Kornimate/medical-research-clean huggingface dataset:
platelet inhibition after pre-hospital ticagrelor using fentanyl compared to morphine in patients with st-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention

Conditions: Acute Myocardial Infarction

Summary: prospective, randomized, open-label, single-center, investigator-initiated trial, including patients with st-segment elevation myocardial infarction (stemi) undergoing primary percutaneous coronary intervention (ppci) within 12 hours of the symptom's onset. the study aims to compare platelet inhibition (pharmacodynamics and pharmacokinetics) of pre-hospital ticagrelor in patients with stemi according to two different analgesia protocols using fentanyl or morphine.

consecutive patients with acute stemi within 12 hours of the symptoms' onset and candidates for ppci will be screened for inclusion in the study. eligible patients who require analgesia for the relief of acute chest pain, defined as visual analogue scale ≥3, will be randomized in a 1:1 ratio into one of the two treatment arms to receive analgesia with either morphine or fentanyl following administration of a pre-hospital loading dose of ticagrelor. randomized patients will undergo primary pci and managed according to the current guidelines of the european society of cardiology. blood samples (10 ml) will be collected at 0, 1, 2, 4, 6, 12 and 24 hours after the loading dose of ticagrelor to assess platelet inhibition using the verifynow p2y12 function and the vasodilator-stimulated-phosphoprotein phosphorylation (vasp) assays, plasma concentration of ticagrelor and its active metabolite (ar-c124910xx) using a validated liquid chromatography/mass spectrometry detection method and the procoagulant action of platelets.

Eligibility criteria:
inclusion criteria: * age \>18-year-old * stemi within 12 hours of symptoms' onset eligible for primary pci with stent implantation. * patient able to give written informed consent. exclusion criteria: * contraindication, intolerance or hypersensitivity to ticagrelor, or any excipients * contraindication, intolerance or hypersensitivity to morphine, fentanyl, or any excipients * active bleeding or bleeding diathesis * history of intracranial haemorrhage * chronic oral anticoagulation treatment * previous antiplatelet treatment * contraindications to antiplatelet therapy * severe renal insufficiency (creatinine clearance \<30 ml/min) * severe hepatic dysfunction * severe chronic obstructive pulmonary disease * periprocedural glycoprotein iib/iiia inhibitors administration * relevant haematological disease * patient who is currently, plans, or has been enrolled in another clinical study involving use of an investigational drug or device within the prior 30 days. * if female, patient pregnant or breastfeeding.
fmri in blood phobia syncope

Conditions: Syncope; Blood Injury Phobia; Autonomic Dysfunction

Summary: we plan to study patient who faint in response to the sight of blood and compare them to healthy subjects who do not. we are going to use a special type of mri scan (functional mri) to determine if there are differences in brain activation in response to seeing bloody or gory pictures that occur before the fainting occurs.

another aim of the study is to determine whether or not differences in personality traits among people with blood phobia is associated with differences in bold signal responses during fmri.

Eligibility criteria:
inclusion criteria: * 18-30 years of age * 1. history of at least one syncopal episode upon exposure to viewing blood (case group) * negative urine pregnancy test on study day exclusion criteria: * vasoactive medications (within 2 weeks of study day) * antihypertensives * beta blockers * vasoconstrictors * psychotropic medications (within 4 weeks of study day) * history of psychostimulant or opiate use * history of alcohol, benzodiazepine or cannabis abuse or dependence

Keywords: syncope faint blood blood injury phobia phobia
characterization of new phenotypes of patients with spinal muscular atrophy treated with smn restoring therapy

Conditions: Spinal Muscular Atrophy

Summary: with the advent of new treatments for asi, new phenotypes are emerging. the investigators propose to describe these new phenotypes by prospectively following children with asi of all types treated with trs and aged under 16 for 2 years. the investigators also propose to evaluate potential assessment tools to determine whether they are relevant for monitoring this population, either routinely or for future clinical trials. the investigators also aim to collect the total costs associated with asi in order to propose a first prospective medico-economic study in france.


Eligibility criteria:
inclusion criteria: * genetically confirmed infantile or juvenile spinal muscular atrophy * treated with a therapy that restores smn protein expression (e.g. nusinersen, risdiplam, onasemnogene abeparvovec) * aged 0 to 15 years inclusive * informed consent signed by both parent(s)/legal guardian(s) and patient's assent * affiliated or beneficiary of a health insurance plan\*. \* for inclusion in france exclusion criteria: * other condition likely to interfere significantly with asi assessment and clearly unrelated to the disease * other associated neurological disease * current pregnancy or breast-feeding (a pregnancy test will also be performed at inclusion). please note that patients with a specific contraindication to mri (i.e. metallic foreign body, claustrophobia and other reasons determined by the investigators) will be allowed to participate in the study, but mri will not be performed.

Keywords: natural history spinal muscular atrophy (sma) risdiplam onasemnogene abeparvovec nusinersen
evaluation of intestinal bacterial and fungal translocation and intestinal microbiota in febrile neutropenic patients in pediatric onco-hematology

Conditions: Febrile Neutropenia

Summary: this pilot study aims to study intestinal bacterial and fungal translocation and the evolution of the intestinal microbiota in patients over the course of their medical surveillance to search for a link between dysbiosis and bacterial/fungal translocation, but also to better understand the elements involved in febrile episodes in these patients (lack of detection of blood microorganisms, translocation of constituent elements of these microorganisms, etc.). we hypothesize that the composition of the intestinal microbiota as well as the phenomenon of intestinal microbial translocation will have an influence on the occurrence of fever and/or bacteremia in neutropenic patients hospitalized in pediatric onco-hematology.


Eligibility criteria:
* inclusion criteria: * information concerning the study set-up, objectives, constraints and the patient's rights is transmitted * the patient and/or their legal guardian must have given their free and informed consent. if the patient is over 18, it is the patient who signs the consent form * the patient must be a member or beneficiary of a health insurance plan * exclusion criteria: * the patient is under state guardianship or safeguard of justice * refusal to sign the consent * it is impossible to give the subject informed information * pregnant, parturient or breast feeding patient
the effect of glucose level and diabetes mellitus on ctrough of olaparib

Conditions: Ovary Cancer

Summary: monitored therapy of olaparib concentrations in the blood of diabetic population probably will assess the need for individual dosing of the drug. the project concerns on the monitored therapy of olaparib in a population of patients with dm, hyperglycemia and normal glucose level. currently, there are no studies assessing the effect of comorbidities and of the administered drugs on the pharmacokinetics of olaparib.

the research is conducted at the poznan university of medical sciences, and the poznan, poland with the approval from the bioethics committee, university of medical sciences, poznan, poland (697/20). the subjects of the research: the c through of olaparib in the patients with ovarian cancer who received olaparib the patients included in the study if they met the following criteria: treatment with olaparib above four days, age \>18 years; no history of allergy to olaparib. the chief criteria for exclusion included allergy to olaparib, age under 18 years, status of the patient which do not allowed the patient to continue the study. administration and blood sampling the patients with an ovarian cancer treated with olaparib (tablets in dose 300mg/12h, 250mg/12h, 200 mg/12h or capsules 400mg/12h, 200mg/12h, 100 mg/12h). blood samples (2 ml) collected at steady state before morning drug administration. the blood samples transferred into heparinised tubes and centrifuged at 2880 g for 10 min at 4 °c. next the plasma transferred to propylene tubes and stored at - 20 °c until analysis. assays the concentrations of olaparib in plasma assayed using the high-performance liquid chromatography (hplc) method with ultraviolet (uv) detection. the method validated according to european medicines agency guideline. the method validation confirmed good precision (cv% \<15%), accuracy (92.3-115.0%) and linearity (r=0.9994) in the range of 100-4000 ng/ml. the severity of olaparib adverse effects assessed by ctcae (common terminology criteria for adverse events) v.5.0 scale.

Eligibility criteria:
inclusion criteria: * ovarian cancer patients treated with olaparib above than 4 days * patient who gave permission to take part in the trial * age \>18 years * no history of allergy to olaparib exclusion criteria: * allergy to olaparib, * age under 18 years, * status of the patient which do not allowed the patient to continue the study.

Keywords: olaparib blood-level testing c through diabetes melitus hyperglycemia
melatonin effects on genital herpes in brazilian women

Conditions: Genital Herpes

Summary: genital herpes is a common and increasingly-common infection worldwide. the annual incidence in the united states is 1.75 per 1000 inhabitants. the etiologic agent is the herpes type 1 and 2 strains simplex virus. classical treatment is with acyclovir which decreases the duration of the disease and prevents rashes but has no curative effect. also, studies show herpes resistance to acyclovir which has stimulating research into new drugs to treat this condition. authors suggest melatonin way be a therapeutic agent in herpetic disease due to its modulatory action in immune and inflammatory responses when administered in adequate doses. therefore, the aim of this study is to evaluate the effects of melatonin in the treatment of genital herpes as well as compare it to acyclovir in a double-blind, prospective and randomized, investigation. outcome measures will include clinical evaluation of patients and laboratory endpoints.

the authors have investigate the relationship of estrogen-dependent malignant tumors with reduced levels of melatonin. it is speculated that the indoleamine can be classified as anti-estrogenic drug, both by its action on estrogen synthesis with aromatase inhibition and by its interference with estrogen receptors. experimentally melatonin prevents promotion and growth of mammary tumors in rodents, probably by interacting with epithelial cell receptor; increasing local immunity by acting as an antioxidant agent and by inhibiting telomerase activity in tumor cells .

Eligibility criteria:
inclusion criteria: * clinical and laboratory diagnosis of genital herpes * real time polymerase chain reaction for herpes type 2 * serology exclusion criteria: * immunodeficiencies * pregnant women

Keywords: acyclovir melatonin
pharmacokinetic/pharmacodynamic of albinterferon alfa-2b in chronic hepatitis b, eag+, infection subjects

Conditions: Chronic Hepatitis B

Summary: this study will assess the efficacy of abf656 in chronic hepatitis b characterized by hbeag positivity. the study is designed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of phase 3 trials. the trial is also designed to generate the pk data in hepatitis b patients to satisfy regulatory requirements in china.


Eligibility criteria:
inclusion criteria: * male or female, aged 18-75 years of either non-child bearing potential or if of child bearing potential on two adequate forms of birth control * chronic hbv infection (serum hbsag detectable for \> 6 months) * serum hbeag positive with hbv dna \>106copies/ml (or \>200,000 iu/ml) * serum alt must be \> 2 x uln but below 10 x uln exclusion criteria: * steroid treatment or immunosuppression 3 months prior to entry. * chest x-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease. * hb\< 10g/dl or, and anc \< 750/mm3 or , and platelet count \< 75,000 mm3 . * significant chronic medical conditions other than chronic hepatitis b which in the opinion of the investigator preclude enrollment into the study. * evidence of hepatic decompensation (i.e., child-pugh score of b or c). * seropositive for hiv, hcv, or hdv (hepatitis delta virus). * history of hypothyroidism or current treatment for thyroid disease. * patients with treated or untreated malignancy of any organs, with the exception of localized basal cell carcinoma other protocol-defined inclusion/exclusion criteria may apply

Keywords: hepatitis b, chronic, hepatitis b e antigens positive
a study of efficacy and safety of php-201 in patients with primary open angle glaucoma or ocular hypertension

Conditions: Primary Open Angle Glaucoma; Ocular Hypertension

Summary: this is a phase 3 study to confirm the efficacy in reduction of intraocular pressure and safety of php-201 ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.

as a selective rock inhibitor, php-201 is designed to alleviate the side effects, which are the disadvantages of existing intraocular pressure reducing agents, while exhibiting sufficient intraocular pressure-lowering effect in glaucoma patients. this clinical trial aims to provide a new therapeutic option by evaluating the efficacy and safety of php-201 0.5% in patients with primary open-angle glaucoma or ocular hypertension who require intraocular pressure reduction therapy.

Eligibility criteria:
subject inclusion criteria: 1. the age of 19 years or older 2. diagnosis of open-angle glaucoma (poag) or ocular hypertension (oh) 3. intraocular pressure(iop) ≤ 35mmhg at both eye and iop ≥ 22mmhg at either eye 4. shaffer's grading \> 2 5. best-corrected visual acuity in both eye equivalent to 0.2logmar 6. able and willing to give signed informed consent subject exclusion criteria: 1. central corneal thickness \ 600㎛ 2. medical history of following * closed-angle glaucoma, pigment dispersion syndrome, pseudoexfoliation, narrow-angle glaucoma * advanced glaucomatous loss; mean deviation (md) \< -12db * moderate to severe inflammatory/infectious disease in either eye * advanced retinopathy * surgical or laser therapy for glaucoma treatment 3. have confirmed the following at the screening visit * sbp ≥ 180mmhg or dbp ≥ 110mmhg * hba1c \> 9.0% * crcl \< 30ml/min * ast or alt ≥ 3 x uln * unstable angina, myocardial infarction, transient ischemic attack, cerebral stroke, coronary artery bypass graft, or coronary angioplasty within 24 weeks * history of malignant tumor with 5 years * history of the causative disease that may cause secondary glaucoma, including a history of steroid administration for more than 4 weeks 4. conditions need to wear contact lenses during the study 5. known hypersensitivity to any component of the investigational product 6. who has administered topical/systemic drugs that may affect the study within a certain period prior to eligibility check or are expected to need administration during the study duration * prostaglandin analogues: 5 weeks * β-blockers: 4 weeks * rock inhibitors: 4 weeks * α/β-adrenergic agonists: 2 weeks * muscarinic agonists: 1 week * carbonic anhydrase inhibitors: 1 week * systemic corticosteroids: 4 weeks 7. pregnant or breast-feeding 8. who disagreed with the use of the methods of proper contraception during the study duration 9. administration or use of other investigational drugs/devices prior to the screening visit within its 5 half-lives or 30 days, whichever is longer 10. unsuitable for participation in the study according to the judgment of the investigator

Keywords: glaucoma primary open-angle glaucoma rock inhibitor
depression screening in patients with lung cancer

Conditions: Depression; Lung Cancer

Summary: rationale: screening tests may help doctors find depression in patients with lung cancer, allow doctors to recommend treatment for depression, and improve the patient's quality of life. purpose: this randomized clinical trial is studying how well depression screening works when the results are or are not shared with patients with lung cancer and their doctor.

objectives: primary * determine the impact of depression screening in patients with lung cancer when the results of the screening are made available to the patient, the physician, both, or neither on detection of depression, provision of depression treatment recommendations, and the quality of the doctor-patient interaction from the patient's perspective. secondary * determine psychological and demographic subsets for the impact of depression screening in these patients when the results of the screening are made available to the patient, the physician, both, or neither on the detection of depression, provision of depression treatment recommendations, and the quality of the doctor-patient interaction from the patient's perspective. outline: this is a multicenter, randomized, double-blind, single-blind, factorial study. patients are stratified according to participating center (memorial sloan-kettering cancer center vs university of kentucky markey cancer center). patients are randomized to 1 of 4 screening arms. * arm i (control): patients complete screening questionnaires about their mood and experience with lung cancer once before and once after a visit with their physician. neither the patient nor physician receives the screening results before the visit. * arm ii: patients complete screening questionnaires as in arm i. only the patient receives the screening results before their visit with the physician; the physician remains blinded to the results. * arm iii: patients complete screening questionnaires as in arm i. only the physician receives the screening results before their visit with the patient; the patient remains blinded to the results. * arm iv: patients complete screening questionnaires as in arm i. both physician and patient receive the screening results before the visit. all patients and physicians are notified of the screening results before the patient leaves the clinic. all patients are offered supportive counseling.

Eligibility criteria:
disease characteristics: * diagnosis of lung cancer * prescreening distress thermometer score \> 3 * zung self-rating depression scale (zsds) score ≥ 44 * no zsds response indicating suicidality patient characteristics: * able to understand english * no evidence of cognitive dysfunction that would impair giving consent prior concurrent therapy: * not specified

Keywords: depression extensive stage small cell lung cancer limited stage small cell lung cancer recurrent small cell lung cancer stage i non-small cell lung cancer stage ii non-small cell lung cancer stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer recurrent non-small cell lung cancer
observational follow-up study of haplo-identical transplants in fanconi disease

Conditions: Fanconi Syndrome

Summary: this observational protocol will allow for an independent, prospective evaluation of the improvement in survival of patients with fanconi disease in hematological deadlock due to the absence of an hla-identical donor and having received a haploidentical transplant.

fanconi's disease is characterised by a constitutional defect in dna repair which results in the occurrence of bone marrow failure and haematological malignancies, mainly myeloid: at the age of 40, the cumulative incidence of these two types of pathology reaches almost 100%. the only curative treatment for haemtalogocial diseases is allogenic hematopoietic stem cell transplant. transplantation modalities must be adapted to the particular susceptibility of these patients to dna bridging agents and radiotherapy. hsc transplantation is indicated with an unaffected matched related or matched unrelated donor when the patient has severe bone marrow failure or a poor prognostic clonal evolution (cytogenetic evolution or proven haemopathy). alternative transplants (9/10 pheno-identical, haplo-identical and placental blood donors) were no longer proposed in most cases due to the frequency of severe complications (graft-versus-host disease, viral infections) and the catastrophic medium-term survival of around 40% (dufort, bone marrow transplant 2012, gluckman biol blood marrow transplant. 2007). the development over the last decade of new haploidentical or phenoidentical 9/10 transplant protocols with unmodified grafts and gvh prophylaxis with post-transplant cyclosphosphamide or ex vivo t-depletion adapted to the particular susceptibility of patients with fanconi disease has reduced the incidence of these severe complications. this observational protocol will allow for an independent, prospective evaluation of the improvement in survival of patients with fanconi disease in hematological deadlock due to the absence of an hla-identical donor and having received a haploidentical transplant

Eligibility criteria:
inclusion criteria: * diagnosis of fanconi disease confirmed by chromosome breakage test and/or genetic analysis * aged between 6 months and 60 years * with severe pancytopenia (2 of the following criteria: reticulocytes \< 60 g/l, pnn \< 0.5 g/l and/or platelets \< 20 g/l or patients with more than 6 transfusions in the last 12 months) * with clonal progression (poor prognostic cytogenetics, myelodysplastic syndrome or acute leukaemia) * with an unaffected haploidentical donor * having signed the consent after having read the information note, consent of both parents for minors, of the guardian for patients under guardianship * having a social security scheme (beneficiary or entitled person) exclusion criteria: * with an unaffected matched related or hla 10/10 matched unrelated donnor * under guardianship
optical coherence tomography angiography in neurological disease

Conditions: Octa; Stroke; Subarachnoid Hemorrhage; Intracerebral Hemorrhage

Summary: optical coherence tomography angiography (octa) is a non-invasive tool that images the neurovascular structures of the eye by using near-infrared light. previous literature has demonstrated the potential of octa as a screening tool in stroke, but its utility in other neurological illness such as intracranial hemorrhage is unclear. hence, this pilot study will gather preliminary data to support future grant applications to investigate this area more fully by recruiting patients with neurological illness and healthy controls and comparing their octa imaging parameters.


Eligibility criteria:
inclusion criteria: * age 18 years or older * patient admitted to the neuroscience intensive care unit with a diagnosis of: subarachnoid hemorrhage, intracerebral hemorrhage, intracranial aneurysm (ruptured or unruptured), intracranial vascular malformation, ischemic stroke, seizure disorder, intracranial infection, intracranial tumor(s), inflammatory demyelinating disease, traumatic brain injury and/or neuromuscular respiratory failure or subjects from the community without major neurologic, cardiovascular, pulmonary or metabolic disease exclusion criteria: * pregnancy * non-english speaking * gcs motor score less than 6 (i.e. must be able to follow commands) * temporary or permanent physical limitation that renders the patient unable to sit up and look inside octa device