Kornimate/medical-research-clean huggingface dataset:
association between dapagliflozin-induced improvement and anemia in heart failure patients (adidas)

Conditions: Anemia; Heart Failure

Summary: the primary objective of this study is to investigate the hemoglobin change and association between hemoglobin change and readmissions due to heart failure, and all-cause death in patients with heart failure treated with dapagliflozin or placebo.

study description brief summary: the primary objective of this study is to investigate the hemoglobin change and association between hemoglobin change and readmissions due to heart failure, and all-cause death in patients with heart failure treated with dapagliflozin or placebo. detailed description: heart failure is one of the most serious health concerns in the world, and it also remains the most common reason for hospitalization in older individuals. in patients with heart failure, anemia is associated with an increased risk of hospitalization and all-cause mortality. the dapa-hf trial demonstrated that dapagliflozin was able to reduce the risk of worsening heart failure (hf) events and cardiovascular death comparing to placebo in patients with reduced ejection fraction on top of standard of care. this is an investigator-initiated, interventional, prospective, double-blind study. the primary objective is to investigate whether anemia correction is one of the prerequisites and determinants related to the beneficial effects of dapagliflozin in patients with heart failure. impact of dapagliflozin treatment on hemoglobin level, heart failure-related readmission and all-cause death will be observed in comparison with placebo in heart failure patients receiving guideline recommended standard therapy during the 3months, 6 months and 1 year follow up.

Eligibility criteria:
inclusion criteria: 1. male or female between the ages of 18 and 100 years. 2. elevated nt-probnp or bnp levels on admission. 3. ejection fraction of 50% or less, and new york heart association (nyha) class ii, iii, or iv symptoms. exclusion criteria: 1. treatment with sglt2-i during the past 3 months of admission,or previous intolerance of an sglt2 inhibitor. 2. severe (egfr \<30 ml/min/1.73 m\^2 by ckd-epi), unstable or rapidly progressing renal disease at the time of randomization. 3. pregnant or breast feeding female patients.

Keywords: heart failure anemia dapagliflozin
efficacy and safety research of cold snare polypectomy and hot snare polypectomy in the treatment of 4-9 mm diameter colorectal 0-isp and 0-ip polyps: a prospective, multicenter, randomized controlled study(fast -rest study)

Conditions: Cold Snare Resection; Hot Snare Resection; Polyps of Colon

Summary: this study will evaluate the efficacy and safety of cold snare polypectomy(csp) and hot snare polypectomy(hsp) in the treatment of colorectal 4-9mm 0-isp and 0-ip polyps, and compare the complete resection rate, postoperative late bleeding rate, intraoperative bleeding rate, en bloc resection rate, operation time and the number of metal clips used. the conclusion of this study will help clinical doctor develop more effective resection strategies for colorectal 0-isp and 0-ip polyps, and provide more effective treatment for patients.

colorectal polyps are one of the precancerous lesions of colorectal cancer, 60-80% of which eventually become advanced colorectal cancer. therefore, early resection of colorectal polyps can effectively reduce the incidence of colorectal cancer. polyps under white light are judged mainly according to the shape, size and color of polyps. at present, the paris classification is often used to divide 0-i uplifted polyps into sessile polyps (0-is), sessile-pedunculated polyps (0-isp) and pedunculated polyps (0-ip). it is generally believed that there are thick arteries in 0-ip polyps, especially thick pedunculated polyps, which are prone to uncontrollable bleeding during operation. 0-is polyps have small scattered blood vessels and low intraoperative bleeding risk, while the morphological and structural characteristics of 0-isp polyps are between the two. the current guidelines recommend hsp for 0-isp and 0-ip polyps \&lt;1 cm, but the internal blood vessels of these polyps are not thick. there is no guidance on whether they can be resected by csp method, and there is a lack of prospective large sample clinical research. this study will include0-isp /0-ip polyps \&lt;1cm, and observe the safety and effectiveness of csp for the above polyp resection , so as to provide reference for the clinical treatment of colorectal polyps.

Eligibility criteria:
inclusion criteria: 1. age: 18-80 years old, male or female 2. at least one polyp with size of 4-9 mm 0-isp or 0-ip is found during colonoscopy 3. voluntarily sign informed consent for endoscopic treatment exclusion criteria: 1. boston bowel preparation scale\<6 points. 2. patients who receive antiplatelet/anticoagulant therapy within 5 days before polypectomy. 3. participants with a contraindication to colonoscopy and polypectomy. 4. patients with inflammatory bowel disease or gastrointestinal polyposis. 5. lesions with submucosal invasion and those suspected of being cancerous at the preprocedural diagnostic evaluation. 6. patients with pregnancy.

Keywords: cold snare resection hot snare resection colorectal polyps
a study of ro5024048 in combination with pegasys and copegus in treatment-naive patients with chronic hepatitis c, genotype 1 or 4

Conditions: Hepatitis C, Chronic

Summary: this 6-arm study will assess the efficacy and safety of ro5024048 (r7128) in combination with the approved doses of pegasys (180micrograms sc weekly) + copegus (1000/1200mg po daily) (soc), versus soc in treatment-naive patients with chronic hepatitis c, genotype 1 and 4. the first 3 groups will receive 1) ro5024048 500mg bid + pegasys + copegus for 12 weeks, followed by soc for 12 weeks; 2)ro5024048 1000mg bid + pegasys + copegus for 8 weeks, followed by soc for 16 weeks; 3) ro5024048 1000mg bid + pegasys + copegus for 12 weeks, followed by soc for 12 weeks. after 24 weeks, patients in these 3 groups who have achieved rapid viral response will stop treatment, and those who have not will receive soc for a further 24 weeks. group 4 will receive ro5024048 1000mg bid + pegasys + copegus for 12 weeks, followed by soc for 36 weeks, and group 5 will receive soc for 48 weeks. group 6 provides retreatment on an open-label basis for patients of group 5 who failed treatment. patients will receive ro5024048 1000mg bid + pegasys + copegus for 24 weeks, followed by soc for 24 weeks. the anticipated time on study treatment is 6-12 months.


Eligibility criteria:
inclusion criteria: * adult patients, 18-65 years of age * chronic hepatitis c, genotype 1 or 4 * treatment-naive exclusion criteria: * no previous treatment with any interferon- or ribavirin-based therapy * other forms of liver disease * hiv infection
a study to assess the effects of an oral dietary supplement on overall facial appearance among healthy adult women with existing skin damage from sun exposure

Conditions: Photodamaged Skin

Summary: the study hypothesis is that imedeen will show effects on skin health, when compared to placebo over a 6 month intervention period with respect to changes in skin appearance, skin density, moisture, and in fine lines and wrinkles.


Eligibility criteria:
inclusion criteria: in general good health and have no contraindications to the study product; have fitzpatrick skin type i-iv as determined by a trained evaluator. have glogau classification of photoaging of ii or iii as determined by the investigator. exclusion criteria: use of any dietary supplement, over-the-counter or prescription product with the indication of improving the appearance or condition of the skin within one month of baseline. history of or current disease or condition of the skin that the investigator deems inappropriate for participation (eg, atopic skin, facial scars, psoriasis, eczema, other scaly inflammatory diseases). subjects who have had a facial cosmetic procedures (eg, fillers, toxins, facial peel) or invasive surgical procedures (eg, laser treatment or face lift) or other facial treatments by a physician or skin care professional within the last 6 to 9 months from baseline (pending procedure type) or plan to have a treatment during the study.

Keywords: trial assessing effects of an oral dietary supplement on overall facial appearance among healthy women with photodamaged skin.
covid-19: safety and immunogenicity of a reduced dose of the biontech/pfizer bnt162b2 vaccine

Conditions: Covid19

Summary: this is a randomized phase iv dose-optimization study evaluating the safety and immunogenicity of two doses of covid-19 mrna vaccines being authorized in the european union since december 2020: vaccine bnt162b2 (comirnaty®; pfizer-biontech) in healthy adults up to age 55 year. immunogenicity will be measured 28 days after first and second dose, and day 180 and day 365 after first vaccination of 20 and 30 mcg of bnt162b2. the primary outcome is the level of binding antibodies for rbd 28 days after the second dose.

background: data from the dose-escalating phase 1 trials from the covid-19 mrna vaccines being authorized in the european union since december 2020, bnt162b2 (comirnaty®; pfizer- biontech) indicate that for the age group 18-55 years a lower dose of the vaccine can induce the same immune response as the full dose. method: this is a randomized multicenter phase iv dose-optimization study evaluating the safety and immunogenicity of demi-doses of a covid-19 mrna vaccine being authorized in the european union since december 2020, bnt162b2 (comirnaty®; pfizer- biontech) in healthy adults up to age 55 year. the study will be performed in employees of mensura edpb at five different sites. objectives: the primary outcome is the level of binding antibodies for rbd 28 days after the second dose. secondary outcomes are safety and reactogenicity after vaccination. the neutralizing antibodies and the cellular immunity 28 days after second dose will be assessed. humoral and cellular immunity will be measured 180 and 365 days after first dose.

Eligibility criteria:
inclusion criteria: working at mensura edpb, not yet vaccinated for covid19 - exclusion criteria: -

Keywords: vaccination covid19 immunogenicity
expanded access to fosmanogepix for patients with serious or life-threatening invasive fungal infections

Conditions: Invasive Fungal Infections

Summary: the eap is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the eortc-msgerc criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication.


Eligibility criteria:
the eap is intended to provide a treatment option for patients with proven or probable serious or life-threatening invasive fungal infection (in accordance with the eortc-msgerc criteria) who have exhausted their treatment options, primarily due to an infection with a resistant fungal pathogen, and for whom no other treatment options are available through marketed drugs or investigational agents in clinical studies ongoing in the respective indication.

Keywords: fungal infection candida anti-fungal yeast mold rare mold
efficacy of a chronic care model supported by self monitoring of blood glucose with bgstar over usual care in improving glycemic control in patients with type 2 diabetes not treated with insulin

Conditions: Diabetes Mellitus

Summary: to demonstrate the superiority of a chronic care model (sinergia model) supported by the self monitoring of blood glucose with bgstar over usual care in improving glycemic control at 12 months in patients with type 2 diabetes not treated with insulin.

the planned study duration is 36 months (9 quarters). the estimated duration of screening/enrollment will be 12 months, followed by the 12-month experimental phase, plus the 12-month follow-up in the observational phase.

Eligibility criteria:
inclusion criteria: * males and females * age ≥ 45 years * type 2 diabetes * first access at the diabetes clinic * any diabetes duration * hba1c \>7.0 and ≤ 9.0% * already treated with any oral antidiabetic agent (oad) or requiring the initiation of therapy with oad * patients not using smbg or using smbg with a frequency ≤1 test/week * written informed consent exclusion criteria: treatment with insulin or need to start insulin regimens or continuous sub-cutaneous insulin infusion at the first access; refusal or inability to give informed consent to participate in the study; conditions / situations such as: * patients with short life expectancy; * patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint according to physician's judgment; * requirement for concomitant treatment that could bias primary evaluation (i.e. corticosteroid treatment); * patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other study site staff or relative of study site staff thus considered directly involved in the conduct of the study; * current addition/abuse of alcohol or drugs; * patients with any mental condition rendering them unable to understand the nature, scope, and possible consequences of the study; * pregnant or breast-feeding women; * patients living too far from investigational center or other conditions reducing the adherence to the protocol; subjects unlikely or unable to comply with the protocol requirements (e.g. illiterate, uncooperative, unable to return for follow-up visit, unable to use bgstar unlikely to complete the study)
safety and efficacy of remote ischemic conditioning in patients with severe stenosis or occlusion of anterior intracranial circulation vessels

Conditions: Acute Ischemic Stroke

Summary: the primary purpose of this study is to examine whether remote ischemic treatment can better the 90 - day neurological outcomes in acute ischemic stroke patients having severe stenosis or occlusion of anterior intracranial circulation vessels.


Eligibility criteria:
inclusion criteria: 1. age is 18 years old or above. 2. severe stenosis (70% - 99%) or occlusion of anterior intracranial circulation vessels, mainly including the intracranial segment of the internal carotid artery, middle cerebral artery (m1, m2) and anterior cerebral artery (a1, a2), which is confirmed by digital subtraction angiography (dsa), computed tomography angiography (cta) or magnetic resonance angiography (mra). 3. patients with clinically diagnosed acute ischemic stroke who received remote ischemic treatment within 72 hours after the onset. 4. the nihss score ranges from 4 to 24. 5. the mrs score before stroke is less than or equal to 1. 6. informed consent. exclusion criteria: 1. patients with vessel recanalization after mechanical thrombectomy (tici grade ≥ 2b). 2. patients planning to receive intracranial endovascular treatment within 3 months. 3. patients with cardiogenic embolism considered as the cause, such as rheumatic mitral or aortic valve stenosis, artificial heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, left ventricular wall thrombus or valvular vegetations, congestive heart failure, bacterial endocarditis, etc. 4. patients diagnosed with acute posterior circulation cerebral infarction. 5. symptoms caused by non - culprit vessels. 6. ipsilateral extracranial vessel stenosis ≥ 70%. 7. systolic blood pressure \> 185 mmhg or diastolic blood pressure \> 110 mmhg, and uncontrollable by antihypertensive drugs. 8. intracranial tumors, arteriovenous malformations or aneurysms. 9. cerebral venous thrombosis or stenosis. 10. any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural) within 90 days before enrollment. 11. severe coagulation abnormalities. 12. any contraindications to remote ischemic conditioning: severe soft tissue injury, fracture or vascular injury of the upper limb, perivascular lesions of the distal upper limb, etc. 13. patients with any serious diseases and a life expectancy of less than 1 year. 14. patients who participated in other clinical trials within 3 months before enrollment or are currently participating in other clinical trials. 15. patients who cannot be followed up (such as those without a fixed residence, overseas patients, etc.). 16. pregnant or lactating women. 17. patients who have previously received remote ischemic treatment or similar treatments. 18. patients whom the researchers consider unsuitable for this clinical study.

Keywords: remote ischemic conditioning anterior circulation acute ischemic stroke occlusion stenosis
antenatal vitamin d3 supplementation in bangladesh: randomized controlled trial

Conditions: Pregnancy

Summary: this study is a randomized placebo-controlled trial of oral weekly vitamin d3 (cholecalciferol) supplementation during the third trimester of pregnancy among women in dhaka, bangladesh. the overall goal of the study is to establish whether there is evidence that improving vitamin d status among pregnant women in bangladesh will enhance the resistance of the infant offspring to infection. the aims of the study are to assess the effect of supplementation on 1) maternal and infant vitamin d status (based on blood concentrations of a vitamin d metabolite) and, 2) markers of neonatal immune function.

the primary aims of this study are: aim #1 - to assess the effect of weekly antenatal administration of oral vitamin d3 (875 mcg/week = 35,000 iu week ≈ 5,000 iu per day) started in the third trimester (26-29 weeks gestation) on maternal vitamin d status and fetal-neonatal vitamin d status (cord blood), in comparison to a placebo control supplement. aim #2 - to demonstrate the maternal and fetal safety of weekly maternal antenatal (second and third-trimester) vitamin d supplementation at a dose of 875 mcg/week by monitoring maternal serum calcium, urinary calcium excretion, cord blood calcium concentration, and newborn clinical parameters. aim #3 - to measure the effect of antenatal vitamin d supplementation on selected biomarkers of fetal-neonatal immune function in cord blood: in vitro stimulated cord blood mononuclear cell (cbmc) ll-37 expression, gene expression related to inflammatory and immunoregulatory pathways, th1/th2 cytokine secretion, and bactericidal properties.

Eligibility criteria:
inclusion criteria: * women aged 18 to \<35 years. * current residence in dhaka at a fixed address * plans to have the delivery performed at the shimantik maternity center, and to stay in dhaka throughout the pregnancy and for at least one month past the date of delivery. * gestational age of 26th to 29th (inclusive), estimated based on the first day of the last menstrual period (lmp). exclusion criteria: * use of any dietary supplement containing more than 400 iu/day (10 mcg/day) of vitamin d within the month prior to enrolment, or refusal to stop taking supplemental vitamin d at any dose after enrollment. * current use of anti-convulsant or anti-mycobacterial (tuberculosis) medications. * severe anemia (hemoglobin concentration \< 70 g/l). * complicated medical or obstetric history that may increase the risk of preterm birth or labor/delivery complications, based on self-report or clinical assessment by physician (e.g., cardiovascular disease, uterine hemorrhage, placenta previa, threatened abortion, hypertension, preeclampsia, preterm labor, or multiple gestation). * prior history of delivery of an infant with a major congenital anomaly, birth asphyxia, or perinatal death (stillbirth or death within first week of life).

Keywords: vitamin d cholecalciferol micronutrients developing countries bangladesh infant, newborn reproductive health infant, newborn, diseases perinatology immunology cathelicidin maternal nutrition physiology
the effects of troponin i surveillance among patients undergoing acute high-risk abdominal surgery

Conditions: Abdomen, Acute; Myocardial Injury After Non-cardiac Surgery; Troponin I; Myocardial Injury; Emergency Surgery

Summary: treatment of disorders such as gastrointestinal tract (gi) perforation, ischemia and obstruction often require acute high-risk abdominal surgery, which is associated with a high risk of complications such as myocardial injury after non-cardiac surgery (mins) and mortality. the majority of patients with mins will not experience any symptoms, and thus mins remains undetected without routine troponin measurements. the investigators hypothesized that implementing surveillance with troponin i as a standard care might be useful as risk stratification, and that increased surveillance, examinations, and subsequent individually based medical interventions, might improve the outcomes for patients with mins.


Eligibility criteria:
inclusion criteria: * eligible patients were 18 years or older * undergoing surgery for gastrointestinal perforation, obstruction, mesenterial ischemia or necrosis, or anastomotic leakage. exclusion criteria: * not undergoing surgery for one of the conditions above
cerebral oxygen saturation and cytochrome oxidase redox state in children with epilepsy: a pilot study

Conditions: Epilepsies, Partial

Summary: the purpose of this pilot study is to describe the relationship of regional cerebral oximetry and cytoximetry, measured using near-infrared spectroscopy, with seizure activity in the periictal period in children with epilepsy.

pediatric subjects with partial (focal) epilepsy seizure disorders will be studied using near-infrared spectroscopy for cytochrome c oxidase (cco) redox state and blood oxygen saturation. along with routine eeg monitoring, a set of light sensors, called optodes, attached to a net/cap/device that goes over the head will be put on. these optodes will send out very weak red light signals, which will pass through the scalp and bounce back to detectors on the netting. the changes in the light signals will be used to calculate the changes in the various forms of the enzyme cco, as well as the amount of oxygen in the blood. we hope to use these measurements to study changes in blood flow and cellular energy usage in the brain during seizures, which might help us to understand epilepsy better in the future and design better treatments.

Eligibility criteria:
inclusion criteria: 1. pediatric epilepsy patients who can provide assent (lower limit age 7). 2. diagnosis of partial (focal) epilepsy and/or frequent interictal spike activity on eeg. 3. clinical eeg supporting diagnosis of partial(focal) epilepsy and/or frequent interictal spike activity exclusion criteria: 1. history of unrepaired or palliated congenital cyanotic heart disease 2. history of traumatic head injury or head wounds to the extent that precludes safe and consistent placement of nirs-eeg probes. 3. guardian does not give consent or patient is unable to consent/assent to participate in the study 4. clinical care provider or investigator determines the patient is not appropriate candidate for the study 5. lack of current seizure care plan in children's hospital medical record 6. known sensitivity or allergy to eeg gel

Keywords: epilepsy cytochrome oxidase redox state childhood epilepsy partial epilepsy nirs near-infrared spectroscopy regional cerebral oxygen saturation