Kornimate/medical-research-clean huggingface dataset:
a phase i multicenter trial to evaluate the safety and immunogenicity of hiv-1 recombinant envelope glycoprotein gp160

Conditions: HIV Infections

Summary: to evaluate the safety and immune response to 160 mcg hiv-1 recombinant envelope glycoprotein gp160. to evaluate the duration of antibody response and its relationship to dose and frequency of inoculation. evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicate that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. a preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.

evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicate that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. a preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest. healthy volunteers are injected on days 0, 30, 180, and 365 with either 160 mcg gp160 vaccine (20 volunteers) or an alum placebo preparation (10 volunteers).

Eligibility criteria:
inclusion criteria subjects must have: * normal history and physical exam. * negative for hiv infection by elisa and western blot (i.e., no reactivity at gp160, gp120, gp41, or p24). * t4 count \>= 800 cells/mm3. * normal chest x-ray and urinalysis. * negative hepatitis b surface antigen. * negative hiv p24 antigen test. * normal skin reactivity by merieux test. exclusion criteria co-existing condition: subjects with the following symptoms or conditions are excluded: * positive ppd. * syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease). subjects with the following prior conditions are excluded: * history of immunodeficiency, chronic illness, or use of immunosuppressive medications. * syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. prior treatment: excluded: * prior blood transfusions or cryoprecipitates within the past 6 months. identifiable high-risk behavior for hiv infection (as determined by prescreening questions designed to identify risk factors for hiv infection), including: * any history of iv drug use. * syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. * more than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.

Keywords: vaccines, synthetic vaccinia virus hiv-1 hiv envelope protein gp160 aids vaccines hiv seronegativity hiv preventive vaccine
performance comparison between comfilcon a and senofilcon c lenses

Conditions: Myopia

Summary: the aim of this study is to determine the clinical performance of comfilcon a in comparison to senofilcon c.

this is a prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, two month dispensing study comparing the clinical performance of comfilcon a and senofilcon c lenses after one month of wear.

Eligibility criteria:
inclusion criteria: a person is eligible for inclusion in the study if he/she: * is between 18 and 34 years of age (inclusive) * has had a self-reported eye exam in the last two years * is a spherical soft contact lens wearer * has a contact lens spherical prescription between -1.00 to -6.00 (inclusive) * has a spectacle cylinder no greater than 0.75d (diopters) in each eye. * can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logmar) or better in each eye. * can achieve a distance visual acuity of 20/30 (0.18 logmar) or better in each eye with the study contact lenses. * has clear corneas and no active ocular disease * has read, understood and signed the information consent letter. * has a contact lens prescription that fits within the available parameters of the study lenses. * is willing and anticipated to be able to comply with the wear schedule (at least 6 days per week, 12 hours/day assuming there are no contraindications for doing so). * is willing to comply with the visit schedule exclusion criteria: a person will be excluded from the study if he/she: * has a history of not achieving comfortable cl (contact lens) wear (defined as 6 days per week; \> 10 hours/day) * presents with clinically significant anterior segment abnormalities * presents with ocular or systemic disease or need of medications which might interfere with contact lens wear. * presents with slit lamp findings that would contraindicate contact lens wear such as: * pathological dry eye or associated findings * significant pterygium, pinguecula, or corneal scars within the visual axis * neovascularization \> 0.75 mm in from of the limbus * giant papillary conjunctivitis (gcp) worse than grade 1 * anterior uveitis or iritis (or history in past year) * seborrheic eczema of eyelid region, seborrheic conjunctivitis * history of corneal ulcers or fungal infections * poor personal hygiene * has a known history of corneal hypoesthesia (reduced corneal sensitivity) * has aphakia, keratoconus or a highly irregular cornea. * has presbyopia or has dependence on spectacles for near work over the contact lenses. * has undergone corneal refractive surgery. * is participating in any other type of eye related clinical or research study. * is habitually using rewetting/ lubricating eye drops more than once per day * is currently wearing daily disposable lenses
temperature management on postoperative delirium

Conditions: Emergence Delirium

Summary: presently, the effects of perioperative temperature management on postoperative delirium remain ambiguous. this study endeavors to explore the influence of intraoperative temperature variations in elderly hip fracture patients on postoperative delirium.

at present, the pathophysiological mechanisms contributing to postoperative delirium in elderly hip fracture patients remain elusive, with predominant research concentrating on neural inflammation, neurotransmitter dysregulation, and metabolic irregularities. the influence of perioperative temperature management on postoperative delirium remains uncertain and may correlate with surgical modality and intraoperative temperature modulation. hence, this study endeavors to juxtapose intraoperative temperature variations among elderly hip fracture patients, probing their ramifications on postoperative delirium.

Eligibility criteria:
inclusion criteria: * age ≥ 65 years * classified as american society of anesthesiologists i-iii * hip surgery patients who agreed to the study exclusion criteria: * non-consent to participate * diagnosed neurological or psychiatric disorders including schizophrenia, epilepsy, parkinson's disease, or myasthenia gravis * coma, dementia, or language impairment affecting communication and assessment * history of neurosurgery * use of antipsychotic medication preoperatively * body temperature exceeding 38°c within 24 hours before surgery.

Keywords: postoperative delirium body temperature hyperthermia hypothermia
effectiveness of flu vaccination and burden of illness among community-dwelling elderly with influenza like illness in brazil

Conditions: Influenza

Summary: the purpose of this research study is to estimate how many elderly people who have symptoms that look like influenza (i.e. an influenza-like illness) actually have the disease and how effective influenza vaccines are in preventing influenza in elderly people. the study will also examine the severity of the disease (e.g. how long are people ill, were there any complications) and how it affects everyday life (e.g. cost, medications, care by family members).


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they can and will comply with the requirements of the protocol. * a male or female \>= 65 years of age. * written informed consent obtained from the subject. * presenting within the first 72 hours of an influenza-like illness. influenza-like illness is defined as the presence of: * fever measured by the patient or physician and at least one of the following symptoms: * sore throat. * coryza (runny nose) and/or nasal congestion. * cough. * availability to be followed up by phone or in person after an interval of approximately 14 - 21 days. exclusion criteria: * receipt of any experimental influenza vaccine within 6 months of the onset of the influenza-like illness. * terminal stage of disease. * subjects living in a nursing home. * use of any investigational or non-registered product planned during the study period. * subjects who have already been enrolled in this study.

Keywords: influenza-like illness vaccine effectiveness elderly influenza
a phase 3 study to evaluate the efficacy and safety of tralokinumab in adults and adolescents with uncontrolled asthma

Conditions: Uncontrolled Asthma

Summary: a 52-week, multicentre, randomized, double-blind, parallel group, placebo controlled, phase 3 study to evaluate the efficacy and safety of tralokinumab in adults and adolescents with asthma inadequately controlled on inhaled corticosteroid plus long-acting β2-agonist

this is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate efficacy and safety of tralokinumab administered subcutaneously in subjects with uncontrolled asthma on inhaled corticosteroid plus long-acting β2-agonist and having a history of asthma exacerbations. approximately 1140 subjects will be randomized globally. subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period.

Eligibility criteria:
inclusion criteria: 1. age 12 -75 2. documented physician-diagnosed asthma. 3. documented treatment with ics at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a laba 4. morning pre-bd fev1 value of ≥40 and \<80% value (\<90% for patients 12 to 17 years of age) of their pnv. 5. post-bd reversibility of ≥12% and ≥200 ml in fev1 6. acq-6 score ≥1.5 exclusion criteria: 1. pulmonary disease other than asthma 2. history of anaphylaxis following any biologic therapy 3. hepatitis b, c or hiv 4. pregnant or breastfeeding 5. history of cancer 6. current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years 7. previous receipt of tralokinumab

Keywords: asthma reactive airways respiratory tract disease obstructive lung disease lung diseases
neuroimaging study of n-acetylcysteine in excoriation (skin-picking) disorder

Conditions: Obsessive Compulsive Disorder (OCD)

Summary: the goal of this clinical study is to understand the brain mechanisms, particularly involving glutamate metabolism and inhibitory control networks, that underlie skin picking disorder (spd) and differ from those in obsessive-compulsive disorder (ocd) . it also aims to explore the effects of n-acetylcysteine (nac) on these brain mechanisms in adults with spd and identify potential imaging biomarkers. the main questions it aims to answer are: how do neuro-metabolism (specifically glutamate measured by magnetic resonance spectroscopy - mrs), brain activity and connectivity (measured by functional mri - fmri) differ between spd, ocd, and healthy controls, particularly in relation to behavioral and cognitive inhibitory control deficits? is there a relationship between glutamate abnormalities in the anterior cingulate cortex and impaired inhibitory control in spd and ocd? does 12 weeks of nac treatment alter glutamate levels, brain function, or connectivity in spd? spd receiving nac will: participants will receive nac tablets. treatment will commence at a starting dose of 1800 mg per day. the dosage will be gradually increased over the initial 2 weeks with a target dose of 3000 mg per day. the daily dose will be administered in two divided doses (1500 mg twice daily at the target dose).


Eligibility criteria:
inclusion criteria: * age between 18-49 years; * y-bocs and ne-ybocs total scores \< 6; hamilton depression scale-17 total score ≤ 7; * han chinese ethnicity, right-handed, education level of middle school or above; * signed informed consent. exclusion criteria: * major physical illnesses, craniocerebral trauma, history of neurological or psychiatric disorders; * pregnant women; * family history of psychiatric disorders; * history of alcohol or substance abuse; * currently meeting any psychiatric diagnostic criteria according to ccmd-3 and dsm-5; * any contraindications for mri scanning.
treatment response in dialysis anaemia

Conditions: Anaemia; Haemodialysis

Summary: anaemia in dialysis patients requires treatment with frequent dose adjustments. there are two current possible treatments for anaemia which are iron and erythropoietin stimulating agents (esa). dosages of these medications are currently guided by a patient's ferritin levels and haemoglobin, but these markers are known to be inaccurate. the current clinical protocol therefore tends towards overuse of both agents which can be associated with toxicity, and the reliance on these markers prevents retrospective assessment of treatment responsiveness. this study is designed to investigate the factors which predict which agent would produce a better response. patients with a fall in haemoglobin will be given treatment with either iron or an increased dose of esa as they are currently, but allocated at random rather than by poorly performing biochemical markers. the iron treated and esa treated groups can then be analysed for factors which predict response in o


Eligibility criteria:
inclusion criteria: * all prevalent haemodialysis patients of the imperial renal and transplant centre will be eligible for inclusion if they have been on dialysis for more than 3 months exclusion criteria: * patients with a bone marrow disorder, active infection or active malignancy will be excluded as these are non-renal causes of anaemia. patients unable to give informed consent will also not be included within the study.

Keywords: haemodialysis anaemia iron erythropoeitin stimulating agents
the protective effect for liver organ in patients with anti-tb drugs using of acetylcysteine (nac)

Conditions: Protective Effect in TB-DIH; TB-DIH Means: Drug Induced Liver Function Abnormalities

Summary: animal studies have shown that inh-rif-induced oxidative injury can be prevented by supporting the cellular antioxidant defense mechanism by n-acetylcysteine (nac). however, there are few published data and large sample sizes regarding the protective effect of nac against hepatotoxicty induced by anti-tb drugs in humans, to our knowledge. therefore, the investigators designed a clinical trial with the aim to see whether nac could protect against anti-tb drug-induced hepatotoxicity (dih)

isoniazid (inh), rifampicin (rif), and pyrazinamide (pza), the first-line drugs used for tuberculosis (tb) chemotherapy, are associated with hepatotoxicity. a high rate of hepatotoxicity has been reported in some developing countries compared with advanced countries with a similar dose schedule. sharifzadeh et al. reported an incidence of 27.7% in iran. the reasons for this higher rate of hepatotoxicity are not completely clear. ethnic variations, advanced age, female sex, alcoholism, underlying liver disease, acetylator phenotype, hepatitis b and c virus, hiv infection, extensive pulmonary parenchymal disease, and hypoalbuminemia have been observed to be the risk factors for the development of drug-induced hepatotoxicity (dih) because of anti-tb treatment. the mechanism of dih induced by anti-tb treatment is not yet fully understood. sodhi et al. proposed oxidative stress as one of the likely mechanisms for inh-rif-induced hepatic injury. it is well established that by augmenting a cellular antioxidative defense system, especially nonprotein thiols, that is, glutathione (gsh), cells can be protected against oxidative injuries produced by various drugs and chemicals. the study will be performed with randomized trial for assessment and protective effects over liver function in patients receiving anti-tb agents and using nac.

Eligibility criteria:
inclusion criteria: 1. new diagnosed to have tuberculosis 2. age \>20 years - exclusion criteria: 1. acute hepatitis in a previous one year 2. tb drugs induced urticaria or steven-johnson syndrome 3. life less than one year due to advanced cancer status 4. non-tuberculosis mycobacteria，ntm patients 5. hiv patients 6. patients can not cooperate 7. allergic reaction for nac

Keywords: tuberculosis acetylcysteine hepatotoxicity
prognostic outcome score in functional neurological disorders

Conditions: Functional Neurological Symptom Disorder

Summary: monocentric retrospective observational cohort study, using a consecutive series of patients hospitalized for fnd from 2012 to 2015 in the neurology department a of the grenoble alpes university hospital. during the discharge staff, an estimation of different prognostic factors had been performed in a consensual way by the medical team for all subjects. it is possible to calculate a score (pos) retrospectively from the data collected during the staff. the following items were evaluated on a likert scale from 1 to 5: quality of adherence to the diagnosis, presence of a current medical treatment, presence of a similar history, duration of evolution of the disorders presented, ability to verbalize, presence of a social adaptation to the disorders, access to psychiatric care. the aim of the study will be to study the properties of the calculated score according to the evolution of the patients. the investigators will retrospectively collect information from the medical records. in addition, the evolution of the disorder since the initial hospitalization will be analyzed via a self-evaluation by the subjects and the study of the current medical records. the investigators will also collect information on the quality of life of the patients in the cohort and their perception of the disease at present. using a clinical global impression (cgi-i) scale on fndstatus, subjects will be classified into two groups by the two principal investigators (dr. vercueil, m. bratanov): the first with a favorable evolution (disappearance of symptoms at the last follow-up, low health care consumption, favorable self-assessment of health status, persistence of symptoms at a low level of disability, satisfactory social and professional integration), and the second with an unfavorable evolution (persistence of symptoms at a disabling level, high health care consumption, unfavorable self-assessment of health status, lack of social and professional integration, multiple medical consultations). the prognostic properties of the pos score will be then studied in order to establish an roc curve that will allow to classify patients in the two groups.


Eligibility criteria:
inclusion criteria: * male or female gender * hospitalization in neurology department a from 2012 to 2015 with a final retained diagnosis of nft * pos score at time of hospitalization available exclusion criteria: * patient under legal protection * inability to complete a self-questionnaire * minor subjects

Keywords: psychogenic
effect of supplementation with vitamin d on the acute bronchitis prevention during the first year of life

Conditions: Acute Bronchitis; Upper Respiratory Tract Infection; Acute Bronchiolitis

Summary: a phase iii multicenter randomized double blind clinical trial will be conducted. after obtaining written consent the infant will be randomized, during the first two weeks of life, to a study group to receive either 400 iu or 1,000 iu / day of vitamin d to the year of age. baseline and all follow up visits (2, 6, and 12 months of life) will include anthropometric measurements and a questionnaire about health issues. a blood sample will be obtained at baseline for analysis of 25oh vitamin d, and at 6 and 12 months for analysis of 25 oh vitamin d, and calcium. healthy term born infants of appropriate size for gestational age will be included. we will need to include 359 children in each group. the primary objective of the study is to decrease the proportion of infants with acute bronchitis during the first year of life by supplementation of 1,000 iu/day vitamin d. secondary otcomes are: to check that the administration of 1,000 iu/day vitamin d decreases the proportion of infants with upper respiratory tract infections, the proportion of children under one year of age hospitalized for acute bronchiolitis, and the demand on the healthcare system due to respiratory infections and absences from work for parents and achieves a higher proportion of children with adequate blood levels 25 oh vitamin d.


Eligibility criteria:
inclusion criteria: * healthy term born infants of appropriate size for gestational age * parents provide informed consent to participate exclusion criteria: * infants with small size for gestational age * infants with gestational age \< 37 weeks * infants with congenital anomalies * infants with chronic gastrointestinal tract, liver, kidney, heart, or neurological diseases * infants with disorders of vitamin d or calcium metabolism or others inborn errors of metabolism

Keywords: vitamin d acute bronchitis upper respiratory tract infection recurrent bronchitis acute bronchiolitis infants
bilirubin decrease under phototherapy exposure in the preterm newborn in incubator

Conditions: Preterm Infant; Jaundice, Neonatal; Phototherapy

Summary: phototherapy is routinely used in neonatal intensive care units for the treatment of jaundice. guidelines focus mainly on bilirubin serum levels to start the phototherapy. only few data are available about clinical management of phototherapy devices and subsequently the impact on bilirubin serum decrease. especially there are no strong recommendations about phototherapy duration, irradiance measurements, incubator temperature and humidity settings. various factors can influence irradiance and thus the preterm infant bilirubin serum decrease. this study aims at evaluating the impact of an educational program on the use and efficacy of phototherapy in a neonatal intensive care unit.

only few data are available about clinical management of phototherapy devices for the treatment of jaundice in the preterm infant. this study is a prospective, monocentric, observational study. preterm infant \< 35 weeks of gestation with a jaundice requiring phototherapy according to nice guidelines can be included for the duration of the phototherapy treatment. the decrease in bilirubin serum level before and after phototherapy treatment will be measured. this decrease in bilirubin serum level will be assessed for two consecutive periods before and after an educational program on jaundice management of the preterm infant. the investigators aim at demonstrating that an educational program could improve phototherapy management and result in a higher decrease in bilirubin serum during treatment of the preterm infant with jaundice.

Eligibility criteria:
inclusion criteria: * preterm infant less than 35 weeks gestation * preterm infant hospitalized in the neonatal intensive care unit of chu amiens-picardie * preterm infant placed in an incubator * preterm infant with a jaundice requiring treatment according to nice guidelines * preterm infant with a no hemolytic disease * preterm infant with informed written consent from the parents exclusion criteria: * preterm infant more than 35 weeks of gestation * preterm infant with hemolytic disease * preterm infant with jaundice related to a cholestasis * jaundice requiring exchange transfusion

Keywords: preterm infant jaundice bilirubin phototherapy educational program