Kornimate/medical-research-clean huggingface dataset:
a pharmacokinetic and pharmacodynamic study of vincristine in children with leukemia

Conditions: Acute Lymphocytic Leukemia; Leukemia

Summary: the pharmacokinetic behavior of vincristine in pediatric patients has not been well characterized. the present study will obtain detailed information on vincristine pharmacokinetics in patients being treated for standard risk all on ccg protocols 1952/1962. a limited sampling strategy will be developed, and the interpatient and intrapatient variability of vincristine pharmacokinetics in children will be studied. a correlation between vincristine neurotoxicity and vincristine pharmacokinetics will be sought.

the pharmacokinetic behavior of vincristine in pediatric patients has not been well characterized. the present study will obtain detailed information on vincristine pharmacokinetics in patients being treated for standard risk all according to or on ccg protocols 1952/1962/1991. a limited sampling strategy will be developed, and the interpatient and intrapatient variability of vincristine pharmacokinetics in children will be studied. a correlation between vincristine neurotoxicity and vincristine pharmacokinetics will be sought.

Eligibility criteria:
inclusion criteria: all patients 1 year and less than 10 years of age. patient must be diagnosed with acute lymphoblastic leukemia. all ccg patients must be enrolled on ccg 1952, 1962 or 1991 protocols, or be treated according to a ccg standard risk all protocol. nci patients must be treated according to ccg 1952 for the treatment of standard risk all. enrollment onto the current trial (ccg b9802) should if possible take place concurrently with enrollment onto 1952/1962/1991 or start of treatment according to a ccg standard risk all protocol. all patients or their legal guardians must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study. exclusion criteria: previous underlying peripheral neuropathy. previous underlying central nervous system dysfunction. children with cns toxicity attributable to other chemotherapeutic agents will not be followed with the purdue pegboard test.

Keywords: neurotoxicity a.l.l. limited sampling dose individualization vinca alkaloids
comparison of the results of bronchoalveolar lavage culture and endotracheal aspirate culture in intubated critically ill covid-19 patients

Conditions: Bronchoalveolar Lavage; COVID-19 Pneumonia; Critical Illness

Summary: introduction: secondary pneumonia is frequently seen in covid-19 cases followed up intubated, and high mortality rates can be observed. isolation of the agent with bronchoalveolar lavage (bal) culture or endotracheal aspirate (eta) culture may increase the success of treatment. this study aimed to retrospectively analyze the results of bal and eta cultures in intubated covid-19 cases. methods: we routinely apply bal culture with bronchoscopy or eta culture within the first 48 hours after intubating. we retrospectively screened cases who underwent bal and eta. they were divided into two groups: group b and e. evaluated parameters were compared in both groups. results: demographic data and blood test results were similar in both groups. intensive care unit (icu) and intubation durations, and culture positivity were statistically significantly higher in group b. although not statistically significant, the mortality rate was higher in group e. the most growth microorganisms were candida species. conclusion: mortality rates were consistent with the literature. since the microorganism isolation rate is higher with bal and antimicrobial treatment is applied more effectively; early deaths were prevented and stay periods were prolonged. in contrast, these durations were shorter in the eta group due to higher mortality. in intubated covid-19 cases, a more effective treatment process can be carried out by clearing the airway with fiberoptic bronchoscopy and by specifically planning the treatment according to the bal culture. this may have a positive effect on prognosis and mortality.


Eligibility criteria:
inclusion criteria: * intubated covid-19 patients * above 18 years old patients exclusion criteria: * non covid-19 patients * non intubated covid-19 patients * below 18 years old patients
effect of preoperative oral carbohydrates on the insulin resistance of elderly patients

Conditions: Old Age

Summary: postoperative cognitive dysfunction (pocd) is more common in older patients, and increased insulin resistance is an important factor for pocd. fasting before surgery is performed to reduce the incidence of pulmonary aspiration after anesthesia. however, prolonged fasting increases insulin resistance. recently, it is recommended to minimize fasting times and consume carbohydrate drinks before surgery. therefore, the investigators investigate whether preoperative carbohydrate drinks can reduce insulin resistance in the elderly patients. fifty patients (age\>65 years) scheduled for arthroplasty will be divided into carbohydrate (n=28) and control (n=28) groups. randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage 2-3 hours before their scheduled operation. in contrast, patients in the control group are fasted from water 2 h before surgery according to standard protocol.


Eligibility criteria:
inclusion criteria: 1. patients undergoing arthroplasty 2. age\>65 years exclusion criteria: 1. the subject is a foreigner or illiterate 2. patients with gastroesophageal reflux disease, gastric emptying disorders, inflammatory bowel disease, or previous treatment for intra-abdominal cancer 3. patients with chronic renal disease or severe cardiovascular disease 4. hba1c \>69 mmol/mol or bmi \>30 kg/m2 5. a duration of ≥5 h between consumption of cho and initiation of surgery.
the effect of varenicline on d2/d3 receptor binding in smokers

Conditions: Nicotine Dependence

Summary: this study will evaluate effects of treatment with varenicline, a smoking cessation drug, on the dopaminergic system by using positron emission tomography (pet) imaging with new radioligand, \[11c\]-(+)-phno. the investigators primary hypothesis is that chronic varenicline administration will increase dopamine (da) receptors levels (\[11c\](+)phno) within the human brain.

subjects will undergo a pre-treatment pet and mri scans for baseline \[11c\](+)phno measures on day 1. subjects will subsequently be provided an initial 2-week supply of study medications (varenicline) and directions for use. any adverse events, compliance to medication and smoking patterns will be noted during these two weeks. varenicline will be used at the same dosage regimen as used for smoking cessation. after subjects go through a post-treatment pet and mri scans on day 10, they will be instructed to set up a quit date. there will then be follow-up visits every 2 weeks for the duration of the medication phase (3 months total) and a visit at 6 months follow-up.

Eligibility criteria:
inclusion criteria: * subjects will be nicotine dependent, males and females of any ethnic origin between 21 and 45 years old. * meet dsm-iv criteria for nicotine dependence, * smoke ≥10 cigarettes/day, baseline ftnd score ≥4, co level ≥10 and are motivated to quit within 30 days of initial intake. * treatment seeking smokers that are willing to use varenicline as a treatment approach for their smoking cessation attempt * no previous use of medication for smoking cessation in previous month prior inclusion. exclusion criteria: * pregnancy (a urine pregnancy test will be performed before each pet in women) * trying to become pregnant or breastfeeding; * have abused alcohol or other drugs of abuse (cocaine, opiates, benzodiazepines, etc) in 3 months prior to randomization. * presence of metal objects in the body (e.g. some artificial joints, bone pins, surgical clips, skull plate, certain part of dental braces) or implanted electronic devices (e.g. cardiac pacemaker, neurostimulator), that preclude safe mr scanning. * claustrophobia. * cardiovascular or cerebrovascular diseases. * major psychiatric disorders including mood, anxiety or psychotic disorders with historical evidence of suicidal or homicidal behaviour. * history of or current neurological illnesses including seizure disorders, migraine, multiple sclerosis, movement disorders, head trauma, cva or cns tumor. gross structural brain abnormalities as revealed by t1 weighted images. * current use or use during the previous month of medication that may affect the cns at the time of scanning (including illicit and non-illicit psychoactive drugs). * learning disability, amnesia or other conditions that impede memory and attention. * allergy to varenicline. * renal insufficiency. * use of other smoking cessation aids

Keywords: varenicline pet imaging [11c]-(+)-phno pet neuroimaging in smokers
protective effect of ulinastatin against negative inflammatory response and organ dysfunction after acute type a aortic dissection surgery (panda i)

Conditions: Acute Aortic Syndrome; Type a Aortic Dissection

Summary: acute aortic syndrome (aas) is a common feature of acute aortic wall events, including aortic dissection, intramural hematoma, aortic ulceration and aortic trauma, and occurs in up to 35 cases per 100,000 cases per year between the ages of 65 and 75 years. ulinastatin has antiinflammatory activity and suppresses the infiltration of neutrophils and the release of elastase and chemical mediators from neutrophils. recent studies have shown that ulinastatin may be cytoprotective against ischemia-reperfusion injury in the liver, kidney, heart, and lung. the authors aim to examine the association between decreased release of inflammatory response to urinary trypsin inhibitor treatment and decreased myocardial and lung injury after acute aortic syndrome surgery.


Eligibility criteria:
inclusion criteria: * the patients are conformed to 2010 acc/aha guidelines for the diagnosis and treatment of thoracic aortic disease (tad) within two weeks of onset; * patients with type a acute aortic syndrome confirmed clinically and radiologically and planning to undergo aortic surgery were enrolled. * the patients' age of 18 years or older. * agree to participate in the study and sign the informed consent. exclusion criteria: * patients allergic to ulinastatin; * lactating women and pregnant women; * patients with mental diseases; * refuse to participate in this study and refuse to sign the informed consent.

Keywords: acute aortic syndrome
treatment of osteoporosis - top1 clinical study

Conditions: Osteoporosis

Summary: this study investigates the effect of zeolite on bone mineral metabolism. the clinical parameters include bone mineral density, bone remodelling markers, fractures and fallings, the subjective evaluation of the overall health status and intensity of the musculoskeletal pain measured by vas.

randomized, placebo-controlled, double-blind study. the study lasts 12 months. study population: the study population will consist of 100 patients with osteoporosis defined according bmd (bone mineral density) criteria: t score -2, 5 on the femoral neck, and, or t -2, 5 on l1-l5, who has not been treated before, or in whom privies treatment did not been successful, despite a gender or age. subjects will be randomized in each cohort to receive pma-zeolite (panaceo) or placebo (1:1). all of them will receive vit d3 800 j daily. the double blind design can be reached by a "third party blinding" where a qualified person, not being involved in the assessment of the study, will administer the study treatment. follow up dxa, ca, p, alp, osteocalcin, cross laps, creatinin will be done to each subject before the treatment, 6 months later and after 12 months. iva (vertebral deformity assessment) will be performed before the treatment and after 12 months.

Eligibility criteria:
inclusion criteria: * 100 subjects with osteoporosis among those, as a subgroup, 20 subjects with diabetes type 2 and osteoporosis * the osteoporosis- was diagnosed by standard dxa measurement (bmd t-score: - 2.5 or below ) exclusion criteria: * chronic renal failure, secondary osteoporosis
bowel and bladder function in infant toilet training

Conditions: Infantile Colic; Constipation - Functional; Bladder Dysfunction; Toilet Training

Summary: the overall purpose is to assess whether assisted infant toilet training during the first year of life can prevent functional gastrointestinal and urinary tract disorders up to 4 year of age. healthy swedish children will be randomized to start assisted infant toilet training at 0-2 months of age or at 10-11 months of age. the toilet training process will be described including mother-to-infant attachment and parental stress.

the mastery of toilet training is an important developmental milestone for children and parents. the age at which children start toilet training has increased during the last decades in the western world. 50 years ago most children were out of nappies by 1,5 years of age. today, wearing nappies by 3-4 years of age is considered normal. meanwhile an increase in functional gastrointestinal and urinary tract disorders and toileting problems is reported by health care professionals. a randomized multicenter intervention study is conducted at child health care centers in sweden to investigate whether assisted infant toilet training initiated during the first year of life can prevent functional bowel and bladder disorders.

Eligibility criteria:
inclusion criteria: * full-term infant (born at gestational week 37+0 to 41+6) exclusion criteria: * infants with malformations or disorders that may affect the gastrointestinal or urinary tract in any relevant way * infants born small for gestational age (sga), \< - 2 standard deviation * parents with insufficient understanding of the swedish language * infants older than 2 months, 1 week and 6 days at inclusion

Keywords: colic constipation bladder dysfunction toilet training
social media intervention for cannabis use in emerging adults

Conditions: Cannabis Use

Summary: the purpose of the study is to develop and test social media interventions to help young people increase well-being and reduce risky behaviors. the study will help researchers learn about ways to deliver wellness information in a way that is appealing and helpful to young people who use facebook.


Eligibility criteria:
inclusion criteria: * self-report using cannabis at least 3 time per week or more often in the past month * active facebook profile * view and click on a social media ad exclusion criteria: * fail identity verification based on 1) internet protocol (ip) addresses, 2) survey time completion, 3) repeat attempts, 4) survey responses, and 5) photo identification via a timestamped selfie sent to the research staff.

Keywords: social media
clinical study to evaluate treatment with oracea® for geographic atrophy (toga)

Conditions: Geographic Atrophy

Summary: this is a prospective, randomized study to evaluate the efficacy and safety of oracea® in the treatment of geographic atrophy due to dry age-related macular degeneration (amd).

eligible participants will complete a 6-month observation phase, followed by a 24-month treatment phase, followed by an end of study visit. eligible participants will be randomized at month 6 in a 1:1 ratio to either oracea (40 mg doxycycline) or placebo capsule to be taken once-daily for 24 months. over the course of the 31-month study, a total of 9 clinic visits and 3 telephone calls are required.

Eligibility criteria:
inclusion criteria: * male or female, age \>/=55 years * best corrected visual acuity of 20/20 - 20/400 in the study eye * best corrected visual acuity of hand motion or better in the non-study eye * clinical diagnosis of geographic atrophy secondary to non-exudative age-related macular degeneration in at least one eye (study eye) * geographic atrophy lesions of ≥ 0.5 and ≤ 7.0 mps disc areas exclusion criteria: * history of or active presence of choroidal neovascularization secondary to exudative age-related macular degeneration in the study eye * history of or active presence of choroidal neovascularization secondary to exudative age-related macular degeneration in the non-study eye requiring any treatment within 12 months prior to day 0 or expected to require treatment for the duration of the study * prior treatment for non-exudative age-related macular degeneration * current or previous history of treatment of the study eye with any tetracycline derivative for any ocular condition. * history of vitreoretinal surgery, corneal transplant, or laser photocoagulation in the study eye * any intraocular or periocular surgery within 90 days prior to day 0 in the study eye. * history of any hypersensitivity to tetracycline components * use of a tetracycline derivative therapy for a concurrent systemic or ocular disorder within 90 days of day 0 * history of sensitivity to the sun

Keywords: geographic atrophy non-exudative age-related macular degeneration macular degeneration dry macular degeneration dry amd
open-label study of duloxetine in the treatment of children and adolescents with major depressive disorder

Conditions: Major Depressive Disorder

Summary: the primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition. whether duloxetine once daily orally is tolerated and safe, in children (aged 7 through 11 years) and adolescents (aged 12 through 17 years) with major depressive disorder.


Eligibility criteria:
inclusion criteria: * male / female outpatients 7 to 17 years of age diagnosed with major depressive disorder (mdd). (must have a children's depression rating scale-revised \[cdrs-r\] with a total score greater than or equal to 40 at visit 1, visit 2, and visit 3 and a clinical global impressions of severity \[cgi-severity\] rating of greater than or equal to 4 at visit 1, visit 2, and visit 3.) * female patients must test negative on a pregnancy at visit 1. exclusion criteria: * have a serious or unstable medical illness, psychological condition, clinically significant laboratory or electrocardiogram (ecg) result, hypersensitivity to duloxetine, or to its inactive ingredients, frequent or severe allergic reactions to multiple medications, uncontrolled narrow-angle glaucoma, acute liver injury (for example, hepatitis) or severe cirrhosis (child-pugh class c) that in the opinion of the investigator would compromise participation in the study or be likely to lead to hospitalization during the course of the study. * have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, pervasive development disorder or borderline personality disorder, as determined by the investigator. * have a significant suicide attempt within 1 year of visit 1 or have a score of 5 or greater on item 13 (suicidal ideation) on the cdrs-r at visit 1, visit 2, or visit 3, or are currently at risk of suicide in the opinion of the investigator. * have a weight less than 20 kg at any screening phase visit. * have previous exposure to duloxetine * female patients who are either pregnant, nursing or have recently given birth.
treatment with continuous sub-cutaneous insulin infusion via a portable pump versus discontinuous insulin infusion via multiple-injections in type 2 diabetes

Conditions: Patient With Type 2 Diabetes Treated With Insulin Using a Baseline/Bolus Strategy

Summary: this is an open multicentre, randomized study to compare two treatment arms. one arm called "intensification of multiple injections" in which the patient will receive one supplementary injection of levemir®: that is to say 5 injections per day, and an arm called "continuous insulin infusion" via an external pump with apidra®. in the pump arm: a favorable effect in terms of improved insulin sensitivity, improved metabolic equilibrium, a decrease in the area under the baseline and prandial hyperglycemia curve noted during the continuous glycemia recording; an improvement in quality of life compared with treatment using multiple injections.


Eligibility criteria:
inclusion criteria: * persons who have provided written informed consent * age \> 18 years * patients with type 2 diabetes treated with insulin using a basal / bolus strategy for at least 6 months * doses of insulin \> 0.7 u / kg / d * hba1c ≥ 7.5 % * without oad for at least 4 weeks (sulfamides, incretines, glinides, acarbose) except metformin * bmi ≥ 28.5 kg / m2 * diabetes diagnosed for at least 10 years * patients able to monitor themselves and manage an insulin pump. exclusion criteria: * patients treated with glitazones during the 3 months preceding inclusion * patients with proliferative ischemic retinopathy not treated by laser * bmi \< 28.5 kg / m2 * presence of implantable material ( ci mri ) * pacemaker ( ci mri ) * pregnancy, breast feeding * medically significant physical or psychiatric inability, patients under guardianship or wards of court * the practice of violent sports * poor conditions of hygiene * professional environment of extreme cold or heat.
total contact soft cast in diabetic foot ulcers

Conditions: Diabetic Foot Ulcer; Diabetes Mellitus; Foot Ulcer; Foot Ulcer, Diabetic; Ulcer; Ulcer Foot; Ulcer, Leg; Ankle Ulcer

Summary: to determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.

this study will evaluate whether the use of a total contact soft cast with or without a removable cam boot is as effective in healing diabetic foot ulcers as more commonly used offloading methods. the total contact soft cast will consist of wound dressing of choice to the ulcer and a plantar foot accommodative offloading felt pad for all foot ulcers, with 4x4 gauze pads added to the arch to create a rocker bottom for metarsophalangeal joint (mpjj) and plantar heel ulcers. the next layers will be: * unna boot from mpjs to just below the knee, * sterile kerlix from mpjs to just below the knee * sterile 4 inch kling wrap from the mpjs to just below the knee, * four inch coban from mpjs to just below the knee, and * ace wraps from mpjs to just below the knee removable diabetic cam boot will be used in patients willing and capable of using it. if patient does not want to use diabetic cam boot then surgical shoe or regular shoe would be options.

Eligibility criteria:
inclusion criteria: - any adult with a diabetic foot ulcer exclusion criteria: * allergy to calamine or zinc oxide * inability to have leg wrapped * inability to be seen weekly or as needed * unable or unwilling to consent * prisoners * persons lacking capacity to consent