Kornimate/medical-research-clean huggingface dataset:
effects of erector spinae plane block on postoperative pain following lumbar fusion surgery

Conditions: Fusion of Spine, Lumbar Region; Anesthesia, Local; Pain, Postoperative; Opioid Use

Summary: the purpose of this study is to determine if the method for injecting local anesthesia affects patients' pain and opioid usage after surgery. the investigators will compare subcutaneous anesthesia, injections of anesthesia under the skin, to a method called erector spinae plane block (espb). an espb injection involves placing local anesthesia along the muscles and bones in the back, using a special type of x-ray called fluoroscopy for guidance. the investigators will use patient reported outcomes (pros) and track subjects' opioid usage to find out if there is a difference between espb and subcutaneous anesthesia. the investigators hypothesize that patients who get espb injections will use less opioids and report less pain after lumbar fusion surgery compared to patients who receive subcutaneous anesthesia injections.


Eligibility criteria:
inclusion criteria: * the individual has signed and dated a study specific informed consent form approved by the institutional review board at ummhc. * the individual is at least 18 years of age. * the individual is skeletally mature (over the age of 18). * the patient is scheduled for a one or two level lumbar spinal fusion. exclusion criteria: * patients unable to consent for themselves. * pregnant women. * non-english speaking subjects. * prisoners. * spinal fusion procedures for a diagnosis of fracture, tumor, and/or infection. * patients who have used greater than 150 morphine milligram equivalents of opioids in the month prior to their operation. * patients with a body mass index (bmi) of 40 or greater.

Keywords: erector spinae plane block spinal fusion patient reported outcomes opioid usage
randomized phase 2 study with gemcitabine alone and combination therapy for patients with advanced biliary tract cancer

Conditions: Biliary Tract Cancer

Summary: to investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of biliary tract cancer * measurable disease must be at least one lesion * chemotherapy-naïve * eastern cooperative oncology group (ecog) performance status 0 or 1 * estimated life expectancy no less than 3 months exclusion criteria: * radiological or clinical evidence of pulmonary fibrosis or interstitial pneumonia
a clinical trial to investigate 18f-azafol in the diagnosis of large vessel vasculitis

Conditions: Giant Cell Arteritis

Summary: the goal of this open-label clinical trial is to evaluate the efficacy of azafol-pet/ct in the diagnosis of gca (giant cell arteritis), to compare azafol- with 2-\[18f\]fdg-pet/ct, and to assess the safety and tolerability of azafol in subjects with suspicion of gca. participants will undergo azafol-pet/ct imaging at a single timepoint.

giant cell arteritis (gca) is the most common systemic vasculitis in the elderly population. 2-\[18f\]fluor-2-desoxy-d-glucose (2-\[18f\]fdg) positron emission tomography (pet)/ computed tomography (ct) is performed to diagnose gca (standard of care, soc) but unable to reliably distinguish atherosclerosis from vasculitis. activated macrophages express folate receptor (fr)-β and are enriched in inflamed vascular tissue in gca. 3'-aza-2'-\[18f\]fluoro-folic acid (azafol) is a nuclear tracer targeting frβ. the investigators hypothesize that azafol is a specific and reliable tracer to visualize activated macrophages in gca and therefore might improve the discrimination of vasculitic and atherosclerotic lesions as compared to 2-\[18f\]fdg-pet/ct.

Eligibility criteria:
inclusion criteria: * individuals ≥ 50 years with clinical suspicion of gca * women of childbearing potential must not have a positive serum pregnancy test at the screening visit * subjects must be able to understand and adhere to all protocol requirements and must voluntarily sign and date an informed consent, approved by an independent ethics committee (iec)/institutional review board (irb), prior to the initiation of any screening or study-specific procedures. * are willing and able to comply with procedures required in this protocol. exclusion criteria: 1. folate deficiency 2. female subjects who are pregnant, breastfeeding, or considering becoming pregnant during the study or within 30 days after the last dose of study drug 3. concomitant treatment with medications that lead to a significant impairment of folic acid levels (methotrexate, pemetrexed, raltitrexed) 4. concomitant glucose-containing infusion or parental nutrition within 6 hours prior to 2-\[18f\]fdg tracer application 5. glucose level \> 10 mmol/l at the timepoint of 2-\[18f\]fdg pet/ct 6. unable to remain in the pet/ct for the duration of the examination 7. unable to lie still for the duration of the examination (45 min) 8. unable not to eat or drink (except water) for 6 hours prior to 2-\[18f\]fdg tracer application 9. prior pet-imaging within 60 days before baseline 10. intake of vitamin supplements containing \> 1mg/day folic acid within 48 h prior to the pet/ct with azafol 11. known hypersensitivity or allergy to folic acid 12. enrolment of the investigator, his/her family members, employees and other dependent persons 13. participation in another study with investigational drug within the 7 days preceding and during the present study.

Keywords: tracer pet imaging
a study of the effects of eplerenone and amlodipine on blood pressure and basal metabolic rate in obese hypertensives

Conditions: Obesity; Hypertension

Summary: obesity and hypertension are independent risks for congestive heart failure (chf) and chronic kidney disease. in obesity induced hypertension, the most common cause of human essential hypertension, the potential importance of mineralocorticoid receptor blockade has not been widely investigated. we propose to test the hypothesis that eplerenone reduces metabolic demand, improves cardiac function and attenuates glomerular hyperfiltration and microalbuminuria in obese patients. our specific aims are to assess changes in basal metabolic rate, cardiac and renal function in obese hypertensive subjects treated with eplerenone compared to amlodipine.

the proposed trial will utilize an open label study design. patients with hypertension and obesity will be recruited. after a 3-week washout period for patients currently on antihypertensive medication, eligible participants will be assigned to receive 25 mg of eplerenone or 5 mg of amlodipine. after a 4 week period on medication, drug will be advanced to 50 mg of eplerenone or 10 mg of amlodipine for an additional 4 weeks. protocol synopsis: 1. recruit 20 study participants with a systolic blood pressure (sbp) between 140 and 160 mmhg and/or a diastolic blood pressure between 90 and 100 mmhg who also have a body mass index \> 30-45. if participants are on antihypertensive treatment, they will undergo a 3-week washout period. the study participants will be identified in the division of hypertension. 2. assign study participants to receive 25 mg of eplerenone or 5 mg of amlodipine per day for 4 weeks. up-titration to eplerenone 50 mg and amlodipine 10 mg for an additional 4 weeks. 3. obtain basal metabolic rate, cardiac output and other indices of cardiac performance, cognitive abilities, and rating of depression and anxiety symptoms at baseline and after 8 weeks of treatment. 4. obtain blood pressure measures at all visits. 5. obtain mood ratings at all visits. 6. compare basal metabolic rate, cardiac output and other indices of cardiac performance between treatment groups. 7. compare difference in sbp and dbp between treatment groups. 8. compare differences in plasma insulin, serum electrolytes, plasma renin activity, cortisol and aldosterone concentrations, urinary albumin excretion, and glomerular filtration rate between treatment groups. 9. compare mood rating as well as symptoms of depression and anxiety between treatment groups.

Eligibility criteria:
inclusion criteria: * systolic blood pressure (sbp) between 140 and 160 mmhg and/or a diastolic blood pressure between 90 and 100 mmhg who also have a body mass index \> 30-45. * women must be post menopausal exclusion criteria: * women of child bearing potential * bmi less than 30 or greater than 45 * a creatinine \> 1.8 for females and \> 2.0 for males * type 1 or type 2 diabetes * current evidence of alcohol or drug abuse problems
pain effect on attention using an ipad game app

Conditions: Cognitive Function

Summary: cognitive performance will be studied over time using an ipad game interface called the nine choice human game (5ch) in normal volunteer subjects before during and after experimentally induced thermal (cold or warm) pain or control (no intervention).

purpose: to assess the effects of pain on performance in a computer game interface of attention and memory and reliability of the repeated testing. rationale: the perioperative period may alter the ability to play an ipad game through changes in attention or memory as result of surgery, anesthesia, pain or medications. this study will describe and quantify and isolate any short term reduction in ability to focus and pay attention to the presence of thermal (cold or warm) pain. objectives: determine if cognitive function is altered from thermal pain (cold or warm) using simple computer/ipad games of attentional performance and cognitive function. design and outcomes: in group 1: no interventions will be used and the subjects will play the ipad game at baseline, 5 minutes later and 10 minutes later. in group 2: the subjects will play the ipad game, then 5 minutes later a thermal probe at 47 degrees c for 90 seconds on the arm or leg will be used while the game is being played. following 10 minutes of recovery, the subject will play the game again, 5 minutes later the subject will have the foot placed in 10 degree water bath or body temperature water bath while the game is played, and the game will be played 10 minutes later after the foot is warm and dry. visual analog scale (vas) pain score from 0-10 will be used to assess discomfort. the subject will be able to stop the game or withdraw at any point. the primary outcome measures will be median cue duration (mcd) in the 9ch game. secondary outcome measures will be number of correct, incorrect, omissions, time to finish trials, and time to quit for the 9ch. a total of 60 subjects will be studied, 20 subject warm probe/cold water, 20 subjects warm probe/body temperature water, and 20 normal subjects with no intervention.

Eligibility criteria:
inclusion criteria: * healthy male and non-pregnant female volunteers between the ages of 18-55. exclusion criteria: * any reported learning disabilities, psychomotor impairment including diagnosis of add/adhd, seizures, debilitating neurologic disorders (muscular dystrophy, multiple sclerosis, etc.), genetic diseases, heart disease, stroke, or memory deficits; anything that would impair the ability to hold the ipad and perform the computer gaming tasks (i.e. blindness, color blindness, upper extremity dysfunction or pain). also any history of cold induced impaired circulation, cold agglutinins or raynaud's or insensitivity to cold.

Keywords: thermal ipad game
efficacy and safety study of bdb-001 in severe covid-19 with ali/ards

Conditions: COVID-19 Pneumonia

Summary: this multi-center, open, randomized study will evaluate the efficacy and safety of bdb-001 injection in severe covid-19 with severe pneumonia, or acute lung injury/acute respiratory distress syndrome. patients will be randomized to two treatment arms (arm a: conventional treatment + bdb-001; arm b: conventional treatment alone).


Eligibility criteria:
inclusion criteria: 1. 18 years old ≤ age ≤ 80 years old, both men or women. 2. confirmed sars-cov-2 infection, and meet at least one of the following criteria: confirmed severe covid-19 in no more than 5 days who meets any of the following criteria: 1. respiratory distress, rr ≥ 30 times/min 2. finger oxygen saturation (spo2) ≤93% in resting state(room air) 3. arterial partial pressure of oxygen to fraction of inspired oxygen (pao2/fio2) ≤ 300 mmhg (1 mmhg = 0.133kpa) in supine position 4. pulmonary imaging shows lesion progression \> 50% within 24-48 hours. symptoms,signs or chest imaging indicates ali/ards; 3. requiring a mask oxygen therapy,high-flow nasal cannula oxygen therapy(hfnc). 4. the informed consent form signed. exclusion criteria: subject who meets any of the following criteria will be excluded from the trial: 1. subjects already progressed into critically severe covid-19 critical severe standards refer to fda guidelines,as shown in appendix 4 or sepsis and sepsis shock. 2. concomitant with the following situation:severe lung disease such as chronic obstructive pulmonary disease (moderate to severe type), lung cancers, active tuberculosis; severe cardiovascular and cerebrovascular disease: unstable angina pectoris, myocardial infarction, postcardiac surgery, cardiac function ≥ grade 3 (nyha classification), or had undergone heart surgery within 6 months before randomization; severe liver diseases (e.g. child-pugh score ≥ grade c); severe kidney diseases, such as renal insufficiency (gfr ≤ 15 ml/min/1.73m\^2); immune deficiencies or immune-related diseases : including organ or bone marrow transplantation, some autoimmune diseases, igg4-related diseases, allergic alveolitis, vasculitis; malignancies. 3. subjects on current treatment with a complement inhibitor such as eculizumab within 1 month before randomization. 4. subjects with hypersensitivity history to any ingredient contained in the drug. 5. a subject has used the following drugs within 2 weeks prior to screening procedures: * calcineurin inhibitors (e.g., ciclosporin, tacrolimus, etc.) * proliferation inhibitors (e.g., everolimus, sirolimus, etc.) * anti-metabolic drugs (e.g., mycophenolate mofetil, mycophenolate, purine sulphate, etc.) * recombinant human granulocyte macrophage colony stimulating factor (rhgm-csf)/recombinant human granulocyte colony stimulating factor (rhg-csf) 6. pregnant or lactating woman. 7. subjects who have participated in other interventional clinical trials in the last 3 months or during this trial. 8. any other circumstances that the investigator considers inappropriate for the participation in this study.

Keywords: covid-19 severe pneumonia ali/ards
the effect of anacetrapib on vascular function and arterial stiffness

Conditions: Atherosclerotic Cardiovascular Disease; Vascular Disease

Summary: there are currently no studies evaluating the effect of anacetrapib on blood vessel function and stiffness of the arteries. the reveal-vasc trial will assess whether anacetrapib, in addition to atorvastatin (ldl-c lowering drug) treatment, results in greater endothelial-dependent vascular function and aortic stiffness in patients with established cardiovascular disease, compared to adding placebo. participants will be asked to provide a blood sample and pulse wave velocity/pulse wave analysis and flow mediated dilation will be carried out to assess blood vessel function and stiffness of the arteries. reveal-vasc is an investigator led sub-study of hps3/timi 55: reveal (randomized evaluation of the effects of anacetrapib through lipid modification): a large-scale, randomized placebo-controlled trial of the clinical effects of anacetrapib among people with established vascular disease (nct01252953) which is coordinated by oxford ctsu. no treatment will be received on this sub-study, therefore only participants who have been enrolled in hps3/timi55 reveal in which participants received anacetrapib with atorvastatin or placebo will be considered for this trial.

reveal-vasc is an investigator led sub-study of hps3/timi 55: reveal. participants who previously enrolled on hps3/timi 55: reveal and received treatment will be invited to participate in this sub-study. participants will attend a screening and an assessment visit during which pulse wave velocity/ pulse wave analysis and flow mediated dilation will be carried out to assess blood vessel function and stiffness. a blood sample will also be taken from participant to assess crp and lipid profile. since participants will have received treatment on the main trial hps3/timi 55: reveal, no treatment will be received on this sub-study.

Eligibility criteria:
inclusion criteria: * participants who have been randomised into the hps3/timi 55- reveal study (nct01252953) exclusion criteria: * any concomitant condition that, at the discretion of the investigator, may affect the participant's ability to complete the study or study procedures * atrial fibrillation at time of assessment * inability to provide informed consent * inability to refrain from caffeine containing products for 6 hours prior to study visit * inability to refrain from smoking for 2 hours prior to study visit

Keywords: vascular diseases lipids cholesteryl ester transfer protein (cetp) inhibition anacetrapib cardiovascular disease cholesterol
efficacy of ac-170 for the treatment of allergic conjunctivitis in the conjunctival allergen challenge (cac) model

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to evaluate the efficacy of different concentrations of ac-170 compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (cac) model.


Eligibility criteria:
inclusion criteria: * positive bilateral conjunctival allergen challenge (cac) reaction exclusion criteria: * known contraindications or sensitivities to the study medication or its components. * any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters. * use of disallowed medications during the period indicated prior to the study enrollment or during the study.
immunomodulatory effect of vitamin d in allogenic post-transplant

Conditions: Hematopoietic Stem Cell Transplantation

Summary: the purpose of this study is to determine whether vitamin d is effective in the prevention of graft-versus-host-disease after completion of allogeneic transplant.

the allogeneic transplant of haematopoietic cell is the only treatment option for many malignant blood diseases. unfortunately, the progression free survival and the quality of life of transplanted patients is limited due to the development of graft-versus-host-disease (gvhd). the development of new prophylaxis strategies of gvhd based in the use of immunomodulator agents (allowing the generation of an immunotolerance state and avoiding the use of immunosuppression) is essential. the gvhd is due to the cytotoxic effect of the donor lymphocytes t against healthy organs and tissues of the receptor. calcineurin inhibitor combined with methotrexate or antibodies anti-lymphocytes t are used as standard prophylaxis. this type of antibodies has demonstrated efficacy to reduce gvhd, but have not increased survival due to increasing the risk of relapses and serious post-transplant infections. due to its interactions with vdr (vitamin d receptor) present in immune system cells, vitamin d is able to inhibit the activation of dendritic cells and the proliferation and production of cytokines by lymphocytes t. based on this effect, the peri- and post- transplant administration of vitamin d might decrease the risk of gvhd in allogeneic transplanted patients, subsequently decreasing the immunosuppressant treatment requirements and improving the prognosis of those patients.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * the patient should accomplish all the criteria to proceed to an allogeneic transplant * the patient or their legal guardians should signed the informed consent approved by the ethics committees of clinical trials exclusion criteria: * hypercalcemia ≥ 10.5 mg/dl * renal insufficiency with creatinine level ≥ 2 x upper limit of normal (1,1 mg/dl) * participation in others clinical trials in which the intervention may affect the result of the study. * patients receiving gvhd immunoprophylaxis with thymoglobuline or gvhd prophylaxis including in vitro or in vivo lymphocytes t depletion (anti-lymphocyte t globulin, alg) * patients receiving a transplant from an haploidentical donor

Keywords: graft-versus-host-disease post-allogeneic transplant haematopoietic progenitors
periodontal phenotype and laterally positioned flap in isolated gingival recession

Conditions: Gingival Recession

Summary: the aim of this study is to estimate the effect of periodontal phenotype on the outcome of isolated gingival recession by laterally positioned flap.the primary objective of study is to assess the changes in gingival margin in the donor tooth after laterally positioned flap over a period of 6 months and to assess the influence of periodontal phenotype on the stability of results of root coverage achieved through laterally positioned flap. the secondary objective of this study is to evaluate root coverage by laterally positioned flap in thick periodontal phenotype and to evaluate root coverage by laterally positioned flap in thin periodontal phenotype.

a variety of surgical techniques have been proposed to achieve successful and predictable root coverage. these include coronally advanced flap, lateral positioned flap (lpf) free gingival graft, free connective tissue graft, and guided tissue regeneration. lpf, originally described by grupe and warren in 1964 is one of the most commonly performed root coverage technique.the procedure has undergone various modification over the years .staffileno and pfeifer and heller advocated the use of split-thickness flap to minimize the potential risk for the development of recession in the donor tooth.wood et al used re-entry procedures to compare crestal radicular bone responses to full and partial thickness flaps. they concluded that regardless of the flap procedure, loss of crestal bone depended on the periodontal phenotype.the term periodontal phenotype refers to phenotypic characteristic of bone and soft tissue that make up the periodontium. periodontal phenotype is typically used to describe the buccolingual tissue thickness and gingival morphology. it is divided into thick flat and thin scalloped type. however there is a paucity of studies in the literature studying the effect periodontal phenotype on the root coverage obtained and its stability over time after lpf. furthermore the impact of periodontal phenotype on the donor area in this procedure has not been explored. therefore the present study is designed with the aim to evaluate the influence of periodontal phenotype on the outcome of root coverage by lpf.

Eligibility criteria:
inclusion criteria * isolated miller's class i, class ii, and class iii gingival recession in the anterior region * gingival recession depth should be ≥2mm. * width of keratinized gingiva ≥3 mm on the immediately adjacent tooth exclusion criteria * patients with a history of systemic condition that might alter the course of disease and /or wound healing such as diabetes mellitus, immunologic disorders. * pregnant and lactating women . * non vital tooth * smokers * caries, cervical abrasion or restoration on the labial aspect of tooth with gingival recession. * periodontal surgical treatment during previous 24 months on the involved sites. * miller's class iv. all potential participants would be explained the need and design of study .only those subjects who consented for the study will be included after obtaining an informed consent.