Kornimate/medical-research-clean huggingface dataset:
reduce cardiovascular calcifications to reduce qt interval in dialysis

Conditions: Cardiovascular Mortality

Summary: research proposal to evaluate the impact of different phosphate binders on the progression of cardiovascular calcification and qt dispersion in new haemodialysis patients.

the risk of developing cardiovascular diseases in patients on hemodialysis is higher than in general population. higher levels of serum phosphate are associated with adverse cardiovascular outcomes, especially in the setting of overt hyperphosphatemia. given the biological importance of serum phosphorus, it is conceivable that also within the normal range values the higher serum phosphate levels may be associated with the worst outcome. several paper have shown that vascular calcifications in dialysis patients are associated with increased relative risk of death; it has also been demonstrated in uremic patients that vascular calcifications decrease arterial elasticity. we previously observed that vascular calcification directly correlate with qt interval (qtc) as well as qt dispersion (qtd) in dialysis. also, qt correction (obtained by the correction of phosphoremia and dyslipidemia) can ameliorate the development of arrhythmia and sudden death. aim of this study is to evaluate the relationship between vascular calcifications and both qtd increase and mortality in incident hemodialysis patients, and to investigate the efficacy of sevelamer to reduce vascular calcifications and qtd.

Eligibility criteria:
inclusion criteria: * incident patients on haemodialysis (ckd stage 5); * an informed consent will be provided at the study entry. exclusion criteria: * congenital prolongation of qt segment syndrome; * qtc \>440 ms; increased qtd; * bradycardia \<50 bpm; * sintomatic arrhythmia or any other significant heart problems; * electrolyte unbalances (especially hypokalemia, hypomagnesemia, hypocalcemia); * abnormal liver function tests; * hypothyroidism.

Keywords: qt interval qt dispersion arrhythmias death tc score
cognitive-behavioral therapy with exercise training in adolescent females with elevated depression symptoms

Conditions: Depression

Summary: purpose: to study the effect of cognitive-behavioral therapy combined with exercise training in adolescent females with elevated depression symptoms background: teenagers are more likely than any other age group to experience psychological issues due to depression, adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. adolescent depression rates have increased in recent years, and "silent killers" are preying on them. teenagers are more likely than any other age group to experience psychological issues due to depression, adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. adolescent depression rates have increased in recent years, and "silent killers" research question: is there is an effect of exercise on depression in adolescent girls.

the interventions start after assessment of depression to know the level of depression by using the center for epidemiological studies depression scale for children (ces-dc), and the exercise intervention consist of physical activity combined with cognitive behavioral therapy. group - a perform regular physical activity in addition to cognitive therapy, group - b perform irregular physical activity in addition to cognitive therapy, group - c cognitive therapy only

Eligibility criteria:
inclusion criteria: * 1. depression adolescent girls 2. all patients should be in school exclusion criteria: 1. obesity 2. malignant diseases 3. psychotic disorders or psychosis. 4. permanent long-term psychiatric medication
deep brain stimulation of nucleus accumbens to prevent opiate relapse

Conditions: Addiction

Summary: nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification, deep brain stimulation of nucleus accumbens will inhibit its activity and thus to effectively prevent the relapse of the opiate dependence.


Eligibility criteria:
inclusion criteria: * age \> 18 years old * long lasting heroin addiction (fulfilled diagnostic-criteria according to icd-10) * at least three detoxication-treatments without a long-term period of abstinence has already taken place * long-term inpatient treatment to support abstinence have occurred * completion of detoxification treatment preoperatively with no somatic symptoms of withdrawal * negative morphine urinalysis and naloxone tests * free patient's decision/informed consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance) exclusion criteria: * clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases, severe personality disorder) * contraindications of a mri-examination, e.g. implanted cardiac pacemaker/heart defibrillator * current and in the last six months existent paranoid-hallucinated symptomatology * foreign aggressiveness in the last six months * stereotactic respectively neurosurgical intervention in the past * contraindications of a stereotactic operation, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases) * serious and instable organic diseases (e.g. instable coronal heart disease) * tested positively for hiv * pregnancy and/or lactation

Keywords: opiate dependence deep brain stimulation nucleus accumbens
cellular stress reactions during graft-versus-host disease

Conditions: Graft Vs Host Disease; Graft Versus Host Disease

Summary: this study has the aim to analyze intestinal expression of cellular stress molecules in patients with intestinal gvhd. patients with colitis and patients without intestinal inflammation will serve as controls.

acute graft-versus-host disease (gvhd) is a major cause of morbidity and mortality in patients undergoing allogeneic hematopoietic cell transplantation (allo-hct). acute gvhd results from a complex multi-step crosstalk between extensive epithelial tissue damage in the patient and activation of the allo-reactive immune system transferred with the donor graft. the conditioning treatment prior to allo-hct creates an inflamed microenvironment with high concentrations of pathogen-associated and danger-associated molecular patterns (pamps and damps) as well as pro-inflammatory cytokines. this inflammation is perpetuated by activation of myeloid immune cells and recruitment of allo-reactive t cells to the intestine. enterocytes are subjected to cellular stress and undergo apoptosis. as a result, patients can develop high-voluminous diarrhea, dehydration, intestinal bleeding, hypalbuminemia, and generalized infections. in this study, the investigators aim to analyze the expression of molecules related to different types of cellular stress in the intestine of patients with acute gvhd. the hypothesis is that some stress-related markers would be upregulated during gvhd. the results will be valuable to study the role of cellular stress reactions during acute gvhd pathogenesis or as potential biomarkers for disease activity.

Eligibility criteria:
inclusion criteria: age \>18 years intestinal biopsy depending on cohort: healthy intestinal tissue, colitis or gvhd

Keywords: gvhd
slv308 for treatment of patients with parkinson's disease experiencing motor fluctuations

Conditions: Advanced Stage Parkinson's Disease

Summary: this study is a multicenter, randomized, double blind, parallel group study of 3 months' treatment with slv308 administered as a monotherapy in patients with advance stage pd. an open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic parkinson's disease, * advance stage of disease, * modified hoehn \& yahr stage ii-iv, * presence of a recognizable 'on' and 'off' state (motor fluctuations) and stable treatment with levodopa for at least 28 days prior to randomization exclusion criteria: * 'on-off' phenomena or 'yo-yoing' and/or an abrupt unpredictable loss of efficacy unrelated to the timing of l-dopa administration, * prevalent expression of troublesome dyskinesias during 'on' time at waking hours, * diagnosis is unclear or a suspicion of other parkinsonian syndromes exists, * previous surgery for the treatment of pd

Keywords: parkinson disease
effects of gender-affirming hormone therapy among transgender women

Conditions: Transgender Women; HIV/AIDS; Cardiovascular Diseases; Metabolic Disease; Coagulopathy

Summary: in this study, investigators plan to evaluate the cardiometabolic effects of initiating gender-affirming hormone therapy among transgender women with and without hiv. as part of this study, participants will undergo cardiovascular and metabolic phenotyping within 3 months of starting and after 12 months of gender-affirming hormone therapy. cardiovascular phenotyping will include cardiac mri/mrs imaging to evaluate cardiac function and structure. metabolic phenotyping will include oral glucose tolerance testing, abdominal mr imaging to evaluate visceral adiposity, and whole body, lumbar, and hip dexa imaging to evaluate fat and lean body mass as well as bone mineral density, respectively. traditional markers of cvd risk as well as immune, hormonal, and coagulation parameters will also be assessed longitudinally.


Eligibility criteria:
inclusion criteria: * transgender women or non-binary individual * age ≥16 * for women with hiv only: on art therapy for ≥3 months * initiation of testosterone suppression with spironolactone or leuprolide and estrogen therapy with oral 17-β estradiol, transdermal 17β estradiol, sublingual estradiol, intramuscular estradiol, or subcutaneous estradiol by medical provider exclusion criteria: * for women with hiv only: cd4 count\<50 * history of cad, acs, ascvd risk score ≥ 7.5%, ldl-c ≥ 190, or angina (e.g. current indication for statin use) * history of heart failure * history of diabetes * egfr \< 30 ml/min/1.73m2 * standard contraindication to mri, including history of severe allergy to gadolinium or dotarem * prior orchiectomy * gender-affirming hormone therapy for greater than 5 months directly prior to enrollment * current or past anti-platelet therapy or anti-coagulant therapy within the last 6 months •current or past statin therapy within the last 6 months * concurrent enrollment in conflicting research study
the addictive diagnostic value of apparent diffusion coefficients to bpmri in the diagnosis of prostate cancer

Conditions: Prostate Cancer

Summary: the goal of this study is to evaluate the diagnostic value of different adc values (incuding adcmin, adcmean, adcratio and adcrange) of bpmri in patients with pi-rads 3-5. the main aim is to evaluate whether different adc values improve the diagnosis of clinically significant prostate cancer (gleasonscore≥3+4, isup grade ≥2) and any-grade prostate cancer (gleasonscore≥3+3, isup grade ≥1).

the study is conducted with suspected prostate cancer. patients with pi-rads scores of 3-5 after completing prostate bpmri chose to undergo prostate biopsy. before patients undergo prostate biopsy, researchers will collecte information on age, bmi, tpsa, f/psa, pv, psad, adcmean, adcmin, adcmax, adcnormal, maximum lesion diameter, location of major lesions, and so on. for prostate biopsy, systematic prostate biopsy ± bpmri cognitive fusion targeted prostate biopsy will be completed under the conditions permitted by physical condition, and gleason score will be clearly given by pathologists if the final diagnosis is prostate cancer. in this study, the pathological result is regarded as the gold standard. roc curve, area under curve, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio and other indicators of diagnostic test were calculated. relevant conclusions are finally drawn by comparing the diagnostic capacity of different adc values for prostate cancer. meanwhile, binary logistic regression analysis will also conduct the odds ratios (ors) and 95% confidence intervals (cis) will be recorded.

Eligibility criteria:
inclusion criteria: 1. the patient met at least one indication of prostate biopsy (chinese expert consensus on prostate biopsy (2022 edition) https://rs.yiigle.com/cmaid/1442948 ); 2. serum psa test was completed in the patient with tpsa \< 100 ng/ml; 3. primary prostate tumor lesion, no history of other tumors; 4. completed 3.0t bpmri examination, pi-rads score ≥3 score, the image is clear and readable; 5. patients fully understand the relevant contents of the study and voluntarily sign the informed consent. exclusion criteria: 1. the patient has contraindications for mri; 2. pi-rads 1-2 of bpmri; 3. the patient had contraindications to prostate biopsy or explicitly refused biopsy; 4. bpmri indicated that the patient had multiple lymph nodes or bone metastases; 5. previous prostate-related surgery; 6. the patient refused to sign the informed consent.

Keywords: prostate cancer prostate biospy biparametric magnetic resonance apparent diffussion coefficient prostate imaging-reporting and data system diagnosis
improving breaking bad news in pediatrics by simulated communication

Conditions: Communication; End of Life; Pediatric ALL

Summary: breaking bad news, especially a death notice, is an essential part of the medical profes-sional communication. being inadequately trained in those skills this may result in un-pleasant psychosocial consequences for everyone involved. this prospective, single-center, randomized controlled trial evaluated the delivery of a death notice to simulation parents out of the perspective of these parents (professional actors), the participants (students) and by video analysis. the simulation patient has prior unexpectedly died during a simulated resuscitation. the intervention group broke the bad news after receiving a short communication

conversations about death and dying present discomfort for both healthcare professionals, patients and their families. these conversations, emotionally laden, pose lasting challenges and impact decision-making. despite extensive medical training, physicians often lack adequate communication skills for such conversations, leading to frustration and distress. delivering bad news, particularly in pediatrics, requires managing not only medical intricacies but also emotional impact. communication skills, crucial for such scenarios, are typically developed over time through observation and practice, yet are often inadequately emphasized in medical training. our study aimed to assess the impact of communication training on medical students delivering death notifications to simulation parents in pediatric simulation scenarios.

Eligibility criteria:
inclusion criteria: * medical students, enrolled at the medical university of vienna. * successful completion the mandatory basic life support training "block 16" in the third year of medical training and * successful completion of the mandatory communication seminar "ärztliche gesprächsführung b" also in the third year of medical training. * obtained written informed consent. exclusion criteria: * quality of the obtained video recordings were unsatisfactory and not usable for analysis * unmet inclusion criteria

Keywords: communication pediatrics palliative care simulation resuscitation breaking bad news
comparative pk study of thc/cbd formulations

Conditions: Cannabis

Summary: a phase i, single center crossover study. the goal of this clinical trial is to learn about self-emulsified thc/cbd powder compared with equivalent dose of thc/cbd oil, orally administerd in healthy volunteers. the main question it aims to answer is: •if the pharmacokinetics profile of one dose of thc/cbd self emulsified (s.e powder) compares to thc/cbd oil (equivalent dose). the secondary is: •if the use of thc/cbd s.e powder is tolerable and safe at least as thc/cbd oil. participants will receive a single dose of thc/cbd s.e powder followed by a 30-day washout period and then a single dose of thc/cbd oil.


Eligibility criteria:
inclusion criteria: 1. subjects must be 21-65 years old. 2. subjects must have a signed study informed consent before any procedure. 3. subjects must have a cannabis license as detailed at procedure no. 106 of the imc-gco , license will be issued and approved by pi at screening visit after signing on informed consent. 4. female subjects must be of non-childbearing potential or, if of childbearing potential, must have a negative urine pregnancy test at screening, visit 1 and visit 2. exclusion criteria: 1. a history of allergic reactions attributed to compounds of similar chemical or biologic composition to thc/cbd. 2. has an underlying medical condition that would preclude study participation. 3. chronic use of medications for underlying medical conditions. 4. use of any medications within 24 hours prior to treatment visit. 5. is currently participating in another study of an investigational agent/medical device. 6. has known psychiatric or substance abuse disorders that would interfere with participating in the study. 7. patients who previously suffered from dysfunction of the: liver, kidneys, heart, blood vessels and immune system (such as transplant recipients or patients undergoing chemotherapy). 8. patients who previously suffered from depression or anxiety. 9. medical history of high blood pressure, low blood pressure or diabetes. 10. patients who experience difficulties in performing daily activities. 11. current cannabis use or positive thc urine test results. 12. pregnant or lactating female subjects

Keywords: powder oil
study of 23me-01473 in patients with advanced solid malignancies

Conditions: Solid Tumor

Summary: this is a first-in-human open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of 23me-01473 given by intravenous infusion in participants with advanced solid cancers who have progressed or are intolerant of available standard therapies.

this study includes a dose escalation portion to determine the maximum tolerated dose (mtd) and/or the recommended phase 2 dose (rp2d) to evaluate the clinical activity of 23me-01473 and further evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in participants with solid malignancies.

Eligibility criteria:
inclusion criteria: 1. phase 1: adults ≥ 18 years of age 2. phase 1: histologically-diagnosed locally advanced (unresectable), or metastatic carcinoma or sarcoma that has progressed after standard therapy for the specific tumor type. 3. adults 18+: eastern cooperative oncology group (ecog) performance status of 0 or 1 4. life expectancy ≥ 12 weeks 5. phase 1: participants with evaluable disease are eligible regardless of tumor type, recist 1.1 can be used to assess disease progression. exclusion criteria: 1. females who are pregnant (positive serum pregnancy test within 7 days prior to study drug administration) or breastfeeding. 2. immune-related medical history 1. active autoimmune disease that has required systemic disease-modifying or immunosuppressive treatment within the last 2 years 2. receipt of systemic immunosuppressive therapy (e.g. steroids) within 4 weeks prior to the start of study drug administration 3. history of idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia, non-infectious pneumonia that required steroids, or evidence of active, non-infectious pneumonitis 4. history of grade ≥ 3 immune-mediated toxicity 3. prior allogeneic or autologous bone marrow transplant, or other solid organ transplant 4. history of a positive test for: 1. hepatitis c virus (hcv) infection, except for those who have completed curative therapy for hcv and have undetectable hcv rna 2. hepatitis b virus (hbv) infection, except for those who are receiving treatment with hbv-active nucleos(t)ide antiviral therapy at the time of study entry and have undetectable hbv dna 3. human immunodeficiency virus (hiv) infection, except those who meet the following criteria: cd4+ t cells ≥ 350 cells/μl, no history of acquired immunodeficiency syndrome (aids)-defining opportunistic infections, hiv rna \< 50 copies/ml, and on a stable antiretroviral regimen for at least 3 months 5. prior anticancer therapy, including chemotherapy, targeted therapy, biological therapy or immune-checkpoint inhibitors within 4 weeks or 5 drug half-lives (whichever is shorter) 6. history of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease free. 7. uncontrolled or symptomatic cns (central nervous system) metastases and/or carcinomatous meningitis 8. recent history (within 6 months) of serious cardiovascular disease

Keywords: cancer phase 1 solid tumor oncology nk ulbp6 immunotherapy
dementia management with interactive technology

Conditions: Dementia; Memory Disorders in Old Age

Summary: to investigate the efficacy of an individualized treatment plan delivered through remote technology along with enhanced staff training within a supervised memory unit on patient outcome, care quality, health care utilization/cost, and staff burden. remote monitoring of activity data will also be explored.


Eligibility criteria:
inclusion criteria: * residents living in a specific locked memory care unit in southeastern louisiana or * family or staff identified as part of the care team of the resident
renin-angiotensin-aldosterone system (raas) blockade and contrast induced nephropathy

Conditions: Radiographic Contrast Agent Nephropathy

Summary: the aim of the current study is to evaluate prospectively whether concomitant administration of renin-angiotensin-aldosterone system (raas) blockers (namely ace-i and arbs') influence the change in estimated glomerular filtration rate or gfr (egfr) after administration of contrast media in patients undergoing non-emergent coronary angiography.

contrast-induced nephropathy (cin) is defined as an absolute or relative increase in serum creatinine compared to the baseline values, together with exposure to a contrast agent and exclusion of alternative explanations for renal impairment. most frequently the renal impairment develops 48 hours post exposure. although raas blocking agents are widely used among patients requiring contrast studies, data regarding the effect of these agents on the development of cin are sparse and inconsistent. patients undergoing percutaneous coronary intervention are frequently treated with raas blocking agents. despite the not infrequent occurrence of cin following percutaneous coronary intervention (pci) no guidelines are available on the topic of the cessation of the raas inhibitors prior to the procedure.

Eligibility criteria:
inclusion criteria: * age \> 18 years, * chronic therapy with ace-i and/or arbs' (confirmed by electronic records in their medical file) and * planned coronary angiography exclusion criteria: * chronic utilization of nsaids and cox-2 selective inhibitors, * chronic treatment with mineralocorticosteroid receptor blocker, and * administration of contrast within 14 days prior to the enrollment.

Keywords: contrast induced nephropathy