Kornimate/medical-research-clean huggingface dataset:
performance of non-invasive monitors during anh

Conditions: Baseline; Hemodilution

Summary: the aim of this study is to assess the responsiveness of the standard minimally invasive hemodynamic monitors used in the operating room to known changes in the intravascular volume status that occur during blood removal and volume replacement with three different standard fluids used during anh.


Eligibility criteria:
inclusion criteria: * those surgical procedures where anh is included in the surgical plan and consent is obtained exclusion criteria: * severe or symptomatic copd, emphysema, renal, hepatic or coronary artery disease as defined by the american college of cardiology (cannon et al., 2001). * esophageal pathology (diverticulum, hiatal hernia, esophageal cancer, esophageal surgery), which introduces risks associated with the placement of the esophageal doppler. * ascites. * bmi \>35 * pregnancy
brazilian cardioprotective diet and nuts in post-acute myocardial infarction

Conditions: Coronary Artery Disease; Myocardial Infarction

Summary: coronary artery disease (cad) is the leading cause of death worldwide. dietary patterns and functional foods may play an important role in the management of cardiovascular risk factors such as overweight and dyslipidemia, as well as inflammation and oxidative stress. however, little is known regarding the effect of diets or specific nutrients on these parameters in individuals with acute myocardial infarction (ami). the brazilian cardioprotective diet (dicabr) is based on brazilian nutritional guidelines and also in a unique and ludic nutritional strategy. in a pilot study, this diet was effective in reducing blood pressure (intragroup comparison) and body weight (intergroup comparison) in individuals with established cardiovascular disease (cvd). however, the effectiveness of this dietary pattern supplemented with different kind of nuts is unknown. the aim of this study is to evaluate the effect of the dicabr supplemented or not with 30g/day of different nuts on cardiometabolic parameters in patients with recent ami. in this parallel randomized controlled trial, 388 patients ≥40 years with a recent diagnosis of ami (60 to 180 days) will be allocated to one of two study groups: 1) dicabr group (dcb, control group); or 2) dicabr group supplemented with mixed nuts (dcbn, intervention group). all patients will receive the same dietary prescription, the dcbn group also will receive 30g/day of nuts (10g of peanuts, 10g of cashew nuts and 10g of brazilian nuts). a pilot study including 100 individuals who will receive only peanuts (30g/day) will be conducted. the primary outcome will be ldl-cholesterol (ldl-c) levels after 16 weeks. in the baseline and at the end of the study (16 weeks), lipid and glycemic profile and anthropometric indexes will be evaluated in both groups; inflammatory and oxidative stress markers, and adipokines will be evaluated in a subsample. it is expected that dicabr supplemented with nuts will be superior to dicabr alone to benefit patients with ami regarding cardiometabolic parameters.


Eligibility criteria:
inclusion criteria: patients ≥ 40 years with previous ami (60 to 180 days). exclusion criteria: * clinical indication of myocardial revascularization surgery (graf /bypass); * hiv positive in treatment/aids; * chronic inflammatory diseases; * cancer; * chemical dependency/alcoholism; * chronic use of anti-inflammatories, anticonvulsants and immunosuppressive drugs; * pregnancy or lactation; * wheelchair users without conditions of anthropometric evaluation; * extreme obesity (bmi ≥40kg / m²); * use of dietary supplements; * rejection/allergy to oilseed consumption; * participation in other randomized studies at the time of enrollment.
tear fluid levels of loteprednol etabonate ophthalmic gel 0.5% following a single instillation

Conditions: Pharmacokinetics

Summary: to assess the levels of loteprednol etabonate (le) in tear fluid following a single topical instillation of le ophthalmic gel 0.5% formulation to healthy volunteers.


Eligibility criteria:
inclusion criteria: * subjects must be healthy volunteers with physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. * subjects must have a best-corrected visual acuity of 20/20 or better in each eye. * subjects must have no active ocular disease or allergic conjunctivitis. * subjects must have a schirmer test (without anesthesia) of ≥ 10mm in 5 minutes. * subjects must not be using any topical ocular medications or systemic medication other than acetaminophen. * male subjects or female subjects who are not of childbearing potential. female subjects are considered to not be of childbearing potential if they are postmenopausal for at least 12 months or permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) exclusion criteria: * subjects having an intraocular pressure less than 5 mmhg or greater than 22 mmhg or any type of glaucoma. * subjects with a history of ocular trauma, infection, or inflammation within the last 3 months. * subjects having any contraindication to the use of, or known sensitivity or allergy to, the study drug(s) or their components. * subjects wearing contact lenses on the day of visit 2 and/or visit 3 of the study * subjects having, at the investigator's discretion, the presence of any significant illness that could be expected to interfere with the study.
long-term safety and tolerability of nov03 (perfluorohexyloctane) in subjects who completed trial nvu-003 (kalahari study)

Conditions: Dry Eye Disease (DED)

Summary: the objectives of this trial are to evaluate the safety and tolerability of perfluorohexyloctane (nov03) ophthalmic solution during long-term use in subjects with dry eye disease (ded) associated with mgd (meibomian gland dysfunction). further objective is to evaluate the efficacy of perfluorohexyloctane (nov03) solution during long-term use in subjects with ded associated with mgd.

the objectives of this trial are to evaluate the safety and tolerability of perfluorohexyloctane (nov03) ophthalmic solution during long-term use in subjects with dry eye disease (ded) associated with mgd (meibomian gland dysfunction). further objective is to evaluate the efficacy of perfluorohexyloctane (nov03) solution during long-term use in subjects with ded associated with mgd.

Eligibility criteria:
inclusion criteria: * signed icf (informed consent form) * subject-reported history of drye eye disease (ded) in both eyes * ability and willingness to follow instructions, including participation in all study assessments and visits exclusion criteria: * women who are pregnant, nursing or planning pregnancy * unwillingness to submit a blood pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control * clinically significant slit-lamp findings or abnormal lid anatomy at screening * ocular/peri-ocular malignancy * history of herpetic keratitis * active ocular allergies or ocular allergies that are expected to be active during the study * ongoing ocular or systemic infection * wear contact lenses within 1 month prior to screening or anticipated use of contact lenses during the study * intra-ocular surgery or ocular laser surgery within the previous 6 months, or have planned ocular and/or lid surgeries over the study period * presence of uncontrolled systemic diseases * presence of known allergy and/or sensitivity to the study drug or saline components * use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears or topical anti-glaucoma medication within 2 months prior to screening
prv-015 in gluten-free diet non-responsive celiac disease

Conditions: Celiac Disease

Summary: this study will evaluate the efficacy and safety of prv-015 in adult patients with non-responsive celiac disease (nrcd) who are on a gluten-free diet (gfd).

prv-015-002b is a phase 2b, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 3 dose regimens of prv-015 in adult patients with nrcd who are on a gfd. eligible subjects include male or female adults, 18 to 70 years of age, with a diagnosis of celiac disease and have followed a gfd for at least 12 consecutive months, yet continue to experience symptoms. study drug (1 of the 3 doses of prv-015 or placebo) will be administered in a double-blind fashion, followed by a safety follow-up period.

Eligibility criteria:
inclusion criteria: * a diagnosis of celiac disease by intestinal biopsy * following a gfd for at least 12 consecutive months * must have detectable (above the lower limit of detection) serum celiac-related antibodies * must have human leukocyte antigen dq (hla-dq) typing consistent with celiac disease (dq2 and/or dq8) * subjects must have had at least one of the following symptoms at least once per week during the month before screening: diarrhea, loose stools, abdominal pain, abdominal cramping, bloating, or gas. * body weight between 35 and 120 kg exclusion criteria: * current diagnosis of any severe complication of celiac disease, such as refractory celiac disease type 1 (rcd-i) or rcd-ii, enteropathy-associated t-cell lymphoma (eatl), ulcerative jejunitis, or gastrointestinal (gi) perforation * diagnosis of any chronic, active gi disease other than celiac disease * presence of any active infection * selective immunoglobulin a (iga) deficiency, defined as having undetectable levels of iga * known or suspected exposure to coronavirus disease 2019 (covid-19) infection in the 4 weeks before screening * administration of a live vaccine within 14 days prior to randomization and the first administration of study drug * history or presence of any clinically significant disease that, in the opinion of the investigator, may confound the subject's participation and follow-up in the clinical trial or put the subject at unnecessary risk * females who are pregnant or planning to become pregnant during the study period, or who are currently breastfeeding
the reducing disparities in access to kidney transplantation (radiant) community study

Conditions: Kidney Disease

Summary: the southeastern kidney transplant coalition is an academic-community collaboration between partners in the kidney disease community who share the common goal of eliminating health disparities in access to kidney transplantation among african american end stage renal disease living in georgia, north carolina, and south carolina. volunteer members of this community-based coalition include patients with kidney disease, dialysis facility staff and providers, transplant centers, quality improvement organizations, and patient advocacy organizations. the burden of kidney disease is highest in the southeast, and yet the rate of kidney transplantation is the lowest in the nation. further, the investigators research suggests that racial disparities in access to kidney transplantation are concentrated in the southeast, where african americans are less likely to access each step in the transplant process. the long-term goal of the investigators coalition is to use community- based participatory research approaches to develop, test, and disseminate sustainable, community interventions improve access to transplant for african american patients with kidney disease. the reducing disparities in access to kidney transplantation (radiant) community study proposes to use community-based participatory research methods to develop a multilevel intervention to reduce racial disparities in access to kidney transplantation. the long-term impact of this application will be to reduce racial disparities in the kidney disease community.


Eligibility criteria:
inclusion criteria: * dialysis facilities within ga were considered for this intervention due to data restrictions. the remaining facilities were selected in a step-wise selection process 1) the presence of a racial disparity in referral or 2) a crude referral risk less than six percent. * the presence of a racial disparity was based on the crude referral risk difference and the standardized referral risk difference. * the remaining facilities had a calculated 6-month crude referral risk mean of 0.06 and all facilities with a crude referral risk less than the mean were selected for inclusion. * the final pool of 134 facilities were randomized to either the intervention or control group using a one to one ratio. exclusion: * facilities with a 6-month population (from june-december 2012) of less than 13 end stage renal disease patients \<70 years of age within a facility were excluded.

Keywords: dialysis facilities african americans racial disparity kidney transplantation community-based participatory research coalition georgia
a study of brief behavioral activation for the treatment of depression in older adult cancer survivors

Conditions: Survivorship

Summary: the purpose of this study is to find out if a psychotherapy method called behavioral activation (ba) can be successfully delivered by telephone or videoconference (remotely) and can effectively treat depression in older adult cancer survivors (oacs)


Eligibility criteria:
inclusion criteria: * as per self-report or medical record, ≥65 years old * as per self-report or medical record, has a history of cancer * as per medical record and/or clinician confirmation: * a patient in msk survivorship clinics and/or * no evidence of disease (ned) and/or * 6 months or more post-treatment (patients on maintenance hormonal therapies are eligible) * fluent in english, as per self-reported fluency of "well" or "very well"\* * as per self-report, able to communicate over video-conference and/or phone for sessions * elevated score on the phq-9: ≥5 (n/a for training case participants) * received a blessed orientation-memory-concentration scale (bomc) score of ≤ 11 (n/a for training case participants) exclusion criteria: * as per pi determination, requires a higher level of care for current passive or active suicidal ideation than current protocol is able to provide. if a participant receives a score of \> 0 on item 9 of the phq-9, they will be referred to study pi for further evaluation. they will be excluded from participation in this study if the pi determines they would be appropriate for a higher level of care than ba may be able to provide. * as per self-report or as documented in the medical record, current untreated (e.g., no medication, no therapy) major psychotic disorder (schizotypal personality disorder, schizophreniform disorder, schizoaffective disorder). patients diagnosed with a major psychiatric disorder will be reviewed by the study pi to determine eligibility prior to consent. * as per self-report or medical record, currently taking antidepressant medication for \< 3 month * as per medical record, patient has impaired decision-making capacity

Keywords: older adult cancer survivors history of cancer 22-248 memorial sloan kettering cancer center
micro-osteoperforations on the rate of canine retraction

Conditions: Malocclusion

Summary: the study aimed to clinically evaluate the effect of micro-osteoperforations on the rate of tooth movement, as evaluated by its effect on the rate of canine retraction.

ten adult patients requiring maxillary first premolars' extraction were enrolled in this split-mouth randomized controlled clinical trial. micro-osteoperforations were randomly assigned to one side of the maxillary arch at the canine-premolar region, and the contralateral side served as the control. mini-screws were used for anchorage reinforcement, and canine retraction was performed using nickel-titanium closed coil springs, delivering a force of 150 grams per side. the primary outcome was the measurement of canine retraction rate throughout the study period from digital dental models obtained every 3 weeks. the secondary outcome was the detection of possible canine tipping during retraction.

Eligibility criteria:
inclusion criteria: * healthy systemic condition with no chronic diseases * no previous orthodontic treatment * adequate oral hygiene * have a healthy periodontium * signed an informed consent exclusion criteria: * have a chronic disease * previous orthodontic treatment * poor oral hygiene or periodontal conidition
proteomic analysis of hla complex in solid cancers: breast, ovary, colon, rectum, stomach, and pancreas

Conditions: Colorectal Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Breast Neoplasms; Ovarian Cancer

Summary: the purpose of this study is to evaluate the presence of proteins in solid tumors which may lead to an immune response

the main objective of the study is to evaluate which proteins are presented by the hla complex of solid tumors. secondary objectives include to evaluate whether an immune response specific to these proteins has actually been provoked and whether there is a similar immune response following recurrence. real specimens will be evaluated using pcr and mass spectrometry.

Eligibility criteria:
inclusion criteria: * patients with adenocarcinoma of breast, colon, rectum, ovary , stomach, pancreas exclusion criteria: * withdrawal of consent * small specimen which does not allow to retrieve tissue without interfering with pathologic evaluation

Keywords: proteomics of solid tumors
echo-guided hemodynamic management strategy in elderly patients undergoing noncardiac surgery

Conditions: Ventricular Dysfunction, Left; Major Adverse Cardiac Events

Summary: elderly patients are the fastest growing surgical population and have an increased risk of postoperative cardiac problems. diastolic dysfunction, or the reduced ability of the heart' s ventricles to fill completely, is common in the elderly population and increases the risk of major adverse cardiac events after surgery. this study will measure diastolic filling and implement fluid and drug management during surgery to determine whether this reduces serious cardiac events related to diastolic dysfunction after surgery in this high-risk population.

elderly patients are the fastest growing surgical population and present with increased risk of postoperative cardiac problems, especially congestive heart failure. diastolic dysfunction is common in the elderly population and increases the risk of major adverse cardiac events after surgery. this project will use dynamic measurements of diastolic filling pressures by echocardiography for goal-directed fluid and drug management during surgery to determine whether this reduces serious cardiac events related to diastolic dysfunction after surgery in this high-risk population.

Eligibility criteria:
inclusion criteria: * age 70 years and older * echocardiographic evidence of grade i, ii or iii lvdd on preoperative transthoracic echocardiography (tte) examination * undergoing vascular surgery including but not limited to : lower extremity bypass,open abdominal aortic aneurysm repair exclusion criteria: * patients with expected hospital stay \< 24 hours * inability to undergo tee and transesophageal echocardiography(tte) * clinical evidence/suspicion of elevated intercranial pressure (icp) * preoperative shock or systemic sepsis * emergency operation * american society of anesthesiologists status v * participation in another clinical trial * general anesthesia not planned for procedure

Keywords: echocardiography hemodynamic management
evaluation of dexamethasone added to the usual infiltration with bupivacaine in inguinal hernia repair mesh

Conditions: Pain, Postoperative

Summary: to evaluate the impact on the postoperative pain of the dexamethasone addition to the usual treatment with bupivacaine in the local infiltration of the surgical area in inguinal hernia repair mesh

this study will be: controlled, prospective, randomized and double blind. randomized experimental study in which all patients scheduled to undergo unilateral inguinal hernia repair and who meet the inclusion criteria and none of the exclusion criteria will be invited to participate. at the time of admission to the study, they were assigned randomly to one of the two branches of intervention: (group a): infiltration with 0.5% bupivacaine in doses of 1.5 mg / kg body weight diluted in physiological solution to a final volume of 30 ml. (group b): infiltration with 0.5% bupivacaine at doses of 1.5 mg / kg body weight + dexamethasone 2 ml (8 mg) diluted in physiological solution to a final volume of 30 ml. pain will be evaluated through the visual analogue scale of 0-10 measured at the 1st postoperative hour, then every 2 hours until discharge, at discharge, at 8 hours, at 24 hours, 48 hours and at 8 days . it will also evaluate analgesic consumption, complications and labor return

Eligibility criteria:
inclusion criteria: 1. patients older than 18 years. 2. unilateral inguinal hernioplasty. 3. that the surgery is performed in the ambulatory surgery unit (uca). exclusion criteria: 1. recurrent hernia. 2. allergies, ongoing infections, diabetes. 3. background of rejection of prosthetic material (mesh).

Keywords: pain hernia repair dexamethasone
tranexamic acid (txa) in pediatric cardiac surgery

Conditions: Bleeding

Summary: the purpose of this study is to determine tranexamic acid plasma levels in children undergoing cardiac surgery at risk of bleeding and to compare two dosing regimens.

tranexamic acid (txa) is administered intravenously to prevent bleeding associated with cardiac surgery and by pass in adult and children. the pharmacokinetic of this product is unknown in the pediatric population. only a few studies report a clinical efficacy with different dosages. the purpose of this study is to determine the plasma level of txa using two different administrations methods: continuous versus intermittent. the second objective is to determine whether fibrinolysis decreased. the population consists in children weighting 10 to 30 kilos, undergoing cardiac surgery and at high risk of bleeding.

Eligibility criteria:
inclusion criteria: * children weighing between 10 and 30kg surgery with cardiopulmonary bypass for congenital heart disease deemed hemorrhagic exclusion criteria: * the patients undergoing a surgical procedure short and simple * patients with past history of convulsions neurologiques especially allergies to the ta * patients with renal insufficiency

Keywords: tranexamic acid in pediatric surgery fibrinolysis and paediatric cardiac surgery