Kornimate/medical-research-clean huggingface dataset:
rct of cbt for insomnia with plwha

Conditions: Insomnia; HIV; Aids

Summary: the proposed study will consist of a randomized controlled trial (rct) comparing a known efficacious treatment for insomnia (cbt-i) to a sleep hygiene (sh) comparison condition.

the purpose of this study is to test whether a group cognitive-behavioral treatment program for insomnia (cbt-i) will help adults diagnosed with hiv to improve the quantity (number of hours) and the quality of their sleep. the pi will compare adults who participated in the cbt-i program to adults who participated in a sleep hygiene group, a common treatment for insomnia. the pi will look at the overall quality of life, and number of hours and quality of sleep of adults who participated in the cbt-i program versus adults in the sleep hygiene group. also, the pi will draw blood to compare how the body responds to medical illnesses between adults in the cbt-i program to adults in the sleep hygiene group.

Eligibility criteria:
inclusion criteria: * english-speaking individuals * over the age of 18 years old with a diagnosis of hiv or aids who is receiving medical care at the grady health system's infectious disease program (idp) * study subjects must meet the criteria for primary or secondary insomnia as defined by the diagnostic and statistical manual of mental disorders, 4th edition, text revision * must experience difficulty initiating or maintaining non-restorative sleep for at least l month (dsm- iv-tr) * the sleep disturbance causes clinically significant impairment or distress in important areas of functioning * sleep efficiency of less than 85%, sleep disturbances that occur three or more days per week, and sleep latency (i.e., time awake after sleep onset greater than 30 minutes) exclusion criteria: * current substance dependence (within the past six months) * active psychosis * bipolar i and ii disorders * neurocognitive impairment and/or a current diagnosis of dementia * lack of independent housing * previous participation in a cbt-i program * employment in a job requiring shift work that impairs the ability to establish a regular sleep schedule
ecmo abi detection with hyperfine

Conditions: Acute Brain Injury; Extracorporeal Membrane Oxygenation Complication; Hypoxia-Ischemia, Brain; Stroke, Acute

Summary: the primary objective is to characterize the prevalence and type of abi following cannulation for pediatric patients who require ecmo support. the secondary objective is to describe the time course and rates of abi using ultralow-field bedside mri relative to both duration of ecmo support and clinical imaging obtained in routine care of pediatric ecmo patients.

extracorporeal membrane oxygenation (ecmo) is frequently used to treat refractory cardiovascular and/or respiratory failure. as the support modality has evolved, survival has significantly improved, yet there are high rates of acute brain injury (abi) in this population due to disease, patient, and treatment factors. this results in significant morbidity and mortality. specifically, thromboembolic, hypoxic-ischemic, and hemorrhagic complications occur during ecmo support, but the investigators are limited in the monitoring and diagnosis of abi while on ecmo as currently available imaging modalities (i.e. ultrasound \[us\], computed tomography \[ct\]) have low sensitivity for early hypoxic, cerebrovascular, and ischemic brain injuries. the sensitivity of these modalities increases only when it is too late to effectively intervene. standard magnetic resonance imaging (mri) is the gold standard to diagnose stroke and ischemic brain injury but is incompatible with ecmo devices. swoop (hyperfine, guilford, ct) is an fda cleared ultralow-field portable mri system that can be used at the bedside and has been studied in critically ill adults with various types of abi. this novel bedside mri has been safely operated in clinical environments with equipment that is typically not mri compatible. a few adult and pediatric ecmo patients have undergone bedside brain mris showing feasibility. yet, what remains unknown is the true prevalence and timing of hypoxic, cerebrovascular, and ischemic brain injuries in pediatric ecmo.

Eligibility criteria:
inclusion criteria * participants that will be or are admitted to the pediatric intensive care unit, cardiac intensive care unit, or the neonatal intensive care unit * ages 0-17 years * participants that are at high risk for undergoing ecmo or are currently undergoing venovenous or venoarterial ecmo • high risk participants include, but are not limited to: * undergoing cardiac surgery * congenital heart disease * congenital diaphragmatic hernia * refractory hypoxemic and/or hypercarbic respiratory failure * vasoactive-refractory shock exclusion criteria * pregnancy * active implants such as: * pacemaker * implanted defibrillator * implanted insulin pump * deep brain stimulator * vagus nerve stimulator * cochlear implant * programmable shunt * mri incompatible surgical hardware (e.g., staples, screws, etc.) * metal-containing tattoos or permanent make-up on head or neck * suspected metal in eye, e.g., * former or current welders, metal workers, or individuals with a metal injury * metal shrapnel * passive implants are considered mri-conditional

Keywords: pediatric
effect of evolocumab in patients at high cardiovascular risk without prior myocardial infarction or stroke

Conditions: Coronary Heart Disease (CHD)

Summary: this study will assess the effect of lowering low-density lipoprotein cholesterol (ldl-c) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (mi) or stroke who are at high risk of a cardiovascular event.


Eligibility criteria:
inclusion criteria: 1. age: adult subjects ≥ 50 (men) or ≥ 55 (women) to ˂ 80 years of age (either sex) and meeting lipid criteria 2. low-density lipoprotein cholesterol (ldl-c) ≥ 90 mg/dl (≥ 2.3 mmol/l) or non-high-density lipoprotein cholesterol (non-hdl) ≥ 120 mg/dl (≥ 3.1 mmol/l), or apolipoprotein b ≥ 80 mg/dl (≥ 1.56 µmol/l) 3. evidence of at least one of the following at screening (without prior myocardial infarction or stroke): a. significant coronary artery disease (cad) b. significant atherosclerotic cerebrovascular disease c. significant peripheral arterial disease d. diabetes mellitus 4. at least 1 high-risk feature exclusion criteria * mi or stroke prior to randomization * coronary artery bypass grafting (cabg) ˂ 3 months prior to screening * estimated glomerular filtration rate (egfr) ˂ 15 ml/min/1.73 m² * uncontrolled or recurrent ventricular tachycardia in the absence of an implantable-cardioverter defibrillator. * atrial fibrillation or atrial flutter not on anticoagulation therapy (vitamin k antagonist, heparin, low molecular weight heparin, fondaparinux,or non-vitamin k antagonist oral anticoagulant) * triglycerides ≥ 500 mg/dl (5.7 mmol/l) measured up to 3 months prior to screening. the most recent results must be used. * last measured left-ventricular ejection fraction ˂ 30% or new york heart association (nyha) functional class iii/iv * planned arterial revascularization

Keywords: high cardiovascular risk no prior myocardial infarction stroke >= 50 years of age (men) >= 55 years of age (women) lipid-lowering therapy
study to gather information about the safety of oral anticoagulation drugs and how well these drugs work in real world for patients with non-valvular atrial fibrillation (irregularly heart beats which is not caused by a heart valve problem)

Conditions: Atrial Fibrillation

Summary: oral anticoagulant (oac) treatment with either vitamin k antagonists (vkas) or non-vitamin k antagonist oral anticoagulants (noacs) is essential in patients with atrial fibrillation for the prevention of stroke or systemic embolism (se) a condition that happens when a blood clot forms elsewhere in the body and travels through the blood stream to plug another vessel. while there are significant number of real-world publications on the use and outcomes of noacs for stroke prevention, evidence from routine clinical practice on the use and outcomes of reduced doses of noacs is scarce. by evaluating routine clinical practice data from national registers in denmark, finland, norway and sweden, researchers want to gather information about the safety and how well reduced doses of noacs work in patients with irregularly heartbeats which are not caused by a heart valve problem (non-valvular atrial fibrillation, nvaf). as a primary aim of this study, treatment with low doses of noacs (xarelto \[generic name rivaroxaban\], eliquis \[generic name apixaban\] or pradaxa \[generic name dabigatran\]) will be compared with vkas (warfarin) in nordic patients with nvaf to assess the occurrence of stroke and systemic embolism \[effectiveness\]) and intracranial hemorrhage a type of bleeding that occurs inside the skull \[safety\]).


Eligibility criteria:
inclusion criteria: * patients with a qualifying oral oac dispensed during the study period * a primary diagnosis indicative of atrial fibrillation during the baseline period exclusion criteria: * age \< 18 years at index date * died on index date * a diagnosis of valvular disease, pregnancy, transient cause of atrial fibrillation or venous thromboembolism in the baseline period or on the index date * hip or knee replacement surgery in the 60 days prior to or on the index date * a dispensed prescription of heparin or fondaparinux in the 60 days prior to or on the index date * a diagnosis of end-stage kidney disease or renal replacement therapy in the baseline period or on the index date * more than one dispensed oac (any dose of rivaroxaban, apixaban, dabigatran, edoxaban, or warfarin) on the index date * a dispensed prescription of an oac (any dose of rivaroxaban, apixaban, dabigatran, edoxaban, or warfarin) during the baseline period
immunotherapy using pluripotent killer-human epidermal growth factor receptor-2 (pik-her2) cells for the treatment of advanced gastric cancer with liver metastasis

Conditions: Liver Metastasis; Gastric Cancer

Summary: objectives: the purpose of this study is to evaluate the safety and efficacy of pik-her2 cells in the treatment of advanced her2 high expressed gastric cancer with liver metastasis patients. methods: this study designs a novel therapy using pik-her2 cells. 40 her2 positive patients with liver metastasis from gastric cancer will be enrolled. they are randomly divided into dendritic cell-precision multiple antigen t cells (dc-pmat) group and pik-her2 cells group. both dc-pmat treatment and pik-her2 cells treatment will be performed every 3 weeks with a total of three periods. the mail clinical indicators are progression-free-survival and overall survival.

a total of 40 patients may be enrolled over a period of 1-2 years.

Eligibility criteria:
inclusion criteria: 1. age 18\~65 years old, male or female 2. life expectancy \> 6 months 3. eastern cooperative oncology group (ecog) score: 0-2 4. the stomach or gastroesophageal junction carcinoma with hepatic metastasis 5. adenocarcinoma 6. the expression of her2 in immunohistochemical tumor tissue should be greater than or equal to 2 levels 7. creatinine is less than 2.5mg/dl; alanine aminotransferase (alt) / aspartate aminotransferase(ast)t less than 3 times of the normal; bilirubin is less than 3mg/dl 8. blood routine conforms to the requirements of the blood sampling 9. signed informed consent 10. patients with fertility are willing to use contraceptive method. exclusion criteria: 1. expected overall survival \< 6 months 2. other serious diseases:the heart,lung,kidney, digestive, nervous, mental disorders, immune regulatory diseases,metabolic diseases, infectious diseases, etc. 3. serum creatinine \> 2.5mg/dl;serum glutamic oxaloacetic transaminase (sgot) \> 5 times of the normal;total bilirubin \> 100μmol/l 4. without signed informed consent.

Keywords: gastric cancer liver metastasis pik-her2 cells dendritic cell-precision multiple antigen t cells
the effect of walking meditation training on glycemic control and vascular function in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: walking meditation training would yield more favorable adaptations than walking alone in improving glycemic control and vascular function in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * the inclusion criteria included type 2 diabetes (as defined by the american diabetes association), a baseline glycosylated hemoglobin (hba1c) value of 7-9%, and no previous exercise training in the past 6 months. all participants were free from diabetic nephropathy, diabetic retinopathy, severe diabetic neurophathy, severe cardiovascular and cerebrovascular diseases. exclusion criteria: * participants were excluded if they dropped out or completed less than 80% of the training schedule.

Keywords: mind and body exercise flow mediated dilation diabetes
effect of pcsk9-antibody (alirocumab) on dyslipidemia secondary to nephrotic syndrome

Conditions: Nephrotic Syndrome

Summary: the study purpose is to determine the hypolipidemic effect of alirocumab co-administered with atorvastatin on levels of triglyceride-rich lipoproteins and ldl compared to monotherapy with atorvastatin in patients with dyslipidemia secondary to nephrotic syndrome.

the trial is randomized (1:1 alirocumab to placebo), double-blinded, placebo-controlled with a cross-over design. the trial will last 10 months and includes a 10 week washout period between study phases.twenty adult subjects with dyslipidemia secondary to nephrotic syndrome and treated with atorvastatin will be recruited. alirocumab or placebo will be co-administered biweekly. safety, efficacy chemistries, vital signs, anthropometry and monitoring for adverse events also will done at each visit.

Eligibility criteria:
inclusion criteria: * nephrotic syndrome (ns) (fsgs, imn or ns and type 2 dm) * atorvastatin * ldl c \>= 70 mg/dl or non-hdl c \>= 100 mg/dl * plasma trigycerides \< 800 mg/dl. * highly effective methods of contraception for pre-menopausal women * post-menopausal women must be amenorrheic for at least 12 months. exclusion criteria: * homozygous fh * fibrates within 6 weeks of screening visit * uncontrolled hypothyroidism * known history of hemorrhagic stroke * known history of loss of function of pcsk9 * use of systemic corticosteroids unless used as replacement therapy for pituitary/adrenal disease with a stable regimen for at least 6 weeks of randomization * previous treatment with at least a single dose of alirocumab or any other anti-pcsk9 monoclonal antibody * other conditions or situations per protocol * laboratory findings or contraindications to background therapies * warnings/precautions of use (when appropriate) as displayed in the respective national product labeling * any currently known contra-indication to study drug, pregnancy or breastfeeding of infants.

Keywords: severe proteinuria dyslipidemia
cyclosporine 0.05% eye drops for vernal keratoconjunctivitis trial

Conditions: Vernal Keratoconjunctivitis; Cyclosporine 0.05% Eye Drops

Summary: to observe and compare the clinical efficacy of cyclosporine 0.05% eye drops with loteprednol etabonate 0.5% and tobramycin eye drops 0.3% in the treatment of vernal keratoconjunctivitis in developing regions of china.

vernal keratoconjunctivitis (vkc) is an allergic disease that severely affects the eyesight of adolescents. vernal keratoconjunctivitis (vkc) usually occurs in temperate regions such as the mediterranean region, the middle east, africa, central america, and the indian subcontinent. in the eu an estimated 3.2 per 10,000 inhabitants (0.03%). it occurs repeatedly and mainly involves type i and type iv hypersensitivity. long-term standardized treatment is necessary. therefore, this research aims to compare the readily available cyclosporine 0.05% eye drops and loteprednol etabonate 0.5% and tobramycin eye drops 0.3% in developing regions of asia (china, jiangxi province) for long-term drug use in vkc patients in developing countries provide evidence.

Eligibility criteria:
inclusion criteria * patients had a noticeable seasonal, and recurrent itching, discomfort(burning, stinging, and foreign body sensation), photophobia and tears, viscous discharge; * slit-lamp microscopy showed conjunctival hyperemia, tarsal papillary, limbal hypertrophy, horner-trantas dots, keratitis in some patients; * no other medication history in recent 2 weeks; * patients have high compliance and are willing to take drugs on time and return to the clinic in time exclusion criteria: * with other related immune diseases or other drug use history in recent 2 weeks; * patients with evident and severe organic diseases or mental diseases; * low compliance, unable to take drugs on time or fail to return to the clinic on time.

Keywords: cyclosporine 0.05% eye drops vernal keratoconjunctivitis immunomodulator olopatadine hydrochloride eye drops
antiplatelet strategy for ccs patients undergoing cabg

Conditions: Chronic Coronary Syndrome; Coronary Artery Bypass Graft CABG

Summary: to evaluate the long-term outcomes of different antiplatelet strategies, including dapt, aspirin monotherapy, and clopidogrel monotherapy, in ccs patients undergoing cabg. a retrospective, population-based cohort study was conducted using data from the korean national health insurance service (k-nhis) database.

the use of antiplatelet agents is crucial in preventing atherothrombotic complications and maintaining graft patency after coronary artery bypass grafting (cabg). while dual antiplatelet therapy (dapt) with aspirin and a p2y12 inhibitor is recommended for one year in patients undergoing cabg for acute coronary syndrome (acs), the optimal antiplatelet strategy for chronic coronary syndrome (ccs) remains unclear. in fact, current guidelines show discrepancies, with the american heart association/american college of cardiology (aha/acc) recommending dapt for one year to reduce the risk of saphenous vein graft (svg) occlusion (class iib), while the european society of cardiology (esc) recommends switching to aspirin monotherapy to reduce bleeding risk and considers dapt only for high-risk patients (class iib). however, aspirin monotherapy may also not be the optimal alternative due to its limited efficacy in preventing thrombotic events and its inability to significantly reduce major bleeding compared to dapt. recently, clopidogrel monotherapy has emerged as a promising alternative, potentially offering both ischemic protection and a lower bleeding risk compared to dapt even compared to aspirin monotherapy. an observational study comparing clopidogrel monotherapy with clopidogrel plus aspirin after cabg found that clopidogrel monotherapy demonstrated comparable to the combination therapy group. while this suggests that clopidogrel monotherapy could be a viable alternative, previous study was limited by its short follow-up duration and lack of bleeding outcome assessment. thus, the investigators performed target trial emulation to evaluate long-term ischemic and bleeding outcomes associated with dapt, aspirin monotherapy, and clopidogrel monotherapy in ccs patients following cabg.

Eligibility criteria:
inclusion criteria: * patients with underwent coronary artery bypass surgery (cabg) between january 2010 and december 2020 exclusion criteria: * in-hospital death * not prescribed sapt or dapt * received cabg due to myocardial infarction or had myocardial infarction * received cabg due to unstable angina or had unstable angina * history of pci * pre-existing intracranial hemorrhage or gastrointestinal bleeding * oral anticoagulant prescription at discharge

Keywords: antiplatelet drug dual antiplatelet therapy single antiplatelet therapy
a study of single and multiple doses of lp-005 in healthy adult participants

Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)

Summary: the purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of lp-005 in healthy volunteers. the study will be conducted in 2 parts: part 1, the single ascending dose (sad) is the first in human (fih) study of lp-005 and part 2, multiple ascending dose (mad).


Eligibility criteria:
inclusion criteria: 1. healthy males or females aged 18 through 50 years 2. male subjects with a weight of ≥50 kg, female subjects with a weight of ≥45 kg, and bmi between 19.0 and 26.0 kg/m² (inclusive). 3. vaccination: meningococcal conjugate vaccine, serogroups a, c, w, y (mpv-acyw) meningococcal conjugate vaccine and streptococcus pneumoniae vaccine should be given 14 days or more before randomisation. 4. male subjects and their partners or female subjects must agree to use one or more non-pharmaceutical contraceptive methods (such as total abstinence, condoms, iuds, partner ligation, etc.) during the trial period and for 6 months after the trial, and do not plan to donate sperm or eggs. 5. the subjects fully understand the purpose, nature, method and possible adverse reactions of the experiment, and voluntarily participate in the experiment and sign the informed consent. 6. the subjects were able to communicate well with the researchers and complete the study according to the protocol. exclusion criteria: 1. participants who are immunocompromised or have one of the following underlying diseases: anatomic absence of spleen (including sickle cell disease); congenital complement component deficiencies (complement component 3 and complement component 4). 2. any history of neisseria gonorrhea, meningitis infection, and guillain-barré syndrome. 3. contraindications to meningococcal vaccination (previous medical history such as epilepsy or other brain disorders). 4. presence or suspicion of active viral, bacterial, fungal, or parasitic infection, including herpes, shingles, or cold sores, within 14 days prior to screening. 5. history of unexplained recurrent infections, or use of systemic antibiotics within 90 days prior to dosing. 6. malignancy or history of malignancy, except non-melanoma skin cancer cured for more than 3 years. 7. positive hiv test (hiv-ab), positive hepatitis b virus (hbv) test (hbsag), positive hepatitis c virus (hcv), positive anti-syphilis helix-specific antibodies. 8. participation in a clinical trial of any other drug within 3 months prior to screening or within 5 half-lives of other clinical trial drugs (selecting the longer time period). 9. women who are pregnant, breastfeeding, or at risk of pregnancy. 10. any condition deemed unsuitable for study participation by the investigator.