Kornimate/medical-research-clean huggingface dataset:
colchicine use for primary prevention of coronary artery disease

Conditions: Coronary Artery Disease

Summary: colchicine has been widely used as an anti-gout medicine in the past decades. some recent clinical trials have proved that low-dose colchicine can be used as a secondary prevention drug for coronary artery disease because of its anti-inflammatory mechanism. however, the effect on primary prevention has not been observed sufficiently. the objective of this study is to determine whether colchicine reduces the incidence of cad in patients and its safety for long-term use.


Eligibility criteria:
inclusion criteria: 1. males and females who have at least 3 risk factors for cad. 2. gfr\>90mmol/l. 3 people are within 40-70 years old.4. patients are not pre-diagnosed with cad, which is defined by negative results of ct coronary angiography. exclusion criteria: 1. patients with any pre-existing diagnosis of coronary artery disease.2.other cardiovascular diseases such as peripheral vascular disease, congestive heart failure and cardiomyopathy.3.cerebrovascular diseases such as cerebral thrombosis and cerebral hemorrhage. 4.currently on treatment with colchicine.5.patients who are known to be allergic to colchicine.6 chronic symptomatic heart failure within the last year and known reduced ejection fraction (lvef≤40 %), documented before recruitment.7.severe hepatic impairment (child-pugh class c) at the time of inclusion into the trial.8.any other non cardiovascular diseases, such as active malignancy requiring treatment at the time of screening or with a life expectancy of fewer than two years based on the investigator´s clinical judgment.

Keywords: coronary artery disease primary prevention adverse events
spyral affirm global study of rdn with the symplicity spyral rdn system in subjects with uncontrolled htn

Conditions: Hypertension; Vascular Diseases; Cardiovascular Diseases; Chronic Kidney Diseases; Diabetes Mellitus

Summary: the purpose of this single-arm interventional study is to evaluate the long-term safety, efficacy, and durability of the symplicity spyral system in subjects treated with renal denervation. additionally, long-term follow-up data will also be collected from eligible subjects previously treated in the spyral pivotal-spyral htn-off med and spyral htn-on med studies.


Eligibility criteria:
inclusion criteria: 1. individual is diagnosed with hypertension and has a baseline office systolic blood pressure ≥140 mmhg 2. individual has a baseline office diastolic blood pressure ≥ 90 mmhg 3. individual has an average systolic baseline home blood pressure ≥135 mmhg exclusion criteria: 1. individual lacks appropriate renal artery anatomy 2. individual has undergone prior renal denervation 3. individual has a documented condition that would prohibit or interfere with ability to obtain an accurate blood pressure measurement 4. individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea 5. individual has an estimated glomerular filtration rate (egfr) of \<45 6. individual has one or more episode(s) of orthostatic hypotension 7. individual is pregnant, nursing or planning to become pregnant 8. individual has primary pulmonary hypertension 9. individual has documented type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus with glycosylated hemoglobin greater than 8.0%
a study to assess whether pde5 inhibitors increase the chance of triggering the onset of acute naion

Conditions: Optic Neuropathy, Ischemic

Summary: the objective of this non-interventional study is to examine whether use of phosphodiesterase inhibitors (pde5s), including use of sildenafil, vardenafil, or tadalafil, triggers the onset of acute naion.

sites will identify patients who meet the entry criteria during the conduct of their normal practice. patients meeting these criteria will be offered participation in the study after reading and completing an informed consent document.

Eligibility criteria:
inclusion criteria: * male aged ≥45 years; * experienced abrupt visual change in only 1 eye exclusion criteria: * pain determined by an ophthalmologist to be consistent with an inflammatory/arteritic process or optic neuritis; * history of naion or optic neuritis. * participation in other studies within 60 days prior to entry in the study.

Keywords: optic neuropathy acute naion pde5 inhibitor
clinical and comparative evaluation of the treatment results of arthroscopic reconstruction of cartilage defects in the knee joint with the use of autogenous cartilage graft with prp gf (platelet-rich plasma with growth factors)

Conditions: Cartilage Damage; Cartilage Injury; Knee Injuries

Summary: clinical and comparative evaluation of the treatment results of arthroscopic reconstruction of cartilage defects in the knee joint with the use of autogenous cartilage graft with prp gf (platelet-rich plasma with growth factors)

the main goal of the research project is to evaluate the results of the treatment of arthroscopic reconstruction of cartilage defects in the knee joint with the use of an autogenous prp gf cartilage graft. the specific objectives are: to compare the results of treatment of analogous areas of the cartilage defects of the knee joint obtained in the study groups using two methods: microfracture and autogenous prp gf cartilage graft (auto cart-arthrex method). the results on the operated limb will be compared in both groups both between the groups and with the results of clinical and biomechanical tests on non-operated limbs.

Eligibility criteria:
inclusion criteria: * age 18-65 years; * surgery for acl damage to the knee joint; * arthroscopic surgery; * no prior knee surgical interventions; * no additional pathologies in this anatomical area; * informed consent of the patient to participate in the study. exclusion criteria: * age under 18 or over 65; * previous surgical interventions in the examined anatomical area; * additional pathologies in this area identified as part of preoperative diagnostics; * damage to the second knee joint; * failure to comply with the rigor of the same rehabilitation treatment protocol.

Keywords: cartilage injury damage defects techniques reconstruction
outcomes of periodontal regenerative treatment

Conditions: Periodontitis; Intrabony Periodontal Defect; Periodontal Regeneration

Summary: the aim of this recall study is to evaluate outcomes of surgical regenerative treatment of periodontal defects in a cohort of patient previously treated for gum disease at the royal london hospital as part of their periodontal care.

this study will be divided in two parts: part 1: a retrospective analysis of short-term outcomes of periodontal regenerative procedures undertaken at the barts royal london dental hospital (rldh); part 2: a single recall visit study in which patients identified through part 1 and willing to consent for the study will be reassessed for medium-term outcomes of the regenerative procedures previously undertaken. for part 1 historic data will be collected from available dental records at rldh and divided in: * timepoint 0: the latest available full mouth periodontal assessment before surgery and x-ray of site/s needing surgical intervention * timepoint 1: the latest available full mouth periodontal assessment after surgery and x-ray of same site/s at timepoint 0 for part 2 data will be collected from patients identified through part 1 and willing to give consent for a single study recall visit: •timepoint 2: single study outcome recall visit (full mouth periodontal assessment and x-ray of same site/s at timepoint 0). due to the nature of the study, the time elapsed between timepoint 0 and timepoint 2 can vary between 1 and 4 years.

Eligibility criteria:
inclusion criteria: inclusion criteria for part 1 of the study: * patient age 18 and older * patients that received periodontal regenerative surgical treatment at barts rldh from january 2017 to january 2019 with and without the use of any biomaterials, bone graft/substitute and membrane or combinations of those. * available full periodontal examination records after non surgical therapy to serve as a baseline for the study and not beyond 12 months before surgery * available radiographic examination of the tooth treated with surgical regenerative procedure at initial examination or after non surgical therapy to serve as a baseline for the study. additional inclusion criteria for part 2: -patient able and willing to give informed consent exclusion criteria: exclusion criteria for part 1: * all the patients that do not match the inclusion criteria will be excluded from part 1. * patients that received regenerative surgical treatment for the management of gingival recession. exclusion criteria for part 2: * unable or unwilling to give consent * pregnant women
kentucky leads collaborative: lung cancer survivorship care program

Conditions: Lung Cancer

Summary: the objective of the kentucky leads lung cancer survivorship care program is to develop, administer and evaluate the impact of a comprehensive psychosocial survivorship care program for individuals diagnosed with lung cancer and their caregivers to improve lung cancer survivorship and delivery of high-quality lung cancer care. the investigators hypothesize that the kentucky leads lung cancer survivorship care program will demonstrate improved quality of life, better symptom control, increased tobacco treatment, and reduced distress among lung cancer survivors and their caregivers.

the study design is a single-arm clinical trial, or a prospective cohort design, where a longitudinal series of data will be collected from participants. participants will be consented and asked to complete a baseline questionnaire (pre) which includes topics measuring quality of life, distress, symptom management, social support, healthy behaviors, demographics and health history. two similar questionnaires will be administered after exposure to the survivorship care program (post and fol). in addition, the consent form requests permission from survivors to collect clinical data from medical records and the kentucky cancer registry regarding diagnosis and treatment for lung cancer. the study will enroll 300 participants, with an estimate of approximately 30 participants enrolled at each site. however, if a participating site enrolls 30 participants and the overall study accrual has not yet been met, the study pi may allow that respective participating site to continue to enroll participants. study accrual is competitive across participating sites until the overall study accrual has been met.

Eligibility criteria:
inclusion criteria: * individuals who have been diagnosed with lung cancer (survivor) or * caregiver of a participating lung cancer survivor * ability to read and write in english exclusion criteria: * individuals with significant psychiatric disturbance that requires a higher level of care * individuals with substance abuse/dependence problem that require a higher level of care * incarcerate individuals or individuals detained within the legal system

Keywords: survivorship care caregiving
a clinical trial of mycobacterium w in critically ill covid 19 patients

Conditions: COVID-19

Summary: the trial is randomized, blinded, two arms, active comparator controlled, clinical trial to evaluate the safety and efficacy of mycobacterium w in combination with standard care as per hospital practice versus standard care alone in critically ill adult patients suffering from covid-19 infection.

in this study, eligible patients will be enrolled after due consent and will be randomized in balance to receive either test drug (along with the standard of care) or placebo (along with the standard of care). the enrolled patients will be monitored for any adverse events (aes) or serious adverse events (saes) throughout the study period. all patients will continue to receive standard therapy till considered requisite by the treating physician. in addition to the standard care for covid-19, patients randomized to test arm will receive single daily dose of 0.3 ml of mw, intradermal, for 3 consecutive days while patients randomized to control arm will receive single daily dose of 0.3 ml of placebo, intradermal, for 3 consecutive days. study duration for each patient will be upto 28 days post-randomization.

Eligibility criteria:
inclusion criteria: * critically ill patients infected with covid-19 (clinical/confirmed) * patient aged 18 years or more of either gender * illness of any duration with respiratory rate ≥25 breaths/minute, and at least one of the following: * radiographic infiltrates by imaging (chest x-ray, ct scan, etc.), or or * spo2 ≤94% on room air, or * requiring mechanical ventilation and/or supplemental oxygen * female patients of childbearing potential must have a negative pregnancy test within 14 days prior to first dose of study medication. * subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedure. exclusion criteria: * pregnant or nursing female. * patients with history of allergy, hypersensitivity, or any serious reaction to study medication * patients with a concomitant medical condition, whose participation, in the opinion of the investigator, may create an unacceptable additional risk. * patient previously enrolled into this study. * patient participating or having participated in a clinical trial with another investigational drug within the last 28 days except for investigational drugs against cancer, leukaemia or hiv. * patients with a life expectancy judged to be less than five days * alt/ast \> 5 times the upper limit of normal * stage 4 severe chronic kidney disease or requiring dialysis (i.e. egfr \< 30) * patients not likely to complete the trial as per judgment of the investigator.
xenon as an adjuvant to propofol anaesthesia in patients undergoing off-pump coronary artery bypass graft surgery.

Conditions: Coronary Artery Disease; Anesthesia

Summary: the investigators hypothesize that the application of 30% xenon as an adjuvant to general anesthesia with a target-controlled infusion of propofol is superior to general anesthesia with propofol alone with respect to hemodynamic stability.


Eligibility criteria:
inclusion criteria: * patients with coronary artery disease scheduled for elective opcab-surgery * patients willing and able to complete the requirements of this study * ejection fraction \>30% exclusion criteria: * lack of informed consent * age \< 18 years * copd gold \>ii * renal dysfunction defined as serum-creatinine \>1.5mg/dl * acute coronary syndrome during the last 24 hours; haemodynamic instability, requirement of inotropic support * single vessel grafting * disabling neuropsychiatric disorders (severe dementia, alzheimer's disease, schizophrenia, depression, low preoperative cognitive state (mmse at baseline \<25), history of stroke with residuals, increased intracranial pressure * hypersensitivity to the study medication * presumed uncooperativeness or legal incapacity

Keywords: xenon anesthesia off-pump coronary artery bypass graft surgery
a cohort for evaluation of open-label prep use and prep preferences among african women

Conditions: HIV Infections

Summary: insight is a prospective, observational, open-label cohort study on women in sub-saharan africa on prep screening, informed choice, and compliance. there are no specific intervention arms or comparative treatment plans. we will follow and observe participants taking prep, not taking prep, as well as those who begin or end prep during the course of the observational period.

primary goals: * estimate hiv incidence using recency testing on samples from women who screen out due to hiv infection, as well as assess hiv incidence prospectively in the cohort. * assess the characteristics of women who initiate prep compared to those who do not initiate prep. * evaluate young women's preferences for attributes of long-acting formulations of prep, using a discrete choice experiment. * assess the acceptability of a patient-facing prep decision support tool to provide young women more informed choice about prep options.

Eligibility criteria:
inclusion criteria: * 16-30 years of age * female exclusion criteria: * not sexually active * over 31 years of age at consent
autologous cultured corneal epithelium (ceca) for the treatment of limbal stem cell deficiency

Conditions: Limbal Stem Cell Deficiency

Summary: the study " autologous cultured corneal epithelium (ceca) for the treatment of corneal lesions associated with limbal stem cell deficiency" is the first clinical trial of this product manufactured at the loex laboratory. the culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency. the study is a phase i/phase ii study with the goal to evaluate safety and efficacy of the ceca graft for the treatment of human patients suffering from limbal stem cell deficiency. the trial is open to all genders. the inclusion of 5 minors is planned.


Eligibility criteria:
inclusion criteria: all genders * adults * minors * lscd in one or two eyes. a minimum of 1-3 mm2 of undamaged limbus is required for a biopsy to be taken without foreseeable adverse consequences for the donor eye exclusion criteria: * donor eye not sufficiently healthy to allow for the harvesting of a 1-3 mm2 limbal biopsy without foreseeable consequences for the donor eye * pregnancy * breast-feeding * incapacitated person * known allergy to aprotinine (trasylol (r)) * hypersensibility to bovine proteins
phase i study to evaluate the diagnostic performance of 89zirconium girentuximab pet in urothelial cancer patients

Conditions: Urothelial Carcinoma

Summary: the aim of this study is to determine if it is practical to use 89zr-tlx250 pet/ct in the staging and detection of localized and metastatic urothelial carcinoma or bladder cancer. the primary objective is to evaluate the feasibility of using 89zr-tlx250 pet/ctas a new diagnostic and staging modality to detect urothelial carcinoma or bladder cancer.

this will be a non-randomised, non-blinded, single centre, phase 1 feasibility study comparing 89zr-girentuximab pet with fdg pet in patients with urothelial carcinoma or bladder cancer. this study would include 2 cohorts of adult patients; those with known metastatic urothelial carcinoma and bladder cancer and those undergoing primary staging for recently diagnosed urothelial carcinoma or bladder cancer. this study is open-label, single centre and eligible patients will receive a single administration of study drug prior to imaging on day 5 (+/- 2 days). pet scans will be independently interpreted by nuclear medicine physicians blinded to the fdg pet findings. for patients proceeding to radical cystectomy, subsequent histological confirmation of areas of increased uptake will be retrospectively correlated with both pet scans.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 or older with bladder cancer or urothelial carcinoma who are able to provide informed consent 2. negative serum pregnancy test in female patients of childbearing potential at screening. confirmation of negative pregnancy test result from urine within 24 hours prior to receiving investigational product. 3. consent to practise double-barrier contraception until a minimum of 42 days after 89zr-tlx250 administration. exclusion criteria: 1. active malignancy other than urothelial carcinoma or bladder cancer 2. administration of a radioisotope within 10 physical half-lives prior to study enrolment. 3. administration of chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to planned administration of 89zr-tlx250 or continuing adverse effects from such therapy 4. planned antineoplastic therapies for the period between administration of 89zr-tlx250 and imaging 5. serious non-malignant disease that may interfere with the objectives of the study 6. renal insufficiency with glomerular filtration rate ≤45 ml/min/1.73m2 7. pregnancy or lactation 8. exposure to murine or chimeric antibodies within the last 5 years 9. known hypersensitivity or human anti-chimeric antibodies against girentuximab 10. exposure to any experimental diagnostic or therapeutic drug 30 days prior to the date of planned administration of 89zr-tlx250 11. contraindications to fdg pet/ct

Keywords: glandular and epithelial
effect of a uterine manipulator on the incidence of lymphovascular propagation (lvsi) in treatment of endometrial cancer

Conditions: Endometrial Cancer; LVSI

Summary: we retrospectively analyzed data and compared the impact of intrauterine manipulators on incidence of lvsi in endometrial cancer patients treated at our department.

endometrial cancers are among the epithelial malignancies of the lining in the uterine cavity. standard treatment is surgical, which includes a hysterectomy. the invasion of carcinoma into the lymphovascular space (lvsi - lymphovascular space invasion) is considered a risk factor for the course of the disease based on the recommended procedures of esgo-estro-esp (2020) in the management of endometrial cancer, in the event of significant lvsi positivity, the female patients are included in the upper-medium risk group. a confirmation of lvsi in the preparation is of diagnostic, therapeutic and theoretical importance. during endoscopy approach, we use two types of uterine manipulators, namely the koh-rumi manipulator (cooper surgical) and the hegar dilatator along with the mccartney tube (lina medical). we analyzed data and compared the impact of intrauterine manipulators on the incidence of lvsi. in addition, we analyzed tumor grading, invasion and primary histology obtaining methods - curettage or hysteroscopy in correlation to incidence of lvsi.

Eligibility criteria:
inclusion criteria: * endometrioid endometrial cancer, * planned primary surgical treatment - hysterectomy, * medical condition enabling anesthesia and surgery, * pre-surgical clinically-determined affecting of the uterine according to mri or ultrasound - ct1a or ct1b exclusion criteria: * non-endometrioid type of tumor in definitive histology, * stage 2 of a disease and higher, * previous chemo or radiotherapy, * inability to adequately complete the surgery, * uterine perforation during surgery
treatment with nivolumab at the fixed dose 40 mg (nivo40) in patients with relapsed/refractory hodgkins lymphoma

Conditions: Hodgkin Lymphoma

Summary: a phase i/ii trial to evaluate the safety and efficacy of nivolumab at the fixed dose 40 mg in patients with relapsed or refractory hodgkins lymphoma.


Eligibility criteria:
inclusion criteria: * diagnosis: histologically confirmed hodgkins lymphoma * relapsed or refractory disease after at least two prior lines of treatment * age 18-70 years old * signed informed consent * no severe concurrent illness exclusion criteria: * uncontrolled bacterial or fungal infection at the time of enrollment * requirement for vasopressor support at the time of enrollment * karnofsky index \<30% * pregnancy * somatic or psychiatric disorder making the patient unable to sign informed consent * active or prior documented autoimmune disease requiring systemic treatment.

Keywords: nivolumab
cryoablation of af: improving the use of the achieve catheter

Conditions: Atrial Fibrillation

Summary: according to data from high volume centres, documentation of entry block with the achieve catheter may be possible in only about to 50% of pulmonary veins. the investigators aim to assess strategies using the achieve catheter that can improve this performance.


Eligibility criteria:
inclusion criteria: * all consecutive patients undergoing atrial fibrillation cryoballoon ablation monitored with the achieve catheter. exclusion criteria: * patients in af at the beginning of the procedure * patients with a previous af ablation procedure

Keywords: atrial fibrillation balloon cryoablation pulmonary veins