Kornimate/medical-research-clean huggingface dataset:
blender biomarkers: a blender sub-study to evaluate the effect of oxygen dose on oxidative stress and organ injury

Conditions: Cardiac Failure; Critical Illness

Summary: to compare the impact of liberal vs conservative oxygen doses on markers of oxidative stress in patients enrolled in the blender trial.

extracorporeal membrane oxygen (ecmo) is a heart lung support device used for patients with severe and cardiac and respiratory failure and carries an increased risk of exposure to very high oxygen tensions. hyperoxia (arterial oxygen \>100mmhg) can lead to the production of reactive oxygen species (ros). excess production of ros and depletion of antioxidant compounds is referred to as oxidative stress and results in inflammation, tissue injury and cell death. the inter-relationship between the production of ros and end organ dysfunction is complicated and remain unclear. a more detailed assessment of the timing of changes in markers of oxidative stress, inflammatory mediators and tissue injury is warranted to understand the processes and potentially identify therapeutic targets. the blender trial is a multicentre trial in ecmo patients to determine whether a conservative oxygen strategy during ecmo reduces icu length of stay and improves patient outcomes compared to a liberal oxygen strategy. currently there have been no studies that look at the underlying pathophysiological changes that occur in patients on ecmo when subjected to different oxygen concentrations. as such the blender study represents a unique opportunity to understand the mechanisms by which hyperoxia may cause tissue injury in patients receiving ecmo. this nested study seeks to elucidate whether exposure to hyperoxia during ecmo results in increased oxidative stress and whether this is correlated with increased risk of tissue injury and organ dysfunction. a better understanding of the mechanism of hyperoxia induced tissue injury may allow treatment to be optimised for patients exposed to hyperoxia as part of their treatment.

Eligibility criteria:
inclusion criteria: * patients receiving venoarterial (va) ecmo * enrolled in the blender trial exclusion criteria: * not enrolled in the blender trial

Keywords: ecmo v-a ecmo oxidative stress oxygen hyperoxia
prognostic value of non-invasive index of endothelial function.

Conditions: Chest Pain; Major Adverse Cardiovascular Events

Summary: the objective of this study is to determine the prognostic performance of endothelial function assessment, using endothelial peripheral arterial tonometry (endo-pat), associated to timi risk score, in patients consulting the emergency department for non-traumatic chest pain. to determine the sensitivity, specificity, negative and positive predictive value of this method that was not previously used for this purpose.

chest pain is a frequent reason for consultation in the emergency room, which can be as much as 5 to 10% of consultants. stratifying the cardiovascular risk for patients consulting for chest pain is sometimes difficult. the endothelium plays a crucial role in maintaining the tone and vascular integrity and in particular the secretion of vasodilator and vasoconstrictor mediators. in most vascular pathologies, this equilibrium will be broken by the attenuation of the vasodilating function of the endothelium. this is called endothelial dysfunction. several tools for measuring endothelial function have been developed, the main characteristics of which are: noninvasive, reproducible, independent operators, predictive of the disease, safe for subjects, inexpensive and easy to use. in this study we will be interested in digital plethysmography which has shown its effectiveness in: * screening for cardiovascular risk in asymptomatic subjects. * the risk of a new cardiovascular event in the sick. * evaluation of the response to certain therapies. goal of the study : the objective of this study is to to determine the prognostic performance of endothelial function assessment, using endothelial peripheral arterial tonometry (endo-pat), associated to timi risk score, in patients consulting the emergency department for non-traumatic chest pain. to determine the sensitivity, specificity, negative and positive predictive value of this method that was not previously used for this purpose, hence the originality of this study.

Eligibility criteria:
inclusion criteria: * any patient ≥ 25 years consulting for chest pain in the emergency department from 8:00 am to 8:00 pm (for the unavailability of the endopat device during the guard). exclusion criteria: * chest pain of traumatic origin. * hemodynamic instability. * myocardial infarction requiring urgent revascularization. * parkinsonism: tremor problem. * refusal, communication problem.

Keywords: endothelial function chest pain major adverse cardiovascular events endo-pat
pharmacokinetics of generic lopinavir/ritonavir in pregnant women

Conditions: HIV Infections

Summary: to determine the pharmacokinetic profile of generic lopinavir/ritonavir tablets to investigate the possible influence of pregnancy and duration of pregnancy to determine the antiviral activity and safety of generic lopinavir/ritonavir® compare pharmacokinetics parameters before and after pregnancy.

haart in pregnant hiv-infected serves two goals, preventing mother to child transmission and providing adequate treatment for the mother. levels of hiv rna at delivery and the use of antiretrovirals (arv) are independently associated with decreased transmission\[1\]. with a haart regimen the transmission rate can be reduced till under the 2 %\[1, 2\]. possibly suitable drugs which can be used during pregnancy is lopinavir/ritonavir based regimens. in thailand, aluvir is not available therefore a generic lopinavir/ritonavir tablet formulation will be used in our study. in order to prove adequate levels of lopinavir/ritonavir, we will record 12-hour pk at third trimester. second trimester and post-partum 12-hour pk are optional. furthermore, we will collect safety and efficacy throughout the study.

Eligibility criteria:
inclusion criteria: * documented positive test for hiv-1 infection * subject is at least 18 and not older than 40 years of age at the day of the first dosing of study medication * subject is able and willing to sign the informed consent form prior to screening evaluations. * pregnant for a maximum of 30 weeks at the day of first dosing of study medication exclusion criteria: * history of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the trial. * relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. * inability to understand the nature and extent of the trial and the procedures required. * abnormal serum transaminases or creatinine, determined as levels being \> 3 times upper limit of normal. * concomitant use of medications that interfere with generic lopinavir/ritonavir pharmacokinetics * active hepatobiliary or hepatic disease (n.b. chronic hepatitis b/c co-infection is allowed) * documented previous virological failure of a lopinavir/ritonavir containing regimen or documented resistance to lopinavir/ritonavir prior to dosing

Keywords: generic lopinavir/ritonavir pharmacokinetics pregnancy antiviral activity safety
magnetismm-4: umbrella study of elranatamab (pf-06863135) in combination with anti-cancer treatments in multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to determine the recommended phase 2 dose and clinical benefit of elranatamab in combination with other anti-cancer therapies in participants with multiple myeloma.


Eligibility criteria:
inclusion criteria: * relapsed/refractory multiple myeloma with at least 3 prior lines of therapy * refractory to at least one imid, one proteasome inhibitor, and one anti-cd38 antibody * measurable disease defined by at least one of the following: 1. serum m-protein \>/= 0.5 g/dl by spep 2. urinary m-protein excretion \>/= 200 mg/24 hours by upep 3. serum immunoglobulin flc \>/= 10 mg/dl (\>/= 100 mg/l) and abnormal serum immunoglobulin kappa to lambda flc ratio * ecog performance status 0 -1 * resolved acute effects of any prior therapy to baseline severity or ctcae grade \</= 1 exclusion criteria: * active plasma cell leukemia * amyloidosis * stem cell transplant with 12 weeks prior to enrollment, or active gvhd * poems syndrome * any active uncontrolled bacterial, fungal, or viral infection * impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment * previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study treatment (whichever is longer) * sub-study a only: previous treatment with bcma bispecific antibody * sub-study b only: previous treatment with bcma directed therapy

Keywords: pf-06863135, multiple myeloma, bcma, elranatamab, bispecific antibody, magnetismm-4
analysis of injury risk factors in elite athletes

Conditions: Athletic Injuries

Summary: background information. the different disciplines of athletics place high physical demands on athletes. these different categories of running vary in terms of physical effort and duration, generating different levels of risk of injury. the description of the main injuries that affect elite athletes in the different athletics disciplines, as well as the identification of the specific risk factors of each discipline, will allow the identification of preventive measures to be implemented. objective. to identify the risk factors for tendon injury in professional long- and middle-distance athletes, according to the type of event, and to identify the best predictive model for tendon injuries based on anthropometric and athletic variables. method. ambispective cohort study. 81 elite athletes will be recruited. the primary variable will be the number of tendon injuries in the last three seasons. the secondary and modifying variables will be: age (in completed years), weekly training load (in minutes), type of footwear (sneakers without carbon plate, sneakers with carbon plate, spiked sneakers without carbon plate and spiked sneakers with carbon plate), diet (balanced, high in carbohydrates, high-protein, controlled hypocaloric and adapted to the training cycle) and the regular practice of another physical activity. the possible confounding variables will be the body mass index, the date of tendon injuries in that period and the time spent as a federated athlete (in completed months). the analysis will calculate the risk of injury in these athletes and assess the influence of confounding factors and trend analysis on the primary variable, stratified by possible confounding factors. expected results. to calculate the risk of injury in elite athletes based on anthropometric and sociodemographic variables. to identify the predictive model of tendon injuries in elite athletes


Eligibility criteria:
inclusion criteria: * elite federated athletes * who have not undergone previous musculoskeletal surgery in the seasons under study * who were federated at least one year before the study period * sign the informed consent document. exclusion criteria: * athletes who have not participated in competition, during the study seasons, for a period of more than 6 months due to a musculoskeletal injury

Keywords: muscle injury athletics risk secondary prevention physiotherapy
clinical study of geranium wilfordii combined with androgen deprivation in neoadjuvant therapy of prostate cancer

Conditions: Prostate CA

Summary: the high incidence of prostate cancer is one of the important diseases that threaten the health of old men in our country. although androgen deprivation therapy is an important treatment option for prostate cancer, although neoadjuvant androgen deprivation therapy combined with radical prostatectomy reduced the positive rate of surgical margins, it did not show statistically significant improvement in prostate-specific antigen (psa). at the same time, few trials reported pathological complete response (pcr) and minimal residual lesion (mrd). the purpose of this project is to verify the efficacy of geranium combined with androgen deprivation in the treatment of locally advanced prostate cancer or oligometastatic prostate cancer before radical prostatectomy through randomized controlled clinical trials, so as to find an effective treatment for locally advanced prostate cancer or oligometastatic prostate cancer.

this study will divide patients into two sections, and eligible patients will be enrolled. patients with locally advanced prostate cancer or oligo-metastatic prostate cancer were divided into geranium combined androgen deprivation therapy group and androgen deprivation therapy group according to a computer-generated random sequence. in the treatment group, except for continuous androgen deprivation treatment, geranium geranium decoction was taken orally every day; the control group only received continuous androgen deprivation therapy, and the usage was the same as the treatment group. after starting the intervention, all patients should be followed up in our hospital 7, 14, 28, 56, 84 days after treatment to review blood psa and other indicators. at the end of the treatment, imaging examinations were followed up and radical prostatectomy was performed 3 weeks later (±7 days).

Eligibility criteria:
inclusion criteria: * ① age ≥18 years and ≤85 years; * histologically confirmed prostate cancer without small cell features; * metastatic prostate cancer was identified by imaging examination with ≤5 oligometastases (bone or lymph node metastases) or ct3-4 stages; ④the score of ecog (eastern cooperative oncology group) was 0-1; ⑤ all patients voluntarily sign informed consent, and can adhere to treatment and follow-up; exclusion criteria: * ①any previous or ongoing pca treatment, including radiotherapy, chemotherapy, adt, etc. * previous prostatectomy; * any other serious basic medical, mental, psychological, and other diseases that, in the judgment of the investigator, may affect the treatment of the patient * allergic to the drugs used; ⑤ refuse to undergo radical prostatectomy; ⑥ according to the investigator's judgment, it is not suitable to participate in this clinical trial;
a study of molidustat for correction of renal anemia in dialysis subjects

Conditions: Anemia; Renal Insufficiency, Chronic

Summary: the purpose of this study is to evaluate the efficacy and safety of molidustat in dialysis subjects with renal anemia who are not treated with erythropoiesis-stimulating agents (esas)


Eligibility criteria:
inclusion criteria: * subject with end-stage kidney disease (eskd) on dialysis (including, hemodiafiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly * body weight \> 40 and ≤ 160 kg at screening * male or female subject ≥ 20 years of age at screening * at least one kidney * not treated with esas and/or hif-ph inhibitors within 8 weeks prior to randomization. however, in case of the patient washed out from esas, when the mean hb (at least 2 central laboratory measurements must be taken ≥ 2 days apart before dialysis) has decrease to ≥ 0.5 dl from the hb level (central laboratory measurement, before dialysis) after the last esa administration, and the interval from the last esa administration to the study drug assignment was over 1 week for epoetin-alpha, 2 weeks for darbepoetin alpha or 4 weeks for epoetin beta pegol * mean of the last 2 hb level (central laboratory measurement, before dialysis) during the screening period must be ≥ 8.0 and \< 10.0 g/dl (2 measurements must be taken ≥ 2 days apart and the difference between the 2 measurements must be \< 1.2 g/dl) with the last screening hb measurement within 14 days prior to study drug assignment * ferritin ≥ 50 ng/ml at screening exclusion criteria: * new york heart association (nyha) class iii or iv congestive heart failure * history of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6 months prior to randomization * sustained and poorly controlled arterial hypertension (defined as systolic bp≥ 180mmhg or diastolic bp ≥ 110mmhg) or hypotension (defined as systolic bp \< 90mmhg) at randomization * proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation)
osa in children referred for adenotonsillectomy

Conditions: Obstructive Sleep Apnea

Summary: in children with osa (obstructive sleep apnea) adenotonsillectomy is regarded as the first choice of treatment. studies in recent years have shown that the procedure does not always have the expected effect. children with osa are at greater risk for complications from the procedure. there is disagreement regarding the need for sleep studies in children prior to surgery in order to verify an osa diagnosis. today less than 10% of these children have polysomnography (psg). the main purpose of this study is to describe the prevalence of osa among children referred for adenotonsillectomy. the investigators will also examine these children prior to and six months after surgery to assess their sleep pattern and quality of life. the project outcome aims to improve the precision and quality of diagnosis and the short and long term effects of treatment of children with osa.


Eligibility criteria:
inclusion criteria: * age 2-5 year * referred for adenoidectomy and/or tonsillectomy exclusion criteria: * craniofacial anomalies * neurological diseases * neuropsychiatric diseases
a study to evaluate the efficacy and safety of cjc-1134-pc in patients with type 2 diabetes who are currently on metformin monotherapy

Conditions: Type 2 Diabetes Mellitus

Summary: this is a multicenter, randomized, placebo-controlled, double-blind, phase ii study. the objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with cjc-1134-pc in patients who are currently on metformin monotherapy.


Eligibility criteria:
major inclusion criteria: * bmi: 27 to 45 kg/m2 * stable type 2 diabetes mellitus for at least 3 months, as defined by the investigator * stable life-style, i.e. diet \& physical activity, as determined by the investigator * stable metformin daily dose ≥1000 mg for at least 3 months * glycosylated hemoglobin (hba1c) at screening ≥ 7.1% and ≤ 11%

Keywords: glp-1, incretin, type 2 diabetes
a comparison of 0.5% loteprednol etabonate versus 1% prednisolone acetate following cataract surgery

Conditions: Intraocular Inflammation

Summary: patients are routinely given steroid eye drops following cataract surgery. this study will compare 2 approved drops:loteprednol etabonate versus prednisolone acetate eye drops used following cataract surgery. patients will be randomly assigned to one drop or the other, and evaluated for inflammation and intraocular pressure as part of the comparison. the study doctor will be masked as to which drop the patient receives to avoid bias.


Eligibility criteria:
inclusion criteria: * subjects age 18 and older undergoing routine cataract surgery. exclusion criteria: 1. subjects being treated for elevated intraocular pressure, retinopathy, maculopathy, cornea or vitreous opacities that would interfere with visual acuity. 2. subjects with diabetes, pseudoexfoliation, uveitis, corneal endothelial disease, or active herpes simplex virus(hsv) or herpes zoster virus(hzv) pupil stretch and/or limbal relaxing incision(lris) will be allowed. 3. subjects with previous ocular trauma or intraocular surgery 4. subjects with sensitivities to steroids. 5. women who are not post-menopausal or are of child bearing potential will be excluded. 6. intraoperative complications during surgery including posterior capsule rupture and vitreous loss 7. subjects with best visual potential in the fellow eye worse than 20/60 8. subjects who are expected to require concurrent ocular or systemic therapy with non-steroidal anti-inflammatory drugs (nsaids) mast cell stabilizers, antihistamines, or decongestants within 2 days prior to or during the 21 days following surgery. (intraoperative nsaids for mydriasis are permitted.) 325 mg aspirin is permitted. 9. subjects who are expected to require concurrent ocular or systemic corticosteroids, immunosuppressants (including restasis) within 14 days prior to or 21 days following surgery

Keywords: intraocular inflammation following routine cataract surgery
chronobiology of meal timing: effects on vascular and renal function

Conditions: Hypertension

Summary: the purpose of this study us to investigate the effects of mistimed eating on blood pressure, kidney function and vascular function.

despite advancements in pharmacologic antihypertensives, hypertension currently affects 1 in 3 americans and accounts for more than $50 billion of health care spending. importantly, hypertension is the leading cause of cardiovascular (cvd) and kidney diseases (ckd). as a result, the aha/acc lowered the diagnostic criteria for hypertension to encourage earlier preventative lifestyle intervention. there is a critical need to identify and implement novel lifestyle interventions in individuals with early-stage hypertension to prevent the subsequent development of cvd and ckd. chronotherapy that aligns behavioral cues (such as time of eating) with the body's internal biological clocks, has gained much attention as a potential strategy to prevent and manage hypertension, however, the underlying mechanisms are not yet fully understood. the purpose of this study is to investigate the effects of mistimed eating on blood pressure, kidney function and vascular function.

Eligibility criteria:
inclusion criteria: * men and women aged 18-45 years * elevated (sbp 120-129; dbp \<80 mmhg) or stage 1 hypertension (sbp 130-139; dbp 80-89 mmhg) exclusion criteria: * history of chronic disease (cv, lung, cancer, renal, sleep apnea, diabetes, autoimmune) * anti-hypertensive medication use * currently pregnant or lactating * current shift worker * travel \>3 time zones four weeks before the start of the study or during the study * insomnia * practiced intermittent fasting in past six months * current nicotine use * current hormone replacement therapy * current melatonin use * current use of antioxidants and unwilling to stop taking them for the duration of the study * unable to provide informed consent
human papilloma virus dna self-test

Conditions: Papilloma Virus, Human

Summary: hpv dna testing by a clinician has been shown to be highly sensitive in detecting cervical disease. can we prove that hpv self-testing will be sufficiently sensitive to detect disease in high risk population who for various reasons would not have routine pap smear screening?

women between the ages of 18 years to post-menopausal with documented abnormal pap smear atypical squamous cells of undetermined significance and higher will be enrolled into the study. patients will be taught how to collect vaginal samples with dacron swab and vaginal tampons by means of instructional video and manufacturer's instruction guide respectively. physicians will perform pap smear and colposcopy. all samples will be sent to the university of louisville lab for processing for hpv dna detection by hybrid capture 2 method.

Eligibility criteria:
inclusion criteria: abnormal pap smear ascus or higher age 18-postmenopausal exclusion criteria: less than 18 years old prior hysterectomy pregnancy use of corticosteroids hiv positive

Keywords: human papilloma virus