Kornimate/medical-research-clean huggingface dataset:
preventing substance use among youth

Conditions: Substance Abuse

Summary: using a 2-group, mixed method group randomized trial design, this pilot study will compare standard implementation versus enhanced replicating effective programs (enhanced rep) to deliver michigan model for health (mmh) in michigan high schools.

background: drug use remains a major public health problem among youth in the united states. effective implementation of evidence-based interventions for youth is critical for reducing the burden of drug use and its consequences. the michigan model for health (mmh) is an intervention that has demonstrated efficacy in reducing adolescent substance use. yet, youth rarely receive evidence-based interventions (ebis) as intended; this is, in part, due to a poor fit between the intervention and the context. the disconnect between the ebi and context is especially pronounced among underserved and vulnerable populations, including among youth exposed to trauma. trauma is a potent risk factor for substance use, abuse, and the development of substance use disorders. consequently, we have a critical need to design and test effective, cost-efficient implementation strategies to optimize the fidelity of school-based drug use prevention to better meet the needs of youth exposed to trauma. the objective of this study is to design and test a multi-component implementation strategy to improve intervention-context fit and enhance fidelity and effectiveness. methods: using a 2-group, mixed method, randomized trial design, this pilot study will compare standard implementation (replicating effective programs: rep) versus enhanced enhanced replicating effective programs (enhanced rep) to deliver mmh. rep is a previously established implementation strategy that promotes ebi fidelity through a combination of curriculum packaging, training, and as-needed technical assistance. enhanced rep incorporates tailoring of the ebi package and training and deploys customized implementation support (i.e., implementation facilitation). this research designs and tests an implementation strategy deployed to systematically enhance the fit between the intervention and the context for a universal drug use prevention curriculum. the proposed research will focus on youth at heightened risk of drug use and its consequences due to trauma exposure. the proposed research is significant because of its potential to have a positive public health impact by preventing and reducing youth drug use and its consequences.

Eligibility criteria:
inclusion criteria: * schools which fail to meet state standards for implementation (less than 80% of curriculum) and/or face one or more barriers to mmh implementation exclusion criteria: * none
effects of a manualized short-term treatment of internet and computer game addiction

Conditions: Addiction

Summary: the purpose of this study is to 1) determine the efficacy of manualized short-term treatment of internet and computer game addiction (stica), assess 2) the durability of treatment response in these patients and 3) the impact on associated psychiatric symptoms, e.g. social anxiety and depression.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of internet or computer game addiction * internet or computer game addiction according to the aica-checklist(assessment of internet and computer game addiction, expert rating) * a score \>/= 7 in the aica-s (assessment of internet and computer game addiction, self rating) * patients with primary diagnoses of internet or computer game addiction * if currently on psychotropic medications, no change in medications and dosages in the past 2 months and during stica treatment * if currently off all psychotropic medications, patient has been off at least 4 weeks * at least 4 weeks off from last psychotherapy and no other ongoing psychotherapy exclusion criteria: * current global assessment of functioning (gaf) \< 40 * severe major depression (bdi-ii score \>/= 29) * current alcohol or drug addictions * personality disorders: borderline, antisocial, schizoid and schizotypal * lifetime diagnoses of schizophrenia, schizoaffective, bipolar or organic mental disorder * current unstable medical illness

Keywords: internet addiction computer game addiction stica short-term treatment psychotherapy internet and computer game addiction
efficacy of a nutrition biscuit in malnutrition management

Conditions: Malnutrition

Summary: the health risks and costs associated with malnutrition can be significantly reduced if symptoms are recognized early and treated effectively. oral nutritional supplements (ons) have been shown to increase nutrient intakes and maintain or improve nutritional status and functional outcomes in patients in a variety of settings. however despite this it is frequently reported that compliance to ons, which are often milk based drinks, is poor. the aim of the present study is to assess the effectiveness of a new biscuit style nutritional supplement in the management of malnutrition. the study is a randomized controlled eight-week intervention study. suitable participants currently being prescribed ons and who meet the study inclusion and exclusion criteria, will be identified by either staff in care facilities, registered dietitians or by general practitioner (gp) surgeries. participants (n=80) will be stratified based on bmi and gender and randomly assigned to either the biscuit ons group (n=40) or to remain on their existing ons prescribed as part of their standard care practice (n=40). changes in anthropometry, functional status, nutritional intake and appetite, general health, gastrointestinal symptoms and biochemistry (correction of nutritional deficiency), as well as compliance and acceptability of ons will be assessed between week 0 and week 8. participants will also be visited mid-intervention (week 4) to ensure well-being and assess compliance. this work is funded by calerrific ltd. and seeks to determine if the new biscuit style nutritional supplement could be used as an alternative to, or in conjunction with, existing ons to improve compliance and aid the recovery of malnourished patients.


Eligibility criteria:
inclusion criteria: * currently requiring oral nutritional supplement (minimum 8 weeks) exclusion criteria: * requiring tube or parenteral nutrition, texture modification or specialised diet * diagnosed chronic renal or liver disease, diabetes t1, cancer cachexia * any other condition whereby taking part in the study may have a negative impact on well-being

Keywords: oral nutritional supplements
assessment of esophageal epithelium integrity with use of a novel mucosal impedance device

Conditions: Gastro Esophageal Reflux

Summary: the objective of this study is to design and use a novel, minimally invasive mucosal impedance (mi) technology to inexpensively and accurately test mucosal health in suspected gastroesophageal reflux disease (gerd) and nonerosive reflux disease (nerd) patients as compared to those without gerd.

during routine esophagogastroduodenoscopy (egd), consented study participants will have the original single channel mi catheter advanced through the working channel of the endoscope. measurements will be taken at 3 locations for 5 seconds each. the catheter will then be removed and a custom-designed balloon assembly will be inserted through the working channel of the endoscope. the balloon assembly will expand to a maximum diameter of 2 cm spanning from the distal to mid esophagus and contain external metal contacts to form 40 impedance channels made up by 10 axial channels spanning a 10 cm axial area and four radial channels.this design will allow us to measure mucosal impedance both axially and radially thus enabling us to assess the discriminating ability of the device for reflux disease. the balloon assembly will be held in place for 5 seconds. once the mucosal impedance data have been recorded, the balloon assembly will be deflated and removed by the investigator. the study procedure will add approximately 1-3 minutes of procedure time for each research participant. those participants who are diagnosed with grade c or d esophagitis at the initial visit will return for a follow-up visit after treatment with proton pump inhibitor (ppi) therapy to determine whether or not esophagitis has healed as part of their standard of care. if no esophagitis is detected at the follow-up egd, we will gather one final comparison mi reading during this visit. if esophagitis is still present, follow-up mi will not be performed.

Eligibility criteria:
inclusion criteria: * patients who are undergoing standard of care egd with or without bravo ph capsule placement exclusion criteria: * age less than 18 years old * patients unable to give informed consent * use of acid suppressive therapy within last 10 days * known history of barrett's esophagus or gastric surgery, other than non-functioning (slipped) nissen fundoplication
comparing protocols for analgesia following elective cesarean section

Conditions: Postoperative Pain; Post-Cesarean Section

Summary: women undergoing elective cesarian section will be assigned to 3 groups for postoperative analgesia: 1. scheduled doses of iv acetaminophen + po ibuprofen 2. scheduled doses of po acetaminophen + po ibuprofen 3. "on demand" doses of acetaminophen, dipyrone and ibuprofen.

a prospective randomised trial. women undergoing elective cesarean section will be randomized to three groups. the treatment will be given for 48 hours after surgery. for evealuating objective pain sensation the investigators will be using the visual numerical score (vns). demographic characteristics and information about breastfeeding and medications' side effects, will be reviewed from patients' medical scores. exclusion criteria: known allergies to one or more of the studies' drugs, general anesthesia, woman undergoing her 3rd cesarean section or more, elective tubal ligation performed at the time of current cesarean section, contraindication for use of one or more of the studies' drugs. number of participants: 120 treatment: all women will receive immediately after surgery, in the recovery room: 1. iv morphin 5 mg, repeat doses every 10 minutes for vns\>3 2. iv tramal 100 mg, once after admitted to mternity ward: * 1st group will be receiving scheduled doses: 08:00 hr, tab. ibuprofen 400 mg, and iv acetaminophen 1 gr 14:00 hr, iv acetaminophen 1 gr 19:00 hr, tab. ibuprofen 400 mg 00:00 hr, iv acetaminophen 1 gr * 2nd group will be receiving scheduled doses: 08:00 hr, tab. ibuprofen 400 mg, and po acetaminophen 1 gr 14:00 hr, po acetaminophen 1 gr 19:00 hr, tab. ibuprofen 400 mg 00:00 hr, po acetaminophen 1 gr * 1st+2nd group will be given additional analgesia if needed according to vns scale: po drops dipyrone 1 gr, for vns\>4, up to 4 times a day, at least 6 hours between doses. tab tramadex 100 mg, for vns\>6, or if pain persists for 1 hour after receiving dipyrone, up to 3 times a day, at least 4 hours between doses. - 3rd group will not receive scheduled pain medication, but offered some only upon patients' request according to vns score: * tab. acetaminophen 1 gr, for vns 1-3, up to 4 times a day, at east 6 hours between doses. * po drops dipyrone 1 gr, for vns 4-7, or if pain persists for 1 hour after receiving acetaminophen, up to 4 times a day, at least 6 hours between doses. * tab ibuprofen 400 mg, for vns 8-10, or if pain persists for 1 hour after receiving dipyrone, up to 3 times a day, at least 8 hours between doses.

Eligibility criteria:
inclusion criteria: * women undergoing elective cesarian section exclusion criteria: * known allergies to one or more of the studies' drugs, general anesthesia, woman undergoing her 3rd cesarean section or more, elective tubal ligation performed at the time of current cesarean section, contraindication for use of one or more of the studies' drugs.
clinical evaluation of a normoproteic diet

Conditions: Severe Insufficient Nutrition

Summary: the main objective of this trial is the clinical evaluation of a normoproteic diet, when this diet is used for total enteral nutrition in geriatric people. for 3 months,all the participants in the study will receive only tube feeding: the experimental group will receive the commercial preparation to evaluate (t-diet plus ®, vegenat sa) and the control group will receive a standard diet (jevity ®, abbott laboratories).

the project includes: * product tolerance study: gastrointestinal and metabolic complications related to the product administration. * the monitoring of the intervention, and clinical and nutritional evaluation of the participants, including anthropometry, quality of life related to the health and clinical and nutritional status analytical evaluation (hematology and biochemistry). * the determination of the major biochemical variables related to the lipid profile and assessment of the antioxidant defense system, and also certain markers of metabolic syndrome and associated cardiovascular risk.

Eligibility criteria:
inclusion criteria: * patients over 65 years old, of both sex, receiving total enteral nutrition by tube. * admitted to medically supervised institutions (homes, health centers). * requirement for total enteral nutrition standard, at least 3 months. * acceptance volunteer to participate in the study by signing the written informed consent (approved by the ethics committee of university hospital virgen de las nieves). exclusion criteria: * patients who receive drugs with lipid composition. * unstable clinical situation. * patients with terminal illness. * refusal or physical or mental inability to cooperate in the study. * participating in another study. * other causes: social causes, humanitarian, non-cooperation, etc..

Keywords: total enteral nutrition severe insufficient nutrition t-diet plus standard lipidic profile quality of life
rgd pet/mri in sporadic vestibular schwannoma

Conditions: Acoustic Neuroma

Summary: the aim of this non-randomised, prospective study is to investigate the applicability and prognostic value of angiogenesis pet/mr with the radioligand 68ga-nodaga- e\[c(rgdyk)\]2 in patients with sporadic vestibuarl schwannomas.

the radioligand 68ga-nodaga- e\[c(rgdyk)\]2 targets the arg-gly-asp (rgd) sequence known to bind with the αvβ3 integrin that is expressed on the surface of angiogenic blood vessels or tumor cells. the radioligand can be used to visualize tumor angiogenesis using pet/mr. a total of 40 patients diagnosed with sporadic vestibular schwannomas will be subjected to an angiogenesis-pet/mr scan. follow-up mr-only scan will be performed (from the time of the angiogenesis pet/mr) minimum 2 months later in regards to calculate growth rate. the uptake of 68ga-nodaga-e\[c(rgdyk)\]2 (standardized uptake values, suvmax) in tumor lesions will be quantified as standardized uptake values (suvmax/suvmean) and compared with pfs, dss and os (dichotomized above/below median suvmax and analyzed by kaplan-meier).

Eligibility criteria:
inclusion criteria: * patients \> 18 years with mri verified sporadic vestibular schwannomas * patients \> 18 år whom max has been in watchful waiting regime in 12 months and/or max. received 1 follow-up mri scan. * must be able to read and understand the patient information in danish and to give informed consent exclusion criteria: * pregnancy * breast-feeding * weight more than the maximum weight limit for the pet/mr bed of the scanner (140 kg) * history of allergic reaction attributable to compounds of similar chemical or biologic composition to 68ga-nodaga-e\[c(rgdyk)\]2 * recent systemic treatment with steroids * hormone treatment incl. birth control pills. * claustrofobia * non-mri compatible implants.

Keywords: 68ga-nodaga-e[c(rgdyk)]2 angiogenesis pet/mr acoustic neuroma
study of the use of humidified warmed gas and the effect on post-operative pain in laparoscopic cholecystectomies

Conditions: Gallstone

Summary: double blind rct comparing elective laparoscopic cholecystectomy using warmed, humidified gas (new) against laparoscopic cholecystectomy with cool, dry gas (usual). sample size of 200 patients. outcome measures are postoperative opiate analgesia use, and post operative numerical pain scores.


Eligibility criteria:
inclusion criteria: * elective laparoscopic cholecystectomy * 18 years of age or over exclusion criteria: * under 18 years of age * prisoners * converted to open operation * secondary invasive procedure during operation * unable to give consent for whatever reason

Keywords: gallstones gallbladder cholecystectomy gallstone disease
melagatran/ximelagatran versus enoxaparin for the prevention of venous thromboembolic events

Conditions: Thromboembolism

Summary: this study is being carried out to study the efficacy and safety of treatment with melagatran injection followed by ximelagatran tablets in preventing blood clots, compared with enoxaparin for a period of 5-6 weeks. a separate visit, independent from the study will be done approximately 6 months after the surgery.


Eligibility criteria:
inclusion criteria: * signed informed consent, * female or male aged 18 years and over * patient scheduled for primary elective hip replacement or patient requiring surgery for hip fracture. exclusion criteria: * history of heparin-induced thrombocytopenia * conditions associated with increased risk of bleeding, renal impairment, known active liver disease or liver insufficiency. * myocardial infarction, ischemic stroke or transient ischemic attack (tia), systemic embolism or venous thrombo-embolism within 30 days of enrollment.

Keywords: prevention of venous thromboembolic events in patients undergoing elective hip replacement or hip fracture surgery
investigation of environmental factors associated with transmission of t. solium in endemic villages of zambia

Conditions: Neurocysticercosis; Taeniosis

Summary: this study aims to determine the prevalence of taeniosis and (neuro)cysticercosis in two districts in the southern (gwembe) and eastern province (chipata) of zambia.

the true prevalence of neurocyticercosis in zambia is not well known. only one study which was a pilot study done in katete district of eastern province demonstrated the prevalence of ncc among people with epilepsy. there is need to provide an accurate estimate of the prevalence of ncc among people with cysticercosis in zambia as well as understand the clinical manifestations of the disease in humans. data on the full range of clinical characteristics of ncc is essential to accurately estimate the burden of the disease in the community. the epidemiology work package within the human health sector will create awareness of the size of the problem by delivering scientifically generated prevalence data on tsct and ncc in various population groups (adults, children, and those living with epilepsy) in two provinces of zambia. this will form an essential prerequisite for the development of public health policy guidelines for the control/elimination of tsct/ncc in the country. further, environmental factors that could play a role in the transmission and maintenance of t. solium eggs will be studied. this will provide essential data in understanding the epidemiology of the parasite in endemic regions.

Eligibility criteria:
inclusion criteria: * willing and able to participate in all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, and taking oral anthelmintic tablets * willing and able to provide informed consent (signature or thumbprint with impartial witness; assent for minors with parental consent). * living in, attending school in, or regularly visiting the bore holes present in, the study communities. * aged 10 years or older exclusion criteria: * unwilling or unable to participate in some or all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, or taking oral anthelmintic tablets. * unwilling or unable to provide written (signature or thumbprint with impartial witness) informed consent (or assent for minors). * living outside of, and not regularly visiting, or attending school in, the study communities. * children aged less than 10 years. * seriously ill individuals (people unable to engage in the normal activities of daily living without assistance because of their illnesses).

Keywords: neurocysticercosis
exercise induced bronchospasm in children

Conditions: Exercise Induced Bronchospasm

Summary: the purpose of the study is to test how well 2 different medications stop asthma symptoms caused by exercising. the two medications that will be tested are "pretreatment with albuterol" and montelukast (singulair®). although both medications are used for treating asthma, we don't know which medicine is better at stopping asthma symptoms caused by exercising.

tthis is a randomized, crossover, placebo controlled trial of 30 patients, 7-17 years old with confirmed eib. patients will be randomized to montelukast treatment for at least 3 days or pretreatment with albuterol before an exercise challenge. villiran and colleagues have shown that the protective effect of montelukast in treating eib is apparent at day 3 of treatment and comparable to treatment for 4 and 8 weeks. it is our hypothesis that pretreatment with albuterol will provide superior protection against breakthrough eib in children with mild asthma compared to montelukast as maintenance therapy added to the current asthma regimen. secondary aims of this study are to measure the effect of montelukast on leukotriene b4 (ltb4) concentrations as measured in ebc, and on inflammation measured by feno level. we hypothesize that since montelukast is a cysteinyl leukotriene receptor antagonist, patients with elevated concentration of ltb4 may have a greater response to this medication. lastly, patients with elevated feno, a measure of airway inflammation respond differently to albuterol than montelukast his study is a randomized, double-blind, double-dummy, crossover clinical trial which will consist of 4 study visits and last up to 3 weeks. thirty children 7-17 years of age with asthma and eib, regardless of current asthma therapy will be eligible for this trial. patients will receive 3-7 days of therapy with either montelukast (5mg or 10 mg capsule) or placebo tablets. after 3-7 days of therapy the patients will be crossed over to receive the alternative therapy. exercise challenges will be completed at screening, baseline, visit 3 and visit 4. all patients will have an albuterol metered-dose inhaler (mdi) to be used on an as needed basis for asthma symptoms.

Eligibility criteria:
inclusion criteria: * children 7-17 years of age * physician diagnosed asthma for at least 6 months * eib diagnosed by a positive exercise challenge at screening and baseline visits * forced expiratory volume in 1 second (fev1) ≥ 70% of predicted at screening and baseline visit exclusion criteria: * history of cardiac dysfunction * unable to perform exercise challenge * use of montelukast