Kornimate/medical-research-clean huggingface dataset:
alt-801 ddi study in healthy volunteers

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: this is a phase 1, open-label, drug-drug interaction (ddi) study of alt-801 under steady state conditions on concomitantly administered medications in healthy subjects. the study will evaluate the effect of alt-801 on the pharmacokinetics (pk) of metformin, warfarin, atorvastatin, digoxin, and the combined oral contraceptive (oc) ethinylestradiol/levonorgestrel. the study will be conducted in 3 parts, as described below. each part will have 2 periods in a fixed sequence, where the first period is without alt-801 administration and the second is with alt-801 at steady state.


Eligibility criteria:
inclusion criteria: * male or female healthy volunteers, age 18 to 55 years, inclusive * body mass index (bmi) 25.0- 40.0 kg/m2 * able and willing to provide written informed consent prior to entry into the study exclusion criteria: * women who are pregnant or breastfeeding * history of diabetes or use of medications for the treatment of diabetes, or hyperglycemia or hba1c ≥ 6.5% * history of pancreatitis or hypersensitivity reaction to glp-1 analogues

Keywords: nash
demineralized bone matrix rotator cuff study

Conditions: Rotator Cuff Injuries

Summary: patients undergoing rotator cuff repair surgery will experience improved tendon healing with the use of demineralized bone matrix augmentation.

this is a prospective randomized study comparing the outcomes of patient undergoing rotator cuff repair with either an interpositional procedure administering demineralized bone matrix (dbm), or a control group without demineralized bone matrix. patient outcomes will be collected and compared between the two cohorts up to a five (5) year post-operative period and will include a range of subjective and functional outcomes, along with radiographic imaging.

Eligibility criteria:
inclusion criteria: * the subject is between the ages of 40 and 75 years. * subject is planning to undergo arthroscopic surgery for full thickness rotator cuff tears (rct) of supraspinatus and infraspinatus muscles, who are candidates for demineralized bone matrix with bmc. * two tendon tear or tear size equal to or greater than 3cm * amenable to double-row repair * primary rotator cuff tears with or without superior labral tear and/or biceps tear) exclusion criteria: * the subject is unable or unwilling to sign the patient informed consent, approved by the institutional review board. * the subject objects to use of allograft * irreparable rotator cuff tear * complete full thickness subscapularis tears of \> than the superior 1/3 of the tendon (lafosse grade 3 and above) * \< 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph * recurrent shoulder instability * intra-articular injections (steroids) within 1 month of surgery * rcr revisions * subject mri taken more than 12 months prior to surgery * pregnant or planning to become pregnant during the study period * workman's compensation case
antihypertensive medications and the risk of sepsis

Conditions: Hypertension

Summary: the primary objective of this study was to assess whether there is an increased risk of sepsis with the use of telmisartan compared with other arbs and with the other major antihypertensive classes, including aceis, beta-blockers, ccbs and thiazide diuretics. a secondary objective was to assess whether the use of arbs and aceis, compared with the other three major antihypertensive classes and with untreated hypertension, is associated with an increased risk of sepsis. a third objective was to evaluate whether the use of telmisartan compared with other arbs, aceis and other major antihypertensive classes is associated with an increased risk of worse outcomes due to sepsis, in particular acute kidney injury and death


Eligibility criteria:
inclusion criteria: - patients, 18 years or older, with at least two-year follow-up in united kingdom's general practice research database (gprd), who had a diagnosis of or treatment for hypertension exclusion criteria: - sepsis, chronic renal failure or on dialysis in the two-year period prior to cohort entry
helicobacter pylori antibiotic susceptibility testing of korea

Conditions: Helicobacter Pylori Infection; Peptic Ulcer; Lymphoma; Gastric Cancer; Gastritis

Summary: the purpose of this study is to make nationwide registry for antimicrobial resistance of helicobacter pylori using single method with agar dilution in korea.

backgrounds: the success rate of helicobacter pylori eradication in korea is not sufficient in recent days. the main cause of eradication failure is known as antimicrobial resistance and previous studies showed that resistant rates were different according to the regions in korea. however, until now, there are not enough studies about the nationwide results for antimicrobial resistance and previous reports used various methods for the resistant test. theories and plans: the nationwide resistant registry of helicobacter pylori using standardized single method, agar dilution test, can be useful for the development of new eradication methods to make eradication rate higher. moreover, the higher rate of helicobacter pylori eradication can reduce the chance of gastric cancer and also can reduce the medical expenses.

Eligibility criteria:
inclusion criteria: * aged 19 to 79 year person who need the examination of helicobacter pylori infection during upper gastrointestinal endoscopy. * no history of helicobacter pylori eradication. * no history of antibiotics within one month. * person who agree on the consent. exclusion criteria: * history of antibiotics more than 3 days sequentially within one month. * history of subtotal gastrectomy. * person who does not agree on the consent.

Keywords: helicobacter pylori
self-expanding multi-layered partially resorbable lightweight polypropylene mesh device (proceed ventral patch® or pvp®) for the treatment of small and medium umbilical ventral hernias

Conditions: Umbilical Hernia

Summary: meshes-devices using dual-sided mesh technology have been developed for the specific indication of small ventral hernias. the design of these meshes allows introduction of a mesh of appropriate size to cover the hernia defect, through a small incision. this technique is very attractive for the surgeon and the patients because the mesh usually can be introduced through a nearly invisible scar in the umbilicus. the avoidance of fixation sutures omits the pain related to these sutures. short-term results and patient satisfaction are very favorable, encouraging the surgeons to continue with the technique, although long-term results of these meshes in good quality studies are lacking.

the aim of this study is to evaluate the safety and efficacy at 12 months after repair of small and medium ventral hernias using pvp™. all patients operated between march 2009 and february 2011 at the participating centers, will be evaluated and described. patients will be evaluated by clinical investigation, questioning and ultrasound. the investigators' main focus will be the incidence of complications related to the use of the device, during the first year. also the investigators look at recurrence rate at 12 months, occurrence of pain at 12 months and foreign body feeling. the trial can be seen as a quality control of a cohort of patients treated with an innovative mesh device. no sponsoring from the company j\&j will be asked or accepted.

Eligibility criteria:
inclusion criteria: * all patients that were treated at the participating centres with a pvp™ for the repair of an umbilical hernia or another abdominal wall hernia before february 2011. exclusion criteria: * no informed consent from the patient. * patients lost to follow up.

Keywords: umbilical hernia repair pvp mesh
analysis of implantation failure and establishment of therapy for implantation failure

Conditions: Infertility

Summary: impaired endometrial growth (thin endometrial thickness) is a critical factor for implantation failure. in this study, effects of vitamin e on endometrial growth are studied.


Eligibility criteria:
inclusion criteria: * endometrial thickness \< 8 mm exclusion criteria: * women with fibroids * women receiving hormone therapy

Keywords: infertile women thin endometrial thickness implantation failure
biological dating of cerebral ischemia with gst-π/prdx1 to detect patients with stroke of unknown onset within the therapeutic window of thrombolysis

Conditions: Stroke, Acute

Summary: the flag1 study will assess the diagnostic performance of biomarkers glutathion s-transferase-π (gst-π) and peroxyredoxin 1 (prdx1) to identify cerebral infarction of less than 4,5 hours in a population of patients with neurological deficiency of less than 12 hours.


Eligibility criteria:
inclusion criteria: * patients over 18 years old * patients with symptoms consistent with stroke and a national institute of health stroke score ≥3 at the inclusion time * time symptom onset ≤ 24 hours at inclusion: * for patients with time of symptom onset is \<4.5h at inclusion, the time of symptom onset has to be precisely known, with a margin of error not exceeding 30 minutes (through patient or witness interview) * for patients with time of symptom onset is \>4.5h at inclusion, knowledge of precise time of symptom onset is not required. for these patients, to ensure onset-to-inclusion time is between 4.5 and 24 hours at inclusion: * last time patient presented no deficit must be less than 24 hours, * symptoms must have been first recognized more than 4.5 hours before blood draw. * possibility to perform mri within the 30 minutes following blood collection * person affiliated to or beneficiary of a social security plan exclusion criteria: * persons referred in articles l.1121-5, l.1121-7, l.1121-8 and l.1122-2 of the french public health code: pregnant, parturient or breastfeeding woman ; minor person (non-emancipated) ; adult person under legal protection (any form of public guardianship) ; adult person incapable of giving consent and not under legal protection. * persons deprived of liberty for judicial or administrative decision. * persons subject to psychiatric care under articles l.3212-1 and l.3213-1 of the french public health code. * known cancer in progression. * known cirrhosis. * myocardial infarctions, stroke, subarachnoid hemorrhage or intracranial injury within 3 months prior to enrolment.

Keywords: acute stroke, biomarkers
study of immunoadsorption to treat severe atopical dermatitis associated with excessively high serum ige levels

Conditions: Dermatitis, Atopic

Summary: the purpose of this study is to determine whether immunoadsorption is effective in the treatment of severe atopic dermatitis associated with excessively high serum ige levels.


Eligibility criteria:
inclusion criteria: * atopical dermatitis * total serum ige level above 5000 ku/l * iga score of 3 or above * no sufficient response to topical corticosteroids/calcineurin inhibitors, uv therapy (at least 4 weeks of therapy), systemic corticosteroids and cyclosporin a (at least 8 weeks of therapy) or no possibility of a prolonged use of this therapy due to adverse events/contraindications * 18 years of age or above * effective contraception during therapy * informed consent exclusion criteria: * unfavorable conditions for peripheral venous access * known hypersensitivity or allergy towards materials used in the adsorber columns * adequate anticoagulation not possible (e.g. multiple allergies towards various anticoagulants) * extreme bleeding tendency during anticoagulation * hypercoagulability * severe cardiovascular disease forbidding extracorporeal circulation * severe systemic infection * serum igg level below 250 mg/dl * severe immunodeficiency (e.g. aids) * treatment with an ace inhibitor (discontinue drug at least 72 h before treatment) * pregnancy * lactation * a condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism or mental dysfunction)

Keywords: serum immunoglobulin e above 5000 ku/l
effect of glutamine supplemented nutrition support on protein and glutamine metabolism in burns

Conditions: Burns

Summary: the total parenteral nutrition (tpn)received as part of your routine burn care has optimal levels of protein and sugar, however the best mixture of amino acids for a patient with burn wounds is not yet known. amino acids occur naturally in the body and the food we eat. the body combines amino acids to make protein. it uses the proteins to do things such as heal wounds, fight infection, and provide energy. we are studying if the body's use of protein is increased after receiving tpn containing the amino acid called glutamine. we hope to learn the best composition of tpn so that the body can more efficiently repair wounded tissues and recover earlier from an acute burn injury.

human and animal studies have demonstrated that glutamine catabolism exceeds glutamine synthesis in burn patients, resulting in a glutamine-depleted status, which compromises liver function, including glutathione status, proline and arginine homeostasis and whole body protein balance (1). the purpose of this study is to directly quantify glutamine / glutamate kinetics in relation to glutamine / glutamate disposal and whole body amino acid balance, by using stable isotope tracers \[1-13c, 15n\]leucine and \[15n2\]urea. we hypothesize that the enrichment of amino acid mixtures with glutamine will attenuate overall body nitrogen catabolism and better maintain proline and arginine homeostasis. the purpose of this study it to 1) investigate the effect of glutamine supplemented total parenteral nutrition (tpn) on whole body metabolic and disposal rate of glutamine, and its rate of de novo synthesis in severely burned patients and 2)explore the impact of glutamine supplementation on whole body protein turnover, studied with l-\[1-13c, 15n}-leucine, and on the metabolic homeostasis of urea cycle.

Eligibility criteria:
inclusion criteria: burn patients being treated at mgh burn unit with one or more of the following criteria: 1) \>=5% tbsa; 2) inhalation injury; or 3) resting energy expenditure (ree) of \>15% of the predicted basal metabolic rate using the harris-benedict equation. must be receiving total parenteral nutrition in the course of their treatment. exclusion criteria: patients with thyroid disease. patients who are not hemodynamically stable or show unstable vital signs patients at the stage of major organ failure, e.g. renal and/or liver failure.

Keywords: parenteral nutrition burn injury stable isotopes glutamate metabolic kinetics glutamine metabolic kinetics
perioperative inflammation and cyclooxygenase 2 (cox-2)

Conditions: Neurosurgery; Pain

Summary: surgery initiates a complex cascade of events involving the release of chemical compounds from nerve endings and damaged tissue which leads to an inflammatory and pain response. the purpose of this investigation is to measure various chemical mediators in the blood and cerebrospinal fluid, and to test the hypothesis that they will be decreased in patients treated with a cox-2 inhibitor.

surgery initiates a complex cascade of events involving the release of nociceptive compounds from nerve endings and damaged tissue which leads to an inflammatory and hyperalgesic response. cox-2 inhibitors are often used for treating pain. this is a double-blind randomized study in surgical patients receiving a spinal drain for surgical purposes. the hypothesis is that valdecoxib will reach therapeutic concentrations in csf, and will decrease plasma and csf concentrations of inflammatory mediators. subjects will receive valdecoxib 40 mg or placebo approximately 1 hr prior to surgery. serial blood and csf samples will be obtained. valdecoxib and cytokine concentrations will be measured.

Eligibility criteria:
inclusion criteria: * patients undergoing surgery requiring lumbar drain placement exclusion criteria: * contraindication to cox-2 inhibitor (renal or hepatic insufficiency) * known adverse reaction to nonsteroidal anti-inflammatory drugs (nsaids) * use of nsaid or cox-2 within 7 days prior to surgery

Keywords: neurosurgery cox-2 inflammation pain
a study to evaluate the efficacy and safety of controlled release arbaclofen placarbil (xp19986) in patients with gastroesophageal reflux disease

Conditions: GERD

Summary: the purpose of the study is to evaluate the efficacy and safety of arbaclofen placarbil (xp19986) compared to placebo in patients with gastroesophageal reflux disease.


Eligibility criteria:
inclusion criteria: 1. history of gerd symptoms (e.g. heartburn episodes) at least 3 times per week 2. discontinuation of drugs used to treat gerd (ppis, h2-blockers) and/or drugs known to cause gerd symptoms (e.g. nonsteroidal anti-inflammatory drugs \[nsaids\]) for 7 days prior to baseline (visit 2); 3. had greater then or equal to 20 postprandial reflux episodes/2 hours recorded using impedance/ph monitoring during screening/baseline period (visit 2) exclusion criteria: 1. history of gastrointestinal disorders other than gerd that may have significantly affected the assessment of reflux episodes or gerd symptoms (e.g. barrett's esophagus, active gastric or duodenal ulcer disease, achalasia, scleroderma, etc.). 2. medical conditions that could have affected assessments of reflux episodes or gerd symptoms (e.g. history of nausea and/or vomiting, neurologic/psychiatric disorders, cardiac disease \[e.g. angina\], lung disease \[e.g. asthma, cough\], etc.)
neurally targeted cognitive training to augment cbt outcomes in pediatric anxiety

Conditions: Anxiety Disorders

Summary: this study will assign participants with anxiety to cognitive behavioral therapy (cbt) with computerized cognitive training (cct). in addition, the study will have a control group and enroll age- and gender-matched anxious children assigned to cbt. the hypothesis of this trial is that cct with cbt will further increase task control network (tcn) activation and connectivity. both groups will have one cbt therapy session each week for 12 weeks. however, for participants in the cct arm plus cbt they will also receive up to 4 weeks of at home cct to complete during the two weeks prior to the first cbt session and during the two weeks after the first cbt session. cct is to be done at home for approximately 30 minutes per day, 5 days per week. additionally, participants in the cct arm plus cbt will receive cct for 30 minutes just prior to cbt sessions 4-12. each group will also have pre and post therapy functional magnetic resonance imaging (fmri) and be asked to complete anxiety severity interviews and questionnaires throughout the study as well as after the treatment. update as of 4/7/2020: enrollment and in-person-only interactions/interventions are temporarily paused due to covid-19 and are expected to resume in the future. this is not a suspension of irb approval. update as of 7/20/2020: enrollment and in-person-only interactions/interventions are resumed.


Eligibility criteria:
inclusion criteria: * parent or guardian willing to give informed consent, and children willing to give informed assent to participate in the study * must be actively enrolled and maintain eligibility in dimensional brain behavior predictors of cbt outcomes in pediatric anxiety (hum00118950; p.i. fitzgerald) to participate in the study. exclusion criteria: * color blindness

Keywords: anxious cognitive behavioral therapy computerized cognitive training
cranial electrotherapy stimulation and acute stress

Conditions: Anxiety State

Summary: the goal of this study is to quantify the effects of 20 sessions of cranial electrotherapy stimulation (ces) on measures of acute stress responses in soldiers. the main question it aims to answer is how 20 sessions of ces will affect soldiers' biochemical (salivary alpha amylase and cortisol), physiological (e.g., heart rate, heart rate variability, respiration rate), emotional (state anxiety), and behavioral (i.e., cognitive task performance) responses. * on day 1, participants will complete a baseline measure assessing their biochemical, physiological, emotional, and behavioral responses to a stressful lethal force decision making task. * in the next four to six weeks, participants will complete 20 ces sessions. * within five days of completing the 20 ces sessions, participants will complete a follow-up measure assessing their biochemical, physiological, emotional, and behavioral responses to the same stressful lethal force decision making task they completed on day 1. researchers will compare the active ces group to the sham ces group to see how 20 sessions of active ces will affect the participants responses to their biochemical, physiological, emotional and behavioral responses relative to the sham ces group.


Eligibility criteria:
inclusion criteria: * 18-40 years of age (17-40 if emancipated minor) * can sit and stand freely. * have not used or experienced ces administration in the past. * agree to have their data stored in a repository (database) for future use. exclusion criteria: * use of prescription medications, other than oral contraceptives * women only: 1. pregnant or plan to become pregnant during the study 2. nursing * history of: 1. a neurological or psychological disorder (such as depression, anxiety disorders, migraines, cluster headaches, seizures, post-traumatic stress disorder (ptsd) or panic attacks). 2. cardiac disease (including arrhythmia or fast or skipped heart beats). 3. implanted medical devices, such as pacemakers. 4. hypertension. 5. insomnia 6. head injury (including neurosurgery, concussion, tbi, skull fracture, hematoma) 7. illness that caused brain injury 8. any other brain-related condition (such as traumatic brain injury) 9. metal in the head (outside of mouth, such as shrapnel, surgical clips, or fragments from welding or metalwork) 10. implanted medical device (e.g., pacemaker, insulin pump)

Keywords: cranial electrotherapy stimulation acute stress
twice daily prevacid for the treatment of laryngopharyngeal reflux

Conditions: Laryngopharyngeal Reflux

Summary: the purpose of this study is to determine whether treatment with twice-daily lansoprazole 30mg (prevacid 30mg) and behavioral modifications for reflux is superior to treatment with behavioral modifications for reflux alone in the treatment of laryngopharyngeal reflux (lpr).

laryngopharyngeal reflux (lpr) is a disorder caused by acid-induced damage to the larynx and pharynx (voice box and throat). the standard care for persons with this disorder is treatment with highly potent anti-acid medications (proton pump inhibitors - prevacid is one of these. nexium, aciphex and prilosec are others). these medications are currently approved by the fda for the treatment of gastroesophageal reflux disease (gerd). although the use of these medications in persons with lpr is widely accepted and sanctioned, this research is being done because these medications are not currently approved by the fda for this use. the purpose of this study is to determine whether treatment with twice-daily lansoprazole 30mg (prevacid 30mg) and behavioral modifications for reflux is superior to treatment with behavioral modifications for reflux alone in the treatment of laryngopharyngeal reflux (lpr).

Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of laryngopharyngeal reflux diagnosed by any combination of patient symptoms, physical/endoscopic findings, and 24 hr dual-probe ambulatory ph-testing. * 18 years of age or older exclusion criteria: * patients with life-threatening complications of laryngeal, pharyngeal or esophageal cancer, subglottic or tracheal stenosis, laryngeal papilloma, airway compromise * elite vocal performs with lpr-related dysphonia * under 18 years of age * pregnant and/or lactating women * persons with known hypersensitivity to any component of the formulation * patients taking theophylline, ketoconazole, ampicillin or digoxin * persons with hepatic and renal insufficiency

Keywords: laryngopharyngeal reflux gastroesophageal reflux disease gerd