Kornimate/medical-research-clean huggingface dataset:
cmv retinitis retreatment trial

Conditions: Cytomegalovirus Retinitis; HIV Infections

Summary: to assess the safety and efficacy of three therapeutic regimens (foscarnet, ganciclovir, or the combination) for recurrent or persistent aids-related cytomegalovirus (cmv) retinitis. although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated, relapses are common and may accelerate due to development of drug resistance, deteriorating immune function, or other factors. treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs.

although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated, relapses are common and may accelerate due to development of drug resistance, deteriorating immune function, or other factors. treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs. patients are randomized to receive foscarnet, ganciclovir, or a combination of the two drugs (administered sequentially). initially, patients undergo single or multiple cycles of induction therapy for 14 days followed by maintenance therapy. patients in whom the retinitis continues to progress or who are intolerant of the initial treatment switch to the alternative drug for further cycles of induction and maintenance. patients on the combination arm in whom retinitis continues to progress are given further cycles of the combination at an increased dose, or, if one drug is causing toxicity, are given further cycles with the alternative drug. patients are followed monthly for 6 months and then every 3 months thereafter.

Eligibility criteria:
inclusion criteria required: * at least 28 days of prior foscarnet or ganciclovir. concurrent medication: allowed: * g-csf. recommended: * antiretroviral therapy. patients must have: * hiv infection or aids. * active cmv retinitis after 28 or more days of either foscarnet or ganciclovir therapy. * at least one lesion with one-quarter disk area or more that can be photographed. * visual acuity of 3 or more letters on etdrs chart (5/200 snellen) in an affected eye. exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: * media opacity severe enough to preclude visualization of both fundi. * retinal detachment not scheduled for surgical repair. patients with the following prior conditions are excluded: * history of intolerance to ganciclovir or foscarnet sufficient to contraindicate use. * history of combination foscarnet/ganciclovir therapy. active drug or alcohol abuse sufficient to prevent compliance.

Keywords: retinitis ganciclovir foscarnet cytomegalovirus infections acquired immunodeficiency syndrome
early intervention in cognitive aging

Conditions: Overweight, Obesity and Other Hyperalimentation (E65-E68)

Summary: nutritional intervention in overweight middle aged individuals with subjective memory complaints.

late-onset ad develops over many years during a preclinical period in which neuropathological changes accumulate before dementia is evident. deposition of amyloid-beta (aβ) in the brain is the earliest recognized biomarker of ad pathology, and, demographically, aβ accumulation begins to accelerate at age 50, a period when the incidence of metabolic disturbance increases as well. hyperinsulinemia associated with insulin receptor resistance has been associated with ad pathololgy, and metabolic disturbance in mid-life increases risk for subsequent dementia. there are indications that subjective memory complaints can be an early indicator of developing neuropathology and may be the first manifestation of future dementia. this research involves intervention studies in different samples of individuals from this population to investigate the extent to which berry fruit supplementation and ketone metabolism might improve cognitive performance in association with enhancement of metabolic function and related factors. the ultimate goal of this research is to develop interventional approaches that might be applied with at-risk individuals in the preclinical period of dementia to forestall or prevent progression of neurocognitive decline.

Eligibility criteria:
inclusion criteria: * overweight; subjective memory complaints exclusion criteria: * diabetes; liver or kidney disease; age-related memory disorder; neurologic or psychiatric condition; substance abuse
adespi: adherence to spiriva® in patients with copd (chronic obstructive pulmonary disease), measured by morisky-8 (mmas-8) scale, in routine medical practice

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the objective of this observational study is to collect and evaluate data on medication adherence of patients on maintenance copd therapy with long-acting anticholinergic (e.g. spiriva® delivered by handihaler® or respimat®) using the mmas-8 questionnaire.

purpose:

Eligibility criteria:
inclusion criteria: * male and female ambulatory outpatients being seen in a participating physicians office for routine care, * patients with a clinical diagnosis of copd and already being treated with the maintenance therapy with long-acting anticholinergic (tiotropium (spiriva® handihaler® or respimat®) at least 1 month and within product label * patient fluent in language of questionnaire and having the cognitive and functional abilities required to fill in the questionnaire alone exclusion criteria: * uncooperative patients as judged by the physician * patients with any conditions excluded as per country specific package insert * patients currently enrolled in any clinical trial which requires a change in medication for their respiratory problems.
observational study in patients with previously unresectable malignant pleural mesothelioma treated with nivolumab and ipilimumab (meso-immune)

Conditions: Malignant Pleural Mesothelioma; Unresectable Malignant Neoplasm

Summary: meso-immune is a retrospective study to assess the efficacy and safety of the combination of nivolumab and ipilimumab used in first-line treatment of adult patients with unresectable malignant pleural mesothelioma (mpm). this combination of treatments has been approved in europe since june 2021 based on the results of the checkmate 743 study. in france, the combination is not yet reimbursed for this population of patients. however, since april 01, 2021, newly diagnosed unresectable mpm patients may be treated with this combination via an early access program. meso-immune study targets these patients included in the early access program with the objective to provide additional results to the checkmate 743 study and confirm the benefit of using this combination in first-line of treatment in this category of patients. total study duration will cover 48 months with an inclusion period of 12 months and a follow-up until 3 years. patients will be recruited retrospectively starting april 01, 2021 until april 01, 2022. meso-immune study will be proposed to all the gfpc centers that have already included patients in the early access program and other centers wishing to participate, in order to analyze a minimum of 150 patients. the total number of sites is evaluated at around 120. the principal investigator in each center will identify the patients eligible for the meso-immune study and will inform them on the study according to the local regulations. patient follow-up will be pursued regularly, in in-patient and out-patient clinics, according to the usual practices of the physicians in each participating center. reevaluation workups will be pursued according to the practices of each center. the information related to patient characteristics, mpm characteristics, treatment characteristics, disease progression, rebiopsy, post treatments, adverse events, date and cause of death, date of last news will be recorded in electronic case-report forms (ecrf). qualitative variables will be presented descriptively in the principal analysis.


Eligibility criteria:
inclusion criteria: * patient with previously untreated and unresectable malignant pleural mesothelioma treated with combination nivolumab and ipilimumab in the setting of the early access program * patient enrolled in the french national health insurance program or with a third-party payer * patient not opposed to the collection of his/her data (an information sheet will be to all living patients; for those who died, documented opposition to data collection in his/her medical file is not required) exclusion criteria: * patient under curatorship or guardianship * patient's explicit refusal to collect his / her data * patients not managed at the investigating center and not followed by a center investigator

Keywords: mesothelioma
a study assessing the safety and tolerability of ly03020 in chinese healthy subjects

Conditions: Schizophrenia; Alzheimer's Disease Psychosis

Summary: this is a single-center, randomized, double-blind, placebo-controlled, ascending single oral dose study to assess the safety, tolerability, and pharmacokinetics of ly03020 in chinese healthy adult subjects.

the study will set 2.5mg, 5mg, 10mg, 20mg, 40mg, 60mg, 80mg and 100mg, a total of 8 dose groups. qualified subjects were enrolled in site at d-1 ( 1 day before administration ) and randomized.the subjects should fast for at least 10 hours before medication administration, with no restrictions on water intake. the subjects will be required to orally take ly03020 or a placebo on an empty stomach upon waking on d1 (the day of medication administration). from d1 to d7, they will undergo safety assessments and pk biological sample collection.

Eligibility criteria:
inclusion criteria: * subjects sign informed consent voluntarily. * male or female aged 18 to 45 years. * body weight ≥ 50.0 kg for male and ≥ 45.0 kg for female, and male or female greater than or equal to 18.5 but less than 26.0 kg/m2 of body mass index (bmi). exclusion criteria: * subjects have any clinically significant medical condition or chronic disease. * subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure,or angle-closure glaucoma.subjects have a abnormal and clinically significant test for ophthalmic examination during screening. * subjects with condition that may interfere with the drug absorption, distribution, metabolism and excretion significantly. * subjects had a history of surgery within 3 months prior to administration, or had not recovered, or have a surgical plan during the study. * subjects have any clinically significant abnormal vital signs, laboratory values, and ecgs. * subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to administration. * subjects have a history of allergic diseases, or allergic to any substance contained in the formulation * subjects have a positive test for hbsag, hcv-ab, hiv-ab, or syphilis serum reaction.
treatment of severe influenza a infection

Conditions: Influenza, Human

Summary: each year, influenza a infection caused great mortality and morbidity, especially among the elderly and individuals with chronic illness. many of these patients are 'late presenters' who are admitted to hospital a few days after symptoms onset and have developed complications secondary to immunodysregulation. antiviral treatment with the neuraminidase inhibitor is of limited usage for patients who presented to the hospital 48 hours after symptom onset. apart from ventilatory and extracorporeal membrane oxygenation support, treatment options for these patients are limited. recent animal study has demonstrated that combinations of an antiviral agent with a cox-ii inhibitor can reduce mortality in mice infected with influenza virus. the investigators therefore propose to enrol patients with severe influenza a infection requiring hospitalization and oxygen support on a randomized controlled trial with celecoxib.

the aim of this double blind randomized controlled trial is to compare the clinical efficacy and safety of celecoxib combined with neuraminidase inhibitors in patients with severe influenza a infection. the hypothesis of this study is that treatment of severe influenza a infection with celecoxib will reduce mortality. the primary outcome to be assessed will be the 28-days mortality rate from hospitalization. the secondary outcomes to be assessed will be safety of the treatment, duration of intensive care, duration of ventilatory and oxygen support, the viral load and cytokine change.

Eligibility criteria:
inclusion criteria: 1) male or female patients ≥18 years 2) written informed consent by patient or next-of kin (if patient is too ill to consent) 3) presumptive diagnosis of influenza a satisfying both clinical and laboratory criteria. the laboratory criteria are defined as at least one rt-pcr positive for influenza a (h1n1, h3n2, h5n1 and h7n9) from respiratory clinical specimens including nasopharyngeal samples and endotracheal aspirates. the clinical criteria are defined as hospitalization with fever or one of the symptoms suggestive of influenza infection including sore throat, rhinorrhea, cough or shortness of breath 2) desaturation to \<90% in room air by pulse oximetry and required oxygen supplement 3) within 7 days of onset of symptoms. patients have to fulfil all the aforementioned criteria. exclusion criteria: 1) age \<18 years. 2) a known hypersensitivity to celecoxib, oseltamivir or zanamivir 3) unable to obtain informed consents 4) influenza a infection diagnosed beyond 7 days from symptom onset 5) patients receiving other antiviral treatment (apart from oseltamivir or zanamivir), n-acetylcystiene, statins and tradition chinese medicine during the current admission 6) patients with renal impairment of creatinine clearance \< 30ml/min

Keywords: severe influenza a celecoxib
preoperative volume substitution in elective surgery patients

Conditions: Hemodynamic Instability; Hypovolemia; Anesthesia

Summary: preoperative fasting can evoke a hypovolemia which may cause a hemodynamic instability during introduction of anesthesia. the purpose of this study is to test the hypothesis that a defined preoperative volume substitution compared to standard procedure will result in a reduced incidence of hemodynamic instabilities during introduction of anesthesia in elective surgery patients.

the preoperative fasting period often lasts longer than 2 hours as recommended by various national and international anesthetic guidelines. thus, hypovolemia is more often then anticipated. in awake patients this condition is often masked. introduction of anesthesia often leads to an unmasking of hypovolemia with a consecutive hemodynamic instability. aim of the study is to test the hypothesis that a preoperative volume substitution (8 ml/kg ringeracetate solution in 15 min. prior to introduction of anesthesia) reduces possible hemodynamic instabilities during initiation of anesthesia.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * thyreoid, parathyroid or gallbladder surgery * general anesthesia exclusion criteria: * coronary artery disease * congestive heart disease (≥ new york heart association (nyha) 2) * insulin dependent diabetes mellitus * renal insufficiency (creatinine \> 2,0 mg/dl) * cerebrovascular disease * severe hypertension (≥ antihypertensive drugs)

Keywords: preoperative volume substitution hypovolemia preoperative fasting
feeding education in patients submitted to coronary angioplasty

Conditions: Coronary Angioplasty; Coronary Disease

Summary: the simple knowledge that practices healthy lifestyle are important to reduce or prevent the progression of cardiovascular diseases it is not enough for effective changes accordingly. to nutritional education be successful, needs to promote changes in eating habits and not just transmit information. this is a behavioral intervention study in 200 consecutive patients submitted to percutaneous transluminary coronary angioplasty. the participants were randomized in two groups: intervention and control. the intervention was a dialogic nutritional counseling and the control arm was a traditional nutritional counseling. all participants will undergo long-term follow-up for cardiovascular events.

patients were hospitalized to realize elective coronary angioplasty in a especialized hospital in cardiovascular disease. all data were obtained by a trained nutritionist.

Eligibility criteria:
inclusion criteria: * preserved cognitive status exclusion criteria: * no availability to attend the meetings of nutritional guidance

Keywords: nutritional intervention nutritional counseling feeding behavior food consumption angioplasty
prognostic potential of prehospital biomarkers in tbi patients

Conditions: Traumatic Brain INjury

Summary: the pretbi iii study aims to investigate the prognostic potential of prehospital and repeated in-hospital s100b, nse and gfap measurements as predictors of neurological outcome in patients suffering severe tbi. knowledge on prehospital s100b, gfap and nse levels as predictors of neurological outcome and mortality may underline the potential of a point-of-care analysis. possibly, the early biomarker levels may contributed to accurate monitoring of biomarker dynamics and hereby support neurosurgeons and anaesthetists in the clinical decision-making regarding treatment and level of care offered to the patient. hypotheses: 1. prehospital s100b level is a significant predictor of unfavourable neurological outcome (dichotomized disability rating scale (drs) and glasgow outcome scale extended (gos-e) measures) in severe tbi patients. 2. prehospital gfap level is a significant predictor of unfavourable neurological outcome (dichotomized drs and gose measures) in severe tbi patients. 3. prehospital nse level is a significant predictor of unfavourable neurological outcome (dichotomized drs and gose measures) in severe tbi patients. 4. combined panel of prehospital s100b, gfap and nse levels is a significant predictor of unfavourable neurological outcome (dichotomized drs and gose measures) in severe tbi patients. 5. unfavourable neurological outcome (dichotomized drs and gose measures) in severe tbi patients can be predicted by dynamics in repeated measurements of s100b, gfap and nse.


Eligibility criteria:
inclusion criteria: * patients presenting with glasgow coma score (gcs) gcs 3-8 suffering relevant trauma and displaying relevant clinical indices compatible with tbi as evaluated by ems staff. patients are considered incompetent due to on-going alteration of mental state. exclusion criteria: * \>6 hours elapsed after trauma, unknown time of trauma, multi trauma, known dementia, chronic psychosis or active central nervous system (cns) pathology.

Keywords: biomarkers point-of-care analysis
improving asthma communication in minority families

Conditions: Asthma

Summary: the purpose of this study is to determine if teaching children with asthma how to talk to their doctor about controlling their asthma including symptom frequency in an asthma diary and medication use techniques, will result in less symptom and missed school days, fewer emergency room visits and reduce the cost of asthma health care.

children with persistent asthma are often not receiving regular preventive asthma care despite experiencing frequent asthma symptoms. when linked to timely and appropriate asthma medication use, good physician-parent-child communication is associated with a decrease in asthma morbidity and mortality. removing obstacles to preventive asthma care and improving communication between the parent-children and pcp are two necessary prerequisites to improving asthma outcomes in low-income minority children. we, the researchers at johns hopkins university, hypothesize that a culturally-tailored parent and child asthma communication intervention (aci) designed to teach parent and child communication skills for use with their health care provider regarding asthma symptom severity, medication use, personal goal of treatment and quality of life issues will significantly reduce emergency room utilization for asthma care. we propose to compare this parent/child asthma communication intervention (aci) to a developed standard asthma education intervention (sae) designed to increase basic asthma self-management. this study will advance nursing science by improving asthma self-management for school age children, who may be self-administering their asthma medications, yet not participate in receiving information or making their own medical decisions regarding their asthma. the proposed study is targeted at low-income minority school-aged children with evidence of poorly controlled, high-risk asthma. if successful, this intervention could have significant practical applications as a component of asthma nurse-case management, to practice currently being employed by many managed care groups across the country as an intervention for their high-risk/high ed use asthma patients. because of the high prevalence and enormous health impact of asthma and the disproportionate asthma burden experienced by minority children, the outcome of the proposed study will have significant pediatric nursing applicability.

Eligibility criteria:
inclusion criteria: * age 6-12 years * physician diagnosis of asthma * reside in metropolitan baltimore * english speaking * able to read 80% of parent educational brochure in english * emergency department (ed) visit within the past 12 months and can identify a primary care provider * no other co-morbid pulmonary disease exclusion criteria: * enrolled in another asthma study
effectiveness allopurinol topical agent prevention capecitabine-induced hand-foot syndrome

Conditions: Hand-foot Syndrome

Summary: hand-foot syndrome (hfs) is a dose-limiting toxicity of capecitabine for which no effective preventative treatment has been definitively demonstrated. this trial is conducted on the basis of preliminary data that a 3% allopurinol-based topical agent may prevent hfs. a randomized, double-blind phase iii trial will evaluate 40 patients receiving their first ever cycle of capecitabine at a dose of either 2,000 or 2,500 mg/m2 per day for 14 days. patients will be randomly assigned to a 3% allopurinol versus a placebo cream, which will be applied to the hands and feet twice per day for 6 months after the start of capecitabine. patients will be examined every month and the investigators will take some photographs of hands and feet. hfs toxicity grade (common terminology criteria for adverse events \[ctcae\]v3.0) will be also collected at baseline and at the end of each cycle. the primary end point is the incidence of moderate/severe hfs symptoms at the end of capecitabine treatment , based on the patient-reported dermatological exploration.


Eligibility criteria:
inclusion criteria: * patients older than 18years-old,that initiate treatment with oral capecitabine, without signs of hand-feet syndrome toxicity. * free acceptance to participate part in this clinical trial, with signature of the form of informed assent approved for the study, writing of the volunteer. exclusion criteria: * age lower than 18 years * precedents of allergy, idiosyncrasy or hypersensitivity to the medicament. * denial of the patient to sign the informed assent. * any disorder or current / previous treatment that, in the opinion of the investigator, incapacitates the patient to take part in the study.

Keywords: hand-foot syndrome capecitabine allopurinol