Kornimate/medical-research-clean huggingface dataset:
safety,tolerability and immunogenicity of vaccination with varivax in healthy indian children (v210-056)

Conditions: Varicella

Summary: to observe the safety and tolerability of the administration of varivax in varicella history negative indian children 12 months to 12 years of age.


Eligibility criteria:
inclusion criteria: * healthy children, between 12 months and 12 years of age * parent or legal guardian should be willing and able to sign the informed consent form prior to entry into the study exclusion criteria: * any immune impairment or deficiency, neoplastic disease, or depressed immunity, including that resulting from corticosteroid or other immunosuppressive therapy * any immunoglobulin or blood products 5 months prior to or expected within 3 months after enrollment in this study any medical condition which, in the opinion of the investigator may interfere with the evaluation of teh study objectives * any other inactivated vaccine administered within 14 days before or expected within 42 days after administration of the study vaccination * any other live vaccine administered within 30 days before or expected within 42 days after administration of the study vaccination * female subjects who are pregnant or nursing * history of anaphylactic or other immediate allergic reactions * hypersensitivity to any of the components of the vaccine administered under this protocol such as gelatin or neomycin * past history of varicella * previous vaccination with any varicella vaccine in either monovalent or combination form * recent household, daycare, or school exposure(in the last 4 weeks) to varicella
clinical characteristics and prognosis of acute cerebrovascular events secondary to patients receiving cardiac electronic implants

Conditions: Stroke; Atrial Fibrillation; Pacemaker

Summary: to investigate the incidence, clinical characteristics and prognosis of acute ischemic and hemorrhagic cerebrovascular disease secondary to the implantation of cardiovascular implantable electronic devices, so as to provide a basis for subsequent treatment strategies and risk factor stratification. this study intends to retrospectively collect the incidence and case characteristics of acute cerebral infarction, cerebral embolism, transient ischemic attack and cerebral hemorrhage in cied patients admitted to the first affiliated hospital of xi 'an jiaotong university and other centers from january 2012 to september 2022. then, the incidence of poor prognosis and related factors of patients within 3 months were followed up by telephone to provide a basis for subsequent treatment strategy and risk factor stratification.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute cerebrovascular disease secondary to cardiac electronic device implantation. * hospitalized from january 2012 to september 2022. exclusion criteria: * patients were absent of cranial ct/mri scan data. * patients refuse to take follow-up interviews.
combination of cryosurgey and nk immunotherapy for recurrent pharyngeal cancer

Conditions: Recurrent Pharyngeal Cancer

Summary: the aim of this study is the safety and efficacy of cryosurgery plus nk immunotherapy to recurrent pharyngeal cancer.

by enrolling patients with recurrent pharyngeal cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and natural killer (nk) cells. the safety will be evaluated by statistics of adverse reactions. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies after cancer recurrence * body tumor 1-6, the maximum tumor length \< 5 cm * kps ≥ 70, lifespan \> 6 months * platelet count ≥ 80×109/l，white blood cell count ≥ 3×109/l, neutrophil count ≥ 2×109/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Keywords: pharyngeal cancer cryosurgery nk immunotherapy
study of dovitinib versus sorafenib in patients with metastatic renal cell carcinoma

Conditions: Metastatic Renal Cell Carcinoma

Summary: this study will evaluate the safety and efficacy of dovitinib versus sorafenib in patients with metastatic renal cell cancer.


Eligibility criteria:
inclusion criteria: * patients with metastatic renal cell carcinoma (mrcc) with histological or cytological confirmation of clear cell carcinoma or a component of clear cell * patients must have received one and only one prior vegf-targeted therapy and one and only one prior mtor inhibitor therapy in the metastatic setting. one vegf targeted therapy (e.g. sunitinib, or pazopanib, or axitinib, or tivozanib or bevacizumab) and one prior mtor inhibitor therapy (everolimus, or temsirolimus or ridaforolimus) * prior cytokines therapy and prior vaccines in the adjuvant setting is permitted. * patients must have had disease progression on or within 6 months of stopping the last therapy. * patients must have at least one measurable lesion at baseline (by recist criteria guidelines v1.1) assessed by computer tomography (ct) scan or magnetic resonance imaging (mri). * karnofsky performance status ≥ 70% * patients must have the following laboratory values: * absolute neutrophil count (anc) ≥ 1.5 x 109/l * platelets ≥ 100 x 109/l * hemoglobin (hgb) \> 9 g/dl * serum total bilirubin: ≤ 1.5 x uln * alt and ast ≤ 3.0 x uln (patients with known liver metastases: ast and alt ≤ 5.0 x uln) * serum creatinine ≤ 1.5 x uln exclusion criteria: * patients who have previously received sorafenib therapy in the neoadjuvant, adjuvant or metastatic setting. * patients who have previously received dovitinib or brivanib in the neoadjuvant, adjuvant or metastatic setting. * patients with brain metastases. radiological imaging (e.g. ct or mri scan) of the brain is required at screening/baseline * patients with another primary malignancy within 3 years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix * patients who have received the last administration of an anticancer targeted small molecule therapy ≤ 2 weeks prior to starting study treatment (e.g. sunitinib, pazopanib, axitinib, everolimus, temsirolimus), or who have not recovered from the side effects of such therapy * patients who have received the last administration of nitrosurea or mitomycin-c ≤ 6 weeks prior to starting study treatment, or who have not recovered from the side effects of such therapy * patients who have undergone major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic) ≤ 4 weeks prior to starting study treatment or who have not recovered from side effects of such therapy * patients with a history of pulmonary embolism (pe), or untreated deep venous thrombosis (dvt) within the past 6 months * patients with concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study other protocol-defined inclusion/exclusion criteria may apply

Keywords: dovitinib tki renal cell cancer rcc mrcc
obstructive sleep apnea treatment in serious mental illness

Conditions: Schizoaffective Disorder; Schizophrenia; Bipolar Disorder; Obstructive Sleep Apnea of Adult

Summary: serious mental illnesses (smi) like schizophrenia and bipolar disorder are two of the most disabling and costly chronic illnesses worldwide. a high proportion of adults with schizophrenia and bipolar disorder have sleep disorders, like obstructive sleep apnea (osa), but tend to be underdiagnosed and undertreated compared to the general population. this study aims to examine feasibility, acceptance, and impact of osa treatment and how it affects cognitive function in people with smi.

sleep disturbances are central to many psychiatric disorders, including schizophrenia and bipolar disorder, with clear implications for cognition, brain health, physical health and aging. obstructive sleep apnea (osa) is typically underdiagnosed and undertreated due to impairment from psychiatric symptoms, limited resources, and stigma. in turn, consequences of untreated osa in smi are dire: in particular, worsening cardiometabolic health, cognitive decline, and death. few studies have examined the impact of treatments for obstructive sleep apnea on cognitive problems in a high-risk group, such as older adults with smi. the goals of the proposed study are to assess the acceptance and effectiveness of positive airway pressure (pap) treatment for osa, and its impact on cognitive and cardiometabolic outcomes as well as biological processes over a 3-month period. in order to determine eligibility, participants will be asked to complete a diagnostic test either at home or overnight in-lab. if diagnosed with sleep apnea, the participant will be offered a 3-month treatment with an automatic pap. in addition, eligible participants will complete weekly check-ins with study staff and a series of detailed interviews, physical and neuropsychological tests, instrumental and clinical assessments, and blood draws every month for a total of 3 months.

Eligibility criteria:
inclusion criteria: control participants: * lifetime absence of major psychiatric illness * 40 to 70 years old * be at risk for or have a diagnosis of obstructive sleep apnea for participants with serious mental illness: * diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder * must not be conservatized * 40 - 70 years old * be at risk or have a diagnosis of obstructive sleep apnea. exclusion criteria: * dsm-iv-tr diagnosis of active alcohol or other substance abuse or dependence in the 3 months preceding enrollment. this will be self-report. * diagnosis of dementia, mental retardation, or other neurological or medical conditions known to affect neurophysiologic or neurocognitive functioning, or autoimmune disease * other major dsm-iv-tr axis i disorder * medical problems that interfere with a participant's ability to complete the assessments * plans to move out of the san diego county area within the following 6 months * diagnosis of osa and currently receiving apap, cpap, or any treatment from a physician.

Keywords: serious mental illness aging positive airway pressure
atripla to stribild switch study to evaluate sleep disturbances

Conditions: HIV; AIDS; Sleep Disorders

Summary: switch patients from atripla to stribild will be evaluated to see if patients have less sleep disturbances.

stribild is a preferred regimen in the department of health and human services guidelines and has demonstrated non-inferiority to atripla in treatment naïve patients out to 144 weeks (gs-102). stribild also has statistically significant less central nervous system side effects, sleep disturbances and lipid elevations compared to atripla. this study will evaluate the efficacy, safety, changes in central nervous system abnormalities and sleep disorders following a switch from virologically suppressed subjects on atripla to stribild.

Eligibility criteria:
inclusion criteria: * hiv+ subjects 18 years of age or older * estimated glomerular filtration rate \> 70 ml/min * must currently be on atripla and taking it for at least 3 months with a hiv-1 viral load \< 50 copies/ml * no antiretrovirals prior to the initiation of atripla * baseline genotyping exclusion criteria: * pregnancy * unable to provide informed consent * enrolled in another study

Keywords: atripla stribild dreams
capturing infectious covid-19 asymptomatic cases in singapore

Conditions: Covid19; SARS CoV-2

Summary: this study is being conducted to assess the performance of the bd veritor™ plus system for rapid detection of sars-cov-2, used in serial testing, in identification of infectious, asymptomatic individuals. this information may be used to inform development of an effective testing strategy by policy makers.

this multi-center, prospective, observational, diagnostic evaluation study is designed to assess the performance of the bd veritor system in the detection of sars-cov-2 in asymptomatic individuals compared to viral culture and a commercially available rt-pcr assay over multiple testing time points. the study will enroll a minimum of 150 asymptomatic, adult participants who test positive for sars-cov-2 during community/traveler screening procedures.

Eligibility criteria:
inclusion criteria: 1. male or female ≥21 years of age at the time of informed consent 2. has a positive screening test for sars-cov-2 by rt-pcr 3. is asymptomatic for covid-19 on the day of their positive screening test (may have symptoms on the actual day of study enrollment) 4. is expected to remain at the study site for the full 6-day study period 5. willing and able to complete all study required procedures 6. provision of signed and dated informed consent form exclusion criteria: 1. history of frequent or difficult to control nosebleeds within the 14 days prior to study participation 2. if, at the discretion of the investigator, involvement in the study is likely to jeopardize the subject's health or their current or future medical treatment
lidocaine-based versus opioid-based induction of anesthesia in emergency laparotomy

Conditions: Post-induction Hypotension; Lidocaine; Opioid; Emergency Laparotomy

Summary: the primary role of anesthesia is to provide unconsciousness, amnesia, immobility, and pain control. other important roles include maintaining stable vital signs and tissue perfusion, preventing and management of organ failure. emergency laparotomy represents a major surgical procedure which is usually performed in patients with acute and chronic comorbidities and is associated with several surgical and medical complications with post-induction hypotension being one of the common and serious complication. thus, it is essential to provide a balanced and safe protocol for anesthesia which maintains adequate hypnosis and antinociception besides vital stability and adequate perfusion. opioid drugs are commonly used within the context of balanced general anesthesia primarily for their antinociceptive effects. opioid drugs had been a basic component of perioperative care for providing analgesia and decreasing the requirements of other hypnotic drugs. however, there are several short- and long-term adverse effects for opioid drugs such as pruritus, postoperative nausea and vomiting, respiratory depression, dependence, and development of chronic pain. furthermore, opioid drugs are claimed to have cardiovascular depressant effects which increases the risk of hypotension if they were used routinely in patients with borderline hemodynamic profile. therefore, there is an increased interest in opioid-sparing and opioid-free anesthesia and several international consensus statements were released to regulate and suggest protocols for opioid-sparing anesthetic regimens. lidocaine-based anesthesia had been recently reported as a successful regimen for induction of anesthesia in elderly population with better hemodynamic profile than opioid-based induction. the investigators hypothesize that lidocaine-based induction of anesthesia would provide superior hemodynamic profile compared to conventional opioid-based induction of anesthesia in emergency laparotomy.


Eligibility criteria:
inclusion criteria: 1. adult patients 2. both gender 3. american society of anesthesiologists (asa) class i-iii undergoing emergency laparotomy. exclusion criteria: 1. patient refusal 2. severe cardiac morbidities (impaired contractility with ejection fraction \< 45%, heart block, arrhythmias, tight valvular lesions) 3. baseline mean arterial pressure \<75 mmhg 4. patients on vasopressor infusion, 5. patients with high shock index (heart rate / systolic blood pressure \>1) 6. pregnant or lactating women, 7. allergy of any of the study drugs 8. hypertensive patients and patients on beta blockers. 9. uncontrolled hypertensive patients or patients receiving angiotensin converting enzyme (ace) inhibitors preoperatively. 10. opioid drug abusers. 11. patients with increased intracranial tension.
impact of external factors(brexit and covid-19) on retention and turnover in the nhs

Conditions: Impact of BREXIT & COVID 19 on Retention and Turnover on NHS

Summary: problems with retention and staff turnover in the health sectors of many western countries have a long history and have thus attracted research attention over the years. the national health service (nhs) in the united kingdom (uk) is not immune to this problem as it is reported that the nhs as an organisation is struggling to meet staffing demands particularly with its nursing and medical workforce. one of the ways to tackle this problem has been to recruit staffs from european union countries. with the exit of uk from the eu, there are concerns on the this departure on staffing. while the uk was still coming to terms with brexit and its effect on the nhs, the current covid 19 pandemic struck and has intensified workload and demands on the health sector, particularly the nhs. as a result of this, many nhs employees believe more should be done to show they are valued and appreciated for all their hard work. turnover is already high among clinical occupations in the nhs as people leave for various reasons. it is therefore important to study the combined effect of these external factors (brexit and covid 19) on turnover and retention in the nhs grampian. it is hoped that this study will be beneficial to nhs grampian management and policy makers as it will aid early identification of intention to leave and possibly enhance staff retention. the study will be carried out in scotland and will be limited to nhs grampian. nurses and consultants who have been in employed in nhs grampian prior to brexit and covid 19 will be invited participate. participants will voluntarily take part in a semi structured interview which may last for about 45 to 60 minutes. the project is self-funded for the award of a phd in management studies.


Eligibility criteria:
inclusion criteria: * must be employed in nhs grampian prior to january 2020. * must be a nurse or consultant exclusion criteria: * limited to nurses and consultants.

Keywords: impact of brexit & covid 19 on retention and turnover on nhs
safety of ai-powered virtual assistant in outpatient management of heart failure

Conditions: Heart Failure

Summary: the aim of this pilot randomized study is to examine whether integrating the sirio-hf virtual assistant (va) into the outpatient management of participants recently discharged from hospital with a new diagnosis of heart failure (hf), may reduce the need for regular medical assessment and the healthcare burden, reduce variability in healthcare, and meet with participant satisfaction, without compromising participant safety and overall care quality.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * newly diagnosed hf with new york heart association class ii-iii symptoms at discharge exclusion criteria * known prior history of hf * severe comorbidities that could affect protocol adherence, in the opinion of the investigator * alternative diagnosis for symptoms such as chronic obstructive pulmonary disease * dementia or other cognitive impairment * currently involved in another interventional clinical trial
can cholesterol lowering drugs influence circulating omega-3 fatty acid levels

Conditions: Hypercholesterolemia; Hyperlipidemia

Summary: the objective of this study is to determine if the administration of a cholesterol lowering drug like ezetimibe will reduce circulating omega-3 fatty acid (ala) levels in patients with heart disease and hypercholesterolemia. the investigators hypothesize that their data will discover that patients receiving ezetimibe require additional dietary supplementation with omega-3 supplements to insure that these beneficial fatty acids are available to these patients.

all patients will undergo drug therapy as required to treat their clinical symptoms including the use of other classes of cholesterol-lowering drugs like statins (that will not interfere with intestinal cholesterol levels). one group of patients will be those who in addition to there existing drug therapy are prescribed ezetimibe to lower circulating cholesterol concentrations. a second group of patients will be those who are not prescribed ezetimibe as part of their normal course of therapy. blood samples will be taken from all patients at the study baseline. all patients will be fasted for 12 hours prior to the blood sample being taken. after 6 weeks a second blood sample will be taken. this will determine if the drug intervention (ezetimibe) influenced the circulating omega-3 fatty acid concentration. it will also be of interest to determine if drug administration (ezetimibe) will influence this process when higher levels of omega-3 fatty acids are given to the patients by dietary supplements of ala. two additional groups of patients will consume a flaxseed oil supplement containing 1g of ala in the form of two capsules daily

Eligibility criteria:
inclusion criteria: * the subject is between 18-80 years old * the subject lives in winnipeg area * the subject is willing to seize intake of oils/ salad dressings/ seafood * the subject is willing to comply with the study schedule exclusion criteria: * the subject had been taking flax oil in the last month * the subject is not willing to undergo dietary restrictions

Keywords: omega-3 fatty acid ala (alpha linolenic acid) ezetimibe flaxseed oil capsules
glp-1 ras in patients with polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. patients with pcos presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. visceral fat dysfunction is an important factor in the onset of pcos. glp-1 receptor agonist is a glucagon-like peptide 1 analog, which is related to improving blood sugar control, weight loss and appetite suppression, and reducing cardiovascular risk. the purpose of this study was to compare whether the combined treatment of glp-1 receptor agonists and calorie restrict diet reduced more visceral fat of overweight/obese patients with pcos at the same weight loss (7%) compared with calorie restrict diet alone.


Eligibility criteria:
inclusion criteria: * female aged 18- 45; * meet 2003 rotterdam criteria; * overweight/obesity,bmi≥24kg/m2. exclusion criteria: * any contraindication to dulaglutide (known or suspected hypersensitivity to dulaglutide or related products, previous acute pancreatitis or chronic pancreatitis, inflammatory bowel disease; personal history or family history of medullary thyroid carcinoma, or personal history of multiple endocrine neoplasia type 2)； * treatment with any other drugs that may interfere with the trial, including traditional chinese medicine, contraceptives, metformin, glp-1ra or pioglitazone within the last 3 months； * chronic kidney disease or severe liver dysfunction； * malignant tumors； * mental illness; * pregnancy or lactation； * inflammatory bowel disease; * recent participation in other weight-loss research projects within the last 3 months.