Kornimate/medical-research-clean huggingface dataset:
a study of tirzepatide (ly3298176) in chinese participants with type 2 diabetes

Conditions: Diabetes Type 2; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Disease; Endocrine System Diseases

Summary: the main purpose of this study is to compare the effect of the addition of tirzepatide or placebo to titrated basal insulin on glycemic control in chinese participants with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes mellitus (t2dm) * have hba1c ≥7.0% (53 mmol/mol) to ≤11% (97 mmol/mol) * have been treated with insulin glargine (u100) once daily alone, or in combination with metformin with or without sglt-2i ≥90 days * have a body mass index (bmi) ≥23 kilograms per meter squared (kg/m²) exclusion criteria: * have type 1 diabetes mellitus (t1dm) * have a history of chronic or acute pancreatitis * have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy that requires acute treatment * have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2 * have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months * have a history of diabetic ketoacidosis or hyperosmolar state/coma within the 6 months * have acute myocardial infarction, or cerebrovascular accident (stroke) or hospitalization due to congestive heart failure (chf) in the past 2 months * have a serum calcitonin level of ≥35 ng/l, as determined by central laboratory * have acute or chronic hepatitis, signs, and symptoms of any other liver disease other than nonalcoholic fatty liver disease (nafld), or alanine aminotransferase (alt) level \>3.0 times the upper limit of normal (uln), as determined by the central laboratory at study entry; participants with nafld are eligible for participation in this trial.
safety and efficacy of heplisav™ hepatitis b virus vaccine compared with engerix-b® vaccine

Conditions: Hepatitis B

Summary: the purpose of this study is to find out if a new investigational hepatitis b virus vaccine, heplisav™, is safe and effective compared with engerix-b® vaccine in subjects 11-55 years old. the primary hypothesis is that the seroprotective immune response of heplisav™ is at least as good as that of engerix-b®.

this study will evaluate the safety and efficacy of two injections of heplisav™, compared with three injections of a commercially available hepatitis b virus (hbv) vaccine, engerix-b®, in subjects 11 to 55 years old. about 2,400 subjects will be included in the study. once subjects are consented, screened, and randomized to treatment, all subjects will receive a total of three injections over a 24-week period, with a follow-up visit at 28 weeks. subjects randomized to engerix-b® will receive 3 injections of active vaccine, while subjects randomized to heplisav™ will receive 2 injections of active vaccine plus 1 injection of placebo. safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity. comparison: subjects will receive treatment with either heplisav™ or the comparator vaccine, engerix-b®.

Eligibility criteria:
inclusion criteria: * willing and able to give written informed consent * is serum negative for hbv antibodies exclusion criteria: * women who are pregnant or breastfeeding * any previous hbv infection * previous vaccination with any hbv vaccine (1 or more doses) * any autoimmune disease * received any blood products or antibodies within 3 months prior to study entry * ever received an injection with dna plasmids or oligonucleotides * received any vaccines within 4 weeks prior to study entry * received any other investigational medicinal agent within 4 weeks prior to study entry

Keywords: hbv vaccine hepatitis b vaccine hepatitis b hepatitis hbv immunostimulatory sequence (iss)
efficacy & safety of orally administered valsartan/amlodipine combo therapy vs amlodipine monotherapy in black patients with stage ii hypertension

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the blood pressure lowering effects of a valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of black stage ii hypertensive patients (mssbp ≥ 160 mmhg).


Eligibility criteria:
inclusion criteria: * 18 years of age or older. * moderate to severe high blood pressure. this is defined as a systolic pressure (the top number) greater than or equal to 160 mmhg and less than 200 mmhg. exclusion criteria: * history of allergy or hypersensitivity to arbs, ccbs, thiazide diuretics * inability to stop all prior blood pressure medications safely * systolic bp ≥ 200 mmhg and/or diastolic bp ≥ 120 mmhg * controlled blood pressure (systolic bp \< 140 mmhg) taking more than 3 antihypertensive medications at screening * systolic bp ≥ 140 mmhg and \< 180 mmhg taking more than two antihypertensive medications at screening * systolic bp ≥ 180 mmhg taking more than one antihypertensive medication at screening * history of autoimmune diseases * history of multiple drug allergies * liver disease * pancreatic injury within 1 year of screening * evidence of kidney impairment or history of dialysis * any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any drug. this could include currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction. * women of child-bearing potential (wocbp), defined as all women physiologically capable of becoming pregnant, would be excluded unless they are post-menopausal, surgically sterile or are using acceptable methods of contraception. the use of hormonal contraceptives is not allowed * pregnant or nursing (lactating) women * history of malignancy of any organ system within the past five years * any severe, life-threatening disease within the past five years * history of drug or alcohol abuse within the last 2 years. * history of stroke, angioplasty, coronary artery bypass graft surgery, heart attack or unstable angina * type 1 diabetes * poorly controlled type 2 diabetes * history of heart failure * arrhythmia * significant valvular heart disease * active gout other protocol-defined inclusion/exclusion criteria may apply

Keywords: blood venous systolic diastolic pulse pressure
a comparative study of ly900014 with insulin lispro (humalog) in participants with type 2 diabetes mellitus (t2dm)

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to evaluate a new formulation of insulin lispro, ly900014, which is a drug that lowers blood sugar. the study will look at how the body processes ly900014, and the effect of ly900014 on blood sugar levels following a standard meal. for each participant, the study will consist of 4 periods and will last approximately 12 weeks from screening to final study follow up.


Eligibility criteria:
inclusion criteria: * have a body mass index (bmi) of 18.5 kilogram per meter square (kg/m²) to 40.0 kg/m² * have a glycated hemoglobin (hba1c) less than or equal to (≤)9.0% * have a fasting c-peptide ≤1.0 nanomole per liter (nmol/l) * are on stable prandial insulin and basal insulin (neutral protamine hagedorn \[nph\] insulin, insulin glargine or insulin detemir) with or without a stable dose of metformin for at least 3 months before screening exclusion criteria: * are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research * have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study * have donated blood of more than 450 millilitre (ml) or more in the last 3 months or provided any blood donation within the last month before screening * any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator * are treated with a csii (insulin pump) * require daily insulin treatment greater than (\>)1.2 units per kilogram per body weight (u/kg/body weight)
a study evaluating the efficacy of qge031 compared to omalizumab in patients with allergic asthma

Conditions: Allergic Asthma

Summary: this study will evaluate the efficacy of qge031 compared to omalizumab in patients with allergic asthma. each treatment's effect in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the forced expiratory volume in one second (fev1) at 12 weeks compared to baseline will be evaluated.


Eligibility criteria:
inclusion criteria: adult patients 18 to 65 years positive skin prick test to one or more common airborne allergens presence of airway hyperresponsiveness documented by a provocative concentration of methacholine causing a 20% fall in fev1 (pc20 fev1) of less than or equal to 16 mg/ml presence of an early asthmatic response demonstrated by an allergen challenge at screening and including a 15% fall in the fev1 patients with a body weight and total ige in a range specified by local country prescribing information for omalizumab exclusion criteria: pregnant or nursing (lactating) women women of child-bearing potential unless they are using a highly effective method of birth control (as further defined in the study protocol) smokers patients with poorly controlled asthma or patients who have had an asthma exacerbation within the past year other protocol-defined inclusion/exclusion criteria may apply.

Keywords: allergies, asthma, ige
tbit system precision and correlation of different blood samples

Conditions: Brain Injuries; Traumatic Brain Injury

Summary: the tbit™ system will detect s100b and gfap concentrations with the blood specimen to produce and compare repeated measures from 3 blood samples from 3 fingersticks from one subject and one 1 venous whole blood sample will be collected from the same subject, on 3 different tbit™ system by 3 different operators.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * presents to the emergency department with suspected traumatic brain injury * blood sample collected for tbit™ system within 12 hours of injury * willing and able to provide informed consent or obtain consent from legal authorized representative (lar) exclusion criteria: * suspect of ischemic or hemorrhagic stroke with subsequent incidental trauma based on ed examination * subject suspect of need of craniotomy for the acute trauma for this event * external signs compatible with a depressed skull fracture based on ed exam * subject requiring administration of blood transfusion after injury and prior to study blood draw * subject for whom timing of injury is unable to be estimated within 1 hour of certainty * subject who had neurodegenerative disease or other neurological disorder including dementia, parkinson's disease, multiple sclerosis, seizures, brain tumors, stroke or tia within the last 30 days, or history of neurosurgery * known or suspected to be pregnant * prisoner or under incarceration * participating in another clinical research study prior to this study completion
effect of platinum-based versus non-platinum-based neoadjuvant chemotherapy in triple-negative breast cancer

Conditions: Triple Negative Breast Cancer

Summary: in this study, individuals with triple-negative breast cancer will receive either a platinum-based or non-platinum-based preoperative chemotherapy treatment. this study will help us identify which option is the most effective and safe.

breast cancer is a significant health concern, and triple-negative breast cancer (tnbc) is a particularly aggressive and lethal subtype. chemotherapy is currently the only recommended systemic treatment for tnbc, with the standard regimen being a combination of anthracyclines and taxanes. platinum agents have shown promising results in tnbc neoadjuvant chemotherapy due to their ability to damage dna and be more effective in tumors with dysfunctional dna repair mechanisms. however, there is still a lack of consensus on the optimal neoadjuvant chemotherapy regimen for tnbc. this study will be conducted to compare the responses and toxicities of platinum-based versus non-platinum-based neoadjuvant chemotherapy in tnbc patients receiving neoadjuvant chemotherapy in the department of clinical oncology of bangabandhu sheikh mujib medical university (bsmmu), shahbagh, dhaka. after pretreatment evaluation, a total of 82 patients who fulfill the inclusion and exclusion criteria will be divided into arm a and arm b by simple random sampling. after the completion of the chemotherapy, all patients will undergo surgical management. a postoperative histopathology report will be collected and assessed by the investigator. during the treatment, the patients will be monitored before each cycle of chemotherapy, including physical examinations and laboratory investigations. all the relevant data will be compiled on a master chart first, and then statistical analysis of the results will be obtained by using windows-based computer software facilities with statistical packages for social sciences. the data will be analyzed using the chi-square test and the "t' test. the results will be presented in tables, figures, and diagrams. a significant value of 'p' will be decided at a level of 0.05 in two-tailed tests.

Eligibility criteria:
inclusion criteria: * triple-negative breast cancer * stage ii and iii exclusion criteria: * double primaries * male breast cancer * pregnant or lactating women * patients with eastern cooperative oncology group (ecog) performance status more than two * patients below 18 years old * initial surgery of the primary site (excluding diagnostic biopsy) * serious concomitant medical illness including clinically significant cardiovascular disease * major surgery or trauma in the previous four weeks

Keywords: triple negative breast cancer platinum neoadjuvant
ehr-embedded ocdt in breast or gi cancer

Conditions: Oral Cancer Directed Therapy; Breast Cancer; Gastrointestinal Cancer; Oral Chemotherapy

Summary: this is research study is for participants with advanced breast or gastrointestinal cancer who have been taking oral chemotherapy medication (oral cancer directed therapy). this study is to help researchers better understand gaps in assessing oral chemotherapy patient toxicity at home, adherence to treatment and integrate toxicity/adherence reporting.

for patients with advanced breast or gastrointestinal cancer prescribed oral cancer directed therapy. * participants will complete epro clinic for all medical oncology scheduled provider appointments during the study period per standard practice * participants between clinic visits, will be asked to complete the oral weekly survey at home via the mobile or web based patient portal. the survey can be completed on a computer, tablet or smartphone at home or on a tablet at the time of scheduled visit. * the first 100 participants to complete the survey will receive a passive care team alert for responses (per dfhcc policy) * the second 100 participants to complete the survey will receive an active care team alert for responses.

Eligibility criteria:
inclusion criteria: * adult age 18 or older * male or female * scheduled visit at df/hcc within the boc or gcc * diagnosis of advanced breast cancer or gastrointestinal cancer * prescribed any ocdt within prior 5 days of screening * english as the primary language (as documented in the ehr, written or spoken, and patient interpreter needed flag = no) * mobile number listed in ehr to allow participation in epp portion of the study * women of any pregnancy status * patients diagnosed with an advanced cancer will be eligible to participate in the study until discontinuation of ocdt or death, whichever occurs first exclusion criteria * adults unable to provide verbal consent * pediatric patients * patients without access to a electronic device (including tablet, computer, aptop or smartphone)

Keywords: oral cancer directed therapy breast cancer gastrointestinal cancer oral chemotherapy
multicentre study to record the mental and physical effects of the covid-19 pandemic (cobesity-study)

Conditions: COVID-19 Pandemic; Overweight and Obesity

Summary: prospective, international multicenter study to investigate the physical and psychological effects of the covid-19 pandemic in two obese patient cohorts (bmi ≥ 25 kg/m²) pre- and post-bariatric surgery. in addition, the investigation of country-specific differences will be performed.

the covid-19 pandemic, first reported in november 2019, has led to a global health systems emergency. the number of confirmed covid-19-associated deaths, according to who, is higher in countries with high obesity prevalence. however, whether obesity is an independent risk factor of the severity of covid-19 remains unclear. obesity represents one of the major health problems worldwide and the covid-19 pandemic is expected to further increase obesity prevalence rates. initial research indicates that the pandemic has also led to an increased incidence and/or worsening of depression and eating disorders. additional weight gain due to the covid-19 pandemic may be suspected to increase the prevalence of psychological comorbidities in patients before weight-reducing surgery compared to patients who have already undergone weight-reducing surgery. therefore, the main aim of this international study is to gain a better understanding of the mental and physical effects of the coronavirus pandemic on obese patients before and after a weight-reducing surgery and use this to develop approaches for solutions. this study also aims to investigate the country-specific differences (germany vs england) as well as the differences in the mental effects experienced by overweight patients who have or have not been infected with covid-19. to achieve these aims, obese patients aged 18 years and older, before and after weight-reducing surgery, will be recruited from the bariatric surgery clinic at king's college hospital, nhs trust foundation as well as from the medical university hospital hamburg-eppendorf, germany. participants will be asked to complete a questionnaire about their health, socio-economic status, and the effects of the covid-19 pandemic on their physical and mental health. the questionnaire will take 15 minutes to complete and can be done at home or during the patient's appointment at the bariatric surgery clinic to minimise unnecessary travel.

Eligibility criteria:
inclusion criteria: overweight and obese patient cohort * age: 18 years and older * bmi ≥ 25kg/m² overweight and obese patient cohort with bariatric surgery * age: 18 years and older * bmi ≥ 25kg/m² * status post sleeve or gastric bypass surgery exclusion criteria: * age under 18 years * cognitive, mental and/or linguistic limitations to complete the questionnaire independently * severe somatic illnesses, such as tumour diseases * pregnancy or breastfeeding * acute need for treatment due to comorbid mental disorders
beta-1 adrenergic inhibition to reduce cardiac injury and inflammation after subarachnoid hemorrhage (badcats)

Conditions: Non-Traumatic Subarachnoid Hemorrhage

Summary: to determine the effect of early metoprolol administration after non-traumatic subarachnoid hemorrhage (sah).

to determine the effect of early metoprolol administration after non-traumatic subarachnoid hemorrhage (sah) on the brain and cardiac tissue damage and inflammation, we will conduct a pilot randomized controlled trial comparing (1) sympathetic nervous system (sns) activation, (2) cardiac rhythm abnormalities, (3) biomarkers of brain and cardiac tissue damage, and (4) and neutrophil activity in patients receiving metoprolol (n=10) or placebo (n=10) for the first 72-hours after sah.

Eligibility criteria:
inclusion criteria: * \>18 years of age * neuro-imaging confirmed non-traumatic subarachnoid hemorrhage exclusion criteria: * traumatic cause of subarachnoid hemorrhage (e.g. fall, motor vehicle accident, other blunt trauma) as this is a different mechanism of hemorrhage. * other forms of traumatic or non-traumatic intracranial bleed including intracerebral hemorrhage (ich), subdural hemorrhage, epidural hemorrhage * pregnancy (as the study medication, metoprolol, has fda pregnancy category c rating) * unstable vital signs not amenable to beta-1 adrenergic receptor inhibitor (b1ari) administration including: * systolic blood pressure \< 80 mmhg not stabilized on vasopressor medications * heart rate \< 50 bpm associated with hypotension * patients requiring vasopressor agents due to hypotension (sbp \<80 mmhg) * other vital sign exclusion at the discretion of the treatment team * previous history of severe heart failure (stage c or d heart failure and/or nyha class iii or iv) * patient or legally authorized representative unwilling to provide informed consent

Keywords: beta-adrenergic blockade cardiac dysfunction inflammation
demographic, clinical, laboratory and genetical characteristics of patients with beta thalassemia intermedia

Conditions: Thalassemia

Summary: the definition of thalassemia intermedia is not generally accepted and the specific clinical and laboratory characteristics varies between patients. some patients are blood transfusion dependent and others are occasionally transfused. also the mutations in the beta globin gene are diverse. another mutations including mutations in the alfa globin gene and in the xmn1 gene can affect the clinical course of this disease. the purpose of this study is to summarize the characteristics of patients with thalassemia intermedia treated at the pediatric hematology unit at the haemek medical center in israel

the characteristics that will be recorded from the medical files include: demographic data, included gender and ethnic origin, family history, age at diagnosis, number and frequency of blood transfusions including age of first transfusion and physical examination findings. the laboratory data included iron metabolism parameters, mutation in the alfa and beta gene and the presence of the xmn1 polymorphism.

Eligibility criteria:
inclusion criteria: -all patients treated at the pediatric hematology unit exclusion criteria: * not enough medical records. * patients who refuse to give consent to perform genetic studies will be included in the study but only the retrospective clinical data will be recorded.

Keywords: beta globin gene alfa globin gene xmn1 polymorphism
diagnostic performance and predictive capacity of immediate urine cytology after transurethral resection of non-muscle invasive bladder cancer; a prospective study

Conditions: Bladder Cancer

Summary: the current study aimed at prospectively assessing the performance of iuc as a predictive tool for residual tumor after primary turbt of nmibc, and possible future recurrence.

the current study aimed at prospectively assessing the performance of iuc as a predictive tool for residual tumor after primary turbt of nmibc, and possible future recurrence.

Eligibility criteria:
inclusion criteria: -patients with primary or recurrent nmibc for whom complete turbt was done exclusion criteria: -patients with concomitant cis, upper tract urothelial tumors, biopsy proven muscle invasion, or low risk nmibc (single, primary, ta, g1 tumor).