Kornimate/medical-research-clean huggingface dataset:
screening for youth alcohol and drug use: a study of primary care providers

Conditions: Substance Related Disorders

Summary: this study evaluates the implementation and effectiveness of two modalities of screening, brief intervention and referral to treatment (sbirt) to reduce adolescent alcohol and other drug (aod) use in a large pediatrics clinic.

health systems have not implemented screening, brief intervention and referral to treatment (sbirt) for adolescents despite research demonstrating its effectiveness. based on prior research that identified barriers to aod screening for adolescents in pediatric primary care (pc) and a pilot study that found sbirt was feasible, well-received and promoted referrals to and initiation of specialty treatment, the current research application proposes to randomize 45 primary care physicians (pcps) in the pediatrics clinic of a medical center within a large, managed care health system, kaiser permanente northern california, to three arms - 1) usual care; 2) sbirt delivered by pcps; and 3) sbirt delivered by behavioral medicine specialists (bms). the study objective is to compare the implementation, effectiveness and cost-effectiveness of sbirt for adolescents in pc in the three study arms. patients will complete evidence-based screening and aod assessment measures which have been embedded in the health plan's electronic medical record (emr). a mixed model will be used to compare implementation outcomes (rates of screening and identification, brief intervention, referral to chemical dependency treatment and treatment initiation), and effectiveness (patient outcomes of aod use and abstinence) at 12 months. the model accounts for the intra-class correlations across patients within providers. cost-effectiveness relative to implementation and patient outcomes will be examined. barriers and facilitators of implementation, and feasibility via qualitative interviews with clinicians and administrators will be examined as well. the study is significant in that it examines issues that must be addressed to spur widespread adaptation of sbirt. the proposed interventions are highly feasible in the current environment of health reform due to increased resources and training to federally qualified health centers and private health plans. it is innovative in using the emr to change clinical practice and systematically integrate aod in pc, and as a platform for collecting research data.

Eligibility criteria:
there are two study populations as described below thus the large age limit range. inclusion criteria: * all adolescent primary care providers at the pediatric primary care clinic will be included. * all adolescent patient electronic records, ages 12-18, at the pediatric primary care will be examined. exclusion criteria: * any adolescent primary care providers not practicing at the pediatric primary care clinic research site will be excluded. * adolescents electronic records who are not part of the research site pediatric clinic will be excluded.
effect of moderate caloric restriction on glomerular growth after kidney transplantation

Conditions: Kidney Transplant; Complications; Glomerular Disease; Weight Gain; Kidney Transplant

Summary: one possible reason that weight gain after transplant may interfere with new kidney function is due to the enlargement of a kidney structure called the glomerulus. the researchers believe that modest caloric intake reduction (cir) early after kidney transplantation can reduce the enlargement (hypertrophy) of the glomerulus associated with kidney transplantation and may improve long term allograft survival, by reducing glomerular hypertrophy mediated progressive glomerulosclerosis.


Eligibility criteria:
inclusion criteria: * recipients of kidney transplants where a post perfusion biopsy is obtained * body mass index between 25-30 kg/m2 at the time of randomization * non-diabetic * have a smart phone or active internet connection at home exclusion criteria: * patients on dual anti platelet agents or are on oral anti coagulation medication * patients who have had bariatric surgery

Keywords: caloric intake reduction dietician
dexmedetomidine in seizure patients

Conditions: Seizure Disorders

Summary: dexmedetomidine is an alpha-2 agonist commonly used during neurosurgery due to its unique properties as a sedative and anxiolytic with minimal respiratory depression. neurosurgical patients frequently come to the operating room on anticonvulsant therapy with a history of seizures. the investigators clinical experience suggests that these patients are resistant to the sedative effects of dexmedetomidine. this effect may represent a pharmacokinetic interaction between the anticonvulsant medications and dexmedetomidine or the higher dexmedetomidine dose requirement could result from abnormal pharmacodynamics due to the underlying seizure disorder. the investigators study aims to investigate the pharmacokinetic and pharmacodynamic differences of dexmedetomidine between patients receiving and not receiving enzyme-inducing anticonvulsant therapy and to identify a potential mechanism for these differences.


Eligibility criteria:
inclusion criteria: * age 18-65, bmi 20-25 kg/m2 * anticonvulsant group: diagnosis of seizure disorder taking carbamazepine or phenytoin for a minimum of 2 weeks * control group: healthy volunteers taking no medications exclusion criteria: * positive urine pregnancy test or lactating * history of allergy to dexmedetomidine or alpha -2 agonists * history of liver, renal or thyroid disease * history of cardiovascular disease including history of arrhythmia or congestive heart failure * history of drug or alcohol abuse

Keywords: epilepsy dexmedetomidine seizure
the effect of probiotics on symptoms of infantile colic

Conditions: Colic

Summary: the aim of this study is to evaluate the effects of a probiotic formulation on the daily crying patterns of infants. it is hypothesized that participants given the probiotic formulation will show a significant reduction in daily crying duration compared to participants receiving the placebo.

participants diagnosed with symptoms of infantile colic will be recruited to participate in this randomized, double-blind, placebo-controlled, two-arm parallel study. eligible participants will be enrolled in this study for 6 weeks, and will undergo a 1-week run-in baseline period followed by a 4-week interventional period, then a 1-week follow-up period. the study will consist of 7 visits (v0 to v6): 4 in-person visits that alternate with 3 phone calls.

Eligibility criteria:
inclusion criteria: 1. healthy male or female. 2. age ≤ 8 weeks old. 3. diagnosis of infantile colic according to the rome iv criteria. infants must show cry or fuss behaviour for 3 or more hours per day, during 3 or more days in 7 days. 4. exclusively breastfeeding and planning to breastfeed for duration of study. 5. with a written informed consent signed by the father, mother, or legal guardian, and with expressed or implied consent of the other parent. 6. with parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits and telephone calls. exclusion criteria: 1. birthweight \< 2500 g. 2. gestational age \< 37 weeks. 3. apgar score at 5 minutes \< 7. 4. partially or fully formula fed infants, with the exception of the first 4 days after birth. 5. stunted growth/weight loss (\< 100 g/week from birth to last reported). 6. gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases or gastrointestinal malformations. 7. fever and/or infectious diseases, or current systemic infections, or history of congenital infections. 8. genetic diseases and chromosomal abnormalities. 9. metabolic diseases or pancreatic insufficiency. 10. immunodeficiency. 11. neurological diseases. 12. suspected or confirmed food allergies and intolerances. 13. use of probiotics, prebiotics, antibiotics, or gastric acid inhibitors by the infant at any time from birth to the moment of screening. 14. use of anti-colic medication at any time from birth to the moment of screening. 15. use of probiotic supplements by the mother between the birth of their infant and the moment of screening. 16. currently enrolled in another clinical study or having participated in another clinical trial from birth to the moment of screening.

Keywords: infantile colic crying time probiotics sleep duration
real-time optimized biofeedback utilizing sport techniques

Conditions: Knee Injuries

Summary: this study will identify the most optimal, focused approach for biofeedback in adolescent females at high risk for anterior cruciate ligament (acl) injury. a six-week randomized, pre/post-testing design will be used to identify biofeedback training effects. the investigators will also determine the effects of hip strategy on retention of decreased knee abduction load with focused biofeedback. a six-month follow-up design will be used to test retention of real-time biofeedback intervention.

real-time optimized biofeedback utilizing sport techniques (robust) represents an innovative new approach to reduce traumatic anterior cruciate ligament (acl) injuries. over the last four decades, these debilitating injuries have occurred at a 2 to 10-fold greater rate in female compared to male athletes with the highest prevalence occurring between the ages of 16-18 years. as a consequence, there is a large population of females that endure significant pain, functional limitations and knee osteoarthritis (oa) as early as 5 years after the initial unintentional injury. to reduce the burden of oa, the national public health agenda for osteoarthritis recommends both expanding and refining evidence-based prevention of acl injury. there currently is a gap in knowledge regarding how to maximize the effectiveness of injury prevention training in young female athletes. the long-term goal is to reduce acl injuries in young female athletes. the objective of this application is to increase the efficacy of biofeedback training to reduce the risk of acl injury. this proposal tests the central hypothesis that biofeedback methodology is needed to maximize the effectiveness of neuromuscular prophylactic interventions. the rationale supporting this proposal is that once the proposed research is completed, health professionals will be more successful at preventing devastating acl injuries through properly optimized and targeted biofeedback training for young at-risk females. this research is innovative because it represents a new and substantive departure from the status quo by recognizing the need to optimize the application of biofeedback training. the work will contribute clinically relevant data in support of a future more robust clinical trial. the proposed research will be significant because it will lead to reduced rates of acl injury in young females. reduction of female injury rates to equal that of males would allow females annually to continue the health benefits of sports participation and avoid the long-term complications of osteoarthritis, which occurs with a 10 to 100-fold greater incidence in acl-injured than in uninjured athletes.

Eligibility criteria:
inclusion criteria: * currently participating on club or school sponsored soccer team exclusion criteria: * current injury that limits participating in sport * male * cannot participate in a 6-week intervention due to time or other constraints

Keywords: anterior cruciate ligament
a peri-intubation oral intervention to reduce oral flora and vap

Conditions: Pneumonia

Summary: the purpose of this study is determine if a single, early dose of chlorhexidine applied within 12 hours after endotracheal tube insertion will reduce the bacteria in the oral cavity and the incidence of pneumonia in trauma victims.

pneumonia is the leading cause of death from nosocomial infections. intubation and mechanical ventilation greatly increase the risk of ventilator associated pneumonia (vap) which is highest in trauma, burn, neurosurgical and surgical patients. oral bacteria have been shown to be responsible for the development of vap since the endotracheal tube provides a pathway for direct entry of bacteria from the oropharynx to the respiratory tract. therefore, reducing the number of microorganisms in the mouth reduces the pool of organisms available for translocation to and colonization of the lung. the tri-service oral health survey showed that military recruits had inferior oral health when compared to their civilian cohorts. further, oral hygiene is likely to deteriorate in combat situations, increasing oral microbial flora. intubation of combat casualties in the future will likely be performed in the field by the emt-b trained combat medic (91w) under adverse conditions. therefore, interventions to reduce oral microbial flora with intubation are attractive to reduce the incidence of vap in combat casualties. this study will test the effect of a single peri-intubation oral intervention on oral microbial flora and the development of vap in traumatic injury. two hundred trauma patients requiring endotracheal intubation will be randomly assigned to either the intervention or control group over an 18-month data collection period. data related to oral microbial flora (measured by semi-quantitative oral culture) and vap (measured by the clinical pulmonary infection score-cpis) will be obtained on study admission, at 24 (oral culture data only), 48 and 72 hours after intubation. the exact wilcoxon two-sample one-sided test will be used to test for difference between groups. cpis data will be compared using an analysis of covariance model. covariates such as baseline oral culture category, trauma-injury and severity score (triss), illness severity (apache iii) and frequency and timing of usual oral care will also be included. the findings from this study will be the first report of an empirically based peri-intubation oral intervention to reduce vap and can be easily applied to the care of traumatic injury in both combat and civilian casualties.

Eligibility criteria:
inclusion criteria: * trauma victim * endotracheal intubation within the past 12 hours * mechanical ventilation exclusion criteria: * diagnosis of pneumonia at the time of intubation * previous endotracheal tube placement in the last 48 hours * burn injuries

Keywords: ventilator-associated pneumonia hospital acquired pneumonia
oral nutritional supplementation in children at risk of undernutrition

Conditions: Undernutrition

Summary: the objective of this randomized, controlled trial is to evaluate the effects of consuming a pediatric oral nutritional supplement (ons) plus dietary counseling for 120 days on anthropometric growth, strength, and nutritional status, compared with dietary counseling alone in undernourished children in the united states.


Eligibility criteria:
inclusion criteria: * child is 36 months - 107 months of age. * child is undernourished as determined by bmi for age z-score or mid-upper-arm circumference z-score * child's caregiver has voluntarily signed and dated an informed consent form (icf), approved by an irb, and provided health insurance portability and accountability act (hipaa) or other applicable privacy regulation authorization prior to any participation in the study. * child's caregiver is willing to abstain from providing non-study oral nutrition supplements during the study period duration. * child's caregiver is able and willing to follow study procedures and record data in parent diaries and complete any forms or assessments needed during the study. * child is willing to consume the study product for the duration of the study, if randomized to intervention group exclusion criteria: * child has a height-for-age z-score ≥ 0. * child is currently drinking an oral nutritional supplement (ons) on a regular basis (≥ 15 days in the past month) * child is participating in another study that has not been approved as a concomitant study by an. * child has been diagnosed with the following: * galactosemia, or an allergy or intolerance to any ingredient found in the study product * acute or chronic infections including but not restricted to respiratory infections, diarrhea, hepatitis b or c, hiv infection or tuberculosis * severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis * neoplastic, renal, hepatic or cardiovascular, hormonal or metabolic disorders, down's syndrome or significant, uncorrected cardiac anomalies that may impact growth * infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or a developmental delay that is considered too severe for participation * disorders of hemoglobin structure, function or synthesis * clinically significant nutritional deficiency requiring specialty nutritional therapy * any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.
an egg based breakfast maintains flexibility in older adults

Conditions: Diabetes; Heart Diseases

Summary: aging is associated with an increased risk for metabolic diseases, such as type 2 diabetes and cardiovascular disease. there is reason to believe that the time of day when specific food groups are eaten affects this risk. the investigators propose that eating foods made up of fat and protein (such as eggs) in the morning for breakfast, rather than foods made up of carbohydrates (such as white-bread toast or sugary cereal) may promote a healthier metabolism. this is because the body is designed to burn fat during times of fasting, such as overnight, during sleep. thus, the body is not prepared to burn sugar early in the morning, when most people eat breakfast. studies with mice have shown that a sugary breakfast meal inhibits the ability of the body to burn fat for the entire day. in contrast, a breakfast meal with more fat enabled the animals to burn fat as well as other fuels throughout the day. the ability to burn fat is thought to minimize risk for obesity, as well as related diseases such as type 2 diabetes and heart disease. the purpose of this study is to determine if, in older adult humans, consumption of a lower-carbohydrate breakfast meal (relative to a higher-carbohydrate meal) is associated with a healthier metabolism.


Eligibility criteria:
inclusion criteria: * • age 55-75 * body mass index 24-29 kg/m2 exclusion criteria: * • current practice of greater than 2h/wk of moderate intentional exercise * uncontrolled diabetes * unwillingness to eat study diets * use of any medication known to affect metabolism * history of eating disorder * difficulty chewing and swallowing solid food * digestive diseases * cognitive impairment * depression * recent weight change (+/- 10 lbs. in the last 12 mo.) * poorly controlled blood pressure (sbp \> 159 or dbp \>95 mm hg) * history of non-skin cancer in the last 5 y * cardiovascular disease event in the past 6 mo. * severe pulmonary disease * renal failure * major liver dysfunction (elevation of liver transaminases \>3x normal in past 2 y; current/recent smoker (within 6 mo.) * use of estrogen or testosterone replacement therapy * current use of oral corticosteroids \>5 days/month on average * current use of medications for treatment of psychosis or manic-depressive illness * use of weight loss medications in the previous 3 months * unable to adhere to diet recommendations
alpha -1- microglobulin (α1m) as an early biomarker in renal extrahepatic manifestations of hcv-infection

Conditions: Renal Injury; HCV

Summary: find the role of alpha one microglobulin (as an early renal tubular biomarker) to identify and evaluate the prevalence of early renal manifestations among patients with chronic hcv and compared these patients with hcv-negative healthy individuals

hepatitis c \[hcv\] infection is known to cause renal manifestations, which are discovered at a late stage when chronic kidney disease (ckd) has already occurred . hcv is both a consequence and cause of renal impairment: first, dialysis patients have an increased risk of infection related to medical procedures and, second, hcv causes pathological changes to the kidneys . hcv seems to influence both renal tubular and glomerular cells as described by different proteinuria profiles and hematuria findings. tubular cell damage may be the earliest sign of renal dysfunction caused by hcv and could potentially be used to identify patients with risk for progression. routine urine analysis could be used to identify high risk hcv patients for early treatment. identifying patients early is of paramount importance in order to offer a prompt intervention and to improve the prognosis in both settings, for this purposes, novel biomarkers could be used one promising biomarker is alpha-1-microglobulin (α1m), a low molecular weight glycosylated protein of molecular weight synthesized by hepatocytes, freely filtered across the glomerulus, and then reabsorbed by the proximal tubule . it can signal proximal tubule dysfunction: higher uα1m concentrations indicate impaired tubular reabsorption . small studies have previously shown that uα1m concentrations increase in acute kidney injury (aki), reflect severity of aki, and are associated with the need for dialysis after nonoliguric aki . elevated uα1m correlates with interstitial fibrosis and tubular atrophy on kidney biopsy, representing chronic kidney damage . furthermore, uα1m appears to predict kidney function decline and ckd progression , acute kidney injury risk and also associated with early tubulointerstitial renal diseases in hcv-glomerulopathy .

Eligibility criteria:
inclusion criteria: hepatitis c virus (hcv )-positive patients: hcv antibody and status confirmed by hcv-rna positive who are either treatment naïve or previously treated. 3. hcv-negative control at outpatients. exclusion criteria: - 1. hiv-positive patients or hepatitis b positive (hbsag) patients or both. 2. previous renal diseases. 3. diabetes mellitus, hypertension, systemic lupus erythematosus, rheumatoid arthritis. 4. patients with active malignancy. 5. alcoholics.