Kornimate/medical-research-clean huggingface dataset:
s-1 and radiotherapy in elderly patients with esophageal cancer

Conditions: Esophageal Cancer

Summary: elderly patients with esophageal cancer will receive thoracic radiation therapy 54gy over 30 fractions, and concurrent with s-1 on days 1-14 and 29-42 at the following dosages: 60, 70, and 80 mg/m(2)/day.

purpose:evaluated the dose-limiting toxicity and recommended dose of s-1 for a future phase ii study when administered concurrently with thoracic radiation in elderly patients (\>70 years old) with esophageal cancer. methods:s-1 was administered on days 1-14 and 29-42 at the following dosages: 60, 70, and 80mg/m(2)/day. thoracic radiation therapy was administered in 1.8gy fractions five times weekly to a total dose of 54 gy.

Eligibility criteria:
inclusion criteria: * histologically documented diagnosis of esophageal cancer * disease must be encompassed in a radiotherapy field.patients with celiac, perigastric, mediastinal or supraclavicular adenopathy are eligible * age:70-85 years * written informed consent. * performance status of 0 to 2 * neutrophil count \>1.5 x 10 to the 9th power/l and platelets \> 100 x 10 to the 9th power/l. * hepatic: total bilirubin less than or equal to 1.5 times upper limit of normal (uln) alanine transaminase (alt) and aspartate transaminase (ast) less than or equal to 2.5 times uln (or less than or equal to 5 times uln in case of known liver involvement * renal: serum creatinine less than or equal to 1.5 times upper limit of normal (uln) exclusion criteria: * evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi. * prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible). * prior systemic chemotherapy or radiation therapy for esophageal cancer

Keywords: s-1 radiation esophageal cancer
sedation monitoring using frontal electroencephalogram, electromyogram and hemodynamic responses to pain in critical care

Conditions: Electroencephalography; Critical Care; Electromyography

Summary: purpose: assessing nociception and sedation in mechanically ventilated patients in the icu is challenging, with few reliable methods available for continuous monitoring. measurable cardiovascular and neurophysiological variables, such as blood pressure, heart rate, frontal eeg, and frontal emg, might provide a medium for sedation and nociception monitoring. the hypothesis of this explorative study is that the aforementioned variables correlate with the level of sedation, as described by the richmond agitation-sedation score (rass). methods: thirty adult postoperative icu patients on mechanical ventilation and receiving intravenous sedation, excluding patients with primary neurological disorders, head injury, or need for continuous neuromuscular blockage. continuous measurements of bispectral index (bis), emg power (emg), emg-derived responsiveness index (ri), averaged blood pressure variability (arv), and surgical pleth index (spi) were tested against repeated rass measurements, and separately against responsiveness to painful stimuli at varying rass levels.


Eligibility criteria:
inclusion criteria: * adult patients (over 18 years old) * postoperative icu admission (planned and un-planned admissions), on mechanical ventilation via an endotracheal tube, with invasive hemodynamic monitoring via an arterial line * receiving intravenous sedation by continuous infusion (propofol, midazolam). exclusion criteria: primary neurological disorders (including stroke, cardiac arrest with probable hypoxic brain injury, intracranial hemorrhage, and head injury with reduced level of consciousness prior to intubation), the continuous use of neuromuscular blocking agents during monitoring, confirmed meningitis or encephalitis, or a short data collection time (less than 12 hours).
a study to assess the safety and reactogenicity of glaxosmithkline (gsk) biologicals' human papillomavirus (hpv) vaccine (cervarix) in healthy female filipino subjects vaccinated according to the prescribing information from the age of 10 years onwards.

Conditions: Human Papillomavirus Infection Leading to Cervical Cancer

Summary: the purpose of this study was to assess the safety and reactogenicity of gsk biologicals' cervarix vaccine in healthy female filipino subjects from the age of 10 years onwards, as per the bureau of food and drugs directive of philippines.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they and/or their lar's can and will comply with the requirements of the protocol should be enrolled in the study. * a female 10 years of age and above at the time of the first vaccination. * written informed consent obtained from the subject. for subjects below the legal age of consent, written informed consent must be obtained from the parent or legal guardian (legally acceptable representative -lar) of the subject and informed assent must be obtained from the subject. * free of obvious health problems as established by medical history and history-directed physical examination before entering into the study. * subjects of childbearing potential must not be pregnant. * subjects must be of non-childbearing potential, or if the subject is of childbearing potential, she must be abstinent (and if so, this must be documented in the source documents at each vaccination visit) or must be using adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or non-investigational product (pharmaceutical product or device). * pregnant or breastfeeding. * planning to become pregnant or likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose. * history of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine. * hypersensitivity to latex (found in syringe-tip cap and plunger). * known acute or chronic, clinically significant neurologic, haematological, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests. * cancer or autoimmune disease under treatment. * previous vaccination against hpv or planned administration of another hpv vaccine during the study. * acute disease at the time of enrolment.

Keywords: cervarix filipinos safety and reactogenicity human papillomavirus
hemadsorption during and after cardiopulmonary bypass to modulate the inflammatory response

Conditions: Inflammatory Response; Chronic Renal Disease; Cardiac Surgery

Summary: chronic kidney disease (ckd) is a risk factor for the development of cardiovascular disease, which increases the risk of death after cardiac surgery. high interleukin 6 (il-6) blood levels is commonly observed in patients with ckd, and this is particularly high after cardiac surgery. high il-6 levels are also associated with increased long-term mortality rate after cardiac surgery. to date, the use of ultrafiltration or endotoxin adsorption systems were not found to improve the clinical outcome, although able to reduce the inflammatory mediators concentrations. in the last years, a new extracorporeal hemadsorption filter (cytosorb) has been developed for removal of inflammatory cytokines and it has been approved by the european union. however, data lack about the impact on clinical outcome of the use of cytosorb in patients with ckd undergoing cardiac surgery with cardio-pulmonary bypass (cpb). the investigators have therefore designed this pilot prospective randomized trial to evaluate the efficacy the intraoperative use of cytosorb for cytokines removal to prevent the inflammatory response associated with the cardiac surgery and complications in patients with ckd.


Eligibility criteria:
inclusion criteria: * all consecutive adult patients (age \>65 years) undergoing cardiac surgery with an anticipated cpb time duration longer than 60 minutes. * presence of ckd defined by a glomerular filtration rate (egfr) \< 60 ml/min/1.73 m2. * consent to participate to the study exclusion criteria: * emergency surgery * acute infective endocarditis * systemic infectious diseases * previous kidney transplant * need for contrast enhancement during surgery * immunosuppressive or long-term corticosteroid therapies * participation to other investigations.

Keywords: hemadsorption
an eight-week study to evaluate the efficacy and safety of sr58611a in patients with generalized anxiety disorder

Conditions: Anxiety Disorders

Summary: the purpose of the study is to evaluate the efficacy and safety of sr58611a in patients with generalized anxiety disorder. the primary objective is to evaluate the efficacy of a 700 mg dose of sr58611a compared to placebo in patients with generalized anxiety disorder (gad).the secondary objectives are to evaluate the efficacy of sr58611a on disability and quality of life in patients with gad and to evaluate safety of sr58611a.

the study is a multicenter, multicountry, randomized, parallel-group, double blind, placebo and paroxetine-controlled study consisting of three segments (a, b, and c). segment a is a 1-week, placebo, single-blind period and segment b is an 8-week, double blind period. all randomized patients must complete a post-study visit 1 week after intake of the last dose of study medication.

Eligibility criteria:
inclusion criteria: * out-patients, 18 to 65 years of age. * patients suffering from generalized anxiety disorder (gad) as defined by diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) criteria and confirmed by the mini international neuropsychiatric interview (mini) plus gad module. * with a total score on the 14-item hamilton anxiety rating scale (ham-a) ³ 20. * having given voluntarily their written informed consent to participate in the study. * able to comply with the protocol and follow written and verbal instructions. * for inclusion into segment b of the study, patients must fulfill the following criteria: * all segment a inclusion criteria. * completion of a minimum of 3 and a maximum of 9 days of treatment in segment a. * not "placebo responders" (i.e., improvement £ 20 % on ham-a total score between v1 and v2) exclusion criteria: * patients with a diagnosis of major depressive disorder as defined by dsm-iv-tr within 6 months of study entry. * patients with a montgomery-asberg depression rating scale (madrs) total score of 18 or higher at screening or baseline visits. * patients having a moderate to high current risk for suicide. * patients with other current anxiety disorder assessed with the mini: agoraphobia, social phobia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, acute stress disorder. * patients with a lifetime history according to the mini of: bipolar disorders, psychotic disorders, antisocial personality disorder. * patients with severe or unstable concomitant medical conditions according to the investigator's judgment. * females who are pregnant or lactating. * female patients of childbearing potential must use an effective method of birth control during the entire study period. * patients with positive test for any illicit drug included in the urine drug screen. * participation in a clinical trial of an experimental therapy within 3 months prior to screening

Keywords: anxiety anti-anxiety agents controlled clinical trial
relationship between albumin/creatine ratio, b12, folate, and frailty index

Conditions: Frailty

Summary: in the literature, the relationship between frailty and various blood tests such as beta-2 microglobulin, crp, procalcitonin, vitamin d, il-1, and il-6 has been investigated (2). in our study, the investigators aim to investigate the relationship between frailty status assessed using frailty scale forms (frailty scale version 9, quality of life scale short form-36) and preoperative levels of albumin/creatinine, b12, folate, ferritin, hemogram, sedimentation rate, and crp in patients undergoing gastrointestinal malignancy surgery. by identifying the relationship among these parameters, the investigators believe that modifiable factors contributing to frailty in patients at risk can be addressed through appropriate interventions.

frailty is a condition associated with a decline in physiological performance. patients are categorized as healthy, pre-frail, or frail based on physiological and functional characteristics. frailty is known to be influenced by various lifestyle factors such as socioeconomic status, psychological factors, diet, exercise, and genetic predisposition. with aging, there is an increase in cognitive and physical dysfunction, which correlates with an increase in frailty. along with frailty, geriatric symptoms, mortality, and other negative health outcomes also increase in the elderly population. therefore, early detection of frailty is crucial to implementing lifestyle changes aimed at improving cognitive and physical status. various assessment scales are used to evaluate frailty, such as the frailty scale version 9, quality of life scale short form-36, and modified 5-item frailty index (mfi-5) in the literature, the relationship between frailty and various blood tests such as beta-2 microglobulin, crp, procalcitonin, vitamin d, il-1, and il-6 has been investigated (2). in our study, the investigators aim to investigate the relationship between frailty status assessed using frailty scale forms (frailty scale version 9, quality of life scale short form-36) and preoperative levels of albumin/creatinine, b12, folate, ferritin,hemogram, sedimentation rate, and crp in patients undergoing gastrointestinal malignancy surgery. by identifying the relationship among these parameters, the investigators believe that modifiable factors contributing to frailty in patients at risk can be addressed through appropriate interventions.

Eligibility criteria:
inclusion criteria: * patients who are over 65 years old. * patients classified under asa (american society of anesthesiologists) risk groups i, ii, and iii. * patients with gastrointestinal malignancy undergoing surgery exclusion criteria: * patients who are under 65 years old. * patients with an asa score of iv or higher. * patients who refuse to participate in the study. * patients undergoing emergency surgeries will be excluded from the study

Keywords: frailty scale albumin/creatine ratio b12 folate
the effect of perioperative lidocaine infusion on neutrophil extracellular trapping

Conditions: Gastric Cancer

Summary: to investigate the effect of perioperative lidocaine infusion on the neutrophil extracellular trapping after minimally invasive surgery for stomach cancer

to investigate the effect of perioperative lidocaine infusion on the neutrophil extracellular trapping, especially citrullinated histone3, neutrophil elastase, myeloperoxidase

Eligibility criteria:
inclusion criteria: * diagnosis of stomach cancer * asa class i-iii * no metastatic disease exclusion criteria: * hepatic, renal disease * chronic inflammatory disease, eg. rheumatoid arthritis * steroid or anti-inflammatory drug medication * allergies to study drugs * neuropsychiatric disease * refusal of participation * breast feeding or pregnancy * weight \< 40 kg
efficacy and safety of diclofenac sodium topical gel 1% applied four times daily in subjects with acute blunt trauma injuries

Conditions: Acute Blunt Soft Tissue Injuries/Contusions

Summary: the purpose of this study is to evaluate the efficacy of dsg 1% compared with placebo applied four times a day in subjects with acute blunt soft tissue injuries/contusions of the limbs


Eligibility criteria:
inclusion criteria: * male or female aged 18 years and over. * fresh impact injury (blunt, traumatic soft tissue injury or contusion) of the upper or the lower limbs, not requiring admittance to hospital, meeting baseline pain intensity level.anticipated time between injury and treatment must be less than 3 hours. exclusion criteria: * pain medication was taken within the 6 hours that precede randomization.any physical impairment that would influence the study's efficacy evaluations, in particular pom such as: peripheral or central neurological disease, significant back pain; in case of acute blunt soft tissue injuries of the lower limbs: symptomatic osteoarthritis of the hips, knees, or feet, or any other painful conditions of the lower extremities (e.g., painful nail, wound, corn, or wart), in case of acute blunt soft tissue injuries of the upper limbs: no painful conditions of the upper extremities.

Keywords: blunt soft tissue injury/contusion
ketamine and glutamate after brain injury : a microdialysis study

Conditions: Head Trauma

Summary: the objective of the study is to compare the effects of 48 hours ketamine infusion versus sufentanil infusion on brain glutamate concentrations measured with microdialysis after traumatic brain injury. we hypothesize that ketamine infusion will decrease high glutamate values faster than sufentanil.

inclusion of 20 consecutive head trauma patients. randomization and double-blind to compare the effects of ketamine versus sufentanil on brain glutamate concentrations measured with microdialysis. ketamine is an anti-n-methyl-d-aspartate (nmda) medication. it is supposed to limit excitotoxicity of amino-acids, especially glutamate. glutamate is known to be elevated in more than 60% of the severe head trauma patients. it induces cortical spreading depression which can aggravate prognosis. it's a daily used medication in anesthesia and intensive care units for sedation and induction of anesthesia. it's the recommended medication for induction of unstable wounded soldiers on the field because of its neutrality on haemodynamic state. sufentanil is the reference opioid for sedation in icu in europe. it can induce hypotension which is deleterious for cerebral perfusion pressure after brain trauma. in our unit, patients with severe head injury are monitored by a triple lumen access device including icp (intracerebral pressure), ptio2 (oxygen pressure in the brain) and microdialysis. this last monitoring allows measurement of brain parenchymal concentrations of small molecules : glucose, lactate, pyruvate, glutamate, glycerol,.... it's a tool to evaluate the metabolic state of the brain divided into 4 categories : normal, hyperglycolysis, ischemia and metabolic crisis. then, we will detail the effects of ketamine on metabolic state of the brain, especially glutamate concentration. normal values are below 10 micromol/ml. after head trauma it can dramatically increase to values up to 50 or even 100 micromol/ml, with normalization after 24 hours. ketamine is expected to decrease these high values faster than described in observational studies.

Eligibility criteria:
inclusion criteria: * \> 18 years old * glasgow coma scale (gcs) \< 9 * \> 3 days of sedation expected at the arrival exclusion criteria: * pregnancy * \< 18 years old * estimated survival \< 48 hours post-trauma * expected sedation \< 3 days * coagulation impairment (platelets\<100.000/mm3 and prothrombin time (tp) \<60%) * cardiac arrest before icu admission * admission \> 12 hours after trauma * multimodal monitoring implanted \> 24 hours post trauma * participation to the study refused by the next of kind * no next of kind

Keywords: traumatic brain injury ketamine microdialysis ptio2 glutamate
sweet thresholds in healthy volunteers study

Conditions: Taste Thresholds in Healthy Volunteers

Summary: the sweet threshold (concentration of sucrose in water) at which healthy participants can detect a sweet flavour will be recorded.

the sweet threshold (concentration of sucrose in water) at which healthy participants can detect a sweet flavour will be recorded by means of application on a cotton bud to the anterior third of the tongue. solutions will be presented in a pseudo-randomised order. mood questionnaires will be completed (to check that participants are indeed healthy). the questionnaires used will be the patient health questionnaire 9 (phq9), beck's depression inventory (bdi) and generalised anxiety disorder questionnaire 7 (gad-7). this data is being collected with the intention of its use for comparison with sweet thresholds established in other populations using the same method of sweet threshold estimation.

Eligibility criteria:
inclusion criteria: . male and female adults of 18 years old and over; * participants without a diagnosis of major depressive disorder (mdd) / anxiety disorder; * participants not taking an antidepressant during the preceding 6 months * not suffering from significant other mental or physical illness, such as confirmed psychosis, end of life care, or any other condition assessed as significant by the site investigator; * willing and able to comply with all study-related procedures; * not having covid 19 or continuing effects of covid 19 including altered sense of taste; * understands the study requirements and the treatment procedures and is able to provide written informed consent. exclusion criteria: * taking antidepressant medication currently or during the previous 6 months; * known or suspected hypersensitivity or intolerance to any taste testing solutions, or any of their excipients; * a history or presence of neurological or confounding psychiatric conditions (such as stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, parkinson's disease, vascular dementia, transient ischemic attack, or schizophrenia); * patients with a diagnosis of chronic pain; * pregnancy or possibility pregnancy, or breastfeeding; * participants using supplements containing psychoactive herbs (for example st johns wort or 5-htp (5-hydroxytryptophan, also known as oxitriptan); * participants regularly using psychoactive stimulants (for example mdma); * participants unable or unwilling to comply with study procedures.

Keywords: taste thresholds healthy volunteers
weight loss and maintenance for rural, african american communities of faith (the word)

Conditions: Obesity

Summary: the word (wholeness, oneness, righteousness, deliverance) is a faith-based weight loss study in rural, african american adults of faith. the study will see whether a weight loss + maintenance intervention will cause participants to maintain their weight better than a weight loss only intervention.


Eligibility criteria:
inclusion criteria: * african american * aged 18 and older * have a bmi ) \> 25 kg/m² * associated with a participating church through membership or participation in a church activity * free of medical problems that might contraindicated participation in a behavioral weight reduction program containing an exercise component * individuals taking sulfonylureas who have a letter from their doctor supporting their participation in the study will be considered eligible exclusion criteria * not had a heart attack or stroke in the past 6 months * not currently on medication that might affect weight loss or require medical monitoring (i.e. insulin) * not pregnant, not pregnant in the previous six months, or lactating * not enrolled in another weight reduction program * agree to complete the program assigned to them * never had weight loss surgery * not have lost more than 10% body weight in the previous 6 months * not have a clinically significant medical condition likely to impact weight or any condition that makes it unlikely the participant would be available to follow the protocol for 18 months