Kornimate/medical-research-clean huggingface dataset:
a study of the safety and efficacy of memantine in moderate to severe alzheimer's disease

Conditions: Dementia of the Alzheimer's Type

Summary: the objective of this study is to evaluate the safety, tolerability, and efficacy of memantine compared to placebo in outpatients diagnosed with moderate-to-severe dementia of the alzheimer's type on a concurrent acetylcholinesterase inhibitor (achei).

memantine is a therapeutic agent that represents a unique class of alzheimer's disease (ad) treatment options. a once daily (qd) dosing regimen in an ad population would simplify administration for the caregiver. the purpose of this study is to evaluate the safety and efficacy of modified release memantine taken once daily in outpatients with moderate-to-severe ad on a concurrent achei.

Eligibility criteria:
inclusion criteria: * ambulatory patients aged \>/= 50 years * diagnostic evidence of probable alzheimer's disease consistent with criteria from the national institute of neurological and communicative disorders and stroke-alzheimer's disease and related disorders association (nincds-adrda) and the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) * confirmatory magnetic resonance imaging (mri) or computed tomographic (ct) scan within the prior 12 months. * mini-mental state examination (mmse) scores \>/= 3 and \</= 14 at screening (visit 1) and baseline (visit 2) * ongoing daily acetylcholinesterase inhibitor (achei) therapy at a stable dose for at least 3 months prior to screening (visit 1). it is preferred that patients continue to receive the same achei therapy for the duration of the study. exclusion criteria: * patients with a modified hachinski ischemia score greater than 4 at screening. * patients who have taken memantine within one month of screening (visit 1) * patients who have a known hypersensitivity to memantine, neramexane, rimantadine, or amantadine. * patients whose achei therapy is likely to be interrupted or discontinued during the course of the study. * patients who are receiving therapy with more than one achei. * patients with computed tomography (ct) or magnetic resonance imaging (mri) evidence of hydrocephalus, stroke, a space-occupying lesion, cerebral infection, or any clinically significant central nervous system disease other than alzheimer's disease. * patients with a dsm-iv axis i disorder other than alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder. * patients who, in the clinician's judgement, are likely to be placed in a nursing home within the next 6 months. * patients who had evidence of other neurological disorders that included, but were not limited to, stroke, parkinson's disease, seizure disorder, or head injury with loss of consciousness within the prior 5 years * patients who had dementia that was complicated by other organic disease * patients who had dementia complicated by the presence of predominant delusions

Keywords: memantine alzheimer's disease moderate to severe alzheimer's disease
trial evaluating the efficacy and safety of oral vadadustat once daily (qd) and three times weekly (tiw) for the maintenance treatment of anemia in hemodialysis subjects converting from erythropoiesis-stimulating agents (esas)

Conditions: Anemia

Summary: this trial will be conducted to demonstrate the efficacy and safety of vadadustat compared to darbepoetin alfa for the maintenance treatment of anemia in hemodialysis participants after conversion from current erythropoiesis-stimulating agent (esa) therapy.

this study consists of three periods: 1. screening period 2. conversion and maintenance treatment period 3. safety follow-up period individual participants will participate in total trial duration of approximately 64 weeks.

Eligibility criteria:
inclusion criteria: * receiving chronic, outpatient three times weekly (tiw) in-center hemodialysis for end-stage renal disease for at least 12 weeks prior to screening * hemodialysis adequacy as indicated by single-pool kt/vurea ≥ 1.2 using the most recent historical measurement within 8 weeks prior to or during screening * use of any approved erythropoiesis-stimulating agents (esas) for at least the 8 weeks prior to screening visit 2 * two hemoglobin (hb) values, at least 4 days apart, measured by the central laboratory during screening within the following prespecified ranges: 1. hb values between 8.0 and 11.0 grams per deciliter (g/dl) (inclusive) in the united states; 2. hb values between 9.0 and 12.0 g/dl (inclusive) in europe * serum ferritin ≥ 100 nanograms per milliliter (ng/ml) and transferrin saturation (tsat) ≥ 20% during screening * folate and vitamin b12 measurements ≥ lower limit of normal during screening exclusion criteria: * anemia due to a cause other than chronic kidney disease (e.g., sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia) * participants meeting cut-off of the following equivalent mean weekly doses calculated over 8 weeks prior to screening visit 2 1. methoxy polyethylene glycol-epoetin beta \> 50 micrograms (µg)/week; 2. darbepoetin alfa \> 100 µg/week; 3. epoetin analogues \> 23000 international units (iu)/week * active bleeding or recent blood loss within 8 weeks prior to randomization * red blood cell transfusion within 8 weeks prior to randomization * current uncontrolled hypertension. * acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure (hf) or new york heart association class iv hf, or stroke within 12 weeks prior to or during screening. * known hypersensitivity to vadadustat, darbepoetin alfa, or any of their excipients

Keywords: vadadustat hemodialysis erythropoiesis-stimulating agents darbepoetin alfa ckd anemia
survey study - sensitivity comparison between melafind and physician group

Conditions: Melanoma

Summary: this survey study purposes to determine and compare the biopsy/referral sensitivity and specificity of melafind to the average biopsy/referral sensitivity and specificity of dermatologists. 241 subjects logged into system but only 183 signed consents and completed the intake survey. out of these 183, 155 were accounted for in the data analysis after exclusions were removed from the pool of subjects.

early detection of melanoma is critical for favorable prognosis, since patients with earlier stage melanomas have a much higher probability of survival than with later stages. the traditional method of early detection has been with serial total body skin exams where the health care provider examines all skin surfaces, including mucosa, for suspicious pigmented lesions. studies have demonstrated that the diagnostic accuracy of physicians for melanoma depends on the level of dermatological training. more important than being able to make a diagnosis of melanoma on clinical impression is the ability to make an appropriate decision to biopsy the lesion. primary care physicians (pcps) are often expected to screen for melanoma and only refer to dermatologists when there is a high clinical suspicion of melanoma. however, if pcps are not adept at diagnosing melanoma, then opportunities for early diagnosis and treatment could be missed. conversely, the morphology of benign pigmented lesions can often mimic that of early melanomas, resulting in potentially unnecessary dermatology referrals, biopsies, and patient anxiety. studies have indicated that there is great variability in the ability of pcps to make a correct decision to biopsy/refer a pigmented lesion (1.5 times greater than dermatologists) as well as for diagnosing melanoma (over 2.5 times greater than dermatologists). to aid in detection of early melanomas, new technologies are being developed. one such technology is melafind, an investigational device that has been developed to give a recommendation for biopsy (or not) of pigmented skin lesions to rule out melanoma. our hypothesis is that melafind will have equal or better sensitivity than pigmented lesion experts in making an appropriate recommendation for biopsy (i.e., melafind will be at least as accurate as dermatologists in recommending biopsy for melanomas).

Eligibility criteria:
inclusion criteria: * board certified physicians or equivalent exclusion criteria: * did not participate in eos protocols 20061 or 20081
the safety and efficacy of cart-19 cells in b-cell acute lymphoblastic leukemia (b-all).

Conditions: B-cell Acute Lymphoblastic Leukemia

Summary: this is a study for patients who have been previously treated for b-all. the purpose of this study is to determine the safety and feasibility of cart-19 cells to the patients with relapsed and refractory cd19+ b-all.

subjects will be staged and the suitability of their t cells for cart-19 manufacturing will be determined at entry phase,. subjects will be collected large numbers of peripheral blood mononuclear cells (pbmc) for cart-19 manufacturing. the t cells will be purified from the pbmc, transduced with cart-19 lentiviral vector, expanded in vitro and then administered to subjects. subjects will have blood tests to assess safety and efficacy, and persistence of the cart-19 cells at regular intervals through four weeks after their last infusion of the study. following the 6 months of intensive follow-up, subjects will be evaluated quarterly for two years with a physical examination, blood tests, bone marrow aspirate, minimal residual disease (mrd) and persistence of cart-19. following this evaluation, subjects will be evaluated health problems every year for an additional thirteen years.

Eligibility criteria:
inclusion criteria: 1. 4 years to 70 years, expected survival \> 3 months 2. cd19 positive b-cell acute lymphoblastic leukemia 3. karnofsky performance status (kps) \>70 4. relapsed after allogeneic or autologous stem cell transplantation (sct); 5. cardiac function: 1-2 levels; liver: tbil≤3 upper limit of normal (uln)，aspartate aminotransferase (ast) ≤2.5 uln，alt ≤2.5 uln; kidney: cr≤1.25 uln; bone marrow: white blood cell (wbc) ≥ 3.0×109/l, hb ≥90 g/l, platelet (plt) ≥ 80×109/l） 6. no serious allergic constitution 7. no other serous diseases that conflicts with the clinical program 8. no other cancer history 9. no serious mental disorder 10. informed consent is signed by a subject or his lineal relation. exclusion criteria: 1. pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test) 2. uncontrolled active infection, hiv infection, syphilis serology reaction positive 3. active hepatitis b or hepatitis c infection 4. recent or current use of glucocorticoid or other immunosuppressor 5. with severe cardiac, liver, renal insufficiency, diabetes and other diseases 6. transaminase \>2.5 uln, bilirubin \>3 uln，creatinine\>1.25 uln 7. participate in other clinical research in the past three months; previously treatment with any gene therapy products 8. researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results
multiparametric mri for assessing breast cancer response to anti-her2 therapy

Conditions: HER2-positive Breast Cancer

Summary: this is a single institution, observational research study in which patients are observed using dwi/dce mri imaging before and after receiving neoadjuvant anti-her2 therapy.

this is not a treatment trial. patients will be treated according to the plan developed by their medical oncologists. only patients planning to receive anti-her2 therapy as part of planned systemic therapy will be eligible for this imaging study. patients and their referring oncologist will be asked to start the anti-her2 therapy 2-3 weeks prior to surgery and after the pre-therapy mri.

Eligibility criteria:
inclusion criteria: * subjects at least 18 years of age. * have a new diagnosis of invasive breast cancer, clinical stage i - iii, her2 positive. * planning to undergo surgical resection plus adjuvant therapy to include an anti-her2 agent. * have tissue block available for review of experimental markers. * be a candidate for mri imaging. * be willing to comply with scheduled visits required for the trial. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * recent therapy for breast cancer prior to baseline mri. * subjects may not receive other investigational agents during the study window for imaging. * contraindications for mri or mri contrast including severe claustrophobia, history of previous reaction to mri contrast, renal disease, congestive heart failure, other significant systemic diseases or any metal in their body, including but not limited to: a brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or defibrillator, cochlear implant, ocular foreign body (e.g. metal shavings), other implanted medical devices: (e.g. swan ganz catheter), insulin pump, metal shrapnel or bullet. * pregnant or nursing.
spinal versus general anesthesia for laparoscopic cholecystectomy

Conditions: Spinal Anesthesia; General Anesthesia; Postoperative Pain

Summary: the purpose of the study is to assess whether spinal anesthesia is or not superior to the standard general anesthesia for fit patients undergoing laparoscopic cholecystectomy.

laparoscopic cholecystectomy under regional anesthesia alone has been reported only occasionally in the past; all these reports included patients unfit to receive general anesthesia, mainly patients with severe chronic obstructive airway disease. regional anesthesia has been used for laparoscopy in fit patients almost exclusively in combination with general anesthesia, in order to extend the analgesic effect during the early postoperative period. surprisingly, in the era of minimally invasive medicine, regional anesthesia has not gained popularity, and has not been routinely used as a sole method of anesthesia in laparoscopic procedures. it is generally accepted that all laparoscopic procedures are merely a change in access and still require general anesthetic; hence the difference from conventional surgery is likely to be small. this statement is predominantly based on the assumption that laparoscopy necessitates endotracheal intubation to prevent aspiration and respiratory embarrassment secondary to the induction of co2 pneumoperitoneum which in turn is not well tolerated in a patient who is awake during the procedure. however, it is surprising that regional anesthesia has been successfully used for laparoscopic cholecystectomy in patients unfit to have the procedure under general anesthesia, but has not been tested in fit patients, in whom any presumed risk would be, theoretically, much lower. we have recently shown in a pilot study the feasibility to perform successfully and safely laparoscopic cholecystectomy with low pressure co2 pneumoperitoneum under spinal anesthesia alone, in fit patients with symptomatic gallstone disease. we have also noticed that spinal anesthesia results in exceptionally minimal postoperative pain. after this pilot study, we designed a controlled randomized trial in order to compare spinal anesthesia with the standard general anesthesia for elective laparoscopic cholecystectomy in fit patients.

Eligibility criteria:
inclusion criteria: * elective laparoscopic cholecystectomy * asa i, ii * bmi\< 30 * normal coagulation profile exclusion criteria: * acute cholecystitis / cholangitis / pancreatitis * previous open surgery in the upper abdomen * contraindication for pneumoperitoneum * contraindication for spinal anesthesia (ie spinal deformity)
multiple sensory interventions on infants' pain and physiological distress during neonatal screening procedures

Conditions: Infant Behavior; Pain, Acute; Physiological Stress; Breast Milk

Summary: the study purposes are to compare the effects of different combinations of sensory interventions on newborns' pain responses, physiological distress (heart rate and oxygen saturation), and crying event during heel stick procedures.

newborns undergo many necessary invasive procedures for routine care, but these treatments may cause stress and pain. the study purposes are to compare the effects of different combinations of sensory interventions on newborns' pain responses, physiological distress (heart rate and oxygen saturation), and crying event during heel stick procedures. this study was a prospective, randomized controlled trial. infants were recruited by convenience sampling in a baby room of a medical center in northern taiwan from september in 2017 to september in 2018. newborns who met the criteria were recruited by blocked random to three treatment groups: (1)gentle touch + verbal comfort, (2) smell + gentle touch + verbal comfort, (3) smell + taste + touch + verbal comfort. pain response was measured by the neonatal infant pain scale (nips). the physical distress events were measured by the abnormal heart rate and oxygen saturation event, and crying event. all data were collected 5 minutes before heel-stick (baseline), during heel-stick and in recovery status.

Eligibility criteria:
inclusion criteria: * gestational age \> 36 weeks, birth weight \> 2200 g, and at least one parent agreed to participate. exclusion criteria: * had congenital anomalies and neurologic impairment
evaluation of the use of empagliflozin in patients with hf with pef in a cardiology outpatient department

Conditions: Congestive Heart Failure (CHF)

Summary: this study aims to evaluate whether the use of a 25 mg dose of empagliflozin compared to the 10 mg dose used would bring additional benefits in the improvement outcomes of the kansas city cardiomyopathy questionnaire (kccq sst), in the 6-minute walk test (6mwt) without causing significant side effects.

this study aims to evaluate whether the use of a 25 mg dose of empagliflozin compared to the 10 mg dose used would bring additional benefits in the improvement outcomes of the kansas city cardiomyopathy questionnaire (kccq sst), in the 6-minute walk test (6mwt) without causing significant side effects. patients will be randomized and will receive one of the two doses of empagliflozin. all patients in both groups will be equally evaluated by the tests, before receiving the medication, and also 8 weeks after.

Eligibility criteria:
inclusion criteria: * patients \>18 years old. * echocardiogram with ejection fraction \> 50% * patients must present at least one of the following items to be included in the study: patients with a previous diagnosis of heart failure with reduced ejection fraction (hfref) who have improved on the echocardiogram to an ejection fraction above 50%, patients with a previous ejection fraction between 40-49% who have progressed to ejection fraction above 50%. for these groups there is no need to perform the score for heart failure with preserved ejetion fraction score (since the diagnosis of hf was already known). patients with signs/symptoms of hfpef, who present structural morphological changes such as left atrium enlargement or left ventricular hypertrophy (lvh). * after recently undergoing the score for heart failure with preserved ejetion fraction score (h2fpef), patients who present scores that place them at least at an intermediate probability of hfpef would be eligible for entry into the study. * signing the consent form exclusion criteria: * patient with type i dm * estimated glomerular filtration rate (egfr), using the chronic kidney disease epidemiology (ckd epi) equation, with a cutoff of \<20 ml/mm/1.73m2 * patient currently using sglt2 antagonists * patient with a history of allergic reaction or significant sensitivity to empagliflozin * female patient who is pregnant or considering becoming pregnant during the study or for 3 months after the last dose of study medication * patients that are breastfeeding * patients considered by the investigator, for any reason, to be an unsuitable candidate for the study * patients with a previous diagnosis of hfpef who presents a low probability of diagnosis after being re-stratified by the previously mentioned score * patients unable to walk or understand/comply with the study protocol.

Keywords: congestive heart failure preserved ejection fraction empagliflozin
cardiovascular imaging and biomarker analyses (ciber)

Conditions: Coronary Artery Disease; Heart Diseases; Heart Failure

Summary: "cardiovascular imaging and biomarker analyses (ciber)" is a single-center, prospective and observational study evaluating the expression of novel biomarkers in patients undergoing cardiacvascular imaging within clinical routine care. it is aimed to evaluate associations with biomarker expressions with ascertained cardiac imaging parameters.

"cardiovascular imaging and biomarker analyses (ciber)" is a single-center, prospective and observational study evaluating the expression of novel biomarkers in patients undergoing cardiacvascular imaging within clinical routine care. it is aimed to evaluate associations with biomarker expressions with ascertained cardiac imaging parameters. furthermore the prognostic value of biomarkers and imaging parameters on mid-term and long-term prognosis will be evaluated. novel biomarkers will comprise blood derived biomarkers including neurohormones, proteins, cytokines, micrornas and metabolomics.

Eligibility criteria:
inclusion criteria: * patients with low to intermediate risk for coronary artery disease exclusion criteria: * under 18 years * mechanical heart valve * pulmonary embolism * deep vein thrombosis * myocardial infarction within the last 3 months * electrical cardioversion within 30 days * status after heart transplant * transient ischemic attack (tia) or stroke within last 30 days * intracerebral bleeding within the last 2 months * acute infection * existing or planned pregnancy * chronic kidney disease with egfr \< 40 ml/min