Kornimate/medical-research-clean huggingface dataset:
s0106b studying bone marrow samples from women with acute myeloid leukemia

Conditions: Leukemia

Summary: rationale: studying samples of bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. purpose: this research trial studies bone marrow samples from women with acute myeloid leukemia.

objectives: * estimate the proportion of acute myeloid leukemia (amls) that originate in cd33+ precursors or in which uncontrolled growth is limited to cd33+ precursors. * explore whether there is an association between the cellular origin of aml (i.e., origination in cd33+ precursors or not) and cytogenetic, molecular, and other patient characteristics. * explore whether overall survival (os), event-free survival (efs), disease-free survival (dfs), response rate (rr), or relapse rate is improved for patients with amls that originate in cd33+ precursors or in which uncontrolled growth is limited to cd33+ precursors compared to patients with clonally involved cells not detected. outline: archived bone marrow samples are analyzed for cd33+ progenitors, x-chromosome inactivation, and somatic mutations (t(8;21), inv(16), flt3/itd, npm1, cebpa, kit) by fluorescence-activated cell sorting, long-term culture in hypoxic condition in cytokine-containing liquid media, and flow cytometry. results are then compared with each patient clinical data.

Eligibility criteria:
disease characteristics: * diagnostic bone marrow specimens from female patients with untreated aml undergoing intensive ("3+7"-like) induction chemotherapy * specimens from the south western oncology group (swog) protocols s0106 (age 18 to 60 years), excluding patients who received gemtuzumab ozogamicin (go), and s9333 (age \> 60 years) patient characteristics: * see disease characteristics prior concurrent therapy: * see disease characteristics

Keywords: untreated adult acute myeloid leukemia adult acute basophilic leukemia adult acute eosinophilic leukemia adult erythroleukemia (m6a) adult pure erythroid leukemia (m6b) adult acute megakaryoblastic leukemia (m7) adult acute minimally differentiated myeloid leukemia (m0) adult acute monoblastic leukemia (m5a) adult acute monocytic leukemia (m5b) adult acute myeloblastic leukemia with maturation (m2) adult acute myeloblastic leukemia without maturation (m1) adult acute myeloid leukemia with 11q23 (mll) abnormalities adult acute myeloid leukemia with del(5q) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myelomonocytic leukemia (m4)
use of the leva pelvic digital health system in women with fecal incontinence

Conditions: Fecal Incontinence

Summary: pilot study to understand the impact of a digital health system, including a phone app and a vaginal probe to treat fecal incontinence in women

subjects meeting inclusion/exclusion criteria at screening will complete training in behavioral therapy for the treatment of fecal incontinence and training in the use of the leva pelvic digital health system. subjects will then participate in 10 weeks of at home pelvic floor muscle training using the leva device twice daily for 2 ½ minutes of training. adherence to the training protocol will be observed digitally, and subjects will receive phone calls every other week from research assistants reviewing their adherence. subjects are expected to participate in at least 80% of the weekly exercises (11 weekly). subjects will return to clinic at 5- and 10-weeks during the study to complete questionnaires. at 5-weeks, subjects will review the use of the device with the study assistant, who will answer any questions and repeat training if the subject desires additional training. following 10 weeks of training, subjects will be free to pursue any additional therapies, but will also retain the leva device and may continue its use if desired. adherence will be monitored for one additional year, with follow up surveys to be completed by mail or digitally at 6- and 12-months

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. fecal incontinence defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment 3. ambulatory exclusion criteria: 1. absence of a vagina 2. stool consistency over the last 3 months that includes items 1 or 7 based on the bristol stool form scale (severe constipation or diarrhea) 3. current or past diagnosis of colorectal or anal malignancy 4. diagnosis of inflammatory bowel disease 5. current or history of rectovaginal fistula or cloacal defect 6. rectal prolapse (mucosal or full thickness) 7. prior removal or diversion of any portion of colon or rectum 8. prior pelvic floor or abdominal radiation 9. refusal or inability to provide written consent 10. inability to utilize smart phone technology ("app" use) 11. fecal impaction by exam 12. stage 3 or 4 pelvic organ prolapse 13. incontinence only to flatus 14. supervised anal sphincter exercise/pelvic floor muscle training with or without biofeedback currently or within the past 6 months. 15. childbirth within the last 6 months 16. neurological disorders known to affect continence, including spinal cord injury, advanced multiple sclerosis or parkinson's disease and debilitating stroke 17. chronic abdominal pain in the absence of diarrhea 18. presence of an active (turned on) sacral neuromodulator within the last 6 months 19. pelvic floor surgery (including anal sphincteroplasty) within the past 6 months.

Keywords: fecal incontinence women
application of mobile dr in the diagnosis of bone trauma in high cold environment

Conditions: Bone Injury; Artificial Intelligence

Summary: in the high cold environment, mobile digital radiography (dr) is used to collect the imaging of bone injury patients, and the artificial intelligence diagnosis module is used to diagnose the injury. the quality of images obtained by mobile or conventional dr and the consistency between artificial intelligence and pure artificial diagnosis will be analyzed respectively. finally, the application value of mobile dr loaded with artificial intelligence diagnosis function in high cold environment is determined.


Eligibility criteria:
inclusion criteria: * patients with new bone injury exclusion criteria: * life threatening. * head injury and fracture. * there are congenital malformations in the bone injury site.

Keywords: artificial intelligence digital radiography
comparative analysis of cost-effectiveness of silver dressing in burns

Conditions: Second-degree Burn

Summary: the evidence is insufficient to determine whether the types of dressings containing silver differ in time / proportion for complete wound healing and pain. we will analyze the cost-effectiveness of these dressings in outpatients, considering the service provided by the brazilian national public health system.

randomized, single-center, single-blinded, controlled clinical trial. adult patients (age between 18 and 65 years), regardless of sex, with second degree burns treated in outpatient regimen will be randomized (1:1) into two groups: 1% silver sulfadiazine and nanocrystalline silver. primary outcome: - proportion of lesions completely epithelialized within 15 days. secondary outcomes: * time in days for complete epithelialization of the burned areas; * number of dressing changes; * level of pain associated with the application and removal of the dressings; * direct medical and non-medical costs; * need for surgery; * incidence of infection; * presence of local adverse reactions.

Eligibility criteria:
inclusion criteria: * adults aged between 18 and 65 years; * regardless of sex and ethnicity; * presenting second degree burns (partial thickness involving the epidermis and part of the dermis, with at least the preservation of some dermal appendages from of which the wound can eventually be epithelialized spontaneously) (artz; moncrief; pritt, 1980) under an outpatient regimen, without the need for surgical debridement of devitalized tissue and skin grafts informed in the initial clinical diagnosis. exclusion criteria: * patients with diabetes; * pregnant women; * patients with intellectual disabilities; * patients with burns to the face or on the palmar face of the hands or on the plantar face of the feet, as the need for specific treatment was felt to prevent functional sequelae; * patients who have already started treatment in other institutions; * those whose burns had happened 5 or more days before their entrance in the hospital; * those incapable of signing the informed consent form or who have declined to participate.

Keywords: burns dressings silver sulfadiazine silver compounds cost
community partnership for telehealth solutions to counter misinformation and achieve equity

Conditions: Colorectal Cancer

Summary: non-randomized, two-arm stepped-wedge trial of a multi-level colorectal cancer screening intervention.

the prime study aims to improve colorectal cancer (crc) screening and follow-up among predominantly latinx populations by using video text messages, mailed fit kits, and patient navigation. the study will address multi-level barriers to screening, including misinformation, lack of access, and social determinants of health. the hypothesis is that a multi-component intervention will increase crc screening rates and follow-up care, reducing disparities in crc outcomes.

Eligibility criteria:
inclusion criteria: * ages 45-64 * eligible for colorectal cancer (crc) screening * current patients (seen in the clinic in the last 6 months) * primary speaker of english or spanish * cell phone listed in electronic health record (ehr) * no recent history of crc screening * resides in one of the neighborhoods included in the main trial exclusion criteria: * colorectal disease (e.g., ulcerative colitis or colectomy) * personal history of colorectal cancer * end-stage or life-threatening diseases * known to be under hospice care * living in a skilled nursing facility * patients who decline research participation will be removed from the patient contact list

Keywords: cancer screening telehealth video text messaging patient navigation stool testing fecal testing latinx health disparities
effects of cbd/cbd-a oral extract on resting-state eeg and neuropathic pain symptoms after sci

Conditions: SCI - Spinal Cord Injury; Neuropathic Pain

Summary: the main purposes of this study are to (1) measure the effect of cbd/cbd-a on pain symptoms, pain intensity, pain unpleasantness, and skin sensitivity to hot and cold temperatures; and (2) measure the effect of cbd on brain electrical activity with electroencephalography (eeg).


Eligibility criteria:
inclusion criteria: 1. men or women; 2. 18-64 years of age with an incomplete or complete acquired traumatic sci; 3. must have experienced neuropathic pain for a minimum of three months before entering the study (neuropathic pain will be assessed using the international sci pain classification); 4. the pain intensity must be in the moderate to severe category, which will be defined as a score of at least four on an nrs (range of 0 to 10). 5. must have previous experience with consuming cannabis and or cannabinoids. exclusion criteria: 1. current drug (dast-10: \>6) or alcohol abuse (audit: \>10); 2. current use of cannabis plant or cannabis products (cbd or cbd+thc) or any other drugs of abuse (unless prescribed) including alcohol; 3. presence of significant medical illness (e.g., diabetes, obesity, cardiovascular disease, hypertension, hepatitis) or other significant neurological trauma; 4. history of or current severe psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia, post-traumatic stress disorder) judged by the investigator to put the subject at greater risk of experiencing an adverse event; 5. adults who are unable to consent, women who are pregnant, breastfeeding, or not practicing an effective form of birth control (condoms, diaphragm, birth control pill, iud), and prisoners; 6. current pregnancy. pregnancy will be evaluated using a pregnancy test during the first study visit. female subjects of childbearing potential will be required to use two forms of effective birth control for the 3 months prior to participating in the study and continuing for 1 month after completion of the study; 7. have a history of renal or hepatic disease: or 8. have elevated serum creatinine above the laboratory upper limit of normal (uln): or 9. have elevated serum transaminases (alt or ast) above the uln: or 10. have elevated total bilirubin above the uln; or 11. take valproate, due increased risk of liver enzyme elevation; or 12. currently using strong cyp2c19 and cyp3a4 inducers; or 13. have suicidal ideation (subjects should be screened for suicidal ideation); or 14. cannot abstain from the use of alcohol during the study period, due to increased risk of sedation; or 15. have a known or suspected hypersensitivity to cannabidiol or tetrahydrocannabinol. 16. have a known or suspected hypersensitivity to sesame seed oil, lecithin, or bovine gelatin.
a study to evaluate the efficacy and safety of asp1707 in postmenopausal female patients with rheumatoid arthritis taking methotrexate

Conditions: Rheumatoid Arthritis

Summary: the objective of this study is to evaluate the efficacy, pharmacokinetics, pharmacodynamics and safety of asp1707 in combination with mtx in postmenopausal female patients with ra.


Eligibility criteria:
inclusion criteria: * subject has ra that was diagnosed according to the 1987 acr criteria or the 2010 acr/eular criteria. * subject meets the acr 1991 revised criteria for the classification of global functional status in ra class i, ii or, iii. * subject has active ra as evidenced by both of the followings: * ≥ 6 tender/painful joints (using 68-joint assessment) * ≥ 6 swollen joints (using 66-joint assessment) * crp (c-reactive protein) of \> 0.3 mg/dl or esr (erythrocyte sedimentation rate) of \> 28 mm/hr at screening. * subject who continuously received mtx and who is able to continue stable dose of mtx. * subject who did not receive the following drugs, or received the drugs with stable dosage: non-steroidal anti-inflammatory drugs, oral morphine or equivalent opioid analgesics, acetaminophen, or oral corticosteroids. exclusion criteria: * inadequate responders to a biologic dmard (disease-modifying antirheumatic drug). * subject has taken other investigational research products are prohibited within 12 weeks (84 days) or within 5 half-lives, whichever is longer, prior to screening. * subject has undergone surgery which has residual effects on the assessed joints, or is scheduled to undergo surgery that may affect the study evaluation of the assessed joints. * subject has another type of inflammatory arthritis other than ra. * subject who meets any of the following criteria of laboratory values at screening: * white blood cell count \<4000/μl * platelet count \<100000/μl * alt (alanine aminotransferase) ≥ 2 x uln (upper limit of normal) * ast (aspartate aminotransferase) ≥ 2 x uln * total bilirubin ≥ 1.5 x uln * positive hepatitis b surface antigen, hepatitis b virus-dna quantitation, or hepatitis c virus antibody * subject has a positive quantiferon-tb gold test or t-spot. * subject has a history of or concurrent malignant tumor. * subject has any ongoing severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, infectious, or autoimmune disease except for ra, or diseases which preclude the subject's participation in the study. * subject has a history of clinically significant allergy. * subject has clinically significant abnormalities on the 12-lead electrocardiogram. * subject has a history of positive human immunodeficiency virus infection.

Keywords: methotrexate asp1707 rheumatoid arthritis
high-dose corticosteroid or tocilizumab for clinical worsening of covid-19

Conditions: COVID-19 Virus Infection; Cytokine Storm; Corticosteroid; Tocilizumab

Summary: covid-19 pandemic has spread all over the world, and hospitalization of the patients with covi̇d-19 pneumonia has become a great burden to the intensive care units. unfortunately there is still no curative method for the disease yet. intensive care units provide general care for the patients; including oxygen therapy, maintenance of the organ systems (e.g., cardiovascular, renal), nutrition, antibiotic therapy for secondary infections, and etc. one of the major problems in covid-19 is macrophage activation syndrome, also known as cytokine storm. it stems from exaggerated inflammatory response, which causes increased cytokine release and results in clinical deterioration of the patients. many drugs have been used to prevent this exaggerated inflammation, like corticosteroids, interleukin (il) receptor blockers, plasma exchange, etc. in this study our aim is to investigate the effectiveness of high dose corticosteroid (methylprednisolone 250 mg for 3 days) and an il-6 receptor antagonist (tocilizumab) in the treatment of the cytokine storm of the covid-19 patients.


Eligibility criteria:
inclusion criteria: * patients with covid-19 pneumonia treated in the intensive care unit * clinical deterioration during intensive care follow-up * first 14 days from the covid-19 diagnosis exclusion criteria: * more than 14 days passed from the covid-19 diagnosis * clinical and laboratory signs of secondary bacterial infection
signos dm2 empowerment study (signos-cgm-empower-201-2022)

Conditions: Weight Loss; Metabolic Syndrome; Diabetes Mellitus, Type 2; Central Obesity; Insulin Resistance; Glucose Intolerance; Metabolic Glucose Disorders

Summary: the use of continuous glucose monitoring (cgm) in earlier data has inspired behavioral changes leading to improved adherence to an exercise plan in individuals and eating habits in people with diabetes. mobile health (mhealth) platforms provide satisfactory, easy-to-use tools to help participants in the pursuit of weight change goals. we hypothesize that the use of cgm data and the signos mhealth platform will assist with weight control in a population of people with type 2 diabetes mellitus who are not using insulin.

the scope of this study is to enroll existing and new signos non-insulin dependent type 2 diabetes mellitus users in a volunteer study that utilizes a continuous glucose monitor (cgm) and mobile health application \[signos\] to optimize general wellness and body weight and composition. this is a no more than minimal risk study.

Eligibility criteria:
inclusion criteria: * medical diagnosis of type 2 diabetes; determined by review of subject-provided most recent hg a1c. * subject is under current care of a primary care provider or specialist * clearance by medical provider to participate in diet, physical activity, and lifestyle changes * 18 years and above * own a smartphone and be willing to install the signos app to personally receive text messages or have access to a web-based survey to self-report their weight. * willingness to complete quality of life questionnaires or other in-app surveys. * willingness to use cgm device * able to speak and read english * be a signos mhealth (mobile/web-based) user exclusion criteria: * medical diagnosis of type 1 diabetes * type 2 diabetes currently using insulin or most recent a1c ≥10% * severe hypoglycemia \<54 mg/dl resulting in seizure or unconsciousness, or requiring assistance/ems/hospitalization - within 3 months prior to enrollment * current medical diagnosis of an eating disorder (such as anorexia nervosa or bulimia) * medical conditions (e.g., such as seizure disorder) requiring a specific medical diet. * inborn error of metabolism such as phenylketonuria (pku), glycogen storage disease, fructose intolerance, maple sugar urine disease (msud). * history of 10 or more soft tissue skin infections (such as cellulitis or abscesses) * intolerable skin reaction from adhesive * currently taking any of the following medications: clozapine, hydroxyurea, or any form of insulin.

Keywords: health and wellness excess adiposity
brilliant study: assessing cognition in myeloma patients undergoing transplant

Conditions: Stem Cell Transplant Complications

Summary: the overall objectives in this study are to identify patterns of cognitive impairment pre- and post-transplant, to assess the similarities of scores of the three cognitive assessments in myeloma patients who undergo autologous stem cell transplant, and to determine if patients prefer the self-assessment, self-administered gerocognitive exam (sage) or the healthcare applied montreal cognitive assessment (moca) assessment.

the overall objectives in this study are to identify patterns of cognitive impairment pre- and post-transplant, to assess the similarities of scores of the three cognitive assessments in myeloma patients who undergo autologous stem cell transplant, and to determine if patients prefer the self-assessment, self-administered gerocognitive exam (sage) or the healthcare applied montreal cognitive assessment (moca) assessment.

Eligibility criteria:
inclusion criteria: * patients with multiple myeloma * patients who will undergo pre-transplant evaluation with intentions to proceed to autologous stem cell transplant after stem cell collection. * patients willing and able to understand and sign an informed consent form * patients 18 yrs of age or older exclusion criteria: * patients with unstable psychiatric illness within the past 3 months of study enrollment. * patients who are considered unable to perform study evaluations at the investigator's discretion. * patients who are unable to read. (if patients require reading glasses, they must be worn at time of test.) * patients who do not proceed to stem cell transplant within 60 days of stem cell collection will be excluded from study. * patients who receive more than one cycle of chemotherapy between the time of stem cell collection and transplant will be excluded from study.
deep brain stimulation effects on gait and balance in patients with parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to evaluate the effect of deep brain stimulation (dbs) on walking in patients with parkinson's disease that have had dbs. while dbs improves parkinson's disease (pd) symptoms and walking in many patients in some of the patients walking problems persist. this study aims to find out what are the best stimulation parameters of the dbs in order to improve walking.


Eligibility criteria:
inclusion criteria: * patients with idiopathic parkinson's disease stage 1-3 that underwent subthalamic nucleus (stn) deep brain stimulation (dbs) and have walking difficulties 6-12 months after dbs. * on stable dose of dopaminergic drugs * age 45-70 years of age exclusion criteria: * past medical history of seizures * renal insufficiency * cardiac arrhythmia * severe arthritis * women of childbearing potential * dementia * less than 45 years of age or older than 70 years of age

Keywords: deep brain stimulation