Kornimate/medical-research-clean huggingface dataset:
topical tranexamic acid application in rhinoplasty

Conditions: Ecchymosis; Eyelid; Edema; Rhinoplasty

Summary: the aim of this study is to examine the effectiveness of topical tranexamic acid application in overcoming periorbital ecchymosis and edema after rhinoplasty, which are common and do not have a standard treatment.

all patients were informed individually about the procedures and written informed consent was obtained before the study. patients who underwent rhinoplasty / septorhinoplasty operation between june 2021 and september 2021 with open technique were included in the study. two groups with at least 25 individuals in each group were included in the study. patients were appointed to either the control or ta group in a randomized-consecutive fashion. patients younger than 18 years or older than 60 years, patients with a history of previous nasal operations, chronic medical conditions, hematologic disorders, fibrinolytic disorders and known allergy to tranexamic acid were excluded from the study. in group ta, ta-soaked pledgets were placed under the skin flap in such a way that both sides reach the osteotomy area and left for 5 minutes. in control group, isotonic saline-soaked pledgets were placed under the skin flap in the same way and left for 5 minutes. surgical pledgets were prepared by nurse and given to the surgeon who did not know which group the pledget belonged to. digital photographs were obtained by the surgeon who performed the operation on the first, third and seventh postoperative days. eyelid edema and periorbital ecchymosis were scored via digital photographs separately by two expert surgeons at our institution independently using a graded scale ranging from 0 to 4. digital photographs of the patients were shown to the examiners in alphabetical order, and information on which groups the patients belonged to was not given. the scores obtained from two different examiners were averaged. statistical analyses were performed using ibm spss for windows (ibm corp., version 26.0, armonk, ny, usa). the gender distribution of the groups was presented by number and percentage. age, ecchymosis and edema degrees were presented by mean ± sd and median (minimum-maximum) values. the chi-square test was used to compare the gender distribution of the groups. the patients' ecchymosis and edema scores were compared among groups using a mann-whitney u test. comparisons within each group was evaluated with repeated measures analysis of variance test (friedman test); if a difference was detected, the wilcoxon signed rank test with bonferroni correction was used to determine the group that made a difference. p ≤ .05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: * primary open approach rhinoplasty under general anesthesia * bilateral lateral osteotomies exclusion criteria: * patients younger than 18 years * patients older than 60 years * history of previous nasal operations * chronic medical conditions, * hematologic disorders * known allergy to tranexamic acid

Keywords: ecchymosis rhinoplasty edema tranexamic acid
evaluation of a targeted magnetic resonance imaging contrast agent in prostate cancer patients

Conditions: MRI Scan

Summary: this phase 1b open label, dose-escalating investigation study is to evaluate the dose dependent initial efficacy of the use of mt218 injection for biomarker targeted mr molecular imaging (mrmi) of prostate cancer in patients scheduled for radical prostatectomy.

phase 1b open label, single-arm, dose-escalating investigation of safety and efficacy of a gadolinium (gd) and peptide based mri contrast agent (mt218) as an extradomain-b fibronectin (edb-fn) targeted molecular mr contrast agent to detect aggressive prostate cancer with comparison of its results with the standard-of-care mutliparametic mri (mpmri) and psma pet/ct and histopathology validation in preprostatectomy patients diagnosed with prostate cancer in their clinical care.

Eligibility criteria:
inclusion criteria * male subjects aged \>18 years. * patients with confirmed gleason score of 8 - 10 prostate cancer, had at least one prostate mpmri and one prostate biopsy. * ability to lie still for mri scanning. * patients must be able to provide written informed consent. * glomerular filtration rate (gfr) \> 60 ml/min within a 30 days of the research mri. key exclusion criteria * any diagnosis of active acute, chronic, or sub-chronic kidney or liver disease. * documented acute prostatitis, symptomatic or severe benign prostatic hyperplasia (bph) or urinary tract infections. * patients with uncontrolled diabetes or hypertension. * patients with active non-prostate malignancy. * patients with contraindications for mri including implantable pace makers, cochlear implants. * patients with uni- or bilateral hip prosthesis. * subjects with other significant medical conditions that would create unacceptable operative risk, compromise retention on study or compromise study related assessments. * major surgery within 4 weeks prior to entry on this study or patients who have not recovered from side effects of such therapy. * prostate biopsy within 4 weeks prior to entry on this study in which inflammation might affect mri result. * subjects who received or will receive any other mri contrast agent within 48 hours prior to mt218 injection or up to 24 hours after mt218 injection. * is determined by the investigator that the patient is clinically unsuitable for the study. * is incapable of understanding the language in which the information for the patient is given. * participation in a concurrent clinical trial or in another trial within the past 30 days.

Keywords: mt218 target gbca peptide mri contrast agent prostate cancer
an extension to study aza ph gl 2003 cl 001 allowing for continuation of azacitidine treatment in patients with myelodysplastic syndromes (mds)

Conditions: Myelodysplastic Syndromes

Summary: at the conclusion of study aza ph gl 2003 cl 001 (nct00071799), eligible participants could be enrolled in an optional extension phase in order to continue treatment with azacitidine until it became commercially available; the continued treatment was for ethical and safety reasons only and not to provide additional efficacy data.

at the conclusion of study aza ph gl 2003 cl 001 (nct00071799), eligible participants could be enrolled in an optional extension phase in order to continue treatment with azacitidine until it became commercially available; the continued treatment was for ethical and safety reasons only and not to provide additional efficacy data. during the extension phase, participants were treated based on 28-day cycles and monitored for hematologic, nonhematologic, and renal toxicities. recommended monitoring procedures included complete blood count with differential and platelets at least once each cycle prior to dosing and as needed, bone marrow biopsy and aspirate as clinically indicated, and additional tests or more frequent monitoring at the investigator's discretion based on the patient's clinical status. the azacitidine dose could be modified for toxicities. laboratory data were not collected during the extension phase.

Eligibility criteria:
inclusion criteria: * participants were considered eligible if they had been randomized to azacitidine treatment in the primary study and were receiving azacitidine at the time of study closure, had completed 12 months of treatment and observation in the primary study, and had signed the informed consent document for the extension phase of the study. * see study: aza ph gl 2003 cl 001 for a list of inclusion criteria for the primary study. exclusion criteria: * none specific to the extension phase of the study * see study: aza ph gl 2003 cl 001 for a list of exclusion criteria for the primary study.

Keywords: myelodysplastic syndromes mds
evaluation of a community health program for the prevention of type 2 diabetes and other cardio-metabolic risk factors in adults: districts of barranquilla and bogota, colombia - january 2017 - december 2019

Conditions: Prediabetic State

Summary: the main aim of this study is to evaluate the feasibility and effectiveness of a program for modifying lifestyles for diabetes prevention type 2 and control cardio-metabolic risk factors in adults with different categories of risk from the primary health care strategy. the project will show the effect of these interventions for the first time in people with different risk of developing type 2 diabetes throughout the life in populations living in colombia located in 2 different cities, one of them in the interior of the country (districts of bogota) and another in the north coast (districts of barranquilla) .

cardiovascular disease (cvd) and type 2 diabetes (t2d) are currently the public health problems fastest growing globally. according to the international diabetes federation (idf) is estimated to have diabetes approximately 382 million people in the world. it is shown that early interventions in lifestyle can reduce the burden of type 2 diabetes and factors of cardiovascular modifiable risk. this is an intervention study in cluster. 36-month integrated into 4 phases: 1. design and adaptation of educational intervention 2. population screening 3. stepwise intervention program 4. evaluation results. for population screening test findrisc validated for the latin american population will be employed and a score of 12 will be considered as a cutoff to all who have a score equal to or greater than 12 (moderate or high risk) they perform a test oral glucose tolerance (ogtt) according to the results 3 groups will be established * high risk group: subjects with findrisc score ≥12 and impaired glucose tolerance (igt) * moderate risk group: subjects with findrisc score ≥12 and impaired fasting glucose or norm tolerant * low risk group: subjects with findrisc score \<12. intervention program: one year of duration, 3 types of programs are established. * lifestyle intervention program_ communitarian: intervention program at community level with low risk group. * lifestyle intervention program_ informative: program information intervention for the group with moderate risk. * lifestyle intervention program_ structured: intervention program for members of high-risk group. an evaluation of the different variables are studied at baseline and the final of the intervention in the three groups established.

Eligibility criteria:
inclusion criteria: * people over age 30 years, residents within the perimeter of the conglomerate in the districts of barranquilla and bogota * wishing to participate and sign informed consent exclusion criteria: * dt2 known and / or treated * history of diseases or events that prevent their participation * neurological disability that does not allow you to make own decisions * pregnant women
efficacy of dexmedetomidine on postoperative analgesia

Conditions: Postoperative Pain

Summary: this prospective, randomized, double-blind study is designed to evaluate the postoperative analgesic efficacy of dexmedetomidine as an adjunct to ropivacaine in erector spinae block in patients undergoing radical mastectomy. the investigators hypothesis is that the administration of ropivacaine 0.5% associated with dexmedetomidine in the blockade via the plane in the erector spinae is less effective in controlling acute postoperative pain in radical mastectomy than the administration of ropivacaine 0.5% without dexmedetomidine.

patients undergoing radical mastectomy are randomly assigned to receive, in addition to standard general anesthesia, a block of the erector spinae plane with ropivacaine at a dose of 0.5% for the control group (n = 13) and ropivacaine at a dose of 0.5% more dexmedetomidine at 0.3 mcg kg (n = 15) for the intervention group. general anesthesia was induced using anxiolysis with midazolam at 30 mcg / kg corrected weight, as induction, propofol at a dose of 1.5 - 2 mg kg, opioid analgesia with fentanyl at a dose of 3 mcg / kg weight corrected with 30% according to ideal weight initial bolus dose, and dose as required, neuromuscular relaxation with cisatracurium at a dose of 0.1 mg / kg.

Eligibility criteria:
inclusion criteria: * patients undergoing radical mastectomy for pathology "breast cancer" * patient undergoing anesthetic technique due to erector spinae plane block * informed consent to perform the anesthesia technique. * karnofsky\> 80 points exclusion criteria: * emergency surgery * patient with mental pathology that prevents pain assessment. * rejection of anesthetic technique. * patient with allergy to local anesthetics * patient with local infection of the puncture site for application of the erector spinae block
argentine registry of lp(a)

Conditions: Lp(A); Hypercholesterolemia; Cardiovascular Diseases; Diabete Type 2; Hypertension

Summary: the argentine registry on lipoprotein(a) (lp(a)), orchestrated by the argentine group for lp(a) study, stands as a pioneering and extensive prospective initiative. this registry systematically collects geolocation data, including patient postal codes, demographic information, and a multifaceted array of health parameters to unravel the intricate associations surrounding lp(a) levels. the dataset encompasses diverse patient characteristics, ranging from standard metrics like blood pressure, weight, and race to broader factors such as diabetes, smoking habits, menopausal status, and hypothyroidism. this holistic approach enables a nuanced exploration of the interplay between lp(a) levels and various risk factors, providing invaluable insights for both clinical and public health considerations. one distinctive feature of this registry lies in its focus on medication history, shedding light on the impact of routine pharmaceutical interventions on lp(a) profiles. additionally, it delves into the intricate web of inflammatory diseases, recognizing their potential role in lp(a) modulation. genetic predispositions are meticulously examined, with a specific emphasis on identifying homozygous and heterozygous variants associated with hypercholesterolemia. this genetic dimension adds a layer of complexity to the understanding of lp(a) dynamics, contributing significantly to the ongoing discourse on cardiovascular risk. the prospective nature of this registry allows for dynamic analyses, fostering a continuous exploration of emerging patterns and trends. by amalgamating geographical, clinical, and genetic data, the argentine lp(a) registry emerges as a comprehensive platform poised to unlock novel facets of lp(a) biology and its implications for cardiovascular health. as the dataset matures, it holds the promise of guiding personalized interventions and refining risk stratification strategies, thereby advancing the landscape of preventive cardiovascular care.


Eligibility criteria:
inclusion criteria: adult patients with validated lp(a) values - exclusion criteria: associated pathologies that can increase the lp(a) value in a non-specific manner -

Keywords: lp(a) cardiovascular risk
efficacy and safety of s 47445 versus placebo as adjunctive treatment in depressed patients not fully recovered from depressive symptoms with a current antidepressant treatment

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to assess the efficacy and safety of s47445 versus placebo as adjunctive treatment of major depressive disorder in patients with an inadequate response to antidepressant therapy.


Eligibility criteria:
inclusion criteria: * outpatients * fulfilling dsm-5 criteria for major depressive disorder confirmed by the brief structured interview m.i.n.i. (single or recurrent episode, current episode ≤ 12 months, current depressive episode of moderate or severe intensity, with or without anxious distress, with or without melancholic features, without mixed features or atypical features, without seasonal pattern, without psychotic features, without catatonic features, without peripartum onset for the current episode) * patients treated for the current depressive episode with an antidepressant treatment with ssri (fluoxetine, citalopram, paroxetine, escitalopram or sertraline) given in monotherapy at recommended dose for at least 6 weeks and no more than 4 months and with a stable dosage for at least 3 weeks * ham-d total score ≥ 20 * clinical global impression severity of illness (item 1): 6 ≥ cgi-s ≥ 4 * antidepressant treatment response questionnaire (atqr) \< 50% for the current ssri * absence of any abnormalities likely to interfere with the conduct of the study (ecg, vital signs, laboratory tests, medical history) exclusion criteria: * depressive episode of mild intensity according to dsm-5 criteria * all types of depressive episodes other than those occurring in a major depressive disorder (persistent depressive disorder (dysthymia) according to dsm-5 criteria, including persistent depressive disorder with intermittent or persistent major depressive episode according to dsm-5, premenstrual dysphoric disorder, substance induced depressive disorder, depressive disorder due to another medical condition, other specified or unspecified depressive disorder, bipolar disorder i or ii, depressed episode, schizoaffective disorder (depressive or bipolar type)) * depression onset within 12 months after a stroke * suicidal risk defined as a score \> 3 on the item 3 of the ham-d scale or in the investigator's opinion * lactose intolerance * patients with hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption * resistant depression for the current episode (patients who have not responded to 1 previous antidepressant treatment before the ssri taken at an appropriate dose) * current panic disorder * obsessive compulsive disorder * current post traumatic stress disorder, current acute stress disorder * current or past psychotic disorder * any severe personality features
transfer factor efficacy in the management of cirrhosis-associated immune dysfunction

Conditions: Cirrhosis; Liver Failure

Summary: this study is aimed to assess the efficacy of human derived transfer factor ( t-lymphocytes homogenate that contains small molecular weight (10 kda) molecules: various ifns, ils, chemokines, endorfins, heat shock proteins) in decreasing rate and/or severity of infections in acute or chronic decompensations of liver cirrhosis and acute on chronic liver failure..

most of mortality from advanced chronic liver disease (acld) is mediated by so- called specific complications of end-stage liver disease (esld); one of the most important is infection (25-30%). infection is responsible for considerable proportion of esld-related mortality. important in pathogenesis of infections in esld is caids (cirrhosis - associated immune dysfunction syndrome), recently re-named to caid (cirrhosis-associated immune deficit). transfer factor (tf) is supposed to act at several points in caid - cascade. this gave rise to hypothesis, that tf could be of benefit in ad/aclf. characteristics of tf it has been shown that transmission fo t-lymphocyte reactivity is transmissible not only by t-cells alone, but also by hommogenate of peripheral white blood cells. later it became clear that for the transmission of cellular immunity is responsible dialysable fraction of t-lymphocytes homogenate (with small molecular weight of 10 kda; consists of amino acids, small peptides, nucleotides etc). this homogenate was named transfer - factor (tf). one dose of lyophilized drug contains: leucocyti dialysatum 200 x 10 6 (contains various ifns, ils, chemokines, endorfins, heat shock protein etc) * stimulates t h 1 response * induces production of il-1, il-2 * activates chemotaxis of immunocompetent cells * increases fagocytic activity * activates antigen-presentation by apcs the aim of this study is to assess the efficacy of transfer factor in decreasing rate and/or severity of infections in aclf.

Eligibility criteria:
inclusion criteria: * admission to hospital at participating liver units or icus or internal medicine wards with acute decompensation (ad) of advanced chronic liver disease or acute-on-chronic liver failure according to clif - c criteria * ability to provide informed consent, exclusion criteria: * disapproval * lymphoproliferative disorders * liver transplantation in the past * pregnancy * suspected. chronic infection in risk locations * cns * peritoneum * known virus-related immune deficiency * malignancy * severe heart failure (nyha \>= iii) * severe lung disease (copd, gold\>3)
a clinical investigation to assess the performance of a polyurethane condom versus a latex condom in healthy monogamous couples

Conditions: Control of Pregnancy; Prevention of Sexually Transmitted Infections

Summary: this investigation is designed to evaluate the performance rate of a polyurethane (pu) condom versus a standard natural rubber latex (nrl) condom.

in this clinical investigation, a new pu male condom (test condom) will be evaluated against a marketed nrl male condom (reference condom). this clinical investigation will also evaluate the in-use tolerance of the test and reference condoms.

Eligibility criteria:
main inclusion criteria: 1. a male and a female subject aged: 18 - 60 years inclusive. 2. all subjects must be generally healthy and in a mutually monogamous heterosexual relationship - current relationship ≥ 3 months. 3. all couples must be sexually active and agree to have penile-vaginal intercourse with a frequency sufficient to meet protocol requirements (a minimum of 5 coital acts over 4 weeks). 4. the female partner should already be on an established highly effective form of non-barrier contraception, unless post-menopausal. 5. couples must agree not to use drugs or non-investigational devices that can affect sexual performance. main exclusion criteria: 1. either partner is or becomes aware of an allergy or sensitivity to the ingredients of the test products, including the test or reference condoms. 2. either partner has a pre-existing skin condition (severe eczema/ psoriasis) or systemic allergic reactions or as confirmed by the subject and physical examination. 3. either partner that needs to use condoms for a specific sexually transmitted infection (sti) protection e.g. discordance for human immunodeficiency virus (hiv) or herpes. 4. subjects that have previous or planned genital surgery, that in the opinion of the investigator would consider the subject unsuitable to participate in the clinical investigation e.g. laser for abnormal smear. 5. male partners that have known erectile or ejaculatory dysfunction. 6. a female partner that has been diagnosed with or treated for vaginal complaints (including vaginal dryness) in the previous 3 months which, in the opinion of the investigator, deems the partner unsuitable for the investigation. 7. any subject who has clinical symptoms or signs of a sexually transmitted diseases (std) or hiv/ aids or has a previous history of high-risk behaviour as judged by the investigator. 8. female partner using medication which in the investigator's opinion would affect vaginal mucosal secretion, such as chlorpheniramine at any time in the 14 days (or 5 half-lives of the drug, whichever is longer) before first condom use. 9. a male partner with abnormal penile anatomy that would, in the opinion of the investigator, affect the ability to keep the condom in place during intercourse. 10. either partner intends to continue to use antihistamines, anti-inflammatory drugs or pain killers for the duration of the investigation.