Kornimate/medical-research-clean huggingface dataset:
consequences of a maternal-fetal chikungunya virus infection

Conditions: Chikungunya Virus Infection

Summary: chikungunya is an infectious disease caused by an alphavirus transmitted by the aedes mosquitoes which has known a worldwide expansion since its re-emergence in 2004. regarding to an unprecedented epidemic, reunionese pediatricians described in 2005-2006 a vertical maternal-fetal transmission of this virus, at the time of childbirth. since then, this mode of transmission has been widely confirmed, with an absolute risk estimated between 15.5% and 48.3%. the main consequences for the child are neuromotor, neurosensory or neurocognitive. they were studied around the age of 2 in 33 children in the chimere cohort, as well as at the age of 5 in a small fraction of these children followed at the c.a.m.s.p (center for early medico-social action). the results suggested an overall delay in psychomotor acquisitions secondary to neonatal infection, affecting the functions of the prefrontal region (in particular coordination and language). performance was correlated with the severity of the clinical presentation (more severe in case of encephalitis or encephalopathy) while remaining suboptimal in children with uncomplicated infection. during neurodevelopmental monitoring, other disturbing traits complemented the spectrum of problems presented by these children, such as microcephaly, cerebral palsy, epilepsy, interaction disorder or attention deficit disorder. at around age 10, the investigators reassessed 21 of these children using the childhood cognitive function and learning (eda) screening test. the investigators would now like to confirm and characterize their impairments using a battery of confirmatory tests around the age of 13.


Eligibility criteria:
inclusion criteria: * child born between march 2005 and july 2006 * of which the mother identified in the chimere cohort or the perinatal register of maternities * exposed: child infected with the chikungunya virus at the time of childbirth * not exposed: child not infected with the chikungunya virus at the time of childbirth, verifying the matching criteria specified in chapter 5.2 * affiliated to a social insurance exclusion criteria: * prematurity \<33 weeks * prenatal alcoholization authenticated by fetal alcohol syndrome * intellectual disability or secondary epilepsy of origin other than chikv infection (caused by acsos or any other cause of brain damage of inflammatory, metabolic or infectious origin)
ceramide nanoliposome in patients with advanced solid tumors

Conditions: Cancer; Carcinoma; Solid Tumors; Tumor

Summary: this study is a dose escalation study of ceramide nanoliposome in patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * signed informed consent/authorization is obtained prior to conducting any study-specific screening procedures. * 18 years of age or order * histologic or cytologic diagnosis of cancer * patients without a curative therapy or whose tumor does not have standard chemotherapy * at least 4 weeks after the last dose of chemotherapy or radiation therapy; 6 weeks for mitoxantrone or mitomycin therapy * eastern cooperative oncology group (ecog) performance status must be ≤2 (appendix a). * adequate hepatic, renal, and bone marrow function: * absolute neutrophil count ≥ 1,000/microliter (ul) * platelets ≥ 100,000/ul * total bilirubin ≤2.0 * ast(sgot)/alt(sgpt) ≤ 2.5 x institutional uln * creatinine ≤1.2 mg/dl or clearance ≥50ml/min (cockcroft-gault) * all participants (male and female) with reproductive potential must practice an effective method of contraception while on this study in order to minimize risks to fetuses. * radiographic evidence of measurable disease tumor lesion (≥ 1cm in greatest dimension) or nodal disease (\>1.5cm in greatest dimension) * men and women of all ethnic groups are eligible for this trial. * females at reproductive age must have a negative urine pregnancy test prior to entry to this study * life expectancy is greater than 12 weeks. * patients with controlled cns disease and off steroids are eligible. exclusion criteria: * uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements. * patients may not be receiving any other concurrent investigational agents, or have received any investigational agent within four weeks of commencing this protocol. * since the teratogenic potential of this combination is currently unknown, females who are pregnant or lactating are excluded. males and females should perform abstinence or use barrier to prevent pregnancy. * history of any other malignancies in the last 2 years except in-situ cancer, non-muscle invasive bladder cancer, basal or squamous cell skin cancer are eligible * patients known to be hiv(+), hep bsag(+), or hep c(+) are excluded as the effect of the agent on immune system has not been assessed * patients with history of hypersensitivity to liposomal products * patients with primary cns malignancies or leptomeningeal disease are excluded
evaluation of endometriosis with 18f-fluoroestradiol pet / mri

Conditions: Endometriosis

Summary: purpose: the primary objective is to evaluate the sensitivity and specificity of 18f-fluoroestradiol (fes) pet/mri for evaluating endometriosis. participants: a total of 12 participants will be recruited from individuals with clinically suspected endometriosis who are scheduled for planned operative laparoscopy at the university of north carolina at chapel hill (unc). procedures (methods): this is a prospective, one arm, single center study of 12 subjects with clinically suspected endometriosis to demonstrate fes pet/mr's clinical utility for diagnosis of endometriosis. this study will be an evaluation of the radiotracer, fes, which binds to estrogen receptors and has previously been used to study estrogen receptor expression in tumors, to detect endometriosis. participants will undergo one fes pet/mr scan within 4 weeks prior to their scheduled surgery. participants will also complete questionnaires regarding their condition, pain, and quality of life.

this is a prospective, one arm, single center study of 12 subjects with clinically suspected endometriosis to demonstrate fes pet-mri's clinical utility for diagnosis of endometriosis. the primary objective is to evaluate the sensitivity and specificity of 18f-fluoroestradiol (fes) pet/mri for evaluating endometriosis. secondary objectives include comparing pet to conventional mri, using histopathology from laparotomy as the gold standard and evaluating association of uptake values (suv-max) with endometriosis health profile -30 (ehp-30) and pain rating scales, controlling for covariates.

Eligibility criteria:
inclusion criteria: * age 18 or older * female of childbearing age * clinically suspected (symptomatic) endometriosis. * scheduled for planned operative laparoscopy with no hormone treatment for at least two cycles * able to provide informed consent or assent exclusion criteria: * male * institutionalized subject (prisoner or nursing home patient) * known history of breast, ovarian or endometrial cancer. * pregnant or breast-feeding women
evaluation of effect of cryoballoon focal ablation system on human esophageal barrett's epithelium

Conditions: Barrett's Esophagus

Summary: this is a feasibility study without a primary study hypothesis or statistical comparison.

the purpose of this study is to assess the safety, feasibility, and performance of the c2 focal cryoablation device in patients with barrett's esophagus (be). at 6 to 8 weeks, the patient will receive a follow-endoscopy to assess stricture formation along with biopsy samples taken. post-operative pain will be noted. additionally, biopsy samples will be evaluated for the presence of residual barrett's esophagus. through evaluation of the histological results, treatment parameters for the ablation of human esophageal epithelium will be better understood. evaluations include, but are not limited to the following: * deployment ease/scope compatibility. * device malfunctions. * time of catheter deployment. * adverse events. * stricture formation at 6 to 8 weeks. * patient pain. * histological evaluation of treatment zone at 6 to 8 weeks for presence of residual barrett's esophagus.

Eligibility criteria:
inclusion criteria: 1. patients scheduled for ablation, emr, and/or surveillance for be (with or without dysplasia). patient is 18 to 80 years of age at the time of consent (inclusive). 2. patient has provided written informed consent (ic) using an informed consent form (icf) that has been approved by the institution's reviewing irb/ec. 3. patient is willing and able to comply with all clinical investigation plan (cip) requirements. 4. patient is deemed operable per standard institutional criteria. exclusion criteria: 1. patient with endoscopically active inflammation in the treatment zone 2. esophageal stenosis preventing advancement of a therapeutic endoscope and/or within 4 cm of treatment zone. 3. patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post treatment instructions or follow-up guidelines. 4. patient refuses or is unable to provide written informed consent. 5. patients that are pregnant.
the adjunctive effect of soft tissue augmentation procedures of moderate-severe peri-implantitis

Conditions: Peri-Implantitis

Summary: the key objective of the study is to compare the effects of soft tissue augmentation using a volume stable collagen matrix or autogenous connective tissue graft or no soft tissue augmentation in addition to bone grafting/implantoplasty in patients who undergo surgical therapy of peri-implantitis with respect to clinical resolution of the infection.

the global burden of periimplantitis is expected to rise with the increasing popularity of dental implants as a replacement option. while many therapeutic interventions have been proposed, none have been proven superior. surgical therapy is often indicated to gain access to the plaque infected implant threads and bone defects. implantoplasty of suprabony defects have shown good results although adverse effects like soft tissue recession are common. thin mucosa results in compromised outcomes following various surgical interventions around implants with increased recession and aesthetic failures. it has also been associated with increased marginal bone loss and severity of periimplantitis. application of autogenous connective tissue grafts during surgical therapy of periimplantitis to increase the keratinised mucosa widths or attenuate post-implantoplasty recession showed promising results. no randomized controlled clinical trials investigating the effects of additional soft tissue augmentation with implantoplasty on periimplantitis lesions have been done so far. in addition, few have evaluated patient reported outcome measures, included non-european subjects and none reported on soft tissue alterations. the effect of soft tissue substitutes on surgical periimplantitis therapy remains unknown.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years old (uzh, fra) or \> 21 years old (sin), male and female. 2. diagnosed with periimplantitis of at least 1 implant in function for at least 1 year diagnostic criteria * presence of bleeding and/or suppuration on gentle probing. * probing depths of ≥6 mm. * bone levels ≥3 mm apical of the most coronal portion of the intraosseous part of the implant. 3. periodontal health (including previously treated periodontitis patients with reduced but healthy periodontium) 4. good oral hygiene (full mouth plaque score \<25%) 5. adequate control of inflammation (full mouth bop \<25%) 6. signed informed consent form exclusion criteria: 1. pregnant or lactating female patient at inclusion 2. allergy or objection to porcine and bovine implantable biomaterials 3. allergy to penicillin or nsaids 4. known or suspected non-compliance, drug or alcohol abuse 5. inability to follow the procedures of the study, e.g. due to language/ comprehension problems, psychological disorders, dementia, etc. of the participant 6. smoking \> 15 cigarettes a day 7. active periodontal disease

Keywords: tissue augmentation of moderate-severe peri-implantitis implantoplasty collagen matrix autogenous connective tissue graft
phase i/ii clinical trial of lbl-015 for injection

Conditions: Advanced Malignant Tumor

Summary: a multicenter, open-label, phase i/ii clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of lbl-015 in patients with advanced malignant tumors.

this study is a single-arm, open-label, multi-center, dose-escalation and expansion phase i/ii study to evaluate the safety, tolerability, pharmacokinetic characteristics, receptor occupancy, immunogenicity and efficacy of lbl-015 in patients with advanced malignant tumors.about 202 patients with advanced malignant tumor will be enrolled. the study is divided into phase i study stage (dose escalation/pk expansion stage) and phase ii study stage (indication expansion stage). patients with advanced or metastatic advanced malignant tumor who have failed previous standard treatment, are not suitable for standard treatment or have no standard treatment are included in the phase i study. after obtaining the rp2d in phase i study ,phase ii study stage (indication expansion stage) was initiated.

Eligibility criteria:
inclusion criteria: 1. agree to follow the trial treatment regimen and visit schedule, voluntarily enroll in the study, and sign the written informed consent form； 2. age ≥18 and ≤75 years old at the time of signing the informed consent form, regardless of gender; 3. have a performance status of 0 to 1 on the eastern cooperative oncology group (ecog) performance status scale； 4. have a life expectancy of at least 12 weeks； 5. there is adequate organ and bone marrow function,conforms to laboratory test results; 6. fertile men and women of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine devices, hormonal contraception, and correct use of condoms) from the signing of the informed consent form to 6 months after the last dose of the investigational drug; women of childbearing age include premenopausal women and women who had menopause less than two years ago. blood pregnancy test results must be negative for women of childbearing age within 7 days prior to the initial dose of the investigational drug. exclusion criteria: 1. received other unapproved investigational drug or treatment within 4 weeks prior to first dose of investigational drug； 2. subjects who underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the initial use of the investigational drug, or require elective surgery during the trial period； 3. use of immunomodulatory drugs within 14 days prior to the initial use of the investigational drug, including but not limited to thymosin, interleukin, and interferon； 4. subjects with an active infection that currently requires intravenous anti infective therapy； 5. history of immunodeficiency, including positive hiv antibody test results； 6. pregnant or lactating women； 7. the investigator's assessment that there may be other factors affecting compliance among participants or that some may not be suitable for inclusion in this study.
a study of safety and efficacy of unr844 chloride (unr844-cl) eye drops in subjects with presbyopia.

Conditions: Presbyopia

Summary: the purpose of this study was to assess the effect of topical unr844-cl (lipoic acid choline ester chloride) ophthalmic solution on near visual function in presbyopic subjects.

this was a multi-center, double-masked, placebo-controlled, randomized, parallel-group study. the total duration of the study was approximately 3 months. approximately 120 presbyopic subjects were to be enrolled into the study. presbyopic subjects aged 45 to 55 years were the primary age group in this study. screening and baseline: subjects were screened for eligibility followed by a baseline visit after which they were randomized to receive either unr844-cl (1.5%, equivalent to 1.3% freebase) or placebo, dosed one drop in each eye twice daily, for 3 months. randomized subjects attended the following study visits after baseline: at week 2, month 1, month 2 and month 3. the primary objective of this study was to assess the efficacy of unr844-cl on binocular distance corrected near visual acuity (dcnva) in presbyopic subjects aged 45 to 55 years with the primary endpoint being the change from baseline in binocular dcnva in subjects aged 45 to 55 years at month 3 after unr844-cl or placebo treatment. there were two secondary endpoints: 1. to assess the efficacy of unr844-cl on achieving 75 or more early treatment diabetic retinopathy study (etdrs) letters in binocular dcnva in presbyopic subjects aged 45 to 55 years with endpoint being the proportion of subjects aged 45 to 55 years achieving 75 or more etdrs letters in binocular dcnva at month 3 after unr844-cl or placebo treatment. 2. to assess the safety of unr844-cl in presbyopic subjects by the frequency of treatment emergent adverse events (aes) and treatment emergent serious adverse events (saes) in all subjects after unr844-cl or placebo treatment.

Eligibility criteria:
inclusion criteria: * written informed consent must be obtained before any assessment is performed * impaired near vision in each eye and when using both eyes, without any near correction * need a certain level of near correction exclusion criteria: * impaired distance vision in either eye, with distance correction (if any) * severe short- or long-sightedness * any significant medical or clinical conditions affecting vision, the eyes or general health

Keywords: presbyopia, adults, randomized study, placebo
corneal thickness changes during corneal collagen cross-linking with ultraviolet-a irradiation and riboflavin

Conditions: Progressive Keratoconus; Thin Corneas

Summary: the purpose of this study is to evaluate the corneal pachymetric variations during and after corneal collagen cross-linking (cxl) treatment with ultraviolet-a irradiation (uva) and hypo-osmolar riboflavin solution in thin corneas.

to evaluate the corneal pachymetric variations during and after corneal collagen cross-linking (cxl) treatment with ultraviolet-a irradiation (uva) and hypo-osmolar riboflavin solution in thin corneas. eighteen eyes of 18 patients, 11 men and 7 women, with progressive keratoconus and thinnest corneal thickness (tct) less than 400µm were included in this study. after the epithelium removal, iso-osmolar riboflavin was applied to the cornea every 3 minutes (30 min). hipo-osmolar riboflavin was then applied every 20 seconds until the tct reached 400µm. uva irradiation was performed for 30 min. pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after uva irradiation, and at 1, 6 and 12 months.

Eligibility criteria:
inclusion criteria: * progressive keratoconus * thin corneas exclusion criteria: * contact lens use for less than 3 weeks * non progressive keratoconus * thinest corneal thickness above 400 micra

Keywords: progressive keratoconus thin corneas cross-linking hypo-osmolar riboflavin
xeljanz special investigation for long-term use in uc patients

Conditions: Ulcerative Colitis

Summary: secondary data collection study: safety and effectiveness of xeljanz in uc patients under japanese medical practice

this investigation aims to examine the safety and effectiveness of xeljanz in post-marketing clinical settings when it is administered chronically to patients with ulcerative colitis, based on the approval conditions.

Eligibility criteria:
inclusion criteria: * patients with ulcerative colitis treated with xeljanz * patients naive to xeljanz in the treatment of ulcerative colitis exclusion criteria: - none

Keywords: xeljanz ulcerative colitis uc long-term
identification and clinical efficacy analysis of biomarkers in sepsis patients

Conditions: Sepsis

Summary: sepsis, a severe response to bacterial infection, lacks understanding of immunometabolic features that can identify high-risk patients. this study aimed to discover immune, biological, and metabolic biomarkers in sepsis patients with poor prognosis and understand the underlying mechanisms of host immune responses.

sepsis is a life-threatening condition resulting from a dysregulated host response to infection and remains a significant global health crisis. accurately identifying high-risk patients and understanding the underlying mechanisms of distinct host responses are crucial. dysregulation of immune and biological responses, along with metabolic remodeling, has emerged as a prevalent characteristic in sepsis patients. however, there is still a need for a comprehensive understanding of specific markers related to immunometabolism and the underlying mechanisms contributing to the disturbance in sepsis pathogenesis. this study aims to investigate the immune, biological, and metabolic profiles of sepsis patients, focusing on the alteration of metabolism in sepsis patients with poor outcomes. the findings of this study will provide valuable insights into dysregulated immunometabolism, shedding light on its contribution to the potentiation of immunopathogenesis in sepsis. eligibility criteria adults over the age of 19 a sepsis patient in icu patients are excluded from the study if the patient or care giver does not agree to participate in the study a bone marrow transplant or an organ transplant patient a do not resuscitation(dnr) patient a patient under the age of 18 outcome measure icu mortality, 28 days mortality use of inotropics, vasopressors crrt(continuous renal replacement therapy), ecmo (extracorporeal membrane oxygenation), interventional lung assist, polymyxin

Eligibility criteria:
inclusion criteria: * adults over the age of 19 a sepsis patient in icu exclusion criteria: * if the patient or care giver does not agree to participate in the study a bone marrow transplant or an organ transplant patient a dnr patient a patient under the age of 18
efficacy of lama added to ics in treatment of asthma

Conditions: Asthma

Summary: the purpose of this study is to evaluate the superiority of the glycopyrrolate bromide (chf 5259 pmdi) versus placebo on top of qvar® pmdi, in terms of lung functions parameters, as well as to assess its safety.


Eligibility criteria:
inclusion criteria: * history of asthma ≥ 5 years and diagnosed before 40 years old * uncontrolled asthma on low-medium doses of inhaled corticosteroid (ics) with acq (asthma control questionnaire) ≥1.5 * pre-bronchodilator fev1 ≥40% and \<90% of their predicted normal value * positive reversibility test exclusion criteria: * pregnant or lactating women * diagnosis of chronic obstructive pulmonary disease (copd) * patients treated for asthma exacerbation in the 4 weeks prior to study entry * patients who are in therapy for gastroesophageal reflux disease * patients who have a clinically significant cardiovascular condition

Keywords: asthma, anticholinergics