Kornimate/medical-research-clean huggingface dataset:
post-mastectomy recovery: comparing preoperative pecs-ii blocks with intraoperative pectoral blocks

Conditions: Mastectomy; Lymphedema; Breast Cancer

Summary: the purpose this research is to compare two different standards of care for pain management and two different standards of care for local numbing medicine for breast cancer patients who will have a total mastectomy.

the purpose this research is to compare two different standards of care for pain management and two different standards of care for local numbing medicine for breast cancer patients who will have a total mastectomy. standard of care intervention is preoperative pecs-ii blocks versus intraoperative pectoral blocks. the medication used are standard of care and include bupivacaine and liposomal bupivacaine. bupivacaine is fda approved and indicated for the local or regional anesthesia or analgesia for surgery procedures and therapeutic procedures. liposomal bupivacaine is fda approved and indicated for adults to produce postsurgical local analgesia and as nerve block to produce postsurgical regional analgesia.

Eligibility criteria:
inclusion criteria: * patients who are 18 years of age or older * patients undergoing mastectomy with or without axillary surgery, with or without reconstruction surgery at ucmc for breast cancer or high-risk of breast cancer. patients with high-risk of breast cancer are those who have atypical/precancerous breast lesion(s), genetic mutation with increased risk of cancer (e.g., brca1, brca2 etc..) and/or a strong family history of breast cancer in the opinion of the investigator. exclusion criteria: * patients undergoing only a partial mastectomy or tissue-based reconstruction. * non-english speaking. * patients who are pregnant. * patients with an allergy to local anesthetics * except: patients with allergies only to topical anesthetics may be included. * patients with a preoperative acute or chronic pain disorder with an opioid prescription that has been prescribed within 30 days of surgery. patients who have not filled such a prescription or who state they have not taken the medications prescribed, may be eligible on a case-by-case basis per investigator judgement. * patients with a history of opioid use disorder. * inability to provide informed consent. * patients who otherwise in the opinion of the investigator are not good candidates for participation (e.g., deemed unreliable for follow-up).
microencapsulated fish oil or conjugated linoleic acid in metabolic syndrome

Conditions: Insulin Resistance; Oxidative Stress; Lipid Profile; Blood Pressure; Anthropometric Measure

Summary: our aim was to assess the effects of a hypocaloric diet, including diet fruit jelly with microencapsulated fish oil or conjugated linoleic acid or placebo, on anthropometry, body composition, insulin resistance and lipid profile in women with metabolic syndrome and genotype pro12pro in the ppar gamma 2 gene.


Eligibility criteria:
inclusion criteria: * adults women (30-45 years old); * diagnosis of metabolic syndrome, as defined by the international diabetes federation; * pro12pro genotype in gene pparγ2. exclusion criteria: participants were excluded if they: * were allergic to strawberries or fish * were pregnant or lactating * took fatty acid supplements * had undergone bariatric surgery or were being treated nutritionally or pharmacologically for reducing bm, or had taken anti-obesity drugs during the previous three months
evaluation of preoperative investigations in patients with liver cancer

Conditions: Primary Liver Cancer; Liver Metastasis

Summary: the aim of the study is to evaluate the diagnostic procedures emission tomography in combination with a ct scan (pet/ct) and endoscopic ultrasonography (eus) in the preoperative evaluation of resectability of patients with primary or secondary liver cancers.


Eligibility criteria:
inclusion criteria: * all patients who are referred to the department of surgery, odense university hospital, for surgical treatment of suspected or biopsy proven primary or secondary liver cancer. exclusion criteria: * age less than 18 years * patients who are not fit for liver surgery because of co-morbidity * patients for whom the extra investigations in the study are considered to give an increased risk because of co-morbidity such as * patients with s-creatinin \> 150 micromol/l * patients who take peroral antidiabetic drugs or have a poorly regulated diabetes mellitus * patients who do not understand the patient information * patients who do not want to participate
electrical stimulation in patients with unipolar major depression

Conditions: Depression

Summary: double blinded randomized trial of etns as adjuvant treatment for major unipolar depressive disorder. the primary objective is to assess the safety and tolerability of etns (external trigeminal nerve stimulation) of the v1 branch of the trigeminal nerve as an adjunctive treatment for adult patients with the diagnosis of unipolar mdd (major depressive disorder).


Eligibility criteria:
inclusion criteria: * outpatients with non-psychotic, unipolar major depressive disorder assessed via the mini structured interview and legally capacitated to sign the informed consent for participation in the study; * a score of ≥ 14 on the ham-d17 with item 1 (depressed mood) ≥ 2; * a history of treatment failure with at least 3 adequate trials antidepressants over the previous 6 weeks and less than 6 medications, with no change in antidepressant medication or dose within the previous 6 weeks, and ongoing use of at least one antidepressant (which will continue during participation in the study); * patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm and lack of self-harming attempt in the past 6 months; * patients with appropriate support to be compliant with the study protocol. exclusion criteria: * patient is mentally or legally incapacitated, unable to give informed consent; * patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime); bipolar disorder (lifetime); dementia (lifetime); delirium or any substance abuse disorder within the past 6 months; eating disorder within the past year; obsessive-compulsive disorder (lifetime); post-traumatic stress disorder within the past year; acute risk for suicide or self-injurious behavior. patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudo-dementia of depression) will be excluded; * patients currently receiving more than six medications for treatment of mdd; * patients with exposure to ect or rtms or any investigational treatment (for any disorder) within the past 6 months; * prior vns and/or dbs therapy (lifetime); * past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, cva, or tias; cerebral aneurysm; parkinson's or huntington's disease; or multiple sclerosis. * current pregnancy, breast feeding, plans to become pregnant during the study, or not using a medically accepted means of contraception; * other medical conditions that would increase the risk of infection or surgical related morbidity and/or would affect compliance with the study protocol.

Keywords: electrodes, implanted electric stimulation therapy
msb11022 in moderate to severe rheumatoid arthritis

Conditions: Moderate to Severe Rheumatoid Arthritis

Summary: the purpose of this study is to compare the efficacy, safety and immunogenicity of msb11022 and humira® in adult participants with rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis based on 2010 american college of rheumatology/european league against rheumatism (acr/eular) criteria * at least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline * must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose * other protocol defined inclusion criteria could apply exclusion criteria: * evidence of untreated or inadequately treated latent or active tuberculosis * evidence of uncontrolled, clinically significant diseases * any second disease-modifying antirheumatic drugs must be washed out prior to the first study dose * other protocol defined exclusion criteria could apply
characterizing response to antipsychotics in schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the goal of this research project is to develop mri-based biomarkers to identify patients with schizophrenia who are most likely to benefit from first-line antipsychotic or clozapine treatment. the mri sequences (nm-mri, mrs and rsfmri) will be created by translating the best scientific evidence into a potential clinical product that has the highest chance of being clinically relevant predictor of treatment response. this study has the potential to significantly improve patient outcomes and reduce unnecessary interventions and costs at the royal's integrated schizophrenia recovery program.

currently, we cannot predict who will get better on first-line antipsychotic versus clozapine treatment. although much evidence shows that dopamine and glutamate function are related to treatment response in schizophrenia, the utility of neuromelanin sensitive mri (nm-mri) as a measure of dopamine and magnetic resonance spectroscopy (mrs) as a measure of glutamate \& glycine (a co-agonist of glutamate receptors) in predicting response to treatment have never been measured in the same sample. the evidence suggests that the function of these two neurotransmitter systems partially determines the response to antipsychotic medications. additionally, an emerging type of resting-state functional mri (rsfmri), naturalistic movie-watching, has been shown to outperform traditional rsfmri for functional connectivity-based prediction of behaviour and will be explored in the current study. given the background information, our hypotheses are: 1.1) first-line antipsychotic users will have higher dopamine turnover resulting in a higher nm-mri signal in the substantia nigra relative to clozapine users. 1.2) first-line antipsychotic users will have lower glutamate and/or glycine concentration as indicated by the mrs signal in the dorsal anterior cingulate relative to clozapine users.

Eligibility criteria:
inclusion criteria: * are voluntary and competent to consent to the study * are between the ages of 18-55 * are english literate * have a diagnosis of schizophrenia or schizoaffective disorder * are currently taking primarily olanzapine or clozapine exclusion criteria: * medication for the treatment of schizophrenia or schizoaffective disorder has changed in the past month * have a significant neurologic, neurodevelopmental, cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, or metabolic-endocrine disorder * are pregnant or breastfeeding * acquire positive urine test result for all drugs of abuse including cannabis * have met dsm-5 criteria for substance use disorder other than tobacco in the last 6 months * have a history of significant head trauma with loss of consciousness for more than 5 minutes * have any contraindication to mri * have any other condition that in the opinion of the investigator(s) could create a hazard to the subject's safety, endanger the study procedures, or interfere with the interpretation of study results

Keywords: antipsychotic treatment response
observational study on blood glucose control in patients with diabetes using modern insulin

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. an observational study evaluating the blood glucose control in patients using a modern insulin: novorapid®, novomix® 30 or levemir® for treatment of type 2 diabetes mellitus in czech republic.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * current treatment with human soluble insulin, insulin nph or premixed human insulin * the selection of the subjects will be at the discretion of the individual physician exclusion criteria: * current treatment with insulin aspart, insulin detemir or biphasic insulin aspart 30 * previous enrolment in this study * hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients. * women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months and considered to be treated by biphasic insulin aspart 30 or insulin detemir
effect of solution-focused support program on anxiety levels of parents during the covid-19 pandemic

Conditions: Anxiety; Parents; Covid19

Summary: in this research, it was aimed to determine the anxiety levels of parents in the covid-19 pandemic and to examine the effects of the solution-focused support program, which is planned to be given to parents with high anxiety levels.

the study is conducted with parents whose children aged 3-6 years, and have high anxiety levels. in collecting research data; an introductory information form prepared by researchers and the state-trait anxiety inventory will be used.

Eligibility criteria:
inclusion criteria: * parents with children aged 3-6, * having internet at home or mobile phone, * parents who volunteer to participate in the study exclusion criteria: * having communication problems, * parents who have not attended at least one session

Keywords: anxiety child nursing practice parents solution-focused support program
diagnostic study of early breast cancer using ultrasound

Conditions: Ductal Carcinoma In-situ

Summary: this is a pilot study designed to investigate new techniques to guide the appropriate diagnosis and treatment of ductal carcinoma in-situ (dcis). the microvascularity and stiffness of the lesion may be prognostic factors that can guide the need for more or less extensive therapy or perhaps only imaging follow-up may be needed.

women who have imaging findings suggestive of dcis, who are having breast ultrasound and who are candidates for surgery will be eligible. they will receive a contrast-enhanced breast ultrasound after the intravenous injection of a microbubble contrast agent which will show the microvascularity. a subset of women will also have ultrasound elastography performed of the abnormality to evaluate its stiffness.

Eligibility criteria:
inclusion criteria: * a woman with imaging signs suggesting a diagnosis of dcis who is scheduled for ultrasound and a biopsy is eligible for the study. * at least 18 years of age exclusion criteria: * pregnant or possibly pregnant or breast feeding * unable to provide informed consent * drug or multiple allergies * known cardiac shunts * known cardiac or chronic pulmonary disease * hypersensitivity to perflutren

Keywords: ductal carcinoma in-situ contrast ultrasound microinvasion elastography
t-piece versus pressure-support for the spontaneous breathing trial

Conditions: Weaning From Mechanical Ventilation; Extubation

Summary: the main objective will be to compare the number of ventilator-free days within the 28 days following the first spontaneous breathing trial between strategies of extubation performing spontaneous breathing trials with t-piece trials or with pressure-support trials. to do that, the study director proposed to conduct a prospective multicenter randomized controlled open-label trial comparing these 2 strategies of weaning in patients at high-risk of extubation failure in the intensive care unit. patients included will be randomized before performing the first spontaneous breathing trial and will be assigned to one of the following two groups according to the weaning strategy: t-piece trial group or pressure-support trial group.


Eligibility criteria:
inclusion criteria: 1. duration of mechanical ventilation prior to the first spontaneous brathing trial \> 24h 2. patients at high-risk of reintubation according to the following criteria: patients older than 65 years, or those having any underlying chronic cardiac or lung disease. 3. patient meeting all weaning criteria according to the international conference consensus on weaning. * respiratory rate ≤ 35 breaths per minute, * adequate oxygenation defined as spo2 \> 90% with fio2 ≤ 0.4 or pao2/fio2 \> 150 mm hg with positive end-expiratory pressure (peep) ≤ 8 cmh2o, * adequate cough, * patient awake with a richmond agitation-sedation scale between +1 and -2 * no continuous sedation, * hemodynamic stability with no need for vasopressors (or minimal dosis). 4. informed consent given by the relatives or the patient himself. exclusion criteria: 1. patients admitted for traumatic brain injury 2. pre-existing peripheral neuromuscular disease (underlying myopathy or myasthenia gravis) 3. do-not-reintubate order at time of the first spontaneous breathing trial 4. patient previously included in the study 5. no health insurance coverage 6. people under protection: pregnant or breastfeeding women, minor patients, subjects with guardianship or under law protection. 7. refusal to participate
evaluation of the pharmacokinetics and the pharmacodynamics of different dry powder inhalation formulations of azd3199 in patients with asthma

Conditions: Asthma

Summary: the purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of single doses of three different dry powder inhalation formulations of azd3199 administered via single inhalation device (sid) compared to azd3199 administered via turbuhaler™ inhaler and compared to placebo in patients with persistent asthma.


Eligibility criteria:
inclusion criteria: * provision of signed and dated written informed consent prior to any study specific procedures * men or women, age ≥ 18 years. women must be of non-childbearing potential or stable on a highly effective contraceptive method for at least 3 months prior to visit 1 and be willing to continue on the chosen contraceptive method throughout the study. * be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to study start * a history of asthma for at least 6 months. * body mass index (bmi) 19-30 kg/m2 exclusion criteria: * significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study * history of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to β2-agonists in general or to azd3199 and/or excipients * prolonged qtcf \> 450 msec or shortened qtcf \<340 msec * history of alcohol/drug abuse or excessive intake of alcohol as judged by the investigator * pregnancy or lactation

Keywords: asthma patients lung function
tumor deposits in colorectal cancer and its prognostic value in survival and metastasis

Conditions: Tumor Deposits; Colorectal Cancer; Prognosis; Survival; Metastasis

Summary: this study aims to evaluate the tumor deposits in colorectal cancer and its prognostic value in survival and metastasis

tumor deposits (tds) are defined as isolated tumor foci found in the pericolonic or perirectal fat or the adjacent mesentery (mesocolonic fat) away from the invasive margin of the tumor without evidence of residual lymphatic tissue. tds are significantly correlated with poor prognosis after colorectal cancer surgery.

Eligibility criteria:
inclusion criteria: * age above 18 years old. * both sexes. * all colorectal cancer patients from stage i to iii colorectal cancer with pathologically positive tumor deposits. exclusion criteria: * patient took neoadjuvant therapy. * no information available on tumor deposits. * colorectal cancer is not the only primary cancer. * patients with incomplete information about follow-up.
prevalence of albuminuria in patients with cardiovascular disease and type 2 diabetes mellitus in china: a national cross-sectional study

Conditions: Cardiovascular Disease; Type 2 Diabetes Mellitus

Summary: the association between cardiovascular disease (cvd) and chronic kidney disease (ckd) is well established. traditional risk factors for cvd and ckd are similar, with type 2 diabetes mellitus (t2dm) being the most prevalent risk factor. however, ckd is underdiagnosed and undertreated in patients with cvd. further understanding of the combination of ckd in cvd patients is important to formulate prevention and treatment strategies for cvd patients and high-risk groups, reduce adverse events in cvd patients, and prevent progression of ckd to end stage renal disease (esrd).

the placard study will include approximately 3,000 patients presenting to the cardiology department with type 2 diabetes and cardiovascular disease. the aim of this study was to assess the prevalence of proteinuria (urinary acr) in type 2 diabetic patients with different cardiovascular diseases, both inpatient and outpatient in the cardiology departments of secondary and tertiary hospitals in china. participants will be recruited at 30 clinical centers for a period of six months.

Eligibility criteria:
inclusion criteria: * age ≥18 years old; * diagnosed t2dm combined with ≥1 cvd (hypertension, coronary heart disease, atrial fibrillation, heart failure); * during the data collection period, they went to the outpatient clinic of the cardiology department of the research center, or received treatment in the cardiology department; * ability to self-sign informed consent (electronic /paper). exclusion criteria: * pregnant or lactating women; * dialysis patients; * other diseases that lead to elevated albuminuria, such as severe infection, confirmed primary glomerular disease, etc.; . malignant tumors being treated (surgery, chemotherapy, radiotherapy or targeted therapy); * cachexia (css score ≥ 5 points); * severe liver disease (child- pugh grade c) ; * participated in an interventional clinical trial in the past three months.
safety and efficacy of a contact lens for daily disposable use

Conditions: Myopia

Summary: this study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact lens compared to the bausch + lomb soflens® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.


Eligibility criteria:
inclusion criteria: * subjects must be myopic and require lens correction from -0.50 d to -6.00 d in each eye. * subjects must be correctable through spherocylindrical refraction to 40 logmar letters or better (distance, high contrast) in each eye. * subjects must be free of any anterior segment disorders. * subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily disposable wear basis for approximately 3 months. exclusion criteria: * subjects with any systemic disease currently affecting ocular health or which in the investigator's opinion may have an effect on ocular health during the course of the study. * subjects using any systemic or topical medications that will, in the investigator's opinion, affect ocular physiology or lens performance. * subjects with any "present" finding during the slit lamp examination that, in the investigator's judgment, interferes with contact lens wear. * subjects who have had any corneal surgery (eg, refractive surgery). * subjects who are allergic to any component in the study care products.

Keywords: contact lens