Kornimate/medical-research-clean huggingface dataset:
evaluation of linezolid pk profile in burns patients

Conditions: Burns

Summary: evaluation of linezolid pk profile in burns patients


Eligibility criteria:
inclusion criteria: * subject with a body mass index (bmi) \< 30 kg/m\&#178;. for patient with major thermal injuries, the weight will be collected before the burn ; * patients with major thermal injuries \>40% body area including 3rd degree burns with full thickness burns ; * patients hospitalized for at least 10 days since their thermal injury occurred ; exclusion criteria: * contra-indications to use linezolid as mentioned in the smpc (summarized product characteristics) : hypersensitivity to linezolid use or to any of its components, non-controlled hypertension, phaeochromocytoma, carcinoid syndrome, hyperthyroidism, bipolar disorders, schizoaffective disorders, acute confused state of mind, pregnancy, and breastfeeding ; * drugs metabolised by monoamine oxydase (mao) should be evaluated for potential drug-to-drug interaction; * subject treated by: selective serotonin reuptake inhibitors (prozac\&#174;, effexor\&#174;, ixel\&#174; \&#133;), tricyclic antidepressant (anafranil\&#174;, sinequan\&#174;, surmontil\&#174;, tofranil\&#174;), 5ht1 receptor agonists (triptan) direct or indirect sympathomimetic (including adrenergic bronchodilator, pseudoephedrine and phenylpropylamine), vasopressor (adrenaline and noradrenaline), dopaminergic drugs (dopamine, dobutamine), phenetidine or buspirone should be evaluated for potential drug-to-drug interaction;
alpha-1 anti-trypsin (aat) treatment in acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: acute myocardial infarction is characterized by an intense inflammatory response. the degree of the response influences clinical outcome, with 'more' inflammation promoting heart failure. in this study we plan to determine whether treatment with plasma derived alpha-1 antitrypsin will quench the inflammatory response in patients with acute st-segment elevation myocardial infarction (stemi).


Eligibility criteria:
inclusion criteria: * acute stemi defined as chest pain (or equivalent) with an onset within 12 hours and ecg evidence of st segment elevation (\>1 mm) in 2 or more anatomically contiguous leads that is new or presumably new * planned or completed coronary angiogram for potential intervention * age\>21 exclusion criteria: * inability to give informed consent * hemodynamic instability as defined as need for inotropic or vasoactive agents, or need for mechanical support devices (including intra-aortic balloon pump) * pregnancy * preexisting congestive heart failure (american heart association/american college of cardiology class c-d, new york heart association iii-iv) * preexisting severe left ventricular dysfunction (ef\<20%) * preexisting severe valvular heart disease * known active infections (acute or chronic) * recent (\<14 days) or active use of anti-inflammatory drugs (not including nsaids or corticosteroids used for iv dye allergy only) * known chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus) * known active malignancy of any type, or prior diagnosis in the past 10 years * anticipated need for cardiac or major surgery * known active cancer (or prior diagnosis of cancer within the past 10 years) * known immunoglobulin a (iga) deficiency

Keywords: acute myocardial infarction heart failure inflammation
the synchronized trial on expectant mothers with depressive symptoms by omega-3 pufas (synchro): open trial

Conditions: Pregnancy; Depression

Summary: the present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty acids for pregnant women with depressive symptoms.

maternal depression can have a significant harmful influence on both mothers and children. considering the possibility of adverse effects of antidepressants and previous meta-analyses showing the positive effects of omega-3 polyunsaturated fatty acids (pufas) supplementation in reducing depressive symptoms, omega-3 pufas may provide a safe strategy. the investigators evaluate efficacy and safety of omega-3 pufas for pregnant women with depressive symptoms.

Eligibility criteria:
inclusion criteria: 1. pregnant women aged 20 years or older 2. between 12-24 weeks gestation 3. a japanese conversational ability in japan site or a mandarin conversational ability in taiwan site to understand the scope of the present trial and to provide written consent for study participation 4. planned to return to the hospital for checkup at 4-6 weeks after childbirth 5. an edinburgh postnatal depression scale (epds) score is 9 or more 6. to have good physical health judged by obstetricians. exclusion criteria: 1. history and current suspicion of psychosis or bipolar i disorder or substance-related disorder or eating disorder or personality disorder 2. the item of epds concerning suicide ideation is 2 or more 3. other serious psychiatric symptoms such as self-harm behavior or in need of rapid psychiatric treatment 4. difficult to expect a normal birth (ex: fetal malformation etc.) 5. having a history of bleeding disorder such as von willebrand's disease 6. regular treatment with aspirin or warfarin within the last 3 months 7. a smoking habit of ≥40 cigarettes per day 8. regular treatment with ethyl icosapentate or regular consumption of omega-3 pufa supplements within the last 3 months 9. a habit of eating fish ≥4 times per week.

Keywords: pregnant women depression depressive symptoms omega-3 fatty acids
comparison of the effects of different exercise protocols in individuals with hallux valgus

Conditions: Hallux Valgus Deformity

Summary: the aim of this study was to determine the effects of 8 weeks of supervised in addition to stretching exercise resisted concentric and eccentric contraction protocol of toe spread out exercise on the angular severity of hallux valgus deformity, changes in the cross-sectional area, stiffness and thickness of the abductor hallucis muscle, electromyographic activities, plantar pressure distribution, foot morphology and gait characteristics, balance and physical performance at the end of the medium and long term.


Eligibility criteria:
inclusion criteria: * being between the ages of 18-65, * being diagnosed with mild or moderate hv according to the radiographic evaluation result, * having flexible hv, * being a volunteer exclusion criteria: * having a neurological disease, * having a systemic disease, * having cognitive disorders such as dementia, alzheimer's, etc., * having spinal problems such as disc herniation, lumbar stenosis, scoliosis, etc., * having claudication, * having idiopathic numbness, tingling, etc. complaints in the lower extremity, * having had lower extremity surgery before, * having a fracture, ligament, or muscle injury in the lower extremity within the last 6 months, * having received foot-related treatment within the last 6 months. * not understanding the exercises, * not being able to continue with exercise sessions, * low homework exercise compliance, * foot structure not suitable for elastographic us examination, * incorrectly measured elasticity values in swe, * not participating in the first or last evaluation.

Keywords: hallux valgus toe spread out physiotherapy ultrasound surface electromyography
mgcd0103 in elderly patients with previously untreated aml/high risk mds or adults with relapsed/refractory disease

Conditions: Myelogenous Leukemia, Acute; Myelodysplastic Syndromes

Summary: in this study, mgcd0103, a new anticancer drug under investigation, is given three times per week to elderly patients with previously untreated acute myelogenous leukemia/high risk myelodysplastic syndrome or adults with relapsed/refractory disease.


Eligibility criteria:
inclusion criteria: * pathologic confirmation of aml or high risk mds. * elderly cohort (70 years of age or more): no prior chemotherapy treatment for aml/high risk mds and not currently candidates for intensive chemotherapy. * relapsed/refractory cohort (18 years of age or more): relapsed or refractory to prior treatment. * ecog performance status of 0 or 1. * total bilirubin \< 1.5 x upper limit of normal (uln). * ast/sgot and alt/sgpt \< 2.5 x uln. * serum creatinine \< 1.5 x uln. * patients must read, understand, and sign a written informed consent form (icf). * women of childbearing potential and male patients' female partners must use an acceptable method of contraception while on study, and for 3 months after study drug treatment. exclusion criteria: * pregnant or lactating women. * patients with uncontrolled, intercurrent illness, active or uncontrolled infections, or a fever \> 38.5c (not due to tumor fever) on the day of scheduled dosing. * patients with serious illnesses or medical conditions, including laboratory results, which, in the investigator's opinion, would interfere with a patient's participation, or with the interpretation of the results. * patients treated with an investigational drug within 30 days prior to study initiation. * known hypersensitivity to hdac inhibitors or to any of the components of mg-0103. * known hiv or active hepatitis b or c. * any condition that may affect the patient's ability to sign the icf and undergo study procedures. * any conditions that will put the patient at undue risk or discomfort as a result of adherence to study procedures.

Keywords: leukemia mds phase ii acute myelogenous leukemia (aml) high risk myelodysplastic syndromes (mds)
arsenic trioxide in treating patients with metastatic liver cancer that cannot be removed by surgery

Conditions: Liver Cancer

Summary: rationale: drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well arsenic trioxide works in treating patients with metastatic liver cancer that cannot be removed by surgery.

objectives: * determine the efficacy of arsenic trioxide in patients with unresectable metastatic hepatocellular carcinoma. * determine the safety and tolerability of this drug in these patients. outline: patients receive a loading dose of arsenic trioxide iv over 1-2 hours once daily on days 1-5\* in week 1 and then twice weekly in weeks 2-8. courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. note: \*the 5-day loading dose is only administered during course 1. after completion of study treatment, patients are followed at 30 days and then periodically for up to 2 years. projected accrual: a total of 15-25 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed hepatocellular carcinoma * unresectable metastatic disease * ascites allowed provided it is minimal patient characteristics: age * over 18 performance status * 0-2 life expectancy * not specified hematopoietic * wbc \> 2,500/mm\^3 * absolute neutrophil count \> 1,500/mm\^3 * platelet count \> 75,000/mm\^3 hepatic * bilirubin \< 2.5 mg/dl * ast \< 2.5 times upper limit of normal renal * not specified cardiovascular * qtc interval ≤ 460 msec and potassium and magnesium normal other * not pregnant or nursing * negative pregnancy test * fertile female patients must use effective double-method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment (during and for ≥ 4 weeks after completion of study treatment for male patients) * no blood, ova, or sperm donation during study treatment * potassium \> 4.0 meq/dl * magnesium \> 1.8 mg/dl prior concurrent therapy: biologic therapy * no concurrent biologic therapy chemotherapy * more than 4 weeks since prior and no other concurrent chemotherapy endocrine therapy * not specified radiotherapy * more than 4 weeks since prior and no concurrent radiotherapy surgery * not specified other * no other concurrent investigational agents

Keywords: adult primary hepatocellular carcinoma advanced adult primary liver cancer recurrent adult primary liver cancer
physician coaching to reduce opioid-related harms

Conditions: Substance Abuse; Chronic Pain

Summary: this project pilot tests an innovative clinical guideline translation and physician coaching model to promote adherence to evidence-based guidelines for the prescribing of opioid pain medications in primary care settings.

this project addresses the urgent need to promote the adoption of evidence-based practices in healthcare by pilot-testing an innovative implementation strategy. the implementation strategy aims primarily to reduce variation in opioid prescribing practices for chronic pain in primary care settings. the standard approach to improving medical practice involves groups of clinical experts reviewing the literature to produce clinical guidelines based on scientific evidence, and disseminating those guidelines by publishing them in medical journals. a clinical guideline has been developed for opioid prescribing for chronic non-cancer pain using this type of approach. the implementation strategy for promoting uptake of the guideline in primary care settings tested in this study consists of three innovations: (1) a process for translating clinical guidelines into a checklist-based implementation guide for clinicians, (2) a physician peer coaching model, and (3) implementation support using tools from systems engineering. this project teams the experts who developed the guideline for opioid prescribing with experts in implementation science and primary care to translate the guideline into an actionable, checklist-based implementation guide. if the implementation strategy is effective in this pilot test, it will be used in a larger cluster-randomized trial to test it against other approaches to evidence-based practice adoption.the long-term goal of this research is to improve the adoption of evidence-based practices in primary care by producing a generalizable model of change.

Eligibility criteria:
inclusion criteria: at each of the 4 coaching intervention sites, we aim to recruit between 3-7 clinical care providers with prescribing authority (e.g., primary care physicians, mid-level practitioners, etc.) to participate in interviews and focus groups. all clinic staff (e.g., medical assistants, office staff) are welcome to participate in coaching site visits and follow up correspondence, but only staff with prescribing authority will be considered research participants. exclusion criteria: * residents will be excluded.

Keywords: opioid
copper t380 iud versus oral levonorgestrel for emergency contraception vs. plan b for emergency contraception

Conditions: Pregnancy

Summary: the purpose of this study is to see if women presenting for emergency contraception (ec) are willing to accept the copper intrauterine device (iud). this study will also compare the use of effective methods of contraception between women who selected the copper iud or plan b 6 months after they received ec.

this study seeks to estimate the acceptance of copper iud use amongst people presenting for ec. this will be accomplished by offering all women who present for ec at participating planned parenthood association of utah (ppau) clinics during the study period the option of having the copper iud or plan b. women who agree to study participation will be followed for 6 months. the primary outcome for the study is the use of a reliable method of contraception 6 months after presenting for ec. secondary outcomes measured will be pregnancies, abortions, repeat plan b use, presence of gonorrhea or chlamydia infection at the time of presentation for ec, number of days to first bleeding episode and duration of that bleeding episode, further bleeding patterns, frequency of unprotected intercourse, use of a barrier method for prevention of sexually transmitted infections, patient satisfaction with the chosen method and symptoms possibly related to contraception use. patients selecting the iud will be assessed for iud expulsion, perforation, and removal.

Eligibility criteria:
inclusion criteria: * women 18-45 years old, in need of ec (had unprotected intercourse within 120 hours), willing to give consent for participation in research, willing to comply with the study requirements, and accessible by telephone. * patients selecting the iud need to identify themselves as desiring long-term contraception. exclusion criteria: * current pregnancy, * had pelvic inflammatory disease or a septic abortion within the past 3 months or gonorrheal or chlamydial infection in the last 60 days, * current behavior suggesting a high risk for pelvic inflammatory disease * allergy to copper, or wilson's disease (for patients selecting paragard) or allergy to levonorgestrel (for patients selecting plan b) * intracavitary of symptomatic uterine fibroids, and abnormalities of the uterus that distort the uterine cavity, * mucopurulent cervicitis, * a previously placed iud that has not been removed * genital bleeding of unknown etiology * ovarian, cervical or endometrial cancer, * small uterine cavity

Keywords: contraception emergency contraception pregnancy prevention after unprotected intercourse
ends (endometriosis & fusobacterium) unveiling the contribution of fusobacterium infection to the development of endometriosis

Conditions: Endometriosis

Summary: this will be a clinical interventional longitudinal study, without pharmacological intervention/device evaluation. a control group would however be recruited for secondary objective 1 and 2. the study is classified as interventional, as fusobacterium detection is not part of the routine management of these patients; from the patients' point of view, participation in the study will involve the execution of additional vaginal and cervical swabs as additional procedure, while the endometrial biopsy will not represent an additional examination, as the study will include only patients for whom this examination is expected as per normal clinical practice.


Eligibility criteria:
inclusion criteria for study group: * age ≥ 18 years; * endometriosis with clinical indication for either hysteroscopy or hysterectomy; * signed informed consent to study participation and to personal data's treatment. inclusion criteria for control group: * need of elective gynecological surgery for causes other than endometriosis and malignancies; * indication for hysteroscopy with endometrial biopsy; * signed informed consent to study participation and to personal data's treatment. exclusion criteria for both groups: * lack of signed informed consent; * menopause * antibiotic therapy in the 30 days before samples collection (including vaginal and cervical swab).
comparison of physical function and quality of life in insulin and non-insulin users with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this clinical trial aims to compare the muscle strength, functional exercise capacity, physical activity levels, and quality of life between insulin-using and non-insulin-using patients with type 2 diabetes. the study will involve participants aged 40-70, diagnosed with type 2 diabetes, and will assess their physical performance through a series of standardized tests. the primary objective is to determine if insulin use impacts the physical fitness and overall health of patients with type 2 diabetes. results from this study could lead to better management strategies for diabetic patients.

this study aims to analyzemuscle strength, functional exercise capacity, physical activity levels, and quality of life (qol) among a control group, insulin-using, and non-insulin-using patients with type 2 diabetes mellitus. a total of 67 individuals with a mean age of 54.68 ± 7.41 years were included in the study. among these participants, 18 were insulin users (group 1), 21 were non-insulin users (group 2) with type ii diabetes, and 28 were healthy individuals (group 3). demographic data of the participants were recorded. grip strength was measured using a hand-grip dynamometer, and quadriceps strength was measured with a handheld dynamometer. functional exercise capacity was evaluated using the 6-minute walk test (6 mwt), and physical activity levels were assessed using the international physical activity questionnaire (ipaq). the short form-12 questionnaire was used to assess qol, the 30-second sit-to-stand test was used for lower extremity strength, and the semmes-weinstein monofilament test was conducted to evaluate protective sensory loss.

Eligibility criteria:
inclusion criteria: * must have been diagnosed with type 2 diabetes mellitus by a specialist doctor at least 5 years ago * must be between 40-65 years of age * must have signed the informed consent form * must be literate exclusion criteria: * presence of active diabetic foot ulcer * history of acute trauma affecting the musculoskeletal system within the last month * presence of musculoskeletal, orthopedic, neurological, or cardiopulmonary diseases * participants who are unable to cooperate to the extent that they cannot understand the given instructions

Keywords: type 2 diabetes muscle strength quality of life
efficacy and safety of the anti- covid-19 vaccin in clinical hematology patients

Conditions: Covid19; Hematologic Malignancy; Vaccine Response Impaired

Summary: coronavirus disease 2019 (covid-19) is an emerging infectious disease that was first reported in december 2019 in wuhan, china. infection with this new coronavirus called sars-cov-2 can lead to fatal pneumonia associated with high rates of hospitalization in intensive care units (icu). hospitalized patients with hematologic malignancies have a higher mortality rate than patients without hematologic malignancies (62% vs. 8%). the severity of covid-19 may be related to their treatment, in particular anti-cd20 used in b lymphoid hemopathies. in fact, anti-cd20 antibodies induce rapid and prolonged depletion of b cells, but they are necessary for development. humoral immune responses. but currently, no immunogenicity data are known for patients with hemopathy or in those on anti-lymphocyte immunochemotherapy.

the aim of this study is to evaluate the humoral response after vaccination against sars-cov-2 in a french multicenter cohort of patients with hemopathies. analysis of hemopathies and immunochemotherapy subgroups will determine whether there is a need to strengthen immunization schedules. in addition, the study wish to assess the safety and clinical efficacy of mrna vaccines in this cohort.

Eligibility criteria:
inclusion criteria: * benign or malignant hemopathy * with priority vaccination indication * having benefited from anti-covid-19 mrna vaccination exclusion criteria: * patients under legal protection * palliative care patients * history of known covid-19 disease (\<1 year)
68ga-aazta-093 pet/ct: first-in-human study

Conditions: Malignant Neoplasm of Prostate

Summary: 68ga-aazta-093 is a novel radiotracer targeting prostate-specific membrane antigen (psma). in this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68ga-aazta-093 pet/ct in patients with prostate cancer.

prostate cancer (pca) is one of the most common malignancies worldwide in men. prostate specific membrane antigen (psma), as known as folate hydrolase i or glutamate carboxypeptidase ii, is overexpressed on the cells of prostatic adenocarcinoma. various low molecular weight radiopharmaceuticals targeting psma such as psma-11, psma-617 for 68ga- or 177lu- labeling have been developed. 68ga-aazta-093, a novel radiopharmaceutical targeting psma, with the urea fragment of a conjugate that employs the aazta chelator for labeling with 68ga(iii). this pilot study was prospectively designed to evaluate the safety, biodistribution, radiation dosimetry and diagnostic value of 68ga-aazta-093 pet/ct and compared with 68ga-psma-11 and 68ga-psma-617 pet/ct in the same group of prostate cancer patients.

Eligibility criteria:
inclusion criteria: * confirmed treated or untreated prostate cancer patients; * 68ga-aazta-093 and 68ga-psma-11/68ga-psma-617 pet/ct within 1 week; * signed written consent. exclusion criteria: * known allergy against psma; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.