Kornimate/medical-research-clean huggingface dataset:
prostate assessment with restriction spectrum imaging (rsi) mri

Conditions: Prostate Cancer

Summary: this single-center study will enroll 40 male participants to complete 2 diffusion magnetic resonance images within 30 days of each other.

participants will undergo prostate mri using a range of b-values and echo times. 40 participants will be invited to complete two such scans within 30 days of each other to evaluate reliability across time. several advanced mri models will be applied to the data, and the models will be assessed for accurate prediction of grade group ≥2 prostate cancer on histopathology, obtained through routine clinical care. we hypothesize that advanced, multi-compartment dmri will yield a reliable, quantitative metric that is superior to standard adc for detection of cspca. rsi is a multicompartment model of diffusion mri that uses data acquired at multiple b-values to distinguish varied diffusion speeds (restricted intracellular, hindered extracellular, and approximately free diffusion). the relative contributions of each compartment are estimated for each voxel in the imaging field of view. rsi cellularity index is a normalized parameter reflecting the contribution of very slow diffusion that is associated with tumor cellularity.

Eligibility criteria:
inclusion criteria: * male, aged ≥18 years, with histologically confirmed adenocarcinoma of the prostate * has already undergone prostate mri and/or scheduled to undergo clinically indicated radical prostatectomy (to permit whole-mount histopathology correlation). * intended treatment and follow-up according to standard of care for prostate cancer * in good general health as evidenced by medical history and ecog performance status 0-2 * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study exclusion criteria: * prior treatment for prostate cancer (cryotherapy, high frequency focused ultrasound, prostatectomy) * hip prosthesis * contraindication to mri, per institutional requirements * patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

Keywords: prostatectomy
patient outcomes evaluation of the ebi vuelock™ anterior cervical plate system

Conditions: Trauma; Tumor; Pseudarthrosis; Scoliosis; Degenerative Disc Disease

Summary: to prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the vuelock™ anterior cervical plate system

the purpose is to prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the vuelock™ anterior cervical plate system.

Eligibility criteria:
inclusion criteria: 1. the patient will undergo anterior cervical fusion with the vuelock™ anterior cervical plate system for treatment of degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusion. 2. the patient must be available for follow-up during the study. 3. the patient must be skeletally mature (epiphyses closed). exclusion criteria: 1. patients with other pathology at the involved spinal level, e.g., osteomyelitis, paget's disease, pathologic fracture, etc. 2. patients with a disease entity or condition that totally precludes the possibility of bony fusion such as known active cancer, etc. 3. pregnant or nursing females. 4. patients who in the opinion of the investigator would be psychologically unwilling or unable to understand or complete the protocol, especially those unwilling or unstable to participate in the follow-up.

Keywords: degenerative disc disease (ddd)
ketamine or neostigmine for serratus anterior plane block in modified radical mastectomy

Conditions: Postoperative Pain

Summary: the aim of this study is to investigate the analgesic efficacy of adding ketamine compared to neostigmine to local anesthetic in ultrasound guided serratus anterior plane block for patients undergoing modified radical mastectomy.

breast cancer is the most common malignancy among females with incidence of 18,660 patients each year in egypt. modified radical mastectomy is considered the main surgical management for breast cancer accounting for 31% of all breast surgery cases. ultrasound guided serratus anterior plane block provides analgesia for breast and lateral thoracic wall surgeries by blocking nerves that are located in a compartment between the serratus anterior and the latissimus dorsi muscles ( the intercostobrachial nerve, lateral cutaneous branches of the intercostal nerves (t3-t9), long thoracic nerve and thoracodorsal nerve). a previous study demonstrated the analgesic efficacy of ketamine in patients undergoing modified pectoral nerve block in breast cancer surgery as evidenced by prolonged time to first rescue analgesia and reduced total opioid consumption. neostigmine has been used as an additive to local anesthetics to prolong the analgesic effect. although there is good evidence for a spinal action of neostigmine, its analgesic efficacy as an adjuvant to local anesthetic is still unclear. the aim of this study is to investigate the analgesic efficacy of adding ketamine compared to neostigmine to local anesthetic in ultrasound guided serratus anterior plane block for patients undergoing modified radical mastectomy.

Eligibility criteria:
inclusion criteria: * ● female patients * type of surgery; modified radical mastectomy (mrm). * physical status asa ii, iii. * age ≥ 21 and ≤ 65 years. * body mass index (bmi): \> 20 kg/m2 and \< 35 kg/m2. exclusion criteria: * ● patients with known sensitivity or contraindication to drug used in the study (local anesthetics, opioids). * history of psychological disorders and/or chronic pain. * contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy. * infection of the skin at the site of needle puncture area * patient refusal. * severe respiratory or cardiac disorders. * advanced liver or kidney disease. * pregnancy. * patient with surgery duration more than two hours
use of uc-mscs for covid-19 patients

Conditions: Corona Virus Infection; ARDS; ARDS, Human; Acute Respiratory Distress Syndrome; COVID-19

Summary: the purpose of this research study is to learn about the safety and efficacy of human umbilical cord derived mesenchymal stem cells (uc-msc) for treatment of covid-19 patients with severe complications of acute lung injury/acute respiratory distress syndrome (ali/ards).


Eligibility criteria:
inclusion criteria: patients \>/= 18 years old diagnosed with covid-19 (as evaluated by pcr test confirming infection with sars-cov-2) will be eligible for inclusion if they meet all of the below criteria. inclusion criteria must all be present within a 24-hour time period at the time of enrollment: 1. patient currently hospitalized 2. aged ≥ 18 years 3. willing and able to provide written informed consent, or with a legal representative who can provide informed consent 4. peripheral capillary oxygen saturation (spo2) ≤ 94% at room air, or requiring supplemental oxygen at screening 5. pao2/fio2 ratio \< 300 mmhg 6. bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest ct scan 7. hypoxemia requiring an increase in the fraction of inspired oxygen (fio2) of ≥ 20% and an increase in positive end-expiratory airway pressure (peep) level of 5 cm h2o or more to maintain transcutaneous oxygen saturations in the target range of 88-95%, or requirement for escalation from oxygen therapy to invasive mechanical ventilation exclusion criteria: 1. pao2/fio2 ≥ 300 at the time of enrollment 2. a previous msc infusion not related to this trial 3. history of pulmonary hypertension (who class iii/iv) 4. history of left atrial hypertension or decompensated left heart failure. 5. pregnant or lactating patient 6. unstable arrhythmia 7. patients with previous lung transplant 8. patients currently receiving chronic dialysis 9. patients currently receiving extracorporeal membrane oxygenation (ecmo) 10. presence of any active malignancy (except non-melanoma skin cancer) 11. any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50% 12. moderate to severe liver disease (ast and alt \>5 x uln) 13. severe chronic respiratory disease with a paco2 \> 50 mm hg or the use of home oxygen 14. baseline qt prolongation 15. moribund patient not expected to survive \> 24 hours

Keywords: covid-19
the boston scientific access trial

Conditions: Renal Disease; Kidney Failure

Summary: the boston scientific access trial seeks to study the safety and to evaluate the success of the fusion™ vascular access graft for patients in need of early vascular access for hemodialysis.

the boston scientific access trial seeks to study the safety and to evaluate the success of the fusion™ vascular access graft for patients in need of early vascular access for hemodialysis. the primary objective is to demonstrate that secondary patency at 6 months for the fusion™ vascular access graft is not less than an objective performance criterion (opc) minus a clinically relevant margin (δ). the opc represents secondary patency at 6 months for the standard of care access grafts. the secondary safety endpoint is the occurrence of cec-adjudicated device or procedure related adverse events through 24 months post implant procedure, or through discharge for patients with unsuccessful device implantation. secondary efficacy endpoints include:primary patency; primary assisted patency; ability to revise a failed graft; early access capability; time to hemostasis. subjects will undergo a thorough medical assessment and physical examination pre-procedure and will be assessed peri-procedure. enrolled subjects with a device implanted will be evaluated at 1, 6, 12, 18 and 24 months post implant procedure.

Eligibility criteria:
inclusion criteria: 1. need for early dialysis access (≤72 hours after implantation): * initiation of maintenance dialysis is recommended per k/doqi or institutional guidelines; or * patient is currently receiving dialysis via catheter 2. no prior implantation of synthetic graft in the arm to be treated 3. life expectancy of at least 2 years, based on physician's assessment of medical condition exclusion criteria: 1. patient younger than 18 years of age 2. any stenosis in the veins proximal to (downstream of) implant site, as determined previously or by current ultrasound 3. pregnancy 4. bleeding disorder, e.g., low platelet count (\<50,000), hypercoagulable state, e.g., antithrombin iii deficiency; antiphospholipid or anticardiolipin antibodies; factor v leiden; circulating lupus anticoagulant; current, active heparin-induced thrombocytopenia; protein c or s deficiency; or history of recurrent deep vein thrombosis not related to av access. 5. active malignancy, e.g., condition either being treated or considered untreatable 6. active systemic infection, e.g., condition either being treated or considered untreatable 7. uncontrolled major symptomatic medical problem, e.g., undiagnosed severe pain, metabolic disturbance, fever, etc. 8. likelihood of poor compliance to required dialysis protocol, e.g., history of poor attendance to required clinic sessions or non-compliance to medication 9. mental incapacity; inability to understand treatment instructions 10. currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study

Keywords: vascular access hemodialysis
national trial of cgm in pregnant women with type 2 diabetes

Conditions: Type 2 Diabetes; Pregnancy

Summary: the goal of this clinical trial is to evaluate the use of glucose sensors in pregnant women with type 2 diabetes to improve insulin regulation, pregnancy and birth outcomes, and enhance quality of life and satisfaction with treatment. the main questions it aims to answer are: * does the use of glucose sensors during pregnancy lead to a clinically significant reduction in hba1c by 0.3% at 36 weeks gestation compared to the control group? * does the use of glucose sensors during pregnancy result in a clinically significant reduction in mean sd-score for birth weight deviation in newborns compared to the control group? researchers will compare the group of women using glucose sensors during pregnancy to a historical control group receiving routine care to see if the sensor improves pregnancy outcomes, glucose control, and birth weights. participants will: * use a glucose sensor from before 14 weeks of pregnancy until 4-6 weeks postpartum. * receive training on how to use the sensor and access ongoing support as needed. * have a follow-up appointment 4-6 weeks postpartum, including a consultation for advice on medical treatment and further management of diabetes after birth.


Eligibility criteria:
inclusion criteria: * pregnant women with type 2 diabetes * attending one of the four centers for pregnancy and diabetes in denmark * 18 years old or above exclusion criteria: * gestationel age 14+0 or above * ekspected birth after end of trial * already using a continous glucose monitor (sensor)

Keywords: cgm in type 2 diabetes cgm in pregnancy
novel biomarkers for early renal injury in children with sepsis

Conditions: Acute Kidney Injury; Sepsis; Gout Flare

Summary: toxicosis often leads to multiple organ failure (mods), with the kidney being the primary target organ due to its sensitivity to infection and ischemia. the kidney's vulnerability makes it a potential early indicator of organ failure, implying that further organ failure may occur later, thereby increasing the risk of patient mortality. several studies conducted on sepsis patients in the pediatric intensive care unit (picu) have revealed that 40.32% of sepsis patients experienced complications with acute kidney injury (aki), and the case fatality rate could rise to 70% once aki occurred. the kidney disease improving global outcomes (kdigo) scale is commonly used as a diagnostic criterion for aki. however, the kidney's robust reserve function poses a challenge for early identification, diagnosis, and intervention of aki since significant increases in creatinine levels and a sharp decrease in urine volume already indicate severe kidney damage. this situation calls for the development of alternative methods. in our previous study, we discovered a strong correlation between urinary oxygen partial pressure and renal organ function impairment in children with sepsis. building upon traditional biochemical indicators such as blood lactic acid levels, we will incorporate non-invasive tests like urine partial pressure of oxygen, renal ultrasound, and cardiac ultrasound, as well as novel markers like kim-1, to establish a model for early recognition and assessment of kidney damage in children with sepsis. by utilizing commonly used biomarkers and the precise effects of urinary oxygen partial pressure, we aim to improve early identification and accurate intervention evaluation for pediatric sepsis kidney injury. this research will provide a crucial foundation for the development of early warning systems, diagnostic guidelines, and treatment protocols for pediatric sepsis kidney injury.


Eligibility criteria:
inclusion criteria: * from may 2021 to december 2024, the study focused on patients admitted to the pediatric intensive care unit (picu) for a duration exceeding three days. specifically, patients with severe infection and those who underwent pediatric neurosurgery were diagnosed with sepsis according to the international standard for childhood sepsis established in 2005, the 2012 surviving sepsis campaign guidelines for pediatric sepsis, and the 2015 expert consensus on sepsis criteria for chinese children with septic shock. the age range of the patients included in the study spanned from 1 month to 16 years old. exclusion criteria: * children who enter picu 24 hours and die or exit picu within 24 hours; genetic metabolic diseases; congenital immune deficiency; can't sign an informed consent form.

Keywords: pediatric, kidney injury, sepsis, gut microbiota, blood metabolome
tocilizumab augmentation in treatment-refractory major depressive disorder

Conditions: Major Depressive Disorder

Summary: this proposed study sets out to examine the antidepressant effects of tocilizumab among patients with treatment-refractory major depression.

as the understanding of the complex relationship between pro-inflammatory cytokines (specifically interleukin-6 \[il-6\]) and depression symptoms becomes clearer, clinical trials to evaluate effective and novel treatments are needed. as there have been no published tocilizumab trials among patients with major depression, this pilot study will adopt a single-arm, open-label design. due to the notion that inflammatory cytokines may play a role in a sub-type of depression, this study will recruit patients with treatment refractory major depressive disorder, for whom established depression treatments have not been effective. in conducting this trial, the investigators seek to examine the potential role of tocilizumab as an augmentation agent, with the hypothesis that it could reduce depression symptomatology in patients with major depression who have not experienced symptom reduction through more traditional antidepressant therapies.

Eligibility criteria:
inclusion criteria: * current diagnosis of major depressive episode * hamilton depression rating scale (hdrs) score of \>20 * in treatment for depression for a minimum of 8 weeks exclusion criteria: * active drug or alcohol disorder in the last three months * history of psychosis, mania or hypomania * acute suicide or homicide risk * history of liver disease including hcv and hbv * hiv * history of heart disease or a heart attack * active or latent tuberculosis, a history of a positive tuberculosis test, or having received the bacillus calmette-guérin (bcg) vaccine * epilepsy or a history of seizures * abnormal thyroid-stimulating hormone (tsh \ 5.0mlu/l) * abnormal liver function tests on screening (alt\>50 u/l or ast\>50 u/l) * low absolute neutrophil count (anc) on screening (\<4000/mm3 * abnormal white blood cell count (\ 10,000mcl) * low platelet count on screening (\<150,000/mm3 * patients with an active or recent infection, for example cellulitis, bacteremia, pneumonia, and pyelonephritis. * recent exposure to uncommon infections (e.g. histoplasmosis, blastomycosis, coccidiomycosis) through recent travel to the ohio and mississippi river valleys and the southwest * pregnant women, breastfeeding women or women of child-bearing age not using contraception * history of or current autoimmune disease, including multiple sclerosis and inflammatory bowel disease * diagnosis of chronic fatigue syndrome * temperature greater than 100.3f at the screening visit or any subsequent visits * dyslipidemia * currently taking oral steroids * currently taking statins * chronic aspirin or nsaid takers * currently taking any immunomodulating medications * inability to consent due to cognitive impairment
immediate release (ir) to sustained release (sr) switching study: study of switching from ir seroquel to sr seroquel in outpatients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to determine that the efficacy of the sustained release (sr) formulation of quetiapine (seroquel) is not inferior to the immediate release (ir) formulation. please note: seroquel sr and seroquel xr refer to the same formulation. the sr designation was changed to xr after consultation with fda.


Eligibility criteria:
inclusion criteria: * a stable dose of quetiapine ir between 300 and 800 mg/day within 4 weeks prior to the enrolment visit (visit 1) as judged by the investigator. * female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study. * able to understand and comply with the requirements of the study, as judged by the investigator. exclusion criteria: * meeting the criteria for any other (than schizophrenia) diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) axis i diagnosis, concomitant organic mental disorder or mental retardation. * patients with substance abuse or dependence, as defined by dsm-iv, and not in full remission. a urine drug screen test will be performed. the investigator will evaluate the results along with medical history to determine if the patient meets dsm-iv criteria for substance abuse or dependence. * risk of transmitting human immunodeficiency virus (hiv) or hepatitis b, via blood or other body fluids, as judged by the investigator. * patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.

Keywords: schizophrenia
studying samples from patients with t-cell acute lymphoblastic leukemia

Conditions: Leukemia

Summary: rationale: studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors identify learn more about biomarkers related to cancer. it may also help doctors to find better ways to treat cancer. purpose: this research studies samples from patients with t-cell acute lymphoblastic leukemia (t-all).

objectives: * determine the metabolic status and regulation of primary t-cell acute lymphoblastic leukemia (t-all) relative to control resting peripheral t cells. * establish the effects of metabolic inhibition on metabolic stress pathways and apoptosis. * determine how metabolic inhibition interacts with chemotherapy or targeted therapy drugs to kill t-all cells. outline: t-all samples cultured alone or with gamma secretase inhibitors (gsi) or pi3k inhibitors are analyzed for metabolic characteristics including glucose transporter 1 (glut1) expression, mitochondrial mass, phospho-flow for 5' adenosine monophosphate-activated protein kinase (ampk), acetyl-coa carboxylase (acc), and mammalian target of rapamycin (mtor) by flow cytometry. t-all samples and normal cd4+ t cells (control) are also exposed to ± 2-deoxyglucose or ± the glutaminolysis inhibitor media and analyzed for metabolic stress responses over time in particular, ampk activation, autophagy (immunofluorescence for lc3-ii processing), and bcl2-associated x protein (bak) and bax activation to indicate apoptosis. these cells (t-all and control) are then cultured with cyclophosphamide, dexamethasone, or the b-cell cll/lymphoma 2 (bcl-2) inhibitor, abt-737, to determine cell death over time.

Eligibility criteria:
disease characteristics: * sample from patients diagnosed with t-all * samples from independent healthy donors obtained through the gulf coast regional blood center (controls) patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: t-cell childhood acute lymphoblastic leukemia untreated adult acute lymphoblastic leukemia t-cell adult acute lymphoblastic leukemia untreated childhood acute lymphoblastic leukemia