Kornimate/medical-research-clean huggingface dataset:
molecular diagnosis of lung cancer via bronchoscopy: the significance of bronchial liquid biopsy (ctdna and ctrna)

Conditions: Non Small Cell Lung Cancer

Summary: the management of lung cancer is a major public health challenge. molecular anomaly testing is recommended from the early stages for optimal and personalized care of all lung adenocarcinomas and non-smoker lung cancers. the search for these anomalies relies on increasingly advanced and sensitive analysis techniques, particularly next-generation sequencing (ngs), which can simultaneously detect various molecular abnormalities in both dna and rna, including point mutations, complex mutations, rearrangements, and amplifications. these techniques are predominantly performed on biopsy specimens embedded in paraffin. however, these biopsies may require invasive and sometimes iatrogenic procedures, and their feasibility, quantity, and quality of the samples can be limited. the turnaround time for analysis results from the time of biopsy is typically around 2 to 3 weeks. in recent years, alongside the improvement in the sensitivity of molecular analysis techniques, liquid biopsy has emerged as a valuable approach, particularly in the analysis of circulating tumor dna (ctdna). ctdna is a non-invasive diagnostic biomarker that has been validated for detecting targetable molecular anomalies similar to those detected by "conventional" biopsies. ctdna can be detected in plasma through a simple blood draw, as well as in cerebrospinal fluid, urine, saliva, or any other "liquid" sample from the patient. the concordance between mutations identified in the tumor and those detected in the blood exceeds 90% specificity in numerous studies. however, the sensitivity of ctdna detection varies depending on the stage of the disease and the sensitivity of the detection technique used. the utility of bronchial ctdna is currently underexplored. however, there is a rationale for investigating ctdna as close as possible to the cancerous lesion at the bronchial level. bronchial ctdna could play a role in molecular diagnosis for distal lesions not visible through endoscopy and could also help reduce costs and turnaround time for molecular diagnosis in larger tumors. the objective of this study is to evaluate the utility of liquid biopsy (ctdna and ctrna) during bronchoscopy in the molecular diagnosis and management of bronchial carcinomas. this is a prospective multicenter french study that will include 50 patients.


Eligibility criteria:
inclusion criteria: * patients referred for bronchoscopy at tnn or psl for diagnostic evaluation or follow-up of known or suspected lung cancer. * age \>18 years. * informed, written, and signed consent. * participants must be covered by a national health insurance scheme. exclusion criteria: * patient refusal * patient benefiting from legal protection measure

Keywords: bronchial ctdna bronchial ctrna bonrchoscopy
phase i safety and tolerability study of birinapant in chronic hepatitis b

Conditions: Hepatitis B

Summary: this study evaluates the addition of birinapant in subjects with chronic hepatitis b who are currently receiving anti-viral therapy with either tenofovir or entecavir. patients will receive either birinapant or placebo in addition to their anti-viral therapy.


Eligibility criteria:
inclusion criteria: * documented history of chronic hepatitis b infection currently being treated with tenofovir or entecavir for at least 3 months * measurable titer of hbsag * hbv dna level \< 2 log copies/ml or 10² copies/ml * no more than child-pugh score of 5 plus a valid fibroscan® of at least 10 readings with a median score of \<7 and interquartile range of \< 30% * adequate liver function, aspartate ast and alt ≤2 x uln * adequate renal function as evidenced by creatinine ≤2 mg/dl exclusion criteria: * participation in any interventional study within 4 weeks prior to screening * known hiv infection, hepatitis c, or other significant hepatic disorder including cirrhosis (child-pugh class b or c) * serious illness or autoimmune disease or other known liver disease * uncontrolled hypertension * impaired cardiac function, uncontrolled cardiac arrhythmias despite medications, or clinically significant cardiac disease * currently breast feeding, pregnant or planning on becoming pregnant * known allergy or hypersensitivity to any of the formulation components of birinapant or placebo, including citric acid * history of cranial nerve palsy * current treatment with anti-tnf therapies or has received treatment with anti-tnf therapies within the last 6 months * use of non-steroidal anti-inflammatory drugs
the effectiveness of probiotics in neonatal jaundice

Conditions: Jaundice, Neonatal

Summary: hyperbilirubinemia is a prevalent problem in babies that necessitates medical attention. probiotic administration as adjuvant therapy may have a positive impact on the pathological neonatal unconjugated hyperbilirubinemia.

neonatal jaundice is a common health care issue that affects approximately 9% of newborns after birth. the percent of neonates who acquire jaundice in the first week of their birth is about 60%. while the percent of breasted neonates who develop jaundice during the first month of their birth is about 10%. phototherapy is the standard therapy for neonates who develop pathological jaundice, as it can alter bilirubin structure and increase its excretion. probiotics can also be used for the treatment of jaundice. the efficacy of probiotics depends on their ability to pass across the git and cause colonization in the intestinal lumen. hence, it leads to a decrease in the bacterial growth in the small bowel, a reduction in the function of the gastrointestinal barrier, and a regulation of the immune system of the host.

Eligibility criteria:
inclusion criteria: * neonate suffered from pathological unconjugated hyper-bilirubinemia with total serum bilirubin (tsb) between 5-15mg/dl and need phototherapy. exclusion criteria: * neonates who have kernicterus. * neonates who have ventilation problem. * neonates who have heart failure. * -neonates who have asphyxia. * neonates who have history of rh incompatibility
clozapine and olanzapine treatment of aggression

Conditions: Schizophrenia

Summary: this was a double-blind randomized study with three treatment arms: clozapine, olanzapine and haloperidol. we compared these three medications in the treatment of aggressive behavior over a 12 week period.

objective: the purpose of our study was the investigation of the effect of atypical antipsychotic agents on interpersonal violence and aggression. we compared the efficacy of two atypical antipsychotic agents, clozapine and olanzapine with one another and with haloperidol in the treatment of physical assaults and other assaultive behaviors in physically assaultive patients with schizophrenia and schizoaffective disorder. method: the subjects were 110 physically assaultive inpatients diagnosed with schizophrenia or schizoaffective disorder. they were randomly assigned to treatment with clozapine (n=37), olanzapine (n=37) or haloperidol (n=36) in a 12-week, double-blind trial. incidents of overt aggression were recorded and their severity was scored with the modified overt aggression scale (moas). psychiatric symptoms were assessed through the positive and negative syndrome scale (panss). we also assessed various side effects and monitored vital signs and drew bloods.

Eligibility criteria:
inclusion criteria: * age: 18 to 60 years. * diagnosis of schizophrenia or schizoaffective disorder. * aggression: one episode of physical assault directed at another person in the hospital and persistence of violence/hostility for two weeks, as evidenced by the presence of some other physical, verbal or property assault or hostility, which would result in a score of 4 or more on the positive and negative syndrome scale (panss) hostility item. exclusion criteria: * patients who were hospitalized for more than a year * patients who had a history of nonresponse to clozapine, olanzapine or haloperidol (defined as a lack of improvement despite a contiguous adequate trial of medication) * patients who had a history of clozapine, olanzapine, or haloperidol intolerance * patients who had medical conditions that would be adversely affected by any of these three medications. * patients who received a depot antipsychotic within 30 days before randomization.

Keywords: schizophrenia aggression clozapine olanzapine
tissue penetration of antibiotics in obesity

Conditions: Obesity

Summary: the purpose of this study is to evaluate cefoxitin pharmacokinetics in obese surgical patients.


Eligibility criteria:
inclusion criteria: * bmi \ 40 * scheduled for elective abdominal or pelvic surgery * surgical plan for intraoperative cefoxitin prophylaxis * able to provide informed consent exclusion criteria: * allergy to cefoxitin * renal or hepatic insufficiency
accuracy of curvature and wavefront aberrations of posterior corneal surface, in keratoconic and post-cxl corneas

Conditions: Keratoconus

Summary: primary objective of this study was to assess the intrasession, intersession and interobserver variability of the pentacam-derived curvature and zernike coefficients in back surface of normal, keratoconic and crosslinked corneas.

the pentacam classic (oculus optikgerate gmbh, heidelberg, germany, software version 1.14r04) was used for the sake of the study.three study groups were formed: 1) normal 2) keratoconus group (kc) included patients with progressive keratoconus and 3) collagen-cross-linking group (cxl) included keratoconus patients that had been treated with uneventful cxl at least on year prior to their enrollment in the study. three consecutive scans were obtained by two experienced operators. the same procedure was repeated within two weeks for the assessment of intersession variability. in all cases acceptable maps had at least 10.0mm of corneal coverage. keratometry (k), asphericity (q), best-fit toric ellipsoid radius (rs), eccentricity (ecc) and aberrometry (6.0mm pupil diameter), were analyzed. furthermore we calculated and studied crms and clrms in order to better appreciate the visual significance of hoas. precision (pre), repeatability (cor) and intraclass correlation coefficient (icc), were calculated for evaluating intrasession and intersession repeatability. bland-altman analysis was used for assessing interobserver repeatability.

Eligibility criteria:
inclusion criteria: * ideal refractive surgery candidate (normal group) * progressive keratoconus (keratoconus group) * corneal collagen cross linking (cxl) treatment at least one year prior to enrollment (cxl group) exclusion criteria: (normal group) * no indications of corneal pathology in slit-lamp biomicroscopy and placido disk-based videokeratography * uneventful ophthalmologic history all groups: * glaucoma * suspicion of glaucoma * history of herpetic keratitis * corneal scarring * severe eye dryness * pregnancy or nursing * current corneal infection * underlying autoimmune disease
vaccine prevention of rabies adopts 4-shot immunization method

Conditions: Rabies Human; Antibody Titer

Summary: a phase iii clinical trial to evaluate the immunogenicity and safety of freeze-dried human rabies vaccine (vero cell) developed by changchun zhuoyi biological co., ltd. inoculated in a 4-dose procedure (2-1-1)

it is to prove that the freeze-dried human rabies vaccine (vero cell) in the population aged 10-60 years, the four dose vaccination program is not inferior to the five dose vaccination program, and the safty、antibody positive conversion rate and geometric mean concentration of the four dose group of the test vaccine are not inferior to the five dose program group 14 days after the first dose vaccination. to compare the immunogenicity of people aged 10-60 years old who were vaccinated 6 and 12 months after the whole vaccination, so as to evaluate the antibody positive rate and gmt 6 and 12 months after the test vaccine was vaccinated.

Eligibility criteria:
inclusion criteria: * the age is 10-60 years old; * underarm temperature ≤ 37.0 ℃. exclusion criteria: * have a history of rabies vaccine immunization or use of rabies virus passive immunization agents； * has been diagnosed with congenital or acquired immunodeficiency disease； * pregnancy (including positive urine pregnancy test) or lactation, planned pregnancy preparation within 2 months.
safety and efficacy of fremanezumab for migraine in adult cadasil

Conditions: Cadasil; Migraine

Summary: researchers are trying to find out more about the side effects of fremanezumab when treating patients with cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (cadasil) for migraine headaches.

subjects will receive 4 to 20 weeks of placebo injections followed by 12 weeks of monthly administered fremanezumab by subcutaneous injection (225 mg split four weeks apart for 12 weeks). following completion of the 12 weeks of therapy, the participant will return to placebo for the washout period. both the patient and the investigator will be blinded to the timing of transition to and from placebo and the transition to and from fremanezumab.

Eligibility criteria:
inclusion criteria * age 18 to 70 years old * english speaking * diagnosis of cadasil confirmed by presence of a pathogenic notch3 gene mutation * diagnosis of migraine for at least 12 months and diagnosis of chronic migraine for at least 28 days according to the international classification of headache disorders * midas score of \>10 points * ability to provide written informed consent exclusion criteria * history of ischemic stroke within 4 weeks of screening assessment * screening blood pressure \>150 mm hg * use of onabotulinum toxin a 4 months prior to trial or other injectable/stimulatory/magnetic method of headache control * use of opiates or barbiturates 4 days prior to trial * patients with competing intracerebral pathology (e.g. history of intracerebral hemorrhage, multiple sclerosis) * nyha class iii or iv congestive heart failure * history of myocardial infarction * history of coronary bypass surgery or coronary stenting * pregnancy or breastfeeding * contraindication to undergoing brain mri per standard clinical practice guidelines * vulnerable populations, including incarcerated inmates, dementia, and inability to provide consent
safety, tolerability, and efficacy of presbidrops (csf-1), a topical ophthalmic drug for presbyopia

Conditions: Presbyopia

Summary: a study to establish safety, tolerability, and efficacy of presbidrops (csf-1) in presbyopic subjects.


Eligibility criteria:
inclusion criteria: 1. men and women between 40 and 65 years of age (inclusive). 2. subjects who provide written informed consent to participate in the study. 3. subjects have signs of presbyopia upon ophthalmic examination. 4. subjects have normal presbyopia with low distance refraction (sphere no greater than ±0.75 diopter cylinder no greater than ±0.75 diopter cylinder \[dc\], refraction along any principal meridian no greater than 1.00 diopter). 5. subjects must have best corrected vision of 20/20 in both eyes, and currently depend on reading glasses or bifocals in which the near addition is \> +1.00 diopter. 6. subjects in general good health in the opinion of the investigator as determined by medical history. 7. women with childbearing potential must have a negative urine pregnancy test at screening and be willing and able to use a medically acceptable method of birth control or they must be postmenopausal. acceptable methods of birth control in this study include: vasectomy, tubal ligation, consistent use of an approved oral contraceptive (birth control pill), intrauterine device (iud), hormonal implants, contraceptive injection or a double barrier method (diaphragm with spermicidal gel or condom with contraceptive foam). postmenopausal women are defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form. 8. subjects must be able to understand the requirements of the study and must be willing to comply with the requirements of the study. exclusion criteria: 1. history of macular disease or any other ocular conditions or congenital malformation. 2. any medical condition known to affect the structure of the uvea, cornea, lens, or retina or main function of the eyes. 3. no cataract or minimal nuclear sclerosis. 4. severe dry eye. 5. any topical ophthalmic medications, other than artificial tears (up to a maximum of 4 times per day) and medications that are associated with fluctuation of accommodative capacity and/or pupil size, unless on a stable dose for at least 3 months before the screening visit. 6. contact lenses for the past three months before the screening visit. 7. a difference of more than 0.50 diopter between the manifest spherical equivalent and the wave front refraction spherical equivalent. 8. pupil size less than 2,5 mm in either eye prior to dilation at ambient light of 8-15 lux prior to the baseline visit. 9. a history of herpes (of any kind) in either eye. 10. cataract surgery and/or refractive surgery in either eye. 11. known contraindication, hypersensitivity, and/or allergy to any study drugs or excipients. 12. any acute illness (eg, acute infection) within 48 hours of first study drug administration, which is considered of significance by the investigator. 13. participation in another clinical trial with drugs received within 30 days of screening. 14. pregnant or currently lactating women.
a phase 1 study of khk4083 in subjects with atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: the objective of this study is to evaluate the safety and tolerability of multiple intravenous (iv) infusions of khk4083 in subjects with moderate or severe atopic dermatitis.


Eligibility criteria:
inclusion criteria: 1. voluntary written informed consent to participate in the study 2. atopic dermatitis diagnosed according to the definition and diagnostic criteria for atopic dermatitis (guidelines for management of atopic dermatitis 2016) established by the japanese dermatological association 3. moderate or severe (≥4.5) symptoms of atopic dermatitis at screening, according to the rajka \& langeland severity index 4. investigator global assessment(iga) ≥3 (moderate) at screening exclusion criteria: 1. any of the following clinically significant concurrent illnesses: * type 1 diabetes * poorly controlled type 2 diabetes (hba1c \>8.5%) * congestive heart failure (class ii to iv of the new york heart association classification) * myocardial infarction within 1 year * unstable angina pectoris within 1 year * poorly controlled hypertension (systolic pressure \>150 mm hg or diastolic pressure \>90 mm hg at screening) * severe chronic lung diseases requiring oxygen therapy * multiple sclerosis or other demyelinating diseases * active malignancies, or onset or a history of treatment of malignancies within 5 years prior to informed consent (except for resected or surgically cured epithelial carcinoma of the uterine cervix, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or ductal carcinoma) 2. current or past history of clinically significant cardiovascular, liver, renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders other than those in 1) 3. alcohol dependence, or drug dependence or a positive result for any of the drug abuse test items 4. past or current history of drug allergy 5. any clinically significant infection requiring hospitalization or iv administration of antibiotics within 8 weeks prior to pre-enrollment 6. any planned surgical treatment during the study 7. any skin disease that may affect the clinical symptom assessment 8. pregnant or lactating women, or women willing to have a child during the study period
prevalence of hpv transmission during medically assisted procreation procedures

Conditions: Human Papillomavirus (HPV); Medically Assisted Procreation (MAP); Infertility

Summary: human papillomavirus (hpv) are ones of the main causal agents of sexually transmitted diseases. numerous hpv genotypes such as 16, 18, 31 or 45 are considered to be at high risk of oncogenicity especially for the anal and cervical mucosa. at the present time, no recommendations exist on the risk related to hpv during medically assisted procreation (map) procedures. the main objective of this prospective multicentric cohort study is to evaluate the prevalence of transmission of hpv via the semen during map program. secondary objectives are to evaluate (1) the prevalence of hpv dna in the sperm fractions of men enrolled in map, (2) the efficacy of spermatozoal pellet preparation procedures to eliminate hpv, (3) the correlation between hpv and male infertility and (4) the correlation between hpv and success rate of procreation. results could contribute to revise guidelines of map procedures and hpv vaccination policy.


Eligibility criteria:
inclusion criteria: * age over 18 * age under 40 for women * signed informed consent by both members of the couple * medical indication of map by ai (artificial insemination), ivf(in vitro fertilization) or icsi (intracytoplasmic sperm injection) method * well understanding of information letter exclusion criteria: * age over 40 for women * informed consent form not signed by one or both partners * co-infection of one of the partners or both by hiv (human immunodeficiency virus) , hbv (hepatitis b virus) and/or hcv (hepatitis c virus) * ivf by only frozen embryo transfer at the time of inclusion * severe oligospermia in male partner (\<500 000 sperm cells)

Keywords: medically assisted procreation
crushed ticagrelor versus eptifibatide bolus + clopidogrel

Conditions: Acute Coronary Syndrome; Angina, Unstable

Summary: patients with troponin-negative acute coronary syndrome (acs) are not routinely pre-treated with p2y12 inhibitors and the rate of high on-treatment platelet reactivity (hpr) remains elevated after a loading dose of ticagrelor at the time of percutaneous coronary intervention (pci). this suggests that faster platelet inhibition with crushed ticagrelor , eptifibatide , or cangrelor is needed to reduce hpr and periprocedural myocardial infarction and injury (pmi). the present study compared the effects of crushed ticagrelor vs. eptifibatide bolus + clopidogrel in troponin-negative acs patients undergoing pci.

platelet activation and accumulation causes the formation of blood clots that may cause heart attack. as a standard of care, the doctor can prescribe medications such as are ticagrelor, eptifibatide, clopidogrel, to prevent the formation of blood clots. 100 patients with unstable angina, both male and female, will be randomized to either group a- crushed ticagrelor or group b- eptifibatide bolus +clopidogrel administrated immediately before pci. platelet function testing, troponin, and ecg will be performed.

Eligibility criteria:
inclusion criteria: * patients with unstable angina/troponin negative acs. exclusion criteria: 1. need for oral anticoagulation therapy (warfarin, dabigatran, rivaroxaban, apixaban, edoxaban) 2. increased risk of bradycardia, and the associated therapy with a strong cytochrome p-450 inhibitors (anti-retroviral agents, antifungal agents and some antibiotics eg. indinavir, nelfinavir, lopinavir, ritonavir, itraconazole, ketoconazole, voriconazole, clarithromycin, telithormycin) 3. surgery\<4 weeks 4. use of any thienopyridines (clopidogrel, prasugrel) 7 days prior to randomization 5. administration of gp iib/iiia inhibitors 6. bleeding diathesis or major bleeding episode within 2 weeks 7. thrombocytopenia (platelet count \< 100000) 8. incessant chest pain 9. hemodynamic instability (mean arterial pressure \ 0.034 ng/ml); renal failure with a serum creatinine \>2.0 mg/dl 10. anemia with hct\<30%.