Kornimate/medical-research-clean huggingface dataset:
open-label study of the long term tolerability and safety of atomoxetine in children with fasd and add/adhd

Conditions: Fetal Alcohol Syndrome; Attention Deficit Hyperactivity Disorder (ADHD)

Summary: determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.

abnormalities of attention, function, and activity level in children exposed to alcohol in utero share similarities and differences to children who do not have alcohol exposure. previous psychological studies have examined either core attention deficit hyperactivity (adhd) symptoms of hyperactivity, inattention, and impulsivity or hypothesized neuropsychological differences in children with fetal alcohol syndrome (fas) and adhd. atomoxetine hydrochloride is a non-stimulant medication used to treat adhd. this study will determine if atomoxetine hcl significantly reduces symptoms of add/adhd in children with fetal alcohol exposure.

Eligibility criteria:
inclusion criteria: * patient must have been between the ages of 4 and 11 years at the time of entry into the double blind study. * patients must meet diagnostic criteria for fasd. * patient must, at entry into doubleblind study, have met dsm-iv criteria for adhd, any subtype. and must have an adhdrs-iv score of \> or + 90% for age and gender on either subtest or total score for children above 5 years of age. * patients will continue atomoxetine/placebo until entry nto this study. * history and physical exam must reveal no clinically significant abnormalities that would preclude safe participation in the study. * patients must be able to swallow capsules. * patients must be of a sufficient mental age (3 yrs) to participate in the study. * patients and parents must be able to communicate effectively with the investigator and coordinator and be judged reliable to keep appointments and participate in data collection. * teacher must agree to cooperate with the study. exclusion criteria: * have received an investigational medication other than atomoxetine in the previous 30 days. * have significant current medical conditions that could be exacerbated or compromised by atomoxetine. * have used maois within one month prior to visit 1. * patients with hypertension. * patients with a previous diagnosis of bipolar disorder, psychosis, or autism spectrum disorder. * patients taking anticonvulsants for seizure control. * patients taking another psychotropic medication or health food supplements purported to have central nervous system activity within 5 half-lives of visit 1. * patients with tourette disorder or any other neurological condition that would interfere with their ability to receive treatment or comply with monitoring. * pubertal girls.

Keywords: fetal alcohol syndrome attention deficit disorder attention deficit disorder with hyperactivity add fas fasd adhd
personalized nutrition delivery to improve resilience in older adult trauma patients

Conditions: Trauma; Critical Illness

Summary: this is a pilot study designed to set up for an randomized clinical trial (rct) comparing the send home pathway to a standard of care nutrition delivery in critically ill older adult trauma patients. subjects will be randomized 3:1 to either send home precision nutrition pathway or control arm. subjects randomized to the send home arm will receive oral nutrition supplements (ons) up to 3 times per day while in the hospital and for 4 weeks after discharge. subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass.

this is a pilot study designed to set up for an randomized clinical trial (rct) comparing the send home pathway to a standard of care nutrition delivery in critically ill older adult trauma patients. the send home pathway supports patients from icu admission to 2-weeks post-hospital discharge, providing a comprehensive and personalized plan of care carried to completion. subjects will be randomized 3:1 to either send home precision nutrition pathway or control arm. subjects randomized to the send home arm will receive oral nutrition supplements (ensure shakes) up to 3 times per day while in the hospital and for 4 weeks after discharge. some subjects in this arm will be asked to participate in an interview after being discharged from the hospital. subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass. they will also be asked to complete walking and strength tests, and surveys about quality of life.these will be done every 3-7 days during hospitalization, at hospital discharge, and at a 3 month post-discharge follow-up visit.

Eligibility criteria:
inclusion criteria: * patients who are at least 60 years old and admitted to the trauma service * patients who have had a standard of care ct scan exclusion criteria: * expected withdrawal of life-sustaining treatment within 48 hours * prisoners * unable to provide informed consent * non-english speakers * traumatic brain injury * allergic to milk or soy ingredients (common allergen in ensure shakes). * pregnancy
angiography combination laparoscopy in patients with obscure gastrointestinal bleeding

Conditions: Surgical Wound

Summary: there were many approaches for patients with obscure gastrointestinal bleeding (ogib). capsule endoscopy (ce), double-balloon endoscopy, deep small-bowel spiral enteroscopy, laparoscopy, computed tomography and angiography have been recommended as investigation. however, of these techniques, the evaluation and management of patients with ogib remains a formidable challenge. we compared the diagnostic yield and long-term outcomes of patients with ogib randomized to angiogram combination laparoscopy or angiogram alone.

consecutive patients who presented with ogib to the second people's hospital of guangdong province between january 2003 and november 2008 were recruited. this study was approved by the ethical committee of the second people's hospital of guangdong province and was designed according to the consort (consolidated standards of reporting trials) guidelines. all patients gave written informed consent before beginning the study. as a standard protocol, all patients presented with melena or hematochezia would receive at least 2 times upper gastrointestinal endoscopy before admission. patients who had nondiagnostic upper gi endoscopy were also offered at least 2 times colonoscopy before admission. all gastrointestinal endoscopies were performed by experienced endoscopists (hanning wang). ogib were defined as patients who had nondiagnostic upper endoscopy and colonoscopy. patients who were \ 150 µmol/l) were also not eligible for this study. all patients were randomized to receive either mesenteric angiography alone or angiography combination laparoscopy in a 1:1 ratio. randomization was performed computer-generated list using a randomly permuted block design. to ensure concealed randomization, the randomization code was put in opaque envelope and kept by researchers not performing angiography or angiography combination laparoscopy. both patients and investigators were unaware of the randomization sequence.

Eligibility criteria:
inclusion criteria: - melena or hematochezia receive at least 2 times upper gastrointestinal endoscopy nondiagnostic upper gi endoscopy were also offered at least 2 times colonoscopy endoscopies were performed by experienced endoscopists. exclusion criteria: - \ 150 µmol/l)

Keywords: obscure gastrointestinal bleeding laparoscopy angiography
the impact of a catheter coating on clinical bacteriuria

Conditions: Bacteriuria

Summary: a prospective multicentre randomized study to assess the impact of a catheter coating on clinical bacteriuria when compared to an uncoated foley catheter. each participant will take part in the trial from the time the participant signs the informed consent form (icf). after the screening visit, the participants will be randomized to either a coated catheter or an uncoated catheter. participants will be assigned to receive trial treatment until the catheter has been removed as per standard hospital guidelines, investigator's decision to withdraw the subject, noncompliance with trial treatment or procedures, unacceptable adverse event, or participant withdraws consent. during the trial urine samples will be taken form the catheter port, temperature will be taken, and participants and healthcare providers will be asked to complete questionnaires.


Eligibility criteria:
inclusion criteria: 1. require insertion or exchange of a catheter as a component of their routine clinical care as per hospital guidelines 2. patients aged 18+ years will be eligible for the study. 3. patient understands and is willing to participate in the study and is able to comply with study procedures and visits. exclusion criteria: 1. patients that have or recently (within 3 weeks) had a urinary catheter and displays symptoms of current urinary tract infection. 2. pregnant or breastfeeding. 3. patients with a potentially immunocompromised conditions (hiv) 4. has a known silicone allergy or sensitivity 5. use of investigational drug or device within four weeks prior to study entry that may interfere with this study. 6. any medication deemed by the investigator to potentially interfere with the study treatment 7. participation in any other clinical study. 8. has a known bloodstream infection or an infection that requires prolonged antibiotic therapy
effects of an ot workstation intervention on knowledge, self-efficacy, and habit formation

Conditions: Occupational Injuries

Summary: the study aims to determine whether a face to face ergonomic workstation intervention has any advantage over an online instructional training program for acquisition of knowledge, self-efficacy, and habit formation.

thirty participants will be recruited from the staff of virginia commonwealth university via recruitment fliers distributed through the staff senate. potential participants will be informed that participation in the study will require them to work with the research team at their computer workstations outside of designated working hours, e.g., before or after work, during lunch break, or on a weekend. potential participants will be reminded that they may need to obtain approval from direct supervisors to use university equipment, i.e., their computer workstations, during non-working hours. all participants will be asked to complete knowledge, self-efficacy, and habit formation survey regarding computer workstation ergonomics via redcap. participants will receive an email with the link to the redcap surveys. those participants randomly assigned to the control group will complete the osha computer workstations etool, available at (https://www.osha.gov/sltc/etools/computerworkstations/wkstation_enviro.html). the etool consists of 5 sections: 1) good working positions, 2) workstation components, 3) checklists, 4) work process, and 5) workstation environment. those participants who are assigned to the intervention group will be contacted by the investigators to schedule face to face visits at their computer workstations. face to face intervention will consist of educating the participant on points of computer workstation ergonomics, direct observation of the participant working at her/his workstation, evaluation of workstation characteristics, instruction on how to alter workstation features, and instruction on best practices for exercise and scheduling of breaks to prevent pain, discomfort, and injury. all participants will be contacted via email 2 weeks following the interventions to complete the post-test knowledge, self-efficacy, and habit formation survey on redcap.

Eligibility criteria:
inclusion criteria: * 21 years old or older. * work at computer workstation at least 30% of a typical day. exclusion criteria: -

Keywords: ergonomics computer workstation habit self-efficacy knowledge
pain disengagement training (open pilot)

Conditions: Chronic Musculoskeletal Pain

Summary: the investigators aim to conduct an open pilot trial to determine the initial feasibility of a self-directed writing-based intervention in individuals with chronic musculoskeletal pain and elevated pain catastrophizing. the investigators will assess the feasibility of recruitment, acceptability of the treatment, credibility and participant satisfaction, treatment adherence, and feasibility of assessments following pre-specified benchmarks.

mind-body interventions are some of the most effective treatments for chronic pain, yet due to lack of resources, many are inaccessible to the patients who need them. the investigators seek to fill this gap by developing and testing pain disengagement training (pdt) for the treatment of chronic pain catastrophizing, a key risk factor for pain interference. the investigators will administer the pdt treatment in a small number (approximately 10) of participants to evaluate initial benchmarks (the feasibility of recruitment, acceptability of the treatment, credibility and participant satisfaction, treatment adherence, and feasibility of assessments) and to assess participants' experience with the intervention using qualitative exit interviews. results will inform the refinement of the intervention for a future larger trial.

Eligibility criteria:
inclusion criteria: 1. outpatient adults (i.e., greater than or equal to 18) 2. has self reported chronic musculoskeletal pain (i.e., pain persisting for at least 3 months) 3. pain score greater than or equal to 4 (moderate) on the numerical rating scale 4. pain catastrophizing score greater than or equal to 20 on pain catastrophizing scale 5. willingness to engage in a writing-based intervention and self-reported ability to write or type for at least 30 minutes in a sitting 6. received care at massachusetts general hospital 7. english verbal and writing fluency exclusion criteria: 1. clinically significant change in therapy or medication in the past 3 months 2. severe untreated mental health condition (e.g., psychosis) 3. active suicidality with history of plan or current intent 4. serious illness expected to worsen in the next 6 months (e.g., cancer) 5. untreated substance use problem that, per patient's self-report, would interfere with the ability to complete the intervention.

Keywords: pain catastrophizing
new imaging biomarkers predictive of ma progression

Conditions: Alzheimer Disease; Magnetic Resonance Spectroscopy; Ultra High Field 7T; Progression of Disease; MR Biomarkers

Summary: the pathophysiology of ad is complex. in addition to amyloid plaques and neurofibrillary degeneration, there is a metabolic alteration of the energy pathways, oxidative phosphorylation and glycolysis, which are involved in brain function. several authors have shown a series of early metabolic dysregulations via an increase in phosphorylation at the origin of neuronal death. ultra-high field imaging (7t mri) may allow, with its better spatial resolution and advanced imaging techniques, to shed light on the mechanisms of progression of alzheimer's disease. a magnetic resonance spectroscopy (mrs) examination can be coupled to brain mri without additional risk for the patient. multinuclear 1h-31p metabolic imaging is a promising tool that can provide information on the metabolic evolutionary profile of ad. thus, we propose a longitudinal study in patients with early-stage ad on 7t mri-mrs.


Eligibility criteria:
inclusion criteria: * french-speaking patients aged 60 to 90 years, * patient in the context of alzheimer's disease \* for which imaging after mri is prescribed as part of the usual diagnostic process, \*alzheimer's disease is diagnosed by the doctor of the memory consultation and is defined by :evidence of a storage disorder in verbal episodic memory at lr/ri defined by a sum of lr \< 17/48 and sum of rt \< 40/48 +/- impairment of executive functions possible (bref, tmt grefex, verbal fluencies) +/- impairment of instrumental functions possible (grémots noun naming, rey's figure, mahieux's battery). * mmse score ≥18, * written informed consent after the patient has been informed, * progressive decline for at least 6 months. exclusion criteria: --partially or completely illiterate patient unable to read and write, * patient with an absolute contraindication to 7t mri * severe psychiatric pathology not balanced, * non-degenerative neurological disease (stroke, multiple sclerosis ...), * patient with tumor or inflammatory pathology, or vascular leukopathy visualized in mri (fazekas score \> 3)
cardiac desynchronization in obstructive hcm, cardio-hcm

Conditions: Hypertrophic Obstructive Cardiomyopathy (HOCM)

Summary: the purpose of this study is to evaluate the benefit of the optimal pacing configuration, including the possibility of biventricular or left ventricular pacing, in hypertrophic obstructive cardiomyopathy patients.

in this study, subjects will be randomized to cardiac resynchronization therapy-defibrillation (crt-d) or cardiac resynchronization therapy-pacing (crt-p) vs pacing therapy aai. randomization will be stratified by indication. optimal pharmacological therapy in both treatment arms. length of follow-up for each subject will be 2y, since all subjects will be followed to a common study termination date.

Eligibility criteria:
inclusion criteria: * patients with hypertrophic obstructive cardiomyopathy with significant left ventricular obstruction (baseline lvot gradient more 50mmhg and severe symptoms exclusion criteria: * hocm intraventricular gradient \< 50mmhg * lv ejection fraction \< 50% * mild symptoms

Keywords: hypertrophic obstructive cardiomyopathy (hocm) pacing
evaluate low doses of aegr-733 on hepatic fat accumulation by mrs

Conditions: Hyperlipidemia

Summary: to determine safety and effectiveness of low-dose therapeutic aegr-733 +/- atorvastatin, ezetimibe or fenofibrate (compared to placebo) on liver fat accumulation measured by magnetic resonance spectroscopy

the goal within the current development program and this study is to investigate whether lower doses of aegr-733 can result in significant reductions in ldl-c and tgs while providing fewer gastrointestinal adverse events and less hepatic fat accumulation than seen in studies with higher doses. the potential for atorvastatin, ezetimibe or the ppar-alpha agonist (fenofibrate) to ameliorate any hepatic fat accumulation will also be investigated. the twelve week dosing schedule allows us to demonstrate the longer term effects of lower doses of mtp-i on hepatic fat accumulation.

Eligibility criteria:
inclusion criteria: 1. ldl-c between 100 and 190 mg/dl 2. hepatic fat under 6.2% per mrs exclusion criteria: 1. pregnant or lactating females 2. uncontrolled hypertension \>180/95 mmhg 3. chronic renal insufficiency - serum creatinine \>2.5 mg/dl at screen 4. liver disease; i.e., hepatitis, cirrhosis 5. major surgery within 3 months of screen 6. cardiac insufficiency 7. hx of malignancy other than basal or squamous cell within past 5 yrs 8. participation in any investigational drug study within 6 wks of screen 9. prior exposure to aegr-733 in past 12 months 10. serious or unstable medical or psychological conditions 11. more than one alcoholic drink per day 12. regular consumption of grapefruit juice or meds known to be metabolized by cyp 3a4 13. currently taking corticosteroids 14. other lipid-lowering meds (washout permitted) 15. fish oil, niacin grater than 200 mg/day and herbal weight loss products (washout permitted) 16. acute cvd or event within previous 6 months 17. diabetes mellitus 18. hepatitis b or c 19. medicated copd 20. idiopathic pulmonary fibrosis 21. g.i. disorders that cause chronic diarrhea 22. fasting triglycerides =/\> 400 mg/dl 23. body mass index \> 35kg/m2

Keywords: ldl hepatic fat
sustained lung inflation in preterm infants

Conditions: Preterm Infant

Summary: this is a randomized controlled study to investigate the effect of application of sustained lung inflation (sli) at birth on the respiratory outcome of preterm infants with respiratory distress syndrome.

enrolled infants (n=160) were randomized before birth into 2 groups (intervention and control group) in a ratio 1:1. randomization was done through an online randomizer (www.graphpad.com), and sealed envelopes were used to assign the infant to one of the two groups.

Eligibility criteria:
inclusion criteria: * gestational age ≥ 27 weeks and ≤ 32 weeks * appropriate for gestational age * weight \>800 grams exclusion criteria: * major congenital anomalies (congenital heart, cerebral, lung or abdominal malformations) * fetal hydrops
evaluation of an airway clearance system

Conditions: Cystic Fibrosis

Summary: the aim of this study is to assess the effectiveness of an airway clearance system.

the study will compare the effectiveness of the monarch™ system and the vest® airway clearance system. all subjects will receive treatment with both systems and endpoints will be compared.

Eligibility criteria:
inclusion criteria: * documented diagnosis of cystic fibrosis (cf) (by sweat test and/or genetics) * age ≥ 15 years * ability to expectorate sputum daily - determined by treating physician * patient must be on a stable regimen of cf medication for 4 weeks prior to visit 1 * patient who requires regular home airway clearance therapy exclusion criteria: * forced expiratory volume in 1 second (fev1) \ 90 % predicted * anticipated requirement for hospitalization within the next three weeks * history of pneumothorax within the past 6 months prior visit 1 * history of haemoptysis requiring embolization within the past 12 months prior to visit 1 * inability to perform monarch™ and/or vest® system therapy as directed * unable or unwilling to complete study visits or provide follow-up data as required per the study protocol * has taken intravenous (iv) antibiotics within the past 4 weeks prior to visit 1 * has ongoing exacerbation or allergic bronchopulmonary aspergillosis (abpa) * pregnant or lactating female * has a pacemaker or implantable cardioverter defribillator (icd)