Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics of lcq908 in patients with renal impairment

Conditions: Renal Impairment

Summary: this study will compare the pharmacokinetics of lcq908 in subjects with varying degrees of renal impairment to healthy subjects


Eligibility criteria:
inclusion criteria: * individuals with renal impairment only * estimated creatinine clearance (clcr) by the cockroft-gault equation ≤80ml/min; * mild renal impairment defined as clcr 50-80 ml/min * moderate renal impairment defined as clcr 30-50 ml/min * severe renal impairment defined as clcr \<30 ml/min * healthy subjects only • estimated clcr by the cockroft-gault equation \>80ml/min exclusion criteria: * all individuals * a past medical history of clinically significant ecg abnormalities or a family history of a prolonged qt-interval syndrome. * female subjects must be of non child bearing potential or use an effective method of contraception. * individuals with renal impairment * renal transplant at any time. * subjects undergoing any method of dialysis (hemodialysis, peritoneal dialysis) within the last 3 months. * history of clinically significant chronic or recurrent urinary tract infection active and requiring antibiotic treatment within the past 30 days. * any medication that is contraindicated in moderate or severe renally impaired population * healthy subjects * history or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or bun and/or urea values, or abnormal urinary constituents (e.g., albuminuria) * evidence of urinary obstruction or difficulty in voiding at screening * history or presence of hepatitis b or c and/or positive hepatitis b surface antigen (hbsag) or hepatitis c test result at screening. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: lcq908, renal impairment, pharmacokinetics
safety and exploratory efficacy study of ucmscs in patients with fracture and bone nonunion

Conditions: Fracture; Bone Nonunion

Summary: the purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with fracture and bone nonunion.


Eligibility criteria:
inclusion criteria: * every patient with non union in the site of bone fracture and nonunion. * age more than 18 and less than 60 years old. * nonunion or delayed union. exclusion criteria: * diagnosis of cancer. * pregnancy or breastfeeding. * patient positive by serology or pcr for hiv, hepatitis b or c infection the patient with accompanied fracture such as hip fracture that could not weight bearing. * any medical or psychiatric condition that in the researcher´s opinion could affect the patient´s ability to complete the trial or hamper the participation in the trial. * patients do not sign the consent forms
metabolic disorders in polycystic ovarian syndrome

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this study is to elucidate the significance of adipocytokine in women with pcos among adiposity, hyperandrogenism and insulin resistance.

polycystic ovary syndrome (pcos) is the most common endocrinopathy in women of reproductive age with a probable prevalence of 5% to 10%. pcos is characterized by chronic anovulation, menstrual irregularities, evidence of hyperandrogenism (either clinical, manifested as hirsutism, acne, male pattern balding, or biochemical, manifested by elevated serum adrenal and/or ovarian androgen concentration). fifty percent of all patients with pcos are obese, and the presence of obesity affects the clinical manifestations of pcos. the underlying pathogenic mechanisms appear to involve insulin resistance and hyperinsulinemia, the magnitude of which is greater in obese than in non-obese women with pcos.

Eligibility criteria:
inclusion criteria: * 1. oligomenorrhea ( less than 6 times spontaneous mc per year) or amenorrhea. 2. hyperandrogenism (either clinical or biochemistry. 3. pco by ultrasound. 4.after menarche, before menopause. exclusion criteria: * 1. hormone therapy in the past 6 months. 2. pregnancy in the past 6 months 3.acute illness found in the past 3 months. 4.systemic disease including autoimmune disease, malignancy, hepatic, renal or cvs disease, and ever received chemotherapy or immunosuppressive agents.
paper-based electrochemical point-of-care device in diagnostic of orthopedic infections

Conditions: PJI; Spondylodiscitis

Summary: periprosthetic joint infections (pji) and spondylodiscitis are considered some of the most costly infectious diseases because require at least one surgery, prolonged hospitalisation, rehabilitation care, prolonged antibiotherapy, and extended absence from work in working-age patients. ortho-poc will face this issue with a smart and highly innovative diagnostic tool, starting from the point-of-care device for infection diagnosis in the orthopedic field developed and published by the coordinator fondazione policlinico universitario agostino gemelli irccs and one partner università degli studi di roma tor vergata. ortho-poc will further go beyond the state of the art by delivering a point-of-care device based on multiparametric analysis, in easily collected synovial fluids or pus. several samples will be analysed using ortho-poc at three different hospitals (fondazione policlinico universitario agostino gemelli irccs, ospedali riuniti di foggia, azienza ospedaliera universitaria policlinico vanvitelli napoli) and the data will be treated with artificial intelligence (ai) to deliver an ai-assisted robust, effective, and smart diagnostic device for pji.


Eligibility criteria:
inclusion criteria: * patients that received a joint implant or spine surgery, clear signs of infection (according to international guidelines) * patients off antibiotic therapy at least for two weeks * sample biopsy of minimum 1 ml. exclusion criteria: * pregnant women, * patient affected by cancer * patient under antibiotic therapy

Keywords: infections; orthopedic surgery; sensor; pji, spondylodiscitis
comparative effectiveness of tirzepatide vs semaglutide in participants with type 2 diabetes and heart failure with preserved ejection fraction

Conditions: Type 2 Diabetes; Heart Failure

Summary: this cohort study aims to assess the comparative effectiveness of tirzepatide versus semaglutide with respect to cardiovascular events in patients with type 2 diabetes and heart failure with preserved ejection fraction.

both semaglutide, a glucagon-like peptide-1 receptor agonist (glp-1ra), and tirzepatide, a glucose-dependent insulinotropic polypeptide (gip)/glp-1ra, are currently approved treatments to control blood glucose in patients with type 2 diabetes (t2d) and to lower weight in patients with obesity, with or without t2d. obesity is a leading risk factor for the onset and the progression of heart failure (hf), especially hf with preserved ejection fraction (hfpef). due to their potent weight-lowering action, semaglutide and tirzepatide have been recently evaluated in placebo-controlled trials conducted among persons with obesity and hfpef, with or without t2d. these trials showed that semaglutide and tirzepatide reduced hf symptoms and hf events, compared to placebo. in this new user, active comparator cohort study, we will identify commercially insured adults (aged \> 18 years) with t2d and hfpef who initiated treatment with tirzepatide or semaglutide between june 1, 2022, and december 31, 2024. we will retrieve information for each study participants using deidentified, longitudinal insurance claims data, including demographic characteristics, health plan enrollment status, inpatient and outpatient diagnoses, procedures, health care visits, hospitalizations, and pharmacy dispensing records. cohort entry is the day of initiation of tirzepatide or semaglutide. the follow-up starts on the day after cohort entry and continue until the occurrence of an outcome, discontinuation, switching, death, end of continuous health plan enrollment or end of the study period. our primary outcome is a composite of hospitalization for hf or all-cause mortality. we will use propensity score adjustment to mitigate the risk of confounding. we will calculate the number of events, incidence rates, and rate differences per 1000 person-years. cox proportional hazard models will be used to estimate hazard ratios with their 95% confidence intervals.

Eligibility criteria:
inclusion criteria: * patients who are new users of tirzepatide or new users of semaglutide * patients with diagnosis of t2d and hfpef, i.e., ef \>= 45%. * age \>= 18 years old * patients with continuous health plan enrollment before and including the treatment initiation date exclusion criteria: * patients with missing age or sex information * patients with type 1 diabetes mellitus, secondary or gestational diabetes * history of diabetes related complications * patients with related chronic diseases. * history of gastrointestinal conditions. * previous exposure to other glp-1ra and pramlintide * patients with prescription dispensing for both tirzepatide and semaglutide on cohort entry date

Keywords: tirzepatide semaglutide type 2 diabetes heart failure cardiovascular disease mortality
post-marketing study to evaluate the efficacy of influenza vaccine

Conditions: Influenza

Summary: as a result of the recent supply shortages in the u.s., as well as an anticipated increase in demand during the coming years, gsk biologicals is pursuing licensure of fluarix in the u.s. under the accelerated approval process; marketing approval most likely will be granted before the start of this clinical trial. gsk proposes to support u.s. licensure of fluarix with this confirmatory post-marketing study. the purpose of the study is to evaluate the efficacy of a single dose of fluarix in preventing influenza in adults during the 2005/2006 influenza season.


Eligibility criteria:
inclusion criteria: * a male or female age between, and including, 18 and 64 years of age at the time of the vaccination. * written informed consent obtained from the subject. * availability to follow up by phone during the study period. * female subjects must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal. if subject is of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination. she must also have a negative pregnancy test at study entry and must agree to continue such precautions for two months after vaccination. exclusion criteria: * history of hypersensitivity to a previous dose of influenza vaccine. * history of allergy or reactions likely to be exacerbated by any component of the vaccine including egg, chicken protein, formaldehyde, thimerosal, gentamicin sulfate or sodium deoxycholate. * acute disease at the time of enrollment. (acute disease is defined as the presence of a moderate or severe illness with or without fever). all vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral temperature \< 37.5°c). * pregnancy * chronic disorders of the pulmonary or cardiovascular system, including asthma * history of requiring regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus.
safety and efficacy of leo 80185 gel in adolescent subjects (aged 12 to 17) with scalp psoriasis

Conditions: Scalp Psoriasis

Summary: the purpose of the study is to evaluate the safety and efficacy of once daily use of leo 80185 gel in adolescent subjects (aged 12 to 17) with scalp psoriasis. leo 80185 gel has marketing approval in many countries under the brand names xamiol® gel and taclonex scalp® topical suspension for the treatment of scalp psoriasis in adults. no studies have been performed in subjects younger than 18 years


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of scalp psoriasis which is of an extent of more than or equal to 10% of the scalp area * a clinical diagnosis of scalp psoriasis which is of at least moderate severity according to the investigator's global assessment * serum albumin-corrected calcium below the upper reference limit at screening visit 2 exclusion criteria: * a history of hypersensitivity to any component of the leo 80185 gel * topical treatment on the trunk and/or limbs with very potent (who group iv) corticosteroids within 2 weeks prior to visit 1 or during the study * topical treatment on the face and/or genital/skin folds with potent or very potent (who groups iii-iv) corticosteroids within 2 weeks prior to visit 1 or during the study * systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp psoriasis within the following time period prior to visit 1 and during the study: * etanercept - within 4 weeks prior to visit 1 * adalimumab, alefacept, infliximab - within 2 months prior to visit 1 * ustekinumab - within 4 months prior to visit 1 * experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to visit 1 * systemic treatment with therapies other than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, retinoids, immunosuppressants, puva) within 4 weeks prior to visit 1 (day 0) or during the study * uvb therapy within 2 weeks prior to visit 1 or during the study * any topical treatment on the scalp (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to visit 1 or during the study * systemic calcium or vitamin d supplements, antacids, diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to screening visit 2 or during the study * planned initiation of, or changes to, concomitant medication that could affect scalp psoriasis (e.g., betablockers, chloroquine, lithium, ace inhibitors) during the study * current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis * subjects with any of the following conditions present on the scalp area: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds * planned excessive exposure to sun during the study that may affect scalp psoriasis * known or suspected disorders of calcium metabolism associated with hypercalcaemia
nivolumab-ipilimumab and chemoradiation for cervical cancer

Conditions: Uterine Cervical Neoplasms

Summary: a total of 112 patients with locally advanced cervical cancer will be randomized 1:1 to standard therapy with cisplatin-based chemoradiation or nivolumab-ipilimumab induction followed by cisplatin-based chemoradiation. the primary outcome will be 3-year disease-free survival.

patients with adenocarcinoma or squamous cell carcinoma of the cervix, figo stage ib2-ib3 node positive or stage iib-iva will be randomized to conventional cisplatin-based chemo-radiation or to 4 cycles of induction immunotherapy with nivolumab 1mg/kg and ipilimumab 3mg/kg every 3 weeks, followed by cisplatin chemo-radiation with concurrent nivolumab 240mg every 2 weeks. primary outcome will be 3-year progression-free survival.

Eligibility criteria:
inclusion criteria: * female participants older than 18 years * documented evidence of cervical adenocarcinoma or squamous carcinoma figo stage ib2-ib3 node positive or stage iib-iva * no prior chemotherapy, immune checkpoint inhibitors or radiotherapy for cervical cancer * who/ecog performance status of 0-1 * at least 1 lesion, not previously irradiated, that qualifies as a recist 1.1 target lesion at baseline. exclusion criteria: * diagnosis of small cell (neuroendocrine) histology cervical cancer * intent to administer a fertility-sparing treatment regimen * undergone a previous hysterectomy * evidence of metastatic disease per recist 1.1 including lymph nodes ≥15 mm (short axis) above the l1 cephalad body or outside the planned radiation field. * history of allogeneic organ transplantation * active or prior documented autoimmune or inflammatory disorders * uncontrolled intercurrent illness * history of another primary malignancy and active primary immunodeficiency * patients with active infection laboratory values that fall into: 1. wbc count (wbc) \< 2000/μl ; 2. neutrophil count \< 1500/μl; 3. platelet count \< 100 x 103/μl; 4. hemoglobin level \< 9.0 g/dl; 5. serum creatinine \> 1.5 x upper limit of normal (uln) unless creatinine clearance is ≥ 40 ml/min (measured or calculated using the cockcroft-gault formula); 6. aspartate aminotransferase (ast)/alanine aminotransferase (alt): \> 3.0 x uln; 7. total bilirubin \> 1.5 x uln (except participants with gilbert syndrome who must have a total bilirubin level of \< 3.0 x uln); 8. any positive test result for hepatitis b virus or hepatitis c virus that indicates the presence of the virus, for example, positive hepatitis b surface antigen (hbsag, australia antigen) or hepatitis c antibodies (anti- hcv) positive (unless the hcv-rna is negative). * participants with a condition requiring systemic treatment or with corticosteroids (\>10 mg daily of a prednisone equivalent) or other immunosuppressive drugs within 14 days of initiating study treatment. * pregnant or breastfeeding woman

Keywords: uterine cervical neoplasms nivolumab ipilimumab chemoradiation anti-pd1 anti-pdl1 anti-ctla4 immunotherapy
a study to evaluate the efficacy, safety and pharmacokinetics of emapalumab in adult patients with hlh

Conditions: Hemophagocytic Lymphohistiocytoses

Summary: hemophagocytic lymphohistiocytosis (hlh) is a rare, life-threatening condition characterized by uncontrolled hyperinflammation which may develop on the background of several clinical conditions (e.g. autoimmune disease, infection, malignancy). emapalumab (previously referred to as ni-0501) is a monoclonal antibody neutralizing interferon-gamma (ifn-gamma), a key cytokine driving the inflammation and tissue damage seen in hlh. the purpose of this study is to assess the efficacy, safety and pharmacokinetics of emapalumab in adult patients with secondary hlh.

study ni-0501-10 is an open-label, single arm, multicenter, phase 2/3 interventional study. the study enrolls adult patients with hemophagocytic lymphohistiocytosis (hlh), specifically newly diagnosed patients with malignancy-associated hlh (m-hlh), and newly diagnosed or previously treated patients with non-malignancy-associated hlh.

Eligibility criteria:
inclusion criteria: * male and female patients of age 18 and older at the time of hlh diagnosis * fulfilment of 5 of the 8 hlh-2004 clinical criteria * patients diagnosed with malignancy-associated hlh must be treatment naïve; patients diagnosed with hlh driven by any other etiology or idiopathic can be either treatment naïve or treatment experienced * patients with non-malignancy-associated or idiopathic hlh who have already received conventional therapy for hlh must have failed prior treatment as per the treating physician's judgement * informed consent signed by the patient or by the patient's legally authorized representative(s) (as required by local law) * willing to use highly effective methods of contraception from study drug initiation to 6 months after the last dose of study drug, if female and of childbearing potential. exclusion criteria: * primary hlh * current or scheduled administration of therapies known to trigger the cytokine release syndrome (e.g. chimeric antigen receptor (car)-modified t cells, bispecific t cell-engaging antibodies) * current or scheduled administration of pd-1/pd-l1/ctla-4 inhibitors * life-expectancy associated with the underlying disease (triggering hlh) \< 3 months * ongoing participation in an investigational trial, or administration of any investigational treatment within 30 days * history of hypersensitivity or allergy to any components of emapalumab * active mycobacteria, histoplasma capsulatum, or leishmania infections * evidence of latent tuberculosis * receipt of a bacille calmette-guerin (bcg) vaccine within 12 weeks prior to screening * receipt of a live or attenuated live (other than bcg) vaccine within 6 weeks prior to screening

Keywords: interferon gamma emapalumab adult hlh malignancy-associated hlh cxcl9
fracture risk with thiazolidinediones

Conditions: Fractures, Bone; Type II Diabetes

Summary: treatment with thiazolidinediones (tzd) has recently been reported to possibly increase the risk of fractures in a randomized trial exploring the efficacy of rosiglitazone (rsg), metformin, or glyburide encompassing 4360 patients with type 2 diabetes. it is hypothesized that spironolactone, a diuretic that is broadly used for the treatment of fluid retention and edema associated with tzd, has a potential protective effect against bone fractures. however, to our knowledge, this has not been tested in diabetic patients treated with tzd. amiloride is another diuretic that shares with spironolactone the anti mineralocorticoid ion gated channels activity and will be analysed in this study with regard to possible protective effect against bone fracture in combination with tzd. this study is a nested case-control study conducted among type 2 diabetes subjects exposed to tzd. the study aims to explore if the risk of fracture is reduced among type 2 diabetic subjects exposed to spironolactone and tzd. the study will compare the odds of any low impact fracture, and hand, foot, upper arm, wrist, and hip fracture incidence in subjects treated with tzd+spironolactone and tzd+amiloride compared to subjects treated with tzd only. the study population will consist of type 2 diabetes patients aged 18 -65 years old exposed to tzd. to be eligible for the study, a subject must have had at least one international classification of disease (icd)-9 code for type 2 diabetes and have at least 6 months or at least 12 months of exposure to tzd (rosiglitazone \[rsg\], pioglitazone \[pio\] or troglitazone) during their follow-up time available in the database.

patients were not recruited for nor enrolled in this study. this study is a retrospective observational study. data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. all diagnoses and treatment are recorded in the course of routine medical practice.

Eligibility criteria:
inclusion criteria: * at least one icd-9 code for type 2 diabetes * at least 6 months or at least 12 months of exposure to tzd (rsg, pio or troglitazone) during their follow-up time available in the database (the subject's study period begin date will be defined as the earliest date of their first tzd prescription. subjects included in the study are required to have at least six months of follow-up time in the database prior to their first tzd prescription) exclusion criteria: * subjects with a diagnosis of paget's disease and osteomalacia * a history of fracture, osteoporosis or cancer prior to the first prescription of tzd (study begin date)

Keywords: thiazolidinediones rosiglitazone amiloride pioglitazone fracture spironolactone