Kornimate/medical-research-clean huggingface dataset:
dapagliflozin effects on epicardial fat

Conditions: Type 2 Diabetes

Summary: the purpose of this research study is to learn about the effect of dapagliflozin (farxiga) on the fat of the heart.


Eligibility criteria:
inclusion criteria: * type 2 diabetes, as defined by ada criteria * hba1c \< 8% measured at least 1 week prior to the study * bmi ≥27 kg/m2 * pre-treatment with metformin as monotherapy * age \> 18 and \< 65 years old * normal and stable hemodynamic status exclusion criteria: * known contra-indications to farxiga, in accordance with risks and safety information included in the latest updated prescribing information * type 1 diabetes, as defined by american diabetes association (ada) criteria * insulin dependent or treated type 2 diabetes * current use of other sglt2 inhibitors, glucagon like peptide -1 (glp- 1) analogs or dipeptidyl peptidase 4 (dpp4) inhibitors * glomerular filtration rate (gfr) \< 60 ml/min/1.73 m2 * signs or symptoms of hypovolemia * patients with poor glycemic control (hba1c ≥ 8%) will be excluded to maximize long-term patient retention without need * history of diabetes ketoacidosis * patients with active bladder cancer or with a prior history of bladder cancer * acute or chronic infective, including genital mycotic infections * clinical signs or symptoms of new york heart association (nyha) class iii-iv heart failure * clinical or laboratory evidences of chronic active liver diseases * acute or chronic infective diseases * cancer or chemotherapy * current use of systemic corticosteroids or in the 3 months prior this study * known or suspected allergy to dapagliflozin, excipients, or related products * pregnant, breast-feeding or the intention of becoming pregnant * females of childbearing potential who are not using adequate contraceptive methods

Keywords: epicardial fat diabetes dapagliflozin
thyroid hormone supplementation in patients with septic shock

Conditions: Euthyroid Sick Syndromes; Septic Shock

Summary: the primary aim of the study would be to determine whether there is a difference in survival in the intensive care unit between the group of patients with septic shock diagnosed with euthyroid sick syndrome who were treated with t3 hormone compared to the group of patients not treated with this hormone. secondary objectives of the research would be: compare the level of thyroid hormones between the examined groups and 1. laboratory indicators of septic shock (c-reactive protein-crp, procalcitonin, leukocytes, acid-base status, lactates) 2. apache ii, sofa and saps ii patient assessment scales, 3. inflammatory prognostic systems (ratio of crp and albumin-modified glasgow prognostic score-mgps, ratio of neutrophils and lymphocytes - nlr, ratio of platelets and lymphocytes - plr, and ratio of leukocytes and crp, prognostic index - pi) 4. hemodynamic stability of patients (map, systolic and diastolic pressure) in the periods of admission t0, t3, t6, t12, t24 and every 24 hours for 4 days, 5. effect of vasoactive drugs, 6. the need for mechanical ventilation categorized as yes or no, in case - number of respirator days, 7. length of stay in the intensive care unit, 8. treatment outcome categorized as 28 day survival.


Eligibility criteria:
inclusion criteria: * all patients who meet the criteria for septic shock according to the definition of surviving sepsis campaigning (the third international consensus definitions for sepsis and septic shock (sepsis-3). jama 2016): persistent hypotension requiring the use of vasoactive drugs to maintain mean arterial pressure ≥65 mm hg ; blood lactates\> 2 mmol / l despite adequate resuscitation volume, * patients with laboratory-proven euthyroid sick syndrome, according to diagnostic criteria which include: normal levels of tsh hormone, low levels of t3 hormone that may accompany low levels of t4 hormone (depending on the stage of critical disease) and absence of previous primary thyroid and pituitary disease. exclusion criteria: * age below 18, * patients with a history of thyroid disease or an enlarged thyroid gland, * psychiatric patients, * patients on hormone therapy (excluding insulin), * those taking amiodarone, corticosteroids or dopamine * pregnant or postpartum mothers 6 months ago, * patients who refuse to participate in the study

Keywords: septic shock euthyroid sick syndrome triiodothyronine
study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of tb006 in participants with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: part 1 of this study will be conducted to determine the safety, tolerability, and pharmacokinetic (pk) profile of multiple doses of tb006, as well as the maximum tolerated dose of tb006, and to assess the immunogenicity of tb006 (production of anti-tb006 antibody). part 2 of this study will be conducted to determine the clinical efficacy of tb006 in participants with mild to severe alzheimer's disease.


Eligibility criteria:
inclusion criteria: * body weight of ≥ 50 kilograms (kg) and body mass index (bmi) between 18 and 35 kg/meters squared (m\^2), inclusive * mini-mental state examination (mmse) score of 24 or less * must be ambulatory * clinical diagnosis of alzheimer's disease (ad) consistent with the following: 1. probable ad, according to national institute of neurological and communicative disorders and stroke - alzheimer's disease and related disorders association (nincds-adrda) 2. meets the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) - criteria for major neurocognitive disorder (previously dementia) * participants or caregiver has the ability to understand the purpose and risks of the study and provide signed and dated informed consent which includes compliance with the requirements and restrictions listed in the inform consent form (icf) and in this protocol. participants whose caregiver signs the informed consent must provide their assent. exclusion criteria: * any medical or neurological condition other than ad that in the opinion of the investigator could be a contributing cause of the participant's dementia (e.g., medication use, vitamin b12 deficiency, abnormal thyroid function, stroke or other cerebrovascular condition, diffuse lewy body disease, head trauma) * history within the past 6 months or evidence of clinically significant psychiatric illness (e.g., major depression, schizophrenia, or bipolar affective disorder) * diagnosis of a dementia-related central nervous system (cns) disease other than ad (e.g., parkinson's disease, huntington's disease, frontotemporal dementia, multi-infarct dementia, dementia with lewy bodies, normal pressure hydrocephalus) * identification of other known cause of dementia or any other clinically significant contributing co-morbid pathologies at screening magnetic resonance imaging (mri), in the opinion of the investigator * participation in any other drug, biologic, device, or clinical study or treatment with any investigational drug or approved therapy for investigational use within 30 days (or 5 half lives, whichever is longer) prior to screening, and/or participation in any other clinical study involving experimental medications for ad within the 60 days (or 5 half lives, whichever is longer) prior to screening

Keywords: tb006 pharmacokinetics pharmacodynamics immunogenicity mild to severe alzheimer's disease
getting to implementation: improving cancer screening for veterans

Conditions: Cancer of Liver; Cancer of Colon; Cirrhosis

Summary: gastrointestinal cancers such as colon cancer and liver cancer cause many deaths in the us. testing could catch these cancers early, helping people live longer. the goal of this study is to compare two different ways of getting more people tested for these cancers: 1) by directly reaching out to the people who need testing or 2) by helping providers fix issues that hold up testing. the main question it aims to answer is: how should healthcare systems go about choosing one or the other? researchers will look at cancer testing rates over time at sites that are trying these different approaches. they will also survey and interview participants from these sites.

researchers will conduct two hybrid type 3, cluster-randomized trials to compare the effectiveness of patient navigation (pn) and implementation facilitation (if) on hepatocellular cancer (hcc) and colorectal cancer (crc) screening completion. trials will enroll 24 sites for the hcc arm and 32 sites for the crc arm, passively enrolling and cluster-randomizing veterans by their site of primary care. multi-level implementation determinants (i.e., barriers and facilitators), preconditions, and moderators will also be evaluated pre- and post-intervention, using consolidated framework for implementation research (cfir)-mapped surveys and interviews of veteran participants and provider participants. comparing findings in the two trials will allow researchers to understand how the barriers and strategies operate differently for a one-time screening in a relatively healthy population (crc) vs. repeated screening in a more medically complex population (hcc).

Eligibility criteria:
inclusion criteria: 1. veterans: * ≥18 years of age * enrolled in veterans health administration (va) * have ≥1 va encounter in the prior 18 months * hepatocellular cancer (hcc) screening subgroup: diagnosis of cirrhosis in electronic medical record * colorectal cancer (crc) screening subgroup: ≥45 years of age, positive fecal immunochemical test (fit) (or other screening stool test) in the last 18 months 2. providers: * healthcare provider or related staff at participating va site or engaged in crc or hcc screening pathways in an included va site (e.g., scheduling) * ≥18 years of age exclusion criteria: 1. veterans: * \<18 years of age * not enrolled in va * no va encounters in the prior 18 months * limited life expectancy (\< 6 months), defined as having a code for hospice 2. providers: * members of the study team will not participate, even if their sites are recruited

Keywords: implementation strategies patient navigation implementation facilitation consolidated framework for implementation research early detection of cancer
resourcefulness group intervention on recovery and quality of life

Conditions: Chronic Schizophrenia; Quality of Life; Recovery

Summary: the purpose of this study was to test the effects of resourcefulness group intervention on facilitating recovery and improving the quality of life in patients with chronic schizophrenia.

purpose: this study aimed to explore the effects of resourcefulness group intervention on facilitating recovery and improving the quality of life in patients with chronic schizophrenia. methods: a longitudinal and interventional study with a quasi-experimental research design and convenience sampling were used in this study. patients with chronic schizophrenia from a psychiatric hospital in northern taiwan were recruited as subjects and were divided under random assignment into the experimental group and the control group with twenty participants in each. the twenty participants in the experiment group were further randomly distributed into two groups. both received resourcefulness group intervention weekly for six weeks, while the control group followed regular care routines and underwent conventional treatment. all participants took a pretest before the intervention, the first posttest after six rounds of intervention, and the second posttest four weeks after the group intervention was completed. data were collected using structured questionnaires, including the chinese version of the resourcefulness scale (c-rs), the chinese questionnaire about the process of recovery (qpr), the whoqol-bref taiwan version, and other personal information.

Eligibility criteria:
inclusion criteria: * subjects who have been diagnosed with schizophrenia by a psychiatrist for more than two years and are currently receiving rehabilitation treatment in a chronic ward. * age between 20-64 years old. * those with stable conditions can communicate in mandarin or taiwanese. exclusion criteria: * exclude clients with intellectual disabilities, organic encephalopathy, substance-related and addictive disorders, personality disorders, dementia, cancers, etc. * those who are unable to understand the contents of the consent form.

Keywords: resourcefulness chronic schizophrenia resourcefulness group recovery quality of life
study to assess change in disease activity and adverse events of ab externo approach for glaucoma gel stent (xen45) implantation in participants aged 45 years or older with open-angle glaucoma

Conditions: Open-Angle Glaucoma

Summary: glaucoma is the second most common cause of blindness in the world, second only to cataracts. this study will assess how safe and effective a glaucoma gel stent is when implanted using the ab externo approach. adverse events and intraocular pressure will be assessed. xen45 is an approved device for the treatment of glaucoma implanted using the ab interno approach (inside the eye). xen45 implanted using the ab externo approach (outside the eye) is being studied in this study. approximately 65 participants aged 45 years or older with open-angle glaucoma will be enrolled in this study at approximately 22 sites in the united states. all participants will receive xen45 implanted using the ab externo approach on day 1 and will be followed for 12 months. participants will attend regular visits during the study at a hospital or clinic. the safety and effect of the gel stent on your glaucoma will be checked by medical assessments and eye examinations.


Eligibility criteria:
inclusion criteria: * glaucoma in the study eye. 1. study eye diagnosed with open-angle glaucoma uncontrolled by medical therapy 2. study eye that meet at least one of the following criteria: * failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery or tube shunt) (a minimum of approximately 15 subjects will be enrolled) * failed one or more cilioablative procedures (e.g., cryotherapy, cyclodiode therapy) * have neovascular glaucoma * have any other condition (e.g., conjunctival scarring, uveitis) in which a conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail than for a person with uncomplicated primary open-angle glaucoma (oag). note: to allow for a subgroup of participants who only have oag uncontrolled by medical therapy (non-refractory glaucoma), a maximum of 10 participants who meet only criterion a (and not b) will be enrolled. exclusion criteria: * a lack of healthy conjunctiva showing free mobility (free of scarring or evidence of prior surgery) in the target area. * excessive intraoperative bleeding, such that visualization in the study eye is impaired. * any anatomy or finding in the study eye that limits the investigator's ability to visualize the anterior chamber, angle, or target area of the conjunctiva. * other surgical complication that in the opinion of the investigator could impede proper placement of the gel stent.

Keywords: open-angle glaucoma glaucoma oag xen45 glaucoma gel stent xen45 glaucoma treatment system
spironolactone for paroxysmal atrial fibrillation

Conditions: Atrial Fibrillation

Summary: to determine whether or not spironolactone can prevent or delay the occurrence of atrial fibrillation.

to determine whether or not adding spironolactone can prevent or delay the occurrence of paroxysmal atrial fibrillation in patients who have received propafenone treatment.

Eligibility criteria:
inclusion criteria: 1. 18 to 80 y/o, 2. paroxysmal af. exclusion criteria: 1. gpt\>100 iu/l or tota bilirubin \>2 mg/dl; 2. creatinine \> 2 mg/dl; 3. serum potassium \>= 5 mm; 4. serum sodium \<=130 mm; 5. uric acid \> 10 mg/dl。

Keywords: atrial fibrillation, spironolactone
redo transcatheter aortic valve implantation for the management of transcatheter aortic valve failure

Conditions: Aortic Valve Stenosis

Summary: transcatheter aortic valve implantation (tavi) is a key-hole technique to replace an aortic heart valve that is narrowed and/or leaking. although tavi is a safe and effective treatment for a faulty aortic heart valve, the new tavi valve will not last forever. because it is a 'tissue' valve (made from the lining of a cow or pig heart), the valve will fail after a period of time as the tissue degenerates. when the tavi valve fails, a viable treatment option is to perform a 'redo tavi' procedure, implanting a second tavi valve inside the first failing valve. the main purpose of this study is to carefully evaluate patients being treated by redo tavi in order to document the short-term and long-term outcomes of the procedure. the study will also obtain information about which factors predict those outcomes. the study will also assess outcomes in patients who present with tavi valve failure but are not suitable for redo tavi, and instead are treated either by open-heart surgery and surgical aortic valve replacement, or by medical therapy (medication). the study will provide doctors the information they need to understand the best way to treat patients who present with tavi valve failure, and in particular how to perform redo tavi procedures with the best possible outcomes for patients.

to determine the acute and long-term outcomes of redo transcatheter aortic valve implantation (tavi) for the treatment of bioprosthetic valve failure (bvf) affecting transcatheter aortic heart valves (thvs) to determine the factors which predict the acute and long-term outcomes of redo tavi to determine the proportion of patients presenting with bvf affecting thvs who are deemed unsuitable for redo tavi by the heart team to determine the acute and long-term outcomes of surgical explantation and surgical aortic valve replacement (savr) for the treatment of bvf affecting thvs to determine the survival of patients presenting with bvf affecting thvs who are managed conservatively - including optimal medical therapy (omt) +/- balloon aortic valvuloplasty (bav)

Eligibility criteria:
inclusion criteria: 1. bio-prosthetic valve failure (bvf) of a transcatheter aortic valve requiring possible reintervention exclusion criteria: 1. bio-prosthetic valve failure due solely to paravalvular aortic regurgitation 2. active endocarditis 3. untreated acute valve thrombosis 4. life-expectancy less than 1 year 5. subject is less than legal age of consent, legally incompetent, or otherwise vulnerable.

Keywords: bioprosthetic valve failure
functional proteins in polycystic ovary syndrome

Conditions: Reproductive Age; PCOS (Polycystic Ovary Syndrome)

Summary: the concentration of functional proteins: kisspeptin, ghrelin, zonulin will be measured and compared in women with polycystic ovary syndrome (pcos) and insulin resistance (ir), in women with pcos without ir, and in women without pcos.

polycystic ovary syndrome (pcos) is currently the most common endocrine disorder in women of reproductive age with an unknown etiology. a predominant metabolic feature of pcos is insulin resistance (ir), which contributes to the pathogenesis and expression of other symptoms of the syndrome, such as hyperandrogenism. the metabolic disturbances in women with pcos result in a higher incidence of cardiovascular diseases and endometrial cancer in the premenopausal age. the gold standard for assessing peripheral tissue sensitivity to insulin is the hyperinsulinemic-euglycemic clamp technique; however, this method is not commonly used in clinical practice due to its complexities. instead, simpler tests, such as the homeostatic model assessment of insulin resistance (homa-ir) and fasting insulin measurements along with glucose tolerance tests, are employed. these methods are utilized for diagnosing insulin resistance rather than identifying predispositions. therefore, there is an urgent need to identify more precise markers of ir that could be used in routine early-stage assessments. given the long-term complications associated with pcos, which can shorten life expectancy, early diagnosis and treatment of ir are crucial. furthermore, such studies may contribute to exploring the etiopathogenesis of the syndrome. the discovery of "markers" that can predict or diagnose metabolic abnormalities at an early stage, prior to the onset of clinical symptoms, would facilitate early intervention and treatment, thus preventing a decline in quality of life associated with pcos. this study will measure and compare the concentrations of locally acting hormones: ghrelin, kisspeptin, and zonulin in three research groups: women with polycystic ovary syndrome (pcos) and insulin resistance (ir), women with pcos without ir, and women without pcos. measurements will be performed using immunoenzymatic methods (elisa) and the erba xl biochemical analyzer. statistical calculations will be conducted using spss statistics software.

Eligibility criteria:
inclusion criteria: * women aged 18-45 years exclusion criteria: * removal of at least one ovary * treated diabetes of any type * diagnosed and treated metabolic diseases * diagnosed and treated autoimmune diseases * diagnosed and treated autoinflammatory diseases

Keywords: insulin resistance kisspeptin ghrelin zonulin metabolic syndrome polycystic ovary syndrome
acceptability and tolerance study of an amino acid formula with hmos

Conditions: Infant Development

Summary: to evaluate the acceptability (including gastrointestinal tolerance and compliance) of a hypoallergenic amino acid infant formula with hmos for the dietary management of cows' milk allergy in infants less than 12 months of age.

this is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a 7-day period, of amino acid formula with hmos, which is a hypoallergenic amino acid for infant formula for the dietary management of cows' milk allergy. the acceptability data from a minimum of 15 participants will be collected in order to submit an application to the advisory committee on borderline substances (acbs) and the hse for the ireland to be reimbursed under the gms and community drug schemes

Eligibility criteria:
inclusion criteria: patients well established and stable on alfamino (or another amino acid formula dependent on feasibility of reaching required numbers) for the dietary management of presumed cma (no gastrointestinal intolerances on current formula). full term infants less than 12 months of age where the amino acid formula is still the sole source of nutrition. full term infants less than 12 months of age where the amino acid formula is required for 1 week to measure gi tolerance and 1 week of exclusive hmo amino acid formula intake. thereafter formula intake data will be collected for the remaining 3 weeks and the child can be weaned at this stage. iwillingly given, written, informed consent from patient or parent/guardian. exclusion criteria: partially or fully breastfed infants. inability to comply with the study protocol, in the opinion of the investigator. previously not tolerated alfamino without hmos. more than 12 months old need an amino acid formula as supplementary use patients with significant renal or hepatic impairment change in current medication or use of additional macro/micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator e.g. thickener, ppis etc (must be recorded in patient case record file). participation in another interventional study within 2 weeks of this study. introduction of complementary feeding during the study period caregiver unable to read and write in english (will need to complete 7 1 monthdays of forms at home).