Kornimate/medical-research-clean huggingface dataset:
acute kidney injury after cardiac surgery based on kdigo criteria

Conditions: Acute Kidney Injury

Summary: the aim of this study was to apply the acute kidney injury criteria based on kdigo classification in a population of patients undergoing cardiac surgery \[coronary artery bypass grafting (cabg) or cardiac valve surgery (cvs)\] and evaluate its impact as a predictor of 30-day mortality.

this was a single center study. we evaluated retrospectively patients from the cardiac surgery intensive care unit in hospital de base, são josé do rio preto medical school, são paulo, brazil. demographics, type of surgery, laboratory data and preoperative, perioperative, and postoperative information were retrieved from a prospectively collected database of 2878 patients older than 18 years undergoing isolated cabg (1786) or cvs (1092), from january 2003 to june 2013. after applying the exclusion criteria (51 patients with incomplete data and 23 patients with end-stage kidney disease) we analyzed 2804 patients in total, 1738 (62%) underwent cabg and 1066 (38%) underwent cvs.

Eligibility criteria:
inclusion criteria: patients undergoing isolated coronary artery bypass grafting or cardiac valve surgery. exclusion criteria: patients with incomplete data and patients with end-stage kidney disease.

Keywords: acute kidney injury kidney failure risk factors clinical outcomes cardiac valve surgery coronary artery bypass grafting morbidity mortality
peer-to-peer tobacco and ends prevention

Conditions: Substance Use

Summary: in phase i, the real media plus prototype will be developed and a usability test conducted among students and teachers. in phase ii a group randomized trial will be conducted among 27 high schools to evaluate the effects of real media plus on smoking and vaping.

in phase i, participants will participate in pilot and usability tests of the curriculum prototype. for the pilot test, teachers and students will use the curriculum prototype and then be interviewed about it. for the usability test, students and teachers will use the revised curriculum and be interviewed/complete short survey. teachers will provide consent and students will have parental consent and their own assent. in phase ii, a group randomized trial will be conducted during spring semester 2020 among 9th grade student in 27 high schools in the hillsborough county public school system randomly assigned to treatment and control (14 treatment and 13 control). all students will complete a pretest survey. students in two health classes in treatments schools will participate in the real media plus curriculum and complete a short immediate posttest survey to rate their experience. all students will then complete two posttests. students will have parental consent and provide their own assent.

Eligibility criteria:
inclusion criteria: attendance at participating schools; 9th grade student status (for student participants, both phase 1 and 2); status as a teacher/counselor (for phase 1); written parental consent and assent from students (phase 1 and 2); written consent from counselors/teachers (phase 1); and all individuals must be willing to participate. exclusion criteria: exclusion criteria include the inability to speak or read american english, use a computer, or navigate the internet and, for youth, lack of parental consent.
sexual health on antidepressants through physical exercise

Conditions: Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological

Summary: preliminary findings from a trial in the investigators laboratory suggest that acute exercise may ameliorate deficits in sexual arousal associated with use of antidepressants. the goal of this project is to evaluate the real-world effectiveness of an exercise-based intervention for these side effects in a community-based sample. the investigators hypothesize that general exercise will help improve sexual functioning in women taking antidepressants, and that exercise immediately before sexual activity - that is, acute exercise - will have an additional beneficial effect above and beyond that of general exercise.


Eligibility criteria:
inclusion criteria: * female * age 18 or older * currently receiving a consistent dosage of escitalopram, citalopram, sertraline, desvenlafaxine, venlafaxine, or duloxetine * currently sexually active * willing and able to exercise * experiencing regular menstrual cycles * not currently pregnant and not intending to become pregnant during trial exclusion criteria: * currently taking more than one psychoactive medication * factors indicating risk of cardiovascular activity, including acute or chronic cardiovascular illness, including clinically significant hypertension (defined as self-reported hypertension or "blood pressure greater than 140/90" or receiving medications designed to treat hypertension); recent chest pain; frequent or recurrent faint or dizzy spells; severe or untreated exercise-related asthma; or musculoskeletal illness or injury that would be expected to worsen with physical exercise. additionally, women will be excluded if they are found to have any of the following as measured during the fitness assessment of the first session: a bmi over 40, waist circumference over 40 inches, waist-to-hip ratio of greater than 0.9, systolic blood pressure greater than 150 or diastolic pressure over 95, or resting heart rate over 90. * factors associated with significant genital nerve damage, including: previous major pelvic surgery that may have caused nerve damage, including hysterectomy, vulvectomy, circumcision, colostomy, cystostomy, or serious bladder, rectal, or abdominal surgery; or neurological impairment due to diabetes, stroke, pelvic nerve damage secondary to trauma, cancer treatments, myasthenia gravis, multiple sclerosis or spinal cord damage. * factors associated with non-normative endocrine function, including: perimenopausal or menopausal status, or \>1 missed menstrual period in the previous 6 months; or currently pregnant, breastfeeding, or having breastfed within the past 3 months; or reporting clinically significant untreated renal or endocrine disease * untreated serious mental health conditions * sexual aversion or distress due to history of unwanted sexual contact
a study comparing ceramic-on-metal articulation to metal-on-metal articulation in cementless primary hip arthroplasty

Conditions: Osteoarthritis

Summary: the aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using m2a-38™ mm cup compared to the metal on metal articulation using the same cup.

the aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using m2a-38™ mm cup compared to the metal on metal articulation using the same cup in regards to the composite clinical success (ccs) rate, as defined in the protocol, at 2 year postoperative.

Eligibility criteria:
inclusion criteria: * patients presenting with osteoarthritis and suitable for primary total hip replacement * patients preoperative harris hip score \<= 70 points * patients aged over 18 and under 75 * patients with limited co-morbidity - asa i-iii * patients with normal urea and electrolyte levels and creatinine levels * patients must be able to understand instructions and be willing to return for follow-up * patients willing to provide blood and urine samples for metal ion analysis at follow up exclusion criteria: * patients preoperative harris hip score \> 70 points * previous prosthetic hip surgery * patients with significant co-morbidity - asa iv - v * dementia and inability to understand and follow instructions * neurological conditions affecting movement * existing metal implant or fixation device * pregnancy * presence of symptomatic arthritis in other lower limb joints
creatine supplementation in pediatric rheumatology

Conditions: Juvenile Systemic Lupus Erythematosus; Juvenile Dermatomyositis

Summary: creatine supplementation may improve strength, muscle mass, bone mass and muscle function in healthy and elderly people. the investigators speculate that creatine supplementation could have therapeutic effects in pediatric rheumatic (i.e., juvenile systemic lupus erythematosus and juvenile dermatomyositis) patients who usually present muscle weakness, muscle wasting and bone mass loss.


Eligibility criteria:
inclusion criteria: * patients diagnosed with lupus systemic erythematosus and juvenile dermatomyositis * physically inactive * stable pharmacological treatment exclusion criteria: * macroalbuminuria * gfr \< 30 ml/min/1.73m2 * use of oral anticontraceptive agents * pregnancy * diabetes mellitus * hypothyroidism

Keywords: rheumatology creatine supplementation quality of life strength juvenile systemic lupus erythematosus juvenile dermatomyositis
safety and efficacy of laparoscopic truncal vagotomy for the treatment of obesity

Conditions: Morbid Obesity

Summary: this two site study will evaluate the safety and effectiveness of laparoscopic truncal vagotomy for the treatment of obesity with baseline study and 18 month post op follow up.

30 morbidly obese patients evenly enrolled at the university of california san francisco and at the university of rochester will be selected for study on a voluntary basis. they will have a bmi of \>35 with at least one obesity related comorbidity or a bmi between 40 and 45. subjects will undergo specific tests of vagal function and baseline metabolic evaluation at baseline. thereafter they will undergo a laparoscopic truncal vagotomy. over 18 months, post operative tests of adequate vagotomy, weight loss, change in body composition and metabolism will be studied.

Eligibility criteria:
inclusion criteria: * male or female age 25-55 * bmi 35-40 with comorbidity and bmi 40-45 with or without comorbidity * stable weight for the last 3 months * willing to use contraceptives * motivated to lose weight * a personal history of at least one professionally supervised 6 month attempt or more than 2 serious attempts to loose weight * fully ambulatory exclusion criteria: * sign of prior major abdominal surgery * history of or signs and /or symptoms of gastro-duodenal ulcer disease * abnormal vagus nerve testing * current use of a list of medication
validation of the dayzz digital sleep training app in insomnia and sleep apnea

Conditions: Insomnia; Sleep Apnea

Summary: the prevalence of sleep disorders has achieved epidemic proportions in western countries. despite this, assessment and treatment of sleep disorders remains infrequent, unattainable, and often costly. dayzz is aware of the need for easily accessible, user-friendly, and affordable treatment strategies for known sleep conditions. this research proposes a randomized controlled outcome study aimed to validate a, digitized, cost-effective mobile app which assesses and manages insomnia and cpap adherence in persons with sleep apnea. the app's sleep training protocols recommend life-style and behavioral changes and tracks these changes with the aim of improving sleep and well-being. in this study, the dayzz app digital treatment protocol will be compared to the standard treatment for these sleep conditions by a sleep professional.


Eligibility criteria:
inclusion criteria: * patients aged 21-65 years of age referred to the carmel hospital sleep clinic and diagnosed by the clinic physician with either sleep apnea (referred for cpap treatment) or insomnia. exclusion criteria: * patient age \<21 years. * patient who is not a member of clalit healthcare services. * persons with insufficient control of the english language required for adequate use of app. * persons with insufficient experience/knowledge and/or use of digital apps/smartphones. * persons with serious medical or psychiatric conditions. * women who are pregnant or breastfeeding. * nighttime shift-workers. * persons who are unable to provide consent due to mental incapacity. * persons referred for evaluation of sleep by ministry of transportation (for licensing purposes). * persons with comorbid insomnia and sleep apnea

Keywords: sleep disorders cognitive and behavioral treatment digital treatment insomnia sleep apnea sleep
is there a role for hip arthroscopy in patients with femoral head fractures?

Conditions: Femur Head Fracture; Arthroscopy

Summary: femoral head fractures, often caused by high-energy trauma, pose significant challenges due to complications like avascular necrosis, post-traumatic osteoarthritis, and sciatic nerve damage. while traditionally treated with open reduction and internal fixation (orif) or total hip replacement (thr), hip arthroscopy has emerged as a minimally invasive alternative that reduces surgical trauma, offers direct fracture visualization and manipulation, and may result in shorter recovery times and fewer complications.

femoral head fractures are uncommon but serious injuries often happen because of high-energy trauma, such as traffic accidents or falls from heights. these fractures can result in complications such as avascular necrosis (if associated with hip dislocations), post-traumatic osteoarthritis, heterotopic ossification, and sciatic nerve damage. the management of femoral head fractures is challenging and depends on several variables, such as the fracture pattern, the degree of displacement, the existence of associated injuries, and the patient's age and physical activity. traditionally, open reduction and internal fixation (orif) or total hip replacement (thr) have been the treatment of femoral head fractures, depending on the extent of the damage and the patient's expectations. however, these procedures have some drawbacks, such as increased blood loss, infection risk, surgical trauma, and implant-related complications. furthermore, thr might not be appropriate for young, active patients who wish to maintain their natural hip joint, whereas orif might not be able to adequately reduce and fixate the fracture fragments, particularly in situations of comminution or impaction. nevertheless, hip arthroscopy has surfaced as a minimally invasive alternative for the treatment of selected femoral head fractures. arthroscopy could be useful in femoral head fractures as it minimizes surgical aggression, in contrast to surgical hip dislocation applied in orif, allowing for direct control of fracture reduction, minimizing surgical morbidity, and optimizing early recovery. hip arthroscopy allows for direct visualization and manipulation of the fracture fragments, as well as the removal of loose bodies and debris from the joint. hip arthroscopy can also be combined with percutaneous fixation techniques to stabilize the fracture and restore joint congruence. when compared to open surgery, hip arthroscopy may offer several benefits, including shorter recovery times, less discomfort, less blood loss, and better cosmetic results. arthroscopic-assisted percutaneous fixation has been reported as an effective treatment in selected cases of femoral head fractures.

Eligibility criteria:
inclusion criteria: * patients with pipkin 1 fractures exclusion criteria: * any associated pelvic fractures * severe medical conditions that prevent the patient from undergoing surgery * delayed presentation after 2 weeks from initial fracture date
vaccination of metastatic breast cancer patients with a cd80-modified allogeneic cancer cell line (ks2422)

Conditions: Metastatic Breast Cancer

Summary: in the last few years there has been a great attempt to develop active immunotherapies for breast cancer patients (bcps) using undefined as well as selected antigens to activate tumor specific t-lymphocytes. the purpose of this phase-i study was to determine the safety and feasibility of vaccinations with an allogeneic breast cancer cell line, ks24.22, genetically modified to express cd80 and her-2/neu, and to evaluate the efficacy of inducing tumor antigen-specific immune responses in human leukocyte antigen(hla)-a\*02-matched patients with metastatic breast cancer.

the trial was designed as an open label phase-i. informed consent was given twice by the patients (1st for hla-typing, 2nd for participation in the vaccination trial). the first four vaccinations, which were given every two weeks, were followed by four monthly vaccinations. additional vaccinations were permitted on request for patients who exhibited stable disease (sd). immediately before administration, ks24.22 cells were thawed and lethally irradiated. ks24.22 cells were adjusted to 10e7/ml in ringer-lactate-solution, transferred to 1 ml syringes and stored on ice until injected within a time frame of 2h. vaccinations were given i.d. in the thigh with a total volume of 1 ml divided between two injection sites.

Eligibility criteria:
inclusion criteria: * proven diagnosis of carcinoma of the breast with distant metastatic disease * patient received either anthracycline- or taxane-based chemotherapy ("state of the art") * karnofsky score (performance status) 80% * hla-\*a0201-positive * minimum life expectancy of 6 month * written informed consent * activation of patient's t-lymphocytes by mitogen antibodies and the cell line used for vaccination exclusion criteria: * manifestation of cns metastases * immunosuppressive disease like aids, autoimmune disease * no serious concomitant systemic medical disorders or active acute or systemic infection * pregnancy * chemotherapies or radiotherapies in the 4 weeks preceding study entry * biological response modifiers (antibodies, tnf, cytokines) or other immune therapies in the 6 weeks preceding study entry (exclusion: hematopoetic growth factors) * organ transplanted patients

Keywords: metastatic breast cancer breast cancer stage iv vaccination cd80 immunotherapy
using real-world evidence to analyze the clinical effects and adverse events of butylphthalide in stroke patients

Conditions: Stroke; Cerebral Infarction; Brain Infarction; Brain Ischemia; Nervous System Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Summary: this is a retrospective, multi-center, real-world study. the researchers plan to include 10,000 cases of ischemic stroke patients using butylphthalide and 10,000 cases of ischemic stroke patients using edaravone. the main purpose is to analyze the effectiveness and safety of butylphthalide and establish the drug risk assessment management plan.

ischemic stroke is a type of syndrome in which blood supply to the brain is impaired due to various reasons, leading to local brain tissue ischemia, hypoxic necrosis, and corresponding neurological deficits. it has a high incidence, high morbidity and disability. features of high recurrence rate. butylphthalide can improve the damage of central nervous system in patients with acute ischemic stroke, and can promote the improvement of patients with neurological deficits. regarding butylphthalide in the treatment of ischemic stroke, there is still a lack of big data research based on the efficacy and safety of the real world. therefore, it is planned to include 10,000 patients who used butylphthalide or edaravone in five hospitals from 2019 to 2021, and record the basic information of the patients, medication status and related test results. the data was cleaned, sorted and analyzed to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke.

Eligibility criteria:
inclusion criteria: * from january 2019 to august 2021, clinicians diagnosed patients with ischemic stroke requiring hospitalization. exclusion criteria: * patients who are unable to obtain information such as medical advice, laboratory test results, etc.

Keywords: butylphthalide ischemic strokes real world research
multi-car t cell therapy for acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this clinical trial is to assess the feasibility, safety and efficacy of multi-car t cell therapy targeting different aml surface antigens in patients with relapsed or refractory acute myeloid leukemia (aml). another goal of the study is to learn more about the function of the multi-car t cells and their persistency in the patients.

acute myeloid leukemia (aml) is a malignant disease characterized by the rapid growth of myeloblasts that build up in the bone marrow and interfere with the production of normal blood cells. in this study, the patients' own t cells will be genetically modified with lentiviral vectors expressing chimeric antigen receptors. the multi-car t cells recognize specific molecules such as cd33, cd38, cd123, cd56, muci, and cll1, which are often found expressed on the surface of aml cells. the engineered car t cells will be infused into patients. the purpose of this clinical study is to assess the feasibility, safety and efficacy of the multi-car t cell therapy against aml. another goal of the study is to learn more about the function of the multi-car t cells and their persistency in the patients.

Eligibility criteria:
inclusion criteria: 1. age older than 2 years. 2. cd33, cd38, cd56, cd123, muci, and cll1 expression can be identified in the malignant cells by immuno-histochemical staining or flow cytometry. 3. karnofsky performance status (kps) score is higher than 80 and life expectancy \> 2 months. 4. adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dl. 5. hgb≥80g/l. 6. no cell separation contraindications. 7. abilities to understand and the willingness to provide written informed consent. exclusion criteria: 1. sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection. 2. active bacterial, fungal or viral infection not controlled by adequate treatment. 3. known hiv or hepatitis b virus (hbv) infection. 4. pregnant or nursing women may not participate. 5. history of glucocorticoid for systemic therapy within the week prior to entering the test. 6. previously treatment with any gene therapy products. 7. patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

Keywords: aml car t muc1,cll1, cd33, cd38, cd56, and/or cd123