Kornimate/medical-research-clean huggingface dataset:
seasonal intermittent preventive treatment with sulfadoxine-pyrimethamine in children in mali

Conditions: Malaria

Summary: recent, randomized controlled trials conducted in areas of perennial malaria transmission have shown that intermittent preventive treatment (ipt) given at the time of vaccination reduced the incidence of the first episode of malaria and severe anaemia during the first year of life by more than 50% without there being any rebound in the subsequent year. however, in countries such as mali, where malaria is highly seasonal and prevalent in older children, ipt in infants may not be the optimum way in which to use antimalarial drugs to prevent malaria. an alternative approach is to give intermittent preventive treatment to children at risk just during the rainy season. here we propose (i) to evaluate the impact of two seasonal ipt (sipt) with sulfadoxine-pyrimethamine (sp) given at 8 weeks interval on the incidence of malaria disease in children of 6 months to 10 years in an area of seasonal transmission, in kambila, mali; (ii) to assess the impact of this strategy on the in vivo response of p. falciparum to sp; (iii) to assess the potential rebound effect of this strategy on the subsequent transmission season after the cessation. children 6 months-10 years in kambila, mali will randomized to receive either ipt with sp twice at 8 weeks interval or no ipt during the transmission season and will followed up for 12 months. subjects will be also followed during the subsequent transmission season to assess possible rebound effect. clinical malaria cases will be treated with sp and followed for 28 days to assess the in vivo response during both periods.


Eligibility criteria:
inclusion criteria: * age 6 months to 10 years * agree to seek initial medical care for all medical illness in the study clinic during the study period * written informed consent by a parent or legal garden, * no plan to travel for a long time during the study period. exclusion criteria: * history of allergy to sulfa drugs or sulfadoxine-pyrimethamine * chronic illness or symptomatic malaria at the time of enrollment

Keywords: malaria intermittent preventive treatment season children
hd vs sd quadrivalent influenza vaccine in adults aged 65 to 79 years in galicia

Conditions: Influenza

Summary: this pragmatic randomized trial is designed to evaluate the relative vaccine effectiveness of qiv-hd vs. qiv-sd in reducing the risk of hospitalization for influenza or pneumonia in adults 65-79 years of age in galicia during 2023/2024 and 2024/2025 seasons.

the study is a pragmatic, registry-based, open-label, active-controlled, individually randomized trial using the infrastructure of the regional vaccination program of galicia for patient recruitment, inclusion, randomization, and vaccine administration and the galician health registries for data collection including baseline information, follow-up data and safety monitoring. participants will have the opportunity of receiving all the information for the trial prior to the vaccination appointment. informed consent will be obtained during the vaccination appointment by the study team prior to their vaccine administration. the participation in the study is voluntary, and only individuals who accept signing the informed consent will be recruited. participants may withdraw from the study at any point. the study aims to randomize at least 114.011 participants over 2 influenza seasons (2023/2024 and 2024/2025) with approximately 57,000 participants per season (pending any further potential sample size adjustments following interim analysis).

Eligibility criteria:
inclusion criteria: * 1. age 65-79 years residing in the community (only individuals who are not eligible to receive qiv-hd as part of the standard of care) * 2. informed consent form has been signed and dated exclusion criteria: * there are no specific exclusion criteria for this study
hand transplantation: functional and quality of life outcomes

Conditions: Amputation; Traumatic, Arm, Upper, Between Shoulder and Elbow; Amputation; Traumatic, Hand; Amputation; Traumatic, Hand, Both; Amputation; Traumatic, Arm: Forearm, at Elbow Level; Amputation; Traumatic, Arm, Upper

Summary: there is an urgent need to develop hand transplant programs in this country. to this end, the university of michigan hospital and health systems is developing such an interdisciplinary program. the transplant center would like to track the patient experience from pre-operative care through surgery and post-operative care. detailed information will be collected from the patient medical records, including: pre-operative screening, demographics, medications; surgical information ; post-operative inpatient and out-patient care; laboratory and other test results; physical assessments, psychological assessments and quality of life assessments.

vascularized composite tissue allotransplantation (vca) is the transplantation of multiple tissues containing skin, muscle, bone, joint, cartilage, nerve, tendon, vessels. vca is useful for functional restoration of patients with severe tissue loss as encountered with massive burns, traumatic injuries, congenital anomalies, and following tumor resection. vca, and specifically hand transplantation, combines the technical excellence of hand surgery/microsurgery with the complex multidisciplinary care rendered in modern solid organ transplantation. the technical demands of hand transplantation, enhanced donor antigen burden of the hand allograft, and complex psychosocial issues pertaining to the recipient account for much of the discrepancy between these 2 related fields. detailed information will be collected from the patient medical records, including: pre-operative screening, demographics, medications; surgical information ; post-operative inpatient and out-patient care; laboratory and other test results; physical assessments, psychological assessments and quality of life assessments. specific outcomes will include allograft survival, allograft rejection, allograft functionality, and quality of life from transplant through 5 years.

Eligibility criteria:
inclusion criteria: * patients who have been evaluated and listed for hand transplantation will be approached to participate in this study. exclusion criteria: * those deemed not to be appropriate for listing by the university of michigan interdisciplinary evaluation team.

Keywords: amputation, hand, forearm, arm, traumatic, transplantation
brain skull deformation as a non-invasive intracranial pressure (icp) measure

Conditions: Subarachnoid Hemorrhage; Stroke; Stroke, Ischemic; Stroke Hemorrhagic; Intracranial Hypertension

Summary: background: although placement of an intra-cerebral catheter remains the gold standard method for measuring intracranial pressure (icp), there are several limitations to the method. objectives: the main objective of this study was to compare the correlation and the agreement of the wave morphology between the icp (standard icp monitoring) and a new nicp monitor in patients admitted with stroke. our secondary objective was to estimate the accuracy of four non-invasive methods to assess intracranial hypertension. methods: we prospectively collected data of adults admitted to an intensive care unit (icu) with subarachnoid hemorrhage (sah), intracerebral hemorrhage (ich) or ischemic stroke (is) in whom invasive icp monitoring placed. measures had been simultaneously collected from the following non-invasive indices: optic nerve sheath diameter (onsd), pulsatility index (pi) using transcranial doppler (tcd), a 5-point visual scale designed for computed tomography (ct) and two parameters (time-to-peak \[ttp\] and p2/p1 ratio) of a non-invasive icp wave morphology monitor (brain4care\[b4c\]). intracranial hypertension was defined as an invasively measured icp \> 20 mmhg for at least five minutes.


Eligibility criteria:
inclusion criteria: - adult inpatients from a dedicated neurological intensive care unit with ischemic (is) or hemorrhagic stroke who needed invasive icp monitoring were prospectively evaluated from march 2019 to march 2020 (before the covid-19 pandemic). exclusion criteria: * we excluded patients with chronic neurological diseases (demyelinating diseases, chronic hydrocephalus, pseudotumor brain), suspected brain death, and patients monitored with non-ventricular sensors (e.g., subdural or epidural).

Keywords: non invasive icp monitor icp wave morphology
metronomic therapy in patients with metastatic melanoma

Conditions: Metastatic Melanoma

Summary: summary: metronomic therapy in patients with metastatic melanoma: a phase ii study of low dose vinblastine, cyclophosphamide, and dacarbazine. patients with measurable metastatic melanoma are eligible. all patients will be treated as outlined below with combined vinblastine, cyclophosphamide, and dacarbazine. patients will be treated continuously, until evidence of progression of disease, or for up to two cycles following disappearance of all disease. a cycle will be defined as three weeks of continuous therapy with a one week rest.

low dose continuous chemotherapy, called metronomic chemotherapy, is designed to target vascular cells and inhibit tumor growth and metastasises. a recent study in a melanoma mouse model has identified low dose vinblastine, cyclophosphamide and dacarbazine as a treatment which improves the animal's survival and is superior to full dose dacarbazine alone. this clinical trial seeks to translate this laboratory model directly into metastatic melanoma patients.

Eligibility criteria:
* metastatic melanoma with measurable disease * patients must be at least 4 weeks from their last immunotherapy, radiation, surgery or chemotherapy (6 weeks for nitrosoureas) and recovered from all ill * karnofsky performance status ≥60% * life expectancy ≥ twelve weeks * adequate end organ function * women should not be lactating and, if of childbearing age, have a negative pregnancy test within two weeks of entry to the study. * appropriate contraception in both sexes * the patient must be competent and signed informed consent. exclusion criteria * concomitant second malignancy except for non-melanoma skin cancer, and non-invasive cancer such as cervical cis, superficial bladder cancer without local recurrence, breast cis. * in patients with a prior history of invasive malignancy, less than five years in complete remission. * have evidence of significant co-morbid illness such as uncontrolled diabetes - uncontrolled brain metastasis: patients with brain metastasis most have been treated with brain radiation therapy or surgery and remain clinically stable for a minimum of 4 weeks.

Keywords: metronomic therapy metastatic melanoma vinblastine cyclophosphamide dacarbazine
effects of low dose naltrexone in fibromyalgia

Conditions: Fibromyalgia; Persian Gulf Syndrome

Summary: low dose naltrexone (ldn) has been reported anecdotally to reduce the symptoms of fibromyalgia, a chronic multisystem illness. the drug may work by regulating natural pain-reducing systems. in this study, we will administer both ldn and placebo to a small group of individuals with fibromyalgia and gulf war syndrome, both chronic multisymptom illnesses, to assess the drug's efficacy in treating the condition.

this study will be a placebo-controlled, double-blind, cross-over drug tria. patients with primary fibromyalgia or gulf war syndrome will be recruited from the stanford university pain management center and the surrounding community. participation in the study will cover 22 weeks. participants will attend a laboratory session 12 times for progress checkups, and will complete daily measures of symptoms.

Eligibility criteria:
inclusion criteria: currently suffering from moderate to severe fibromyalgia or symptoms of gulf war syndrome age 18-65. not taking any opioid analgesic not pregnant or planning to become pregnant. exclusion criteria: any known allergy to naltrexone or naloxone. actual or planned pregnancy.
circulating tumor cell detection in hepatocellular carcinoma

Conditions: Circulating Tumor Cell

Summary: the investigators examined circulating tumor cells (ctc) in the perioperative peripheral blood of hundreds of hcc patients undergoing liver cancer surgery using cellsearch technology between 2013 and 2016. although the investigators have done a preliminary study of the above data and published some results, the previous study was only a basic analysis. now the investigators plan to carry out further in-depth analysis of these data, including hospitalization data, follow-up results, surgical tumors and blood specimens, and make full use of biostatistics, molecular biology, pathology and other related techniques to elucidate the association between the levels of ctc or ctc clusters and patients' disease during the perioperative period, and to explore the molecular basis of ctc production in hepatocellular carcinoma.

from 2013 to 2016, cellsearch technology was used to detect the number of circulating tumor cells (ctc) in peripheral blood of hundreds of hcc patients undergoing liver cancer surgery during perioperative period. the analysis results confirmed that the level of ctc before and after surgery were significantly correlated with overall survival (os) and disease-free survival (dfs) of patients. ctc level changed before and after surgery, but there was no statistical difference. preoperative ctc was more correlated with patients' disease-related clinical parameters, while postoperative ctc was an independent prognostic indicator of patients after surgery. in addition, the investigators' study found that ctc clusters level can be a new marker of tumor progression in hcc patients. based on the above data, the investigators will perform retrospective analysis to compare the relationship between ctc level and clinical indicators of hcc patients. participants were divided into groups according to pathological type, differentiation degree, clinical stage, invasion degree, recurrence and metastasis of tumors. combined with immunohistochemistry and quantitative pcr results, the correlation of ctc in tumor genesis, pathological model, degree of differentiation, tumor stage, invasion, metastasis and expression of other tumor markers was studied.

Eligibility criteria:
inclusion criteria: * the pathological diagnosis was primary liver cancer. * undergoing radical surgical treatment * no preoperative antitumor therapy was received * between 18 and 80 years old exclusion criteria: * with distal metastasis * with other tumors * perioperative death * recurrence within one month after surgery * lost contact before the first follow-up
virtual autopsy in cardiology, cardio- and vascular-surgery

Conditions: Death

Summary: today complex vascular and cardiological interventions are performed in severely ill patients. autopsy is the reference standard for quality control for almost two centuries, but autopsy rates for patients dying in hospitals are decreasing rapidly. virtual autopsy has shown to be a good alternative for classic autopsy.

patients dying within 96h after a cardiological intervention of a cardio-/vascular-surgery are eligible to be included in the study. if the next of kin give oral informed consent a virtual autopsy based on a ct angiography followed by a classic medical autopsy will be performed. ante mortem findings will be compared to findings from both autopsy methods and presented to the clinicians. primary outcome will be the inter-method agreement. secondary outcome will be the satisfaction of the clinicians evaluated by a standardized questionnaire.

Eligibility criteria:
inclusion criteria: * 18 years or older and * dying after a cardiological intervention or a cardio-/vascular surgery and * oral informed consent from next of kind exclusion criteria: * not fulfilling all inclusion criteria

Keywords: quality control cardiosurgery cardiology vascular surgery icu
comparison of pureed rice using a gelling agent and standard pureed rice

Conditions: Swallowing Disorder

Summary: the texture of the pureed diet is likely to be most useful factor predictive of the prevention of aspiration pneumonia. however, it has not been previously reported what kinds of texture of the pureed diet can prevent aspiration pneumonia. using endoscopic swallowing evaluation, we attempt to compare two kinds of the pureed diets to choose the better texture of pureed diets in elderly patients with severe dysphagia.

the degree of dysphagia is evaluated using hyodo.komagane score (0-12). subsequently, a randomized, crossover trial using pureed rice containing a gelling agent (softia u, nutri co., ltd., yokkaichi, japan), or standard pureed rice is performed in patients with dysphagia. the extent of pharyngeal clearance after swallowing of each pureed rice and test jelly (isotonic green jelly®, nutri co., ltd., yokkaichi, japan) is scored as follows: 1. no remains 2. pharyngeal clearance is obtained after swallowing of test jelly once 3. pharyngeal clearance is obtained after swallowing of test jelly twice 4. pharyngeal clearance is obtained after swallowing of test jelly three times and more 5. in spite of swallowing of test jelly, pharyngeal residues remain and/or penetrate into larynx. evaluation primary outcome: the pharyngeal clearance score (1-5) secondary outcome: patient feeling regarding pharyngeal clearance after the swallowing of pureed rice and/or test jelly (0 remains -100% complete clearance)

Eligibility criteria:
inclusion criteria: * hospitalized patients who underwent endoscopic swallowing evaluation at showa inan general hospital exclusion criteria: * an age less than 65 years old or the presence of an acute infection.

Keywords: pureed diet dysphasia
ezetimibe in patients hypo-responsive to statins

Conditions: High Cholesterol; Coronary Artery Disease

Summary: response to statin therapy for elevated low density lipoprotein is variable and may be influenced by cholesterol absorption. this study will evaluate whether combination therapy with atorvastatin/ezetimibe will be superior to atorvastatin alone in subjects who have less than 25% ldl reduction on starting dose statin (eg, atorvastatin 10 mg daily or simvastatin 20 mg daily).

specific aim 1 to identify a patient population seen in the university of california, san diego general internal medicine and cardiology subspecialty clinics as well as referrals from community physicians who are hyporesponsive to statin therapy (defined as an initial ldl reduction of \<25% in response to 10mg of atorvastatin or 20mg of simvastatin- expected mean reduction is 35% -37% for starting dose simvastatin and atorvastatin). specific aim 2 to test the hypothesis, with a prospective study, that a hyporesponse to statin therapy may be related to increased cholesterol absorption, and that this hyporesponse may be overcome by the addition of ezetimibe, a specific cholesterol absorption inhibitor. specific aim 3 to evaluate whether patients with less than 25% ldl reduction on 10 mg of atorvastatin (or 20 mg of simvastatin) would achieve significantly greater ldl reduction with combination therapy (atorvastatin/ezetimibe) than with statin dose titration (using atorvastatin).

Eligibility criteria:
inclusion criteria: * patients will need to have an ldl-c level of 130 mg/dl or greater without treatment. * they must have demonstrated an initial ldl-c reduction of less than 25% on 10 mg of atorvastatin or 20 mg of simvastatin. * eligible patients will be those deemed by their physicians to be eligible for lipid lowering therapy with a statin and to have stable cad, cad equivalent per ncep guidelines, or framingham risk of 10-20%. exclusion criteria: * recent (\<3 months) diagnosis of acute coronary syndromes due to ethical considerations \[10\]. * pregnant patients, those planning to become pregnant, or those who are breast feeding, those with liver disease, history allergic reaction to any agent used in the trial, history of myositis, myopathy, pancreatitis, hypertriglyceridemia (tg \> 400 mg/dl), history of significant alcohol or drug abuse, history of organ transplantation, or patient refusal.
adme study in healthy male subjects with ta-8995

Conditions: Dyslipidemia

Summary: a study to measure the absorption, metabolism and excretion of a single dose of radiolabelled ta-8995 (10mg) in healthy male subjects.


Eligibility criteria:
inclusion criteria: * healthy male subjects exclusion criteria: * clinically significant abnormalities
a comparison of isis 2922 used immediately or later in patients with cytomegalovirus (cmv) of the eyes

Conditions: Cytomegalovirus Retinitis; HIV Infections

Summary: to determine a clinically safe and effective dose of intravitreally injected isis 2922 and to compare the safety and efficacy of immediate versus delayed treatment in aids patients with previously untreated, peripheral cytomegalovirus ( cmv ) retinitis.

in stage 1 (dose escalation), patients receive either 75 or 150 mcg intravitreal isis 2922. in stage 2 (randomization), patients are enrolled in either the immediate treatment group or delayed treatment group. immediate treatment consists of intravitreal isis 2922 every 7 days for 3 injections (induction) then every 14 days for 18 weeks (maintenance). patients in the delayed treatment group receive no immediate anti-cmv treatment but are monitored weekly for disease progression. if disease progresses, patient receives isis 2922 on an identical dosage regimen as those on immediate treatment. patients may continue isis 2922 on a biweekly extended maintenance schedule if dose is considered safe and the cmv retinitis is clinically controlled. per 2/8/96 amendment, patients are now in stage 2 at 150 mcg.

Eligibility criteria:
inclusion criteria patients must have: * aids. * clinical diagnosis of previously untreated peripheral cmv retinitis in one eye. * leading edge of a cmv retinitis lesion is at least 750 microns from zone one. note: * patients with cmv retinitis in zone three only may be eligible if the lesions can be reliably photographed to follow progression. exclusion criteria co-existing condition: patients with the following symptoms or conditions in the eye to be treated are excluded: * external ocular infections. * other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus. * ocular conditions that will obstruct visualization of the posterior ocular structures. * retinal detachment. * silicone oil in eye. patients with the following other symptoms or conditions are excluded: * known or suspected allergy to phosphorothioate oligonucleotides. * syphilis. * pseudoretinitis pigmentosa. concurrent medication: excluded: * current treatment for extra-ocular cmv infection. * ganciclovir. * foscarnet. * mellaril. * stelazine. * thorazine. * clofazimine. * ethambutol/fluconazole combination. * investigational medications for cmv retinitis. concurrent treatment: excluded: * investigational procedures for cmv retinitis. patients with the following prior conditions are excluded: * history of surgery to correct retinal detachment in the eye to be treated. * history of syphilis. prior medication: excluded: * prior anti-cmv retinitis treatment in either eye. * anti-cmv therapy for extra-ocular infection within the past 2 days.

Keywords: aids-related opportunistic infections acquired immunodeficiency syndrome antiviral agents cytomegalovirus retinitis