of hyperkalemia is significantly elevated above the optimized cutoff point according to the ai-ecg algorithm.

Eligibility criteria:
inclusion criteria: * age greater than/equal to 50 years and able to provide consent. * patients with egfr (from serum creatinine) \ 5.2 meq/l. exclusion criteria: * patients underage \< 50. * do not meet inclusion criteria. * unstable patients requiring emergent resuscitation. * patients unable to provide consent.

Keywords: electrocardiogram (ecg) artificial intelligence (ai) neural network hyperkalemia emergency department (ed) smartphone alivecor kardia 6 l ecg device
the clinical markers for parp inhibitors-related efficacy in ovarian cancer

Conditions: Ovarian Cancer; Clinical Marker; PARP Inhibitor

Summary: epithelial ovarian cancer (eoc) is the most lethal gynecological malignancy. parp inhibitors(parpi) are an important progress in eoc treatment. the available evidence suggests that brcamt or hrd-positive is an effective biological marker for parpi. however, in our previous clinical observation, it was found that the tumor burden may be the potential clinical markers parpi. we intend to develop a real-world study to confirm the potential clinical markers and explore new clinical markers for parpi.

this study intends to conduct a systematic real-world study to observe the relationship between the clinical characteristics of eoc patients and the efficacy of parpi based on our existing research foundation and stratified analyse these correlations by brca and hrd status.

Eligibility criteria:
inclusion criteria: 1. subjects join the study voluntarily and sign informed consent; 2. female subjects are older than 18 years; 3. ecog(eastern cooperative oncology group) physical status score is 0-2; 4. life expectancy≥3 months; 5. histologically confirmed figo(international federation of gynecology and obstetrics ) iii/iv ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; participants must have high-grade serous or endometrioid histology; 6. patients should test for brca gene and will perform test for hrd status if who harbor brcawt in the same laboratory designated by the researcher; 7. patients received parp inhibitor as maintenance therapy or monotherapy for more than four weeks. exclusion criteria: 1. personnel involved in the formulation or implementation of the research plan; 2. patient participated in other clinical trails using other experimental drugs at the same time as the study; 3. the subjects had other malignant diseases in past 2 years, except skin squamous cell carcinoma, basal-like carcinoma, breast intraductal carcinoma in situ, or cervical carcinoma in situ; 4. previous or currently diagnosed myelodysplastic syndrome (mds) or acute myeloid leukemia (aml); 5. patients who are pregnant or lactation, or who plan to become pregnant during study treatment.

Keywords: ovarian caner, parp inhibitor, clinical marker
a study of efficacy and safety of glofitamab in combination with salvage therapy in a real-world setting in chinese adult patients with relapsed or refractory b-cell non-hodgkin lymphoma.

Conditions: B-cell Non-Hodgkin Lymphoma

Summary: the purpose of this study is to assess the efficacy and safety in the real-world settings of glofitamab in combination with salvage therapy among chinese adult patients with relapsed or refractory b-cell non-hodgkin lymphoma.


Eligibility criteria:
inclusion criteria: * be diagnosed as b-nhl * relapse or refractory to previous treatment * participants who will be treated with glofitamab exclusion criteria: * participant who currently participates in or with plan to participate in any interventional clinical trial * any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.
studies of avian influenza transmission to humans in egypt

Conditions: Avian Influenza

Summary: the main focus of the study is: * to estimate seroprevalence of ai in poultry-exposed and non-exposed human populations. * to estimate the incidence of ai in poultry-exposed and non-exposed human populations. * to investigate risk factors associated with ai infections in occupationally-exposed poultry workers. the secondary objectives of the study: * to investigate patterns in transmission of ai to household contacts of ai clinical cases * to isolate ai viruses from acute cases * to monitor the pathogenicity and disease severity of ai viruses causing human infections

this 4-year prospective cohort study to compare individuals with occupational exposure to poultry with non-poultry exposed adult controls for evidence of incident and previous infections with ai viruses. at the start of this study, study staff will obtain informed consent, and a blood sample will be obtained from study volunteers to establish baseline levels of antibodies against avian influenza types h4-h12. subjects will be interviewed regarding their exposures, medical history, and behaviors using a close-ended questionnaire specifically tailored for this study. after one year, study subjects will be interviewed again to note any changes in exposure variables. at this time, another blood sample will be obtained and tested for any changes in antibodies' levels. the same procedures will be repeated at the final visit after another year. exposed individuals will be selected from rural areas where poultry is commonly raised. non-exposed controls will be selected from urban neighborhoods in cairo.

Eligibility criteria:
inclusion criteria: * be willing to participate by signing a consent/assent form, completing the study questionnaire, and permitting the withdrawal of blood. * does not buy poultry from live bird markets (for controls only). exclusion criteria: * any known immunosuppressive condition or immune deficiency disease (including hiv infection), or ongoing receipt of any immunosuppressive therapy. * any individual with unknown poultry exposure status, or who was exposed to poultry more than 5 years ago. * children who are less than 2 years old when baseline enrollment is performed.

Keywords: serology poultry h5n1 virus hpai virus
retrospective evaluation of efficacy of meta-peng block

Conditions: Hip Fractures; Hip Injuries

Summary: the components of the lumbar plexus and capture the articular branches of hip capsule may be effectively blocked by administering a relatively high volume of local anesthetic deep to the iliacus muscle at the level of the anterior inferior iliac spine. we can provide both the blockade of the pericapsular nerve group supplying the hip capsule and the cutaneous blockade. here, we aimed to present our novel technique we named 'deep iliacus plane block (dipb)'.

many regional anesthesia techniques are used in hip surgeries for various goals, such as optimizing neuraxial positioning and relieving pain in the perioperative period, and have been the subject of clinical researches in the last few decades. the lumbar plexus is important in administering anesthesia and analgesia during hip and knee surgeries. comprising the femoral nerve (fn), lateral femoral cutaneous nerve (lfcn), and obturator nerve, it collaborates with the sacral plexus to ensure comprehensive innervation of the lower limb. we hypothesized that by administering a relatively high volume of local anesthetic deep to the iliacus muscle at the level of the anterior inferior iliac spine (aiis), we could effectively block the lumbar plexus components and capture the hip capsule's articular branches. we can ensure both the blockade of the pericapsular nerve group supplying the hip capsule and the cutaneous blockade. here, we aimed to present our cadaveric evaluation and retrospective evaluation of patients underwent meta-peng block, which we consider the proof-of-concept for our hypothesis of the technique we named 'deep iliacus plane block (dipb)'.

Eligibility criteria:
inclusion criteria: * asa-1, asa-2 and asa-3 patients who underwent hip surgery under spinal or general anesthesia exclusion criteria: anticoagulant drug use known allergy to the medications to be used infection in the area where the needle will be inserted missing data
reliability and validity of strength measurements of the lower limbs in children with bilateral spastic cerebral palsy.

Conditions: Children; Cerebral Palsy; Muscle Weakness

Summary: specific musculo-tendinous adaptations in children with cerebral palsy (cp) have an influence on muscle strength and consequently on functional behavior and participation. evidence of strength training programs has been shown on level of body function but transfer to levels of activity and participation is still limited. lack of transfer is related to lack of specificity of the training and poor overall quality of the interventions (intensity, duration, frequency and/or type). the use of functional strength exercises to assess and train strength of the lower limbs in children with cp is well implemented in the most functional children with cp (gmfcs-level i). to assess isometric strength the hand held dynamometer (hhd) can be used in clinical settings but reliability of this tool is questionable. the aim of this study is to adapt existing functional strength tests for less functional children with cp (focussing on gmfcs level ii and iii) and to investigate the correlation with isometric strength measurements and other functional parameters.

specific musculo-tendinous adaptations in children with cerebral palsy (cp) have an influence on muscle strength and consequently on functional behavior and participation. evidence of strength training programs has been shown on level of body function but transfer to levels of activity and participation is still limited. lack of transfer is related to lack of specificity of the training and poor overall quality of the interventions (intensity, duration, frequency and/or type). the use of functional strength exercises to assess and train strength of the lower limbs in children with cp is well implemented in the most functional children with cp (gmfcs-level i). the aim of this study is to adapt existing functional strength tests for less functional children with cp (focussing on gmfcs-level ii and iii) and to investigate the correlation with isometric strength measurements and other functional parameters.

Eligibility criteria:
inclusion criteria: * bilateral spastic cp * gmfcs ii-iii * 6-18 y * no botox until 4 months before testing * no orthopedic surgery until 1 y before testing * good cooperation

Keywords: cerebral palsy children functional strength measurement lower limbs reproducability
vinorelbine in treating older women with stage iv breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of vinorelbine in treating older women who have stage iv breast cancer.

objectives: * determine the objective response rate in elderly women with stage iv breast cancer treated with oral vinorelbine. * determine the toxicity profile of this drug in these patients. * determine the time to progression in patients treated with this drug. * determine the quality of life of patients treated with this drug. * assess individual variation in responses (toxicity and/or activity), pharmacokinetic parameters, and/or biologic correlates due to genetic differences in enzymes involved in the transport, metabolism, and/or mechanism of action of this drug in these patients. outline: patients receive oral vinorelbine once weekly. courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. quality of life is assessed at baseline and then after completion of the second course. patients are followed every 3 months for 5 years.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed stage iv breast cancer * eligible to receive first- or second-line chemotherapy * at least 1 unidimensionally measurable lesion * at least 20 mm in longest diameter * must be completely outside prior irradiation port unless there is proof of progressive disease after completion of prior radiotherapy * no untreated brain metastases * current metastatic cns disease allowed only if previously treated and clinically stable at study entry * no meningeal carcinomatosis * hormone receptor status: * not specified patient characteristics: age: * 65 and over sex: * female menopausal status: * not specified performance status: * ecog 0-2 life expectancy: * at least 12 weeks hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * total bilirubin no greater than 1.5 times upper limit of normal (uln) or * direct bilirubin normal if total bilirubin elevated or less than 2.5 times uln because of gilbert's syndrome renal: * creatinine no greater than 2 times uln other: * no grade 2 or greater peripheral neuropathy * no other significant medical condition that would preclude study * no active infection within the past 2 weeks * no dysphagia or inability to swallow intact capsules prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics * no more than 1 prior chemotherapy regimen for metastatic disease * no prior vinca alkaloids * at least 4 weeks since other prior chemotherapy and recovered endocrine therapy: * prior hormonal therapy allowed * no concurrent hormonal therapy radiotherapy: * see disease characteristics * no prior radiotherapy to 25% or more of bone marrow * at least 3 weeks since prior radiotherapy and recovered surgery: * at least 3 weeks since prior major surgery

Keywords: stage iv breast cancer recurrent breast cancer
a study to evaluate the efficacy and safety of combination therapy of brii-179, brii-835 and peg-ifnα in participants with chronic hepatitis b virus (hbv) infection (enhance)

Conditions: Chronic Hepatitis B Virus (HBV) Infection

Summary: this phase 2, randomized, double-blind study will evaluate the clinical efficacy and safety of the combination therapy of brii-179, brii-835, plus peg-ifnα compared to peg-ifnα in adult participants with chronic hbv infection without cirrhosis receiving neucloes(t)ide reverse transcriptase inhibitors (nrtis) as background therapy.


Eligibility criteria:
inclusion criteria: * male or female aged 18-60 years. * body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2. * chronic hbv infection for ≥ 6 months. * on nrti therapy with hbv dna \< lloq for ≥ 6 months. * serum alt and ast ≤ uln at screening visit. exclusion criteria: * any clinically significant chronic medical conditions other than chronic hbv infection that makes the participant unsuitable for participation in the study. * significant liver fibrosis or cirrhosis. * history of clinically significant chronic liver disease from any cause other than chronic hbv infection. * history of hepatic decompensation. * diagnosed or suspected hepatocellular carcinoma. * current or past history of infection with hiv, hcv or hdv. * any laboratory test abnormality that may contradict treatment with peg-ifnα. * known history of immunological function impairment. * history of intolerance to intramuscular or subcutaneous injection.
febuxostat effect on chronic kidney disease progression and carotid intima-media thickness

Conditions: Carotid Intima- Media Thickness

Summary: this study aimed to evaluate the impact of febuxostat on both carotid intima-media thickness and disease progression in individuals with chronic kidney disease

for all participants, comprehensive data collection was performed, encompassing detailed medical histories including patients' clinical and demographic characteristics (age, gender, bmi, associated comorbidities as htn, and dm, etiology of ckd.) laboratory investigations were conducted at baseline and after a three-month follow-up period. these investigations included: serum uric acid., creatinine, blood urea nitrogen, calcium, phosphorus., albumin., magnesium, intact parathyroid hormone (ipth), lipid profile (cholesterol, triglycerides, ldl, hdl), urine protein to creatinine ratio. radiological investigations: carotid artery duplex (medial wall thickness) was also conducted at baseline and after a three-month follow-up period. thickening of the artery wall is a hallmark of atherosclerosis and vascular calcification.

Eligibility criteria:
inclusion criteria: * age of 18 years or older * ckd stages iii to iv * asymptomatic hyper uricemia * stable dose of all medications including aceis or arbs for blood pressure control at least three months before enrolling exclusion criteria: * comprised active infections. * acute kidney injury. * active and advanced malignancy. * history of hypersensitivity to febuxostat. * women who are taking oral contraceptives, pregnant or lactating * patients with established cardiovascular disease. * patients with liver disease. * patients receiving mercaptopurine, theophylline and azathioprine. * patients on steroids or other immunosuppressive treatment.
a retrospective observational study on the long-term effects of ipilimumab-treated pediatric participants in the dutch melanoma treatment registry (dmtr)

Conditions: Melanoma

Summary: this is an observational, national, retrospective study consisting of pediatric patients with advanced (spread or unremoveable) melanoma identified in the dmtr in the netherlands


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trials, please visit www.bmsstudyconnect.com. inclusion criteria: * less than 18 years of age at first dose of monotherapy ipilimumab used for treatment of advanced melanoma * histological or cytological confirmation of advanced (unresectable or metastatic) melanoma exclusion criteria: -participation in a clinical trial within the past 4 weeks prior to first dose with ipilimumab or concurrently other inclusion/exclusion criteria apply