Kornimate/medical-research-clean huggingface dataset:
local antibiotics for breast implants

Conditions: Implant Complication; Implant Infection; Implant Site Infection; Implant Capsular Contracture; Implant Site Pocket Infection; Implant Expulsion; Antibiotic Side Effect

Summary: the breast-ab trial is a multi-center, randomized, double blind, placebo-controlled trial investigating the efficacy of local application of gentamicin, vancomycin and cefazolin in decreasing all-cause implant explantation after breast reconstruction.

the breast-ab trial will include women undergoing breast reconstruction with implants. the objective is to determine the efficacy of local antibiotics in decreasing all-cause implant explantation. participants will be randomized to local application of placebo or gentamicin, vancomycin and cefazolin in a saline solution onto the implant and the dissected breast pocket. all patients undergoing unilateral breast reconstruction will be randomized to the trial drug or placebo in a ratio of 1:1. all patients undergoing bilateral reconstruction will be randomized to the trial treatment on one of their breasts and placebo to the contralateral breast. a total number of 1274 of breasts undergoing breast reconstruction will be included in the trial.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * biologically female * signed informed consent * scheduled for breast reconstruction with implants or expanders including: 1. immediate or delayed reconstructions 2. bilateral or unilateral reconstructions 3. with or without simultaneous flap reconstruction exclusion criteria: * pregnancy * breast feeding * known allergy towards vancomycin, gentamicin and cefazolin * known anaphylactic reaction towards other beta-lactam antibiotics or aminoglycosides * known allergy towards neomycin * known impaired renal function with gfr \< 60 ml/min * participation in investigational drug trials and projects concerning disinfecting agents in the breast implant cavity * myasthenia gravis
bone marrow adiposity and fragility fractures in postmenopausal women

Conditions: Fractures, Bone; Bone Marrow Disease; Fat Disorder; Adiposity

Summary: the purpose is to determine in a case-control study if an association exist between bone marrow adiposity and fragility fractures in post-menopausal women.


Eligibility criteria:
inclusion criteria: * post-menopausal women : 50-90 years old * group 1 (cases) : occurence of incident major osteoporotic fracture less than 12 months * group 2 (controls) : no history of fragility fracture exclusion criteria: * implants that are contraindicated for the magnetic resonance (mr) examination. * implants that might create a health risk or other problem during an mr exam include: 1) cardiac pacemaker or implantable defibrillator, 2) catheter that has metal components that may pose a risk of a burn injury, 3) a ferromagnetic metal clip placed to prevent bleeding from an intracranial aneurysm, 4) an implanted medication pump (such as that used to deliver insulin or a pain-relieving drug), and 5) a cochlear implant. * body mass index \[bmi\] \>38 kg/m2, weight \>140 kg * disease or current use of medications known to affect bone density, including oral glucocorticoids, treatments for osteoporosis (bisphosphonates, raloxifene, calcitonin, or pth), hormone therapy. * chronic kidney disease with dfg \<30 ml/mn

Keywords: marrow adipose tissue bone marrow adiposity
digital therapeutic based investigation to improve glycemic control in patients with type 2 diabetes and residual hyperglycemia on stable medical therapy

Conditions: Diabetes Mellitus, Type 2

Summary: randomized, controlled, multicenter, pragmatic, pivotal trial with open-label extension evaluating the hypothesis that bt-001 an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control, will lower hemoglobin a1c (hba1c) compared to a control application added to usual care and across a broad range of patients in a real-world setting

this randomized, controlled, multicenter, parallel-arm, pragmatic pivotal trial with extension will evaluate the hypothesis that bt-001 compared to a control application, both on top of usual care, will lower hba1c in real world clinical practice. approximately five-hundred (500) adults with type 2 diabetes will be randomized (1:1) to bt-001 or the control application. most clinical data will be collected via the electronic medical records (emr) system with limited additional contacts to ascertain adverse device effects (ades), adverse events (aes) and clinical events which may have occurred outside the health system and were not recorded in the emr. for primary efficacy endpoint assessment, a requisition form for hba1c at a local laboratory will be provided if hba1c is not available from the emr within the 90- and 180-day time windows. during the extension phase, biomarker endpoint data will only be collected from the emr. for all participants, clinical and healthcare utilization data will be extracted from their emr for the period from 180 days prior to enrollment to 720 days after enrollment.

Eligibility criteria:
inclusion criteria: * age 18-75 years, inclusive at the time of signing the informed consent * type 2 diabetes on stable anti-diabetic regimen for at least three (3) months * hba1c 7.0% to 10.9% (within thirty \[30\] days of signing the informed consent form \[icf\]) * able to use bt-001 e.g., english fluent, smartphone is capable of running the study intervention. exclusion criteria: * current use of outpatient prandial insulin * in the opinion of the investigator, life expectancy \< one (1) year * covid-19 diagnosis within thirty (30) days prior to randomization.
pain processing in inflammatory and non-inflammatory chronic pain syndromes

Conditions: Fibromyalgia; Rheumatoid Arthritis

Summary: fibromyalgia (fm) is a chronic musculoskeletal pain disorder that afflicts up to 4% of the general population. the evaluation of pain mechanisms in fm has shown predominant central abnormalities and therefore has been designated as nociplastic pain syndrome. rheumatoid arthritis (ra) is characterized by polyarthritis and pain from inflamed tissues, consistent with nociceptive pain. fm and ra patients may utilize overlapping pain mechanisms resulting in nociceptive and nociplastic pain.


Eligibility criteria:
inclusion criteria: * ages 18-70 * fulfills the 1990 and 2011 american college of rheumatology criteria for fm * fulfills the 2010 acr-eular classification criteria for ra * healthy volunteers: no significant pain/fatigue/depression/anxiety. exclusion criteria: * diabetes * cancer * advanced liver, kidney or cardiovascular disease * neuropathic pain
testing an evidence-based program for clinician burnout

Conditions: Burnout

Summary: the goal of this clinical trial is to pilot test an app-based mindfulness training program in reducing burnout in physicians and nurses.

the main question\[s\] it aims to answer are: primary aim: determine if the app-based training reduces the level of cynicism (i.e., one of the two main dimensions of burnout). secondary aim: determine if the app-based training reduces the level of emotional exhaustion (i.e. one of the two main dimensions of burnout), anxiety, worry, depression and intolerance of uncertainty. determine if the app-based training increases self-compassion, non-reactivity and non-judging about inner experiences. participants will be asked to: * use an app-based mindfulness training program * complete online surveys at baseline, immediately post-intervention and 1 month after the post-intervention as follow up

Eligibility criteria:
inclusion criteria: * being a physician, resident physician or nurse * able to speak english because all study activities will be conducted in english. * 18+ years * direct patient care exclusion criteria: * if using psychotropic medication - not on a stable dosage at least 6 weeks

Keywords: burnout mindfulness physicians nurses resident physicians
helicobacter pylori eradication with clostridum butyricum capsule and bacillus coagulans tablets

Conditions: Gastritis; H Pylori Infection; Dyspepsia

Summary: this study aims at evaluating efficacy clostridum butyricum capsule and bacillus coagulans tablets in h. pylori eradication. it is hypothesized that clostridum butyricum capsule , bacillus coagulans tablets monotherapy or clostridum butyricum capsule plus bacillus coagulans may have some positive effect on h. pylori eradication.

the study will include three phases: screening, treatment and follow-up. screening: during this phase subjects eligibility will be evaluated after informed consent signature. endoscopy and urea breath test will be performed in addition to the baseline routine evaluations. treatment: subjects are randomly assigned to treatment and will be treated for 8weeks. follow-up: includes one visits. eradication of h. pylori will be confirmed through urea breath test(ubt).

Eligibility criteria:
inclusion criteria: 1. age between 18\~70,both gender. 2. patients with upper gastrointestinal symptoms and with documented h.pylori infection. 3. patients are willing to receive eradication treatment. 4. women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter. exclusion criteria: 1. patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with h. pylori. 2. contraindications to study drugs. 3. substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease. 4. constant use of anti-ulcer drugs ( including taking proton-pump. inhibitors(ppi) within 2 weeks before the \[13c\] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening). 5. pregnant or lactating women. 6. patients were diagnosed with gastroduodenal ulcer and malt lymphoma. 7. underwent upper gastrointestinal surgery. 8. patients with barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia. 9. evidence of bleeding or iron efficiency anemia. 10. a history of malignancy. 11. drug or alcohol abuse history in the past 1 year. 12. systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d). 13. enrolled in other clinical trials in the past 3 months. 14. patients who has psychological problem or poor compliance. 15. refuse to sign informed consent.

Keywords: gastritis h pylori infection
influence of yoga in patients with neurocardiogenic syncope

Conditions: Syncope, Vasovagal

Summary: syncope is a common problem that many clinicians may encounter in various outpatient settings. neurocardiogenic syncope (ncs) is a benign condition characterized by a self limited episode of systemic hypotension. patients are usually managed with education on syncope, anxiety management, and coping skills. it has been established that practice of yoga could relieve stress and anxiety. in a different study, they also found that yoga positively influences cardiovascular function by decreasing the heart rate and blood pressure. the main objective of yoga is to achieve control over the autonomic nervous system and able to control functions like heart rate, blood pressure and respiratory rate. based on the findings that yoga relieves stress and reduces heart rate, the investigators propose to study if yoga can decrease the frequency of ncs and also reduce the symptoms associated with these episodes.


Eligibility criteria:
inclusion criteria: * diagnosis of recurrent neurocardiogenic syncope * at least one episode of syncope or pre-syncopal event in the last 3 months prior to enrollment exclusion criteria: * previously established diagnosis of any psychiatric illness. * previous history of coronary artery disease, myocardial infarction, congestive heart failure, carotid sinus hypersensitivity * established diagnosis of tachy and/or brady arrhythmias, except cardioinhibiotry neurocardiogenic syncope. * history of pacemaker, icd or crt-d implantation. * other conditions where yoga should be avoided are: 1. pregnant women 2. subjects with untreated or uncontrolled high blood pressure 3. subjects with past history of pnuemothorax. 4. subjects with severe cervical spondylitis and cervical, thoracic or lumbar disc prolapse. 5. subjects with carotid stenosis 6. subjects with history of psychosis (evidence of acute episodes with deep and prolonged meditation) or substance abuse. 7. subjects with the history of epilepsy ( evidence of acute episodes with deep and prolonged meditation) 8. subjects with glaucoma 9. subjects with history of total hip replacement.

Keywords: neurocardiogenic syncope yoga
a study of tirbanibulin ointment and diclofenac sodium gel for the treatment of adult participants with actinic keratosis on the face or scalp

Conditions: Keratosis, Actinic

Summary: the purpose of the study is to evaluate the incidence of biopsy confirmed invasive squamous cell carcinoma (scc) in the selected treatment field (tf) after administration of topical tirbanibulin 10 milligram (mg)/gram (g) ointment or diclofenac sodium 3 percent (%) gel over the 3-year study period.


Eligibility criteria:
inclusion criteria: * a treatment field (tf) on the face or scalp (excluding lips, eyelids, ears, and inside the nostrils), that: a) is a contiguous area measuring 25 cm\^2, b) contains 2 to 8 clinically typical, visible, and discrete actinic keratosis (ak) lesions, and c) has an overall clinical picture that is consistent with olsen grade 1 * if a women of child-bearing potential (wocbp), that is, fertile, defined as a female in the life period from menarche and until becoming post-menopausal (no menses for 12 months without an alternative medical cause) or permanently sterile (with hysterectomy, bilateral salpingectomy or bilateral oophorectomy at least 3 months prior to screening), she must: a) have a negative urine pregnancy test using a highly sensitive method at screening and on day 1 prior to treatment administration. b) be using effective methods of birth control. c) agree to have pregnancy tests while in the study and at the end of the study * participants should be willing to avoid sunlight or ultraviolet (uv) light exposure, including the use of tanning beds, to the face or scalp during the study * participants should have the ability to understand the purpose and risks of the study, willingness and ability to comply with the protocol, and provide written informed consent in accordance with institutional and regulatory guidelines exclusion criteria: * the location of the tf is: a) on any location other than the face or scalp. b) within 5 centimeters (cm) of an incompletely healed wound. c) within 10 cm of a suspected basal cell carcinoma (bcc) or other neoplasm. d) on the lips, eyelids, ears, or inside the nostrils, periorbital, perioral, or the skin surrounding the nostrils * presence in the tf of: a) clinically atypical and/or rapidly changing ak lesions b) hyperkeratotic or hypertrophic lesions, recalcitrant disease (had cryosurgery on 2 previous occasions), and/or cutaneous horn. c) confluent ak lesions (that is, non-discrete lesions, as per inclusion criterion 2). d) persisting ak lesions at the screening visit following topical treatment with diclofenac sodium 3 percent (%) gel * history of any malignant skin tumour in the tf or history of skin tumour in any region of the body which has metastasized or in which metastasis within the study period is likely * history of any malignant tumour with systemic antitumor treatment (including radiotherapy) within 12 weeks prior to the screening visit or systemic antitumor treatment is expected while on the study * immunocompromised participants, including participants with a history of chronic systemic lymphoma or chronic myeloid leukaemia, or organ transplant recipients
collecting and storing samples of bone marrow and blood from patients with relapsed acute lymphoblastic leukemia or non-hodgkin lymphoma

Conditions: Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Non-Hodgkin Lymphoma; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Non-Hodgkin Lymphoma

Summary: this research study is collecting and storing samples of bone marrow and blood from patients with relapsed acute lymphoblastic leukemia or relapsed non-hodgkin lymphoma. collecting and storing samples of bone marrow and blood from patients with cancer to study in the laboratory may help doctors learn more about cancer and help predict the recurrence of cancer.

objectives: i. establish a mechanism to bank specimens of tumor cells and host germline dna from patients with acute lymphoblastic leukemia (all) at first and subsequent relapse. ii. make these specimens available to qualified researchers to study the biology of all. outline: this is a multicenter study. patients undergo collection of bone marrow and peripheral blood at diagnosis of relapse and/or at the end of the first month of treatment. patients are followed periodically for up to 10 years.

Eligibility criteria:
inclusion criteria: * diagnosis of acute lymphoblastic leukemia (all) or prior history of non-hodgkin lymphoma * in first or subsequent marrow relapse with ≥ 25% blasts in bone marrow and/or peripheral blood * bone marrow and/or peripheral blood samples (≥ 5 ml) required at the time of diagnosis of relapse * no concurrent systemic antileukemic treatment administered for current relapse * intrathecal chemotherapy allowed * on-therapy relapse allowed
restrospective analysis of mace in patients treated with drug-elluting balloons.

Conditions: Coronary Arterial Disease (CAD); Restenosis, Coronary; Bifurcation Coronary Disease

Summary: retrospective analysis of data collected in an institutional database of coronary interventions with use of drug-eluting balloons, with a prospective follow-up for major adverse cardiovascular events and living status.


Eligibility criteria:
inclusion criteria: * adults (\>=18 years of age) * who underwent a coronary angioplasty with drug-eluting balloon between january 2010 and december 2025 * identified in the institutional procedure database exclusion criteria: * incomplete or non-available data on the post-procedural clinical follow-up * procedures where other devices were used in combination with drug-eluting balloons.
intravenous n-3 fatty acids and sudden cardiac death in hemodialysis patients

Conditions: Renal Failure, Chronic

Summary: the main purpose of this study is to investigate whether intravenous infusion of a lipid emulsion with a high content of n-3 polyunsaturated fatty acids can improve heart rate variability and ventricular repolarization and reduce ventricular arrhythmias in hemodialysis patients.

cardiovascular disease is the most common cause of death in haemodialysis (hd)patients, and half of these deaths are due to sudden cardiac death caused by ventricular arrhythmias. hd patients have an attenuated heart rate variability (hrv) and a high frequency of ventricular arrhythmias, both of which are predictors of sudden cardiac death(scd). n-3 polyunsaturated fatty acids (pufa) improves hrv and reduces the risk of scd. n-3 pufas are obtained from fatty fish and fish oil and are incorporated into cell membranes after long-term ingestion. however, it is not known if this incorporation is essential or merely serves as storage for n-3 free pufas to be release during for instance myocardial ischaemia. the study hypothesis is that intravenous infusion of a lipid emulsion with a high content of n-3 pufas will improve hrv and ventricular repolarization and reduce ventricular arrhythmias via an acute increase in free non-esterified n-3 pufas in plasma. in a randomized, placebo-controlled design a n-3 pufa rich emulsion (or placebo) will be administered during hemodialysis treatment. the two study groups will be compared with respect to heart rate variability, ventricular repolarization parameters, ventricular ectopic beats and arrhythmias and the content of n-3 pufa in plasma and cell membranes will be compared.

Eligibility criteria:
inclusion criteria: * age \> 18 yrs * end-stage renal failure * maintenance haemodialysis treatment \> 3 months exclusion criteria: * allergy to fish or egg protein * body weight \< 50 kgs * chronic supraventricular tachycardia * implanted pacemaker * myocardial infarction within 6 months * pci or cabg within 6 months * stroke or tia within 6 months * hba1c \> 10 % * alat \> 100 u/l * triglycerides \> 3 mmol/l * ongoing infection * tendency to severe blood pressure drops during dialysis treatment * malignancy * psychiatric disorder * pregnancy

Keywords: renal failure, chronic death, sudden, cardiac heart rate variability tachycardia, ventricular ventricular premature complexes ventricular repolarization eicosapentaenoic acid docosahexaenoic acid
a study of efavirenz in combination with stavudine and didanosine

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give efavirenz plus stavudine plus didanosine to hiv-infected patients who have never received anti-hiv treatment.

patients will be given combination treatment with efavirenz, stavudine, and didanosine.

Eligibility criteria:
inclusion criteria patients must have: * documented hiv infection with plasma hiv-rna greater than or equal to 10,000 copies/ml. * a life expectancy of at least 12 months. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * current bilateral peripheral neuropathy greater than or equal to grade 2. * any clinically significant laboratory findings obtained during the screening evaluation (see laboratory values). * any clinically significant disease (other than hiv infection) or clinically significant findings during screening of medical history or physical examination. * any malignancy that requires systemic therapy. * proven or suspected acute hepatitis due to any cause. * recurrent episodes of moderate to severe diarrhea, or vomiting lasting more than 4 days within 3 months prior to dosing. * active aids-defining opportunistic infection or disease. concurrent medication: excluded: astemizole, cisapride, clarithromycin, ketoconazole, itraconazole, midazolam, rifabutin, rifampin, terfenadine, thalidomide, triazolam, vincristine, zalcitabine. patients with the following prior conditions are excluded: * history of acute or chronic pancreatitis. * life expectancy less than 12 months. * difficulty in swallowing capsules/tablets. * hypersensitivity to any component of the formulation of efavirenz, stavudine, or didanosine. prior medication: excluded: * any other experimental drug within 30 days of introducing study treatment. * vaccination within 3 weeks of screening visit. * interferon started within 30 days of initiating study treatment. * prior antiretroviral therapy. risk behavior: excluded: - current alcohol or illicit drug use which would interfere with compliance with dosing schedule and protocol evaluations.

Keywords: didanosine drug therapy, combination stavudine reverse transcriptase inhibitors efavirenz