Kornimate/medical-research-clean huggingface dataset:
octreotide lar in the induction of immunologic response in nens patients

Conditions: Neuroendocrine Tumors

Summary: evaluating the impact of octreotide lar on the immune response by studying regulatory t-cell (t-reg) and myeloid-derived suppressor cells (mdsc) and the immunoregulatory cell population in peripheral blood of net g1 / g2 patients treated with octreotide lar

mdscs and t-regs will be evaluated at baseline pre-treatment with octreotide, after 15 days, at three and at six months and before each octreotide lar administration for 12 months. mdsc cells will be detected by surface receptors lin-, cd11b, cd14, cd15, cd33, cd124-il4-ra, cd184-cxcr4, cd279-pd1, hla-dr and t-reg cells from cd3, cd4, cd8 receptors , cd25, cd39, cd45ra, cd45r0, cd62l, cd127, cd152-ctla-4, cd184-cxcr4, cd278-icos, cd279-pd-1. briefly, cd4 + cells will be separated by negative selection, using the mixture of human cd4 antibodies. octreotide is currently a registered drug to the fda, ema and aifa with the indication for the treatment of well and moderately differentiated nets functioning and not working on the front line. .

Eligibility criteria:
inclusion criteria: * signed informed consent prior to initiation of any study-specific procedures or treatment, as confirmation of the patients awareness and willingness to comply with the study requirements. * patients ≥18 years of age. * patients with histologically confirmed well and moderately differentiated neuroendocrine tumors with ki67 ≤ 20% (ki67 must be quantified in percentage) and candidates for treatment with octreotide. * ecog performance status (ps) of 0-2. * at least 28 days since prior the last radiation therapy or surgery. * estimated life expectancy of ≥12 weeks. exclusion criteria: * patients \< 18 years of age. * according to the current smpc of the prescribed drug agent. * previuos treatment with octreotide. * psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would prevent the patient from meeting the study requirements. * serious active infection requiring i.v. antibiotics and/or hospitalization at study entry. * patients who are treated with any medicinal product that contraindicates the use of the study drug, may interfere with the planned treatment, affects patient compliance or puts the patient at high risk for treatment-related complications. * pregnant or lactating females. serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. women of childbearing potential (defined as inferior to 2 years after last menstruation and not surgically sterile) not using effective, non hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly). perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential * patients with meningeal carcinomatosis * patients with known positive hiv status

Keywords: octreotide neuroendocrine tumors immunological response
sgc stimulation, perioperative vascular reactivity, and organ injury in cardiac surgery

Conditions: Endothelial Dysfunction; Vascular Diseases; Kidney Injury; Brain Disease; Vascular Inflammation

Summary: the goal of this mechanistic clinical trial is to learn about the effects of medications called soluble guanylyl cyclase stimulators on vascular function and markers of kidney and brain injury in patients having heart surgery. the main questions it aims to answer are: 1. does soluble guanylyl cyclase stimulation improve blood vessel function compared to placebo? 2. does soluble guanylyl cyclase stimulation decrease markers of kidney injury and brain injury compared to placebo? participants will be randomized to a soluble guanylyl cyclase stimulator called vericiguat or placebo, and researchers will compare vascular function and markers of brain and kidney injury to see if vericiguat improves vascular function and reduces markers of injury. this will provide important information to determine the underlying reasons that patients have some kidney and brain function problems after having heart surgery.

patients undergoing elective cardiac surgery will be randomized to the soluble guanylyl cyclase stimulator vericiguat versus placebo before surgery through the day of surgery and vascular function will be quantified using ultrasound and direct assessment of arterial relaxation ex-vivo. markers of brain and kidney injury will be measured in plasma and urine.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. elective open-heart surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy exclusion criteria: 1. intolerance to vericiguat 2. use of other soluble guanylyl cyclase stimulators or current use of phosphodiesterase-5 inhibitors 3. pregnancy or breast feeding. pregnancy will be excluded in women of child-bearing potential by a urine or serum beta hcg test 4. renal replacement therapy within 30 days prior to screening 5. estimated glomerular filtration rate \<15 ml/min per 1.73 m2 per chronic kidney disease epidemiology collaboration (ckd-epi) equation at time of screening 6. systolic blood pressure less than 120 mmhg at the time of screening 7. prior kidney transplantation 8. history of significant liver dysfunction (defined as child-pugh class c) 9. surgery scheduled to be performed with circulatory arrest 10. surgery scheduled to correct a major congenital heart defect 11. extracorporeal membrane oxygenation (ecmo) prior to surgery 12. active systemic infection or surgery for infectious endocarditis 13. ventricular assist device or intraaortic balloon pump support prior to surgery 14. prisoners
a study to evaluate the safety and immunogenicity of monovalent opv2 in children aged 1 to 5 years in lithuania

Conditions: Poliomyelitis

Summary: a phase 4 study to evaluate the safety and immunogenicity of monovalent oral polio vaccine type 2 in healthy ipv-vaccinated children aged 1 to 5 years in lithuania.

sabin 2 will be withdrawn from routine use globally from april 2016 as per the sage recommendations at the time of writing this protocol. after this cessation of opv2, stockpiles of mopv2 will be maintained for potential use if necessary in response to a future outbreak. however, there is a risk of cvdpv2 from sabin 2 in settings of low population immunity. research is ongoing to develop vaccines that are genetically more stable than the currently available sabin 2-containing opvs. to generate data on immunogenicity, safety, and genetic stability on the sabin 2 vaccine (mopv2) and as a future comparator for new polio vaccine research after the global switch from topv to bopv, this study with mopv2 is performed to evaluate safety, immunogenicity (humoral and intestinal) and genetic stability endpoints of mopv2 in children aged 1 to 5 years for better understanding of the stockpile use of this vaccine, and any potential new polio vaccine with a type 2 component in the future.

Eligibility criteria:
inclusion criteria: 1. 1 to 5 years of age, previously vaccinated with three or four doses of ipv. 2. healthy without obvious medical conditions that preclude entry of the subject into the study as established by the medical history and physical examination. 3. written informed consent obtained from 1 or 2 parent(s) or legal guardian(s) as per country regulations. exclusion criteria: 1. previous vaccination against poliovirus outside the national immunization schedule. 2. any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus (hiv) infection. 3. family history of congenital or hereditary immunodeficiency. 4. major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine). 5. known allergy to any component of the study vaccines or to any antibiotics. 6. administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. 7. acute severe febrile illness at day of vaccination deemed by the investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all in/exclusion criteria are met.). 8. member of the subject's household (living in the same house or apartment unit) has received opv in the last 3 months. 9. subject who, in the opinion of the investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
a study of pm8002 in combination with chemotherapy in patients with nen

Conditions: Neuroendocrine Neoplasm

Summary: pm8002 is a bispecific antibody targeting pd-l1 and vegf. this study will evaluate the efficacy and safety of pm8002 in combination with folfiri as second line treatment for neuroendocrine neoplasm (nec and ki-67≥55% g3 net).

this is a phase ii, single arm study assessing the efficacy and safety of pm8002 in combination with folfiri as second line treatment for neuroendocrine neoplasm (nec and ki-67≥55% g3 net) who failed first-line platinum-based chemotherapy

Eligibility criteria:
inclusion criteria: 1. signed informed consent form before any trial-related processes; 2. aged ≥ 18 years; 3. ki-67≥55% g3 net and nec were confirmed histologically or cytologically by pathological diagnosis in this study; 4. subjects failed first-line platinum-based chemotherapy; 5. adequate organ function; 6. the eastern cancer cooperative group (ecog) performance score of 0 or 1; 7. expected survival ≥ 12 weeks; 8. had at least one measurable tumor lesion according to recist v1.1; exclusion criteria: 1. history of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs; 2. evidence and history of severe bleeding tendency; 3. history of severe cardiovascular diseases within 6 months; 4. subjects should provide formalin-fixed-paraffin-embedded (ffpe) tumor samples during the screening period (up to 24 months); 5. current presence of uncontrolled pleural, pericardial, and peritoneal effusions; 6. history of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation; 7. history of alcohol abuse, psychotropic substance abuse or drug abuse; 8. human immunodeficiency virus (hiv) infection or known acquired immunodeficiency syndrome; 9. pregnant or lactating women; 10. other conditions considered unsuitable for this study by the investigator.

Keywords: second line nec g3 net
thromboxane receptor antagonist to improve endothelial function

Conditions: Cardiovascular Diseases; Vascular Dilation

Summary: this study evaluates whether addition of the thromboxane receptor antagonist to chronic aspirin therapy improves endothelial function and reduces non-platelet thromboxane generation in patients with established cardiovascular disease. half of participants will receive ifetroban and the other half will receive matching placebo for the 4 week study period.

thromboxane is a prostaglandin produced in healthy individuals mainly in platelets, where it mediates platelet activation and vasoconstriction via binding to cellular thromboxane-prostanoid (tp) receptors. the cardioprotective effect of aspirin is due to suppression of platelet thromboxane generation and reactivity. unfortunately 25-50% of patients with cardiovascular disease taking asa continue to generate thromboxane from non-platelet sources, which significantly increases their risk of atherothrombosis and death. evidence suggests that oxidative stress is a potent stimulus for thromboxane generation in endothelial cells that involves autocrine/paracrine signaling through the tp receptor. this clinical trial addresses the central hypothesis that vascular endothelial cells under oxidative stress are a major source of non-platelet thromboxane generation in patients with cardiovascular disease and that antagonism of the tp receptor will suppress its formation and improve endothelial function.

Eligibility criteria:
inclusion criteria: * males and females 18-80 years of age with established cardiovascular disease * take \>=81 mg daily of aspirin as part of their daily medical regimen * urine thromboxane b2 metabolites \>1145 pg/mg creatinine on screening. * able to provide written consent and comply with protocol-specific procedures. exclusion criteria: * chronic oral anticoagulation with a non-vitamin k antagonist. * anticipated change or interruption in aspirin therapy during the study period. * st segment myocardial infarction within the past 30 days. * cardiac surgery within the past 30 days. * stage 4-5 renal failure or on renal replacement therapy. * an ongoing uncontrolled severe inflammatory condition. * pregnant,intending to become pregnant or breast feeding. * known ifetroban or aspirin sensitivity inability to perform vascular testing. * participation in another investigational drug trial within 30 days of randomization.
a phase iii study in subjects with primary open angle glaucoma or ocular hypertension in china

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: this is a phase iii study that includes a single arm, open-label, multi-dose pk study cohort and a randomized, evaluator-masked, active drug-control multicenter study. subjects diagnosed with poag (primary open angle glaucoma) or oht (ocular hypertension) who meet eligibility criteria will washout of their current iop lowering medication(s), if any. the study will investigate plasma pharmacokinetics of multi-dose 0.002% de-117b eye drops (1 drop at a time administered once daily for 7 days) in chinese subjects with primary open angle glaucoma or ocular hypertension. it will investigate the safety of multi-dose 0.002% de-117b eye drops (1 drop at a time administered once daily for 7 days) in chinese subjects with primary open angle glaucoma or ocular hypertension. there will be a bridging cohort and extension follow-up phase


Eligibility criteria:
inclusion criteria: * patients diagnosed with primary open angle glaucoma or ocular hypertension in both eyes. * corrected visual acuity ≥0.2 in both eyes. * anterior chamber angle grade ≥2 (shaffer scale) in both eyes. * central corneal thickness ≥480 μm to ≤600 μm in both eyes. * at completion of the washout phase, iop ≥22 mmhg in at least one eye and ≤34 mmhg in both eyes at all measurement time points. exclusion criteria: * consider visual field disorder at risk for progression during the study based on the current clinical examination result. * severe visual field disorder (e.g., mean deviation lower than -12 db, as assessed by humphrey field analyzer). * any corneal abnormality or other condition potentially interfering with reliable applanation tonometry. * history of iritis or uveitis. * presence of any active external ocular disease, inflammation, or infection of the eye or eyelids. * history of macular oedema, retinal detachment, or diabetic retinopathy, or current retinal disease at risk for progression during the study. * history of refractive keratotomy. * history of invasive surgery for glaucoma (including laser therapy). * anterior segment or intraocular surgery (other than glaucoma) within 90 days prior to start of washout phase. * history of severe eye injury. * history of allergy to agents that were to be used during the study (e.g., benzalkonium chloride, instillation anesthetics, fluorescein, latanoprost eye drops). * intended use of prohibited concomitant medications or therapies during the study. * required use of contact lenses from 1 week before treatment phase initiation and during the study. * pseudophakic eye, aphakic eye. * current participation in another clinical study, or participation and treatment with study medication within 90 days before the start of the washout phase. * females who are pregnant, nursing, or potentially pregnant (e.g., positive pregnancy test), planning a pregnancy during the study, or unable to use appropriate contraception during the study.
garnering effective telehealth 2 help optimize multidisciplinary team engagement

Conditions: Children With Complex Chronic Conditions

Summary: the purpose of this study is to determine the effectiveness of the get2home intervention bundle.


Eligibility criteria:
inclusion criteria: * patients with complex chronic disease based on a pediatric medical complexity algorithm (pmca) score of 3 and their families and their primary care providers * discharged from pediatric hospital medicine service at our hospital exclusion criteria: * patients who live independently without a parent or guardian in the home, including those that live at skilled nursing facilities * patients admitted for end of life care * patients admitted for suicidal or homicidal ideation * patients who previously enrolled in the study * patients in county custody
comparing the effect of the water drinking test on intraocular pressure

Conditions: Glaucoma

Summary: a test that was common in the 1960's and was used to detect primary open angle glaucoma was the water drinking test (patients drank 1 quart of water to stress the fluid drainage mechanism of the eyes. intraocular pressure was then measured over the next hour). recently this test has been demonstrated as a predictor of peak eye pressure during the day. the purpose of this study is to compare the results of the water drinking test between eyes that have undergone trabeculectomy and eyes that have undergone tube shunt surgery.


Eligibility criteria:
inclusion criteria: * prior trabeculectomy or tube shunt for the treatment of glaucoma * age 21-90 years exclusion criteria: * inability to give informed consent * current ocular infection * more than 1 prior trabeculectomy, or more than 1 prior tube shunt * previous refractive surgery * pregnant women * heart failure * renal failure or uncontrolled urine retention * corneal abnormalities preventing reliable iop measurement

Keywords: water drinking test trabeculectomy tube shunt
metformin-dipyridamole interaction trial

Conditions: Diabetes

Summary: the antihyperglycemic drug metformin and the thrombocyte aggregation inhibitor dipyridamole are often used concomitantly in patients with diabetes who have suffered a transient ischemic attack or stroke. it has recently been suggested that the gastrointestinal absorption of metformin is mediated by the equilibrative nucleoside transporter 4 (hent4). dipyridamole has been reported to inhibit hent4 transport in vitro. the aim of this research proposal is to study the pharmacokinetic interaction between metformin and dipyridamole. the investigators hypothesize that dipyridamole reduces the gastrointestinal absorption of metformin. if this hypothesis can be confirmed, then the results of this study can explain in part the high variability in plasma metformin concentrations in patients treated with diabetes, and can be used to optimize pharmacotherapy in patients with diabetes.


Eligibility criteria:
inclusion criteria: * age 18-50 years * written informed consent exclusion criteria: * smoking * hypertension (systolic blood pressure \> 140 mmhg and/or diastolic blood pressure \> 90 mmhg) * diabetes mellitus (fasting glucose \>7.0 mmol/l or random glucose \>11 mmol/l) * history of any cardiovascular disease * concomitant use of medication * renal dysfunction (mdrd \<60 ml/min) * ecg abnormalities, other than firs grade av-block or right bundle branch block

Keywords: effect dipyridamole on pharmacokinetics of metformin
effectiveness and safety of fulvestrant in postmenopausal women with advanced breast cancer hr+, her2-

Conditions: Breast Neoplasm Female

Summary: a phase iv, single arm study will be performed in postmenopausal women with locally advanced or metastatic breast cancer. all patients included will receive fulvestrant from dr. reddy's laboratories, in accordance with local practice and the regulatory authorization of the drug in colombia. this study will be carried out for 1 year and approximately 40 patients will be included in 2 research centers selected for its conduct. patients who meet the inclusion criteria and who do not have to be discarded from entering the study due to meeting any of the exclusion criteria, will be evaluated to determine the effectiveness and tolerability of the administration of dr. reddy's fulvestrant at a dose of 500 mg / month plus an additional indicated dose 14 days after the initial dose, for 12 months of follow-up or until disease progression or the appearance of unacceptable toxicity. the assessment of tolerability will be carried out based on the collection of data related to adverse events from the first dose administered.


Eligibility criteria:
inclusion criteria: 1. postmenopausal women (defined as those with permanent cessation of menstruation for more than 12 months, regardless of whether their menopausal condition occurred naturally or was artificially induced), ambulatory or hospitalized 2. diagnosis of advanced breast cancer hr +, her2- 3. positivity for hormone receptors (either estrogen, progesterone, or both). 4. negative for human epidermal growth factor receptor 2 (her2). 5. acceptance of informed consent, if it is required by local regulatory standards. exclusion criteria 1. history of previous treatment with fulvestrant. 2. concomitant treatment with antitumor drugs other than cyclin inhibitors (abemaciclib, palbociclib, ribociclib). 3. pregnancy. 4. lactation. 5. hypersensitivity to any of the excipients included in the complete formulation of fulvestrant from dr. reddy's laboratories limited. 6. renal insufficiency grade 4 or 5 (creatinine clearance \<30 ml / min / 1.73 m2 according to the classification of the national kidney foundation). 7. hepatic failure (child-pugh c stage). 8. performance status ecog ≥ 3.
performance and nutrition program for athletes in adaptive sports

Conditions: Spinal Cord Injuries; Physical Disability

Summary: researchers are trying to evaluate and recommend sustainable and effective health and wellness programs for people with spinal cord injury (sci) and other physical disabilities.


Eligibility criteria:
inclusion criteria: group1 (group with spinal cord injury): * participants with traumatic or non-traumatic spinal cord injury * able to perform progressive exercise program * willingness to participate in study group 2 (able-bodied group): * functional upper extremity range of motion * able to perform progressive exercise program * willingness to participate in study group3 (other physical disability group): * participants with a physical disability other than spinal cord injury * able to perform progressive exercise program * willingness to participate in study exclusion criteria: all groups: • any documented or reported health condition that would be contraindicated to a progressive exercise program
pediatric caudal dexmedetomidine enhances postoperative analgesia of magnesium sulphate in lower abdominal surgeries

Conditions: Pain, Postoperative

Summary: the study will conduct to compare the efficacy of magnesium sulphate \& dexmedetomidine used as adjuvants to bupivacaine in caudal block to provide intra-operative anesthesia as well as post -operative analgesia in pediatric patients.

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Eligibility criteria:
inclusion criteria: * healthy male and female children, asa i and ii,aged 6 months to 6 years, , undergoing elective surgical procedures expected to last more than 90 min, and scheduled to receive general anesthesia combined with caudal extradural block exclusion criteria: * allergy to local anesthetics,coagulation disorders, infection at site of injection, anatomic abnormalities and congenital anomalies like spina bifid, asa iii or higher, parental refusal and the current use of calcium channel blockers or medication that may affect the neurologic system

Keywords: dexmedetomidine magnesium sulphate