Kornimate/medical-research-clean huggingface dataset:
the bleeding with antithrombotic therapy study 2

Conditions: Cerebrovascular and Cardiovascular Diseases

Summary: the purpose of this study is to determine the incidence and severity of bleeding complications in patients with cerebrovascular and cardiovascular diseases treated with oral antithrombotic therapy.


Eligibility criteria:
inclusion criteria: * patients with cerebrovascular or cardiovascular diseases who start or continue taking oral antithrombotics (antiplatelets and/or anticoagulants) to prevent vascular events * patients who are able to receive mri * provision of written informed consent either directly or by a suitable surrogate exclusion criteria: * mri contraindication * any condition that in the opinion of the responsible physician or investigator that renders the patient unsuitable for the study
biomarkers in multiple myeloma

Conditions: Hematological Patients; Newly Diagnosed Multiple Myeloma; Chemotherapy

Summary: the association between multiple myeloma (mm) and venous thromboembolism (vte) is well known. indeed, the incidence of vte is increased in patients with newly diagnosed mm and in patients treated by immunomodulatory drugs in combination with glucocorticoids. moreover, the clinical outcome of mm is supposed to be correlated to the risk of thrombosis. at the biological level, a number of hemostasis abnormalities participate in increasing vte incidence. yet, data on predictive biomarkers linked to vte are limited.

there is a need to discern predictive biomarkers in order to better identify patients at risk of developing vte, to decipher the mechanisms by which myeloma treatments interfere and in fine to choose an adequate thromboprophylaxis. in this context, it is important to document the precise expression of coagulation factors and to profile point-of-care tests for coagulation monitoring in newly diagnosed mm patients, before and during treatment. in addition, thromboprophylaxis is systematically included in therapeutic mm strategies, especially direct oral anticoagulants, without knowing whether potential drug interactions are occurring. this study aims at evaluating and validating predictive biomarkers of vte in mm, and at identifying patients whose thromboprophylaxis is required and may potentially be adjusted because of drug interactions.

Eligibility criteria:
inclusion criteria: * patient affiliated to a social security regimen or beneficiary of the same * signed written informed consent form * confirmed diagnosis of de novo multiple myeloma, non-previously treated and requiring treatment. exclusion criteria: * pregnant women * patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent * refusing participation * patient whose follow-up or life expectancy is less than 6 months.

Keywords: hematology multiple myeloma chemotherapy thromboprophylaxis
cardiopulmonary exercise testing and oscillometry for the evaluation of dyspnea

Conditions: Breathing, Mouth; Lung Function Decreased; Dyspnea; Shortness of Breath

Summary: this study will determine if airway resistance to airflow and pressure, measured by oscillometry, is associated with abnormal findings on cardiopulmonary exercise testing in subjects who are experiencing shortness of breath.


Eligibility criteria:
inclusion criteria: * willingness to perform breathing test * must be able to speak and understand english * referred for cardiopulmonary exercise testing exclusion criteria: * unable to provide consent or perform oscillometry test
preventing childhood obesity through a mindfulness-based parent stress intervention

Conditions: Child Obesity

Summary: this study will examine the mediator/moderator variables that affect efficacy of a parent stress intervention with nutrition education (pmh+n: parenting mindfully for health) vs. control intervention with nutrition education (ctl+n) on parent stress, parenting, health behaviors and child obesity risk. a non-randomized historical control group will also be assessed during the intervention and follow-up periods throughout to obtain outcome assessment without any interventions being provided.

this is a 5-year interdisciplinary project to assess a 12-week parenting mindfully for health (pmh) + nutrition counseling (n) versus contact control intervention (c) + nutrition counseling (n), to examine short-term and long term enduring effects of pmh+n to promote healthy eating and physical activity in parent and child, and prevent childhood obesity risk in 2-5 year olds, via changes in parent stress and parenting. a non-randomized historical control group will also be assessed during the intervention and follow-up periods throughout to obtain outcome assessment without any interventions being provided.

Eligibility criteria:
inclusion criteria: * family with a child between 2-5 years * bmi of parent ≥30kg/m2 * parents aged 18 yrs or older * high parent stress (pss mean score ≥25) * low income family as determined by hhs poverty guidelines exclusion criteria: * diagnosis of mental retardation, autism or other pervasive developmental disorder for child; * current serious psychiatric or medical disorder requiring immediate treatment, including active alcohol or substance use disorders (confirmed by urine toxicology screening and history), psychotic illnesses, suicidal ideation, untreated diabetes, cardiovascular disease, cancers or any other active current illnesses that preclude study participation for child or parent; * inadequate english proficiency to complete questionnaires.
trial of computerized met for adolescent substance use

Conditions: Drug Abuse; Alcohol Abuse; Nicotine Dependence

Summary: the purpose of this study is to test the effects of a computerized, self-directed motivational enhancement therapy program for adolescent substance use (imet), in comparison to clinician-delivered met and treatment as usual (tau), on treatment engagement and substance use. the investigators hypothesize that both imet and met will be more effective than tau in engaging/retaining patients in treatment and in reducing substance use during a 12-month follow-up period. the investigators also hypothesize that self-directed imet will be as effective as the clinician-guided met in increasing treatment engagement and abstinence during the 12-months follow-up period.


Eligibility criteria:
inclusion criteria: * completed initial visit at the treatment program; * be available to return for imet/met sessions (if assigned) * be available to complete all follow-up measurements * a past-12-month crafft score \>1 * have used substances on \>6 days (not including tobacco use) during the 90 days preceding their visit exclusion criteria: * unable to speak and understand english, or read english at a 5th grade reading level * youth deemed by the clinical team to require immediate hospitalization or referral to more intensive residential treatment

Keywords: substance abuse drug abuse alcohol abuse tobacco adolescent
task-based grounding program

Conditions: Aggressive; Defiant Disorder, Oppositional; Attention Deficit Hyperactivity Disorder

Summary: the purpose of this study is to improve the availability of brief interventions to help children with defiant, aggressive and disruptive behaviors by creating a brief scalable intervention for parents delivered via telehealth. as phase 1 study, we are conducting a 2-arm pilot feasibility rct in order the intervention, measures, and procedures to be used in a larger efficacy trial. the first arm will include a 3-session behavioral therapy treatment we call task-based grounding and the second arm will be an enhanced treatment as usual comparison group.

the investigators have developed a 3-session psychosocial intervention for parents of children between 9-14 with disruptive behaviors. the intervention uses telehealth visits along with written and online resources to teach them parent management skills. to evaluate the acceptability of this intervention and the feasibility of our methods, the investigators will recruit 20 parent-child dyads to participate in this study. this is a mixed methods pilot feasibility rct design. the investigators designed this study to test the acceptability of the intervention to parents and test the feasibility of our recruitment, retention, measurement, and delivery mechanisms for both the experimental and comparison conditions. the investigators will use a block randomization method to separate parent-child dyads into either treatment or comparison groups. the treatment condition involves 3 telehealth visits and a set of parenting resources. the enhanced treatment as usual condition will involve contact with a "care navigator" that will assess behavior problems in the child and help the parents find an appropriate referral to care in their community. both groups will be followed for 10 weeks, provide outcome data, and participate in semi-structured qualitative interviews to accept acceptability.

Eligibility criteria:
inclusion criteria: * participating parent-child dyads must include a child between the ages of 9-14 years old and adult over the age of 18. * the child must have a vanderbilt oppositional defiant disorder score \>3 * the participating caregiver must be a legal guardian of participating child exclusion criteria (child refers to the primary participant's child) * child ever been hospitalized for a psychiatric problem * child ever attempted suicide or stated that they had a plan to attempt suicide within the past year. * child ever engaged in self-harm behaviors * child has significant legal history such as adjudicated of a crime or been in diversion * child has ever been diagnosed with: obsessive compulsive disorder, post traumatic stress disorder, intellectual disability or developmental delay, speech or hearing delay, autism spectrum disorder, schizophrenia or another psychotic disorder, a substance abuse disorder (or had serious concerns about substance use). * parent can communicate in spoken english * parent is under the age of 18.

Keywords: oppositional defiant disorder behavioral parent training
effect of a non-invasive brain stimulation technique on smoking cessation behaviors

Conditions: Tobacco Use Disorder

Summary: in this pilot study, the feasibility of using tdcs (a non-invasive brain stimulation technique) while performing a task requiring cognitive flexibility will be examined in smokers and initial data will be collected regarding the effect of tdcs on smoking cessation behaviors. smokers will be randomized to receive either active or sham tdcs daily for 5 days after which they will attempt to quit smoking. smoking behavior after the attempted quit date will be assessed at four weekly visits.


Eligibility criteria:
inclusion criteria: * be between the ages of 18 and 64 * smoked (on average) at least 5 cigarettes per day * be motivated to quit smoking exclusion criteria: * unstable medical or psychiatric conditions * any medical conditions with neurological sequelae * history of loss of consciousness of greater than 30 minutes duration or loss of consciousness with neurological sequelae * have any medical condition or use any medication that would either increase risk of subjects participating in this study (e.g., medications that lower the seizure threshold) or that would impact measures of interest (e.g. smoking cessation medications). * are pregnant or planning to become pregnant during the study * current use of pacemaker, intracranial electrodes or implanted defibrillator
concurrent adjuvant carboplatin and accelerated radiotherapy for triple negative breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine the safety and effectiveness of a combination of chemotherapy and radiotherapy in breast cancer patients after breast surgery.

preliminary experience in the neo-adjuvant setting of locally advanced breast cancer (labc) has recently demonstrated that hormone receptors negative patients have approximately 50% chance to achieve a pathological response after concurrent chemo-radiation. in a multi-institutional collaboration of 105 patients it was found that triple negative (tn) tumor carriers achieved pathological response in 54% of the cases and that the response reflected on 5-year disease free survival and overall survival. our group has speculated that these effects on the risk of distant recurrence could depend on the recovery of antitumor immunity among the patients achieving pathological response, after tumor cell death induced by concurrent chemo-radiation. the investigators are proposing a novel study that translates these findings to the adjuvant setting of tn tumors. tn breast cancer is a more aggressive form of the disease often coinciding with basal-like tumors. brca mutated-cancer is more frequently tn. the current protocol converges the experience nyu has developed in accelerated prone breast radiotherapy with encouraging finding from the use of concurrent chemoradiation in labc. the investigators will study the feasibility of combining weekly carboplatin with concurrent 3-weeks prone breast radiotherapy in the adjuvant setting of 35 women with tn tumors, after segmental mastectomy and nodal assessment. primary endpoint of the study is acute toxicity of the combined regimen, with a target of \< 25% of grade ii-iii dermatitis.

Eligibility criteria:
inclusion criteria: * age older than 18 * pre- or post-menopausal women with stage i and ii breast cancer, triple negative tumors * biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm * status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (tumors \< 5 mm in size do not require nodal assessment) or after mastectomy * no previous chemotherapy * patient needs to be able to understand and demonstrate willingness to sign a written informed consent document exclusion criteria: * previous radiation therapy to the ipsilateral breast * active connective tissue disorders, such as lupus or scleroderma * pregnant or lactating women

Keywords: triple negative breast cancer adjuvant therapy carboplatin chemotherapy radiation therapy chemo-radiotherapy accelerated radiotherapy
irreversible electroporation(ire) for lung neoplasms accompanied by respiratory function insufficiency

Conditions: Lung Neoplasms Accompanied by Respiratory Function Insufficiency

Summary: the purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (ire) for lung neoplasms accompanied by respiratory function insufficiency.

by enrolling patients with lung neoplasms accompanied by respiratory function insufficiency adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous ire for lung neoplasms accompanied by respiratory function insufficiency.

Eligibility criteria:
inclusion criteria: * lung neoplasms accompanied by respiratory function insufficiency diagnosed by positive biopsy or non-invasive criteria, * not suitable for surgical resection, * eastern cooperative oncology group (ecog) score of 0-1, * a prothrombin time ratio \> 50%, * platelet count \> 80x10\^9/l, * ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post nanoknife procedure, * able to comprehend and willing to sign the written informed consent form (icf), * have a life expectancy of at least 3 months. exclusion criteria: * cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * any active implanted device (eg pacemaker), * women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the nanoknife™ ledc system, * are in the opinion of the investigator unable to comply with the visit schedule and protocol evaluations.

Keywords: irreversible electroporation lung neoplasms respiratory function insufficiency
estimation of malignancy rates within humedica patient populations sampled to be representative of liraglutide initiators and leader™ trial participants

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in the united states of america. the aim of this study is to estimate incidence rates of all malignant neoplasms, specific subgroups of malignant neoplasms, and acute pancreatitis among cohorts of antidiabetic drug users standardized to be representative of leader™ trial participants or liraglutide initiators within the humedica electronic health record (ehr) database.


Eligibility criteria:
inclusion criteria: * all cohort members: members of each of the cohorts must have at least 12 months of baseline coverage within humedica prior to the patients' index date (cohort- specific index dates are defined below). within humedica, baseline coverage will be defined as the date from the earliest observed encounter up to and including the index date. patients must have at least 1 diagnosis of t2dm (250.x0 or 250.x2) prior to and including the date of the qualifying prescription, no prior diagnosis (inclusive of the index date) of t1dm (250.x1 or 250.x3) and no diagnosis of gestational diabetes within the previous 12 months (inclusive of the index date). patients will not be eligible for inclusion if they have prior prescriptions for glp-1 analogues (including liraglutide and exenatide) during the interval that would be considered the baseline period * liraglutide-like cohort: to be eligible for inclusion in the liraglutide-like cohort, patients must have at least one qualifying prescription for an oad. qualifying oads will be specified that share similar labelled or unlabelled indications as liraglutide * leader™-like cohort: to be eligible for inclusion in the leadertm-like cohort, patients must meet the following inclusion and exclusion criteria: patients will be eligible for inclusion after meeting the overall inclusion and exclusion criteria in addition to the following: ages 50 and over. hba1c at least 7% exclusion criteria: * patients will be excluded from the leader™-like cohort if any of the following are observed prior to meeting the inclusion criteria defined above: calcitonin \>= 50ng/l. baseline dpp-4 or pramlintide. chronic heart failure diagnosis, nyha class iv. acute coronary or cerebrovascular event within 14 days prior to initiation. current continuous renal replacement therapy. end-stage liver disease. solid organ transplant. malignant neoplasm
from acute to chronic postoperative pain in patients for elective cholecystectomy

Conditions: Pain

Summary: chronic pain is a wellknown complication after cholecystectomy. intensity of the pain in the first week after the operation is a predictive factor for the development of chronic pain, but it is unknown whether the risk is more related to one of the different components of acute pain (ie somatic, visceral, referred). furthermore the chronic pain has not been systematically described in terms of type of pain or sensory abnormalities etc. (allodynia, hyperalgesia etc.). the purpose of the study is to examine whether intensity of components of acute pain is predictive for development of chronic pain after cholecystectomy and to characterize the chronic pain by quantitative sensory testing. dna-samples are collected to examine genetical factors, important for perception of pain, and the development of chronic pain.


Eligibility criteria:
inclusion criteria: * patients for elective cholecystectomy * 18 years or older at the day of the operation * capable of speaking, reading and writing danish exclusion criteria: * previous abdominal operation * patients with preoperative neuropathies * patients with other diseases in the nervous system, preoperative paresthesias or other sensory disturbances.

Keywords: postcholecystectomy pain chronic postoperative pain visceral pain referred pain somatic pain quantitative sensory testing
obstructive sleep apnea airway evaluation

Conditions: Obstructive Sleep Apnea

Summary: current practice guidelines recommend obstructive sleep apnea (osa) patients to stay in the post anesthetic care unit (pacu) until the risk of respiratory depression has subsided. inevitably, a greater demand on hospital resource utilization in these patients will increase health care cost. polysomnography (psg) and screening questionnaires can identify osa but they are limited by accessibility and false positive results, respectively. inaccurate osa identification misguides postoperative surveillance plan. in contrast with mri and ct scans, ultrasound is more accessible and more likely a practical tool for osa screening. however, before clinical application, airway ultrasound (us) exam must undergo vigorous testing to check its utility, accuracy, inter-observer reliability and its ability to identify osa and its severity.

the investigators plan to recruit surgical patients at risk of osa, exposed to sedatives,and/or general anesthesia. surface ultrasound measurements will be conducted in a separate setting, and be correlated with the sleep study results, and a set of ultrasound parameters will be validated in this setting. relevant clinical outcomes will be captured as well.

Eligibility criteria:
inclusion criteria * age≥18 * asa physical status i - iv; * suspected to have osa for clinical reasons such as high risk on screening questionnaire i.e., a stop-bang score \>3, and referred to have a sleep study for osa diagnosis by the clinical team at any point of care during the perioperative period (such as the clinic using the screening tool, during or after surgery in the ward experiencing recurrent upper airway obstructive events, need for cpap in the postoperative period and / or suspected to have obstructive airway events). or; * patients who were recently diagnosed to have osa and underwent a laboratory sleep study within the last year. * patients who were recently diagnosed to have osa but are non-compliant with treatment. compliance defined as: median nightly cpap or apap use \> 70% of the nights, and for longer than 4 hours of nightly use during the last 3 months),43 or using oral appliance use (use \> 70% of nights, and for longer than 4 hours of nightly use in the last 3 months. exclusion criteria * failure to understand and provide consent * past history of oral, head and neck surgery (e.g., osa corrective surgery) * active head \& neck disease (e.g., cancer, infection and radiotherapy); * inability to perform breathing tests per instruction * patients currently on treatment for osa (as this may interfere with the upper airway dimensions and the us assessment may not be accurate)