Kornimate/medical-research-clean huggingface dataset:
core temperature variations during midazolam vs propofol sedation for neuraxial anesthesia

Conditions: Body Temperature Changes; Anesthesia

Summary: the present study is a pilot study aiming to compare the variation in core temperature (measured through the non-invasive device spot-ontm3mtm) in patients submitted to neuraxial anesthesia for orthopedic procedures, during sedation with midazolam vs propofol.

in this study the investigators will select 20 patients scheduled for orthopedic surgery of the knee or foot with neuraxial anesthesia (subarachnoid or sequential blocks). sedation for these procedures with midazolam or propofol is daily practice in the investigators' department. so the patients will be randomized, through the envelope method, in 2 groups with 10 patients each: "midazolam group" and "propofol group". in the "midazolam group" the investigators will administer 0,05mg/kg of midazolam, being 2/3 administered before the neuraxial block and 1/3 after. in the "propofol group" the investigators will administer 0,033mg/kg of midazolam before the neuraxial block, and immediately after installation of the block the investigators will start a propofol target-controlled infusion (tci) pump (schnider model) with an effect concentration set at 1mcg/ml. this pump will be turned off at the end of the surgery. the neuraxial block will be performed inside the operating room and preferentially in lateral decubitus. the choice of drug and dosage used for the block will be left to the anesthesiologist, to mimetize day-to-day practice. the limit dermatome of sensory block will be noted. the investigators will administer to every patient: cefazolin 2g iv bolus, ketorolac 30 mg iv bolus, pantoprazole 40 mg iv bolus, paracetamol 1g iv perfusion (initiated 30 minutes before the end of surgery). central temperature will be monitored with the spotontm3mtm device from entering till leaving the operating room, through a sensor placed in the patient's forehead. room temperature will be kept at 17 degrees celsius (ºc). patients will be warmed with a underbody forced-air blanket (bairhuggertm3mtm) set at 38ºc and maximal flow, initiated after performing the neuraxial block and stopped right before leaving the operating room. data will be analyzed with the statistical package for the social sciences (spss) program.

Eligibility criteria:
inclusion criteria: * scheduled for orthopedic surgery of the foot or knee * indication to neuraxial anesthesia * surgery duration \> 30 minutes exclusion criteria: * preference for deep sedation * preference for no sedation * kidney failure * hepatic failure * no signed informed consent
chromium and insulin action

Conditions: Type 2 Diabetes

Summary: the effect of chromium to improve glucose levels in diabetes is controversial. the hypothesis of the study was to evaluate the effect of supplementing the diet of individuals with type 2 diabetes with chromium picolinate and assessing the effect on blood glucose levels and insulin sensitivity

the primary clinical strategy to improve metabolic control in patients with type 2 diabetes consists of lifestyle modification combined with pharmacologic intervention. however, alternative strategies, e.g. nutritional supplementation with over-the-counter agents, are extensively practiced by a large number of patients and are frequently undertaken without first informing the medical provider. unfortunately, considerable controversy exists regarding use of dietary supplements in subjects with diabetes because efficacy data for many of the supplements consists of only uncontrolled studies and anecdotal reports. as such, there is a paucity of data in humans in regard to the effect of most commercially available supplements to improve metabolic abnormalities. one supplement that has attracted considerable clinical interest is chromium (cr). however, routine use of cr in subjects with diabetes is not currently recommended. in part, the controversy surrounding cr supplementation stems from the lack of definitive randomized trials, the lack of "gold standard" techniques to assess glucose metabolism in the studies reported, the use of differing doses and formulation , and the study of heterogeneous study populations (4). as such, conflicting data has been reported that has contributed greatly to the confusion among healthcare providers concerning cr supplementation. in order to provide a comprehensive clinical evaluation of cr, we conducted a randomized, double-blinded, placebo-controlled trial in subjects with type 2 diabetes, and over a 10 month period of observation, used established techniques to assess changes in insulin sensitivity, body composition and glycemic control.

Eligibility criteria:
inclusion criteria: type 2 diabetes on diet therapy or low dose oral agent - exclusion criteria: significant cardiovascular, hepatic or renal disease -

Keywords: insulin glucose body weight chromium
paravertebral block for percutaneous radiofrequency ablation of liver lesions

Conditions: Liver Tumor

Summary: percutaneous radiofrequency ablation of liver lesions causes patients acute pain during and after the procedure. during the procedure patients need deep sedation and cannot be collaborative. furthermore post-operative analgesia is necessary. the aim of this study is to evaluate if the ultrasound-guided paravertebral block (tpvb)with a single injection can provide anesthesia and post-operative analgesia in these patients.

the purpose of this study is to evaluate if single injection tpvb, ultrasound guided, ens assisted, is advantageous compared to deep sedation (ds)in patients undergoing percutaneous radiofrequency ablation of liver lesions with respect to post-operative analgesia (at rest and in movement)and vomiting. furthermore we collect data on operator and patient satisfaction. in this study patients are randomly divided into two groups (20 patient each): tpvb and ds. in tpvb group the block is performed in lateral position at level of t7 with bupivacaine 5mg/ml. in ds group the procedure is conducted under local and intravenous anesthesia, and a post-operative analgesia is assigned. data on patient, on procedures (duration, number and position of lesions etc.), complications with the anesthesiological technique are collected. the intensity of post-operative pain is assessed at 3-6-12 and 24 hours after procedure in both group using vrs pain scale at rest and in movement. any concomitant event like nausea, vomiting, respiratory complications etc are recorded.

Eligibility criteria:
inclusion criteria: * written consent asa i-iii exclusion criteria: * allergy to local anesthetic infection in the site of planned injection
effect of nmn (nicotinamide mononucleotide) on polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of the study is to understand the effect of nicotinamide mononucleotide (nmn) on patients with polycystic ovary syndrome.

this study aims to evaluate the effects of nmn on reproductive endocrine and metabolism, chronic inflammation, and reproductive outcomes in women with polycystic ovary syndrome (pcos), and to explore its underlying mechanisms to provide the intervention strategies for pcos.

Eligibility criteria:
inclusion criteria: 1. individuals who are 20 to 40 years old, planning to become pregnant or infertile women. 2. individuals who are diagnosed as pcos according to the revised 2003 rotterdam diagnostic criteria: if 2 out of 3 criteria are met: 1) oligo- and/or anovulation; 2) clinical and/or biochemical signs of hyperandrogenism; 3) polycystic ovaries, and exclusion of other aetiologies (congenital adrenal hyperplasia, androgen-secreting tumors, cushing's syndrome). 3. individuals who can insist on continuous monitoring in the outpatient clinic. 4. individuals who are not participating in other research projects currently or 3 months before the intervention. exclusion criteria: 1. individuals who suffering from other diseases that may cause hyperandrogenism and ovulation abnormalities. 2. individuals who are during pregnant, lactation or menopause. 3. individuals who currently receiving weight-loss drugs or surgery or within the past 2 months. 4. individuals who take niacin, nicotinamide, or other vitamin b3-related supplementation currently or within the past 2 months. 5. individuals who need regular medication to treat chronic diseases such as diabetes, hypertension, gout, hyperuricemia, etc. 6. use of medications that affect hormone levels, appetite, carbohydrate absorption, and metabolism within the past 2 months. 7. individuals with severe liver diseases or kidney disease that are ineligible to participate in the study. 8. a medical history of severe cardiovascular and cerebrovascular diseases. 9. individuals who currently suffer from severe gastrointestinal diseases or undergo gastrointestinal resection that may affect nutrient absorption. 10. individuals who drink more than 15g of alcohol per day or have a smoking habit. 11. individuals who need drug treatment for any mental illness such as epilepsy and depression. 12. cancer patients. 13. individuals who suffer from infectious diseases such as hepatitis b, active tuberculosis, aids, etc.

Keywords: polycystic ovary syndrome reproductive endocrine metabolism gut microbiota nmn
correlation study of isotype switching and neutralizing capacity to the covid-19 variants strain

Conditions: COVID-19

Summary: the level of neutralizing antibody was detected by using the constructed pseudovirus covid-19 variant at baseline , 1 month , 6 months and 12 months after primary vaccination, within 15 days after booster immunization at 12 months . and the ability of igg subclasses to neutralize and cross immunization of variant strains was analyzed.

in 150 individuals who received primary and booster covid-19 inactivated vaccine, the neutralization ability of antibodies against covid-19 mutant after primary and booster immunization was evaluated by constructing pseudotyped sars-cov-2 variants. the contribution and influence of igg subclasses on neutralization capacity were assessed by elisa assay. all participants were recruited aged between 18 and 59 years old. every participant was familiarized with the aim of the study and asked to sign an informed consent agreement and was required blood sampling at the day 0 of first dose vaccine and 1 month, 6 months after 2nd dose of primary immunization. all participants had received 1 dose of booster immunization at 12 months after fully primary vaccination. then 150 people were divided into four groups, blood samples were taken on days 0,3,7,10 and 14 to detect neutralizing antibodies and igg subclasses separately. every sample was detected sars-cov-2 variants strain alpha, beta and delta neutralizing antibody, and rbd-igg1, igg2, igg3, and igg4. every individual was conducted a detailed analysis correlation of isotype switching, neutralizing antibody titer and cross immunity against covid-19 variants after primary and booster vaccination.

Eligibility criteria:
inclusion criteria: * between the ages of 18 and 59 * healthy * no vaccination with covid-19 before become participant * agreed to take a blood sample exclusion criteria: * who cannot take the covid-19 vaccine due to some personal reasons * history of sars-cov, sars-cov-2, or middle east respiratory syndrome infection * high-risk epidemiology history within 14 days before enrolment (eg, travel or residence history in communities with case reports, or contact history with someone infected with sars-cov-2) * axillary temperature of more than 37·0℃ * history of allergy to any vaccine component.

Keywords: cohort study isotype switching neutralize antibodies covid-19 variants strain
achieving rapid, safe and sustained glucose control in adolescents with suboptimally controlled type 1 diabetes using advanced hybrid closed loop systems

Conditions: Diabetes Mellitus, Type 1

Summary: the rational of this study is to assess if ahcl systems are able to achieve a better metabolic control (better glucometric data) after 2 weeks, 1 months. 6 months and 1 year after the start, in adolescents in not good glycaemic control.


Eligibility criteria:
inclusion criteria: * all children met the american diabetes association (ada) criteria for t1d diagnosis with a current hba1c of ≥8.5%. * age range 12-17 yrs old exclusion criteria: * patients with a diagnose of genetic form of diabetes will be excluded.
health in individuals with a spinal cord injury: a prospective study

Conditions: Spinal Cord Injuries

Summary: individuals with a spinal cord injury need to exercise regularly to prevent the decline of health that results from a sedentary lifestyle. the purpose of this investigation is to examine the effects of a pre-existing exercise program and respiratory training on measures of health and quality of life in individuals who elect to participate in an existing 8-week supervised exercise program.

the life expectancy of individuals with spinal cord injuries (sci) has increased over the past decade. yet, this population continues to present with an increased risk of a number of secondary health conditions, many of which occur sooner and at a higher rate than the normative population. as a program established to address this post-rehabilitative exercise participation necessity, it is determined that the spinal mobility fitness program, if found effective, can have vast positive effects in addressing aspects of health, function fitness, and overall quality of life for individuals with sci. in addition to the need for exercise respiratory training is an important component of prevention of illness in individuals with a spinal cord injury. genitourinary, skin disease and respiratory disorders are the top 3 reasons. developing effective respiratory training programs in addition to exercise programs are critical for the prevention of illness and enabling a high quality of life. pneumonia and septicemia are the two leading causes of decreased life expectancy in this population. adding respiratory training to the spinal mobility program would be an appropriate intervention to further prevent health decline in these individuals.the spinal mobility course runs for eight weeks two times each year for 8 sessions for 4 to 5 hours each on saturdays. additionally individuals can participate in spinal mobility fitness training up to 3 times a week for one to three hours.

Eligibility criteria:
inclusion criteria: * 18 years and older * individuals with spinal cord injury * medically stable * able to participate in the spinal mobility program exclusion criteria: * individual with spinal cord injury who is medically unstable * cannot participate in an exercise program

Keywords: exercise respiratory training
duloxetine versus duloxetine plus non-drug therapy for depression

Conditions: Depression

Summary: the primary purpose of this study is to determine if duloxetine plus non-drug intervention is more effective than duloxetine alone in patients with depression.


Eligibility criteria:
inclusion criteria: * male or female outpatients at least 18 years of age who, in the opinion of the investigator, meet criteria for major depressive disorder (mdd) as defined by diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) criteria. exclusion criteria: * have a previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders. * serious medical illness or clinically significant laboratory abnormalities that, in the judgment of the investigator, are likely to require medication/ intervention/hospitalization during the course of the study. * abnormal thyroid stimulating hormone (tsh) concentration (outside the reference range of the performing laboratory). note: patients diagnosed with hyperthyroidism or hypothyroidism who have been treated on a stable dose of thyroid supplement for at least the past 3 months, have medically appropriate tsh concentration, and are clinically euthyroid are allowed. * moderate or severe hepatic impairment, including but not limited to acute liver injury (such as hepatitis), and severe (child-pugh class c) cirrhosis.
darbepoetin alfa administered once every 4 weeks in the treatment of subjects with anemia of cancer

Conditions: Anemia

Summary: the purpose of this trial is to demonstrate benefit with respect to hematopoietic response in subjects with anemia of cancer randomized to darbepoetin alfa once every 4 weeks.


Eligibility criteria:
eligibility criteria: - subjects with non-myeloid malignancies - subjects can not be on chemotherapy - anemia of cancer - eastern cooperative oncology group (ecog) status of 0 to 2 - hemoglobin less than or equal to 11.0 g/dl - adequate renal and liver function - written informed consent

Keywords: non-myeloid malignancies myeloma anemia of cancer
trial to evaluate safety, tolerability, and parmacokinetics of aln-ttr02 in healthy volunteer subjects

Conditions: TTR-mediated Amyloidosis

Summary: the purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of aln-ttr02 in healthy volunteer subjects.


Eligibility criteria:
inclusion criteria: * body mass index must be between 18.0 kg/m2 and ≤ 31.5 kg/m2; * non-smokers for at least 3 months preceding screening; * females subjects must be of non-childbearing potential e.g., post-menopausal or pre-menopausal with surgical sterilization; * males agree to use appropriate contraception; * medical history must be verified by either a personal physician or medical practitioner as appropriate; * willing to give written informed consent and are willing to comply with the study requirements. exclusion criteria: * known hepatitis b surface antigen (hbsag), hepatitis b virus (hbv), hepatitis c virus (hcv) or human immunodeficiency virus (hiv) infection * multiple drug allergies or know sensitivity to oligonucleotide * history of drug abuse and/or alcohol abuse * receiving an investigational agent within 3 months prior to study drug administration * subjects with safety laboratory test results deemed clinical significant by the investigator; * received prescription drugs within 4 weeks of first dosing * subjects who have donated more than 500 ml of blood within the 3 months prior to aln-pcs02 or placebo administration; * subjects who have used prescription drugs within 4 weeks of first dosing * considered unfit for the study by the principal investigator * employee or family member of the sponsor or the clinical study site personnel

Keywords: attr
striving to quit-wisconsin tobacco quit line

Conditions: Smoking Cessation; Smoking; Nicotine Dependence

Summary: this study is designed to test the hypotheses that incentives can increase both participation in smoking cessation treatment and resulting cessation rates when they are offered to medicaid badgercare plus members.

aim 1: to determine the extent to which contingent financial "treatment incentives" (i.e., incentives for biochemical verification visits, treatment engagement, and abstinence) versus "attendance incentives" (i.e., incentives for only attending the biochemical verification visits), increase rates of smoking cessation . participants will be badgercare plus tobacco users who enroll in wisconsin tobacco quit line (wtql) services. aim 2: to determine the extent to which treatment incentives vs. attendance incentives increase rates of engagement in smoking cessation treatment through the wtql when offered to badgercare plus members who smoke. aim 3: to determine the cost-effectiveness of the smoking cessation program when paired with treatment incentives and when paired with attendance incentives. aim 4: to identify moderating and mediational effects regarding the clinical benefit of incentivized smoking treatment aim 5: to determine the reach of an incentivized smoking cessation treatment that depends upon primary care clinic staff, a fax-to-quit referral mechanism and a state quit line.

Eligibility criteria:
inclusion criteria: * enrollment in wisconsin medicaid (badgercare plus) * resides in study area (one of 25 counties) * member of participating hmos * 18 or older * english speaking * has smoked daily (at least 5 cigarettes each day) over the last week * willingness to attend visits at his/her pcc (primary care clinic) every 6 months (3 times over a 12 month period), provide urine samples, and complete follow-up phone calls * willingness to inform the wtql as to any change in address, phone number, clinic attended, or health plan. exclusion criteria: * not enrolled in wisconsin medicaid (badgercare plus) * not reside in study area * not a member participating hmos * less than 18 years of age * not english speaking * does not smoke daily (at least 5 cigarettes each day) over the last week * not willing to attend visits at his/her pcc (primary care clinic) every 6 months (3 times over a 12 month period), provide urine samples, and complete follow-up phone calls. * not willing to inform the wtql as to any change in address, phone number, clinic attended, or health plan.
danish lung cancer screening trial (dlcst)

Conditions: Lung Cancer

Summary: the trial is a randomised trial comparing annual ct screening for lung cancer with no screening in 4104 smokers and former smokers between the age of 50 and 70 years. the goals are: 1) to evaluate if annual ct screening can reduce lung cancer mortality by more than 20 % (in collaboration with the nelson trial in the netherlands, 2) to evaluate psychological effects of screening including the effects of false positive diagnoses, and 3) to evaluate possible effects on smoking behaviour. the trial is funded in full by the danish ministry of interior and health.

the trial is a parallel randomized controlled trial comparing either a yearly low dose ct scan or no screening. it is scheduled to enroll 4000 smokers and former smokers, and the study is scheduled to last 5 years, i.e. an initial (prevalence) screening is followed by 4 annual (incidence) screenings. in addition the following investigations are done: a prospective, longitudinal questionnaire assessment of enrolled participants who have received a false positive diagnosis. the questionnaire will focus on the consequences of receiving a false positive diagnosis. answers from enrolled subjects who have received a false positive diagnosis will be compared to their own "baseline" responses, and responses from subjects who have received a negative result of their own low-dose ct scans all participants will annually be questioned regarding smoking habits, their motivation for cessation of smoking and will be advised to refrain from smoking to assess the effect of participation in a screening protocol for lung cancer on cessation of smoking. socioeconomic consequences of screening for lung cancer will be assessed by longitudinal registration of costs and benefits (e.g. morbidity, hospitalization, gp consultations etc. assess the value of pet scanning when screening for lung cancer.

Eligibility criteria:
inclusion criteria: * smoking exposure \> 20 pack years * quit smoking \< 10 years * fit to undergo treatment * pulmonary function test \> 30 % of expected (fev1) exclusion criteria: * bodyweight \> 130 kg * formely treated for lungcancer, breastcancer, melanoma or hypernephroma. * serious co-morbidity with life expectancy below 10 years. * treated for other malignant diseases within the last 5 years. * treatment for pulmonary tuberculosis within the last 2 years.

Keywords: lung cancer ct scan screening