Kornimate/medical-research-clean huggingface dataset:
mineral and bone disorders outcomes in stage 5d of chronic kidney disease

Conditions: End Stage Renal Disease; Hyperparathyroidism, Secondary

Summary: the mbd-5d is a prospective observational study with a case-cohort and a cohort design. eligible patients are receiving hemodialysis and have secondary hyperparathyroidism. the study's three goals are (1) to record the patients' characteristics, and variation in the patterns of their treatment; (2) to analyze factors associated with variation in those medical practice patterns; and (3) to identify practice patterns and other factors that affect hospitalization, mortality, and other patient-level outcomes.

the mbd-5d is a 3-year prospective observational study with a case-cohort and a cohort design. eligible patients comprise all patients who are receiving hemodialysis at the participating facilities, and who also have secondary hyperparathyroidism(2hpt). the study has 3 goals: to record the characteristics of those patients and variation in the patterns of their treatment; to analyze factors associated with variation in those medical practice patterns; and to identify the practice patterns and other factors that affect hospitalization, mortality, and other patient-level outcomes. in the case-cohort study, the outcomes are relatively infrequent events (all-cause and cardiovascular mortality). the cohort study includes a randomly selected sample of 40% of all study participants; and the outcomes are hospitalization, parathyroid interventions, bone fracture, mbd management status, etc. explanatory variables comprise medications and other factors likely to be associated with outcomes of dialysis and of 2hpt, and facility-level practice patterns.

Eligibility criteria:
inclusion criteria: * patients receiving hemodialysis * patients whose intact pth concentration is at least 180 pg/ml (106 pg/ml for whole pth) or patients who are receiving intravenous active vitamin d sterols or oral active vitamin d sterols (falecalcitriol) exclusion criteria: * patients have been undergoing hemodialysis for less than 3 months

Keywords: outcomes study hemodialysis ckd-mbd
covid-19: pediatric research immune network on sars-cov-2 and mis-c

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); Multisystem Inflammatory Syndrome in Children (MIS-C); Coronavirus Disease 2019 (COVID-19)

Summary: the primary objectives of this study are: * to determine the proportion of children with severe acute respiratory syndrome coronavirus 2 (sars-cov-2) related death, rehospitalization or major complications after infection with sars-cov-2 and/or multisystem inflammatory syndrome in children (mis-c), and * to determine immunologic mechanisms and immune signatures associated with disease spectrum and subsequent clinical course during the year of follow-up.

this is a prospective, multicenter, observational cohort study to assess short and long-term clinical outcomes and immune responses after severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection and/or multisystem inflammatory syndrome in children (mis-c) in children (e.g., defined as individuals who have not reached their 21st birthday at the time of enrollment). sars-cov-2 causes coronavirus disease 2019 (covid-19) participants will be identified through active recruitment measures within hospitals and through ambulatory and laboratory-based databases of sars-cov-2 positive individuals \<21 years of age. the study will enroll a minimum of 250 subjects from a diverse racial/ethnic background, from participating medical centers in the united states. the study period of participation is 1 year (12 months).

Eligibility criteria:
inclusion criteria: 1. severe acute respiratory syndrome coronavirus 2 (sars-cov-2) detection from a respiratory specimen, and/or 2. meets criteria for multisystem inflammatory syndrome in children (mis-c), and/or 3. meets criteria for mis-c, except has involvement of only 1 organ system cases meeting clinical criteria for mis-c but without known sars-cov-2 exposure, and who are being treated as mis-c by the treating physician, but with negative sars-cov-2 pcr and pending or negative antibody testing, may be enrolled as subjects. if subsequent antibody testing is positive, cases will be labelled as confirmed mis-c. if sars-cov-2 antibody testing is negative, subjects will be labeled at the end of the study as suspected/not confirmed mis-c. exclusion criteria: 1. subject and/or parent/guardian who are not able to understand or be willing to provide informed consent and where applicable assent --note, for this observational cohort study, participation in other covid-19 studies is not an automatic exclusionary criterion.

Keywords: participants <21 years of age observational cohort study immunological responses post infection
a study of ak146d1 for injection in the treatment of advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is an first-in-human, phase i clinical study aimed at evaluating the safety, tolerability, pk, immunogenicity, and preliminary antitumor efficacy of ak146d1 for injection in advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. be able to understand and voluntarily sign the written informed consent form. 2. aged of ≥ 18 years and ≤75 years. 3. ecog ps 0 or 1. 4. the expected lifespan is ≥3 months. 5. histologically-confirmed unresectable advanced solid tumors with disease progression or intolerance to standard treatment or no standard treatment available. 6. at least one measurable lesion according to recist v1.1. 7. have sufficient organ function. 8. females subjects must not be pregnant at screening or have evidence of non-childbearing potential. agree to use medically accepted methods of contraception exclusion criteria: 1. having other active malignancies within 3 years. 2. currently participating in another interventional clinical study. 3. presence of active metastases to the central nervous system. for patients with asymptomatic brain metastasis or stable symptoms after treatment can be included. 4. having received any treatment targeting trop2 or nectin4 or any treatment with topoisomerase i inhibitor agents. 5. having received systemic anti-tumor treatment within 4 weeks or 1 cycle interval of the regimen or major surgical operations within 4 weeks before the first administration. 6. toxicity of previous antineoplastic therapy has not resolved to nci ctcae 5.0 grade 1 or lower. 7. subjects with clinically significant cardiovascular or cerebrovascular diseases or risks. 8. subjects with active autoimmune diseases requiring systemic treatment within 2 years. 9. known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first dose. 10. known to be positive for hiv and other infections. 11. previous history of severe hypersensitivity reactions. 12. live attenuated vaccines were received within 4 weeks. 13. subjects with a history of mental illness and incapacitated or limited capacity. 14. any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.
a trial to investigate the effectiveness of testosterone treatment in men with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this is a multicenter, prospective, placebo-controlled, double-blind randomized phase ii clinical trial assessing the effect of testosterone treatment vs. placebo treatment for 96 weeks duration on whole brain atrophy in men with ms.


Eligibility criteria:
inclusion criteria: men, aged 18-60, with a diagnosis of multiple sclerosis by 2010 revised mcdonald criteria

Keywords: ms
prospective evaluation of the itclamp50 to provide temporary wound closure

Conditions: Hemorrhage; Wound Closure; Bleeding

Summary: early and effective control of severe bleeding is critical to survival of trauma patients. the itclamp™50 is a health canada approved medical device for temporary wound/skin closure that quickly controls bleeding by sealing the skin. similar to a clip, the device seals the skin edges within a pressure bar, enabling the creation of a hematoma where blood collects under pressure to form a stable clot until definitive repair. the itclamp50 is indicated for use as a skin closure device for short-term soft tissue approximation, including use in trauma wounds, lacerations, junctional bleeds or surgical incisions. the purpose of this prospective clinical study is to evaluate the effectiveness and safety of the itclamp50 in the ambulance (pre-hospital) and emergency department setting. this will be accomplished by observing patients with the device applied from the pre-hospital through to patient discharge. the hypothesis is that the itclamp50 will be safe and effective at providing temporary wound closure to control hemorrhage in the pre-hospital and emergency department setting.


Eligibility criteria:
inclusion criteria: * the device is indicated for use to control external hemorrhage from all compressible areas and to close wounds on the torso (chest and abdomen). the final decision to apply the device will be left with the care provider; however, their rationale will be reviewed in the post-use questionnaire. exclusion criteria: * the device is contraindicated for application to specific regions (e.g., eyes and genitals), application on patients less than the size of maturity, and wounds in which the skin edges cannot be approximated.

Keywords: hemorrhage control wound closure
effect of early use of levosimendan versus placebo on top of a conventional strategy of inotrope use on a combined morbidity-mortality endpoint in patients with cardiogenic shock

Conditions: Cardiogenic Shock

Summary: cardiogenic shock (cs) mortality remains high (40%). despite their frequent use, few clinical outcome data are available to guide the initial selection of vasoactive drug therapies in patients with cs. based on experts' opinions, the combination of norepinephrine-dobutamine is generally recommended as a first line strategy. inotropic agents increase myocardial contractility, thereby increasing cardiac output. dobutamine is commonly recommended to be the inotropic agent of choice and levosimendan is generally used following dobutamine failure. it may represent an ideal agent in cardiogenic shock, since it improves myocardial contractility without increasing camp or calcium concentration. at present, there are no convincing data to support a specific inotropic agent in patients with cardiogenic shock. our hypothesis is that the early use of levosimendan, by enabling the discontinuation of dobutamine, would accelerate the resolution of signs of low cardiac output and facilitate myocardial recovery.


Eligibility criteria:
inclusion criteria: adult patient ≥ 18 years with cardiogenic shock defined by: * adequate intravascular volume * norepinephrine to maintain map at least at 65 mmhg for at least 3 hours and less than 24h. at inclusion the dose must be \<1 microgram/kg/min under norepinephrine base or \<2 microgram/kg/min under norepinephrine tartrate, or/and dobutamine since at least 3h and less than 24h and at dose ≥ 5 microgram/kg/min at inclusion. * tissue hypoperfusion: at least 1 sign (lactate ≥ 2 mmol/l; mottling, capillary refeel time \> 3 seconds, oliguria \<500ml/24h or ≤ 20 ml/h during the last 2 hours, scvo2 ≤ 60% or veno-arterial pco2 gap ≥ 5 mmhg); exclusion criteria: * myocardial sideration after cardiac arrest of non-cardiac etiology * immediate or anticipated (within 6 hours) indication of extra corporel life support * use of va-ecmo or impella or lvad; * cardiogenic choc post cardiac surgery under cardiopulmonary bypass (cpbp) weaned for less or equal of 6 hours. * chronic renal failure requiring hemodialysis * cardiotoxic poisoning * septic cardiomyopathy * previous levosimendan administration within 15 days * cardiac arrest with non-shockable rhythm; * no flow time higher \> 3 minutes; * cardiac arrest with unknown no flow duration; * total duration of cardiac arrest (no flow plus low flow) \> 45 minutes; * cerebral deficit with fixed dilated pupils * patient moribund on the day of enrollment * irreversible neurological pathology * known hypersensitivity to levosimendan or placebo, or one of its excipients * pregnant woman, birthing or breastfeeding mother * minor (not emancipated) * person deprived of liberty for judicial or administrative decision; * adult subject to a legal protection measure (such as guardianship, conservatorship)

Keywords: heart failure levosimendan
a phase ii trial of pg2 in patients with advanced pharyngeal or laryngeal squamous cell carcinoma under concurrent chemoradiotherapy

Conditions: Cancer-related Fatigue

Summary: eighty to 90% of scchn (squamous cell carcinoma of head and neck) patients in taiwan were betel quid chewers. thirty to 40% of them experienced mucositis world health organization (who) grade 3 from cisplatin/flurouracil (fu) in neoadjuvant chemotherapy setting. this was higher than the 8-11% reported in the western populations and was related to oral submucous fibrosis from betel quid chewing.severer toxicities, esp. mucositis, could be anticipated in patients of betel quid chewing treated by concurrent chemoradiotherapy (ccrt) with cisplatin/fu.pg2 injection is proved to be safe for clinical use and is effective in stimulating the recovery of hematopoiesis and immunity from chemotherapy-induced myelosuppression. it also improved the quality of life, especially in fatigue, among advanced cancer patients. this study will be investigated the effect of pg2 injection in relieving the adverse events of concurrent chemoradiotherapy, such as fatigue, myelosuppression, mucositis, body weight loss, and even the compliance of radiotherapy and chemotherapy in treatment of patients with advanced pharyngeal or laryngeal scchn.


Eligibility criteria:
inclusion criteria: * histological confirmation of squamous cell carcinoma * primary tumor site in the head and neck area * stage iii or iv disease * measurable locoregional disease and no distant metastasis * no prior cancer treatment * 20-70 years old * kps ≧ 70 * adequate bone marrow, liver, and renal function * fed with gastric tubes but without intestinal malabsorption or obstruction * not pregnancy and use a reliable contraceptive method during the study * signed informed consent * willing and able to complete quality of life questionnaires exclusion criteria: * decompensated liver function * serious concomitant illness that might be aggravated by chemotherapy * active cardiac disease preceding the entry into the study * severe uncontrolled hypertension * uncontrolled infection * history of other malignancy * pregnant or breast feeding * receiving other concomitant chemotherapy, radiotherapy or any other anticancer treatment * mental status not suitable for clinical trials * intestinal obstruction or malabsorption.

Keywords: cancer-related fatigue astragalus polysaccharides concurrent chemoradiotherapy squamous cell carcinoma of head and neck
randomized controlled clinical evaluation to compare vanguard cruciate retaining and agc total condylar knee implants

Conditions: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis

Summary: this evaluation is being conducted on the relative new knee system, the vanguard cruciate retaining (cr) to evaluate clinical efficacy of the vanguard cr components.

this clinical trial was initially designed as a multi-centre, randomized controlled study, comparing the vanguard cr with the agc in routine use. the study now is a single centre study. the vanguard cr system has been specifically designed to give greater knee stability through the use of more anatomic patello-femoral kinematics.

Eligibility criteria:
inclusion criteria: * pre-op knee score of \<70 * scheduled to undergo primary total knee replacement with any of the following indication: 1. pain and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis. 2. one or more compartments involved. * need to obtain pain relief and improve function * ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations * a good nutritional state of the patient * full skeletal maturity of the patient, patients who are at least 18 years of age. * patients of either sex * consent form read, understood, and signed by patient exclusion criteria: * pre-op knee score greater than or equal to 70 * infection * osteomyelitis * previous partial or total prosthetic knee replacement on the operative side * skeletal immaturity of the patient, patients who are less than 18 years of age. * sepsis * uncooperative patient or patient with neurological disorders who are incapable of following directions * osteomalacia * distant foci of infections * rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram * vascular insufficiency, muscular atrophy, or neuromuscular disease in affected limb * incomplete or deficient soft tissue surrounding the knee
incidence, diagnosis, management and outcome of acute mesenteric ischemia

Conditions: Acute Mesenteric Ischemia

Summary: this is a prospective, multicentre observational study screening all adult patients admitted to a participating hospital over a 6-month study period (may be adjusted to 4-8 months according to recruitment) and including all patients with suspicion of or confirmed acute mesenteric ischaemia (ami). only admission data and hospital mortality outcome will be collected for patients in whom suspicion of ami is not confirmed. for patients with confirmed ami full data collection regarding diagnostics, management and long-term outcome is required. investigators aim to recruit 40-50 sites with expected median of 10-20 patients with confirmed ami per site during the study period (naturally depending on the size of the hospital). the start of the study is planned for spring 2022. the aim of the study is to identify the incidence of ami and its different forms in adult hospitalized patients, and to describe patient characteristics (demographic, clinical and laboratory) at baseline, applied diagnostics and management, as well as outcomes in patients with ami. an additional aim is to compare the baseline characteristics and outcomes of patients with confirmed ami to those of patients with suspected ami in whom the diagnosis was not confirmed.


Eligibility criteria:
inclusion criteria: all patients with suspected ami exclusion criteria: age \<18 years consent declined by patient or next of kin chronic mesenteric ischaemia without an acute event
a multi-centre randomized double blind 52-week study to assess the safety of qva149 compared to qab149 in patients with copd who have moderate to severe airflow limitation

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this study is to assess the safety and tolerability of two different doses of qva149 and qab149 in patients with moderate to severe airflow limitation.


Eligibility criteria:
inclusion criteria: * male and female adults aged ≥40 years * patients with stable copd according to gold strategy (gold 2011). * patients with airflow limitation indicated by a post-bronchodilator fev1 ≥ 30% and \<80% of the predicted normal, and a post-bronchodilator fev1/fvc \< 0.70. * current or ex-smokers who have a smoking history of at least 10 pack years. * patients with an mmrc ≥ grade 2 exclusion criteria: * history of long qt syndrome or prolonged qtc * patients who have had a copd exacerbation that required treatment with antibiotics and/or systemic corticosteroids and/or hospitalization in the 6 weeks prior to visit 1. * patients with type i or uncontrolled type ii diabetes * patients with a history of asthma or have concomitant pulmonary disease * patients with paroxysmal (e.g. intermittent) atrial fibrillation. only patients with persistent atrial fibrillation and controlled with a rate control strategy for at least six months could be eligible * patients who have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of safety * other protocol defined inclusion/exclusion criteria may apply

Keywords: copd, qab149, qva149, indacaterol maleate, gylcopyrronium bromide
antioxidant and immune effects of vitamin k2

Conditions: Oxidative Stress; Inflammation

Summary: the aim of the study is to obtain insight into a dose-dependent effect of vitamin k2 on oxidative stress and specific markers of the immune system.


Eligibility criteria:
inclusion criteria: * self-reported postmenopausal (at least one year after the final menstruation) * bmi ≥25 and ≤32 kg/m2; * plasma dp-ucmgp concentration in highest 50-66% of the screened population * non-smoking, defined as not smoking currently and not having smoked (at all) in the year before study start; * healthy as assessed by the health questionnaire and according to the judgment of the study physician; * voluntary participation; * having given written informed consent; * willing to comply with study procedures; exclusion criteria: * plasma dp-ucmgp concentration \>1000 pmol/l at screening * treatment with oral antibiotics within 2 months of the start of the study * any vaccination in the month before study start or any scheduled vaccination during the study period * use of antioxidant or vitamin k and d supplements; * use of antioxidant or vitamin k and d supplements in the month before the start of the study; * use of aspirin or medication with established antioxidant or anti-inflammatory properties; * use of medication that interferes with vitamin k or blood coagulation; * use of statins to reduce level of low-density lipoprotein cholesterol in the blood; * hyperlipidaemia, diabetes, hypertension, intestinal disease, diseases with an inflammation component; * hormone replacement therapy in women; * follow a vegetarian or vegan diet; * participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before day 1 of this study; * alcohol consumption for men \> 28 units/week and \>4/day; for women: \>21 units/week and \>3/day; * reported unexpected weight loss or weight gain of \> 3 kg in the month prior to pre-study screening, or intention to lose weight during the study period; * reported slimming or medically prescribed diet; * recent blood donation (\<1 month prior to day 01 of the study); * not willing to give up blood donation during the study;
diabetic neuropathy topical treatment

Conditions: Diabetic Neuropathy; Pain

Summary: comparative study of efficacy and safety of ketamine, clonidine, mixture of both and placebo in patients with diabetic neuropathic pain


Eligibility criteria:
inclusion criteria: * diabetes mellitus type i or ii * mono or polyneuropathy * treatment with tricyclic antidepressant, carbamazepine during 3 weeks at least * preserved cognition exclusion criteria: * ulcerative or infection or vesicle lesion in pain site * pregnancy * breast feeding

Keywords: neuropathic pain ketamine clonidine association