Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of tirelizumab plus chemotherapy versus chemotherapy alone in patients with lymph node positive gastric cancer after surgery

Conditions: Gastric Cancer

Summary: lymph node positive patients after d2 radical surgery for gastric cancer, who started to be treated at yixing people's hospital in april 2021, were selected and enrolled into the study group according to the patients' wishes: immune (tirelizumab) combined with chemotherapy (xelox regimen) or control group: chemotherapy alone (xelox regimen). each enrolled patient signed an informed consent form approved by the ethics committee, signed, and dated. efficacy and adverse effects were assessed in both groups.


Eligibility criteria:
inclusion criteria：(1) with a good bone marrow reserve, e. g. : leukocytes ≥ 4 × 109 / l, neutrophils ≥ 1.5 × 109 / l, platelets ≥ 100 × 109 / l and hemoglobin ≥ 90 g / l.(2) cardiopulmonary function was unremarkable.(3) there were no abnormalities in liver and kidney function. for example: creatinine ≤ 1.5 × uln or a calculated serum creatinine clearance ≥ 50 ml / min (calculated according to the cockcroft gault formula), albumin ≥ 30 g / l, and total bilirubin ≤ 1.5 × uln, alanineaminotransferase (alt) / aspartate aminotransferase (ast) ≤ 2 × uln.(4) international normalized ratio / activated partial thromboplastin time ≤ 1.5 × uln.(5) age older than 18 years, karonfsky performance status (kps) score ≥ 80, and premedication patients' bone marrow status, liver and kidney function, and cardiopulmonary function had little impact on prognosis. exclusion criteria: had a previous history of immunodeficiency, or had other acquired, congenital immunodeficiency diseases, or a history of organ transplantation; preexisting thyroid dysfunction and, with medical therapy, thyroid function still cannot be maintained within the normal range; women who were pregnant or lactating; those with a history of substance abuse who are unable to abstain or who have a mental disorder.
coronary artery bypass and nitrate oral supplementation

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine whether oral sodium nitrate administration prior to coronary artery bypass surgery can reduce perioperative levels of troponin t. in addition, plasma and urine surrogate markers of renal, hepatic and brain injury will be monitored.

nitric oxide (no) is an important mediator in the cardiovascular system and has been shown to have protective properties in ischemia-reperfusion injury. inorganic nitrate, an oxidation product from endogenous no production and also a constituent in green leafy vegetables, can be recycled, via nitrite, back to bioactive no in the body. recent research has shown beneficial effects of nitrate and nitrite in animal models of myocardial ischemia-reperfusion injury. moreover, dietary nitrate reduces blood pressure and oxygen cost during exercise in humans. during coronary bypass surgery the heart undergoes ischemia-reperfusion injury and troponin t is most often released from the myocardium. the aim of the present study is to investigate if preoperative inorganic nitrate, in doses easily achievable from the diet, can affect troponin t release as well as other surrogate markers of injury to the liver, kidneys and the brain. in addition, plasma and urine samples will be collected for markers of oxidative stress and inflammation (scrp and cytokines). patients planned for bypass surgery who give their written informed consent will, the night before surgery, get a standardized, low-nitrate meal where after they receive sodium nitrate on two occasions preoperatively; the night before and in the morning before surgery. plasma and urine samples will be collected at various time points up to 72 hours after surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing coronary artery bypass surgery * over 18 years of age exclusion criteria: * over 80 years of age * pregnancy * reoperation * intended heart valve or additional surgery * angina or troponin release above 45 nmol/l \< 48 hours before surgery * medication with organic nitrates/nitrites \< 24 hours before surgery * medication with glibenclamide or corticosteroids * significant renal, pulmonary or hepatic disease

Keywords: sodium nitrate coronary artery bypass surgery ischemia-reperfusion myocardial injury
nutritional supplementation of flavonoids quercetin and curcumin for early mild symptoms of covid-19

Conditions: COVID-19

Summary: the purpose of this study is to investigate the therapeutic benefits of flavonoids nutritional supplements quercetin and curcumin for early mild symptoms of covid-19.

flavonoids nutritional supplements quercetin and curcumin have demonstrated strong antioxidant, broad-spectrum anti-viral and anti-inflammatory properties including against the respiratory tract infections. they are widely used to boost the immunity against infections and keeping healthy life-style. results from recent published studies have shown positive results for quercetin and curcumin in patients with covid-19. in the present study the investigators aim to study the combined beneficial effects of quercetin and curcumin in addition to standard of care for managing early mild symptoms of covid-19 in community-based patients.

Eligibility criteria:
inclusion criteria: * patients must be 18 years of age or older, of either gender * patients must be tested positive for sars-cov-2 by rt-pcr * patients must exhibit typical symptoms of covid-19 disease at screening such as fever, fatigue, a dry and contagious cough, loss of appetite, body aches, shortness of breath, mucus or phlegm, sore throat, headache, chills, sometimes withshaking, loss of smell or taste, congestion or runny nose, nausea, or vomiting, diarrhea, muscular pain etc. * patients must be in the early stage of covid-19 disease who do not require hospitalization at the time of screening * patients must be under the care of a physician for diagnosis of covid-19 * patients who have signed informed consent exclusion criteria: * patients with proven hypersensitivity or allergic reaction to quercetin or curcumin * patients with known chronic kidney disease with estimated creatinine clearance \< 50 ml/minute or need for dialysis * patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure * patients taking anticoagulant/antiplatelet drugs such as coumarine, heparine, aspirin, clopidrogel, dalteparin, enoxaparin, ticlopidine and warparin. * patients with gallstone obstruction * hypothyroid suppering patients * patients with moderate or severe thrombocytopenia (platelet count \<100 ×10⁹/l); * pregnant patients
study to evaluate the safety of co-administration of gsk biologicals' poliorix and infanrix in healthy children in russia

Conditions: Poliomyelitis

Summary: the purpose of this study is to assess reactogenicity and safety of simultaneous administration of gsk biologicals' inactivated poliomyelitis vaccine poliorix and gsk biologicals' dtpa-vaccine infanrix vaccines in healthy children in russian federation in their first year of life according to national calendar of prophylactic immunisation of russian federation.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female aged 3 months including at the time of the vaccination. * written informed consent obtained from the parent of the subject. * healthy subjects as established by medical history and clinical examination and thermometry before entering into the study, that don't have contraindications for vaccination against diphtheria, tetanus, pertussis and poliomyelitis exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth. * administration of immunoglobulins and/or any blood products from birth or planned administration during the study period. * planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the vaccination, except recombinant hepatitis b vaccine, haemophilus influenzae type b vaccine and seasonal/pandemic influenza prophylactic. * participation in another clinical study at any time during the study, in which the subject has been or will be exposed to an investigational or a non-registered product (pharmaceutical product or device). * previous vaccination against diphtheria, tetanus, pertussis and poliomyelitis if by any reasons it was made in timeframe not stated by national calendar of prophylactic vaccines of russian federation. * medical history of convulsions and progressive neurological disease. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination (no laboratory testing required). * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * chronic diseases and serious congenital defects. * acute disease at the time of enrolment.

Keywords: poliomyelitis diphtheria primary immunization pertussis children tetanus
effects of rock climbing on parkinson's disease

Conditions: Parkinson Disease

Summary: this research study is being conducted to understand the outcomes of participation in the up ending parkinson's rock climbing program (24 sessions, or twice per week for about 12 weeks) on walking \& mobility, hand strength \& dexterity, and psychological well-being in individuals with parkinson's disease (pd). the rock climbing sessions are administered and supervised by up ending parkinson's, and are tailored to the skill level of the participant. participants will answer questionnaires and complete physical performance tests twice, first prior to beginning the sessions and then again after the 24 sessions have been completed.

parkinson's disease (pd) compromises multiple systems (neurological, musculoskeletal, cardiopulmonary, cognitive) over time, leading to functional decline. additionally, individuals with pd may experience stressors commonly associated with chronic illness that can negatively impact psychological well-being. exercise is commonly prescribed for individuals with pd and recently, interventions that are vigorous in nature and community- and performance-based are gaining traction (e.g., dancing, boxing, rock climbing). despite increasing popularity, the evidence-base for these programs is still developing and far from conclusive. recommendations are strong for: community-based exercise, intensive aerobic and resistance training, and external cueing (osborne et al., 2022). rock climbing (rc) contains each of these elements and could potentially be a therapeutic intervention for people with pd. yet little is known about the outcomes of this particular form of organized physical activity programs for this health condition. one such program is the rock climbing experiences offered by the upending parkinson's rock climbing (ueprc). the specific aims of this study are to characterize the effects of ueprc on: 1) mobility and walking; 2) upper extremity (ue) functioning and 3) psychological and social well-being. participants will complete 24 rock climbing sessions tailored to their skill levels supervised by ueprc over approximately 12 weeks.

Eligibility criteria:
inclusion criteria: * at least 18 years old * diagnosis of parkinson's disease * hoehn \& yahr score 1-3 * able to speak and read in english; * able to ambulate at least 10 meters with no assistive device or human assistance exclusion criteria: * neurological disease diagnosis other than pd; * uncontrolled cardiovascular, pulmonary, neurological, or metabolic disease which may impact the ability to exercise or in which exercise is contraindicated; * cognitive or psychiatric impairment precluding informed consent or ability to following instructions; * pregnancy; * inability to ambulate 10 meters without assistive device or human assistance
learning curve of aortic arch replacement surgery in chinese mainland with stanford type a aortic dissection

Conditions: Cumulative Sum Learning Curves; Stanford Type A Aorta Dissection

Summary: stanford type a aortic dissection is the most common cause of death caused by aortic disease in chinese mainland. patients who are hospitalized need immediate surgical treatment.emergency aortic arch replacement is difficult and risky. different surgical methods have different effects on postoperative prognosis. aortic arch replacement is divided into total-arch replacement (sun's operation) and hemi-arch replacement. in this study, and the learning curve of aortic arch replacement surgery was evaluated with cumulative cum curve.


Eligibility criteria:
inclusion criteria: * age over 18 years who underwent surgery for stanford type a aorta dissection without concurrent cardiac surgery exclusion criteria: * data miss greater than 10%
interest of plasma micrornas

Conditions: Septic Shock

Summary: icu acquired muscle weakness (iamw) is a common disease that is associated with high morbidity and mortality. patients with septic shock are particularly at risk. the diagnosis of iamw is clinical and based on the rating of the medical research council score (mrc score). a mrc score lower than 48 defines the iamw. but this evaluation is only usable in sufficiently awaken patients. several studies have highlighted the role of micrornas in regulating physiological processes and diseases related to the skeletal muscles. to date, no study was interested in iamw. the aim of this study is to compare the microrna detection kinetics on the appearance of iamw. in septic shock patients, the kinetics of nine micrornas will be compared between two groups: those with iamw (iamw + group) and those without iamw (iamw - group).

micrornas (mir-1, mir-21, mir-133, mir-155, mir-206, mir-208a, mir-208b, mir-486, mir-499) will be measured at day 1, day 2, day 5 and day 7 after septic shock onset.

Eligibility criteria:
inclusion criteria: patients with septic shock criteria: * at least two of the following criteria: temperature \ 38 ° c, heart rate \> 90 beats / minute, respiratory rate\> 20 breaths / minute or paco2 \ 12,000 / mm3 or \< 4000 / mm3 * refractory hypotension (blood pressure \< 90mmhg or need norepinephrine) or lactate ≥ 4 mmol / l exclusion criteria: * age\<18years * patients with preexisting neuromuscular disease * pregnancy * moribund patients with early therapeutic limitation * patients who had a seizure in the last 6 months

Keywords: muscle weakness micrornas septic shock
randomized, double-blind safety and efficacy study of lisdexamfetamine dimesylate (ldx) in children and adolescents aged 6-17

Conditions: ADHD

Summary: the main aim of this study is to see if giving ldx to children and adolescents aged 6-17 years with adhd decreases symptoms of adhd.


Eligibility criteria:
inclusion criteria: 1. subject is a male or female aged 6-17 years inclusive at the time of consent. 2. subject must meet diagnostic and statistical manual of mental disorders, fourth edition - text revision (dsm-iv-tr) criteria for a primary diagnosis of adhd based on a detailed psychiatric evaluation. 3. subject must have a baseline adhd-rs-iv total score ≥28. 4. subject has blood pressure measurements within the 95th percentile for age, gender, and height at screening and baseline. 5. subject is able to swallow a capsule. exclusion criteria: 1. subject has failed to respond to more than one adequate course (dose and duration) of stimulant therapy. one course must have been a long-acting formulation. 2. subject has a conduct disorder. oppositional defiant disorder is not exclusionary. 3. subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently, demonstrating active suicidal ideation. 4. subject has glaucoma. 5. subject weighs less than 22.7kg (50lbs). 6. subject is significantly overweight based on centre for disease control and prevention body mass index (bmi)-for-age gender specific charts at screening. significantly overweight is defined as a bmi \>97th percentile for this study. 7. subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or methylphenidate. 8. subject has a documented allergy, hypersensitivity, or intolerance to any excipients in the test or reference products. 9. subject has a history of seizures (other than infantile febrile seizures), a tic disorder, or a current diagnosis and/or a known family history of tourette's disorder. 10. subject has a known history of symptomatic cardiovascular disease, advance arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug. 11. subject has a known family history of sudden cardiac death or ventricular arrhythmia. 12. subject is well controlled on their current adhd medication with acceptable tolerability. 13. subject has a pre-existing severe gastrointestinal tract narrowing (pathologic or iatrogenic).
strength training for osteoporosis prevention during early menopause

Conditions: Bone Loss; Bone Loss, Age-related; Osteoporosis; Musculoskeletal Diseases

Summary: the goal of this clinical pilot trial is to learn about the feasibility of a high-intensity resistance training intervention in peri- and early menopausal females. the main question it aims to answer are: -is a 9-month resistance training intervention feasible (e.g., recruitment rates, protocol adherence, attrition) secondary aims include examining changes in bone health, muscle strength, and menopausal symptoms. participants will participate in a 9-month progressive, supervised, resistance training intervention. researchers will compare secondary outcomes between the exercise group and a wait-list control group.

the stop-em trial will examine a 9-month supervised, progressive, resistance training program in peri- and early menopausal females. primary outcomes include recruitment rates, protocol adherence, and attrition. a waitlist control group will allow us to examine the effect of the exercise program on bone density, structure, and strength, muscle strength, and menopausal symptoms. participants will be randomized to the exercise or control group. the exercise group will attend twice weekly, in-person, supervised, progressive resistance training and build up to 80-90% of estimated 1 repetition maximum (1rm). the study will take place at the university of calgary. findings will be used to decide whether to continue to the definitive trial.

Eligibility criteria:
inclusion criteria: * 45-60 years old. * menopause status of peri- or early menopausal: stages -2 or -1 of the stages for reproductive aging 10+ staging system or are within 5 years of their last known menses. exclusion criteria: * females who are pregnant or planning pregnancy within the next year. * orthopaedic conditions that may be made worse with exercise. * has low back pain, hypertension, lipidemia, diabetes, or cardiovascular disease. * has a history of metabolic bone disease. * has had an osteoporotic fracture within the last 5 years. * had previous treatment with osteoporosis pharmacotherapy. * has active glucocorticoid use. * is currently participating in progressive resistance training or has in the previous 6 months. * has low serum vitamin d (25(oh)d) \< 30 nmol/l or serum calcium \<2.10 mmol/l.

Keywords: exercise resistance training strength training
a dose-escalation study of enmd-2076 administered orally to patients with advanced cancer

Conditions: Advanced Cancer

Summary: a dose-escalation trial designed to assess the safety and tolerability of treatment with enmd-2076 administered orally over a range of doses in patients with advanced cancer that is refractory to current treatment or for which no curative therapy exists.


Eligibility criteria:
inclusion criteria: * have histologic proof of advanced cancer that has progressed after treatment and has no standard therapy that is curative or provides clinical benefit. * meet the modified recist criteria or have disease that can be followed for clinical benefit. * are greater than or equal to 18 years of age. * ast and alt ≤ 2.5 times upper limit of normal (uln) * total bilirubin ≤ uln * creatinine ≤ 1.5 x uln * absolute neutrophil count ≥ 1500 cells/mm3 * platelets ≥ 100,000/mm3 * hemoglobin ≥ 9.0 g/dl * have an eastern cooperative oncology group (ecog) performance status of 0 or 1 * agree to use effective contraceptive methods prior to study entry, during study participation, and for at least 30 days after the last administration of study medication. * have the ability to understand the requirements of the study, provide written informed consent which includes authorization for release of protected health information, abide by the study restrictions, and agree to return for the required assessments. exclusion criteria: * women who are pregnant or nursing. * have received radiotherapy or chemotherapy less than two weeks prior to first dose of study medication and have not recovered from all acute toxicities from prior treatments. * have participated in any clinical trial involving conventional or investigational drugs within 28 days prior to initiation of enmd-2076 dosing. * have active, acute, or chronic clinically significant infections. * have uncontrolled severe hypertension or congestive heart failure. * have active angina pectoris or recent myocardial infarction (within 6 months). * have chronic atrial fibrillation or qtc of greater than 470 msec. * have had major surgery within 21 days of starting therapy. * have planned surgical treatment of tumor(s) * have additional uncontrolled serious medical or psychiatric illness. * have any medical condition that would impair the administration of oral agents including significant bowel resection, inflammatory bowel disease or uncontrolled nausea or vomiting. * have a 2+ protein by urinalysis or a history of nephrotic syndrome. * known central nervous system metastasis. * have history of deep vein thrombosis or pulmonary embolus, unless they are receiving therapeutic anticoagulation with warfarin or low-molecular-weight heparin.
a first in human, single dose, safety and tolerability study of mkc253 inhalation powder in healthy adult males

Conditions: Diabetes Mellitus, Type 2; Healthy Males

Summary: 26 subjects will be enrolled into 5 different dose groups. the trial will consist of a screening, a dosing and a follow-up visit. dosing at visit 2, of mkc253 inhalation powder, glucagon-like peptide-1 (glp-1) will be given at 5 dose levels.

this phase 1a , single-dose trial incorporates an open-label, ascending dose strategy to determine the safety \& tolerability of mkc253 (glp1/technosphereâ®)inhalation powder. the trial consists of a screening, dosing and a follow-up visit. single dose administration of mkc253 occurs at the dosing visit. five doses are being assessed: 0.05, 0.45, 0.75, 1.05 \& 1.5 mg glp-1. dosing of each ascending cohort will occur after the principal investigator has reviewed all safety/tolerability data

Eligibility criteria:
inclusion criteria: * healthy males = 18 and = 45 years of age * written informed consent. * body mass index (bmi) of \< 30 kg/m2 * non-smoker * normal pulmonary function and performance on pulmonary function tests exclusion criteria: * clinically significant disease including diabetes mellitus * fasting blood glucose \> 110 mg/dl (6.1 mmol/l) * significant psychiatric condition or drug or alcohol abuse * any other condition which, in the opinion of the pi, makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent and/or impair the subject's ability to participate in the trial * inability to perform pft maneuvers meeting recommended american thoracic society (ats) standards of acceptability and repeatability criteria

Keywords: healthy diabetes mellitus: type ii