Kornimate/medical-research-clean huggingface dataset:
g-poem for refractory gastroparesis after esophagectomy with gastric pull-through

Conditions: Gastroparesis; Esophageal Cancer

Summary: this is a retrospective study assessing the effectiveness of endoscopic pyloromyotomy in patients suffering from gastroparesis and/or symptoms of delayed gastric emptying after esophagectomy with gastric pull-through. several, mainly european, centres which perform g-poem on a routine basis will be asked to participate. the main reason to assess the effectiveness of g-poem in this specific subgroup of patients is the fact this specific subgroup of patients is often being excluded from trials assessing efficacy and safety of g-poem. the participating centres will be asked to report appropriate patients among those who have undergone g-poem since 2015 till december 2023. patients fulfilling inclusion and not having exclusion criteria will be included into the analysis; the minimum follow-up is set to 6 months after g-poem. the main outcome is the symptomatic response at 6, 12 and 24 months (measured by gcsi score). other endpoints will be change in other symptoms not covered by gcsi, change in gastric emptying rate and safety of the procedure. for each enrolled patient a case report form (crf) will be filled in and delivered to the leading centre via an online database or in other forms if preferred by the respective centres. the leading centre will be responsible for data collection and analysis.


Eligibility criteria:
inclusion criteria: * patients who underwent g-poem after esophagectomy with a gastric pull-through for confirmed (scintigraphy or breath test) or presumed gastroparesis. (some centres perform g-poem in patients whose gastroparesis was not confirmed by a scintigraphy or a breath test, therefore it is only presumed. this particular subset of patients will be analysed separately.) * total gcsi score before g-poem at least 1.0. * at least 6 months follow-up after g-poem. exclusion criteria: * organic pyloric obstruction
biomarker levels as a predictor of concussion severity outcomes (blacout)

Conditions: Concussion, Mild; Neurocognitive Dysfunction

Summary: the overall research aim of this pilot study is to determine if the structural brain protein calpain-cleaved αii-spectrin n-terminal fragment (sntf) can be used as a blood biomarker to accurately identify patients who will have more severe symptoms and reduced neurocognitive functioning after sustaining a concussion. concussion is also referred to as mild traumatic brain injury (mtbi) in the literature. both terms will be used interchangeably throughout this application.

the novel aspect of the proposed study relates to the fact that the stnf protein is the first evidence that a biomarker in human blood can help clinicians determine a specific patient's clinical outcome from a concussion. this in turn will help clinicians and concussion specialists with designing treatment protocols very early after the initial injury that could have significant impacts on the health of the patient. this study has several important benefits to the scientific community. concussion treatment today is uncertain. some patients are back to baseline one or two days post injury whereas other patients are experiencing debilitating symptoms for months after the injury. until the patient begins to report symptoms, the course of treatment cannot be determined. other biomarkers for concussion diagnosis are being evaluated, but this is the first biomarker to show promise for patient stratification and earlier intervention and treatment for the subset of cases at high risk of suffering brain damage and persisting dysfunction after concussion. currently, no prognostic method exists for identifying at an early and potentially treatable stage the small subset of concussion sufferers at risk of diffuse axonal injury and persisting brain functional impairment.

Eligibility criteria:
inclusion criteria: patient is ≥ 8 years old 2. ability to enroll within 24 hours of injury 3. ability to follow-up with patient 30 days following enrollment 4. concussion by history or physical examination (head injury and symptoms such as headache, nausea, vomiting, dizziness, fatigue, irritability, or poor concentration following the injury) 5. gcs ≥ 13 6. abbreviated injury score (ais) ≤ 3 7. plan to be discharged from the emergency department to the outpatient observation unit or to home exclusion criteria: non-english speaking 2. trauma team activation (tta) 3. abnormal acute intracranial ct/mri findings 4. blood alcohol level (\> 200 mg/dl) 5. previous head injury within 30 days of enrollment 6. pre-existing neurologic disorder associated with cerebral dysfunction and/or cognitive deficit (such as dementia, cerebral palsy, mental retardation, epilepsy, dyslexia) 7. pre-existing psychiatric disorder (such as bipolar disorder and schizophrenia) as indicated by medical history 8. planned admission to a hospital inpatient unit
modulation of dyspnea perception during exercise in copd patients using attentional distraction

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) is a major health problem whose prevalence is increasing rapidly. the gradual decrease in exercise tolerance is one of the usual consequences of copd that affects the functional independence and quality of life of patients. in copd patients, breathlessness and muscle fatigue are the main symptoms limiting exercise. recent studies have shown that most of the physiological mechanisms of psychological factors such as emotions, motivation, memory, personality, expectations, or prior experience can greatly influence and modulate the perception of breathlessness. it has been proposed that the attentional distraction (visual or auditory) during exercise may be associated with a decrease in anxiety and shortness of breath and could improve exercise tolerance in copd. we therefore propose to study the impact of attentional strategies of distraction on the perception of dyspnea and walking tolerance in patients with copd. the research hypotheses are: i) compared with exposure to a strategy of negative attentional distraction during exercise, exposure to a strategy of positive attentional distraction will improve walking exercise tolerance in patients with copd; ii) for a given level of effort, sensory perception and emotional perception will be enhanced by exposure to a strategy of positive attentional distraction. ten subjects with moderate to severe copd will be recruited at the research center of the institut universitaire de cardiologie et de pneumologie de québec (criucpq). during an assessment visit, we will measure complete pulmonary function, body composition and maximal functional capacity during a maximal incremental test work performed on a treadmill. during two subsequent experimental visits, and after spirometry control, participants will perform a walking test performed on a treadmill at an intensity corresponding to 75% of maximum effort during maximal incremental test. the test will be carried out in combination with a strategy of either positive attentional distraction, neutral attentional distraction or negative attentional distraction . the order of the condition will be randomized.


Eligibility criteria:
inclusion criteria: * smoking history \> 10 pack-years * post-bd fev1 \[30-80 % predicted value\] * post-bd fev1/fvc \< 70 % * age \[50-80 yrs\] * voorips score \< 9 exclusion criteria: * exacerbation \< 4 weeks * asthma, neoplasia, cardiac failure, diabetes * neuromuscular limitations * major depression or other psychiatric disorders * bmi \> 30 kg/m2 * pao2 \< 60 mmhg or oxygenotherapy * involvement in a structured and regular physical activity program

Keywords: exercise tolerance dyspnea affective distraction
smart@home feasibility trial

Conditions: Asthma; Asthma in Children

Summary: the proposed research addresses the limitations or lack of a digital platform to provide remote care of medically complex patients. previous attempts have had poor clinical validity and suffered lack of patient engagement. the study team will deconstruct the previously implemented smart platforms to create a roadmap, platform, and template to guide clinicians to create new tools. results from phase 1 of this project highlighted the need for connectivity between the smart@home app and bluetooth-enable devices to provide objective disease activity data as well as integration with epic electronic health record so that providers can use the data to inform treatment planning and decision making. a subsequent pilot user validation trial is also needed to confirm development goals were met. conducting a pilot user validation trial of the smart@home asthma tracker, spirometer, and action plan is the purpose of the next phases of this study. a beta test the smart@home asthma tracker and asthma action plan algorithm will take place with approximately 8 participants. beta testing will have participants record simulated increases in symptoms to ensure appropriate levels of care is communicated via the app. then, a group of 40 adolescent (ages 12-17) patients with asthma for a 6-month pilot randomized control trial (rct). participants will be randomized into either the imaap smart@home (n=20) or control (n=20) groups following the completion of baseline measures to test the interactive asthma action plan functionality and impact.


Eligibility criteria:
inclusion criteria: * patients diagnosed with a chronic medical condition requiring regular treatment, i.e., asthma * ages 11-17 * english fluency for patient and caregiver exclusion criteria: * diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review * diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review

Keywords: asthma
study on communication comprehension in the schizophrenic spectrum

Conditions: Schizophrenia Simple

Summary: the purpose of the present study is to evaluate the effect of emotional prosody on the perception of emotional discourse in the schizophrenic spectrum. the investigators hypothesize that participant may use emotional prosody as an emotional cue to understand the emotional content of discourse.

the integration of ortholinguistic and paralinguistic functions in language, particularly of the emotional prosody, is necessary to interact adaptively with others. people in the schizophrenic spectrum have social difficulties. is emotional prosody comprehension altered in these people? according to edwards et al. (2002), there is methodological issues concerning the tasks used to answer this question. investigators built an emotional judgment task more adapted to study the perception of emotional prosody in the schizophrenic spectrum than the classical paradigm designed to evaluate participants with cerebral injury. the investigators have elaborated a material that consists of 140 short sentences (7±2 words) with a simple syntactic structure. the verbal content expressed positive, neutral or negative emotions. these sentences were announced by four professional actors (two female) with an emotional prosody content congruent or inconsistent with the verbal content. participants will have to evaluate the emotional intensity of the recordings on a five points likert scale, from strongly negative to strongly positive. psychotic experiences of all participants will be evaluated too.

Eligibility criteria:
inclusion criteria: * having a diagnosis of schizophrenia and being in a stable phase of the disease * having between 18 to 60 years old * speak french or using french at school * accepting not to use psychoactive substances during the preceding 48h * being affiliated to the french social security * providing their written informed consent non-inclusion criteria: * having not audio deficits, nor visual uncorrected deficits * having not suffering from depressive symptoms during the last 6 months exclusion criteria: - having no neurological, nor psychiatric disease except schizophrenia for the patients groups.

Keywords: emotional prosody, schizophrenia
a study to evaluate the safety of exposure to wegovy during pregnancy

Conditions: Pregnancy; Obesity; Overweight

Summary: this is an observational, retrospective, cohort study using administrative insurance claims data. the aim of this non-interventional study (nis) is to compare maternal, fetal and infant outcomes of women exposed to wegovy during pregnancy to a reference population not exposed to wegovy, so that participants and healthcare providers can make informed treatment decisions.


Eligibility criteria:
inclusion criteria: * evidence of a pregnancy end event on a medical claim (example, live birth, stillbirth, or spontaneous abortion) during the pregnancy identification period (that is, 04 june 2021 - 17 february 2027). * aged 15-45 and female on the date of the last menstrual period (lmp). * continuous enrolment in the database with medical and pharmacy benefits for at least 6 months prior to the date of lmp through 42 days after the pregnancy end date. * among the pregnancies that meet the inclusion criteria, three main cohorts of interest and two sub cohorts will be identified (one wegovy-exposed cohort and two comparison cohorts): * wegovy-exposed- for greater than or equal to 1 day of wegovy exposure from estimated conception date (lmp +14) - 35 days to end of pregnancy. * other aom-exposed- greater than or equal to1 day of phentermine, diethylpropion, benzphetamine, phendimetrazine, orlistat, or bupropion/naltrexone exposure, defined as the following: * benzphetamine, diethylpropion, orlistat, or phendimetrazine exposure from estimated conception date-1 day to end of pregnancy. * phentermine or bupropion/naltrexone exposure from estimated conception date- 5 days to end of pregnancy. * cohort with overweight/obesity- * greater than or equal to 1 diagnosis code for obesity or bmi greater than or equal to 30 kilogram per meter square (kg/m\^2) on a medical claim during the six month pre-pregnancy period. * greater than or equal to 1 diagnosis code for bmi greater than or equal to 27 kg/m\^2 or less than 30 kg/m\^2 on a medical claim and greater than or equal to 1 non-diagnostic medical claim for dyslipidemia, type 2 diabetes mellitus, or hypertension during the six month pre-pregnancy period. * no exposure to wegovy or other aom during the defined exposure window in pregnancy. * among wegovy-exposed and other aom-exposed pregnancies, the subset with first trimester exposures will be identified as those with greater than or equal to 1 days of exposure at \< less than 14 wga. exclusion criteria: * pregnancies exposed to other glucagon-like peptide-1 receptor agonist (glp-1 ra) during the exposure identification window (estimated conception date - 35 days through pregnancy end date). * pregnancies with exposure to both wegovy and other aom during the exposure identification window (estimated conception date - 35 days through pregnancy end date). * pregnancies resulting in multiple infants will be excluded from the analysis of infant outcomes.
ctdna guided adjuvant treatment with elacestrant: tbcrc-068

Conditions: ER+ Breast Cancer

Summary: this is a single-arm, phase ii study examining elacestrant in the adjuvant treatment of patients with er+ breast cancer who test positive for circulating tumor dna (ctdna) during the screening period of the trial.

this is a single-arm, phase ii study examining elacestrant in the adjuvant treatment of patients with er+ breast cancer who test positive for circulating tumor dna (ctdna) during the screening period of the trial. patients with er+ breast cancer anatomic stage iib or iii at diagnosis who are at least five years from diagnosis and have completed intended course of adjuvant endocrine therapy and are currently off endocrine therapy will be screened with ctdna testing. patients who test positive for ctdna during the screening phase will receive treatment with elacestrant for one year and continue ctdna testing and imaging with ct scans every three months. during the follow-up period, patients in the study will continue to be ctdna tested every six months and monitored for one year and will be allowed to continue on elacestrant for an additional year, resume standard endocrine therapy, or continue with standard of care surveillance during follow up.

Eligibility criteria:
inclusion criteria: 1. women or men aged 18 years and older. 2. previous diagnosis of anatomic stage iib or anatomic stage iii histopathologically or cytologically confirmed er+, her2-, breast cancer per local laboratory as per asco/cap guidelines. in the context of this trial, er status will be considered positive if \>10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry, with or without progesterone receptor positivity. patients who are pr positive but er-negative are not eligible. 3. participants must have been diagnosed with er+her2- breast cancer at least five years ago and no more than 15 years ago and must have completed adjuvant endocrine therapy. 4. participants must be off endocrine therapy for at least six months prior to screening. exclusion criteria: 1. known current metastatic disease. 2. known contraindication to receiving elacestrant as per fda package insert. 3. current treatment with endocrine therapy. 4. prior treatment with elacestrant or other investigational serds. 5. current or past invasive cancer other than breast cancer, except: 1. adequately treated basal or squamous cell carcinoma of the skin. 2. cancer survivors of previously diagnosed invasive cancer who were treated with curative intent and have no evidence of disease recurrence for five years or more and are considered low risk for future recurrence by the treating physician. 6. patients in the screening phase, or in the randomized trial (treatment phase), cannot start receiving therapy on another therapeutic clinical trial.

Keywords: stage iib stage iii ctdna
effect of treatment dairy for spasticity

Conditions: Spasticity, Muscle

Summary: 1. assessing whether the treatment diary can help optimize the overall treatment of patients. 2. to assess whether the patient finds the treatment diary useful and worth spending time on. also if the patient finds it easier to evaluate the treatment and, if necessary, set new goals. 3. to assess whether the patient's quality of life is increased by the use of the treatment diary.

hypothesis: a treatment diary will increase the patient's awareness of which spasticity symptoms are significant and can enable the patients to evaluate the treatment more easily. this will result in more relevant treatment goals. at the same time the treatment can be better addressed to the individual patient at routine controls. in addition, the treatment diary will result in closer cooperation between the physiotherapists and occupational therapists and the physician who administers the botulinum toxin. this collaboration is expected to lead to better common goals and optimization of treatment. finally, it is expected that the above will help to increase the patient's quality of life.

Eligibility criteria:
inclusion criteria: * patients must have received at least two previous treatments before inclusion, ie. with approx. 3 months apart, and it is assessed that the patients have good effect of the treatments in relation to the agreed treatment goals. exclusion criteria: * patients where changes are planned regarding their treatment for muscle overactivity during the study period. patients where the disease is not stable and where it may have a major influence on the treatment effect of botulinum toxin treatment during the study period and where it can be difficult to set smart (specific, measurable, accepted, realistic, timed) goals. patients who have previously been treated and have used a treatment diary in connection with the botulinum toxin treatment. patients who can not collaborate on completing goals and evaluating treatment effect due to language or cognitive problems. patients who at the same time are being treated with botulinum toxin in the bladder. if significant changes occur in the patient's health, which may involve new cancer, stroke, multiple sclerosis attack, etc. during the study period, the participant will be withdrawn from the study.

Keywords: treatment diary
effectiveness of irk-19® on body weight control

Conditions: Overweight; Metabolic Syndrome

Summary: this randomized, double-blind, placebo-controlled, and parallel clinical study aims to investigate the effectivness of a pumpkin seed extract (irk-19®) on weight management.


Eligibility criteria:
inclusion criteria: 1. bmi: 25-30 kg/m2 2. waistline circumference: ˃ 80 cm exclusion criteria: 1. pregnant women or preparing for pregnancy. 2. lactating women. 3. women gave birth 6 months before the study. 4. subject uses diuretic, corticosteroids, anti-depressant medications, or antipsychotic medications. 5. subject has undertaken obesity-related surgeries within one year prior to the study or other surgeries within six months prior to the study. 6. change of body weight of subject is over 5% within 3 months before the study. 7. subject has serious diseases (e.g., cardiovascular diseases). 8. cancer patient. 9. subject has engaged in another study within 3 months before the study. 10. subject uses another dietary supplement related to weight management during the study.
estetrol (e4)/drospirenone (drsp) drug-drug interaction (ddi) study

Conditions: Contraception

Summary: the present study is designed to determine the effect of valproic acid (val), a ugt2b7 inhibiting drug, on the pharmacokinetics (pk) of estetrol (e4)

in the present study, e4/drsp will be administered alone (treatment a) and in combination with val (treatment b) following two sequences a-b or b-a.

Eligibility criteria:
inclusion criteria: * healthy premenopausal, aged 18-45 years (inclusive) at the time of signing informed consent. * for subjects who are sexually active and are of childbearing potential: willing to use a highly effective non-hormonal method of contraception from screening until the follow-up assessment, such as (but not limited to): non-hormonal intra-uterine device (copper iud), bilateral tubal occlusion, vasectomised partner, or sexual abstinence in a heterosexual relationship; this is acceptable when it is in line with the subject's preferred and usual lifestyle. if a subject is usually not sexually active but becomes active, they, with their partner, must comply with the contraceptive requirements as stated earlier. * body weight ≥45 kg, and a body mass index between 18.0 and 30.0 kg/m² (inclusive). * negative serum pregnancy test at screening and a negative urine pregnancy test at day -1. exclusion criteria: * the use of: * any prescription drugs, including oral or vaginal hormonal contraceptives, from 28 days prior to first dose administration until study completion; * any herbal medication or dietary supplements acting on cytochrome p450 3a4 (cyp3a4) functions (i.e., st john's wort), from 28 days prior to first dose administration until study completion; * any over-the-counter medication (including paracetamol or dietary supplements (including vitamins and herbal products ), from 14 days prior to first dose administration until study completion. limited use (i.e., up to 1200 mg/day) of ibuprofen is allowed; * any depot progestogen preparations or an injectable hormonal method of contraception, from 6 months prior to the first dose administration until study completion. * history of hypersensitivity, serious adverse reaction, or existing contraindication to e4, drsp or val, or excipients.

Keywords: estetrol drospirenone uridine diphosphate glucuronosyltransferase-2b7 drug-drug interaction valproic acid