Kornimate/medical-research-clean huggingface dataset:
confirmatory efficacy trial of a gluten-free diet in a subgroup of persons with schizophrenia who have high levels of igg anti-gliadin antibodies (aga ig)

Conditions: Schizophrenia; Gluten Sensitivity; Schizo Affective Disorder

Summary: this study purpose is to conduct a confirmatory double-blind randomized controlled trial in an inpatient setting of the effects of a tightly controlled gluten-free diet (gfd) to improve negative symptoms in people with schizophrenia or schizoaffective disorder who have antibodies to gliadin (aga igg). as part of the project investigators will also confirm outcomes such as cognitive symptoms, changes in peripheral and central inflammation as well as gut/blood brain barrier permeability.

this study is a randomized double blind clinical trial being funded by nimh. investigators will need to enroll 40 cases with aga igg positivity in order to present a powered and convincing result about the efficacy of gluten withdrawal in the subpopulation of persons with schizophrenia with elevated aga igg levels. investigators will recruit a minimum 50 to ensure they are well powered without question, and to account for dropouts. investigators will use a battery of measures of peripheral and central inflammation as well as gut permeability at baseline and endpoint to confirm the relationship of these outcomes to changes in aga igg and symptom changes in the clinical trial. investigators will test negative symptoms as a primary outcome but will test changes in other symptom domains such as positive symptoms. after the completion of the 5 week confirmatory study, investigators will discharge participants and follow them for 8 weeks in their own environment to test the maintenance of the effect following the stringent gfd, and provide education on gluten free shopping, cooking and eating.

Eligibility criteria:
inclusion criteria: 1. dsm-iv/dsm 5 diagnosis of schizophrenia or schizoaffective disorder 2. positive for antibodies to gliadin (igg \> 20 u) 3. sans total score ≥ 20 and the affective flattening or alogia global item ≥ 3 4. age 18- 64 years 5. same antipsychotic for at least 4 weeks 6. ability to consent determined by a score of 10 or greater on the evaluation to sign consent. exclusion criteria: 1. persons already on gluten free diets 2. positivity to tissue transglutaminase (ttg) antibodies or known history of celiac disease 3. pregnant or lactating females 4. medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol 5. meets dsm-5 criteria for alcohol or substance use disorder (other than nicotine) within the last month 6. gluten ataxia, as measured by the brief ataxia rating scale additional exclusion for those participating in optional imaging component: 7. non-removable ferromagnetic metal on or within the body 8. current claustrophobia 9. inability to lie supine for 1.5 hours
portal vein flow velocity as a screening tool for oesophageal varices in cirrhotic patients

Conditions: Cirrhosis Portal

Summary: portal vein flow velocity as screening tool for prediction of oesophageal varices in cirrhotic patient without upper endoscopy

portal vein flow velocity as screening tool for prediction of oesophageal varices in cirrhotic patient without upper endoscopy with its high cost \& complications using portal vein flow velocity and the relation between it \& presence of oesophageal varices in cirrhotic patient \& its efficacy as a primary tool for these cases

Eligibility criteria:
inclusion criteria: * cirrhotic patients with oesophageal varices * cirrhotic patients without oesophageal varices exclusion criteria: * patients with hepato-cellular carcinomas \[hccs\], portal vein thrombosis, hepatic encephalopathy. * patients with positive hcv antibody, but without liver cirrhosis diagnostic criteria
family-based crisis intervention with suicidal adolescents in the ed

Conditions: Suicide

Summary: the family based crisis intervention (fbci) is an emergency psychiatry intervention designed to sufficiently stabilize suicidal adolescents within a single ed visit so that they may return home safely with their families. this study is a randomized clinical trial of fbci v. tau in an urban emergency department.

in current practice, treatment as usual (tau) for suicidal adolescents includes evaluation, with little or no intervention provided in the emergency department (ed), and disposition, usually to an inpatient psychiatry unit. the family based crisis intervention (fbci) is an emergency psychiatry intervention designed to sufficiently stabilize suicidal adolescents within a single ed visit so that they may return home safely with their families. the intervention works intensively with both the adolescent and the family, so that the caregiver has the knowledge and skills to help the adolescent after discharge. in this study, suicidal adolescents (ages 13-18) and their families presenting for psychiatric evaluation to a large pediatric ed were randomized to receive fbci or treatment as usual (tau). patients and caregivers completed self-report measures of suicidality, family empowerment, and satisfaction with care provided at pre-test, post-test, and 3 follow up time-points over a one-month period. clinicians contacted the adolescent and caregiver at these timepoints to administer the questionnaires and assure safety planning was being carried out.

Eligibility criteria:
inclusion criteria: * adolescent presenting to the ed with suicidality * presence of a consenting parent or legal guardian with whom the adolescent resided. exclusion criteria: * either adolescent or parent/guardian lacked fluency in english; * adolescent was not medically stable, including intoxication; * adolescent demonstrated cognitive limitations prohibiting completion of research instruments; * adolescent presented with active psychosis; * adolescent required physical or medication restraint in the ed.

Keywords: family-based crisis intervention adolescent suicide
home-based non-invasive brain stimulation and hand tracking rehabilitation for people with chronic stroke

Conditions: Stroke

Summary: this is a device feasibility study, which will assess telerehabilitation in people with chronic stroke using a combination of noninvasive brain stimulation and finger tracking training. telerehabilitation allows patients to train in their own home which also allows for longer training periods than what is currently allowed clinically. noninvasive transcranial direct current stimulation (tdcs) uses two surface electrodes connected to a small battery that will be attached to the head. this will be used to modulate neuronal excitability. with sensors attached to fingers and the wrist, the patient will move the joints to track a target displayed on a screen. the combined treatment will be applied in two experiments. the first will be on 3 patients coming to our lab and the second on 3 patients in their home, both under supervision. we will integrate the two components and test the resulting and novel treatment system for technical feasibility, which will set the stage for future efficacy studies under federal grant support. we hypothesize that the developed system will be safe and feasible.

this study will assess the feasibility of a telerehabilitation protocol involving non-invasive brain stimulation. therefore, the two arms of the study are 1) implementation of this protocol in a controlled laboratory setting and 2) implementation of this protocol in a patient's home, being set up by the patient but controlled remotely using a blue-tooth system by an investigator in a different location. the two arms of this study will occur successively with the first arm being completed with three patients followed by the second arm being completed with a second group of three patients.

Eligibility criteria:
inclusion criteria: * adult at least 18 years old * stroke duration \>6 months, * mini-mental state examination score 24 or higher * presence of tactile sensation on the scalp * at least 10 degrees of active finger or wrist motion in the stroke hand * ability to walk 100 feet and transfer independently exclusion criteria: * seizure within past two years * pregnancy * metal inside the had (dental metal is permitted) * implanted medical devices incompatible with tdcs
reducing disparities in primary prevention of cardiovascular disease

Conditions: Cardiovascular Diseases; Cholesterol, LDL

Summary: cardiovascular disease (cvd) is the leading cause of disparities in years of life lost by race and low socioeconomic status. statins have been shown to decrease the risk of cardiovascular events among individuals with high cvd risk. yet, despite increased statin use and overall declining cvd rates, disparities in statin use and disparities in the control of high cholesterol by race, ethnicity, and socioeconomic status have persisted. objective: to improve the appropriate use of statins for primary cardiovascular disease prevention among high risk individuals at community health centers through a system of population health management that uses electronic health record (ehr) data to identify patients for targeted education and outreach. aim 1: conduct a randomized controlled trial among individuals with 10-year risk for myocardial infarction or coronary death of 10% or higher to determine if the population health management intervention, compared to usual care, results in higher rates of documented statin treatment discussions within 6 months (primary process outcome), higher rates of statin prescribing within 6 months (secondary process outcome), and higher rates of significant low-density lipoprotein cholesterol (ldl-c) lowering defined as a follow up ldl-c ≥30 mg/dl lower than baseline (primary clinical outcome). aim 2: interview patients who received the intervention to identify barriers to success aim 3: assess the overall costs of the intervention and the costs per each patient who achieves significant ldl-c lowering compared to patient who received usual care.


Eligibility criteria:
inclusion criteria: * men \>= 35 and women \>= 45 years old * ldl-c completed in the past 5 years * not currently prescribed lipid lowering medication * \>= 1 face to face visit to a study site in the 6 months prior to the start of the study or a visit during the enrollment period * the 10-year risk of coronary death or myocardial infarction (based on framingham risk score) is at least 10% and the ldl-c is above 100 mg/dl exclusion criteria: * previously diagnosed with any of the following: coronary disease, peripheral arterial disease, carotid artery disease, abdominal aortic aneurysm, or diabetes mellitus * primary language is not english or spanish

Keywords: statin treatment cardiovascular disease high cholesterol care management
antiviral therapy in decompensated hepatitis c virus (hcv) cirrhosis

Conditions: Liver Cirrhosis, Experimental

Summary: to evaluate: 1. the impact of combined antiviral therapy (peginterferon plus ribavirin) on natural history of patients affected with hcv decompensated cirrhosis, after sustained virological response. a controlled study. 2. safety and efficacy of antiviral therapy in this population by using a statistically significally number of patients as controls.

decompensated hcv cirrhosis is a relevant problem as its clinical evidences predisposes to an high mortality risk, with a survival rate of 50% at 5 years (1,2). davis et. al processed a mathematical model of the natural history of chronic hepatitis c and projected the total number of cases with cirrhosis increased by more than 50% by 2010 and then plateaued (3). as a result, there will be a dramatic increase in the number of cases with complications of liver failure and decompensated events of cirrhosis will increase to 25% in 2010, 32% in 2020, 36% in 2030, and 38% in 2040 (3, table 1).liver transplantation is the treatment of choice but the limited number of organ donor makes not realizable for the major of patients. furthermore, age over 65 years correlated disease is not accepted to enter into the list of liver transplant. to prevent these patients from worsening their liver disease has positive economic implications in terms of health care resources used as diagnostic tests, clinic visits, drug therapy, hospitalization for management of complications, and later on, liver transplantation, and indirect costs related to lost work time and impaired quality of life. our controlled study on antiviral treatment of decompensated cirrhotics has shown that hcv clearance by therapy can be life-saving, improves hepatic function, and reduces disease progression. treatment should be encouraged in ctp classes a and b, and especially in patients infected by genotype 2. the benefit of treating patients with genotype 1 remains unproven.

Eligibility criteria:
inclusion criteria: hcv cirrhotics admitted to hospital for a decompensated event, such as ascites, variceal bleeding, and hepatic encephalopathy - exclusion criteria: rapid deterioration of liver and/or renal function, detection of hepatocarcinoma, infection with hiv or hbv viruses, current alcohol or drug abuse, chronic invalidating disease, bacterial infections, platelets \ 3 mg/dl, and serum creatinine \>2.0 mg/dl. -
recovery of bladder and sexual function after human spinal cord injury

Conditions: Urinary Bladder, Neurogenic; Blood Pressure; Autonomic Dysreflexia; Bowel Incontinence

Summary: this study will incorporate critical cross viscero-visceral intersystem interactions to 1) investigate in a controlled laboratory setting and then with mobile at-home monitoring the extent, severity, and frequency of occurrence of autonomic dysreflexia with respect to daily bladder and bowel function, in conjunction with identifying potential underlying mechanisms by examining urinary biomarkers for several specific vasoactive hormones, and 2) to regulate cardiovascular function therapeutically as part of bladder and bowel management using spinal cord epidural stimulation.


Eligibility criteria:
arm 1 inclusion criteria: * at least 18 years of age; * ais a to d; * neurogenic bladder and bowel dysfunction; * stable medical condition arm 2 inclusion criteria: * at least 18 years of age; * ais a to d; * neurogenic bladder and bowel dysfunction; * use of intermittent catheterization for bladder emptying; * prior implantation of a medtronic sces array arms 1 and 2 exclusion criteria: * prior botox injections of the bladder and/or bladder augmentation surgery; * colostomy bag, * ventilator dependent; * any implanted pump (i.e. baclofen pump, pain pump, etc.); * pregnant at the time of enrollment or planning to become pregnant during the time course of the study
alexander technique, routine physical therapy, balance, posture, functional mobility , chronic, hemorrhagic, stroke

Conditions: Chronic Hemorrhagic Stroke

Summary: materials and methods design: the randomized controlled trial. setting: nusrat abdul rauf centre for enablement, faisalabad. sample size:40 in each group. experimental group: recieve alexander technique with routine physical therapy. control group: recieve routine physical therapy.

control group: routine physical therapy duration: two days a week for 16 weeks. trunk stabilising exercises time duration will be 15 minutes, straight static standing.time duration 15 minutes. shoulders extend. threestepsfeet placement.10cm away. open eye target at 2m away. arms by side. ankle strategy. 40 minutes with rest of 5 minutes after 10 minutes. raise heel with straight foot \& straight head. 20 minutes. foot raise with straight foot \& straight head. 20 minutes. rest.5 minutes. experimental group: alexander technique + routine physical therapy duration for two days a week for 16 weeks. lessons will be 32. verbal instructions in trunk stabilising exercises. lift the lumber, head in centre, fix hands and feet. the time duration will be 15 minutes, verbal instructions in stance phase: relax-lighten up-relax-pull-up. "shoulder back", "head up", "tummy in" and "stand up straight". hip and feet width apart. straight static standing.time duration 15 minutes. shoulders extend. threestepsfeet placement.10cm away. open eye target at 2m away. arms by side. ankle strategy. 40 minutes with rest of 5 minutes after 10 minutes. raise heel with straight foot \& straight head. 20 minutes. foot raise with straight foot \& straight head. 20 minutes. rest.5 minutes.

Eligibility criteria:
inclusion criteria: * chronic hemorrhagic hemiplegic stroke. * age40-60yrs. * both genders. * intact cognition by mmse. * muscle tone assessment by ashworth scale. * right or left side. * 6th month onset. exclusion criteria: - * dizziness. * vertigo. * cerebellum damage. * hearing impairment. * vision impairment

Keywords: cerebrovascular accident
adjuvanted influenza vaccine in stem cell transplant

Conditions: Transplantation; Influenza Vaccines

Summary: influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia. although the annual influenza vaccine is recommended for transplant patients, studies have shown that nonadjuvanted vaccine has poor immunogenicity. there are no studies that define the effect of adjuvanted vaccine in this population. the purpose of this study is to determine if a vaccination with fluad® results in improved immunogenicity as compared to standard vaccine in allo-hsct recipients. immunogenicity will be assessed by standard quantitative antibody titer assessments and using cell-mediated immunity measurements.

the investigators plan to study the immunogenicity of two different types of the influenza vaccine in 240 allogeneic stem cell transplant patients during the 2015-2016 season. patients will be randomized to receive either adjuvanted influenza vaccine or nonadjuvanted. antibody titers will be evaluated by a standard hemagglutination inhibition assay. the investigators hypothesize that the patients who receive the adjuvanted influenza vaccine will reach significantly higher response to the vaccine. this study advances research on the prevention of serious viral infections in transplant recipients. results from this study have the potential to directly improve patient care. if the use of the adjuvanted influenza vaccine is successful, this strategy may lead to a significant reduction in burden of disease, hospitalizations, and long-term morbidity. the co-administration of vaccine with an adjuvant is a potentially promising method of boosting immunogenicity. two adjuvants have been used in influenza vaccines: as03 and mf59. both are oil-in-water emulsions. as03 was used in the monovalent pandemic a/h1n1 vaccine in canada and europe. adjuvanted vaccines have been studied in the hematopoietic stem cell transplant population with most studies done in using the as03-adjuvanted pandemic vaccine. mf59 adjuvant has been used in seasonal influenza vaccine in canada and europe for people ≥65 years old. mf59-adjuvanted vaccines have not been well studied in hematopoietic stem cell transplantation but could represent a significant advance if they show greater immunogenicity than the standard non-adjuvanted influenza vaccine. both fluad® and the standard 2015-2016 nonadjuvanted vaccine will contain 15 microgram antigen from each strain and will be injected in a standard dose (0.5 ml) in the deltoid muscle by trained personnel.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * greater than 3 months post-transplant * allogeneic hsct exclusion criteria: * has already received influenza vaccination for 2015-2016 season * egg allergy * previous life-threatening reaction to influenza vaccine (i.e. guillain barre syndrome) * febrile illness in the past one week * receipt of intravenous immunoglobulin (ivig) in the past 30 days or planning to receive ivig in the next 4 weeks * unable to provide informed consent * unable to comply with study protocol
prospective evaluation of a risk score for postoperative pulmonary complications in europe

Conditions: Complication of Surgical Procedure; Acute Respiratory Failure, Adult; Postoperative Respiratory Complications; Pulmonary Failure; Surgical Complications From General Anesthesia

Summary: prospective evaluation of a risk score for postoperative pulmonary complications in europe (periscope) is a multi-centre, international observational study of a random-sample cohort of patients undergoing a nonobstetric in-hospital surgical procedure under general or regional anaesthesia during a continued 7-day period of recruitment.

prospective evaluation of a risk score for postoperative pulmonary complications in europe (periscope) is a multi-centre, international observational study of a random-sample cohort of patients undergoing a nonobstetric in-hospital surgical procedure under general or regional anaesthesia during a continued 7-day period of recruitment. participating centres throughout europe will contribute routine clinical data describing all eligible patients who undergo surgery during a continuous week (7-days) at convenience of every department within a period of two months from may 1st to july 1st 2011. a questionnaire of around 50 items will be filled during the pre, intra and postoperative periods. the follow-up will end at discharge. the aim of the periscope study is to validate a simple score to predict postoperative pulmonary complications(ppcs). this score has recently been published in anesthesiology and you can access linking to: http://journals.lww.com/anesthesiology/fulltext/2010/12000/prediction_of_postoperative_pulmonary.20.aspx timeframe participants will be followed for the duration of in-hospital stay, an expected average of maximum 5 weeks.

Eligibility criteria:
inclusion criteria: patients undergoing a non-obstetric in-hospital surgical procedure, elective or emergent, under general anaesthesia (alone or in combination with regional/neuraxial anaesthesia), neuraxial anaesthesia or plexus block (with and without sedation). exclusion criteria: 1. age \<18 years 2. obstetric procedures or any procedure during pregnancy 3. regional anaesthesia alone, except to neuroaxial and plexus anaesthesia 4. procedures outside the operating room 5. procedures related to a previous postoperative complication 6. transplantation 7. patients with preoperatively intubated trachea 8. outpatient procedures, defined as those requiring less than one day's stay for a patient alive at discharge.

Keywords: operative surgical procedures postoperative pulmonary complications (ppc) epidemiological study ariscat score risk score europe periscope observational study mild respiratory failure severe respiratory failure acute lung injury (ali) acute respiratory distress syndrome (ards) suspected pulmonary infection pulmonary infiltrate pleural effusion atelectasis pneumothorax bronchospasm aspiration pneumonitis cardiopulmonary edema prospective evaluation nonobstetric in-hospital surgical procedure general or regional anaesthesia continued 7-day period recruitment