Kornimate/medical-research-clean huggingface dataset:
koa family: california's obesity prevention project

Conditions: Weight Loss; Diet Habit; Physical Activity; Overweight and Obesity

Summary: the purpose of this study is to learn if a new whole-person lifestyle program improves the health of low-income mothers.

this study will employ a randomized controlled trial (rct) design to test a newly developed obesity reduction program, koa family, among overweight or obese mothers. an exploratory, uncontrolled study will assess its acceptance among normal-weight mothers. koa family consists of a 6-month whole-person lifestyle program (wplp) combined with text messaging and social media support and the opportunity to take part in a neighborhood tree planting campaign. this multi-pronged program is intended to reduce weight in the short-term while building self-empowerment and connections to community resources so that participants can sustain long-term weight loss. koa family will be implemented in select communities in yolo and sacramento counties, california. overweight or obese study participants will be randomized to either an intervention or control group; all normal-weight participants will be assigned to the intervention. all participants will complete a survey and have their height and weight measured at baseline and 3-, 6-, 9- and 12-month follow-up. intervention participants will also take part in a focus group at the 3-month midpoint of the intervention.

Eligibility criteria:
inclusion criteria: * comfortable speaking and reading english * primary caregiver for ≥1 child, aged 3-17, who lives at home * living in a low-income household (at or below 185% of the federal poverty level) * living in the study site catchment area * ability to receive and send text messages * bmi ≥ 25 kg/m2 for rct study * bmi ≥18.5 and \<25 kg/m2 for exploratory study exclusion criteria: * pregnant * breastfeeding * within 2 years postpartum * life-threatening illness * institutionalization (i.e., not free-living in the community) * moderate to severe mental illness * receiving nutrition therapy from a health or health care provider (licensed or unlicensed) * had or are considering bariatric surgery * medically diagnosed eating disorder * taking medication that affects weight * thyroid disease * type 1 or type 2 diabetes without medical clearance from the participant's physician * plans to move away from study site catchment area during the one-year study period

Keywords: nutrition
neuroprotection by magnesium sulfate given to women at risk of very preterm birth

Conditions: Preterm Birth; Periventricular Leukomalacia; Brain Ischemia; Intracranial Hemorrhages

Summary: magnesium is neuroprotective in neonatal animal models of acquired hypoxic-ischemic and/or inflammatory cerebral lesions. it is associated with a significant reduction of perinatal death and cerebral palsy in some observational studies. the objective of the study is to assess if prenatal magnesium sulfate given to women at risk of preterm birth before 33 week's gestation is neuroprotective.

this is a randomized controlled trial at 18 french tertiary hospitals with stratification by center and multiple births in women at risk of preterm birth before 33 week's gestation and without vascular disease of pregnancy. women received 4 g of a 0.1 g/ml magnesium sulfate solution or isotonic serum chloride solution (0.9%). the main outcome measures are rates of mortality up to discharge, of severe white matter injury (defined by the presence of cavitations and/or intraparenchymal haemorrhages on cranial ultrasonographic studies) and of combined death and severe white matter injury. the secondary outcome measures are rates of white matter injury (defined by the presence of cavitations and/or intraparenchymal haemorrhages and persisting hypechogenicities at 15 day intervals on cranial ultrasonographic studies), follow-up at two years of age

Eligibility criteria:
inclusion criteria: * women pregnant with single, twin or triplet very preterm fetuses younger than 33 week's gestational age if birth was expected or planned within 24 hours exclusion criteria: * women with vascular disease of pregnancy * women with severe malformation or chromosomal abnormalities in the fetus * women with hypotension * renal insufficiency * cardiac rhythmic abnormalities * intake of calcium channel inhibitors * digitalis or indomethacin less than 24 hours * persistence of signs of cardiovascular toxicity or tachycardia for more than one hour after cessation of betamimetic intake * myasthenia * emergency c section

Keywords: brain protection white matter injury neurodevelopmental sequelae magnesium sulfate intraventricular hemorrhage
effects of oral glucose and teduglutide on plasma lipoproteins

Conditions: Hyperlipidemias

Summary: some of the fat (triglyceride) from the food humans eat gets stored in the bowel. this triglyceride can then be released into the blood when another meal is consumed or in response to hormones. how the gut hormone glucagon-like peptide-2 (glp-2) and glucose release the triglyceride from the gut is not known. the research team in this study is interested in finding out how teduglutide (a degradation resistant form of glp-2) ang glucose, given together, release stored triglyceride from the gut by evaluating how blood lipoproteins respond to teduglutide in healthy individuals.

the lipoprotein response will be performed in 15 healthy individuals recruited by newspaper advertisements. a member of the study team will explain the study in detail on visit 1, and if the individual is interested in participating, informed consent will be obtained and preliminary screening will occur. on visit 2 participants will receive a high fat liquid meal after an overnight fast. hourly blood samples will be taken for 5 hours, followed by a subcutaneous teduglutide injection and simultaneous glucose drink. following the injection and drink, blood samples will be taken every 15 minutes for the first hour and every 30 minutes for the subsequent 3 hours.

Eligibility criteria:
inclusion criteria: * men and women, aged 18 to 60 years. * body mass index 20 to 27 kg/m2 exclusion criteria: 1. patients with active inflammatory bowel disease 2. patients with pre-existing celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption 3. patients with active bowel malignancy 4. patients with diabetes mellitus or known/ suspected motility disorders of the gut 5. patients with decompensated liver disease 6. patients on ezetimibe or bile acid sequestrants 7. patients who are pregnant or breastfeeding. 8. patients with renal disease. 9. patients on benzodiazepine. 10. unstable cardiac or respiratory disease 11. any changes to medication in the preceding month 12. patients with hypersensitive to revestive or any ingredient, active or a history of the drug within the last 5 years 13. patients with gi malignancy (gi tract, hepatobiliary, pancreatic)

Keywords: intestinal lipoprotein gut peptide chylomicrons glucose
black economic equity movement

Conditions: Mental Health Wellness 1; Health Care Utilization; Financial Hardship; Education, Professional

Summary: the primary goal is to understand the potential impacts of guaranteed income (gi) on black youth and young adults' financial, emotional, and physical well-being. the main question it aims to answer is: what are the impacts of gi on black young adults' investments in their future, mental health and unmet mental and sexual/reproductive health service needs? participants will receive guaranteed income for 12 months and will be offered enrollment in financial capability programs.

the beem project is a randomized controlled crossover trial in which 300 low-income black emerging adults (bea) (aged 18-24) are allocated to receive a $500/month guaranteed income (gi) either during the first twelve months of follow-up (phase i) or to receive gi in the second 12 months of a total of 24 months follow-up (phase ii). all participants will be offered enrollment in financial capability programs (including peer learning circles and individual financial coaching) to bolster gi effectiveness and will also receive a periodic cell phone-based text messages to ensure that bea with unmet health service needs receive referrals. the investigators hypothesize that this intervention will increase bea's investment in their future (education, employment training), improve mental health (depression, anxiety), and reduce unmet mental health and sexual/reproductive health service needs.

Eligibility criteria:
inclusion criteria: * between 18-24 years of age at enrollment * self-identify as african american or black * live in a low-income housing tax credit (lihtc) qualified census tract (qct) in san francisco or oakland. youth who are homeless or marginally housed in san francisco and oakland are also eligible; those who are marginally housed will need a letter from a youth agency that can affirm their marginal housing status. * must not be currently enrolled in another gi project * must have lived in the us for at least 3 years. * must provide informed consent exclusion criteria: * participation in another gi program at the time of enrollment * lived in the united states for less than 3 years * have plans to permanently leave the bay area * being under the influence of alcohol or other substances at the time of enrollment.
silver doped ceramic coated orthopedic implants

Conditions: Implant Site Infection; Implant Infection

Summary: in this study, ce (european conformity) marked, domestic manufactured standard orthopedic implants will be used after silver ha coating with electrospray method in 30 patients requiring hip joint prostheses, intramedullary nails or external fixator in 30 patients to antimicrobial effectiveness. these patients will be tasted for liver and kidney functions and blood and urine silver levels in addition to routine tests such as full blood, complete biochemistry, c-reactive protein, erythrocyte sedimentation rate required in the normal diagnosis and treatment processes,

in this study, considering the differences in bone contact surface area and interactions; hip joint prostheses, intramedullary nails and external fixator implants to be used in 30 patients . ce (european conformity) marked, domestic manufactured standard orthopedic implants will be used in patients after silver ha coating with electrospray method. these patients will be tasted for the evaluation of liver and kidney functions and blood and urine silver levels in addition to routine tests such as full blood, complete biochemistry, c-reactive protein, erythrocyte sedimentation rate required in the normal diagnosis and treatment processes, and will be monitored for at least 12 months. the performance of coating to be applied and any unwanted side effects in normal conditions of use will be evaluated..

Eligibility criteria:
inclusion criteria: 1. men and women between the ages of 18-65 2. patients without heart, lung, renal or hepatic insufficiency 3. patients without epilepsy, cerebrovascular attack or ischaemia 4. patients without antibiotic allergy 5. patients who have low immune defense mechanisms such as malignancy, diabetes mellitus, polytrauma, and open fracture 6. patients using oral or parenteral corticosteroids, methotrexate, cyclosporine or other immunosuppressive drugs - - exclusion criteria: 1. pregnant women 2. patients with another silver implant in their body, such as a silver-coated stent 3. patients with known allergy or hypersensitivity to silver 4. patients with too many antibiotics due to recurrent infections

Keywords: silver hydroxiapatite coating antimicrobial medical device
efficacy and safety of the biosimilar natalizumab pb006 in comparison to tysabri®

Conditions: Relapsing-Remitting Multiple Sclerosis (RRMS)

Summary: this is a multi-center, randomized, parallel arm, double-blind study with a total duration of subjects' participation of 48 weeks. approximately 260 participants with relapsing-remitting multiple sclerosis will be randomized to receive 12 doses of either pb006 or eu-licensed natalizumab.

this is a phase 3 multicenter, double-blind, active-controlled, randomized, parallel-group study to assess the equivalence in efficacy and similarity in safety of biosimilar pb006 compared to tysabri in patients with rrms. all eligible patients will be randomly assigned to one of two treatment groups in a 1:1 ratio, to receive a total of twelve intravenous (iv) infusion of either pb006 or tysabri at a dose of 300 mg at each intravenous (iv) infusion administered with every single one intravenous (iv) infusion administered every 4 weeks of either pb006 or tysabri at a dose of 300 mg starting at visit 1 (week 0) through visit 12 (week 44), for a total of 12 infusions. the end-of-study visit (visit 13, week 48) will be performed 4 weeks after the last infusion

Eligibility criteria:
inclusion criteria: * male and female patients (age ≥18 to 60 years), with relapsing-remitting multiple sclerosis (rrms) defined by the 2010 revised mcdonald criteria * at least 1 documented relapse within the previous year and either ≥1 gde t1-weighted brain lesions or ≥9 t2-weighted brain lesions at screening * kurtzke expanded disability status scale (edss) score from 0 to 5 (inclusive) at screening exclusion criteria: * manifestation of multiple sclerosis (ms) other than relapsing-remitting multiple sclerosis (rrms) * relapse within the 30 days prior screening and until administration of the first dose of study drug * prior treatment with natalizumab, alemtuzumab, ocrelizumab, daclizumab, rituximab, cladribine, or other b- and t-cell targeting therapies * prior total lymphoid irradiation or bone marrow or organ transplantation * patients with john cunningham virus (jcv) index \>1.5 at screening * past or current progressive multi-focal leukoencephalopathy (pml) diagnosis * severe renal function impairment as defined by serum creatinine values \>120 micromol per litre
esmolol versus dexmedetomidine during intracranial procedures

Conditions: Intracranial Aneurysm; Intracranial Neoplasms

Summary: patients undergoing intracranial procedures may experience severe hypertension and tachycardia due to intracranial hypertension and to increased release of adrenaline. preventing perioperative sympathetic activity is of great importance. a common technique is using b-blockers like esmolol, which effectively block perioperative hemodynamic changes during intracranial surgery. a2 agonists, like dexmedetomidine-dex are now being used as a component of a balanced anesthesia during neurosurgical procedures. this study aimed to evaluate whether esmolol or dex attenuates perioperative changes in patients undergoing elective craniotomy with fast track neuroanesthesia.

patients scheduled for elective craniotomy are randomized to receive dex 1γ/kg over 10 minutes following by continuous infusion of dex 0.7γ/kg (group d) or esmolol 500mcg/kg over 5 min following by continuous infusion of 300mcg/kg/min (group e). patients in both groups are subjected to a standardized anesthesia comprising of induction with propofol, fentanyl, rocuronium, and maintained with oxygen-air: 1/1, sevoflurane and bolus fentanyl in order to access the same level of anesthesia (bis 40-50). the hemodynamic variables at various stages of surgery (hr-heart rate, map-mean arterial pressure) and recovery characteristics are also recorded. it is also performed monitoring of cerebral oximetry (invos).

Eligibility criteria:
inclusion criteria: * patients with asa physical status 1-3 * glasgow coma scale:13-15 * hunt-hess: 0-3 exclusion criteria: * patients with asa physical status \>3, * body mass index (bmi) over 30, * indication for rapid sequence induction, * any contraindication for receiving b-blocker, * glasgow coma scale (gcs) \<13, * history of drug abuse, * neurologic deficit or preoperatively foreseen delayed extubation, * preoperative heart rate\<45.

Keywords: esmolol dexmedetomidine opioids
response to influenza vaccination in pediatric oncology patients

Conditions: Hematologic Malignancy; Pediatric Cancer; Transplant-Related Cancer

Summary: influenza infection occurring during oncologic treatment or following hematopoietic cell transplantation (hct) is associated with increased risk of morbidity in the form of lower respiratory tract infection (lrti) and mortality relative to otherwise healthy patients. the study participants have been diagnosed with a hematological malignancy and are eligible to receive the current seasonal influenza (flu) vaccine. primary objective * to determine the feasibility of opening a longitudinal prospective study of iiv immunogenicity in pediatric leukemia patients. * to describe the immunogenicity, as measured by the development of cell- and/or antibody-mediated influenza specific responses 3 to 5 weeks following vaccination, in a cohort of pediatric leukemia patients. secondary objectives * to describe whether an immune response, as measured by development of cell- and/or antibody-mediated influenza specific responses, is detectable 1-2 weeks following vaccination in a cohort of pediatric leukemia patients. * to describe the durability of immunogenicity by measuring cell - and antibody- mediated influenza specific responses at 6 months and 1 year following vaccination in a cohort of pediatric leukemia patients. exploratory objectives * to estimate the clinical effectiveness of influenza vaccine in this cohort by monitoring for the development of clinical diagnosis of influenza in the cohort of enrolled pediatric oncology patients. * to correlate results of immune cell frequency in blood, as measured by complete blood count with differential, with development of an immune response to iiv.

this is a prospective, 2-stage, non-therapeutic study to characterize the immunogenicity of influenza vaccination among pediatric oncology patients at st. jude. the first stage of the study will consist of a feasibility phase to assess the feasibility of opening a longitudinal prospective study of iiv immunogenicity in pediatric leukemia patients. the second stage will assess the immunogenicity of iiv among pediatric leukemia patients in a larger samples size. the investigator will collect about one teaspoon of blood from the study participant up to 6 times over a year for a total of 6 teaspoons a year. the investigator will also collect some information about the study participant's underlying condition, flu testing and overall health from the medical record during this time.

Eligibility criteria:
inclusion criteria: * patient ≤ 18 years old at the time of consent receiving care at st. jude children's research hospital * diagnosed with a hematological malignancy * eligible to receive the current seasonal influenza vaccine exclusion criteria: • previously received at least one dose of the current seasonal influenza vaccine.

Keywords: influenza infection
therapeutic effects of hydrogen on steroid-refractory/or steroid-dependent cgvhd

Conditions: Chronic Graft-versus-host Disease

Summary: this study suggested that hydrogen has a potential as an effective and safe therapeutic agent on cgvhd.

the investigators will evaluate clinical response rate, time to treatment failure (ttf), overall survival (os), and toxicity in cgvhd patients.

Eligibility criteria:
inclusion criteria: * written informed consent * male * not pregnant female * patients \<65 years old * diagnosis of cgvhd steroid refractory (no response after prednisone ≥1mg/kg ) or steroid-dependent cgvhd (had an initial response followed by a cgvhd flare upon steroid taper) * patient intolerant to steroid therapy exclusion criteria: * patients with stable disease, not well controlled by the current treatment * pregnancy * hiv positive * severe liver or renal impairment: serum creatinine \>2.5 mg/dl; serum bilirubin\>2.5 mg/dl (without evidence of hepatic cgvhd) * uncontrolled malignancies including the persistence of the underlying malignancy before the allogeneic transplantation and the relapse of hematopoietic malignancy * any other investigational agents administered within last four weeks * cardiac insufficiency (\>grade ii, new york heart association classification) * inability to comply with medical therapy or follow-up
safety and immunogenicity of venezuelan equine encephalomyelitis vaccine (vee c-84) as a booster to vee tc-83

Conditions: Venezuelan Equine Encephalomyelitis

Summary: the study is designed to assess the safety and immunogenicity of venezuelan equine encephalomyelitis vaccine, inactivated, dried, c-84, tsi gsd 205, as a booster vaccination.

study objectives: primary: to assess safety of venezuelan equine encephalomyelitis vaccine, inactivated, dried, c-84, tsi gsd 205, as a booster vaccination as a single dose or a three-dose series, and to assess immunogenicity of venezuelan equine encephalomyelitis vaccine, inactivated, dried, c-84, tsi gsd 205, as a booster vaccination as a single dose or a three-dose series secondary: to assess incidence of vee infection in c-84 boosted personnel.

Eligibility criteria:
inclusion criteria: * at least 18 years old. * vee prnt80 \< 1:20 before immunization. * (females) negative urine pregnancy test on the same day before vaccination. not planning pregnancy for 3 months. * actively enrolled in the sip. * at risk for exposure to virulent vee virus (with up-to-date risk assessment). * previous tc-83 vaccination * up-to-date (within 1 year) physical examination/tests. * sign and date the approved informed consent. * willing to return for all follow-up visits. * agree to report adverse event (ae) up to 28 days after vaccination. exclusion criteria: * over age of 65 years * clinically significant abnormal lab results including evidence of hepatitis c, hepatitis b carrier state, or elevated liver function tests. * history of immunodeficiency or current treatment with immunosuppressive medication. * (females) currently breastfeeding. * confirmed human immunodeficiency virus (hiv) titer. * any known allergies to components of the vaccine. * a medical condition that in the judgment of the principal investigator (pi) would impact subject safety (i.e-vaccination and or exposure to another alphavirus). * administration of any vaccine within 28 days of c-84. * any unresolved aes resulting from a previous immunization.

Keywords: encephalitis, viral infections, neurologic diseases, alphavirus infections, vee
informativeness to digital rectal examination

Conditions: Colon Cancer; Upper Rectum Cancer; Diverticulitis; Rectal Bleeding; Hernia

Summary: digital rectal examination is an act clinically performed daily by physicians and surgeons. it remains the key diagnostic test and directs the therapeutic management of cancer of the lower and middle rectum. it can be done in two main positions: lateral decubitus, and supine. however, no randomized study in colorectal surgery is not interested in evaluating the best position to perform a full rectal exam.


Eligibility criteria:
inclusion criteria: * colon or upper rectum cancer operated or not * recurrent of colon or upper rectum cancer * rectal bleeding * hernia exclusion criteria: * woman * paraplegic man * bedridden patient * current or previous pelvic radiotherapy * history of prostatectomy * emergency

Keywords: rectal examination colorectal cancer