Kornimate/medical-research-clean huggingface dataset:
a study to learn about the study medicine called pf-07799933 in people with advanced solid tumors with braf alterations.

Conditions: Melanoma; Non-Small-Cell Lung Cancer; Thyroid Cancer; Glioma

Summary: the purpose of this clinical trial is to learn about the safety and effects of the study medicine (called pf-07799933) administered as a single agent and in combination with other study medicines (called binimetinib) in people with solid tumors. this study is seeking participants who have an advanced solid tumor with a certain type of abnormal gene called "braf" and available treatments are no longer effective in controlling their cancer. all participants in this study will receive pf-07799933. pf-07799933 comes as a tablet to take by mouth, 2 times a day. depending on the part of the study, participants may also receive another study medicine: * people with melanoma or other solid tumors may also receive binimetinib. binimetinib comes as a tablet to take by mouth, 2 times a day. * people with colorectal cancer may also receive cetuximab. cetuximab will be given weekly (or every two weeks) in the clinic as a shot given in the vein or port (intravenous, iv). participants may receive the study medicines for about 2 years. the study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.


Eligibility criteria:
this study is seeking participants who meet the following eligibility criteria: inclusion criteria: * diagnosis of advanced/metastatic solid tumor including primary brain tumor. * qualifying braf alteration (v600 or non-v600 class ii/class iii braf alteration), in tumor tissue and/or blood (ie circulating tumor deoxyribonucleic acid \[dna\], or ctdna). * disease progressed during/following last prior treatment and no satisfactory alternative treatment options (part 1 and part 2). * tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies exclusion criteria: * brain metastasis larger than 4 cm * systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment. * for participants who may get binimetinib on study, history or current evidence of retinal vein occlusion (rvo) or concurrent neuromuscular disorder associated with elevated creatine kinase (ck)
effect of gabapentin on postoperative morphine consumption after sleeve gastrectomy

Conditions: Postoperative Complications

Summary: the evidence regarding effects of pain modulator like gabapentin on postoperative pain after sleeve gastrctomy is sparse. gabapentin has anti-hyperalgesic and postoperative opioid-sparing properties.this study will highlight the effectiveness of preoperative use of gabapentin for postoperative pain management in morbidly obese patients.

research problem: laprocopic sleeve gastrectomy is the most common surgical procedure performed for reducing weight in morbidly obese patients. laparoscopic surgery is considered to be less invasive than open surgery. the treatment of pain in obese patients is a challenge. administering opioids, can have an increasing effect of respiratory depression in patients already at risk of sleep apnea. the evidence regarding effects of pain modulator like gabapentin on postoperative pain after sleeve gastrctomy is sparse. gabapentin has anti-hyperalgesic and postoperative opioid-sparing properties. the analgesic effect of gabapentin appears to be related to the surgical procedure undertaken, a more procedure-specific evaluation is needed for different types of surgeries.. research significance: this study will highlight the effectiveness of preoperative use of gabapentin for postoperative pain management in morbidly obese patients. research objectives: to evaluate the effect of preoperative administration of gabapentin on postoperative pain, postoperative morphine consumption and preoperative anxiety in patients coming for laparoscopic sleeve gastrectomy. research methodology: inclusion criteria: asa i and ii, age 18-50 years, either sex, planned surgical procedure laparoscopic sleeve garstectomy, bmi 30-45 . exclusion criteria: patients taking any sedative, tranquillizers , history of sleep apnoea ,contraindications to gabapentin, methods patients will be randomly assigned into two groups, group-control and , group- gabapentin of 25 each. anesthesia and postoperative course will be standardized. vas scale will be used for assessment of preoperative anxiety and postoperative pain. post operatively pain assessment and morphine consumption will be performed for 24 hours in pacu and ward

Eligibility criteria:
inclusion criteria: * asa 1 and 2 * bmi 35 - 45 exclusion criteria: * patients taking any sedative or tranquillizers * any contraindication to gabapentin.
a prospective colorectal liver metastasis database with an integrated quality assurance program

Conditions: Liver Metastasis; Colorectal Carcinoma

Summary: this prospective database has two main objectives; * to evaluate the complication rates, 30-day and 90-day mortality from different surgical strategies for unresectable, borderline resectable or initially unresectable liver metastasis from colorectal cancer. * to establish baseline quality parameters for different surgical strategies for unresectable, borderline and initially unresectable colorectal liver metastasis (crlm) patients.


Eligibility criteria:
inclusion criteria: * with histologically proven colorectal adenocarcinoma with liver metastasis. * with unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer assessed by a clinician or by a multi-disciplinary tumor board (mdt). * unresectable is defined as no possibility of completely resecting all tumor due to size, location or number of deposits. * borderline is defined as potentially operable but technically or biologically more challenging to resect as evaluated by the mdt. * initially unresectable is defined as metastasis that have been down-sized after conversion chemotherapy and evaluated by the mdt to be resectable * discussed by a multidisciplinary team before surgery. * participants of the mdt must include at least one liver surgeon, one radiologist and one oncologist. they will determine the resectability of the crlm according to local practice. * with a possibility of a surgical procedure (resection with or without portal vein embolization, intraoperative local ablative technique or a combined approach) assessed during the mdt. * age ≥ 18 years. * before patient registration, written informed consent must be given according to ich/gcp, and national/local regulations. exclusion criteria: * any psychological, familial, or sociological condition potentially hampering understanding of the research project. * any other malignancy other than in situ carcinoma of the cervix or non-melanoma skin cancer (unless there has been a disease-free interval of at least 5 years)

Keywords: liver metastasis colorectal carcinoma unresectable borderline resectable initially unresectable
preclinical studies of omalizumab in chronic rhinosinusitis with nasal polyposis

Conditions: Chronic Rhinosinusitis With Nasal Polyps; Nasal Polyps

Summary: the goal of this study is to examine the mechanism of action of omalizumab in ex vivo tissue culture of whole human nasal polyps from patients with chronic rhino sinusitis with nasal polyposis (crswnp), such that specific molecular markers of inflammation can be identified.

objectives: aim 1. the investigation will identify the specific tissue compartment distribution of immunoglobulin e (ige) expression within human nasal polyps. colocalization studies will examine functional interaction of ige with effector cells. aim 2. the investigation will examine the direct effect of omalizumab on expression of type 2, 1, and 3 inflammatory pathways in human nasal polyp tissue from phenotypically characterized chronic rhinosinusitis with nasal polyposis (crswnp) patients. study rationale: human nasal polyps express high local tissue ige. however, the tissue distribution, cellular location and functional consequence of ige accumulation within the polyp tissue is not known. phase 3 studies of omalizumab demonstrated efficacy, with responders. however, the reason for non-responder outcomes in a subset of crswnp patients was not understood. therefore, the goal of this study is to examine the mechanism of action of omalizumab in crswnp, such that specific responders for this treatment can be identified and therapy can be optimally directed.

Eligibility criteria:
inclusion criteria: * sinonasal inflammation for greater than 12 weeks which include at least 2 of the following symptoms: nasal obstruction/congestion, nasal discharge (anterior or posterior), facial pressure/pain, reduction of sense of smell * confirmation of the clinical symptoms by (2a) ct scan evidence of paranasal sinus mucosal inflammation, and/or (2b) endoscopic exam evidence of purulence from the sinuses or ostiomeatal complex * presence of nasal polyps seen on endoscopic exam or sinus ct scan * adults from age of 18-100 will be eligible * all potential participants will be required to sign an institutional review board (irb) approved research consent form. exclusion criteria: * children under the age of 18 will be excluded * no pregnant or lactating females, prisoners, mentally disabled, or persons unable to give informed consent will be contemplated for inclusion. * the subject groups will also exclude those with disease secondary to a clearly defined anatomic process, such as facial trauma, and obstruction due to sinonasal neoplasm. * to eliminate confounding variables in our ex vivo experimental studies, any subject with a history of exposure to oral or systemic iv glucocorticoids within 2 weeks of surgery or any immunomodulatory biologics will be excluded. these include, but are not limited to systemic treatment with biologics omalizumab, dupilumab, mepolizumab, benralizumab, reslizumab, or rituximab.

Keywords: chronic rhinosinusitis with nasal polyps eosinophilic nasal polyposis nasal polyps
evaluation of improved outcomes among ambulatory diabetes and/or hypertensive patients - an intervention study (cpclint)

Conditions: Type 2 Diabetes Mellitus; Hypertension

Summary: the goal of this interventional study is to compare improved outcomes among diabetes and/or hypertensive patients sequel to educational intervention. the study aims to answer the following questions: * what are the patients' levels of health literacy, medication adherence, disease knowledge, attitude to disease, physical activity? * does educational intervention by pharmacists improve health outcomes of patients with diabetes and/or hypertension? * are there associations between patient-related variables such as health literacy, medication adherence, disease knowledge, attitude to disease? participants' anthropometric measurements and point-of-care testing for disease monitoring e.g., blood pressure, blood glucose would be carried out. baseline assessment of participants would be done to evaluate their levels of health literacy, medication adherence, disease knowledge, attitude to disease, physical activity. patients' baseline assessment would be carried out, after which they would receive educational materials and would be followed up by pharmacist. the baseline assessments would be repeated at three and six months after the intervention to measure the effectiveness of the intervention.

the anthropometric measurements would include weight, height, waist circumference, hip circumference, from which the body mass index and waist-hip ration would be calculated. the assessment of the disease knowledge and attitude would be done using validated semi-structured questionnaires earlier designed by the principal investigator and used among ambulatory patients with diabetes and/or hypertension accessing care in tertiary healthcare facilities. the validated international physical activity questionnaire (ipaq) would be utilized for participants' physical activity assessment.

Eligibility criteria:
inclusion criteria: * minimum of 18 years of age * patients must be diagnosed with diabetes and/or hypertension * patients must be on at least one medication * patients who access one of the selected community pharmacies for prescription refill exclusion criteria: * non-consented patients * patients not based at the study site

Keywords: diabetes hypertension interventional study health literacy physical activity medication adherence pharmacist community pharmacy
espb vs tpvb for postoperative analgesia after the nuss procedure

Conditions: Nerve Block; Analgesia; Pectus Excavatum

Summary: this is a prospective randomized double-blind non-inferiority trial designed to test the hypothesis that erector spinae plane block (espb) is non-inferior to thoracic paravertebral block (tpvb) in postoperative pain control after pectus excavatum repair.


Eligibility criteria:
inclusion criteria: * age between 4 to 18 years scheduled for elective nuss surgery written informed consent is obtained from parents of each patient. exclusion criteria: * coagulation dysfunction. american society of anesthesiologists physical status 4 or 5. allergy to study medication. local infection at the site of injection or systemic infection. inability to understand chinese.
students education training in emotional connection

Conditions: Child Development; Premature Birth

Summary: the purpose of this study is to assess the effectiveness of different educational modules in training graduate students from columbia university irving medical center campus and from the columbia school of social work to assess the emotional connection of mother/child dyads with accuracy. the investigators hypothesize that after completing the educational module involving recorded dyad interactions, subjects will achieve coding reliability with the pi.

the purpose of this study is to develop and test educational modules designed to instruct students how to assess the quality and strength of mother-child relationships. the approach will use constructs of emotional connection that were used in development of an investigational observation-based screening instrument, the welch emotional connection screen (wecs). the wecs allows healthcare providers to rate the emotional connection of a mother-child relationship in just a few minutes of observed face-to face interaction, and shows preliminary predictive properties when performed in the first year of life. administration of the wecs involves watching recorded interactions of a child sitting face-to-face on the mother's lap, and scoring the interaction on sliding scales per 4 domains. during the wecs development, the nurture science program of columbia university irving medical center created and coded hours of parent-child interaction videos. these videos will be used to assess and train the students (subjects) on rating mother/child dyads around emotional connection. subjects will rate the quality of mother-child relationships in video training sets after completing one of two educational modules: a) a lecture-style webinar describing evidence base and instructions on how to score the wecs b) a guide written in clear explicit translatable language (cetl). training set results of students in these groups will be compared to results of students who received no prior training. training set results will be analyzed for the reliability statistic between student scores and key scores established by writer of the scale and pi. subjects will then spend 3 months without further training in emotional connection or practice coding wecs. subjects will then rate the quality of mother-child relationships for videos of dyads they hadn't previously seen. the main outcome of this study is the comparison of reliability statistics and maintenance between students who completed different educational modules.

Eligibility criteria:
inclusion criteria: * graduate students from the columbia university irving medical center campus and from the columbia school of social work exclusion criteria: * refusal to participate

Keywords: emotional connection martha g. welch nursing education
investigating social competence in youth with autism

Conditions: Autism Spectrum Disorder

Summary: our treatment, sense theatre, combines several well-documented, effective behavioral strategies and theatre techniques. the proposed project will extend previous findings showing improving improvement in memory for faces. the multisite randomized control trial will include a large sample of 240 children with autism spectrum disorder (asd) randomly assigned to the experimental (sense theatre) or an active control condition (tackling teenage together).

recent findings from a randomized control trial (rct) show immediate between-group effects and evidence of target engagement on the hypothesized mechanism of action, memory for faces, which was evaluated by neuropsychological and event-related potential (erp) measures. moreover, the rct demonstrated treatment effects on social communication skills that generalized to home and community settings. finally, maintained treatment effects were observed on communication symptoms. the proposed project will extend these findings and provide a stronger test of efficacy using a multisite rct of sense theatre with a large sample of participants with asd (8 to 16 years) randomized to an experimental and an active control group. the rct will assess target engagement of memory for faces and functional change in social interaction with peers. thus, the overarching aim of the study is to determine whether detected changes in face memory and social interaction are due to the sense theatre treatment and the extent to which these changes generalize and maintain. if predicted results occur, it will provide strong empirical support for a community-based treatment that has generalized effects on a set of core deficits that otherwise have life-long consequences for children and adolescents with asd. 8/18/2021: record was updated to delete the outcome measure "computer memory for faces" as it was not included as a primary outcome variable in the institutional review board (irb) approved protocol dated 9/13/2017.

Eligibility criteria:
inclusion criteria: * children with high-functioning asd (iq \> or = to 70). exclusion criteria: * children who evidence aggression toward other people.

Keywords: autism
safety study of tecadenoson to treat atrial fibrillation

Conditions: Atrial Fibrillation

Summary: assess the tolerability and safety of a rapid bolus of tecadenoson at different dose levels when given alone and in combination with a beta-blocker (esmolol) in patients with atrial fibrillation to control rapid heart rate. explore the pharmacokinetic and pharmacodynamic effects when given alone and in combination with beta-blocker (esmolol).


Eligibility criteria:
inclusion criteria: * have a diagnosis of atrial fibrillation in need of treatment for rate control * be able and willing to abstain from any antiarrhythmics, including atrioventricular (av) nodal blocking agents (except for esmolol per protocol), from no later than 8:00 p.m. on the day prior to dosing until completion of the last dose period assessment * be able and willing to abstain from xanthine- or chocolate-containing foods, beverages, and medications * females must be post-menopausal or sterilized; or if of childbearing potential, must not be breastfeeding and must have a negative pregnancy test at screening and no intention of becoming pregnant during the course of the study. males and females must be using adequate contraception during the study. exclusion criteria: * have a known accessory pathway * have active myocardial ischemia or recent acute coronary syndrome * have acute or overt heart failure, bradycardia, heart block greater than first degree, or cardiogenic shock * have allergies or contraindications to treatment with esmolol or aminophylline, or any of their constituents * have a supine cuff systolic blood pressure \< 90 mm hg * be undergoing treatment with theophylline/aminophylline preparations, trental® (pentoxifylline), or carbamazepine * have asthma or other reactive airways disease currently on-treatment * have a history of an active or chronic pancreatic disease or clinically significant increased levels of serum amylase or lipase
patent foramen ovale (pfo) and risk of perioperative stroke

Conditions: Patent Foramen Ovale

Summary: this is a multi-centre, prospective cohort study to determine if asymptomatic pfo is a risk factor for developing perioperative overt and covert stroke in patients undergoing non-cardiac surgery.

there is emerging evidence regarding the increased risk of perioperative stroke in patients with pfo, leading to an important clinical practice question: whether pfo should be considered in the perioperative risk assessment in non-cardiac surgery patients. the evidence base, however, comes from retrospective studies with numerous limitations. patients referred for general, orthopedic, urological, gynecologic, spinal, or thoracic surgery will be screened and consented during the surgery pre-admission clinic visit, and then undergo pfo screening using transcranial doppler (tcd) and transthoracic echocardiography (tte). patients screened pfo+ (n=102) and matched pfo- controls (n=102) will have dw-mri between postoperative days 2 and 7. study personnel will conduct phone surveys at 30-day and 1-year post-surgery to collect data on other clinical outcomes. patients will also be administered cognitive and patient-reported outcome measures assessments before enrollment, and 30-day and 1-year follow-up.

Eligibility criteria:
inclusion criteria: 1. patients 18 years and above; 2. referred for an elective, non-cardiac, non-vascular and non-brain surgery; 3. with an estimated hospital length of stay ≥2 days. we will include patients referred for general, orthopedic, urological, gynecologic, spinal or thoracic surgery. exclusion criteria: 1. patients in need for long-term, perioperative anticoagulants; 2. those with comorbidities that potentially increase the risk of perioperative stroke; 3. contraindications to mri; 4. unable to complete or adhere to the study.

Keywords: patent foramen ovale perioperative stroke diffusion-weighted magnetic resonance imaging