Kornimate/medical-research-clean huggingface dataset:
study to evaluate the effects of nmra-323511 among healthy elderly and adults with agitation associated with dementia due to alzheimer's disease

Conditions: Alzheimer's Disease; Healthy Elderly

Summary: this study consists of 2 parts, part a and part b. part a is a single center, randomized, double-blind, placebo-controlled cohort designed to evaluate the safety, tolerability, and pharmacokinetics (pk) of nmra-323511 among healthy elderly. part b is a multicenter, randomized, double-blinded, placebo-controlled, parallel-group cohort to evaluate the safety, tolerability, and efficacy of nmra-323511 among adults with agitation associated with dementia due to alzheimer's disease. part a consists of a screening period (up to 28 days), a 10-day treatment period, and a 10- day follow-up clinic visit after last dose of study treatment. part b consists of a screening period (up to 28 days), an 8-week treatment period, and a 10-day follow-up clinic visit after last dose of study treatment.


Eligibility criteria:
inclusion criteria: part a * healthy participants * age 65 to 80 years * body mass index (bmi) ≥18.0 and ≤32.0 kg/m\^2 at the screening and check-in visit part b * participants aged 55 to 90 years * diagnosis of probable ad or alzheimer's clinical syndrome according to the national institute of aging-alzheimer's association criteria at least 12 months prior to screening * agitation meets the international psychogeriatric association (ipa) consensus definition * mini-mental state examination (mmse) score = 5 - 24 (mild to severe dementia) at screening exclusion criteria: part a * participant is actively suicidal * is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit * diagnosis of epilepsy taking anticonvulsants for seizure control, history of seizures part b * dementia or memory impairment due to a reason other than ad * clinically significant neurologic disorder other than ad * have any clinically significant and uncontrolled medical condition note: other protocol defined inclusion/exclusion criteria may apply

Keywords: alzheimer's disease agitation associated dementia nmra-323511
can diet- and exercise-induced weight loss improve asthma control in adults?

Conditions: Asthma; Obesity

Summary: the goal of the study is to investigate the efficacy of an evidence-based weight loss intervention, on a background of quality health care, on asthma control among obese adults. the intervention will employ a combination of recommended dietary and physical activity changes, and behavioral modification techniques.


Eligibility criteria:
inclusion criteria: participants will meet all of the following: * age: 18-70 years of age; * obesity: bmi \>30.0 kg/m2; * physician-diagnosed asthma that is poorly controlled: * documented diagnosis of asthma on the current medical problem list * currently prescribed an anti-asthma medication * overall score \<20 on the asthma control test (act)64 or a score\<3 on any of the first four act questions regarding symptoms, nighttime awakening, interference with normal activity, and saba use for symptom relief * demonstrable airway reversibility * seen in primary care at kaiser at least once in the preceding 24 months; * kpnc member for \>1 year. exclusion criteria: any of the following will exclude participants from the study: * inability to speak, read or understand english; * intermittent asthma, defined as either seasonal asthma or (daytime asthma symptoms \< 2x/week and nocturnal symptoms \< 2x/month and no use of long-term control medications); * diagnosis of copd (emphysema or chronic bronchitis) on the current medical problem list or suggested by spirometry at baseline; * unwilling to attempt weight loss, including unwillingness to perform self-monitoring; * body weight change (+/-) \> 10 pounds or use of weight-loss medications in the preceding 3 months; * inability to perform pulmonary function tests by spirometry in a consistent manner; * significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, diabetes, renal, liver), unstable heart disease, heart failure, and ongoing substance abuse; * diagnosis of psychiatric disorders that would limit adequate informed consent or ability to comply with study protocol; * regular use of medications that can cause weight gain (e.g., oral corticosteroids, insulin, certain oral hypoglycemics, certain antidepressants, etc.); * under treatment for cancer or another condition that may prevent completion of follow-up; * diagnosis of a terminal illness and/or in hospice care; * use of a pacemaker or other implanted medical devices; * pregnant, planning to become pregnant, or lactating; * actively enrolled in a care management program focused on weight loss at kaiser or elsewhere; * already enrolled or planning to enroll in a research study that would limit full participation in the study or confound the observation and interpretation of the study's findings; * family household member already enrolled in the study; * no longer receiving primary care from kaiser, or planning not to do so within the study period; * pcp determination that the study is inappropriate or unsafe for the patient; * investigator discretion for clinical safety or protocol adherence reasons.
use of fibryga, a fibrinogen concentrate in real world: retrospective collection of clinical data

Conditions: Bleeding

Summary: to describe the characteristics of patients treated with fibryga®, the indications and conditions of use of fibryga® and, for patients treated " on-demand", the short-term outcomes.


Eligibility criteria:
inclusion criteria: * patient with fibrinogen deficiency (congenital or acquired) * having received an treatment with fibryga® during the recollection period * having been informed of the potential retrospective collection of their data by a clinical research associate mandated by octapharma® when fibryga® has been delivered and who did not refuse. exclusion criteria: * n/a
effect of a test meal on satiation hormones in obese and normal weight adolescents

Conditions: Endocrine System Diseases

Summary: the objective of this study is to examine ghrelin, amylin, glucagon and glucagon-like peptide (glp)-1 responses to a test meal in lean and obese individuals.

the primary hypothesis is that obese adolescents have a disturbed balance of hormones associated with appetite regulation with less suppression of ghrelin and attenuated stimulation of glp-1 secretion in response to meal intake compared to lean normal weight controls. a second aim of the study was to test which gastrointestinal peptides are most associated with insulin resistance.

Eligibility criteria:
inclusion criteria: * caucasian youth * pubertal tanner stage x, y, or z exclusion criteria: * fasting plasma glucose \> 7.0 mmol/l * significant illness * taking medications
naltrexone and clonidine combination (atnc05) in the treatment of chronic back pain

Conditions: Back Pain; Lower Back Pain; Cervical Pain

Summary: the study includes back pain of the cervical, thoracic, and the lumbar regions.


Eligibility criteria:
inclusion criteria: the subject has chronic back pain for \> 3 months in the lumbar, thoracic or cervical regions. the average pain intensity scale during the screening week is 4/10 - 8/10 (on an 11-point numeric pain intensity scale with 0 = no pain and 10 = worst pain imaginable). the subject has not taken opioid medications 7 days prior to initiation of study drug. the subject has a heart rate of 60bpm or above and/or systolic blood pressure 90 or above. the subject is willing to refrain from using nsaids, acetaminophen or muscle relaxants, unless for rescue, for the duration of the study the subject is willing to refrain from using opioid medications and excessive alcohol for the duration of the study. the subject is able to read, understand and follow the study instructions, including completion of questionnaires at home. the subject must sign an informed consent document indicating willingness to participate. if the subject is a female, she must be post-menopausal, not currently pregnant or nursing. a female of child bearing potential should be using a reliable contraception method during the course of the study. exclusion criteria: the subject has a positive urine drug screen. the subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease. the subject has any significant deviations from normal in physical examination, electrocardiogram (ecg), echocardiogram or clinical laboratory tests, as evaluated by the investigator. the subject has a history of an allergic reaction to the components of the study drug. the subject has acute back or cervical pain. the subject has muscular back or cervical pain. the subject has back or cervical pain other than chronic radicular pain.

Keywords: back pain cervical pain neuropathic pain radicular pain
melatonin plus aminoacids for sarcopenic elderly

Conditions: Sarcopenia

Summary: to evaluate the effectiveness of melatonin and essential aminoacid supplementation on body composition, protein metabolism, strength and inflammation. the investigators performed a randomized controlled parallel groups preliminary trial in 159 elderly sarcopenic people (42/117 men/women) assigned to 4 groups: isocaloric placebo (p, n=44), melatonin (m, 1 mg/daily, n=42,), essential aminoacids (eaa 4 g/daily, n=40) or eaa plus melatonin (eaam, 4 g eaa and 1 mg melatonin/daily, n= 30). the period of intervention was 4 weeks. data from body composition (dxa), strength (handgrip test) and biochemical parameters for the assessment of protein metabolism (albumin) and inflammation (prc) were collected at baseline and after the 4-week intervention


Eligibility criteria:
inclusion criteria: * aged \> or equal 65 years * sarcopenic patients, following the rosetta study criteria: skeletal muscle index \[smi\] was \<7.23 kg/m2 in men and \<5.45 kg/m2 in women) and loss of strength, evaluated by dynamometer and defined as \<30 kg for men and \<20 kg for women, using the average value of the two handgrip measurements of the dominant hand. exclusion criteria: * acute illnesses * severe liver dysfunction * severe heart dysfunction * severe kidney dysfunction * severe dementia * uncontrolled diabetes * dysthyroidism * any endocrinopathies * neoplasia * patients treated with steroids * patients entirely unable to walk
prophylactic use of entecavir for hbsag positive lymphoma patients treated with rituximab-based immunochemotherapy

Conditions: Hepatitis B

Summary: the purpose of this study is to identify the effect of prophylactic entecavir in hbsag positive lymphoma patients treated with rituximab-based immunochemotherapy.

hbsag positive lymphoma patients are treated with entecavir when they receive rituximab-based immunochemotherapy. entecavir 0.5mg daily is administrated from day 1 of immunochemotherapy and/or chemotherapy to 12 months after completing immunochemotherapy and/or chemotherapy.

Eligibility criteria:
inclusion criteria: * treatment-naive patients with b-cell lymphoma * hbsag positive at baseline * treated with rituximab-based immunochemotherapy * life expectancy of more than 3 months exclusion criteria: * younger than 18 years old * hbsag negative at baseline * pregnant or lactating women

Keywords: lymphoma hepatitis b virus therapeutic uses antiviral agents rituximab
chips (control of hypertension in pregnancy study): a pilot trial

Conditions: Transient Hypertension, Pregnancy

Summary: prior to undertaking chips which will be a large and difficult trial, we believe we need to first determine whether clinicians will comply with the interventions of 'less tight' and 'tight' control of dbp, and whether the interventions will result in differences in mean dbp between groups. a pilot will also allow us to confirm the ability of centres to identify eligible women and the willingness of women to join chips.

to determine whether 'less tight' control of mild-moderate non-proteinuric maternal hypertension, aiming for a diastolic blood pressure (dbp) of 100mmhg, can decrease the risks of adverse perinatal outcome without increasing maternal risk compared with 'tight' control, aiming for a dbp of 85mmhg.

Eligibility criteria:
inclusion criteria: * dbp 90-109mmhg due to pre-existing or gestational hypertension; live fetus(es); and 20-33+6 weeks. exclusion criteria: * dbp consistently \< 85mmhg by home bp monitoring; severe systolic hypertension; proteinuria; contraindication to either arm of the trial or to prolongation of pregnancy; or known lethal/major fetal anomaly.

Keywords: hypertension blood pressure pregnancy
mindfulness based cognitive therapy for youth with anxiety at risk for bipolar disorder

Conditions: Anxiety; Bipolar Disorder

Summary: children who have parents with bipolar disorder are at risk for developing anxiety disorders.

children who have parents with bipolar disorder are at risk for developing anxiety disorders. typical treatments for anxiety in children are ssri antidepressants. however, these medications may accelerate the onset of mania or hypomania in children with a family history of bipolar disorder or cause suicidal thinking in children. studies trying alternative treatments to anxiety and possible bipolar disorder in children are needed, to establish other methods for treating childhood mental health. these studies can also help with early intervention and possible future prevention strategies for bipolar disorder. this study involves treating anxious children with mindfulness based cognitive therapy. they will have 12 weeks of mindfulness therapy in a group with other children where they will be led by a trained group leader, how to pay attention to anxiety cues and react differently.

Eligibility criteria:
inclusion criteria: * 10-17 years old * at least one parent with bipolar disorder * meets clinical criteria for a specific anxiety disorder * pars -5 item scale score \> 10 at screening and baseline of initial study phase * fluent in english; * provision of written informed consent/assent * agrees to participate in 75% of sessions exclusion criteria: cannot have any of the following: * documented diagnosis of mental retardation or iq \<70 * previous participation in mindfulness-based treatment * substance use disorder within last 3 months * judged clinically to be suicide risk * concurrent treatment with psychotropic medication (certain exceptions apply, ask for details) * psychotherapy initiated within 2 months prior to screening or plan to initiate psychotherapy during study participation * any lifetime diagnosis of bipolar disorder, cyclothymia, schizophrenia, or other psychotic disorder * any symptom that requires admission to an inpatient psychiatric unit * anxiety symptoms resulting from acute medical illness or acute intoxication or withdrawal from drugs or alcohol

Keywords: bipolar disorder anxiety mindfulness high risk cognitive behavioral
efficacy study of high dose symlin to treat type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the hypothesis of the study is that those obese patients with type 2 diabetes mellitus who do not respond to the fda approved dose of 120 mcg of pramlintide (symlin®) 3 times daily with expected glucose control require higher than fda approved dosage. the primary objective of the study is to determine whether higher doses of pramlintide (symlin®) in patients with type 2 diabetes mellitus control glucose better than the fda approved dose of 120 mcg three times daily. the secondary objectives include proving whether higher dose pramlintide (symlin®) is more efficacious in causing weight loss and reduction in waist circumference than standard dose pramlintide (symlin®),to determine whether blood levels of certain hormones correlate with need for higher dose therapy,and to determine whether or not the rate of common adverse effects exceeds the maximum fda approved pramlintide (symlin®) dose of 120 mcg three times daily.


Eligibility criteria:
inclusion criteria: 1. age 18-80 years. 2. type 2 diabetes mellitus. 3. obese (bmi \> 30 kg/m2), waist circ. \>35" women, \>40" men. 4. basal insulin plus at least 2 injections of mealtime insulin daily or pre-mixed insulin. 5. on stable insulin dose for at least 3 mos (baseline + 20%, no minimum). 6. if pramlintide treated, on stable full dose for at least 3 months. 7. a1c \> 7.0% and \< 9.0%. 8. women of childbearing age if using a reliable form of birth control. 9. women of childbearing age if post tubal ligation or surgical menopause. 10. able to consent. 11. willing to perform self-monitoring of glucose. 12. willing to attend study visits. 13. written informed consent to participate in the study. 14. agreement to maintain prior diet and exercise throughout the full course of the study. exclusion criteria: 1. age \ 80 years. 2. confirmed gastroparesis or taking medications affecting gastric motility. 3. a1c \ 9.0%. 4. recurrent severe hypoglycemia or hypoglycemic unawareness. 5. chf. 6. creatinine clearance \<30 ml/min. 7. history of mi \<6 mos prior to enrollment. 8. history of ventricular arrhythmia. 9. history of cancer or chemotherapy \<6 mos prior to enrollment. 10. laboratory abnormalities as follows: 1. liver enzymes \>3x uln. 2. hematocrit less than 30. 3. serum creatinine \>2.5 mg/dl. 4. fasting triglycerides \>500 mg/dl. 11. cirrhosis. 12. pregnancy or nursing. 13. inability to provide consent. 14. unwilling to attend study visits. 15. unwilling to perform self-monitoring of glucose. 16. chronic oral or parenteral glucocorticoid therapy (over one week of treatment) within 3 months prior to screening. 17. investigational drug treatment within 3 months prior to screening. 18. donation of blood, significant blood loss or transfusion within 3 months of screening. 19. history of acromegaly or cushing's syndrome. 20. use of prohibited concomitant medications. 21. type 1 diabetes mellitus. 22. acute metabolic complication (hyperosmolar state) \<6 months prior to screening.

Keywords: pramlintide glucose type 2 diabetes mellitus amylin
tezepelumab (tezspire) regulatory postmarketing surveillance in korea

Conditions: Severe Asthma

Summary: the objectives of this study are to describe the occurrence of adverse events and the effectiveness of tezepelumab in patients receiving tezepelumab as indicated for severe asthma in south korea.

primary objective(s): * to estimate the incidence proportion of adverse events (aes), adverse drug reactions (adr1s), serious adverse events (saes), serious adverse drug reaction (sadrs), unexpected2 adverse events, unexpected adverse drug reactions and expected adverse drug reactions, separately among patients receiving tezepelumab for severe asthma in routine clinical practice. * to describe the nature (type), severity, and causality of adverse events (aes)/adverse drug reactions (adrs) and actions taken to address aes among patients receiving tezepelumab for severe asthma in routine clinical practice. secondary objective(s) : * to estimate the proportion of patients with improved asthma control from baseline to week 24 after tezepelumab initiation or the last known routine visit \[i.e., end of treatment (eot)\] * to estimate the incidence rate of adverse events (aes) , adverse drug reactions (adrs), serious adverse events (saes), serious adverse drug reaction (sadrs), unexpected adverse events, unexpected adverse drug reactions and expected adverse drug reactions per unit time, separately among patients receiving tezepelumab for severe asthma in routine clinical practice. exploratory objective(s): * to estimate the incidence proportion of aes by demographic and clinical characteristics * to estimate the proportion of patients with improved asthma control from baseline to week 24 after tezepelumab initiation or the last known routine visit by demographic and clinical characteristics this is a prospective, single-arm, multicenter, observational study to evaluate the safety and effectiveness of tezepelumab from treatment initiation up to 24 weeks in patients who are prescribed tezepelumab according to its approved indication for severe asthma in south korea. the asthma control effectiveness assessment will be an evaluation of change from treatment initiation up to 24 weeks after treatment initiation. this study design will reflect the actual management of these subjects in routine clinical practice. the treating physician will determine the treatment plan, as well as the frequency of laboratory and clinical assessment, if necessary, based on routine practice.

Eligibility criteria:
inclusion criteria: 1. patients who are treated with at least one dose of tezepelumab according to the indication in the locally approved prescribing information 2. patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study exclusion criteria: 1. other off-label indications according to the locally approved prescribing information 2. current participation in any interventional trial

Keywords: severe asthma
short term outcomes in hospitalized patients with liver cirrhosis

Conditions: Liver Cirrhosis

Summary: this study will be conducted to assess the baseline characteristics and evaluate the 90-day mortality of patients admitted with liver cirrhosis. also, the study will be done to identify the risk factors of 90-day mortality.

liver cirrhosis is the end spectrum of all chronic liver diseases characterized by advanced fibrosis, scarring, and formation of regenerative nodules leading to hepatic architectural distortion. liver cirrhosis is a major cause of health burden worldwide. according to the global burden of disease study, liver cirrhosis caused 1.2% of global disability-adjusted life years and 2% of all deaths worldwide in 2010, the 14th leading cause of mortality. the progress rate of compensated cirrhosis to decompensated cirrhosis is approximately 58% and once it progresses to decompensated cirrhosis, its mortality rate within 5 years becomes 85% without liver transplantation. since the progression of cirrhosis is accelerated each time a complication recurs, the management and treatment of the complication are critical in enhancing the quality of life and the life expectancy of patients . post-discharge outcomes are an integral component of healthcare, as they may aid in determining the success and longevity of treatment and how clinicians approach future cases . this study will focus on the short-term outcomes of patients hospitalized with liver cirrhosis to provide insight into methods for future healthcare interventions.

Eligibility criteria:
inclusion criteria: - diagnosis of liver cirrhosis, adult (age ≥ 18 years old) and patients willing to give consent during the selected period. exclusion criteria: - patients with ages \< 18 years or patients that will be lost on follow-up will be excluded from the study.
hysteroscopic vs. cervical injection for sentinel node detection of endometrial cancer

Conditions: Endometrial Cancer

Summary: hysteroscopic vs. cervical injection for sentinel node detection of endometrial cancer: a multicenter prospective randomized study

hysteroscopic vs. cervical injection for sentinel node detection of endometrial cancer

Eligibility criteria:
inclusion criteria: * signed informed consent from the patient; * histological diagnosis of endometrial cancer (including type i and ii ec); * early stage (figo stage \< 4); * age older than 18 years. exclusion criteria: * preoperative diagnosis of extra-uterine disease; * preoperative suspicious of gross positive nodes; * execution of neoadjuvant chemotherapy; * contraindication to upfront general anesthesia and or mini-invasive surgery; * systemic infections ongoing; * pregnancy ongoing.

Keywords: cervical injection hysteroscopic injection