Kornimate/medical-research-clean huggingface dataset:
cervical spine motion during tracheal intubation: video laryngoscope vs rigid video stylet

Conditions: Intubation

Summary: in this study, investigators are going to compare cervical spine motion during tracheal intubation using video laryngoscope or rigid video stylet in patients with simulated cervical immobilization.

in patients with an unstable cervical spine, neck extension during tracheal intubation may result in harmful events such as spinal cord injury. thus, it is important to minimize cervical spine motion in these patients. in this randomized crossover study, investigators are going to compare cervical spine motion during tracheal intubation using video laryngoscope or rigid video stylet in patients with simulated cervical immobilization.

Eligibility criteria:
inclusion criteria: * patients aged 18-80 years undergoing elective endovascular cerebral aneurysm coiling to general anesthesia in a neuroangiography suite exclusion criteria: * patients with upper airway abnormalities such as inflammation, abscesses, tumors, polyps, and trauma * patients with a medical history of gastroesophageal reflux disease and previous airway surgery, at high risk for aspiration, coagulation disorders, or a hunt hess grade of 3-5

Keywords: cervical spine motion video laryngoscope rigid video stylet
evaluation of same for hot flashes

Conditions: Healthy, no Evidence of Disease; Hot Flashes

Summary: rationale: s-adenosyl-l-methionine may help relieve hot flashes in women based upon its ability to potentially modulate serotonin. purpose: this phase ii trial is studying the side effects and how well s-adenosyl-l-methionine works in treating hot flashes in women with a history of breast cancer or those who do not wish to take estrogen due to a perceived increased risk of breast cancer.

objectives: i. to evaluate the impact of same on hot flash scores in women with a history of breast cancer or women who do not wish to take estrogen therapy for fear of increased risk of breast cancer. ii. to evaluate the toxicity of same in this study population. iii. to evaluate the effect of same using quality-of-life (qol) measures. outline: during the first week, participants will complete a daily, prospective hot flash diary and complete baseline questionnaires and will not be taking any study medication. after this baseline week, participants will receive oral s-adenosyl-l-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.

Eligibility criteria:
inclusion criteria: * women with a history of breast cancer (currently without malignant disease) or women who have no history of breast cancer but who wish to avoid estrogen due to a perceived increased risk of breast cancer * bothersome hot flashes (defined by their occurrence \>= 14 times per week and of sufficient severity to make the patient desire therapeutic intervention) * presence of hot flashes for \>= 1 month prior to registration * life expectancy \>= 6 months * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1 * ability to complete questionnaire(s) by themselves or with assistance * negative pregnancy test done =\< 7 days prior to registration for women of childbearing potential only exclusion criteria: * any of the following current (=\ = 4 weeks and must not be expected to stop the medication during the study period): antineoplastic chemotherapy, androgens, estrogens, progestational agents, other herbal supplements, including soy, vitamin e, flaxseed, and megadose vitamins (herbal teas, multivitamins, and vitamin d are allowed), warfarin (1 mg of daily warfarin is allowed for central line patency), medications interacting with same (antidepressants, monoamine oxidase (mao) inhibitors, meperidine, dextromethorphan, pentazocine, tramadol, gabapentin, and levodopa) * pregnant women * nursing women * women of childbearing potential who are unwilling to employ adequate contraception * known allergy to same * current use or use within the past 6 months of same * clinically significant acute or chronic progressive or unstable neurologic, psychiatric, hepatic, renal, cardiovascular, respiratory, metabolic, or systemic disease precluding participation in the study * history of bipolar disorder or parkinsonism

Keywords: hot flashes, dietary supplements, symptom management
evaluation of the "intranasal fentanyl" protocol in pediatric surgical emergencies at strasbourg university hospital

Conditions: Musculoskeletal Pain

Summary: emergency trauma departments receive thousands of patients each year whose main symptom is pain. in recent years, intranasal fentanyl (fin) has entered the therapeutic arsenal to treat pain in the emergency department. various studies have validated its effectiveness for musculoskeletal pain as well as its tolerance and safety of use. since then, new protocols have been implemented including this treatment. in this study, the investigators propose to retrospectively study the quality of prescription of intranasal fentanyl in the treatment of pain in the emergency department and the quality of monitoring of this treatment in current practice.


Eligibility criteria:
inclusion criteria: * child \< 18 years old * child treated in the pediatric emergency department of strasbourg university hospital * child who has benefited from intranasal fentanyl between 08/01/2022 and 09/31/2024. * child (and/or his/her parental authority) who has not expressed, after information, his/her (their) opposition to the reuse of his/her health data for the purposes of this research. exclusion criteria: * refusal of the child (and/or his/her parent) to participate in the study * patient's medical file not incomplete * child not domiciled in france.

Keywords: pain syndrome intranasal fentanyl pediatric pediatric surgical emergency
cognitive strategies for weight loss

Conditions: Obesity

Summary: the goal of this clinical trial is to compare weight change and other related outcomes associated with three different behavioral weight loss interventions (standard behavioral, prevent, and promote) in adults with obesity. the main questions it aims to answer are: * which of the three internet-delivered weight loss programs results in the greatest weight loss? * how do key weight-related behaviors (e.g., adherence, diet, physical activity) differ across the arms? * what individual characteristics predict success in each arm? * what are the underlying mechanisms of each approach? * are there any potential adverse outcomes associated with any of the conditions (e.g., depression, weight stigmatization, increased body image concerns). participants will: * signed informed consent * complete a baseline assessment * be randomized to 12 months of either standard ibwl, prevent or promote * complete a training workshop to learn arm-specific cognitive strategies * complete a 12-month internet-delivered weight loss program, requiring self-monitoring of intake and exercise and viewing of 12 weekly lessons followed by 9 monthly lessons * complete an assessment at 3 months (during treatment) * complete a refresher workshop on arm-specific cognitive strategies at 3 months * complete an assessment at 6 months (during treatment), 12 months (at the conclusion of treatment), and 18 months (6 months after treatment


Eligibility criteria:
inclusion criteria: * participants will be between the ages of 18 and 70, have a bmi between 25 and 45 kg/m2, and have regular (i.e., weekly) access to the internet, defined as owning a smart phone with internet capabilities, and/or having a broadband or wi-fi connection at home or work. exclusion criteria: * exclusionary criteria include: 1) current enrollment in a weight loss program, 2) currently taking weight loss medications, 3) history of bariatric surgery or planned bariatric surgery in the next 18 months, 4) individuals who are pregnant, nursing, or have plans to become pregnant within the next 18 months, 5) individuals planning to relocate outside the area in the next 18 months, 6) any medical condition for which weight loss would be contraindicated, 7) neurological or psychiatric conditions including but not limited to schizophrenia and bipolar disorder, 8) inability to attend assessments at the weight control and diabetes research center in providence, ri. individuals with mobility issues, dizziness, or history of heart disease, diabetes, or cancer will be required to provide physician consent prior to enrolling.
kidney function indexed extracellular volume before and after obesity surgery

Conditions: Obesity

Summary: obesity promotes chronic kidney disease and is accelerating its shift to the stage of renal replacement. bariatric surgery is a treatment for severe or morbid obesity whose renal benefit is currently unknown. the glomerular filtration rate (gfr) is the best parameter to define the kidney function. it can be estimated using formulas by assaying endogenous markers (creatinine, cystatin c) or measured with an exogenous tracer glomerular filtration (51 cr-edta). bariatric surgery alters the production of endogenous markers and the extracellular volume (vec) with 2 important consequences on the assessment of gfr: the formula to estimate gfr is not possible to compare renal function before and after surgery because of the variation in production of endogenous glomerular filtration markers in the same subject; decreasing vec predicted decreased gfr after surgery, since these parameters are in part proportional to each other. our working hypothesis is that bariatric surgery protects the kidneys of patients with chronic kidney disease. to demonstrate this, investigators propose to compare the ratio dfg / vec before and after gastric bypass. goals the main objective is to measure the effect of gastric bypass on the report dfg / vec. secondary objectives are to assess the effect of gastric bypass on the albumin / urine creatinine and evaluate the performance of the main gfr estimating formulas in people with severe or morbid obesity.


Eligibility criteria:
inclusion criteria: * topic gfr estimated by having the simplified formula of mdrd \<60 ml / min / 1.73 m² * topic with bmi ≥ 40 kg / m², or ≥ 35 kg / m² * subject having at least one comorbidity could be improved after surgery after failure of medical treatment: hypertension , osahs and other severe respiratory disorders, severe metabolic disorders, particularly type 2 diabetes , debilitating musculoskeletal diseases, steatohepatitis nonalcoholic . * topic who signed the informed consent * topic affiliated to the social security * male or female topics * elderly 18 to 70 inclusive exclusion criteria: * non- caucasian person because the necessary correction factors and not always available for the formula to estimate gfr ( cockcroft , salazar and corcoran ) . * no major under guardianship * nobody hospitalized without his consent and not protected by law * private person of liberty * pregnant woman, knowing that a pregnancy test will be performed for women of childbearing age . results will be communicated to the patient by a doctor of his choice. * rapidly progressive glomerulonephritis * nephrotic proteinuria ranking
a safety tolerance and experimental hyperalgesia study of oral ngx426 in healthy male voluneteers

Conditions: Healthy; Hyperalgesia

Summary: the purpose of this study is to determine the effects of ngx426 on intradermal capsaicin induced pain in hyperalgesia.


Eligibility criteria:
inclusion criteria: * healthy males, age 21-55 exclusion criteria: * allergy to study drug
markers for predicting risk of breast cancer in women of different races

Conditions: Breast Cancer

Summary: this research is being done to learn more about the risk of developing breast cancer by studying cells from both normal breast tissue and breast cancer tumor tissue. the goal is to study cells, genes, and gene products to help us to learn how to detect cancer in its earliest stages, and if this information may differ in patients with different ethnic backgrounds.

evidence suggests that, besides reduced access to care, the increase in breast cancer incidence and mortality in aa (african american) compared to ea (european american or caucasian) women is influenced by the biology of the tumor. gene methylation changes caused by environmental factors starting at birth is one mechanism through which genetic and non-genetic factors could affect development of breast cancer and which could underlie disparities in aggressiveness. the investigators were the first to show that a panel of genes was hypermethylated specifically in aa-er-negative tumors in young women in comparison to ea-tumors in women of the same age. gene promoter methylation is found at low levels in healthy breast tissues from women without cancer. race and family history of cancer increase the likelihood of these early events. thus, epigenetic changes may be early events in transformation of breast cells and tumor formation. this study will enroll women from different ethnic backgrounds undergoing mastectomy in order to collect normal and tumor tissue to study these genetic changes and breast cancer risk.

Eligibility criteria:
inclusion criteria: * women * 18 years and older * histologically proven infiltrating carcinoma of the breast on diagnostic biopsy. note: individuals planning bilateral mastectomy procedures (for either bilateral cancers or contralateral prophylactic procedures) either at the same time or in the future will be asked to have tissue removed for the study from both breasts. * er-negative, any pr status, and any her2 status (i.e., er-, pr any, her2- or er-, pr any, her2+; "triple positive" breast cancers are not eligible). * unresected, untreated breast cancer planning surgical management with mastectomy (with or without axillary nodal evaluation/dissection and/or with any other clinical assessment). * willing and able to sign an informed consent form exclusion criteria: * none.

Keywords: mastectomy
pregabalin (lyrica) for the treatment of restless legs syndrome

Conditions: Restless Legs Syndrome

Summary: this study will evaluate the safety and efficacy of pregabalin (lyrica) in treating patients with restless legs syndrome (rls) in a double-blind, placebo-controlled trial.


Eligibility criteria:
inclusion criteria: 1. outpatients with rls diagnosed by a movement disorder specialist/ sleep specialist . 2. patients must report some degree of pain which occurs on a regular basis. 3. age 18 years to 80 years. 4. women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study. 5. stable doses of all medications for 30 days prior to study entry and for the duration of the study. 6. willing and able to provide informed consent. 7. willing to comply with protocol. - exclusion criteria: 1. any illness that in the investigator's opinion preclude participation in this study. 2. pregnancy or lactation. 3. concurrent participation in another clinical study. 4. current treatment with a dopamine agonist (unless stopped at least 2 weeks prior to baseline). 5. dementia or other psychiatric illness that prevents the patient from giving informed consent (mini mental status exam score less than 24). 6. legal incapacity or limited legal capacity. 7. presence of severe renal disease bun 50% greater than normal, patients must have evidence from their pcp or urologists of normal psa and urodynamic tests within the last 12 month. normal bun levels should be within a range of 5 to 20 mg/ d l and creatinine between .7 and 1.4 mg/ d l. labs will be requested from pcp. 8. presence of major hepatic impairment (cirrhosis, viral hepatitis, nonalcoholic steatohepatitis, wilson's disease, or hemochromatosis). lft must show non-clinically significant results (albumin range 3.0-6.0; alkaline phosphatase range 40-150; alt range 0-55; ast range 5-34). 9. presence of severe daytime sleepiness. 10. present complaints of somnolence, dizziness, blurred vision, bleeding tendencies, cardiac abnormalities. 11. patients taking dopamine agonists for any condition other than rls. -

Keywords: restless legs syndrome rls pregabalin lyrica
clinical evaluation of carestream dual energy and digital tomosynthesis

Conditions: Solitary Pulmonary Nodules

Summary: the purpose of this study is to evaluate the imaging performance of dual energy and digital tomosynthesis (de-dt) application against the commercially available predicate devices.

the acquisition system will consist of using site equipment including the carestream drx-evolution x-ray system, and the predicate carestream drx plus detector and the investigational de-dt application. de study design thirty to forty (30-40) patients will receive a dr standard of care chest exam using the drx plus detector and a de exam. each de patient exam includes high energy and low energy image exposures using the investigational device. these images are used by the de console software to generate additional de images (e.g. bone and soft tissue). dt study design fifteen to twenty (15-20) patients will receive a dr standard of care chest exam using the drx plus detector, and a dt exam. each dt patient exam includes a scout image (chest pa) and a dt scan using the investigational dt sw. the dt scan is used by the dt console software to generate tomographic images. 11 phantoms of various anatomy will be imaged with linear tomography (lt) as predicate and dt for investigational.

Eligibility criteria:
inclusion criteria: age 18 years and older. subject has provided informed consent. study participant is scheduled to have a chest ct exam. study participant is able to stand and be still during the exams. exclusion criteria: human subject specific: not able or willing to provide informed consent, or consent is withdrawn. study participant is a female of child bearing age.

Keywords: pulmonary nodule
oracle-nirs: lipid core plaque association with clinical events: a near-infrared spectroscopy study

Conditions: Coronary Atherosclerosis

Summary: this is a multi-center, investigator initiated study that will prospectively examine treatment strategies and outcomes of patients who underwent clinically-indicated near infrared spectroscopy (nirs). the information collected will be used to determine the frequency of nirs imaging performed at the participating sites and to examine the clinical outcomes of the nirs-detected lipid core plaques (lcps).


Eligibility criteria:
inclusion criteria: 1. patients who have undergone/ will be undergoing nirs imaging at each of the participating centers. exclusion criteria: none

Keywords: lipid core plaques (lcps) vulnerable plaque near infrared spectroscopy
erlotinib and chemotherapy for 2nd line treatment (tx) of metastatic colorectal cancer (mcrc)

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to see if alternating chemotherapy with erlotinib increases tumor shrinkage in people with metastatic colorectal cancer. the investigator will also be studying the side effects (good and bad) of alternating chemotherapy with erlotinib on metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: patients must fulfill all of the following criteria to be eligible for study entry: * age 18-80 * able to provide informed consent * biopsy proven unresectable metastatic adenocarcinoma of the colon or rectum * documented progression on prior first-line oxaliplatin-based or irinotecan-based regimen for metastatic colorectal cancer * radiographically measurable disease with at least one bidimensionally measurable lesion of \> 1 cm * prior first-line regimen must have been completed at least 4 weeks prior to study treatment * use of biologic agents with first-line chemotherapy permitted * previous adjuvant regimens must have been greater than 6 months before inclusion * adequate organ function including bone marrow, liver and renal function as defined by the following values: absolute neutrophil count \> 1500/microliter; hgb \> 9 g/dl; platelets \> 90,000/microliter; international normalized ratio \< 1.8 (unless in therapeutic range if taking warfarin or other warfarin-derivative anticoagulants and are being monitored regularly for changes in prothrombin time or international normalized ratio); bilirubin \< 2 times the upper limit of normal; alkaline phosphatase \< 3 times the upper limit of normal; aspartate aminotransferase/alanine aminotransferase \< 5 times the upper limit of normal; serum creatinine \< 1.5 times the upper limit of normal * eastern cooperative oncology group status \< 2 exclusion criteria: patients meeting any of the following criteria are ineligible for study entry: * prior second-line chemotherapy regimens for colorectal cancer * prior treatment with erlotinib or gefitinib * central nervous system metastasis * second malignancies less than 5 years prior to enrollment. completely resected basal or squamous cell carcinoma of the skin is allowed. * untreated/unresolved bowel obstruction * inability to take oral mediations * hiv positive * pregnancy * other uncontrolled medical illnesses * current diarrhea \> grade 2 * symptomatic angina or uncontrolled congestive heart failure

Keywords: colon cancer metastatic colorectal
family fit iterative app development

Conditions: Weight Gain Prevention; Physical Inactivity

Summary: the overall aim of this study is to test the acceptability and usability of a mobile application (app) for family-based physical activity and weight gain prevention among parent/guardian and child (ages 9-12 years) dyads.

this study includes a 12-week active intervention period. interested participants will complete a study orientation webinar, then continue to a baseline visit and online questionnaires if interested. they will then complete 7-days of accelerometry monitoring to measure current physical activity levels. if eligible, they will attend a brief kick-off meeting to receive their fitbits and study apps. the intervention period is 12 weeks, all remotely delivered. the intervention focuses on families working to increase their moderate- to-vigorous intensity physical activity. at 12 weeks, families will attend a brief in-person assessment visit and complete online questionnaires and 7 days of accelerometry, and complete a semi-structured interview via zoom to discuss their experiences and provide feedback for future program modifications.

Eligibility criteria:
inclusion criteria: 1. parent (or legal guardian) must: * be between 18-65 years old * use a mobile apple or android device (e.g., smartphone, tablet) * have a mobile data plan or reliable access to home wi-fi * have an active facebook account 2. child must: * be 9-12 years old * live in the residence of parent (at least 50% of the time) 3. child and parent must: * be able to speak and read english. * be insufficiently physically active (adult: \<150 minutes/week moderate physical activity or \<75 minutes/week vigorous physical activity, child: \<6 days/week of 60 minutes moderate- to vigorous-intensity physical activity) * be able to engage in physical activity. * live within 75 miles of the uf campus exclusion criteria: 1. parent currently, or trying to become, pregnant. 2. current participation in a structured physical activity or weight loss program (children playing sports will be permitted) 3. currently enrolled in a research study focused on changing diet or physical activity. 4. use of weight loss medications 5. child current use of fitbit (or similar physical activity device) 6. history of eating disorder 7. one parent and one child per family unit may enroll

Keywords: family-based physical activity exercise mobile technology wearables