Kornimate/medical-research-clean huggingface dataset:
study to examine pain relief with supplemental intrathecal morphine in tka patients

Conditions: Acute Pain

Summary: this is a prospective, randomized, double-blinded, placebo-controlled study designed to examine pain relief following intrathecal morphine sulfate (0.2mg) in patients undergoing total knee arthroplasty (tka) under spinal anesthesia in addition to a femoral nerve catheter. the protocol consists of two parts: (1) a prospective patient recruitment study and (2) a retrospective assay for endocannabinoids on previously collected specimens.

this is a prospective, case-controlled randomized, double-blinded, placebo-controlled study expected to enroll up to 100 patients scheduled to undergo unilateral total knee arthroplasty (tka) under regional anesthesia (defined as intrathecal spinal + femoral nerve blockade + femoral nerve catheter for post-operative analgesia) at stony brook hospital. the patients were randomized to receive either it morphine 0.2 mg (group 1) or placebo (group 2) in combination with their standard-of-care spinal anesthesia. post-operatively, the patients were given an intravenous patient-controlled analgesic opioid for breakthrough pain. only the pharmacist preparing the drug/placebo has knowledge of how each subject was randomized. study staff completed multiple questionnaires regarding subjects' pain scores and patient disability from pain to assess changes between different study periods (ie. pre-operative, post-operative and follow up). biological samples were also taken from each subject to measure and analyze differences and changes in endocannabinoid levels.

Eligibility criteria:
inclusion criteria: * scheduled for unilateral tka under regional anesthesia * asa class 1, 2 or 3 * able to give informed consent * able to understand english exclusion criteria: * medical condition(s) that prevents use of regional anesthesia (e.g. infection at site of injection, coagulopathy, severe hypovolemia, severe aortic or mitral stenosis, increased intracranial pressure, severe spinal deformity, spinal cord hardware or stimulator implanted) * allergy to morphine * morbid obesity (bmi \> 45) * respiratory compromise (difficult airway, severe emphysema or copd) * obstructive sleep apnea (only if diagnosed in a sleep disorders clinic and cpap was prescribed) * chronic pain with opioid usage over 100 mg morphine-equivalents po/day * history of abuse of opioids or other drugs of abuse * scheduled for bilateral tka * revision of knee arthroplasty * any medical condition that would affect the patient's ability to metabolize or excrete the study drugs (e.g. chronic kidney failure with patient on dialysis) or other medical condition that in the investigator's opinion would render the patient unsuitable for this research study

Keywords: morphine tka pain tkr arthroplasty
cognitive bias modification for youth anxiety

Conditions: Anxiety

Summary: research in the last fifteen years suggests that anxious individuals selectively attend towards threatening information. attention modification interventions for internalizing adults have been developed to target cognition at this basic level; these programs have demonstrated initial efficacy in attention bias and anxiety symptom reduction. to date, there have been minimal published studies of attention modification in youths with clinical levels of anxiety. this study is a large randomized efficacy-effectiveness trial (n = 498) to test the benefit of this low-cost, computerized attention modification intervention (cognitive bias modification (cbm) computer application) for anxiety disorders and symptomatology in youth ages 12 to 17. this trial conducted will compare three intervention arms, all of which include underlying treatment as usual (tau). the investigators directly test the level of clinical support ("scaffolding") needed to adequately deliver self-administered cbm to anxious youth, a finding that will be key to preparing for future deployment-focused trials. the investigators will compare an attention control version of the cbm program (arm 1) to two active versions of the cbm intervention that have varying levels of patient clinical support: a self-administered cbm program that participants download and install on their home computers (self-administered cbm-only; arm 2), and the same cbm program paired with an adherence promotion (ap) component delivered via brief telephone calls from study "coaches," including as needed, brief motivational enhancement and/or technical assistance (self-administered cbm+ap; arm 3). the investigators expect that youth receiving cbm and cbm+ap will have improvement in anxiety symptoms and functioning. the investigators will also complete a cost-effectiveness analysis to examine potential costs offset by this intervention.


Eligibility criteria:
inclusion criteria: * youth age between 12.0 and 17.9 years old * youth, parent able to complete assessments in english * youth performing at 7th-12th grade achievement level * youth vision sufficient to read book of typical size print * youth access to home computer, internet for 3 months * assessment of childhood disorders (adis)-confirmed diagnosis of generalized anxiety disorder (gad) and/or social phobia (sop) and/or separation anxiety disorder (sad) exclusion criteria: * youth diagnosis of learning or processing problem * youth diagnosis of attention deficit hyperactivity disorder (adhd), except if symptoms are stable and controlled by medication for \> 1 mo. * youth diagnosis of psychotic disorder * youth primary complaint of condition other than anxiety (as determined by the research interviewer during the baseline survey) * psychotic features or delayed inform/visual processing

Keywords: anxiety youth anxiety cbm cognitive bias modification adolescents
effects of a dietary supplement containing l-arabinose and trivalent patented food-source of chromium on blood glucose and insulin

Conditions: Pre-diabetes

Summary: this study was designed to examine changes in capillary blood glucose and venous insulin levels after a 70 gram oral sucrose challenge with and without simultaneous consumption of a dietary supplement containing l-arabinose and a patented version of chromium (la-cr).

this study concluded that consumption of the la-cr supplement in conjunction with a 70-gram sucrose challenge led to a significant reduction of capillary blood glucose and venous insulin as compared to the sucrose challenge without the la-cr supplement. this finding may provide an important tool to reduce the adverse effects associated with elevated glucose and insulin levels.

Eligibility criteria:
inclusion criteria: * all study subjects were required to contact their family physician to ensure they had no medical conditions that would preclude their participation. exclusion criteria: * diabetics, and * those not approved by their physicians.

Keywords: glucose insulin l-arabinose chromium
redox status and immune function

Conditions: Skeletal Muscle Damage; Aseptic Inflammation; Skeletal Muscle Function

Summary: in this investigation the investigators utilized n-acetylcysteine (nac) supplementation to enhance reduced glutathione (gsh) stores during an 8-day recovery period from a strenuous eccentric exercise protocol in order to test the hypotheses: i) redox status perturbations in skeletal muscle are pivotal for the immune responses and ii) antioxidant supplementation may alter immune cell responses following exercise-induced muscle microtrauma.

the major thiol-disulfide couple of gsh and oxidized glutathione (gssg) is a crucial regulator of the main transcriptional pathways regulating aseptic inflammation and recovery of skeletal muscle following aseptic injury. antioxidant supplementation may hamper exercise-induced inflammatory responses. the objective was to examine how thiol-based antioxidant supplementation affects immune mobilization following exercise-induced skeletal muscle microtrauma. in a two-trial, double-blind, crossover, repeated measures design, 10 young men received either placebo or nac (20 mg/kg/day) immediately after a muscle-damaging exercise protocol (300 eccentric contractions) and for eight consecutive days. blood sampling and performance assessment were performed pre-exercise, 2h post-exercise and daily for 8 consecutive days.

Eligibility criteria:
inclusion criteria: * recreationally trained (vo2max \> 45 ml/kg/min) * engaged in regular exercise for ≥3 times/week for \> 12 months * non-smokers * abstain from exercise during the course of the two trials * no consumption of performance-enhancing substances, antioxidants, caffeine, alcohol and/or medications during the study. exclusion criteria: * nac intolerance * recent musculoskeletal injuries of the lower limbs * febrile illness * history of muscle lesion.

Keywords: muscle injury exercise redox status immune cells
glioma brain tumours - e12513 - sensiscreen glioma

Conditions: Glioma

Summary: validation of a new platform for the molecular characterization of patients affected by glioma. the new platform includes a series of faster, less expensive real-time pcr methodologies that, in comparison to standard analyses (ds, ms-pcr), are also characterized by higher sensitivity and consequently can be able to identify mutations in ctdna extracted from liquid biopsies as well. the development of these assays will allow the analysis of molecular markers alteration even in liquid biopsies, providing a less invasive sampling than tissue biopsies, a procedure that sometimes is characterized by side effects or that allow the collection of few tissues for the histological and molecular diagnosis. this study will not interfere with the patients routine treatment pathway and there will be no deviation from the standard of care: the molecular characterization of the tissues will be performed according to the standard diagnostic routine using the currently approved methodologies. for the retrospective study, it will be used the left-over dna. for the cohort, that includes the collection and the subsequent analysis of liquid biopsies (prospective study), blood and csf will be sampled during surgery. the mutations in the molecular markers will be analyzed in tissue as well as in plasma and cfs samples by the new real-time based assays. then, the qualitative and quantitative values obtained on liquid biopsies with the new methodology will be compared to the results of the standard methodologies already obtained, for diagnostic routine, on surgical tissue samples of the same patients.


Eligibility criteria:
retrospective cohort inclusion criteria: * patient with available tissue material or with available molecular data concerning the tissue biopsy obtained during surgery and analyzed for diagnosis exclusion criteria: * insufficient amount of tumor cells in the tissue biopsy for the molecular characterization * inability to consent and follow the procedures of the study (for alive patients) prospective cohort inclusion criteria: * age ≥ 18 years old * affected by suspected glioma and requiring surgery * patient with available tissue material or with available molecular data concerning the tissue biopsy obtained during surgery and analyzed for diagnosis * written informed consent exclusion criteria: * insufficient amount of tumor cells in the tissue biopsy for the molecular characterization * inability to consent and follow the procedures of the study * women who are pregnant or breast feeding
long-term safety and efficacy of abp 501 in subjects with moderate to severe rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this open-label study is to evaluate the long-term safety and efficacy of abp 501 in adults with moderate to severe rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: * subject was randomized into protocol 20120262 (nct01970475) and completed the week 26 visit exclusion criteria: * subject experienced a serious adverse event (sae) or an adverse event (ae) in the 20120262 study that could cause extension treatment to be detrimental * subject completed study 20120262 but cannot be dosed within 4 weeks of the week 26 visit of study 20120262 * current infection requiring the use of oral or intravenous antibiotics other inclusion/exclusion criteria may apply

Keywords: arthritis rheumatoid
level of physical activity and fear learning

Conditions: Generalized Anxiety Disorder; Social Anxiety Disorder; Panic Disorder

Summary: the proposed experimental study will be the first to investigate whether exercise vs. sitting enhances consolidation of extinction learning in adults with high as and anxiety disorders, and the mechanistic pathways of expectancy, affect, and key stress response markers.

this is an experimental study (not a treatment study) aiming to examine the effects of acute exercise vs. sitting on fear extinction learning in a 2-day paradigm. 50 eligible (after screening) men and women ages 18-60 with high anxiety sensitivity (as) and an anxiety disorder (generalized anxiety disorder, panic disorder, social anxiety disorder) will participate in a consecutive 2-day paradigm. participants will be randomized to 1 of 2 conditions immediately following the emotional learning paradigm: 1) moderate intensity exercise (n=25) or 2) sitting(n=25), for 20 minutes. day 2 will include testing of emotional learning. primary outcomes are physiological arousal (skin conductance, heart rate) during day 2 procedures. mechanistic factors, including expected negative consequences of exercise, affect during exercise, threat/shock expectancy, and changes pre-post exercise in stress related neuroendocrine markers (cortisol and alpha-amylase) and their effects on extinction recall will be measured.

Eligibility criteria:
inclusion criteria: * males and females ages 18-60 * a primary diagnosis of a dsm-5 anxiety disorder (generalized anxiety disorder, panic disorder, social anxiety disorder) * anxiety sensitivity index-3 score of ≥23 (i.e., high anxiety sensitivity) * able and willing to provide informed consent exclusion criteria: * lifetime bipolar disorder or psychosis * past 3 months substance use disorder or eating disorder * current ptsd (past ptsd \> 6 months prior to screening is allowed) * high risk for exercise according to the physical activity readiness questionnaire and american college of sports medicine guidelines with excluded active medical conditions including heart conditions, lung disease, bone/joint problems, or seizures * women who are currently pregnant * acute suicide risk (active suicidal ideation with plan and intent) as indicated by a score of ≥4 on the columbia suicide severity rating scale (c-ssrs) * benzodiazepine use * current substance abuse or positive urine toxicology screen (recreational use of marijuana is permitted based on clinical assessment on the mini structured diagnostic interview that it does not meet criteria for cannabis use disorder) * stable psychiatric medications for at least 4 weeks prior to experimental procedures
mesh ablator versus cryoballoon pulmonary vein ablation of symptomatic paroxysmal atrial fibrillation

Conditions: Symptomatic Paroxysmal Atrial Fibrillation

Summary: the purpose of this prospective randomized single-center trial is to compare efficiency and safety of two pulmonary vein ablation systems in patients with symptomatic paroxysmal atrial fibrillation using the arctic front® versus the hd mesh ablator® catheter.

primary objective: • efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient. secondary objectives: * detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain mri prior and within 2 days after pv ablation. * detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain mri within 6 months after pv ablation. * determination of spontaneous recurrence rate of atrial fibrillation using a subcutaneously implanted loop recorder (reveal xt®). * characterization of non-neurological major complications (death, atrial-esophageal fistula, pulmonary vein stenosis, pericardial tamponade) * rate of iatrogenic interatrial septal defects after transseptal puncture for pv ablation.

Eligibility criteria:
inclusion criteria: * patients with ecg-documented symptomatic paroxysmal atrial fibrillation and at least one ineffective antiarrhythmic drug treatment exclusion criteria: * previous ablation procedure for atrial fibrillation or cardiac surgery within 3 months * left atrial diameter \> 50mm or ejection fraction \< 35% * instable coronary artery disease or clinically relevant cardiac valve insufficiency * hyperthyroidism, pregnancy or lactation; coumadin or heparin intolerance * concomitant disease with expected lifespan \< 2 years * contraindications for mri or acute cerebral infarction detected by brain mri immediately (\< 24 hours) before catheter ablation.

Keywords: mri left-sided atrial catheter ablation paroxysmal atrial fibrillation cryoballoon technique mesh ablator catheter stroke silent stroke major complications
frontal lobe oxyhemoglobin levels in patients with lower extremity burns assessed using a fnirs

Conditions: Walking

Summary: investigators investigate the patterns of cortical activation using the nirst in patients with peripheral neurological injury caused by lower extremity burns.

understanding the mechanisms associated with locomotor networks may be of benefit for rehabilitation of burn victims with neurological locomotor deficits. however, the effects of peripheral neurological injury on locomotor network remains unknown. a wearable functional near-infrared spectroscopy (fnirs) device has been developed for studying cortical hemodynamics. changes in cortical activity has not previously been documented in patients with burn injury. investigators assessed 15 patients with lower extremity burns and 11 healthy controls. investigators measured walking-related cortical activity using an fnirs device at baseline and during usual walking. cortical activity was measured by evaluating relative changes in oxyhemoglobin level. the nirst analysis tool v2.1 was utilized to analyze fnirs data in a matlab environment.

Eligibility criteria:
inclusion criteria: * burn patients with lower extremity or upper extremity thermal injury * patients who could walk unassisted for at least 5min. exclusion criteria: * patients with critical systemic conditions * severe cognitive impairment * had severe pain * unable to walk.

Keywords: burn near-infrared spectroscopy (nirs)
evaluation of covid 19 knowledge anxiety and expectation levels of turkish physicians, survey study

Conditions: COVID-19; Physician-Patient Relations

Summary: it is aimed to measure the general health information of turkish physicians about covid 19 pandemic, to evaluate anxiety levels and to evaluate future expectations in this period.


Eligibility criteria:
inclusion criteria: * turkish physicians * work active in pandemic hospital exclusion criteria: * work in another country * retired physicians

Keywords: covid-19 turkish physicians
image guided reirradiation of high-grade glioma

Conditions: Malignant Glioma; Glioblastoma

Summary: the purpose of the study is to evaluate the short- and long term toxicity of radiotherapy to patients with recurrent high-grade glioma who have previously received radiotherapy and to determine the best dose and treatment regimen. positron emission tomography (pet) using an amino acid tracer, 18-fluoro-ethyltyrosine (18f-fet), is used for target delineation.the study examines, in four sequential treatment groups, the effect of dose, hypofractionation and treatment volume on toxicity. upon completion of the phase i part, the study progresses to phase ii where the best dose- and treatment regimen will be chosen for treatment.


Eligibility criteria:
inclusion criteria: * recurrent high-grade glioma * previous focal radiotherapy for high-grade glioma * no standard treatment options available/indicated * ecog (eastern cooperative oncology group) performance status 0 or 1 or 2 * life expectancy \> 3 months * hemoglobin value \> 6 mmol/l (transfusion permitted) * able to understand oral and written danish exclusion criteria: * disseminated recurrent disease * infection or wound dehiscence or other pathological condition in meninges/skull/scalp * symptoms of elevated intracranial pressure * very early recurrence following primary radiotherapy (\< or equal to 3 months) * contraindications to magnetic resonance imaging (mri) or positron emission tomography (pet) * other previous radiotherapy to the brain than primary course of irradiation

Keywords: reirradiation recurrent glioma positron emission tomography amino acid tracer
ُefficacy of insulin versus hyalase hydro-dissection of median nerve in rheumatoid arthritis patients

Conditions: Treatment Resistant Carpal Tunnel in RA Patients

Summary: carpal tunnel syndrome (cts) is a common peripheral entrapment neuropathy in rheumatoid arthritis patients proved by nerve conduction studies and ultrasound parameters, this study aims to evaluate the effect of hydro-dissection using insulin versus hyalase versus saline, ultrasounic guided as an effective treatment

carpal tunnel syndrome (cts) is a common peripheral entrapment neuropathy in rheumatoid arthritis patients proved by nerve conduction studies and ultrasound parameters, this study aims to evaluate the effect of hydro-dissection of median nerve inside ct twice injections with interval 2 weeks using insulin and 10 cc saline versus hyalase and 10 cc saline versus 10 cc saline, ultrasounic guided as an effective treatment of ct

Eligibility criteria:
inclusion criteria: * rheumatoid arthritis in remission exclusion criteria: * active rheumatoid arthritis
seroquel xr in adults with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the efficacy of seroquel xr in schizophrenia patients with acute worsening symptoms. consequently, to assess whether the study drug is safe and acceptable on the daily dose basis, orally given, up to 600 mg once a day for 42 days.


Eligibility criteria:
inclusion criteria: * patient meets the dsm-iv criteria for schizophrenia * patient has a panss total score ≥ 70 at baseline * patient has a cgi-s score of ≥ 4(moderately ill) at baseline * patient is healthy on the basis of physical examination and vital signs at baseline exclusion criteria: * positive urine drug screen for opiates, amphetamine, barbiturate, cocaine, cannabis, or ecstasy abuse * has history of neuroleptic malignant syndrome, seropositive for anti-hiv, hepatitis b or c virus antigen * patient with unstable or inadequately treated diabetes mellitus * use of potent cytochrome p450 inhibitors or inducer within 14 days before baseline

Keywords: quetiapine efficacy in schizophrenia