Kornimate/medical-research-clean huggingface dataset:
phase 2 study of the safety of diannexin in kidney transplant recipients

Conditions: Kidney Transplantation

Summary: the purpose of this study is evaluate the safety and tolerability of diannexin in kidney transplant recipients.

ischemia-reperfusion injury, which occurs when the blood supply to an organ, or part of an organ, is cut off and subsequently restored, is an important clinical problem in the organ transplant setting. diannexin, a recombinant form of the endogenous human annexin v protein, is in development as a therapeutic agent designed to prevent ischemia-reperfusion injury following organ transplantation. pharmacology studies indicate that diannexin has protective effect in various ischemia-reperfusion injury and organ transplantation models. diannexin binds to phosphatidylserine on cell surfaces, which is believed to underlie its ability to attenuate ischemia-reperfusion injury. in a completed phase 1 trial, diannexin was judged safe and well tolerated in healthy adult subjects. the present study is designed to determine the safety and tolerability of single escalating doses of diannexin in kidney transplant recipients.

Eligibility criteria:
inclusion criteria: * scheduled to receive a kidney transplant from a deceased expanded criterion donor (ecd) or a donor cardiac death (dcd) donor that was exposed to no more than 36 hr of cold ischemia prior to transplantation, or scheduled to receive a kidney transplant from a standard criterion donor (scd) that was exposed to 24-36 hr of cold ischemia prior to transplantation * willing to use adequate contraception for at least 4 weeks after dosing * willing and able to provide written informed consent and to comply with the requirements of the study exclusion criteria: * if female, subject is pregnant or lactating * known bleeding diathesis * inr at screening \> 1.5 * platelet count at screening below lln and judged clinically significant * use of plavix, anticoagulants other than aspirin, antithrombotics, and/or blood-thinning agents within 10 days prior to study entry * previous receipt of an organ transplant * will receive concurrent transplant of any additional organ(s) * clinically significant active infection at study entry * surgery within 2 weeks prior to study entry * believed to have used an illicit drug and/or abused alcohol within 3 months prior to study entry * presence of a psychiatric illness that might interfere with study participation * cancer, other than basal cell or squamous cell cancer of the skin, within 2 years prior to study entry * scheduled to receive a kidney transplant from a low risk donor * currently participation, or participated within 30 days prior to study entry, in an investigational drug study * known allergy to kanamycin * history or presence of any medical condition or disease that could place the subject an unacceptable risk for study participation

Keywords: kidney transplantation ischemia-reperfusion injury phosphatidylserine binding
a non-interventional, patient registry for the collection of pre-defined safety data in patients prescribed thelin

Conditions: Pulmonary Arterial Hypertension

Summary: the thelin patient safety registry is a post-marketing program in the european union (eu) that is designed to supplement the reporting of spontaneous adverse events (ae) and better characterize known and potential safety signals for thelin. the registry is a secure, restricted access, electronic system which collects anonymous, pre-defined, patient-level data on demographic variables, safety monitoring measurements (i.e. liver function tests, haemoglobin and international normalized ratio (inr) measurements), concomitant medications, information on aes and thelin drug discontinuation. regular review of the data is conducted to assess the frequency of identified safety risks and to monitor for the emergence of new safety signals at monthly pharmacovigilance meetings, quarterly signal detection meetings, and for each periodic safety update report (psur).

non-probability sample

Eligibility criteria:
inclusion criteria: * evidence of a personally signed and dated informed consent document by the patient indicating that he/she (or a legally acceptable representative) has been informed of all pertinent aspects of the study is a requirement for inclusion. * additional inclusion criteria reflect the approved label for thelin as outlined in the smpc. exclusion criteria: * there are no specific exclusion criteria for enrollment in the thelin patient safety registry, with the exception of those reflected in the approved label for thelin as outlined in the smpc.
effect of fluticasone furoate on methacholine challenge

Conditions: Asthma

Summary: the study will determine the effect of inhaled fluticasone furoate on airway responsiveness to methacholine in mild asthmatics.


Eligibility criteria:
inclusion criteria: * forced expiratory volume in one second (fev1) greater than or equal to 65% predicted * methacholine pd20 less than or equal to 400mcg * no allergen exposure (if atopic) or respiratory infection for at least 4 weeks prior to study start exclusion criteria: * regular use of inhaled corticosteroid within 4 weeks of study start * poorly controlled asthma * current smoker or ex smoker with greater than 10 pack year history * pregnancy or breast-feeding * health concern/condition that would preclude participation for safety reasons
neurofeedback from the supplementary motor area for tourette syndrome

Conditions: Tourette Syndrome in Adolescence

Summary: this is a clinical trial where adolescents aged 10-16 years old with tourette syndrome (or chronic tic disorder) are randomized to receive either real-time functional magnetic resonance imaging (fmri) neurofeedback targeting the supplementary motor area (for the experimental intervention) or real-time fmri neurofeedback (nf) from a control region (for the control intervention).

the training portion of this study involves three fmri nf sessions, with six nf scans per session. nf scans alternate between up-regulate and down-regulate blocks in which participants are cued to increase or decrease activity in the target region while receiving feedback on activity in the region at the bottom of the screen in the form of a line graph. the experimental group receives feedback from the supplementary motor area (sma) and the control group receives feedback from a control region of the brain.

Eligibility criteria:
inclusion criteria: * boys and girls, 10 to 16 years of age * a current diagnosis of tourette syndrome (ts) or chronic tic disorder (ctd), with active tics that can be executed without head movement, and a ygtss score of at least 13 (for ts participants) or at least 12 (for ctd participants) * currently stable medication treatment and no planned changes in medication for the duration of the study. * family residence within 2 hours of yale medical center with ability and willingness to attend assessment and fmri visits. * children and their parents are expected to be able to speak and understand spoken english in order to participate in a clinical assessment of ts and related psychopathology. * subjects will be free of: 1) metal medical implants or braces, 2) pregnancy, and will have 3) a body weight of less than 250 lbs. and 4) no claustrophobia. exclusion criteria: * intelligence quotient below 80 * current diagnosis of autism spectrum disorder, bipolar or psychotic disorder or current suicidality * significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, seizure disorder * recently initiated psychotherapy. participation in the study will not be allowed within 8 weeks of the initiation of psychotherapy. ongoing, concurrent psychotherapy (that was initiated at least 8 weeks previously) for the child will be allowed, but parents will be asked not to initiate any new psychotherapy for the child during the study * subjects may also be excluded after the first mr scan if we are unable to localize the two regions in their brain that are used as targets for the active and control neurofeedback conditions.
differential expression of cytokines, transcriptome and mirna in coronavirus disease 2019 (covid-19) egyptian's patients

Conditions: Corona Virus Infection

Summary: the aim of this effort is to study host-pathogen interaction in egyptian patients infected with covid-19. the investigators will perform genome-wide mirna and transcriptome screens in the infected patients along with healthy ones for comparison. all types of cytokines play pivotal roles in immunity, including the responses to different viral infections. therefore, the investigators will study the cytokines profile in response to that infection. by comparing mirna and transcriptome screens along with cytokines profiles, an important molecule might be identified that could play role in the inhibition of the covid-19 outbreak. in addition, this information will help us gaining awareness of the immune process and knowing about the genes involved in the immune response against covid-19 with an emphasis on the expression of cytokines.

coronaviruses are a group of viruses that cause diseases in mammals and birds. in humans, coronaviruses cause respiratory tract infections that can be mild, such as some cases of the common cold, and others that can be lethal, such as severe acute respiratory syndrome (sars), (middle east respiratory syndrome) mers, and covid-19. they contain a positive-sense, single-stranded rna genome. the genome size ranges from approximately 27 to 34 kilobases. it has a 5' methylated cap "5'leader, utr", replicas/transcriptase enzyme, spike (s) protein, envelope (e) protein, membrane (m) protein, nucleocapsid (n) protein, 3'untranslated region (3'utr), and a poly (a) tail, respectively. the s protein has a major role in eliciting the protective immunity during infection with sars-corona virus (sars-cov) by inducing neutralizing-antibodies and t-cell responses. it is also the most mutated part of the coronavirus genome. the aim of this effort is to study host-pathogen interaction in egyptian patients infected with covid-19. the investigators will perform genome-wide mirna and transcriptome screens in the infected patients along with healthy ones for comparison. all types of cytokines play pivotal roles in immunity, including the responses to different viral infections. therefore, the investigators will study the cytokines profile in response to that infection. by comparing mirna and transcriptome screens along with cytokines profiles, an important molecule might be identified, which could play role in the inhibition of the covid-19 outbreak. in addition, this information will help us gaining awareness of the immune process and knowing about the genes involved in the immune response against covid-19 with an emphasis on the expression of cytokines.

Eligibility criteria:
inclusion criteria: * confirmed covid-19 patients, and patients aged above 18 will be considered in this project. exclusion criteria: * patients with more than one of these chronic diseases; diabetes mellitus, hypertension, cardiac diseases, and livers diseases grade 2 and 3 will be excluded.

Keywords: covid-19 cytokines storm mirna transcriptome microarray
efficacy and safety study of aprepitant injection for prevention of post-operative nausea and vomiting

Conditions: Post-operative Nausea and Vomiting (PONV)

Summary: a randomized, double-blind, placebo-controlled, multi-center phase iii study to compare the efficacy and safety of aprepitant injection and placebo in the prevention of post-operative nausea and vomiting (ponv).,

in this study, a randomized, double-blind, placebo-controlled multicenter study will be conducted to evaluate the efficacy and safety of aprepitant injection in the prevention of post-operative nausea and vomiting (ponv).

Eligibility criteria:
inclusion criteria: age ≥18 and ≤75 years old; 18 \< bmi≤30kg/m\^2, body weight ≥45kg; laparoscopic gynecologic or abdominal surgery under general anesthesia that was expected to last at least 1 hour. expected or agreed to stay in the hospital for 24 hours or more after surgery; exclusion criteria: diagnostic surgery; scheduled for postoperative transfer to an intensive care unit; requiring placement of a nasogastric or orogastric tube after surgery; post-operative vomiting may pose significant risk;
community-based nutrition program effectiveness evaluation in afghanistan

Conditions: Child Malnutrition; Breast Feeding; Nutrition

Summary: the study will be a mixed methods, two-arm, cluster-randomized controlled trial. the primary aim of this evaluation is to measure the effectiveness of the community-based nutrition package intervention on child feeding practices among parents/caregivers to children 6 to 23 months of age in afghanistan.

the study will be a mixed methods, two-arm cluster-randomized controlled trial (crt). health facilities eligible to implement the cbnp in their catchment areas will serve as the unit of implementation and be randomly allocated to treatment or control groups. for each health facility, up to four health posts, among the 6-10 health posts typically attached to a health facility, will be randomly selected. households in communities served by selected health posts will be mapped and a list of households with eligible participants will generated from which a random sample will be selected. structured questionnaires will be administered to separate samples of women with children 6-23 months of age at baseline then approximately 18 months later. semi-structured, in-depth interviews will also be conducted with a sub-set of selected women and samples of their husbands and mothers-in-law at baseline and endline.

Eligibility criteria:
inclusion criteria: * married adult woman (all married women are considered adults in afghanistan, regardless of age) * has a child between 6 and 23 months of age. for women with more than one living child between ages 6 and 23 months, questions will be asked regarding dietary experiences for the elder of the two. for twins or multiple order siblings, the eldest will be selected based on birth order. * resident in the household exclusion criteria: no specific exclusion criteria.

Keywords: nutrition breastfeeding handwashing food security low and middle income country infant and young child feeding
pet/mri study of men with highly suspicious mri lesions that showed no clinically significant prostate cancer following mri fusion targeted biopsy

Conditions: Prostate Cancer

Summary: the principal aim of this study is to determine if pet/mri imaging with 18-f fluciclovine (axumin) identifies those men with false negative mri fusion targeted biopsy (mrftb) of pi-rads 4 and 5 lesions. pi-rads 4 and 5 mri lesions are highly suspicious for clinically significant prostate cancer and require future repeat mri imaging and possible repeat prostate biopsy depending on the results of the repeat mri. men, who had negative mrftb within past 12 months of pi- rads 4 or 5 mri lesion will be included in this diagnostic study. the repeat mri is standard of care at nyu langone health. the investigation aspect of the study is to perform an axumin scan the same day as the mri. those men with persistent highly suspicious lesions will under mrftb. the biopsy results will be compared with intensity of axumin uptake within the prostate. the urologist will have the discretion to biopsy axumin avid lesions not detected by mri.


Eligibility criteria:
inclusion criteria: * the participant has undergone mrftb of an mri lesion at the department of urology or at nyu langone health within past 12 months and has signed informed consent to participate in the nyu urology prostate biopsy database. * the most recent mrftb of a pirads 4 or 5 lesion did not show clinically significant prostate cancer. exclusion criteria: * the urologist who performed the initial mrftb does not feel a repeat mri is indicated. * any contraindication to prostate biopsy including untreated urinary tract infection * prior allergic reaction to axumin * patient refuses mri
an efficacy and safety trial of intravenous zoledronic acid twice yearly in osteoporotic children treated with glucocorticoids

Conditions: Osteoporosis

Summary: this study was designed to evaluate the efficacy and safety of zoledronic acid compared to placebo in osteoporotic children treated with glucocorticoids

in march 2017, novartis stopped enrollment as the study was not feasible to be conducted due to low enrollment and other recruitment challenges. patients receiving the treatment continued to receive the treatment per protocol.

Eligibility criteria:
key inclusion criteria: * a diagnosis of chronic rheumatologic conditions or inflammatory bowel disease or duchenne muscular dystrophy requiring systemic glucocorticoids (i.v. or oral) within 12 months prior to screening * lumbar spine bmdz-score of -0.5 or worse * evidence of at least at least 1 vertebral compression fracture of genant grade 1 or higher (or radiographic signs of vertebral fracture) within 1 month from screening visit or one or more, low-trauma, lower extremity long-bone fracture which occurred sometime within the 2 years preceding enrollment in the study or two or more, low-trauma, upper extremity long-bone fractures which occurred sometime within the 2 years preceding enrollment in the study * consent/assent to study participation key exclusion criteria: * history of primary bone disease (oi, idiopathic juvenile osteoporosis, rickets/osteomalacia) * any medical condition that might have interfered with the evaluation of lumbar spine bmd, such as severe scoliosis or spinal fusion. patients with less than 3 evaluable vertebrae by dual energy x-ray absorptiometry (dxa) evaluation in the region of interest lumbar 1 (l1) to lumbar 4 (l4), * hypocalcemia and hypophosphatemia * serum 25-hydroxy vitamin d concentrations of \<20 ng/ml or \<50 nmol/l * estimated glomerular filtration rate (gfr) \<60 ml/min/1.73 m2 * serum creatinine increase between visit 1 and visit 2 \>0.5 mg/dl (44.2 μmol/l) * uncontrolled symptoms of cardiac failure or arrhythmia * any prior use of bisphosphonates, or high dose sodium fluoride

Keywords: osteoporosis, children and adolescents, zoledronic acid, chronic inflammation, duchenne muscular dystrophy, glucocorticoids, chronic inflammatory conditions
arrest pad (peripheral arterial disease)

Conditions: Arterial Occlusive Disease; Intermittent Claudication; Insulin Resistance

Summary: this trial will test the hypothesis that inflammation and insulin resistance contribute to reduced walking distance in subjects with intermittent claudication by impairing vascular reactivity and skeletal muscle metabolic function.

people with peripheral arterial disease (pad), an important clinical manifestation of atherosclerosis, often suffer symptoms of intermittent claudication that impair their walking ability and adversely affect their quality of life. people with pad are also at increased risk for adverse cardiovascular events, including myocardial infarction, stroke and death. unfortunately, medical therapies directed to the functional and limb-threatening manifestations are limited. little attention has been paid to the biologic processes that cause pad, and to atherogenic mechanisms that may preferentially affect the peripheral circulation. vascular inflammation and insulin resistance are two important and interdependent conditions that are associated with atherosclerosis. subjects in this trial (160 adults with stable intermittent claudication who are not taking insulin or insulin-sensitizing medications, such as thiazolidinediones) will be randomized in a placebo-controlled, parallel design manner, to atorvastatin 80 mg orally daily (to reduce inflammation) and pioglitazone 45 mg orally once daily (to improve insulin sensitivity). forty healthy adult subjects, age and gender-matched to a subset of the study group, will be enrolled to serve as a control population. primary and secondary study endpoints include: treadmill walking time, endothelium-dependent vasodilation, and insulin-mediated skeletal muscle glucose uptake.

Eligibility criteria:
inclusion criteria: * symptomatic intermittent claudication for \>= 6 months * resting ankle/brachial index (abi) \<=0.90 * maximal treadmill walking time between 1-20 minutes * \>= 20% decrease in abi post treadmill exercise * 4 week statin wash-out prior to initial study testing (if applicable) exclusion criteria: * myocardial infarction or coronary artery bypass surgery within past 6 months * lower extremity revascularization (surgical or percutaneous) within past 6 months * transient ischemic attack or ischemic stroke within past 6 months * pregnancy * uncontrolled hypertension (systolic pressure \> 180mmhg and/or diastolic pressure \> 100mmhg * serum creatinine \>2.5 * hepatic transaminases (ast, alt) \> 3x upper limit of normal (uln) * creatine kinase \> 5x uln * known hypersensitivity to hmg-coa reductase inhibitors * insulin dependent type 2 diabetes * current treatment with thiazolidinedione

Keywords: peripheral arterial disease intermittent claudication
pre-operative intra-nasal dexmedetomidine or insulin for prevention of early post-operative cognitive dysfunction in patients undergoing elective coronary artery bypass graft.

Conditions: Post Operative Cognitive Dysfunction

Summary: on pump coronary revascularization is a very common leading cause for post-operative cognitive dysfunction regarding patient age grouping and diffuse systemic inflammatory response induced by bypass machine . many factors are incriminated as pre-operative sleep disturbance, previous history of neurocognitive dysfunction. the accumulating evidence refers to an incidence between 20-40% with majority among geriatric population. the primary pathology is still elusive and many trials are under evaluation. neuro-inflammation, hypo perfusion, fat emboli and reperfusion injury are among the most postulative aetiologias. the corner stone in the pathology of postoperative cognitive dysfunction is abnormal sleep rhythm. intra-nasal insulin can provide neuroprotection via providing insulin growth factor and obtund neuronal apoptosis , while dexmedetomidine can antagonize neural-degeneration via regulation of systematic inflammatory cytokines including interleukin 1β, tumor necrosis factor-α, and nf-κb, inhibiting the expressions of toll-like receptor , and through α2 adrenoceptor-mediated anti-inflammatory pathways


Eligibility criteria:
inclusion criteria: * adult population, 60 years or above, both sex, candidate for elective on pump coronary revascularization exclusion criteria: * combined reperfusion and valve replacement operations. * emergency or redo cabg surgery. * preoperative mmse less than 20 * diabetic or chronic alcoholic population. * pre-operative cardiomyopathy (ejection fraction less than 40%). * previous cerebro-vascular stroke or carotid endarterectomy. * previous history of carotid endarterectomy. * history of heparin resistance. * preoperative history of dementia, language impairment, severe visual and hearing impairment, any psychiatric disorder. * chronic use of hynotics, mode stabilizing drugs or melatonin. * reoperation for emergency surgical issues during hospital stay. * patient refusal * loss to follow up ( patient dyscompliance, mortality) * population with failed weaning from cpb and the use ventricular assisted device ( intraaortic ballon- impella) * pre or post operative pacing.