Kornimate/medical-research-clean huggingface dataset:
changes in physician performance through continuous professional development

Conditions: Asthma; Health Personnel

Summary: the purpose of this study is to determine whether having physicians evaluate their management of certain diseases as part of board recertification results in improved patient care.

in the year 2000, the american board of internal medicine introduced continuous professional development as part of its board recertification process. the purpose of these changes were to achieve the following goals: * to improve the quality of patient care; * to affirm the high standards expected of a self-regulating, accountable profession; * to foster continuing scholarship and self-improvement; * to offer diplomats a portfolio of credentials attesting to competence; and * to add value to the health care system. the most notable change in the new recertification process was the addition of practice improvement modules (pims). these modules require physicians to review how well they manage a particular chronic disease within their practice and to develop an improvement plan for their practice. in april 2005, it became a requirement that all internists complete a pim as part of board recertification. currently, it not known whether having physicians evaluate their management of certain diseases as part of board recertification will achieve its intended goal of improving patient care. therefore, the purpose of this trial is to assess whether practice improvement modules result in improved clinical performance. the pim selected for this study will focus on asthma. as pims seek to improve the quality of care within a practice, the unit of randomization in this study will be clinics (i.e., practices) within the henry ford health system. we will enroll practicing, board-certified internists within the henry ford medical group (\~40 internists or 20 per arm). clinics (\~16 or 8 per arm) will then be randomized to either complete the pim or not complete the pim. participating internists at a site randomized to complete the pim will be encouraged to work together to complete the asthma pim. participating internists at control sites will continue usual care and will not be asked to complete an asthma pim. comparisons: we will assess differences in asthma care by prospectively surveying patients seen by physicians in the intervention group and control group following the intervention period. these analyses will be adjusted by the baseline characteristics of asthma patients seen by participating physicians.

Eligibility criteria:
inclusion criteria: * previously board-certified in internal medicine * practicing general internist within the henry ford medical group exclusion criteria: * none

Keywords: asthma education, medical, continuing american board of internal medicine recertification continuous professional development practice improvement
tranexamic acid versus placebo to reduce perioperative bleeding after major hepatectomy

Conditions: Blood Loss, Surgical

Summary: blood loss was reported as a prognostic risk factor of morbidity and overall survival after hepatic resection. the aim of this study prospective randomized was compare the efficacy of the administration of tranexamic acid versus placebo to reduce perioperative bleeding after major hepatectomy (\> 3 hepatic segments).


Eligibility criteria:
inclusion criteria: * signature of the consent form * patients with hepatic lesion needing a major hepatectomy (≥ 3 hepatic segments) exclusion criteria: * absence of signature of the consent form * patient with cirrhosis * minor hepatectomy (\< 3 hepatic segments) * hepatectomy associated with vascular resection * contraindication of tranexamic acid : history of arterial or venous thrombosis , disseminated intravascular coagulation, severe renal insufficiency, history of epilepsies , intrathecal or intraventricular injection * pregnant or lactation

Keywords: specify the primary condition or disease being studied major hepatectomy
a prospective study in patients undergoing primary ventral hernia repair using parietex™ composite ventral patch

Conditions: Hernia

Summary: the objective of this study is to assess the recurrence rate following the use of parietex™ composite ventral patch in primary ventral hernia repair by open approach with intra-peritoneal positioning.

prospective, multicenter, multinational non-comparative study. primary endpoint: primary hernia recurrence\* rate at 24 month follow-up. the evaluation of hernia recurrence will be performed during a physical examination and by ultrasonography. secondary endpoints: primary hernia recurrence\* rate at 1, 6 and 12 month follow-up. the evaluation of hernia recurrence will be performed during a physical examination and confirmed by ultrasonography. (\*recurrence is defined as a clinically manifested bulge or a protrusion exacerbated by a valsalva maneuver.) safety parameters: deep and superficial infection (a surgical site infection (ssi) will be defined in the study according to the centers for disease control and prevention (cdc) criteria for diagnosis of ssi). pain / chronic pain other post-operative complications (complications related to visceral adhesions, ileus, seroma, hematoma...) analgesics consumption risk factors (severity and treatment) efficacy parameters: recurrence of primary ventral hernia operative time time of the mesh positioning length of hospital stay ease of use (mesh handling and manipulability, comfort of use ...) return to daily activities/ work patient satisfaction patient comfort (carolina's™ comfort scale (ccs) - qol questionnaire) visit schedule: baseline visit (preoperative) \& operative/discharge visit post-op: phone call day 10 1 month 6 months 12 months 24 months duration: 12 months recruitment and 24 months follow-up up to 12 sites in europe and the united states will be included in this study

Eligibility criteria:
inclusion criteria: * all patients (adult ≥ 18 years) at participating centres undergoing primary ventral hernia repair with the device by open approach * signed informed consent form by the patient or the legally authorized representative * intraoperative inclusion criteria :size of the defect: ≤ 4 cm exclusion criteria: * emergency procedure * current participation in other trials * history of previous hernia at the same location. * pregnant women: women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period * patient \< 18 years * bmi \> 35 * asa score ≥ 4 * the investigator determined that the patient will not be able to comply with the required follow-up visits

Keywords: parietex composite ventral patch pco vp or pcovp primary ventral hernia repair panacea
can mimic emotional expression training help improve emotion processing

Conditions: Healthy

Summary: the main aim of the present study is to investigate whether mimicking emotional expressions training via facereader software can improve emotional processing and recognition in healthy subjects, especially individuals with hityer autistic traits.

some mood and trait questionnaires such as autism spectrum quotient, social responsiveness scale,state-trait anxiety inventory,beck's depression inventory etc are asked to complete. 90 healthy male subjects will receive 16 times (4 times a week , 4 weeks) of mimicking emotional expressions training via facereader. during training, 3 times of fnirs (t2,t9 and t16) were recorded simultaneously. fmri scanning, including emotion processing and emotion recognition tasks, 7 minutes resting data, ans dti data will be collected before and after the training. after fmri scaning, behavioral ratings (i.e. intensity and valence) and eye-tracking data will be collected.

Eligibility criteria:
inclusion criteria: * healthy subjects without past or current psychiatric or neurological disorders exclusion criteria: * history of head injury; * pregnant, menstruating, taking oral contraceptives; * medical or psychiatric illness.

Keywords: mimic facial expression training autistic trait mirror neuron system emotion processing emotion recognition
morphine-midazolam in pre-hospital traumatic patients with severe acute pain

Conditions: Acute Traumatic Pain

Summary: administration of midazolam with morphine in patients with severe acute pain is a routine practice in the management of pre- and post-operative patients but has not been evaluated in pre-hospital setting. the investigators aim to evaluate the co-analgesic effect of midazolam in the pre-hospital management of traumatic patients with severe acute pain. in a multicenter prospective randomized double-blind placebo-controlled trial, the investigators would like to compare the analgesic effect and safety of the intravenous morphine 0.10 mg/kg and midazolam 0.04 mg/kg with the intravenous morphine 0.10 mg/kg and placebo in pre-hospital traumatic adults. assessment will be done at the baseline using a validated numeric rating scale (nrs). the primary outcome will be the proportion of patients with a pain score less than or equal to 3 after 20 minutes. the secondary outcomes will be in between-group comparison of: the treatment safety, pain score every 5 minutes during 30 minutes and the total morphine dose required until obtaining a pain score less than or equal to 3.

patient will be included in pre-hospital setting. they must have an acute pain nrs greater than or equal to 6 from a traumatic origin. the participation of the study for each patient will be the time of the pre-hospital setting. the study will stop when the patient arrives at the hospital. patient will be randomized after obtaining an informed consent. then, the nurse will administered intravenous morphine 0.10 mg/kg and midazolam 0.04 mg/kg or intravenous morphine 0.10 mg/kg and placebo. only the nurse will be aware of the treatment received by the patient. every 5 minutes, life constants and pain score will be recorded on the case report form. assessment will be done at the baseline using a validated numeric rating scale. the primary outcome will be the proportion of patients with a pain score less than or equal to 3 after 20 minutes. the secondary outcomes will be in between-group comparison of: the treatment safety, pain score every 5 minutes during 30 minutes and the total morphine dose required until obtaining a pain score less than or equal to 3.

Eligibility criteria:
inclusion criteria: * 18 to 70 years old * conscient with spontaneous ventilation * acute pain with an traumatic origin : pain escape superior or egal to 6/10 * taking care by french reanimation and urgency mobile services (smur). exclusion criteria: * younger than 18 years old or older than 70 years old * chronical respiratory insufficiency * severe hepatocellular insufficiency, * myasthenia * known allergy to morphine or benzodiazepin, * already treated for a chronical pain, * pregnant women * treated by morphine * patient unable to evaluate his/her pain * any acute and severe hemodynamic, respiratory or neurologic deficiency * needed an local analgesia * patient who received an other antalgic treatment

Keywords: acute traumatic pain, pre-hospital setting, midazolam
neoadjuvant befotertinib combined bevacizumab or platinum-based double chemotherapy for resectable locally-advanced egfr mutation-positive non-small cell lung cancer

Conditions: EGFR; Non-Small Cell Lung Cancer; Locally Advanced Non-Small Cell Lung Cancer; Pemetrexed; Carboplatin; Bevacizumab; Antineoplastic Agents; Tyrosine Kinase Inhibitor

Summary: this study targeted patients with resectable stage ii-iiia non-small cell lung cancer with egfr mutation


Eligibility criteria:
inclusion criteria: * nsclc patient with egfr sensitive mutation as confirmed by needle biopsy; * at stage ii-iiia (tnm staging, version 8) as identified by chest ct, pet-ct or/and ebus; * no systemic metastasis (confirmed by head mri, whole body bone scan, pet-ct, liver and adrenal ct, etc.); * with the feasibility to receive radical surgery ; * good lung function that could tolerate surgical treatment; * aged 18-75 years; * at least one measurable tumor foci (the longest diameter measured by ct shall be \> 10 mm); * other major organs shall function well (liver, kidney, blood system, etc.): * ecog ps score shall be 0-1; * the child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. the child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial; * the patient shall sign the informed consent form. exclusion criteria: * the patient has undergone any systemic anti-cancer treatment for nsclc, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.; * the patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure \[≥ grade ii specified by new york heart association (nyha)\], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment; * the patient is a carrier of hiv; * the patient has had or is currently suffering from interstitial lung disease; * the patient had undergone other major systemic operations or suffered from severe trauma within 3 months before the trial; * the patient is allergic to befotertinib or its any excipients; * the patient is allergic to bevacizumab or its any excipients; * the patient is allergic to platinum-based double chemotherapy or its any excipients; * the female patient is in pregnancy or lactation period; * there are any conditions under which the investigator considers the patient is not suitable to be enrolled.

Keywords: egfr-tki nsclc chemotherapy bevacizumab locally advanced non-small cell lung cancer
ms paths normative sub-study

Conditions: Healthy Volunteer

Summary: the primary objective of this study is to determine the normative range of brain volume and brain volume change in healthy control (hc) participants whose age, race, and gender distribution is approximately matched to the age, race, and gender distribution of patients with multiple sclerosis (ms) enrolled in study 888ms001. the secondary objective is to use the results of the primary endpoint to ensure consistency of brain volume measurements across ms paths centers.


Eligibility criteria:
key inclusion criteria * ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local participant privacy regulations. key exclusion criteria * history of human immunodeficiency virus. * confirmed or suspected pregnancy. * diagnosis of migraine requiring medication or any other participant-reported diagnosis of a neurological disease or condition (e.g., stroke, transient ischemic attack, epilepsy, brain infection, brain surgery, prior head injury or concussion, or brain tumor). * any participant-reported diagnosis of an autoimmune disorder (e.g., rheumatoid arthritis, sjögren's syndrome, scleroderma, or systemic lupus erythematosus). * standard mri exclusion criteria, including claustrophobia, inability to lay still in the magnet (e.g., tremor), or any type of implanted metal in the body that would be affected by the strong magnetic field. note: other protocol defined inclusion/exclusion criteria may apply

Keywords: imaging research
efficacy of intravenous (iv) paracetamol for treatment of acute pain

Conditions: Acute Pain

Summary: the purpose of this study is to determine whether iv paracetamol is as effective as iv morphine sulfate on control of the acute pain in patient with limb trauma.

limb trauma is a painful condition that requires urgent analgesic treatment . intravenous opioids and nsaids are used extensively to control pain; both of them are with side effects. paracetamol is a safe and effective analgesic that is used by oral or rectal routs for pain control, and in therapeutic doses has less side effects than morphine and nsaids, and approved as a safe and effective analgesic in emergency department. recently iv paracetamol has become available in european countries and also in iran. efficacy and safety of iv paracetamol has been studied in post operation conditions and asserted but in emergency setting it has been studied only in renal colic situation. therefore, the investigators want to study the efficacy of iv paracetamol in limb trauma and compare it with iv morphine sulfate.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute limb trauma * age\>=18 years * acute pain of score 3 or greater on visual analogue scale exclusion criteria: * unstable hemodynamic (systolic blood pressure under 90 mmhg) * known sensitivity to opioids or paracetamol * any other known contraindication to morphine sulfate or iv paracetamol (including severe allergy to these drugs, acute bronchial asthma, upper respiratory tract obstruction) * previous administration of analgesic during 6 hours ago * pregnant women * previous inclusion to the study * diagnosed heart failure * renal failure * pulmonary failure or hepatic failure

Keywords: paracetamol morphine sulfates acute pain
study of migra-zen relief plus in the treatment of chronic migraine headache

Conditions: Chronic Migraine

Summary: the purpose of this study is to study migra-zen relief plus, an all-natural herbal dietary supplement product, with respect to alleviating and/or stopping migraine headache pain compared to a placebo when used prophylactically. this study will involve subjects suffering from chronic migraine headaches.

the purpose of this 90-day, randomized, double-blind, placebo controlled study is to evaluate the efficacy of an all-natural herbal dietary supplement product, (investigational product, or ip), with respect to alleviating and/or stopping migraine headache pain compared to a placebo when used prophylactically every day, and to evaluate the safety/risk of its use by observing the absence/presence of adverse event (ae/sae) reports and the normalcy of blood work, urinalysis, and liver enzyme tests. the primary end-point is the time-course and depth of the frequency reduction of migraine attacks. the secondary end-points will be the absence/presence of detectable adverse liver function and urinalysis test results as well as the dearth/abundance of ae/sae reports that may indicate patient safety/risk when using the ip.

Eligibility criteria:
inclusion criteria: * male or female subjects 18 years of age or older. * prior to this study subject must have been diagnosed with migraines according to ihs criteria by a qualified healthcare professional with some experience in the diagnosis of migraines and have suffered with them for one year prior to the start of the study. * migraine symptoms/attacks must have presented for a minimum of the last consecutive three (3) months at a minimum average frequency of six (6) times per month and must have been severe-extreme (grade 7-10) on a linear scale of 0-10, where 0=no pain and 10=unbearable maximum pain. * subjects who are able to follow the protocol as designed by rzn nutraceuticals, inc. and teva pharmaceutical industries. * generally good health exclusion criteria: * subjects currently taking any prophylactic treatment for migraine headaches * history of head trauma or brain cancer. * candidate subjects with any medical condition that, in the opinion of the investigators or intake staff, would jeopardize the safety of the patient, affect the validity of the data collected from the subject, or would challenge the subject's ability to complete the study protocol for 90 days. * known renal insufficiency or kidney disease of any grade * any illness causing severe coughing so as to avoid introducing "coughing migraine" per ihs classification 4.2, g44.803. * history of drug addiction. * females of child-bearing potential who do not practice medically acceptable methods of contraception surgical, sterilization, intrauterine device (iud), hormonal preparations or double barrier method (e.g. condom or diaphragm and spermicide) * subjects with uncontrolled hypertension (e.g. bp\>150/100).
the impact of rph201 on chronic vegetative state (cvs): fmri study

Conditions: Chronic Vegetative State

Summary: the aim is to evaluate the impact of rph201 on brain activity in chronic vegetative state patients. the assessment will be done using clinical measurements and functional mri studies.


Eligibility criteria:
inclusion criteria: * chronic vegetative state patients exclusion criteria: * allergic reaction to treatment * patients that can not undergo mri * pregnancy

Keywords: chronic vegetative state functional mri
evaluation of an ascensia blood glucose meter and app system

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to assess the usability of the onyx system in the hands of subjects with insulin dependent diabetes mellitus (iddm) or insulin-using subjects with non-iddm.


Eligibility criteria:
inclusion criteria: * be aged 18-75 years, male or female * read and understand english * have diagnosis of type 1 or insulin-using type 2 diabetes for at least 6 months * be taking multiple daily injections (mdi) of at least two pre-meal bolus injections daily or using an insulin pump * performing self-monitoring of blood glucose at home at least twice daily * have an ios mobile device or android mobile device with blue tooth capability * ios device: ipod or iphone 5 or later version with ios 8.0 software or higher (no tablets) * android: smart phone, 4.4 version and higher (no tablets) * be willing to utilize the onyx app on personal mobile device which communicates to meter to manage diabetes (including use of the bolus calculator) * be ambulatory and have transportation to the study site exclusion criteria: * hemophilia or any other bleeding disorder * pregnancy * physical, visual or neurological impairments that would make the person unable to perform testing with the bgm * working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company. * a condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee on the subject disposition form). * proliferative retinopathy or history of retinal laser surgery
efficacy of adapted physical activity on a walking platform in elderly patients hospitalized for cancer surgery

Conditions: Oncology; Elderly Patients; Surgery

Summary: the aim of this study was to evaluate the efficacy of daily use of a walking platform to improve recovery of preoperative walking speed at hospital discharge following oncological surgery in patients aged 65 or older.


Eligibility criteria:
inclusion criteria: * men or women aged 65 or over * candidate for scheduled major oncological surgery and/or surgery with high morbidity * patient able to walk for 10 minutes on the walking platform at the time of the test * patient affiliated to a social security system * signature of informed consent prior to any specific study-related procedure exclusion criteria: * patient with severe undernutrition (bmi\ 15% in 6 months or \>10% in 1 month) * emergency surgery * physical contraindications preventing use of the platform * simultaneous participation in another clinical study that could compromise the conduct of this study * patients deprived of their liberty, under guardianship or subject to a legal protection measure, or unable to express their consent. * patient unable to undergo trial follow-up for geographical, social or psychopathological reasons.

Keywords: adapted physical activity walking platform