Kornimate/medical-research-clean huggingface dataset:
a study of tqb2450 injection combined with anlotinib hydrochloride capsule versus paclitaxel for injection (albumin bound) in subjects with triple negative breast cancer (tnbc)

Conditions: Triple Negative Breast Cancer

Summary: this study is a randomized, positive parallel controlled, multicentre phase iii clinical trial to evaluate the efficacy and safety of tqb2450 combined with anlotinib versus paclitaxel for injection (albumin bound) in subjects with advanced triple negative breast cancer.


Eligibility criteria:
inclusion criteria: * 1.eastern cooperative oncology group (ecog) performance status of 0 to 1; life expectancy ≥ 3 months. 2.histologically confirmed triple negative breast cancer. 3.has at least one measurable lesion. 4.newly diagnosed stage iv or recurrent/metastatic triple negative breast cancer who are not suitable for surgery. 5.prior local radiotherapy for metastatic sites is allowed. 6.adequate laboratory indicators. 7.understood and signed an informed consent form. 8.no pregnant or breastfeeding women, and a negative pregnancy test. exclusion criteria: * 1.has received anti-angiogenic drugs or other pd-1 / pd-l1 / ctla-4 antibody therapy or other immunotherapy against pd-1 / pd-l1 / ctla-4. 2. severe hypersensitivity occurs after administration of other monoclonal antibodies. 3. has other malignancies (except cured skin basal cell carcinoma and cervical carcinoma in situ) within 3 years. 4. has any active autoimmune disease or history of autoimmune disease. 5. has a clear clinical diagnosis of interstitial pneumonia, pulmonary fibrosis, drug-induced pneumonia, or active pneumonia. 6. peripheral neuropathy ≥ grade 2. 7. immunosuppressant or systemic or absorbable local hormone therapy is required to achieve the aim of immunosuppression (dose \&gt; 10mg/ day prednisone or other therapeutic hormones) and is still used within 2 weeks after the first administration. 8. has multiple factors affecting oral medication. 9. has uncontrolled and repeated drainage pleural effusion, pericardial effusion, and ascites. 10. has any signs of bleeding or history. 11. has unrelieved spinal cord compression. 12. has symptomatic central nervous system (cns) disease and / or cancerous meningitis, pia mater disease. 13. has received other anti-tumor therapy within 4 weeks before the first administration. 14. has any serious and/or uncontrollable disease. 15. has received vaccination or attenuated vaccine within 4 weeks before the first administration. 16. according to the judgement of the investigators, there are other factors that may lead to the termination of the study.
impact of literacy level on patient education and health among people with arthritis

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Polyarthritis

Summary: people with poor literacy may have worse health and less knowledge about how to manage their disease than patients at high reading levels. patients with arthritis usually receive information on how to manage their disease that is written at an 11th grade reading level. the purpose of this study is to compare the health outcomes of patients with arthritis given either standard 11th grade level materials or interactive, in-person arthritis education along with materials written at a lower reading level.

patients with poor literacy report worse health and know less about managing their disease than patients with better literacy. this study will compare the disease outcomes of arthritis patients at three different reading levels who receive either standard arthritis materials written at an 11th grade reading level or an in-person, interactive, text-free session along with lower reading level materials. the study will determine the most effective methods of educating patients with poor literacy about their disease. patients with systemic inflammatory rheumatic conditions (rheumatoid arthritis, psoriatic arthritis, and seronegative polyarthritis) will be assessed and placed into one of three reading levels: 8th grade or lower; 9th to 11th grade; or 12th grade or higher. patients from each reading level will be randomly assigned to one of two intervention groups. group 1 will receive disease-specific material from the arthritis foundation written at an 11th grade reading level. group 2 will receive plain language materials, an arthritis glossary, and a one-hour, in-person session with a study educator using interactive, text-free methods. the study educator will help the patient with reading-related problems either by study visit or by telephone for 6 months postsession. all patients will receive a medication calendar. patients will be followed for one year after the intervention and will be assessed for changes in health status, disease activity, communication with the physician, self-management of their arthritis, understanding of and adherence to prescribed treatment, and satisfaction with their intervention.

Eligibility criteria:
inclusion criteria: * native english speaker * patient at the rheumatology clinic at brigham and women's hospital, boston, massachusetts * diagnosis of rheumatoid arthritis, psoriatic arthritis, or seronegative polyarthritis

Keywords: arthritis health literacy patient education self-efficacy
a non-interventional study to evaluate diabetes related quality of life, frequency and impact of hypoglycemia in t2dm

Conditions: Type II Diabetes Mellitus

Summary: this is a non-interventional, cross sectional, multicentric study in t2dm patients which will involve a single visit for study related procedures. this study will be conducted in approximately 5,000 patients at around 300 hospitals/primary care clinics across india. approximately 18-20 patients per site will be enrolled. this study has been designed to evaluate diabetes related quality of life (dqol), frequency and impact of hypoglycaemia in relation to hba1c control and to assess disease modifying variables-bmi and bp in t2dm patients on oral / injectable anti-diabetic drugs with/without insulin therapy.

a non-interventional study to evaluate diabetes related quality of life, frequency and impact of hypoglycemia in type 2 diabetes patients on pharmacotherapy (insight)

Eligibility criteria:
inclusion criteria: * patients with diagnosis of t2dm for \> 1 year prior to entry in the study willing and able to complete the questionnaire and on pharmacotherapy * patients who are currently treated with a single or combination of injectable/oral antidiabetic drugs with or without insulin therapy * treatment type must be unchanged in the previous 3 months. however, dose modifications are allowed * patients who agree to participate in the study and give their written informed consent exclusion criteria: * patients with type 1 diabetes * patients with diabetic ketoacidosis and/or hyperosmolar hyperglycaemic state * patients with secondary diabetes (including disease of the exocrine pancreas, endocrinopathies) * patients with concurrent treatment involving systemic glucocorticoids. however, inhaled, locally injected and topical use of glucocorticoids is allowed * patients suffering from severe cardiac, hepatic, renal diseases as judged by the investigator * any condition of the patient which may have an impact on objective and outcome of the trial example: patients currently undergoing major/ minor surgical

Keywords: non interventional study, type ii diabetes mellitus, quality of life
preoperative auricular acupuncture in elective cesarean section.

Conditions: Anxiety Reduction, Elective Cesarean Section

Summary: preoperative anxiety before cesarean section is common and may be severe. stress consequences are often deleterious for the mother and for the upcoming newborn. means to reduce anxiety before cesarean section are limited. anxiolytic drugs are avoided in the context of the birth of a newborn. auricular acupuncture has been shown to relieve anxiety disorders. the aim of this study is to evaluate the anxiolytic effect of auricular acupuncture administered before an elective cesarean section. anxiety will be measured at t0: inclusion (approximately 1-2 hours before cesarean section) and t1: departure to surgical unit (approximately 30 minutes to 1 hour after t0). patches (needle or needle-free) will be set up at t0 just after the initial anxiety assessment (anxiety visual analog scale avas).


Eligibility criteria:
inclusion criteria: * all patients american society of anaesthesiologists 1or 2 targeted for elective cesarean section under spinal anesthesia * aged over 18 years * affiliation to social security * participation consent signed after oral and written information exclusion criteria: * guardianship * psychological disorders preventing informed consent * long-term antidepressant or anxiolytic * previous history of auricular acupuncture * refusal of participation in the study * cesarean section for placenta accreta * presence of a pacemaker
cannabinoids in bipolar affective disorder

Conditions: Bipolar Affective Disorder

Summary: some people with bipolar disorder who use cannabis (marijuana) claim that it eases the symptoms of depression and mania. there are many chemicals (called cannabinoids) found in cannabis but two particular ones appear to have medicinal (therapeutic) effects. these two compounds are: delta-9-tetrahydrocannabinol (thc) and cannabidiol (cbd). these cannabinoids appear to have mood, anxiety, and sedative effects as well as have antipsychotic and anticonvulsant properties. this study will try to find out if these cannabinoids can be of benefit as an add-on treatment in bipolar disorder and what effects it has on thinking power and memory.

this study will be a within-subject, random order, double-blind cross-over study with standard clinical and neuropsychological ratings. duration is 13 weeks per subject. clinical assessments including mood ratings will be performed weekly. instructions and practice on the use of the spray will be given under supervision during a 2-week run-in period before baseline. patients can control the dosage of cannabinoids according to their symptoms by administering up to a maximum of 48 pump-controlled sprays per day. patients will be asked to abstain from using cannabis (other than the study drug) during the study. patients will be treated for 4 weeks with either the sublingual thc:cbd spray or placebo spray. this will be followed by a 2-week washout period before another 4 weeks of treatment with whichever study medication was not initially used. neurocognitive testing will be performed 3 times during the study. a mood diary will be completed daily by each patient at home.

Eligibility criteria:
inclusion criteria: * outpatients between the 19-60 years of age with a diagnosis of bipolar disorder. * women must not be currently pregnant and must use a reliable method of contraception for the duration of the study. * subjects must be on stable medication (4 weeks minimum) for their bipolar illness (symptomatic despite current treatment), must be able to provide written informed consent, must adequately understand written and verbal english. exclusion criteria: * those not meeting the inclusion criteria and those not able to give informed consent. * women who are currently pregnant or nursing. * those at immediate risk of harming self or others; * those who have a clinically significant medical illness or other significant psychiatric illness; * currently abusing alcohol or drugs; * currently being treated with an investigational medication or medication that is contraindicated with cannabinoids; * have a known allergy to cannabis-based products.

Keywords: bipolar therapeutic potential neurocognitive performance cannabinoids
evaluation of a human immunodeficiency virus (hiv) blood screening assay

Conditions: Healthy Donors; HIV Positive

Summary: to test blood samples from volunteer donors of whole blood and blood components using a new investigational test that detects human immunodeficiency virus (hiv) infection. results will be compared to the current hiv screening assay.


Eligibility criteria:
inclusion criteria: * healthy donors that have consented to study

Keywords: healthy donors hiv positives
mindfulness-based group therapy for inpatients with schizophrenia spectrum disorders

Conditions: Psychotic Disorder

Summary: a single-centered randomized controlled trial with a parallel-groups design is utilized, comprised of mindfulness-based group therapy (mbgt) in the experimental condition, and treatment as usual (tau) in the control condition. participants in the experimental condition continued their regular psychiatric treatment (tau) next to the participation in the mbgt. in order to evaluate possible psychotherapeutic effects, self-report and other clinical questionnaires including interviews and app-based assessments are evaluated before (t0), and after the four-week intervention (t1). ward psychiatrists identify eligible participants and invite them to participate in the study. an eligibility screening is held by the study assistant at baseline, introducing the study, providing informed consent in written form, as well as conducting the self-report measures and app-based assessments. a blinded psychiatrist who works independently of the (co-) therapist conducts the remaining rater-questionnaires. due to the psychotherapeutic nature of the study, information about the treatment allocation had to be shared with the co-therapist and the participants. randomization was conducted by the random group generator (pubmed, 2018). the data management plan includes standard procedures for data-handling such as using anonymized identification codes for patient data. the participants have the right to access their data, and the right to claim an annihilation. the data is being stored in locked cupboards, only allowing researchers involved in the study to access the data.


Eligibility criteria:
inclusion criteria: * male and female participants * treated as psychiatric inpatients at the psychosis - or social-psychiatric day ward * between 18 and 65 years of age * diagnosis of a schizophrenia-spectrum disorder according to the diagnostical and statistical manual 5th edition) and the international statistical classification of diseases and related health problems(icd-10) code f2 * ability to give informed consent * willingness and ability to engage in psychotherapeutic group therapy * low to moderate psychotic state indicated with a score of 6 \< for each item at the positive scale of the positive and negative syndrome scale (panss, peralta \& cuesta, 1994) exclusion criteria: * a score ≥ 6, suggesting an acute psychotic episode with severe psychotic symptoms (peralta\& cuesta, 1994) * acute suicidality, assessed by item eight of the calgary depression scale for schizophrenia \> 1 (addington, addington, maticka-tyndale, \& joyce, 1992) * any neurological disorders that may affect cognitive functioning * acute substance abuse other than nicotine and prescribed medication
clinical study to assess safety, pk and pd parameters of cdr132l

Conditions: Heart Failure

Summary: this is a phase i, randomized, double-blind, placebo-controlled study to assess safety, pharmacokinetics and pharmacodynamic parameters of cdr132l in patients with stable heart failure of ischemic origin (nyha 1-3).

objectives: primary • to assess the safety of one single and one repeated dose of cdr132l in patients with stable heart failure of ischemic origin (nyha 1-3). secondary • to characterize the pharmacokinetic (pk) profile of cdr132l in patients with stable heart failure of ischemic origin. exploratory • to determine the effect of cdr132l on pharmacodynamic (pd) parameters.

Eligibility criteria:
inclusion criteria: * stable heart failure of ischemic origin exclusion criteria: * heart failure of non-ischemic origin (hypertensive heart disease, myocarditis, alcoholic cardiomyopathy and cardiac dysfunction due to rapid atrial fibrillation),
point of care ultrasound lung artificial intelligence (ai) validation data collection study

Conditions: Pleural Effusion; Lung Consolidation

Summary: this study is being conducted to collect image data and relevant clinical data from medical records of patients with suspicion of lung consolidation or pleural effusion. the information will be used to test the performance of artificial intelligence (ai) in identification of features associated with the above lung conditions.

this is a prospective, observational, multi-center, post-market clinical study. enrollment will continue (up to a maximum of 500 adult subjects and up to 300 pediatric subjects) until diagnostic lus exams are acquired for each of the following groups: approximately 500 adult subjects targeting: * approximately 175 exams from patients positive for lung consolidation * approximately 175 exams from patients positive for pleural effusion * approximately 150 exams from patients negative for both conditions approximately 300 pediatric subjects targeting: * approximately 150 exams from patients positive for lung consolidation * approximately 150 exams from patients negative for lung consolidation

Eligibility criteria:
inclusion criteria: 1. subjects presenting to the emergency department, admitted to the hospital, or seen in the outpatient setting with suspicion of pleural effusion or lung consolidation who received chest imaging to include chest x-ray or ct, or for whom chest x-ray or ct are planned. suspicion of pleural effusion or lung consolidation may be based upon imaging findings or presentation of symptoms including (but not limited to) dyspnea, hypoxia, tachypnea, rales, or dullness. 2. all attempts should be made for subjects to undergo scanning of 14 lung zones (adults) and 12 lung zones (pediatrics). attempts should also be made to capture all required lung zones in adults and pediatrics. instances where all zones cannot be captured need to be documented and reason for inability to scan them provided in edc. see section 8.1.3 lung ultrasound exams. 3. subject is willing to provide informed consent (or assent where age appropriate) to participate in the study. subjects under 18 years of age require informed consent of a parent or guardian and assent as required by institutional irb. 4. weight of subject is greater than or equal to 10 kg. exclusion criteria: 1. subject has pathology precluding safe and pain-free ultrasound probe placement such as burn, significant soft tissue injury or surgical incisions. 2. current imprisonment. 3. pregnancy (self-reported) 4. subjects with breast implants 5. prior pleurodesis procedure. 6. history of severe lung disease and home oxygen use 7. presence of subcutaneous air that precludes imaging 8. body mass index (bmi) \> 40 9. significant scoliosis (cobb angle ≥ 20 degrees). 10. pediatric subjects with chronic lung diseases other than asthma. 11. pediatric subjects on chronic respiratory support (i.e., nasal canula, cpap, bipap, or tracheostomy).

Keywords: artificial intelligence diagnostics
a comparative study of using scorpion antivenom versus scorpion antivenom and prazosin

Conditions: Morality

Summary: interventional study designed for the evaluation of characters and the outcome of scorpion sting patients will admit to sohag university hospitals in 2 randomized groups. the first group will receive scorpion antivenom only whether by the intravenous or the intramuscular route of administration. the second group will receive a combination of prazosin plus scorpion antivenom whether by the intravenous or the intramuscular route of administration. both groups will receive proper first aid and supportive treatment

tools of the study: 1. dose and administration of prazosin: 30 μg/kg/dose of prazosin will be delivered orally every 6 hours 4 doses, in adults we shouldn't exceed 1 mg per dose. prazosin will be delivered using a nasogastric tube while securing the patient's airway in the event of vomiting or unconsciousness. every 30 minutes for the first three hours, every hour for the following six, and then every four hours until improvement, blood pressure, pulse rate, respiration rate, and oxygen saturation will be measured. when pain is the only symptom, prophylaxis shouldn't be given. to avoid the first-dose phenomenon, the patient should remain in a laying position for around 3 hours (even while the case is being examined) (shoreit et al., 2019). dose of antivenom 1-1 ampoule intramuscular and/ or, 2-1 to 5 polyvalent anti-scorpion serum ampoules produced by the vaccine \& serum institution (vacsera)in egypt according to the severity of the case on 200 to 500 ml glucose 5% infusion and assess the patient clinically to repeat the dose after 4 to 6 hours. (shoreit et al., 2019) 2. a prepared sheet containing 1. the demographic characteristics of each patient 2. vital signs and degree of coma at time of admission of the patient. 3. first aid management as resuscitation. 4. supportive management will be done to the patients during the admission will be recorded. 5. cardiac enzymes measurements, duration of hospital stay and the outcome of patients in each group.

Eligibility criteria:
inclusion criteria: * history and clinical diagnosis of scorpion sting * admit in sohag university hospitals * during the period from february 2023 to july 2024. * accepting informed written consent from the case itself or the first degree relative if the case will underage or in a coma. exclusion criteria: * .all other envenomation cases or poisoning will be excluded.

Keywords: mortality, scorpion, antivenom, prazosin
protective effect of eecp against negative inflammatory response and organ dysfunction after cardiovascular surgery

Conditions: Coronary Heart Disease (CHD); Cardio-pulmonary Bypass; Congestive Heart Failure Chronic; Cardiogenic Shock Acute

Summary: enhanced external counterpulsation (eecp) is a noninvasive, non-pharmacologic intervention proven to increase nitric oxide bioavailability in patients with coronary artery disease. although eecp showed short-term effects in improving coronary flow in patients with coronary slow flow, whether such improvement is durable remains uncertain, and the relationships between such improvement and changes in multiple organ functions as well as inflammatory markers have not been elucidated. the purpose of this study will be to evaluate the potential clinical benefits of eecp on organ function and proinflammatory cytokine concentrations during post-acute sequela of cardiovascular surgery.


Eligibility criteria:
inclusion criteria: * age \> 18 years; * patients with stable angina pectoris, unstable angina pectoris, acute myocardial infarction, congestive heart failure, cardiogenic shock; * patients chronic heart failure; * patients are ready to received cardiovascular surgery during this hospital admission. * patients agree to participate in the study and sign an informed consent form. exclusion criteria: 1. moderate to severe aortic insufficiency; 2. dissection aneurysm; 3. significant pulmonary hypertension; 4, a variety of bleeding diseases or bleeding tendencies, or use anticoagulants, inr\>2.0; 5, active phlebitis, venous thrombosis; 6. there is an infection in the counterpulsating limb; 7. uncontrolled hyperhypertension (\>170/110mmhg); 8. uncontrolled arrhythmias: frequent premature beats, rapid atrial fibrillation, etc. 9. pregnancy.

Keywords: cardiac surgery cardiopulmonary bypass cardiogenic shock