Kornimate/medical-research-clean huggingface dataset:
evaluation of postoperative quality of recovery score in radical prostatectomy with erector spinae plane block

Conditions: Postoperative Pain

Summary: radical prostatectomy is performed with a median incision below the umbilicus. although the position is supine, the waist extension movement is created in order to facilitate access to the surgical site. the investigator think that this may be a factor affecting the postoperative comfort, not only in the pain in the surgical field, but especially in patients with low back pain (facet joint pain, etc.). techniques that provide quality postoperative recovery with reduced morbidity and rapid return to daily activities are important for anesthesiologists. in this study, the investigator aimed to evaluate the postoperative recovery quality (quality of recovery score (qor-40)) of patients who underwent open radical prostatectomy and underwent erector spina plan block and wound infiltration for postoperative analgesia.

patients will be randomly divided into 2 groups as group e (esp block) and group w (wound infiltration). before the operation, the esp block will be applied to the patients in the prone position under sedation by same anesthesiologist. group e (esp block) will be applied bilaterally, 20 ml of %0.25 bupivacaine between the erector spinae muscle and transverse process at the 11th thoracic level. fifteen minutes after the block, the patient's dermotamal examination will be evaluated and patients with successful block will be included in the study.at the end of the operation,wound infiltration will be administered under general anesthesia in supine position by surgeon. subfascial and subcutaneous wound infiltration is performed (20 ml of 0.25% bupivacaine each). at the end of the operation, the patients with a modified aldreate score ≥9 will be sent from the postoperative anesthesia unit. all patients will be equipped with iv tramadol patient-controlled analgesia (pca) device. the solution will be prepared such that tramadol is 4 mg / ml. pca 10 mg bolus dose will be delivered with 15 min lock-out time. in the postoperative period, the patient was evaluated by another researcher who blind to the groups at the 2st and 6th, 12th and 24th hours. visual pain scores (vas) in rest and movement, hemodynamic values, tramadol consumption, nausea-vomiting score, ramsey sedation scale, postoperative complications will be recorded. a 40-item recovery of quality of score will be applied in the preoperative and postoperative period to evaluate the patient's quality of life.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologist physical status i-iii * radical prostatectomy exclusion criteria: * infection in the incision area * coagulation disorder * known allergy history against to the study drugs * lack of adequate cognitive activity in the use of patient-controlled analgesia and vas

Keywords: erector spinae plane block wound infiltration radical prostatectomy postoperative pain
autonomic function in copd and risk for atrial fibrillation

Conditions: Chronic Obstructive Pulmonary Disease

Summary: in the presented study, autonomic function as well as risk for atrial fibrillation will be assessed to characterize the relation between risk of atrial fibrillation and autonomic function.

atrial fibrillation (af) has been suggested as relevant comorbidity in patients with chronic obstructive pulmonary disease (copd). the evaluation of the total atrial conduction time via tissue doppler imaging (pa-tdi interval) can be used to identify patients with increased risk of new onset af. autonomic function can be assessed by different non invasive clinical investigations. the investigators hypothesise that pa-tdi interval is increased in acutely exacerbated copd (aecopd) compared within stable copd and that increased pa-tdi is related to impairment of autonomic function. for this purpose, 25 patients with aecopd and 25 patients with stable copd were characterized by clinical characteristics, laboratory tests, lung function, electrocardiography, echocardiography and autonomic function.

Eligibility criteria:
inclusion criteria: * patients with chronic obstructive pulmonary disease, exacerbated or stable between the age of 40-80 years with sinus rhythm who gave informed written consent exclusion criteria: * inability to give written consent, acute myocardial infarction with st-segment elevations in last 30 days, severe acute or chronic renal dysfunction, severe heart failure, atrial fibrillation, severe valve disease, severe hypotension, active malignant disease, active rheumatic disease

Keywords: atrial fibrillation autonomic function cardiopulmonary interaction
a trial on the use of point-of-care ultrasound in the assessment of breast symptoms

Conditions: Breast Cancer

Summary: the high cost of diagnostic equipment, limited expertise, and inadequate infrastructure are major barriers to early breast cancer diagnosis in low- and middle-income countries. point-of-care ultrasound (pocus) offers a relatively low-cost, portable solution that, when combined with artificial intelligence (ai)-driven image analysis, has the potential to significantly expand access to breast assessment in these settings. the purpose of this study is to evaluate the performance of pocus for women with focal breast symptoms and to assess the performance of ai to analyze pocus images. the study will be divided in two parts: a prospective interventional study and a retrospective multicase multireader study.

in this trial we want to understand if the use of pocus is non-inferior to standard of care (soc) and if the combination of pocus ai can reach non-inferior performance to that of breast radiologists. there is a need for breast diagnostic tools in underserved countries since late-stage diagnosis is a major cause of the high breast-cancer mortality in low-and middle-income countries. showing that pocus can be sufficient for an assessment of focal breast symptoms can provide evidence for a broader use. also, enabling automated interpretation using ai can add to the value of this low-cost and accessible solution. the first part of the trial is a prospective open-label accuracy study with paired design. the intervention of pocus as a targeted diagnostic method for women with focal breast complaints will be compared with soc. we will also be able to compare pocus with the individual components of soc (mammography and standard ultrasound) and retrospectively with pocus ai. the second part of the trial is a single-blinded retrospective paired mulitcase multireader study. in this part we can directly assess pocus and pocus ai without the influence of mammography and benchmark to a larger group of radiologists and in addition compare with standard ultrasound

Eligibility criteria:
inclusion criteria: * women (≥18 years of age) referred to diagnostic imaging with a suspicion on malignancy exclusion criteria: * individuals unable to comprehend the study information due to language barriers or cognitive impairments.

Keywords: artificial intelligence, point-of-care ultrasound
a comparison of corneal aberrations in subjects with contralateral acrysof iq toric intraocular lens (iol) and acrysof iq iol with limbal relaxing incision (lri)

Conditions: Cataract; Astigmatism

Summary: the purpose of this study was to evaluate and compare postoperative corneal aberrations and visual parameters in patients contralaterally implanted with an acrysof iq toric intraocular lens (iol) and acrysof iq aspheric iol with concomitant limbal relaxing incision.


Eligibility criteria:
inclusion criteria: ocular criteria must be met in both eyes. * willing and able to understand and sign an informed consent; * willing and able to attend postoperative examinations per protocol schedule; * have cataracts that require extraction followed by implantation of a posterior chamber intraocular lens and used as an on-label procedure; * free of disease(s)/condition(s) listed in the "caution" section of the acrysof iq and acrysof iq toric package inserts; * have regular, bowtie shaped corneal astigmatism and qualify for an sn6at3, sn6at4 or sn6at5 intraocular lens (iol) in both eyes; * have the second surgery at least one week following the first eye implant but not later than one month after the first implant. * other protocol-defined inclusion criteria may apply. exclusion criteria: * previous corneal surgery; * planned multiple procedures during cataract/iol implantation surgery; * ocular disease and/or condition that may compromise study results; * pregnant or planning pregnancy during course of study; * other protocol-defined exclusion criteria may apply.

Keywords: cataract toric iol acrysof lri astigmatism
goal international queri - protocol chrc 2019 goal international

Conditions: Dyslipidemia

Summary: this quality enhancement research initiative (queri) is a knowledge translation medical practice activity based on decision making support through feedback to physicians on their management of dyslipidemia in order to achieve guidelines recommended ldl-c levels in high risk patients. physician interaction has three distinct components: 1. capture of data as reported by participating physician; 2. highlight (by providing feedback) where management may be optimized based on guidelines or recommendations; 3. identify challenges faced by physicians resulting in the care gap..

the goal queri international will engage approximately 115 health care practitioners (hcp) who will enroll up to 2500 patients with management observations based on four visits by the patients in an outpatient setting. the timing of the visits will be baseline, 6±2 months, 12±2 months, and 18±2 months during which patient management by their physician will be captured using the electronic data capture form (dcf). the dcf will be created and managed by the chrc.

Eligibility criteria:
inclusion criteria: 1. adults ≥ 18 years old 2. high risk for cardiovascular morbidity and mortality such as prior history of clinical cardiovascular disease and/or history of familial hypercholesterolemia 3. ldl-c within the past 6 months above recommended level despite maximal tolerated statin therapy ± ezetimibe for the past 3 months. exclusion criteria: 1. current treatment with pcsk9 inhibitor 2. current participation in investigational study 3. prior participation in the goal program
intratumoral phil12 get

Conditions: Basal Cell Carcinoma

Summary: electroporation provides non-viral gene delivery method for plasmid dna. its clinical application was already proven in preclinical and in clinical trial in treatment of melanoma skin metastases with plasmid coding il-12, in usa. intratumoral gene transfer of plasmid coding for il-12 has proven safe end effective, having good local tumour control and some evidence indicates on abscopal effect. the eu directives recommend the use of plasmids without the gene for antibiotic resistance. for this purpose we constructed plasmid coding for il-12 in accordance with the eu regulatory requirements. in the proposed study we intend to study the safety and tolerability of the constructed plasmid, phil12, in treatment of basal cell carcinomas in patients with operable tumors in head and neck region. the study is designed as exploratory, dose escalating with the aim to determine the dose of plasmid that produces il-12 expression in the tumours with best biological activity, infiltration of the immune cells and no toxicity.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed, previously untreated cutaneous basal cell carcinoma located in head and neck region. * solitary tumors, with largest diameter up to 3 cm, in the region where curative surgery is feasible. * age 18-years or older. * life expectancy \> 3 months. * physical performance in accordance with the karnofsky scale ≥ 70 or \< 2 in accordance with world health organization (who) scale. * the patient must be capable of understanding the treatment procedure and possible adverse events, which may arise during treatment. * the patient must be capable of signing the informed consent to participate in the clinical study (voluntary and conscientious consent after education). * prior to inclusion in the trial, the patient must be presented at a multidisciplinary advisory team meeting. exclusion criteria: * known malignancy elsewhere in/on the body. * lesions not suitable for treatment with get (invasion into the bone, infiltration of large vessels). * a life-threatening infection and/or severe heart failure and/or liver failure and/or other life-threatening systemic diseases. * significantly reduced lung function, which requires the determination of dlco. patients should not be treated if dlco is abnormal. * treatment with immunosuppressive drugs, steroids and other drugs that would affect poor wound healing. * age under 18-years. * major disruptions in the coagulation system (who does not respond to the standard therapy - replacement of vitamin k or freshly frozen plasma). * a chronic decline in the kidney function (creatinine \> 150 µmol/l). * epilepsy. * pregnancy and breast-feeding. * the patient's incapability of comprehending the purpose or course of the trial, or not agreeing to be included in the trial. * patients unwilling or unable to comply with the protocol requirements and scheduled visits.
impact of the puncture of the rp6 point on the ampliation and injuries of the perineum during childbirth

Conditions: Perineum; Injury

Summary: during the study period, any patient who enters labour and reports to the maternity ward and meets the inclusion and non-inclusion criteria is offered to participate in the study by the midwife acupuncturist present. after signing the informed consent, a numbered envelope with the randomization arm is assigned to the patient. the acupuncturist midwife does not perform the delivery herself. at the time of the expulsive efforts, she punctures the point drawn at random. the patient's participation in the study ends when she leaves the labour room after the birth.

during the study period, any patient who enters labour and reports to the maternity ward and meets the inclusion and non-inclusion criteria is offered to participate in the study by the midwife acupuncturist present. she's responsible for explaining the purpose and practicalities of the study orally and issues a written information document. the information provided is the same regardless of the midwife present. if she agrees to participate in the study, the patient signs the consent form. after signing the informed consent, a numbered envelope with the randomization arm is assigned to the patient. the acupuncturist midwife does not perform the delivery herself. at the time of the expulsive efforts, she punctures the point drawn at random. she collects the clinical research form from the time the patient signs the consent form until she leaves the labour room after the birth. the patient's participation in the study ends when she leaves the labour room after the birth. no further follow-up is planned.

Eligibility criteria:
inclusion criteria: * primiparous or multiparous women who have never given birth vaginally * term patients (after 37 weeks of amenorrhea) * patients delivering a fetus in cephalic presentation * patients speaking and understanding french. exclusion criteria: * patients suspected of having a fetal macrosomy (greater than the 97th percentile) on the last ultrasound * patients with twin pregnancies * excised patients * patient who has made an acupuncture preparation during pregnancy * patients with fetal death in utero * patients requiring medical termination of pregnancy

Keywords: acupuncture perineum injury delivery
single-photon emission computed tomography (spect) to predict peritoneal chemotherapy

Conditions: Peritoneal Carcinomatosis

Summary: spect was performed in 51 patients after cytoreductive surgery in combination with intraperitoneal chemotherapy. the detected volume was compared to the number of subsequent sequential postoperative intraperitoneal chemotherapy courses that could be performed without further surgical intervention. spect data was found to predict feasibility of sequential postoperative intraperitoneal chemotherapy.


Eligibility criteria:
inclusion criteria: * cytoreductive surgery and intraperitoneal chemotherapy * single-photon emission computed tomography (spect) before the second course of treatment

Keywords: intraperitoneal volume peritoneal carcinomatosis cytoreductive surgery spect intraperitoneal chemotherapy
patterns of fatty acids in framingham offspring

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension; Atherosclerosis

Summary: to study the absolute concentrations and percent of fatty acids in 480 plasma samples from an age and sex stratified random sample of subjects in the framingham offspring study in order to calculate the distribution of fatty acids in this general population and to determine the inter-relationships among levels of fatty acids, in particular w3 and w6 fatty acids, with lipoproteins and apolipoproteins.

background: in 1988, research suggested that high intake of saturated fat increased the risk of cardiovascular disease and cancer, and feeding polyunsaturated fatty acids decreased plasma lipid values. however, understanding of the roles of specific types of fatty acids in nutrition and health remained limited. this was primarily because the technology for analysis of fatty acid compositions in human tissue had only recently achieved the required specificities and secondarily because application of the technology on the large scale of an epidemiologic study had to await recent advances in automation of the chromatography. also intervention studies, aimed at reducing dietary intake of polyunsaturated fatty acids for long periods of time, were either impractical or unethical. the study was conducted to confirm preliminary results suggesting greater prevalence of low levels of essential fatty acids, particularly w3 fatty acids, among people with cardiovascular disease and hypertension, and to provide further confirmatory evidence to results that hyperlipidemia was inversely associated with essential fatty acid levels. design narrative: subjects were randomly selected from existing lists so that six men and six women were selected from each age-year group from 30 to 69 broken down as follows: ages 30-34; 35-39; 40-44; 45-49; 50-54; 55-59; 60-64; 65-69. plasma samples for these subjects were retrieved from storage in batches and analyzed. the prevailing distribution of fatty acids in the general population was calculated. the interrelationships were studied among levels of fatty acids, particularly w3 and w6 fatty acids, with lipoproteins and apolipoproteins. relationships among fatty acid compositions of different lipid fractions were explored and their relationship with various cardiovascular risk factors were evaluated. over 60 fatty acids were quantitated using capillary gas-liquid chromatography. tables of reference values were produced for the general population and for selected subpopulations. multivariate analysis was used to correlate fatty acids and other biochemical markers. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
educational intervention and social support in diabetes mellitus

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to evaluate the impact of an educational program for people with diabetes mellitus based on the family social support.

h0: the person with diabetes who participates in the educational group whose family member/caregiver receives educational interventions hasn't greater glycemic control. ha: the person with diabetes who participates in the educational group whose family member/caregiver receives educational interventions has greater glycemic control.

Eligibility criteria:
inclusion criteria: * people with dm2 * both sexes * minimum age of 40 years * able to dialogue * lack of complications in advanced exclusion criteria: * hemodialysis treatment * amaurosis * sequelae of stroke and/or heart failure * previous amputations at any level of the lower limb * active ulcer in the lower limbs * people in wheelchairs and/or litter * people with limited understanding of the instruments due to cultural factors

Keywords: nursing care diabetes mellitus health education patient compliance social support self-efficacy adaptation strategy
tenofovir combination or mono-therapy for mdr chb

Conditions: Chronic Hepatitis b With Multidrug Resistance

Summary: treatment of multidrug resistant (mdr) chronic hepatitis b (chb) is still a challenging issue. hence, the investigators will perform a multicenter prospective cohort study for the evaluation of tenofovir disoproxil fumarate (tdf)-based therapy for mdr chb at real life settings.

inclusion criteria were chb patients with resistance to more than two classes of nucleos(t)ide analogues (na) and hepatitis b virus (hbv) dna level ≥200 iu/ml. patients will receive either tdf-base combination therapy or tdf monotherapy. the primary end point is virologic response (vr) defined by an undetectable hbv dna (\<20 iu/ml) at month 36.

Eligibility criteria:
inclusion criteria: * chb patients with: 1. documented hbsag positivity at least 6 months before enrollment 2. age \>18 years old, 3. confirmed genotypic resistance to more than two classes of nas 4. hbv dna level ≥ 200 iu/ml 5. compensated liver diseases (defined by child-pugh-turcotte score \ 3 g/dl; total bilirubin \<2.5 mg/dl; no history of esophago-gastric variceal bleeding, ascites, over hepatic encephalopathy) 6. willingness to give an informed consent. exclusion criteria: 1. laboratory abnormalities of low serum phosphorous level \ 1.5 mg/dl, decreased creatinine clearance rate \<50 ml/min, absolute neutrophil count \<1000 cell/ml, or low hemoglobin level \<10 g/dl (if female, \<9 g/dl) 2. no definite evidence of genotypic resistance 3. positive antibody test for hepatitis c virus, hepatitis d virus, or human immunodeficiency virus 4. hcc 5. a proof of pregnant or lactating women 6. evidence of active alcohol consumption (140 g per a week for men and 70 g per a week for women) 7. any untreated malignancy.