Kornimate/medical-research-clean huggingface dataset:
trial of a patient education tool for leiomyoma

Conditions: Uterine Leiomyoma

Summary: the goal of this study was to assess whether using a multimedia tool would enhance patient education and counseling on uterine leiomyomata.

women with leiomyomata confirmed on imaging who presented as a new patient to the gynecology clinic at a single institution were randomized to receive either standard counseling or multimedia counseling using the drawmd ob/gyn ipad application. participants completed a pre-counseling questionnaire, received the designated method of counseling, and then completed a post-counseling questionnaire.

Eligibility criteria:
inclusion criteria: * non-pregnant * english speaking * women aged 18-60 years * presence of fibroids confirmed on imaging * no confirmed or suspicion of malignancy exclusion criteria: -
intensive care anxiety in sars-cov-2 patients

Conditions: Anxiety

Summary: it should be known by the clinician that covid-19 patients are prone to anxiety, and these disorders need to be properly diagnosed and addressed to improve prognosis, shorten hospital stay and avoid long-term mental health problems.


Eligibility criteria:
inclusion criteria: * above 18 years old * covid pcr +, * admitted to intensive care, * conscious, cooperative patients exclusion criteria: * having hearing and speaking problems, * can't speak turkish or english, * who do not have the cognitive level to understand and answer the questions, * communication problems such as dementia and alzheimer's, * patients receiving sedation
device-detected cardiac tachyarrhythmic events and sleep-disordered breathing (dedicates)

Conditions: Sleep Disorder; Cardiac Arrythmias; Cardiac Event; Cardiac Implantable Electronic Device

Summary: this prospective multicenter registry study aims to determine whether device-detected sleep-disordered breathing events are associated increased risk of cardiac arrhythmias or other cardiovascular outcomes.

the prevalence of sdb high in patients with cardiac implantable electronic device (cied). recently, device-detected sdb events showed a correlation with sleep-disordered breathing (sdb) diagnosed by polysomnography. thus, cied will facilitate early detection and monitoring of sdb in patients with cieds. few studies investigated prognostic value of cied-detected sdb in risk of cardiovascular events. therefore, the primary aim is to determine whether device-detected sdb are associated with increased risk of cardiac arrhythmias or other cardiovascular morbidities using a prospective multicenter registry.

Eligibility criteria:
inclusion criteria: * age ≥ 19years * cha2ds2vasc score ≥ 1 in male or ≥ 2 in female exclusion criteria: * cied without atrial lead * persistent or permanent atrial fibrillation (af) or flutter * history of catheter of surgical ablation of af * valvular steno-insufficiency more than moderate degree * chronic obstructive pulmonary disease * under current treatment for sleep-disordered breathing * life expectancy \< 1year
the effect of multifidus and transversus abdominis muscle activation on balance in hemiplegic patients

Conditions: Hemiplegia

Summary: patients with post-stroke hemiplegia may develop balance disorder and limitation in ambulation ability due to multiple mechanisms. the effects of core muscles on maintaining normal posture, balance and ambulation ability are known. the positive effects of core stabilisation exercises on balance in hemiplegic patients have been shown in previous studies. in this study, we planned to investigate the effects of bilateral transversus abdominis and bilateral lumbar multifidus muscles on balance in patients with stroke-related hemiplegia.

loss of function in the trunk muscles of stroke patients leads to both balance problems and excessive effort to maintain balance. while ambulation ability of some patients is completely lost due to stroke, in others, impaired balance and increased postural oscillation lead to fear of falling and increased risk of falling. in previous studies, it has been shown that there is a significant relationship between static balance and duration of hospital stay and functional abilities after stroke. in another study, it was shown that the control ability of the trunk muscles in the early post-stroke period was a strong factor affecting general life activities in the first six months after stroke. trunk muscles are innervated by both hemispheres unlike the extremities. therefore, unilateral stroke may impair the function of trunk muscles on both the contralateral and ipsilateral sides. several studies have shown dysfunction of bilateral trunk flexor, extensor and rotator muscles in patients with unilateral stroke. many studies have proven that core stabilisation exercises are effective on both balance and gait function and general life activities in hemiplegic patients. the aim of this cross-sectional study was to investigate the effect of ultrasound-guided bilateral transversus abdominis and bilateral lumbar multifidus muscle activations on balance in hemiplegic patients.

Eligibility criteria:
inclusion criteria: * patients aged 18-65 years * time after stroke must be at least 1 month * unilateral stroke * must be cognitively compatible in terms of cooperation * standing balance with/without support and/or sitting balance without support * bmi\<30 exclusion criteria: * patients with a history of hemiplegia in the opposite half of the body * patients with extruded or sequestered lumbar hernia and/or history of lumbar operation * patients with a history of lumbar vertebral fracture * patients with traumatic brain injury * patients with neuromuscular muscle disease that may lead to muscle atrophy * patients with sensory defects * patients with cerebellar defects * patients with vestibular balance disorders (vertigo, etc.) * patients with parkinson's disease * patients with balance problems due to visual impairment * patients with pre-stroke balance problems

Keywords: hemiplegia transversus abdominis multifidus balance stroke
injection methods in finding the sentinel lymph node during lymphatic mapping and sentinel lymph node biopsy in patients with invasive breast cancer

Conditions: Breast Cancer

Summary: rationale: diagnostic procedures, such as lymphoscintigraphy using an injection under the nipple or near the tumor, may help doctors find out how far the disease has spread. purpose: this clinical trial is studying two different injection methods to compare how well they find the sentinel lymph node during lymphatic mapping and sentinel lymph node biopsy in patients with invasive breast cancer.

objectives: * compare subareolar injection with peritumoral injection in identifying the sentinel node during breast lymphatic mapping in patients with invasive breast cancer. * compare the lymphatic drainage patterns using lymphoscintigraphy of the breast with subareolar injection vs peritumoral injection. outline: at least 2 days before scheduled surgery, patients receive technetium tc 99m sulfur colloid by peritumoral injection followed by lymphoscintigraphy. images are obtained at 30 minutes and after 2 and 3 hours, provided no drainage is noted. patients then receive technetium tc 99m sulfur colloid by subareolar injection followed by another lymphoscintigraphy. at the time of surgery, patients receive isosulfan blue by subareolar injection. a handheld gamma probe is used to locate the sentinel node. if the sentinel node is identified, it is excised and the scheduled breast surgery is performed. if the sentinel node cannot be identified, patients undergo the scheduled breast surgery. projected accrual: a total of 100 patients will be accrued for this study within 12.5 months.

Eligibility criteria:
inclusion criteria: 1. patients must have either pathologic, radiologic or clinical evidence of breast cancer with invasion, suspicious for invasion or microinvasion. 2. patients who are candidates for a total mastectomy or segmental mastectomy or axillary dissection. 3. patients who have undergone neoadjuvant chemotherapy who have an fna confirmed lymph node positive for metastatic disease prior to induction chemotherapy and are then found to have grossly palpable disease but are ultrasound node negative at time of study entry. 4. patients must sign an informed consent and be registered before the procedure is performed. exclusion criteria: 1. a pregnancy test will be required preoperatively in women of childbearing potential and patients who are pregnant will be excluded from this study. 2. patients who have undergone neoadjuvant chemotherapy who have an fna confirmed lymph node metastatic disease prior to induction chemotherapy and are then found to have grossly suspicious palpable disease and are ultrasound node positive at the time of study entry. 3. patients with known allergy to isosulfan blue dye or any related compounds.

Keywords: recurrent breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage ii breast cancer
phosphodiesterase 4 inhibitor, roflumilast, and the effects of inhibition in severe asthma

Conditions: Asthma

Summary: this study evaluates the effects of roflumilast on restoring response β2 adrenoreceptor agonists in low t2, obese asthmatics. one group of participants will receive roflumilast for 3 months, while the other will receive a placebo.

t2 low asthma is common in obese asthmatics. new evidence suggests that hyperinsulinemia and insulin resistance, both common in obesity, are associated with an increased risk of concurrent asthma. targeting phosphodiesterase 4 inhibitors (pde4) allows for examination of a mechanism potentially linking obesity and asthma as well as identification of readily available and safe options to treat hyperinsulinemic, overweight asthmatics. it is hypothesized that obesity and hyperinsulinemia contribute to asthma by impairing β2 adrenoreceptor function and that this can be rescued the pde4 inhibitor, roflumilast.

Eligibility criteria:
inclusion criteria: * have a physician diagnosis of asthma. * require treatment with moderate to high-dose \>2500mcg/day of fluticasone or equivalent, or use of oral steroids also two of the following: * requirement for additional daily treatment with other controller medication * daily asthma symptoms * forced expiratory volume / forced vital capacity (fev1/fvc) \< 70% and fev1\< 80% predicted * ≥1 urgent care visits/year * ≥3 oral steroid bursts/year * near-fatal asthma event. * exhaled nitric oxide (feno)\<30 ppb * peripheral blood eosinophil count \< 300 (x10-6/ul) * obesity, bmi≥30 exclusion criteria: * less than 18 years of age * baseline fev1 \<30% predicted * pregnant or nursing women * current smokers or subject with \>20 pack year history * any history of intolerance of, or reaction to, roflumilast. * prisoners * patients with liver disease * subjects with hepatic impairment (contraindicated in moderate-to-severe liver impairment: child-pugh score class b/c) for example. * patients with clinically significant psychiatric history (i.e., suicidality, etc.) and psychiatric illness * patients using strong cyp 450 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin).

Keywords: hyperinsulinemia phosphodiesterase 4 inhibitor
a study of c-car039 treatment in subjects with r/r nhl subjectsnon-hodgkin's lymphoma

Conditions: B-cell Non-Hodgkin's Lymphoma

Summary: this is a single-center, open-label study to evaluate the safety and efficacy of c-car039 in relapsed and/or refractory b-nhl patients.

the study will include the following sequential phases: screening, apheresis and c-car039 manufacturing, baseline testing, lymphodepleting, c-car039 infusion, and follow-up visit.

Eligibility criteria:
criteria: inclusion criteria: 1. age 18-70 years (include 18 and 70), male or female; 2. expected survival ≥ 12 weeks 3. ecog score 0-2 4. cd19 or cd20 positive b-nhl confirmed by cytology or histology according to who2016 criteria, including dlbcl, pmbcl, tfl, fl and mcl 5. relapsed or refractory disease after ≥ 2 lines (for fl, at least 3 lines) of standard therapy or relapsed after autologous stem cell transplantation (asct); 6. for cd20-positive subjects, they should have received at least one regimen containing anti-cd20-targeted therapy (such as rituximab). if they do not complete the regimen due to intolerance, the cause of intolerance should be recorded; 7. no contraindications of apheresis. 8. at least one measurable lesion according to lugano 2014 criteria; 9. adequate organ and bone marrow function 10. the patient volunteered to participate in the study and signed the informed consent. exclusion criteria: 1. malignant tumors other than diffuse large b-cell lymphoma, follicular lymphoma and mantle cell lymphoma within 5 years before screening, except fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical operation and breast ductal carcinoma in situ after radical operation; 2. active hiv, hbv, hcv or treponema pallidum infection; 3. any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy 4. any other uncontrolled active disease that hinders participation in the trial; 5. any situation that the investigator believes would compromise the safety of the subject or interfere with the purpose of the study; 6. female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after c-car039 infusion; 7. active or uncontrolled infections requiring systemic treatment within 14 days before enrollment; 8. patients who have previously been infected with tuberculosis. 9. administered corticosteroids and/or other immunosuppressants within 7 days before apheresis. and 5 days before the infusion of c-car039; 10. patients with central nervous system involvement; 11. any systemic antitumor therapy performed within 2 weeks before enrollment; 12. those with medical conditions that prevent them from signing the written informed consent or from complying with the study procedures; or those who are unwilling or unable to comply with the study requirements; 13. other conditions was considered unsuitable for enrollment by the investigator.

Keywords: cd19/cd20-directed car-t cells
lidocaine mucilage-icg as an optical agent for tumor delineation during breast-conserving surgery

Conditions: Breast Cancer

Summary: around 15%-30% of patients receiving breast-conserving surgery (bcs) for invasive breast carcinoma or ductal carcinoma in situ (dcis) need a reoperation due to tumor-positive margins at final histopathology. currently available modalities used for intraoperative surgical margin assessment all have specific limitations. in order to improve intraoperative tumor localization and surgical margin assessment in bcs, we developed a fluorescent tracer, the lidocaine mucilage-icg tracer, which could be locally injected and detected by fluorescent camera systems during operation. in this study, we aim to evaluate the efficacy of lidocaine mucilage-icg as an agent for intraoperative tumor delineation.


Eligibility criteria:
inclusion criteria: * female at least 18 years old * histologically or cytologically confirmed breast carcinoma * patients planned to receive a breast-conserving surgery * patients received a preoperative breast magnetic resonance imaging * informed consent form understood and signed * patient agrees to all follow-up visits * eastern cooperative oncology group(ecog) performance status 0 to 1 within 14 days of study entry * women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the surgery exclusion criteria: * psychiatric or other condition that may interfere with the study * known allergy or contraindication to any study drug * patients received neoadjuvant therapies * patients received an excision biopsy of the tumor * breast feeding period * pregnant (female of childbearing potential only)

Keywords: breast conserving surgery; fluorescence-guided surgery
watershift - pilot study

Conditions: Total Body Water; Nocturnal Polyuria

Summary: the aim of this pilot was to study how body water behaves between the different internal water pools of the human body, what the role and influence of the interstitium is and what the effect is of body position on the distribution and allocation of bw between different body parts (trunk, legs, arms). to study this, 2 techniques that have not been used before in urological research were tested on their usefulness: * the first technique is a recent bia device, which distinguishes itself from earlier devices by measuring impedance at different electrical currencies in different body parts (arm/limb/trunk). this technique made it possible to observe the influence of body position on the distribution of bw in these body compartments. rationale for this research question is mainly the link between np and edema that was found in earlier research and the fact that body position seemed to have an impact on the size of edema. for this reason, it can be suggested that body position and thus edema will have an impact on whether or not np occurs. * the second technique uses deuterium as a biological marker. with this technique the distribution, storage, allocation and excretion of bw was examined among the urological most relevant water pools (blood, urine and interstitium).


Eligibility criteria:
inclusion criteria: * healthy individuals * ages between 18 and 30 * bmi between 18 and 24.9 exclusion criteria: * intake of medications except of oac * patients with pacemaker or neurostimulator
persistence of bactericidal antibodies in adolescents and adults who had received a single dose of menactra® vaccine

Conditions: Meningococcal Infections; Meningitis

Summary: to evaluate the persistence of bactericidal antibodies in adolescents and adults who received one dose of menactra® vaccine approximately four to eight years earlier

subjects who received one dose of menactra® or menomune® in study mta04, mta12, mta19 (nct00777790), or mta21 (nct00777257) will be eligible for enrollment in trial this study. all eligible subjects will provide a blood sample at visit 1, after which their participation in the study will be terminated. an age-matched meningococcal-vaccine naïve control group will be recruited to provide a blood sample for baseline antibody level evaluation. no vaccine will be administered in this study.

Eligibility criteria:
inclusion criteria : * for subjects aged ≥ 18 years: informed consent form signed and dated by the subject * for subjects aged \< 18 years: informed consent form signed and dated by the subject and the subject's parent/legal guardian * subject (and parent/legal guardian if subject is \< 18 years of age) able to attend the scheduled visit and comply with all trial procedures * for group 1: previously received only one dose of meningococcal vaccine (menactra®, received in study mta04, mta12, mta19, or mta21) * for group 2: previously received only one dose of meningococcal vaccine (menomune®, received in study mta04) * for group 3: aged 14 through 27 years and never received any meningococcal vaccine exclusion criteria : * participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding inclusion * known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy \> 2 weeks * chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator * current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures * receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune responses * known human immunodeficiency virus (hiv), hepatitis b, or hepatitis c seropositivity * history of invasive meningococcal disease (confirmed either clinically, serologically, or microbiologically) * for groups 1 and 2: previous vaccination (including booster) against meningococcal disease, with the exception of the menactra® or menomune® vaccination received in trial mta04, mta12, mta19, or mta21 * subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent * received oral or injected antibiotic therapy within the 72 hours prior to the blood draw (temporary criteria)

Keywords: menactra® menomune® meningitis meningococcal infections
soundbite hearing system long term multi site patient use study

Conditions: Single Sided Deafness; Conductive Hearing Loss

Summary: this study is designed to collect data about the soundbite™ hearing system to answer specific questions. the hearing system has been cleared for commercial distribution by the food and drug administration (fda). sonitus hopes to learn from a larger group of users what features and settings of this device provide the best hearing ability for people diagnosed with single sided deafness (ssd) or conductive hearing loss (chl).

the sonitus soundbite hearing system prosthetic device is a bone conduction device that has been fda cleared for treatment of single-sided deafness (ssd) and conductive hearing loss (chl). the sonitus soundbite hearing system consists of an in the mouth (itm) component an external microphone component, worn behind the ear (bte), a calibration interface cable and pc-controlled calibration software for subject calibration. a charger is also provided to charge the itm and the bte. the objective of this multi-sites observational study is to assess the long-term patient use of the sonitus soundbite hearing system.

Eligibility criteria:
inclusion criteria: * patients who are 18 years or older * clinical diagnosis of a moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (normal hearing is defined as a pure tone average (pta) air-conduction (ac) hearing threshold (measured at 0.5, 1, 2, and 3 khz) of better than or equal to 25 db hl) * patients diagnosed with conductive hearing loss where the pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 khz) is better than or equal to 25 db hl. * at least two contiguous molar or premolar teeth with no untreated tooth decay. -patients with tooth decay present are to first have restorations before being fitted for soundbite * healthy attachment to those teeth with tooth pockets limited to no more than 5mm * no mobile teeth * bone loss no greater than a 34% average on the mesial and distal sides of the tooth as measured on x-ray on the teeth on which the device will be worn. exclusion criteria: * the soundbite hearing system and all portions of it are contraindicated for use in an mri environment and should be removed prior to mri exposure * the soundbite hearing system is not to be used in patients with known hypersensitivity to any of the components including allergies to polymers. * the soundbite hearing system is contraindicated for vulnerable populations that are unable to sue their hands such as paraplegics or others that are unable to comply with the warnings in the product's labeling.

Keywords: sonitus medical soundbite single sided deafness conductive hearing loss unilateral hearing loss