Kornimate/medical-research-clean huggingface dataset:
her-2 mutations in tumor samples from patients with advanced non-small cell lung cancer treated on clinical trial ecog-2598

Conditions: Lung Cancer

Summary: rationale: collecting samples of tumor tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in dna and identify biomarkers related to cancer. purpose: this laboratory study is looking at her-2 mutations in tumor samples from patients with advanced non-small cell lung cancer being treated with trastuzumab on clinical trial ecog-2598.

objectives: * correlate clinical response to trastuzumab (herceptin®) with the presence of mutation in the her-2 kinase domain in tumor samples from patients with advanced non-small cell lung cancer treated on protocol ecog-2598. * correlate mutations with time to progression and survival of these patients. outline: this is a multicenter study. tissue specimens are analyzed by polymerase chain reaction to assess mutations in the her-2 gene. laboratory/biomarker analysis data is correlated with clinical data from protocol ecog-2598. projected accrual: a total of 22-44 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of non-small cell lung cancer meeting ≥ 1 of the following criteria: * recurrent disease * stage iiib with pleural or pericardial effusion * stage iv disease * treated on protocol ecog-2598 patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: recurrent non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer
mechanisms of pharyngeal collapse in sleep apnea, study b

Conditions: Sleep Apnea

Summary: in obstructive sleep apnea (osa), the upper airway recurrently closes during sleep. the mechanisms that lead to airway closure are not completely understood. some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (progressive expiratory narrowing, pen) preceding an obstructive apnea. the cause of pen is unknown. the investigators will test if lung volumes and low respiratory drive play a role in pen.

the mechanisms that lead to airway closure in osa are not completely understood. some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (progressive expiratory narrowing, pen) preceding an obstructive apnea. the investigators will test if lung volumes and low respiratory drive play a role in pen. to this end, the investigators will visualize the pharynx of sleep apnea patients during sleep using a thin endoscope during sleep while simultaneously measuring lung volumes, genioglossus electromyogram, and pharyngeal pressure during flow-limited breaths. flow limitation will be induced by sustained reductions of continuous positive airway pressure (cpap).

Eligibility criteria:
inclusion criteria: * normal subjects or patients with osa exclusion criteria: * any unstable cardiac condition (other than well controlled hypertension) or pulmonary problems. * any medication known to influence breathing, sleep/arousal or muscle physiology * concurrent sleep disorders (insomnia, narcolepsy, central sleep apnea or parasomnia) * claustrophobia * inability to sleep supine * allergy to lidocaine or oxymetazoline hydroclhoride * for women: pregnancy

Keywords: sleep apnea pathophysiology
oxtellar extended release (oxcarbazepine extended release) patients with trigeminal neuralgia

Conditions: Trigeminal Neuralgia

Summary: to evaluate the affect oxtellar xr (extended release) has on neurology patients with trigeminal neuralgia (tn), and if it impacts their quality of life.

oxcarbazepine has been used off-label for tn for many years, but has a twice daily dosing. with the once daily dosing it should theoretically help with patient adherence and possibly decrease side effects, which is common with extended release formulations. specifically the investigators are looking at how well tolerated oxtellar xr is, and if it has the same efficacy as standard treatments. it is a pilot study, so it will be difficult to gather data and have powerful outcomes, but this will give pilot data for future trials. patients will be screened for inclusion and exclusion criteria and after will participate in 3 visits following the initial one. various tests will be administered to measure treatment satisfaction and tolerability throughout the visits. the patients will not have to pay for any of the study visits or medications. a parking voucher will be provided as needed.

Eligibility criteria:
inclusion criteria: * age \> 18 to 75 * subject reported history of trigeminal neuralgia average pain rated as \> lower end of moderate on the vas * trigeminal neuralgia diagnosis (primary or type 1 or idiopathic tn) * history of pain rated as at least a 4 on the visual analog scale (vas) * treatment naïve * patients who do not tolerate carbamazepine * women of reproductive age who agree to highly effective birth control * complete blood count (cbc) 30 days prior to entering study * comprehensive metabolic panel (cmp) 30 days prior to entering study exclusion criteria: * intolerance/hypersensitivity to trileptal, oxcarbazepine, or oxtellar * psychosis, drug/alcohol misuse, or malignancy (except skin cancer) within the last 2 years * any clinically significant medical condition that would prevent study from being completed safely (determined by subjects current neurologist) * current seizure disorder or history of seizures * pregnant females * breastfeeding females * women of reproductive age not using or unwilling to utilize highly effective contraception (defined as double-barrier method) * a severe pain condition, other than trigeminal neuralgia, which may impair the self-assessment of pain due to trigeminal neuralgia * concurrent medication treatment with: equetro, phenytoin, dilantin, phenytek, oxcarbazepine, trileptal, rifampin, rifadin, rimactane and st. john wort * renal impairment or hemodialysis * hepatic impairment * history of hyponatremia (serum sodium \< 125 ng/dl)
new-onset heart blocks after noncardiac surgery: a retrospective study of more than 280,000 patients

Conditions: Heart Block; Risk Factor

Summary: this study aimed to investigate new-onset heart blocks after noncardiac surgery, identify risk factors, and develop a prediction model.

objective: this study aimed to investigate new-onset heart blocks after noncardiac surgery, identify risk factors, and develop a prediction model. methods: a retrospective cohort study included 281,497 patients aged 18 or older who underwent noncardiac surgery at a single center between jan 2008 and aug 2019. the main outcome was postoperative new-onset heart blocks within one year, including atrioventricular and bundle blocks. prognostic impact was assessed using kaplan-meier survival curves and time-dependent cox regression analysis. perioperative data was used for machine learning models (logistic regression, support vector machine, random forest, decision tree). model performance was measured using the area under the receiver operating characteristic curve (auc).

Eligibility criteria:
inclusion criteria: * patients above 18 yrs undergoing noncardiac surgery at the first medical center of the chinese people's liberation army general hospital (plagh) from january 1, 2008 to august 1, 2019. exclusion criteria: * surgical duration of less than 30 minutes * incomplete data

Keywords: postoperative new-onset heart blocks noncardiac surgery machine learning prediction model prognosis
robot therapy in pediatric emergency

Conditions: Child, Only

Summary: the investigators are evaluating if the use of humanoid robots is an optimal distraction strategy in order to produce positive emotional states and facilitate the diagnosis and to reduce treatment time in pediatric age in emergency situations.


Eligibility criteria:
inclusion criteria: * children between the ages of 3 and 10 with white, green and yellow triage code exclusion criteria: * red triage code * inadequate knowledge of the italian language, * yellow triage code in case of: headache for recent trauma with visual impairment; headache with neck rigidity or vomiting; indifference to the environment; dyspnea and increased respiratory work; intoxication by inhalation of toxic substances; significant trauma to the head with altered state of consciousness.
role of nutrition in patients over 75 years of age with stroke

Conditions: Stroke

Summary: stroke in elderly subjects has a more severe clinical presentation (in terms of frequency of aphasia, hemiplegia or consciousness disorders), and a worse functional and vital prognosis. patients older than 75 years also show excess mortality. one of the hypotheses to explain this situation is the high level of frailty in this population. many tools to measure the concept of frailty have been developed. one important dimension of these tools is the nutritional status. indeed, protein-energy malnutrition in the elderly, though a frequent situation, is also a complex phenomenon. the aim of this study is therefore to analyse the impact of protein-energy malnutrition, as a marker of frailty, on the early prognosis (at 28 days) in the aftermath of stroke in subjects older than 75 years hospitalized in dijon chu.


Eligibility criteria:
inclusion criteria: * patients with symptomatic stroke defined according to who criteria (including cerebral infarction and intracerebral haemorrhage) managed at the stroke icu, neurology 1, neurology 2, internal medicine 2 or geriatrics at dijon chu during the period from 1st november 2015 to 30th september 2016. * patients aged 75 years and older. * patients who have provided informed consent to take part in the study. exclusion criteria: * patients with meningeal haemorrhage or tia. * patients who refuse to take part in the study. * patients with hypo-albuminemia not related to malnutrition: chronic infectious or inflammatory syndrome, nephrotic syndrome, exudative enteropathy, hydration disorders. * subjects in custody. * patients (or person of trust) who cannot be contacted by telephone during the follow-up.
infant severe sepsis and bacterial meningitis in malawi

Conditions: Infant Bacterial Meningitis

Summary: this study aims to improve the outcome of infants (\<2 months) with severe sepsis and meningitis at the queen elizabeth central hospital, blantyre, malawi. currently who recommends the treatment of infant severe sepsis and bacterial meningitis with 14 to 21 day course of penicillin and gentamicin as first line. the second line treatment is cefotaxime or ceftriaxone. severe bacterial infections are common in infants under 2 months of age and the mortality is very high (\~50%). there are several reasons for this; one is that the first line antibiotics used are no longer as effective as they used to be. bacterial resistance to the first line antibiotics has increased and some infections especially of the central nervous system may only be partly treated and not eradicated by present therapy. first line treatment is cheap and available but requires 4 injections a day, for at least 14 days, a total of 58 injections. many mothers find this number too much and abscond. the investigators second line therapy is ceftriaxone which is also available and cheap and the advantage of being given as a daily injection. the disadvantage is that it can cause (reversible) jaundice particularly in premature babies and it must not be given with calcium products. the investigators do not give calcium to the investigators infants as the investigators cannot routinely check electrolytes. all the most common causes of bacterial meningitis in this age group in the investigators setting are sensitive to ceftriaxone. the investigators wish to undertake an open randomized trial of penicillin and gentamicin v ceftriaxone as first line treatment for infant meningitis. the investigators are able to monitor for side effects. the investigators hypothesise that the ceftriaxone arm will have 20% less deaths that the penicillin and gentamicin group.


Eligibility criteria:
inclusion criteria: * children less than 2 months * suspicion of bacterial meningitis * parental/guardian informed consent exclusion criteria: * infant with hyperbilirubinaemia * infant requiring calcium * infant know to be hypersensitive to any of the three drugs * infant who has been an inpatient for more than 72 hours * infant with congenital central nervous system abnormalities
opicapone as adjunctive therapy to levodopa-carbidopa intestinal gel in parkinson's disease

Conditions: Parkinson Disease; Effect of Drug

Summary: levodopa-carbidopa intestinal gel (lcig) is an effective therapy for complicated parkinson's disease (pd). few studies have explored the efficacy and safety of the potential combination of lcig with catechol-o-methyltransferase (comt) inhibitors, particularly opicapone (opc).

22 pd patients were randomized into lcig monotherapy (n-opc 11 patients) and lcig+opc (add-opc 11 patients), further divided according to opc adding time (e-opc within one month and l-opc after one month from lcig implant). data on pd clinical aspects, montreal cognitive assessment (moca), unified parkinson's disease rating scale (updrs), unified dyskinesia rating scale (udysrs), electroneurography (eng), and pharmacological therapy (levodopa equivalent dose-ledd) were collected before lcig implanted (t0) and in the following 12 (t1) months.

Eligibility criteria:
inclusion criteria: 1. lcig implantation not longer than 30 months before the study enrollment, 2. presence of nocturnal akinesia (assessed by medical history and through item 2.9 of mds-updrs part ii (\> 2), or/and 3. persistence of morning or afternoon akinesia (assessed by item 4.3 in mds updrs -iv( \>2 ). exclusion criteria: 1. hoehn \& yahr (h\&y) \>4, 2. cognitive decline (moca\< 17), 3. more than 30 months after lcig positioning, 4. not compliant with treatment and follow-up visits.
a study of baricitinib (ly3009104) in participants from 2 years to less than 18 years old with active jia-associated uveitis or chronic anterior antinuclear antibody-positive uveitis

Conditions: Uveitis

Summary: the reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with active juvenile idiopathic arthritis (jia)-associated uveitis or chronic anterior antinuclear antibody-positive uveitis from 2 years to less than 18 years old.


Eligibility criteria:
inclusion criteria: * participants must have a diagnosis of jia-u or chronic anterior antinuclear antibody (ana) positive uveitis without systemic features. * participants must have active anterior uveitis, defined as cellular infiltrate in the anterior chamber of sun criteria grade ≥1+ at screening and randomization, despite prior treatment with adequate doses of topical steroid therapy and methotrexate (mtx). * participants must have an inadequate response or intolerance to mtx. * participants must be on a stable dose of corticosteroid eye drops for at least 2 weeks prior to screening with a maximum of 4 drops/day/eye at screening. * participants and their partners of child bearing potential must agree to use 2 effective methods of contraception for the duration of the study and for at least 1 week following the last dose of investigational product. exclusion criteria: * participants must not have a history or presence of any autoimmune inflammatory condition other than jia, such as crohn's disease or ulcerative colitis. * participants must not have any contraindications to adalimumab. * exception: participants who are biologic disease-modifying antirheumatic drug (bdmard) inadequate response or intolerance with a contraindication to adalimumab may be enrolled, as they will be assigned to baricitinib. * participants must not have increased intraocular pressure ≥25 millimeters of mercury (mm hg) or that required treatment, including increases in medications, surgery, or hospitalization, within 4 weeks prior to baseline that, in the opinion of the investigator, would pose an unacceptable risk to the participant. * participants must not have had intraocular surgery within the 3 months prior to screening (such as for cataract(s), glaucoma or vitrectomy). * participants must not have a current or recent (\<4 weeks prior to baseline) infection. * participants must not have a positive test for hepatitis b virus (hbv) at screening. * participants must not have evidence of active tuberculosis (tb) or untreated latent tb.
performance of symmcora® vs. v-loc® suture material in patients undergoing laparoscopic total hysterectomy

Conditions: Abnormal Uterine Bleeding; Endometriosis; Uterine Prolapse; Uterine Cancer; Ovarian Cancer; Fallopian Tube Cancer; Cervical Cancer; Endometrial Cancer

Summary: the aim of this study is to show the superiority of the new unidirectional barbed suture (symmcora® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic surgeries without an increase in the complication rate. secondly, the superiority of symmcora®, mid-term unidirectional compared to the v-loc®, unidirectional will be assessed regarding the mean time to close the vaginal cuff. the study will be performed in routine clinical setting, the only difference will be the randomization into two different suture groups. both suture materials which will be applied to approximate the vaginal cuff are approved and carrying the ce-marks. additionally, both sutures will be applied in their intended use. neither additional invasive measures nor additional burden in regard to the patient will be performed.


Eligibility criteria:
inclusion criteria: * females undergoing an elective, laparoscopic total hysterectomy * age ≥ 18 years * written informed consent exclusion criteria: * emergency surgery * open surgery * patients undergone immunosuppressive drug treatment within the prior 6 months * patients with hypersensitivity or allergy to the suture material. * participation in another clinical study * non-compliance of patient

Keywords: barbed suture hysterectomy laparoscopy minimal invasive
study of ono-7914 alone and in combination with ono-4538 in patients with solid tumors

Conditions: Solid Tumor

Summary: this study is dose escalation study to evaluate the tolerability and safety of ono-7914 alone and in combination with ono-4538 in patients with advanced or metastatic solid tumors


Eligibility criteria:
inclusion criteria: 1. patients with advanced or metastatic solid tumor 2. patients with ecog performance status of 0 or 1 3. patients with a life expectancy of at least 3 months exclusion criteria: 1. patients with severe complication 2. patients judged to be incapable of providing consent for reasons such as concurrent dementia
cherl, connecting primary care patients with community resources to facilitate behavior change

Conditions: Tobacco Use Disorder; Alcohol Abuse; Lack of Physical Activity; Poor Diet

Summary: the investigators want to find out if providing a community health educator referral liaison (cherl) helps practices help their patients change risky behaviors (tobacco use, physical inactivity, unhealthy diet, and risky drinking) by connecting patients to available services in the community or directly providing behavior change support.

what is this about? prescription for health (p4h) is a national initiative funded by the robert wood johnson foundation. nine projects have been funded nationally in this second round to advance the goals of improving health behavior identification and delivery in primary care practice. each project is conducted through a practice-based research network (pbrn). in michigan, our pbrn is called the great lakes research in practice network (grin). what is the purpose of the cherl project? in our study, we want to find out if providing a community health educator referral liaison (cherl) helps practices help their patients change risky behaviors (tobacco use, physical inactivity, unhealthy diet, and risky drinking) by connecting patients to available services in the community or directly providing behavior change support. primary care providers play a key roll in encouraging patients to choose healthy behaviors. however, effective behavior change requires long term follow up and support that may not be readily available within the office practice. cherl can help provide or link to those services thus helping the healthy message promoted by the clinician to have a more powerful and lasting effect. what is the cherl intervention? with this funding, we will hire and train a cherl to work with practices. the purpose of the cherl is for him/her to help secure behavior change support for your patients either by referring to an available resource within the community or directly providing the service. this service is available to patients with or without chronic disease diagnoses (i.e, patients with diabetes, heart disease, hypertension, obesity, back pain, lung disease, or generally healthy with opportunities to change unhealthy habits). patients are referred to the cherl and he/she will determine an appropriate next step for your patient - either referral to a community program or the cherl will provide brief telephone counseling. the health care provider will receive feedback specifically on each patient referred. in addition, some practices (consultant-enhanced) will receive additional assistance from the cherl, as he/she serves as a consultant to the practice, helping the practice to identify systematic mechanisms for identification and referral of at risk patients to the cherl.

Eligibility criteria:
inclusion criteria: * patients, clinicians, and their staff participating in this grin study. exclusion criteria: * patients, clinicians, and their staff who are not participating in this grin study.

Keywords: tobacco use