Kornimate/medical-research-clean huggingface dataset:
using mobile devices for neurofeedback to reduce opioid use in chronic pain

Conditions: Chronic Pain; Opioid Use

Summary: the purpose of this study is to develop and test the feasibility of a commercially-ready mobile neurofeedback app for individuals with chronic pain. thirty (30) participants who are prescribed opioids for chronic pain will use the new mobile neurofeedback app and an eeg headset for 10 minutes at a time, 4 times a week for 12 weeks and provide feedback about using the app.

in this sttr phase i project, crosscomm will collaborate with duke university to develop a commercial-ready mobile neurofeedback technology and test its feasibility among patients using opioids to treat chronic pain. specific aim 1 is to develop a commercial-ready mobile neurofeedback app and will be built according to commercial standards of robustness and maintainability. specific aim 2 is to test feasibility of the commercially available mobile app in n=30 patients with chronic pain prescribed opioids. participants will be recruited for a baseline interview with the duke behavioral health \& technology lab after passing a preliminary telephone screen. after providing informed consent, participants will provide data on demographics, pain symptoms, and opioid consumption. each participant will download the mobile neurofeedback app to their smartphone and be instructed to use the intervention for 10 minutes a day, 4 times a week for 12 weeks. study coordinators will conduct four teleconference sessions (weeks 1, 3, 6 and 9) to reinforce training, troubleshoot difficulties, and support intervention utilization. after the 12-week mobile neurofeedback intervention, the investigators will collect follow-up data, including pain measures, mobile app (usage, satisfaction, \& usability), and user feedback on the human-computer interface. data from these will inform further app refinement preparing for sttr phase ii.

Eligibility criteria:
inclusion criteria: * reports chronic pain (≥4 on 0-10 numeric rating scale (nrs) on most days during the past 3 months) * prescribed opioids for pain management exclusion criteria: * history of seizures * plans to have pain-related surgery in the next 3 months * has an implanted medical device that could experience interference during eeg, such as a spinal cord stimulator or pacemaker

Keywords: chronic pain opioids prescription opioids pain musculoskeletal pain mobile apps mobile health neurofeedback eeg feedback biofeedback alternative therapy
efficacy study of nitazoxanide suspension in the treatment of rotavirus disease in children

Conditions: Rotavirus Infection; Viral Gastroenteritis Due to Rotavirus

Summary: the purpose of this study is to determine the effectiveness of nitazoxanide suspension compared to placebo in treating rotavirus disease in pediatric patients less than 6 years of age.


Eligibility criteria:
inclusion criteria: * age \< 6 years. * patients with diarrhea (defined as 3 or more liquid stools per day). * stool positive for rotavirus by elisa. exclusion criteria: * other identified causes of diarrhea at screening (pathogenic protozoa, bacteria, viruses or lactose intolerance). * serious systemic disorders incompatible with the study.

Keywords: rotavirus viral gastroenteritis gastroenteritis
clinical utility evidence for tissuecypher®

Conditions: Gastro-Intestinal Disorder; Barrett Esophagus

Summary: cernostics has developed a new diagnostic test, and this study will measure how gastroenterologists and foregut surgeons make diagnostic and treatment decisions when presented with different information in the context of simulated clinical cases. the results of this study could contribute to improved quality of care for patients by encouraging better care practices and adherence to evidence-based guidance. the data from this study will be provided to all participating physicians and submitted to a national journal for publication. the study plans to enroll up to 249 physicians.


Eligibility criteria:
inclusion criteria: * board-certified gastroenterologist or gi surgeon for at least two years * averages at least 20 hours per week of clinical and patient care duties over the last six months * performs either diagnostic endoscopy, interventional endoscopy, upper gi surgery, or bariatric surgery * practicing in the us * english speaking * access to the internet * informed and voluntarily consented to be in the study exclusion criteria: * non-english speaking * unable to access the internet * not practicing in the us * not averaging at least 20 hours per week of clinical or patient care duties over the last six months * does not perform either diagnostic endoscopy, interventional endoscopy, upper gi surgery, or bariatric surgery * does not voluntarily consent to be in the study
mode of sedation during endovascular treatment of vertebrobasilar stroke

Conditions: Stroke Thrombectomy

Summary: optimal anesthetic mode is not established for patients with vertebrobasilar stroke undergoing endovascular treatment. we want to investigate whether a procedural sedation mode approach is feasible compared to general anesthesia

endovascular treatment has become standard of care for many patients with acute ischemic strokes due to large vessel occlusions and is recommended by several national and international guidelines. several studies have shown that anesthetic modality during endovascular treatment might affect the functional outcome. while much evidence has been generated for ischemic stroke of the anterior circulation, only a few studies have investigated anesthetic modalities in strokes with occlusions of the vertebrobasilar arteries. the majority of patients with vertebrobasilar occlusion strokes undergo endovascular procedure in general anesthesia and not a less burdensome sedation despite the lack of evidence for that approach. a few retrospective studies and a small single-center prospective randomized trial investigating this topic indicate that primary procedural sedation might be a feasible anesthetic approach. here we aim to provide further high-level evidence by conducting a prospective randomized clinical trial with a probe (parallel-group, open-label randomized controlled with blinded endpoint evaluation) design for this research question.

Eligibility criteria:
inclusion criteria: 1. decision for thrombectomy according to local protocol for acute recanalizing stroke treatment 2. age 18 years or older, either sex 3. national institutes of health stroke scale (nihss) ≥ 4 4. acute ischemic stroke in the posterior circulation with isolated or combined occlusion of vertebral artery (va) and basilar artery (ba) 5. informed consent by the patient him-/herself or his/her legal representative obtainable within 72 h of treatment (deferred consenting procedure) exclusion criteria: 1. intracerebral hemorrhage 2. coma on admission (glasgow coma scale ≤ 8) 3. severe respiratory instability, loss of airway protective reflexes or vomiting on admission, where primary intubation and general anesthesia is deemed necessary 4. intubated state before randomization 5. severe hemodynamic instability (e.g. due to decompensated cardiac insufficiency)
effectiveness of combined medication treatment for aggression in children with attention deficit with hyperactivity disorder (the spicy study)

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: this study will determine the advantages and disadvantages of adding one of two different types of drugs to stimulant treatment for reducing aggressive behavior in children with attention deficit with hyperactivity disorder (adhd).

attention deficit with hyperactivity disorder (adhd) is a common childhood mental disorder that affects 3% to 5% of all american children. symptoms of adhd commonly include inability to focus or exercise normal inhibition, and in some cases, aggressive behavior. approximately 33% to 50% of children with adhd develop oppositional defiant disorder (odd), and about 20% to 40% develop a conduct disorder (cd). these disorders are characterized by defiant, belligerent, and otherwise aggressive behavior. treatment for adhd generally includes use of stimulant medications that decrease impulsivity and increase attentiveness, such as methylphenidate (ritalin) or dextroamphetamine (dexedrine), but these do not always affect aggression. to treat aggression in adhd, many physicians prescribe additional medications, including the mood stabilizing medication valproate and the antipsychotic medication risperidone. there is no clinical evidence proving that using multiple types of medications is safe and effective. this study will treat children with adhd and aggression with a combination of stimulants and antipsychotic or mood stabilizing medications to determine whether the aggressive behaviors and adhd symptoms are reduced without harmful side effects. this study has two phases. during the first phase, which will last 3 to 6 weeks, participants will be treated with normal adhd stimulant medications. during the second phase, those whose aggressive behavior is not effectively suppressed by stimulant medication alone will then be randomly assigned to also receive valproate, risperidone, or placebo for 8 weeks. after 8 weeks, children whose aggression persists will be switched from either valproate to risperidone or risperidone to valproate for another 8 weeks. those on placebo will not switch medications. all participants will attend weekly monitoring visits for 11 to 16 weeks over the course of the study. at these visits, aggression levels and medication side effects will be assessed. families will also meet with the researchers to discuss the child's progress and will attend behavioral counseling with a therapist.

Eligibility criteria:
inclusion criteria: * presence of adhd * presence of persistent, clinically significant aggression * presence of odd or cd exclusion criteria: * presence of psychosis * presence of a major developmental disability * presence of a major mood disorder * contraindications to stimulant, valproate, or risperidone treatment

Keywords: attention-deficit/hyperactivity disorder aggressive behavior oppositional defiant disorder conduct disorder
psychosocial impact of early puberty in girls aged 6 to 8 years

Conditions: Early Puberty

Summary: gnrh agonists are used in the treatment of precocious puberty in order to improve adult height.however,the psychosocial impact of precocious puberty is often used by the clinician at diagnosis to justify treatment, but can not yet be properly assessed. it can not be considered as a rational neither for the indication to treatment, nor to assess its potential efficacy. the overall objective of this work is to improve the conditions leading to the therapeutic decision and the procedures for monitoring girls with idiopathic central precocious puberty.

during the day hospital, the diagnostic workup for precocious puberty will be performed and include: * a clinical examination with pubertal stage assessment. * a gnrh test * a pelvic ultrasound * an mri will be performed later after the results of gnrh test confirming precocious central puberty. these reviews are conducted as part of usual care and are required to validate the inclusion criteria of patients. the cbcl questionnaire will be completed by patient's parents and the first semi-structured interview will be conducted by a sociologist assisted by the psychologist, dedicated to the study. patient's follow-up will be planned 6 months after inclusion, including similar investigations (except mri).

Eligibility criteria:
inclusion criteria: * 6 to 8 years old girls, with idiopathic central precocious puberty defined as: * onset of clinical signs between 6 and 8 years excluded: breast development (tanner stage s2 or more), possibly with pubic hair or accelerated growth rate. * the gnrh test: lh peak\> 5 iu / l during the test. * pelvic ultrasound: uterine length\> 34 mm * the normality of the hypothalamic-pituitary region assessed by magnetic resonance imaging (mri). * parental informed and written consent exclusion criteria: * parents and / or children do not speak french * other chronic disease * the child does not benefit of the french social security cover

Keywords: early puberty psychosocial impact qualitative assessment
topical application of silver nanoparticles and oral pathogens in ill patients

Conditions: Critical Illness

Summary: the purpose of this study is to determine whether oral topic silver nanoparticles are effective to reduce potential pathogen microbial loads in mechanical ventilation patients.

all patients were performed with oral hygiene as recommended by the clinical practice guidelines for the prevention, diagnosis and treatment of pneumonia associated with mechanical ventilation. after that, placed the treatment of an innocuous gel compound with 12ppm of silver nanoparticles or gel alone according to randomization. then obtain and plant samples taken before the treatment 6 hours after. comparing the results of the baseline sample with the final.

Eligibility criteria:
inclusion criteria: 1. patients with at least 24 hrs application endotracheal tube and ventilator support were nasogastric tube ,in the icu of hospital central "dr. ignacio morones prieto" 2. patients with at least 24 hours of icu admission. 3. sedo - analgesia patients in a coma or induced coma. 4. over 15 years old 5. informed consent signed by a family member or legal guardian of the patient. exclusion criteria: 1. the patient is not taking part in another study that cause conflict with the present test. 2. patients who develop bronchiectasis , severe or massive hemoptysis , cystic fibrosis. 3. patients with known sensitivity to silver. 4. patients who had reported difficult intubation in the record. 5. patients whose physical condition does not allow the completion of the oral examination, proper sampling or application of gel. 6. pregnant women 7. patients with oral mucositis

Keywords: silver nanoparticles antimicrobial activity
imcardia for dhf to treat diastolic heart failure (dhf) patient a pilot study

Conditions: Heart Failure With Normal Ejection Fraction

Summary: this study is designed to evaluate the imcardia safety and to demonstrate system functionality in patients undergoing av replacement with respect to 36 months follow up.


Eligibility criteria:
inclusion criteria: 1. male or female able to understand and sign a informed consent 2. be 50 years of age or older 3. nyha class iii, iv 4. ef \>55% 5. candidates for aortic valve replacement due to aortic stenosis. 6. agrees to attend all follow- up evaluations exclusion criteria: 1. free wall thickness less than11.5mm 2. adhesions are expected from a previous surgery or medical condition (e.g. s/p chest radiation therapy etc.) 3. presence of significant myocardial scars (e.g. postinfarction) at proposed site for implant of imcardia™device attachment screw. 4. likely to be need cabg following the implantation of the imcardia™ 5. intra-cardiac thrombus/mass 6. myocarditis 7. acute/chronic pericarditis 8. not a candidate for sternotomy 9. active infection 10. stroke, surgery or icd within 3 months 11. acute coronary syndrome during the past 6 months 12. left ventricular regional wall motion abnormalities 13. significant valvular disease other that aortic stenosis 14. significant pulmonary disease 15. a history of alcohol abuse, drug addiction, or other psychosocial condition that would preclude successful participation, or clear judgment and informed consent in the opinion of the principal investigator 16. participating in another trial (other than non-therapeutic or interventional observation) within the last 60 days. 17. history of noncompliance to medical therapy

Keywords: dhf (diastolic heart failure) hfnef (heart failure with normal ejection fraction
purine metabolism enzyme snp to uric acid production

Conditions: Gout; Hyperuricemia

Summary: determine whether a relationship exists between polymorphisms of the genes xdh, hprt1, and prps1 and gout, hyperuricemia, or the dose of xanthine oxidase (xo) inhibitors to reach a goal serum uric acid of less than 6 mg/dl. this study is observational in nature as no dose adjustment of xo inhibitors will be made by study investigators.

background: our recent gout study demonstrated a relationship between the xanthine oxidase (xo) single nucleotide polymorphism (snp) 2107a\>g to the dose of allopurinol needed to reach a goal serum uric acid level of 6 mg/dl or less. this study had some limitations but suggests that specific snps could be related to dose of allopurinol needed to treat. objective: to determine the relationship of multiple purine enzyme snps of genes encoding prps1, hprt1, and xo to the dose of xanthine oxidase inhibitor needed to achieve a goal treatment uric acid level of less than 6 mg/dl. another primary outcome will be to determine relationship of two xo snps to hyperuricemia/gout. a secondary outcome will be to determine the frequency of these snps tested. design: patients will be consented for enrollment in either the gout/hyperuricemia group or a control group. control group patients will have neither gout nor hyperuricemia. no patients will be enrolled if they are overproducers of uric acid. it is anticipated that 200 patients will be enrolled in each group for a total of 400 patients over the next 2 years.

Eligibility criteria:
inclusion criteria: * the study will be open to all adults over age 18 years of age who satisfy at least one of the conditions below: * have asymptomatic hyperuricemia (serum uric acid level \> 7.0 mg/dl) on at least 2 separate occasions, * clinical diagnosis of gout, * have neither asymptomatic hyperuricemia or gout but will serve as part of the control group (approximate age/gender matched control) exclusion criteria: * to best isolate the relationship between purine enzyme snps to hyperuricemia or gout and its treatment, factors which could elevate the serum uric acid level independent of protein function need to be excluded. specifically, patients who are "overproducers" of serum uric acid will be excluded: * have a myeloproliferative disorder (hematologic malignancy such as leukemia or lymphoma) * are actively receiving therapy for any neoplasia (aside from non-melanoma skin cacner) * have greater than 5% of skin involvement from psoriasis * have a known history of xanthinuria * consume more than 14 drinks per week of alcoholic beverages patients that are pregnant or nursing will not be enrolled. patients to be enrolled in the control group will also be excluded from enrollment if they have any of the conditions above.

Keywords: xanthine oxidase gout hyperuricemia snp single nucleotide polymorphisms
efficacy of oral moisturizing jelly on oral health and nutrition in post-radiotherapy head and neck cancer patients

Conditions: Cancer of Head Neck; Radiation-Induced Xerostomia; Dry Mouth

Summary: this randomized control trial aims to investigate the efficacy of oral moisturizing jelly in head and neck cancer patients with xerostomia.

oral moisturizing jelly is a novel edible, gel-based artificial saliva. it has been proven effective in reducing dry mouth sign and symptoms in elderly patients with xerostomia. this randomized control trial intends to determine if continuous use of oral moisturizing jelly may be effective in reduction of signs and symptoms of dry mouth, improvement of biochemical properties of saliva, subjective swallow ability, appetite, tolerance to spicy food, energy intake and reduce umami taste recognition threshold.

Eligibility criteria:
inclusion criteria: 1. xerostomic head and neck cancer patients who finish radiotherapy for at least 1 month. 2. if undergoing chemotherapy, have to finish for at least 2 weeks. 3. have subjective dry mouth scores at least 3 4. can perform oral intake without aspiration 5. can communicate well exclusion criteria: 1. has recurrence of cancer 2. has mucositis more than grade 1 3. has oral infection such as candidiasis
the diabetic and idiopathic gastroparesis efficacy, safety, and tolerability (digest) study

Conditions: Gastroparesis

Summary: study 0099 explores the efficacy and safety of multiple doses of velusetrag in the treatment of symptoms in subjects with diabetic or idiopathic gastroparesis. three dose levels of velusetrag will be evaluated and compared to placebo for approximately 12 weeks of therapy. in addition, the study will be used to evaluate the psychometric properties of the gastroparesis rating scale (grs), a daily patient-reported outcome (pro) measure.


Eligibility criteria:
inclusion criteria: * symptoms of gastroparesis (eg, nausea, early satiety, fullness, bloating, upper abdominal pain, retching or vomiting) for at least 3 months prior to screening * composite score ≥2and \<5 on nausea, bloating, feeling excessively full after meals, and not able to finish a normal-sized meal items (on the gcsi-2w) at screening * delayed gastric emptying by either ges (gastric emptying scintigraphy) or gebt(gastric emptying breath test) * upper gastrointestinal obstruction ruled out by endoscopy or other imaging (eg, computed tomography) after the onset of gastroparesis symptoms * willing to abstain from prohibited medications, including but not limited to, anticholinergics, acetylcholinesterase antagonists, or promotility medications (eg, metoclopramide, domperidone, prucalopride, erythromycin) for: 24 hours prior to gastric emptying test during screening, if applicable; 24 hours prior to start of the baseline period; and during the baseline period * gcsi-24h 7-day mean composite score ≥2.5 and \<5 at day 1 exclusion criteria: * if type 1 or type 2 diabetic, a glycosylated hemoglobin (hba1c) level \>11% * prior history of gastric surgery, including but not limited to gastrectomy, gastric bypass, gastric banding, pyloroplasty, vagotomy, or fundoplication, which has manipulated the natural anatomy of the stomach * history of intrapyloric botulinum toxin injection within 3 months of screening or currently has functioning implantable electric stimulator * history of alcohol or drug abuse or dependence within the last year prior to screening

Keywords: gastroparesis diabetic idiopathic