Kornimate/medical-research-clean huggingface dataset:
a study comparing lbal to humira® in subjects with active rheumatoid arthritis despite methotrexate therapy

Conditions: Arthritis, Rheumatoid

Summary: this is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of lbal compared to humira® in subjects with active rheumatoid arthritis despite methotrexate therapy.


Eligibility criteria:
inclusion criteria: * male or female patients from 20 years to 75 years of age when signing informed consent. * diagnosed as having ra (rheumatoid arthritis) according to the revised 1987 acr (american college of rheumatology) criteria for at least 3 months prior to screening * patients who have inadequate response to mtx administered for at least 12 weeks before the beginning of screening period and on a stable dose. exclusion criteria: * patients with active tuberculosis or latent tuberculosis based on current clinical symptoms, chest x-ray test and ifn-γ release assay at screening * patients with any of the following concomitant diseases and/or history within 24 weeks before the first administration of investigational products in this study; serious infectious disease, opportunistic infection, chronic or recurrent infectious disease * patients with any seropositive result for hepatitis b or hepatitis c or hiv * patients who have any of the following diseases; sepsis, demyelinating disorders, lymphoproliferative disease, infection with prosthetic joint, autoimmune diseases other than rheumatoid arthritis
enriched canned tuna with fibre or polyphenols on satiety

Conditions: Overweight

Summary: the purpose of this study is to evaluate the satiating effects of different canned tuna preserved in olive oil enriched with soluble fiber or polyphenols on overweight subjects (bmi ≥25 and \<30 kg / m2). some studies have shown the contribution of high-fiber foods in the reduction of the cardiovascular risk.

a randomized, cross-over and double-blind pilot study with 3 study arms is being performed to evaluate the satiating properties of different canned tuna preserved in olive oil enriched with soluble fiber or polyphenols on overweight subjects. the investigators included 12 participants (6 men and 6 women) between 18 and 55 years (bmi ≥25 and \<30 kg / m2). all volunteers will be randomized into 3 study groups, and participants will receive the 3 different study products in order during the 3 experimental phases.

Eligibility criteria:
inclusion criteria: * men and women from 18 to 65 years old. * body mass index (bmi) ≥25 and \<30 kg/m2. * adequate cultural level and understanding for the clinical trial. * signed informed consent exclusion criteria: * subjects with bmi ≥30 or \<25 kg /m2 * subjects diagnosed with diabetes mellitus. * subjects with dyslipidemia on pharmacological treatment * subjects with hypertension on pharmacological treatment * subjects with established diagnosis of eating disorder * smokers or those subjects with high alcohol consumption (\> 2-3 servings/ day in men and\> 1 serving/day in women (1 serving = 1 glass of wine or 1 bottle of beer) * subjects under pharmacological treatment (except oral contraceptives) * subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet * subjects with sensory problems * subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients * pregnant or breastfeeding women * women with menstrual irregularities (absence of menstrual cycle at least 2 months) * subjects with intense physical activity. * subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption * subjects with a diagnosis of celiac disease or a gluten intolerance

Keywords: satiety polyphenols fibre visual analogue scale cross-over tuna
hyperbaric oxygen therapy and spect brain imaging in carbon monoxide poisoning

Conditions: Neuropsychiatric Sequelae of Carbon Monoxide Poisoning

Summary: that spect brain imaging tracks and is consistent with clinical history and physical exam as well as cognitive testing.

the study is a retrospective review of the pi's experience using spect brain imaging and hyperbaric oxygen therapy in the diagnosis and treatment of non-acute phases of carbon monoxide poisoning. the purpose is to see if the spect brain imaging is consistent with the clinical condition and cognitive testing on the patients.

Eligibility criteria:
inclusion criteria: * adults and children with non-acute carbon monoxide poisoning who underwent spect brain imaging as part of their evaluation and treatment exclusion criteria: * none.

Keywords: carbon monoxide poisoning brain injury
the effect of dexmedetomidine on neuroendocrine stress hormone release and heart rate variability in patients undergoing major spinal surgery

Conditions: Spinal Stenosis

Summary: surgical stress induces stress hormone release and sympathetic hyperactivation. dexmedetomidine has sympatholytic effect and attenuates stress responses. this study investigate the effect of dexmedetomidine on stress responses and autonomic nervous system balance in patients undergoing major spine surgery.


Eligibility criteria:
inclusion criteria: * patient between 20 and 70 of age with asa physical status ⅰ-ⅲ * patient scheduled for major spine surgery exclusion criteria: * asa physical status ⅳ * congestive heart failure * severe hepatorenal disease * insulin dependent dm(diabetes mellitus) * cancer or metastasis * pregnancy * problem with communication
a study to examine the clinical effectiveness of tafamidis in patients with mixed phenotype hereditary transthyretin amyloidosis

Conditions: Hereditary Transthyretin Amyloidosis (ATTRv) Cardiomyopathy (CM), Mixed Phenotype

Summary: this study will examine the clinical effectiveness of tafamidis in patients with mixed phenotype hereditary transthyretin amyloidosis using data that already exist in patients' medical records.


Eligibility criteria:
inclusion criteria: * age ≥18 years at diagnosis * diagnosed with attrv-cm, mixed phenotype * treated with tafamidis (vyndaqel 80 mg \[four 20-mg tafamidis meglumine capsules\] orally once daily or vyndamax 61 mg \[one 61-mg tafamidis capsule\] orally once daily) for ≥6 months * have had ≥1 pre- and ≥2 post-treatment neurologic assessments exclusion criteria: * history of organ transplant * wild-type ttr genotype * individuals who are non-ambulatory * prior treatment with any disease-modifying therapy (investigational or approved) alone or in combination, except tafamidis, as either vyndaqel 80 mg (four 20-mg tafamidis meglumine capsules) orally once daily or vyndamax 61 mg (one 61-mg tafamidis capsule) orally once daily * peripheral neuropathy attributed to causes other than attr amyloidosis (e.g., diabetes mellitus, b12 deficiency, hiv infection)

Keywords: transthyretin amyloidosis cardiomyopathy tafamidis polyneuropathy progression
evaluation of neurotoxic effect of sevoflurane-based anaesthesiaguided by short-term olfactory identification

Conditions: Neurotoxic Effect of Sevoflurane-Based Anaesthesia

Summary: nowadays there is increasing doubts about the safety of anesthesia . anesthesiologists have to console the worried patients, who are anxious about the potential risks of anesthetic-induced brain damage, by suggesting that any detrimental effects would be "mild".anesthetics are responsible for postoperative taste and odor defects and cognitive dysfunction.

aims: the aim of this study is to assess the effect of isoflurane, sevoflurane, propofol and regional anesthesia on the olfactory threshold, olfactory identification and endocrine regulation of associative memory in the postoperative period in old age group. methods: 600 patients (\> 60years ) fulfilling the criteria of the american society of anesthesiologists and ii status were selected for this prospective single-blinded randomized controlled study. patients were randomized into one of four groups to receive regional anesthesia (control group), general anesthesia with sevoflurane, general anesthesia with isoflurane and total intravenous anesthesia with propofol. mini-mental state examination (mmse), olfactory threshold, and olfactory identification were tested at 12 hours preoperatively (t0), at 3 hours postoperatively (t1) and at the time of discharge or postoperative 3 days (t2). in addition, serum melatonin levels were estimated at t0 and t1. n-butyl alcohol was used to test the olfactory threshold and the pocket smell test tm series (psts) was used to test olfactory identification. data were analyzed using the one-way analysis of variance, kruskal-wallis or mann-whitney tests.

Eligibility criteria:
inclusion criteria: * american society of anaesthesiologists i and ii physical status * aged from 60 to 75years * scheduled for elective surgery with the anticipated duration of 100-120 min. * surgical procedures included hernia repair, * varicose vein surgery, * incisional hernia repair, * minor gynecological procedures, * lower limb orthopedic procedures, * minor urological procedures exclusion criteria: * patients with recent airway infection, * allergic rhinitis, * nasal polyps, * history of alcoholism, * smoking, * mental retardation, * psychiatric illness, * neurosurgical or oto-rhino-laryngeal surgery * patients with a history of olfactory deficits and cognitive impairment

Keywords: general anesthesia. neurotoxicity, olfaction, olfactory identification. sevoflurane.
coa-aptic caregiver concept elicitation study

Conditions: Pain Measurement

Summary: this is a concept elicitation study to identify important aspects of pain assessment, treatment, and response to treatment in children under than 3 years of age from a caregiver's perspective.

the purpose of this study is to identify important endpoints and outcomes for use in pediatric trials for acute pain therapeutics in infants and young children from a caregiver's perception. study team members will conduct phone-based qualitative interviews, using a semi-structured interview guide, with 42 primary caregivers of pediatric patients under 3 years of age who are experiencing or have experienced acute pain. once participants give verbal consent, they will fill out a demographics form. interviews will last about one hour and will address the participant's experience recognizing and managing their child's acute pain. the investigators will use these concept elicitation interviews to identify important aspects of acute pain assessment, treatment, and response to treatment in children who are under 3 years old. interviews will be audio recorded and transcribed with participant permission. transcripts or interviewer notes will be reviewed by two analysts and will be double coded until inter-rater reliability is reached by agreement of at least 80%. the study team will conduct a thematic analysis of the coded transcripts. this is a minimal risk study. all information will be kept confidential and information will be stored on a secure network which is only accessible to the study team.

Eligibility criteria:
inclusion criteria: 1. cares for a child who is both: * between 0 and \<3 years of age * experiencing or has experienced acute pain in one of the following categories: * malignant or non-malignant visceral or hematologic disease * surgery (or other procedure) * trauma or injury * congenital conditions 2. is over the age of 18 years old. 3. can speak and understand english. 4. is capable of and willing to provide informed consent for interview participation and to collect medical data from the child's medical record. exclusion criteria: 1. lack of access to a telephone or computer for interview 2. has a child with acute pain that is extremely premature (less than 32 weeks gestation at the time of enrollment) and no other eligible child.

Keywords: acute pain pediatrics
procoagulant activity in patients with community acquired pneumonia, pleural effusion and empyema

Conditions: Pneumonia; Pleural Effusion; Empyema

Summary: community acquired pneumonia (cap) is still one of the most important causes of morbidity in adults. (1) in severe cases, parapneumonic effusions or empyema may develop. in these patients, a transitional fibrin neomatrix constitutes part of the acute inflammatory response as seen in sepsis. the aim is to study the fibrinolytic activity in patients with cap alone versus cap with parapneumonic effusions with and without empyema.

community acquired pneumonia (cap) is still one of the most important causes of morbidity in adults. (1) in severe cases, parapneumonic effusions or empyema may develop. in these patients, a transitional fibrin neomatrix constitutes part of the acute inflammatory response as seen in sepsis. (2) the increased vascular permeability, mediated by several cytokines, such as il-1, il-6, il-8, tumor necrosis factor (tnf), and platelet activator factor, allows migration of inflammatory cells, an increased fluid accumulation and bacterial invasion into pleural space. (3) at this stage, activation of the coagulation cascade leads to procoagulant activity and decreased fibrinolysis with deposition of fibrin in the pleural space. the activation of the fibrinolytic system produce the d-dimer and follow by increased other procoagulant markers like thrombin anti thrombin, fragment 1.2 (4-5) several studies showed that the plasma d-dimer levels were increased even in community-acquired pneumonia patients. moreover, others reported that serum levels of at-iii, d-d and crp at admission appear to be useful biomarkers for assessing the severity of cap. however, no data exists about the fibrinolytic profile in patients with cap alone in compare to cap with parapneumonic effusion with and without empyema. aim: to study the fibrinolytic activity in patients with cap alone versus cap with parapneumonic effusions with and without empyema.

Eligibility criteria:
inclusion criteria: * all patients that will be admitted with cap to the pulmonary department in meir medical center and have no exclusion criteria will be included in the study. exclusion criteria: * patients younger than 18 years old * patients with anticoagulant treatment, primary coagulopathy, nephrotic syndrome, surgery, other infection in the month preceding the study, an abnormal liver or renal function test(s), a history of deep vein thrombosis in the last year or patients with acute coronary syndrome.

Keywords: fibrinolytic activity community acquired pneumonia (cap) pleural effusion
impact of pasireotide on postoperative pancreatic fistulas following distal resections

Conditions: Surgical Complications

Summary: between 2000 and 2016 258 distal pancreatectomies were performed at our university hospital which were included in our analysis. pasireotide was used in between july 2014 and april 2016. patients received 900-ug pasireotide administered twice daily perioperatively. we analyzed patients who received octreotide treatment separately. complications such as fistulas (popf), delayed gas-tric emptying (dge), postoperative hemorrhage (pph), reoperations and mortality were recorded and analyzed 90 days postoperatively

in total, between 2000 and 2016 in our university hospital there were 276 elective distal pancreatectomies performed. in this retrospective cohort study, we included 258 of those distal pancreatectomy patients in the database in to our analysis. pasireotide was administered preoperatively to all patients undergoing distal pancreatic resection between july 2014 to april 2016, as a part of a new practice in our clinic. one patient received both pasireotide and octreotide, for whom drug delivery was stopped after one day, and who was ex-cluded from analysis. we also excluded nine patients because insufficient data were found. seven patients were excluded because they were recruited to another clinical study. in total, 47 patients (18%) received 900-ug pasireotide administered subcutaneously twice daily for a week or until discharged from the hospital. we analyzed separately 31 (12%) patients who re-ceived octreotide peri-operatively. all other 180 (70%) distal resection patients operated on beween 2000 and 2016 constituted the control group. the drug used in this study, pasireotide (signifor), was supplied by novartis europharm ltd. (novartis, basel, switzerland). the drug manufacturer did not take part in the study nor did it cover any costs. we collected information about the patient age, gender, the american society of anesthesiologists (asa) physical status classification, tumor histology and grade and type of resection. in addition, we recorded postoperative information, the length of the hospital stay, fever following surgery (\>38 °c), complications and surgical and other re-operations.

Eligibility criteria:
inclusion criteria: all distal pancreatic resection patients in our time frame exclusion criteria: included in another clinical trial, received both medications, inadequite patient records
berlin magnetic seizure therapy depression trial 01

Conditions: Unipolar Depression; Bipolar Depression

Summary: this treatment pilot study will investigate clinical efficacy and adverse effects of magnetic seizure therapy (mst) in patients currently experiencing a unipolar or bipolar depressive episode. the investigators will perform add-on tests to assess clinical and cognitive response to treatment. it is hypothesized that mst will have an antidepressant efficacy with a beneficial neurocognitive adverse effect profile.


Eligibility criteria:
inclusion criteria: * patient is diagnosed with a severe major depressive episode * patient is in a chronic current mde and/or has had a history of recurrent mdes * patient has not had an acceptable clinical response due to failure with at least 2 antidepressant treatments during the current episode * patient has a score \> 20 on the hamd24 * patient is stable on current psychotropic medication for at least 4 weeks * patient is \> 25 and \< 80 years exclusion criteria: * atypical depression or psychotic depression (according to dsm iv) * other relevant psychiatric axis i or axis ii diseases * relevant neurological diseases * relevant cardiac or pulmonary diseases with enhances anesthesiological risk (asa score \> 3) * patient is currently enrolled in another investigational study not associated with the current study * patient has a history of, or evidence of, significant brain malformation or significant head injury
the opt-in project

Conditions: Opioid-Related Disorders

Summary: prescription opioid overdose represents a public health crisis. a number of efforts have been implemented to address opioid prescribing and opioid risk mitigation strategies for prescribers, but relatively few efforts have sought to address this problem directly with individuals who use opioids. this gap likely fails to fully address the inherent reinforcing nature of the medications that make it challenging to reduce use. the specific aim of this study is to pilot test a toolkit that pairs an intervention with the distribution of naloxone. external facilitation (supervision check-ins) will aid translation to delivery by non-research staff. firstly, data will be collected from participants over time as a control group, prior to training site staff. next, non-research staff will be trained on the intervention. staff at the site will use the online "toolkit" developed in the beginning of this project to deliver the interventions and naloxone to their clients/patients as part of usual care. after staff at the site(s) are trained, additional data will be collected from participants during the intervention period and after 3-months.

based on feedback from non-research site staff, the opt-in project implementation package was tailored for optimal delivery in the site setting. the translation strategy will be evaluated using the re-aim framework, which includes reach (e.g., number of individuals receiving intervention), effectiveness (e.g., patient/client outcomes), adoption (e.g., numbers trained), implementation (e.g., fidelity of intervention delivery) and maintenance (e.g., sustained in routine practice over time) with mixed qualitative and quantitative methods with intervention recipients.

Eligibility criteria:
inclusion criteria: * speaks english fluently * receiving services at one of the investigator's partner sites * history of opioid use exclusion criteria: * medically unstable * prisoners * inability to speak and understand english * inability to give informed, voluntary, written consent for any reason

Keywords: drug overdose substance-related disorders chemically-induced disorders risk reduction behavior harm reduction
comparison of minimally invasive versus open spinopelvic fixation for unstable sacral fractures

Conditions: Sacral Fracture

Summary: the aim of this retrospective study is to evaluate patients with vertically unstable high-energy sacral fracture operated on at our institution with spinopelvic fixation, to compare the traditionally open method of fixation with the minimally invasive fixation. the aim of the research is to determine whether minimally invasive surgical techniques can achieve comparable fracture reduction and functional outcome as open surgical approaches. another aim is to determine whether the minimally invasive surgical procedure leads to shorter patient hospitalization, lower perioperative blood loss, and lower postoperative complications.

this retrospective study included 51 patients with vertically unstable sacral fracture operated at our institution with open or minimally invasive spinopelvic fixation over a period of 11 years (2014-2024). the patients were divided into two groups. one group of patients underwent open spinopelvic fixation, the other group underwent minimally invasive spinopelvic fixation. each patient underwent a ct scan before and after surgery. the degree of fracture dislocation and reduction was measured in three planes at each examination. the degree of reduction was divided into four groups according to residual dislocation. in the perioperative period, blood loss, the length of the surgical procedure from the first incision to the suture of the wounds, and radiation exposure were monitored. intraoperative blood loss was calculated from the waste in the surgical suction system. functional outcome was assessed one year after surgery. a standardized questionnaire according to the majeed score was used to assess functional outcome.

Eligibility criteria:
inclusion criteria: * patient with high energy vertically unstable sacral fracture * patients operated with open or minimally invasive spinopelvic fixation * patients followed up for at least one year exclusion criteria: * patients with low-energy osteoporotic fractures of the sacrum * patients with insufficiency fractures of the sacrum * patients operated on using a method other than spinopelvic fixation * patients who were not followed up for at least one year after surgery