Kornimate/medical-research-clean huggingface dataset:
study of abt-888 in combination with bortezomib and dexamethasone in patients with relapsed refractory myeloma

Conditions: Multiple Myeloma

Summary: the combination of parp inhibitor (abt-888) with a proteasome inhibitors (bortezomib) have demonstrated significant anti-myeloma effects in preclinical lab and animal studies. the goal of this phase i trial is to evaluate in patients with relapsed or refractory multiple myeloma the safety, toxicity profile and tolerability of abt-888 (veliparib) administered on a schedule including twice daily oral dosing for 14 days followed by 1 week rest in combination with standard dosing of bortezomib.

this is a dose-finding / dose escalation phase i trial of abt-888 (veliparib) in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. abt-888 is given orally (po) twice daily (every 12 hours) for 14 days in a 21 days cycle. first dose to be given within 1 hour of bortezomib on day 1. planned starting dose is 20 mg po every 12 hours. starting dose escalation is planned until an mtd is reached.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of multiple myeloma. * measurable disease, according to the international myeloma working group criteria. * ecog performance status 0, 1 or 2. * patients must have received prior treatment for mm and have relapsed or progressed on prior therapy; no limit on number of prior treatment regimens, but prior treatment must be completed 2 weeks prior to registration. prior exposure to bortezomib is not an exclusion criteria as long as patients did not progress or relapse while receiving or within 3 months of completing trt with bortezomib * prior radiation, completed at least 4 weeks prior to registration, is permitted. * adequate marrow reserve, liver and renal function exclusion criteria: * patients with a history of other malignancies, except: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, prostate cancer with stable psa for \> 3 years, or other solid tumours curatively treated with no evidence of disease for \> 5 years. * patients with preexisting grade 2 (or higher) sensory neuropathy or grade 1 sensory neuropathy with neuropathic pain. * pregnant or lactating women * patients receiving concurrent treatment with other anti-cancer therapy any other investigational agents. * active or uncontrolled infections * patient with known documented congenital or acquired risk factor for thromboembolic event * patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive
association of cytokines with the development of complications in burn and toxic epidermal necrolysis (tens) patients

Conditions: Inflammatory Response; Multi Organ Failure; Nosocomial Infection; Deep Vein Thrombosis

Summary: this study will involve blood draws to test for specific cytokines. the study goal is to gain a better understanding of the role of inflammatory response in the development of specific complications in burn and tens patients.


Eligibility criteria:
inclusion criteria: * is ≥18 years of age * has been admitted to the joseph m. still burn center at doctors hospital augusta with a burn diagnosis, or tens or sjs diagnosis (confirmed or non-confirmed), with an expected length of stay to be at least 7 days * the subject or their legally authorized representative is able to provide informed consent * has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) exclusion criteria: * is moribund, or in the opinion of the investigator is not expected to survive * has sustained an electrical burn
cardiac and renal biomarkers in arthroplasty surgery

Conditions: Renal Injury; Anesthesia; Myocardial Injury; Arthropathy of Knee; Arthropathy of Hip

Summary: the investigators will compare the effect of spinal anesthesia to general anesthesia on the level of high sensitivity cardiac biomarkers in patients undergoing hip or knee arthroplasty. the investigators will also measure renal biomarkers in urine to evaluate kidney injury in the postoperative period.

the study will enroll a total of 140 adult patients undergoing hip or knee arthroplasty (equal numbers) at barnes-jewish-hospital. these procedures will be randomized with 50% of the procedures performed under spinal anesthesia and 50% procedures performed under general anesthesia. patients randomized to spinal anesthesia will receive sedation with dexmedetomidine up to 1 mcg/kg/min, and then add small dose of propofol (up to 50 mcg/kg/min) and fentanyl at the discretion of the anesthesia provider the richmond agitation and sedation scale (rass) -2 to -3. headphones to play music will be offered to patients undergoing spinal anesthesia to minimize the noise generated from the surgical intervention. the investigators will study the effect of spinal anesthesia versus general anesthesia on cardiac biomarker levels in hip and knee arthroplasty population (levels of hs-ctni postoperatively compared to baseline values) also, the incidence of postoperative renal injury using investigational renal biomarkers, myo-inositol oxygenase (miox) and nephrocheck

Eligibility criteria:
inclusion criteria: * adult patients, age 60 years or older * ability to provide informed consent * american society of anesthesiologists (asa) classification ii or higher exclusion criteria: * hip fracture procedures * contraindications to neuraxial anesthesia per the american society of regional anesthesia (asra) guidelines * procedure anticipated duration is longer than expected planned spinal anesthesia duration
stroke ready: a stroke preparedness brief intervention

Conditions: Stroke

Summary: this is a randomized controlled behavioral intervention trial to assess the efficacy of a brief intervention to increase stroke preparedness.

this is a randomized controlled behavioral intervention trial to assess the efficacy of a brief intervention to increase stroke preparedness. subjects will be randomized to a brief face-to-face stroke preparedness intervention compared to a healthy lifestyle stroke risk reduction intervention. the primary outcome is behavioral intent to call 911 using a self-administered survey

Eligibility criteria:
inclusion criteria: * over 18 years of age exclusion criteria: * none

Keywords: stroke preparedness behavioral intervention
comparative study on the efficacy and safety of microwave ablation and lobectomy in the treatment of ground glass nodules located in the pulmonary hilar region

Conditions: Pulmonary Nodule, Multiple; Pulmonary Nodule, Solitary

Summary: ggo is a characteristic focus of early lung cancer. due to the abundant peripheral blood vessels and bronchial tissues around the ggo lesions located in pulmonary hilar, only lobectomy could be used for the surgical treat of hilar ggo lesions which will make the significantly decline of the pulmonary function after surgery and affect the quality of life to a great extent. our previous study has reported a new blunt-tip mwa electrode (mtc-3ca-ii3, vison medical inc.) for the treatment of ggo lesions. the blunt-tip mwa electrode could improve the safety of ggo ablation, significantly reduce the occurrence of bleeding and hemoptysis, which made it possible to ablate ggo in the hilar region safely. in this study, the blunt-tip mwa electrode was used in the treatment of patients with hilar ggo lesions, and the efficacy and safety of microwave ablation and lobectomy in the treatment of ground glass nodules located in the pulmonary hilar region were evaluated and compared.


Eligibility criteria:
inclusion criteria: 1. the age ranged from 18 to 75 years old, male or female; 2. ggo lesions in the hilar region were diagnosed by imaging examination (ct / pet-ct). during the follow-up of 6-12 months, the lesions increased by more than 2mm, the solid components increased, or there were obvious solid components, or the ggos were judged to be highly malignant by imaging. 3. the size of ggo lesions was 8mm-3cm, and the number of nodules was ≤ 3. 4. there was no lymph node metastasis, intrapulmonary metastasis or distant organ metastasis; 5. after multidisciplinary evaluation, the patients were feasible for lobectomy and ct guided microwave treatment; 6. no bleeding tendency, normal coagulation function or coagulation dysfunction can be corrected after treatment; 7. patients and /or family members agreed to join the clinical trial and signed informed consent. exclusion criteria: 1. the general condition of the patient is very poor, ecog physical fitness score \> 2, unable to tolerate lobectomy and mwa treatment, or has relevant contraindications; 2. the lesions had received other treatments before; patients with regional lymph node metastasis or distant metastasis or with pleural fluid and ascites; 3. patients with poor compliance; 4. severe heart, lung, kidney, brain and other important organ diseases; 5. the researcher believes that it is not suitable for inclusion
diagnostic and therapeutic applications of microarrays in liver transplantation

Conditions: Liver Dysfunction

Summary: interliver is a prospective observational study of the relationship of the molecular phenotype of 300 liver transplant biopsies to the histologic phenotype and the clinical features and outcomes. a segment of a biopsy performed as standard-of-care for indications, or by center protocol, will be used for gene expression study.

the current standard for biopsy-based diagnoses of dysfunction of liver transplants is histology (the banff system), an arbitrary international empirical consensus based on lesions and rules, similar in principle to the kidney, heart, and lung histology systems. recent data-driven approaches using molecular and conventional technologies indicate that such systems frequently produce incorrect diagnoses - perhaps 40-50% in abnormal kidney or heart transplant biopsies and even more in lung biopsies, with great potential for harm to patients due to inappropriate treatment. to address this unmet need and improve diagnostics in the area of organ transplantation, the alberta transplant applied genomics centre (atagc, university of alberta) has developed a new diagnostic system - the molecular microscope® diagnostic system (mmdx) that interprets biopsies in terms of their molecular phenotype, and combines the molecular and histopathological features of transplant biopsies, plus clinical and laboratory parameters, to create the first integrated diagnostic system. the mmdx, developed first in kidney transplant biopsies because phenotypes are well established, will now be adapted to liver transplant biopsies. the present study will develop a reference set of liver biopsies, adapt the mmdx system to assess and report molecular phenotype of liver biopsies; and validate and refine this system in 300 unselected prospectively collected for clinical indications and a standard of care biopsies from north american and european centers. in addition to demonstrating the real-time feasibility and potential value of this system in patient care, the study will develop and optimize a transparent and user-friendly reporting format to communicate this information to clinicians and obtain detailed feedback to improve its utility. thanks to increasing interest and support from participating centers, interliver has already received 861 biopsies from 739 participants and will extend the reference set to 900 biopsies.

Eligibility criteria:
inclusion criteria: * biopsy for clinical indications exclusion criteria: * no consent, pregnant women

Keywords: liver transplant global gene expression molecular diagnostics
evaluation of the efficacy of low-frequency repetitive transcranial magnetic stimulation on unilateral neglect in patients with subacute-chronic phase after ischemic stroke

Conditions: Neglect, Hemispatial

Summary: the aim of this study was to randomize stroke patients with unilateral neglect into 2 groups, active and sham groups, and to examine the effects of active inhibitory repetitive transcranial magnetic stimulation on the reduction of neglect symptoms, functional recovery and independence of these patients in activities of daily living.

patients diagnosed with ischemic stroke at least 1 month ago, with unilateral neglect, receiving inpatient rehabilitation at stroke clinics, and meeting the study criteria for both genders between the ages of 18-80, will be divided into two groups. a total of 22 stroke patients, informed about the applied treatments and potential risks, and providing written consent, will be randomly assigned to receive either active repetitive transcranial magnetic stimulation (rtms) combined with conventional rehabilitation (mirror therapy and visual scanning training) or sham (imitation) repetitive transcranial magnetic stimulation (rtms) combined with conventional rehabilitation. the study will include 22 randomly selected patients with neglect, with 11 planned in the intervention group and 11 in the control group. patients will receive active rtms or sham rtms for a total of 10 sessions, each lasting 20 minutes, alongside conventional rehabilitation over a period of 2 weeks. rtms applications will be conducted once daily before the daily rehabilitation program.

Eligibility criteria:
inclusion criteria: * first-time ischemic stroke * patients at least 1 month after the stroke * to be aged between 18 and 80 years old * presence of unilateral neglect * no significant cognitive impairment (mmse \> 24 points) * signing an informed consent form indicating willingness to participate in the study exclusion criteria: * epilepsy, history of seizure * metallic implant in the area of stimulation (cochlear implant, brain pacemaker, drug pump etc.) * presence of cardiac pacemaker * severe general condition disorder or accompanying neurological disease * aphasi * pregnancy * under 18 years of age and over 80 years of age * visual impairment

Keywords: i̇skemic stroke transcranial magnetic stimulation unilateral neglect
effect of childhood radioiodine therapy on salivary function

Conditions: Xerostomia; Hyperthyroidism; Thyroid Cancer

Summary: radioiodine (i-131) therapy for thyroid disease is known to decrease salivary function in adult patients. the impact of pediatric i-131 exposure on salivary function is unknown. the investigators goals are to answer this question by measuring salivary gland function before and after i-131 administration in children who receive radioiodine therapy at our hospital for thyroid disease.

radioiodine (i-131) therapy for thyroid disease is known to decrease salivary function in adult patients. the impact of pediatric i-131 exposure on salivary function is unknown. the investigators goals are to answer this question by measuring salivary gland function before and after i-131 administration in children who receive radioiodine therapy at our hospital for thyroid disease. we will use a modified shirmer test to measure saliva production and a questionnaire to evaluation symptoms of xerostomia.

Eligibility criteria:
inclusion criteria: * patients who have been treated with radioiodine therapy * patients who have never received radioiodine therapy (negative control group) exclusion criteria: * non-english speaking subjects will be excluded due to our lack of translation support resources at this time. of note, participation in our study cannot benefit participants in any way.
intrathecal morphine and local infiltration analgesia in total knee arthroplasty

Conditions: Pain, Postoperative

Summary: double-blinded randomized control study investigating intrathecal morphine as an additive to spinal anesthesia in patients undergoing elective total knee arthroplasty. the investigators aim to include a total of 120 patients, randomized to two equal groups. participants in the intervention group are administered intrathecal 0,2mg morphine and 12,5mg bupivacaine for spinal anaesthesia. participants in the placebo group are administered 12.5mg bupivacaine and saline to match the volume of intervention goup. primary end points are opioid consumption and possible adverse effects.


Eligibility criteria:
inclusion criteria: * elective primary total knee arthroplasty * asa i-iii * written consent exclusion criteria: * rearthroplasty * asa iv-v * inadequate spoken finnish for reliable pain assessment * dementia or otherwise impaired cognition * contraindication for any medication or substance used in survey protocol * weight \<50kg or bmi ≥35 kg/m2 * preoperative spo2 less than 93% * clinical suspicion that subject can not use pca adequately * history of substance abuse or current excessive use of alcohol * preoperative use of either pregabalin, gabapentin or strong opiates
dual task in female patients with fibromyalgia

Conditions: Fibromyalgia; Dual Task; Physical Function; Psychosocial Problem

Summary: the aim of our study is to examine the relationship between dual task and physical and psychosocial factors in female patients with fibromyalgia. we will perform dual task test, 6 min walking test, the baecke habitual physical activity questionnaire, multidimensional fatigue inventory-20, tracking test, general self-efficacy scale the toronto alexithymia scale, the revised fm impact questionnaire, the social support scale.

dual-tasking is a procedure that requires an individual to perform two tasks simultaneously to compare performance with single-task conditions, and the characteristics associated with dual-task performance in patients with fibromyalgia are unclear. therefore, in our study, we focused on examining the relationship between dual task and physical and psychosocial factors. patients with a diagnosis of fibromyalgia will be included in our study. dual-task assessment of women with fm is with the "dual task test", aerobic capacity with the "6 min walking test", physical activity level with the "baecke habitual physical activity questionnaire", fatigue levels with the "multidimensional fatigue inventory-20", cognitive levels with the "tracking test", self-efficacy levels with the "general self-efficacy scale", alexithymia levels with the "toronto alexithymia scale", quality of life with the "revised fm impact questionnaire", motivation levels with the "social support scale" will be evaluated .

Eligibility criteria:
inclusion criteria: * women aged 30-75 years * patients diagnosed with fibromyalgia by a rheumatologist according to criteria set by the american college of rheumatology * patients who can communicate effectively with study staff. * patients who have read, understood and signed the informed consent form exclusion criteria: * those who are pregnant * participants who could not sit and stand in a chair even once, or climb stairs unaided * other rheumatic diseases and other severe somatic or psychiatric disorders such as cancer, severe coronary disease, or other serious somatic or psychiatric disorders such as schizophrenia

Keywords: fibromyalgia dual task physical function psychosocial problem
evaluation of 4-factor pcc in doac-associated intracranial hemorrhage

Conditions: Intracranial Hemorrhage

Summary: intracranial hemorrhage (ich) can occur due to traumatic and spontaneous events.1 the incidence of non-traumatic, spontaneous ich is approximately 40,000 to 67,000 cases per year while the incidence of traumatic brain injury (tbi) is nearly 1.7 million annually

the authors found that ac use preinjury was associated with ich progression, immediate neurosurgery intervention, and death after initial scan. ac use has also been associated with worse functional outcomes, and patients are less likely to be discharged home compared to those without ac use prior to injury.6 with increasing prevalence of ac, hospitals are seeing admissions for ich, making knowledge of optimal ac reversal essential.

Eligibility criteria:
inclusion criteria: * • ≥18 years of age * ich (traumatic and spontaneous) * administration of at least one dose of 4f-pcc * admitted to the mhs between july 1, 2018 and may 30, 2023 * rivaroxaban or apixaban use prior to admission exclusion criteria: * • warfarin or dabigatran use prior to admission * prisoners * pregnancy * \<18 years of age
immune homeostasis in sepsis and septic shock

Conditions: Sepsis; Immunologic Paralysis; Immunologic Suppression; Immune Deficiency

Summary: detailed description of immune response and its dynamics in sepsis and septic shock patiens by means of transcriptomics, flow-cytometry and cytokine analysis.


Eligibility criteria:
inclusion criteria: * sepsis/septic shock (sepsis-3) * age ≥18 * informed consent * inclusion within first 24hrs after development/diagnosis of septic shock exclusion criteria: * disagreement of the patient or legal representative with the entry into the study * patients with primary or secondary immunodeficiency * presence of active haematological malignancy or an active non-haematological malignancy

Keywords: sepsis septic shock immune response immunoparalysis transcriptomics flow-cytometry immunomodulation
effect of gastric bypass on the absorption of metformin

Conditions: Obesity; Gastric Bypass

Summary: background: gastric bypass is the most commonly performed type of bariatric (obesity) surgery, has dramatically increased in popularity and is now considered to be preferred treatments in severely obese patients that fail non-surgical therapy - particularly in patients with type 2 diabetes. drug malabsorption is a potential concern post-gastric bypass because intestinal length is reduced. purpose: the purpose of this controlled, pharmacokinetic study is to determine whether the absorption of a single dose of metformin, the first line drug treatment in patients with type 2 diabetes, is significantly reduced after gastric bypass. methods: a single dose of standard release metformin 1000 mg will be administered to patients who have undergone gastric bypass and to patients who have not received surgery but are on the wait list (wait-listed controls). blood sampling and urine sampling will occur in standardized fashion over the ensuing 24 hours to measure and compare the absorption of metformin between study arms. 34 patients total will be recruited. significance: following completion of this study, we will better understand how gastric bypass affects metformin absorption. ultimately, this information will help to ensure that this patient population is receiving optimal doses of this important drug treatment.


Eligibility criteria:
inclusion criteria: patients living within and around edmonton that have been referred to the alberta health services weight wise program exclusion criteria: 1. undergone or undergoing revision of a previous bariatric procedure 2. any major post-operative gastrointestinal complications, such as an anastomotic leak, outlet obstruction or persistent vomiting 3. currently on metformin therapy 4. any contraindications to metformin therapy such as: 1. allergy to the drug 2. chronic metabolic acidosis 3. history of lactic acidosis 4. liver failure or baseline liver enzymes higher than 3-fold above the upper limit of normal 5. congestive heart failure 6. renal failure (glomerular filtration rate \< 60 ml/min) 7. alcoholism 8. acute illness 9. fatty liver disease 5. pregnant or nursing 6. not taking furosemide or nifedipine (both drugs may increase metformin absorption by 15-20%)the day of visit 2. 7. any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the study protocol

Keywords: obesity gastric bypass metformin pharmacokinetics absorption