Kornimate/medical-research-clean huggingface dataset:
a pharmacokinetics study to evaluate safety and tolerability of jnj-37822681 in participants with stable schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate safety, tolerability and pharmacokinetics (explores what the body does to the drug) of jnj-37822681 in participants with stable schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

this is a double-blind (neither physician nor participant knows the treatment that the participant receives), multi-center (conducted in more than one center), randomized (treatment group assigned by chance), and multiple-dose titration study of jnj-37822681 in participants with stable schizophrenia. the total study duration will be approximately of 8 weeks per participant, consists of 4 parts: screening (that is, 21 days before study commences on day 1); double-blind treatment (14 days); follow-up (7 to 14 days after last dose administration). participants will be randomly assigned to treatment with ascending dose levels of jnj-37822681 once daily and twice daily. efficacy will primarily be evaluated by positive and negative syndrome scale and clinical global impression-severity scale. safety will be barnes akathisia rating scale, abnormal involuntary movement scale and simpson angus rating scale. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * have schizophrenia diagnosis by diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) * known history of schizophrenia of at least 12 months by the referring psychiatrist * positive and negative syndrome scale score at screening less than 70 * body mass index (bmi) between 18 and 35 kilogram divided by square meter inclusive (bmi =weight per square height) * female participants must meet any one of the following: postmenopausal (amenorrhea for at least 12 months and follicle stimulating hormone levels of greater than 40 milli-international unit (miu ) per milliliter at screening), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation or otherwise be incapable of pregnancy) exclusion criteria: * any medical condition that could potentially alter the absorption, metabolism or excretion of the study medication, such as crohn's (serious inflammation of any part of the gastrointestinal tract) disease, liver disease, or renal disease * relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine or immunologic diseases * history of neuroleptic malignant syndrome * female participants of childbearing potential * significant risk of suicidal or violent behavior

Keywords: schizophrenia jnj-37822681 placebo
nag-excretion during cardiopulmonary bypass

Conditions: Renal Impairment

Summary: nag is a protein excreted in urine in cases of tubular damage, and is considered a biomarker of kidney injury. elevated urinary nag is seen after cardiac surgery, but the clinical significance, pattern of excretion and links to perioperative factors are poorly described. we plan a study of the pattern of nag-excretion during cardiac surgery with cardiopulmonary bypass, and explore possible associated variables.

the standard biomarker of aki, serum creatinine, has poor specificity and sensitivity in the early phases of renal injury. since the therapeutic window is likely to be in the earlier stages before renal injury is manifest, there is a need for novel diagnostic methods. in the recent years, several new biomarkers of kidney injury have been introduced. to date, none has proven outstanding regarding precision in early detection of aki. nag (n-acetyl-b-d-glucosaminidase) is a lysosomal enzyme with high molecular weight. due to its size, nag does not normally pass the glomerulus apparatus, but urine levels are elevated after tubulus damage. nag excretion in urine is seen in aki after cardiac surgery, exposure to nephrotoxic agents and after renal transplantation. however, its role in clinical decision-making is yet to be established. we aim to study the excretion pattern of urinary nag during and after cardiac surgery with cardiopulmonary bypass. association with perioperative variables will be explored.

Eligibility criteria:
inclusion criteria: * expected cardiopulmonary bypass time exceeding 60 minutes * elective surgery exclusion criteria: * end-stage kidney disease with dialysis * ongoing treatment with nephrotoxic antibiotic agent

Keywords: cardiopulmonary bypass
a music-based mobile app for people living with alzheimer's disease and related dementias (adrd)

Conditions: Dementia; Agitation; Depressive Symptoms

Summary: the purpose of this pilot is to develop a mobile application that detects physiological measures of individuals with alzheimer's disease and related dementias and triggers auto-play of personalized songs in a wearable device. the investigators will test the feasibility and acceptability of the app. this app may be an important tool to include in daily caregiving in a home setting by extending established benefits of music therapy for people with alzheimer's disease and related dementias.


Eligibility criteria:
inclusion criteria for person with dementia * a person with adrd exhibits neuropsychiatric symptoms of dementia such as agitation, restlessness, depressed mood, etc. * stability with or without psychotropic or anti-depressant medications * ability to hear with or without an assistive device inclusion criteria for caregivers * family or close friend caregiver of persons with dementia * must be able to read and write in basic english exclusion criteria for all participants * inadequate hearing * history of psychosis or other mental disorders other than depression * presence of substance or alcohol abuse
outcome of postnatal depression screening using edinburgh postnatal depression scale

Conditions: Depression, Postpartum

Summary: the objective of the present study is to evaluate the effectiveness of postnatal depression screening by comparing the mental health outcome (at 6 months postpartum) of mothers under the edinburgh postnatal depression scale (epds) screening programme versus usual clinical practice (usual practice), using randomized controlled trial design. with the use of the epds for the screening of postnatal depression, it is expected that more mothers in need of intervention (including mental health intervention, guidance in childcare and parenting, counseling in family relationships, etc) will be picked up and offered appropriate intervention, compared to the usual practice. it is hypothesized that the mental health of the group of women under the epds screening programme will be better than those under the usual practice, on subsequent follow-up.


Eligibility criteria:
inclusion criteria: 1. chinese mothers of newborn babies \<= 2 months who are registered with the 4 maternal and child health centres under study; 2. normally resident in hong kong (hong kong id card holder, or hk birth certificate \[with status of permanent resident indicated established\] holder, or people who have been granted unconditional stay in hong kong, or passport holders having valid travel document showing the right to land in hong kong, or permission to land, or eligibility of hk permanent id card verified, or entitlement to the right of abode in hk) exclusion criteria: 1. those who do not use the chinese language (in both the written and spoken form); 2. those who are under active psychiatric contact; 3. those who delivered in hospitals which are still conducting their own epds screening programme.

Keywords: postnatal depression randomized controlled trial screening outcome edinburgh postnatal depression scale
observational study to reduce medication errors

Conditions: Medication Errors

Summary: a medication error is a failure in the treatment process that leads to, or has the potential to lead, to harm to the patient.1 medication errors are a common unfortunate occurrence in hospital. they can occur in different phases of the therapeutic process (prescribing, distribution, administration and monitoring) and have significant impact on morbidity and mortality. prescribing faults and prescription errors are major problem among medication errors .prescription errors account for 70 % of medication errors that could potentially result in adverse drug effects.2 overall it has been estimated prescription errors affect 7 % of medication orders, 2% of patient days and 50 % of hospital admissions.3,4 when harm arises from a medication error it is potentially preventable. the medication errors project was devised to analyze and limit through educational audit and other tools, as much as possible, damages due to the therapeutic process. the project will include 5 phases. preliminary phase: organizational meetings. phase i: patient monitoring: a monitor in collaboration with health professionals of involved units will review all patient charts and will register all adverse drug reactions(adrs). all adrs will be introduced by the monitor in a database. health professional will be invited to send the reports of observed adrs. evaluation of adrs : a panel of experts will evaluate if the adrs are due to medication errors or not. phase ii :educational audits directed to health professionals will be organized. tools to reduce the medication errors will be proposed. phase iii: the same procedure of the first phase. final phase (iv): analysis of data with publication of a scientific article.


Eligibility criteria:
inclusion criteria: * all patients hospitalized in the involved units who gave their informed consent. patients hospitalized during the week-end will be enrolled on the next monday. exclusion criteria: * all patients with evident mental and physical problems and all patients who did not give their informed consent.

Keywords: medication errors, patients hospitalized, adrs, adverse events
an expanded clinical study of triple therapy for refractory solid tumors that failed first-line treatment for recurrence and metastasis

Conditions: Advanced Cancer; Metastatic Cancer

Summary: the clinical efficacy of chemotherapy /pd-1 monoclonal antibody/targeted therapy, chemotherapy /pd-1 monoclonal antibody/targeted therapy + noninvasive electromagnetic wave hyperthermia and chemotherapy /pd-1 monoclonal antibody/targeted therapy + noninvasive electromagnetic wave hyperthermia + autosomatic immunotherapy in the treatment of refractory refractory solid tumors with first-line treatment failure was compared.


Eligibility criteria:
inclusion criteria: 1. patients previously diagnosed with solid tumor by histopathology and/or cytology; 2. aged 18 and 80, regardless of gender; 3. ecog score of general physical condition was 0\~2; 4. the expected survival time is at least 3 months; 5. patients with metastatic and recurrent tumors who failed conventional first-line therapy (including those above first-line therapy) and need to change treatment regimens; 6. according to recist standards, at least one measurable objective tumor index (spiral ct detection target lesion 10mm); 7. wbc 3.0109 /l hb 90g/l plt 75.109 /l at baseline upon enrollment; 8. normal liver function a) liver: total bilirubin 2.0 mg/dl(34.2umol/l), 2.5 times the upper limit of ast and alt, 5 times the upper limit of ast and alt in patients with liver metastasis b) kidney: creatinine 2.5 mg/dl(221umol/l), creatinine clearance rate 60 ml/min; 9. understand and sign informed consent and voluntarily participate in clinical research exclusion criteria: 1. severe active infection and other serious complications; 2. patients with a history of autoimmune diseases, including but not limited to multiple sclerosis, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, excluding vitiligo; 3. prednisone can be used in patients with systemic corticosteroid or other immunosuppressive hormone therapy. 0.5 mg/kg/day (maximum cell count group 40 mg/day) or other similar drugs in the same cell count group, inhaled corticosteroids for chronic obstructive pulmonary disease (copd) or topical administration; 4. patients who have undergone major organ transplants; 5. patients in the active stage of viral hepatitis; 6. patients with coagulation dysfunction; 7. have uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia; 8. pregnant or lactating women. 9. symptomatic brain metastases or mental disorders; 10. participated in clinical trials of new drugs within 4 weeks before enrollment; 11. if the patients are randomly assigned to the hyperthermia treatment group, they need to refer to the exclusion requirements of hyperthermia (the hyperthermia site contains metal or thermal implant, skin allergy to heat, and body position cannot cooperate). 12. other factors considered by researchers are not suitable for candidates.
walnut intervention on metabolic syndrome (wims)

Conditions: Metabolic Syndrome X

Summary: the purpose of this study is to determine whether a daily supplement of 30 grams of walnut is effective in the treatment of metabolic syndrome (mets).

metabolic syndrome (mets), a constellation of metabolic abnormalities including central obesity, dyslipidemia, elevated blood pressure and hyperglycemia, is associated with the development of type 2 diabetes and cvd. it has become one of the major public health challenges in china due to rapidly nutrition transition and the nature of obesity epidemic. treatment of mets in china is very important for the prevention of the epidemic of its consequences (such as cvd and type 2 diabetes). compelling evidence from recent human studies has demonstrated that diet and lifestyle modifications are effective means in mets management. walnut is a complex food source containing high amounts of polyunsaturated fatty acids (pufa), as well as plant protein, vitamin e and other substances that may have an impact on health. therefore, the aim of this study is to investigate the effect of walnut supplementation on the management of mets in adult chinese men and women in a randomized, controlled clinical trial. a total of 200 participants with mets (defined by ncep-atpⅲ criteria) will be randomly assigned to a walnut-supplemented diet (30 grams/day) or an isocaloric control diet for 12 weeks. effects of walnut supplementation will be evaluated by measuring metabolic profile (bmi, blood pressure, total cholesterol, triglyceride, ldl-c and hdl-c, fasting glucose and insulin, hba1c), inflammatory markers (crp and il-6), markers of endothelial function (e-selectin, icam-1 and vcam-1), and fatty acid profile.

Eligibility criteria:
inclusion criteria: * with metabolic syndrome. metabolic syndrome was defined based upon the updated national cholesterol education program adult treatment panel iii criteria for asian-americans as presenting at least 3 of the following components: 1) waist circumference ≥ 90 cm for men or ≥ 80 cm for women; 2) triglycerides ≥1.7mmol/l; 3) hdl cholesterol \<1.03 for men or \<1.30 for women; 4) blood pressure ≥130/85 mmhg, or current use of antihypertentive medications; 5) fasting glucose ≥5.6mmol/l or previously diagnosed type 2 diabetes or on oral antidiabetic agents or insulin. * being able to comply with the specified feeding conditions * being able to eat walnuts * being between the ages of 35 and 60 years exclusion criteria: * pregnancy or lactation * use of insulin * severe kidney disease * cardiovascular diseases, stroke, cancer and psychological disorders * walnut allergies or frequently eating walnuts or other nuts (\>90 grams/week) * drug or alcohol abuse.

Keywords: walnut lipids blood glucose
pilot introduction of oral cholera vaccine in orissa, india

Conditions: Cholera

Summary: the purpose of this study is to provide evidence for policymakers and key opinion leaders on the pilot implementation of cholera vaccination using the newly licensed oral cholera vaccine (ocv) in india. the pilot introduction will provide the evidence for the feasibility, costs and population acceptance of large-scale cholera vaccination using the indian vaccine (using vaccination coverage rates and other measures).

severe diarrhoeal disease caused by vibrio cholerae o1 and o139 has long been an important cause of mortality and morbidity in india. the availability and recent licensure of the modified bivalent killed whole cell ocv in india provides hope that the disease may be controlled in areas where the disease is a problem. on april 10, 2009, a meeting was organized by the indian council of medical research (icmr), the department of biotechnology and the ivi. the recommendations from the meeting are as follows: * as the modified wc vaccine is safe, effective, and cost-effective, it was suggested that the national technical advisory group on immunization (ntagi) should consider recommending introduction of the vaccine in public health programs targeted to appropriate populations in india. * vaccination should be initiated in selected highly endemic and/or slum areas such as known areas in west bengal or orissa. the pilot vaccination programs will be monitored and evaluated. further expansion to other areas and wider policy changes will be made in a step-by-step fashion based on the pilot programs. logistical and operational issues need to be defined. the aim of the study is to conduct a pilot introduction of the modified killed oral cholera vaccine in a public health setting in a population of \~50,000 before implementing in a larger scale. primary objective: to determine the feasibility, acceptability and costs associated with pilot introduction of the modified killed whole cell oral cholera vaccine in india when given in a public health setting. secondary objective: to identify challenges to mass oral cholera vaccine implementation.

Eligibility criteria:
inclusion criteria: * aged 12 months and older * non-pregnant exclusion criteria: * age less than 12 months * pregnant * too ill/old to get out of bed

Keywords: cholera vaccination oral cholera vaccine mass vaccination oral whole cell cholera vaccine
innovative liver elasticity, attenuation, and dispersion ultrasound study

Conditions: Nonalcoholic Steatohepatitis; Ultrasound; Elastography

Summary: the objective of this study is: (1) to investigate the correlation of ultrasound parameters (sw speed, dispersion slope, attenuation value, normalized local variance, liver / kidney intensity ratio) with the pathological parameters (fibrosis, intralobular inflammation, ballooning degeneration and steatosis); (2) to evaluate the diagnostic performance of sw speed for liver fibrosis, dispersion slope for intralobular inflammation and attenuation value for steatosis by comparison with the tissue diagnosis by liver biopsy.


Eligibility criteria:
inclusion criteria: * nonalcoholic fatty liver disease (nafld) patients who are scheduled for liver biopsy for the differential diagnosis of nash and/or nafld patients who are scheduled for the mr elastography (mre) and mri-proton density fat friction (mri-pdff). * without a history of alcohol use, which lead to alcoholic hepatic involvement (pure alcohol below 30 g/day for male, 20 g/day for female). exclusion criteria: * patients with endocrine disorder (hypopituitarism, growth hormone deficiency, hyperthyroidism etc.), serious nutrition disorder, and drug-induced hepatic involvement (steroid, tamoxifen, valproic acid, amiodarone etc.), which may lead to the steatosis * hepatitis b, hepatitis c and hiv patients * primary biliary cholangitis, primary sclerosing cholangitis, and autoimmune hepatitis patients * wilson's disease, α1-antitrypsin deficiency, and hemochromatosis patients * malignant liver tumor, common bile duct stone, and jaundice patients * patients after jejunoileal bypass surgery or massive intestinal resection surgery * patients whose treatment changes during the period between imaging examination and liver biopsy, including medications such as antidiabetic drugs and other treatments which may change the fat deposition or inflammation of liver.

Keywords: nonalcoholic steatohepatitis ultrasound elastography dispersion
safety and efficacy study of autologous fibroblasts in the treatment of severe facial acne scarring

Conditions: Acne Scarring of the Face

Summary: the purpose of this study is to evaluate the safety profile and the treatment effect of isolagen therapytm and placebo when administered to facial acne scars.


Eligibility criteria:
inclusion criteria: 1. male or female, between 18 years and 65 years of age. 2. investigator assessment of the acne scarring on each cheek of moderate to severe. 3. a history of acne scarring for more than 3 years. 4. subject assesses the appearance of both sides of their facial acne scars as dissatisfied or very dissatisfied with appearance. exclusion criteria: 1. significant active acne. 2. use of oral antibiotic or retinoid active acne therapy within one year of enrollment. 3. presence of hypertrophic scars on the cheeks. 4. more than 20% of treatment area comprised of ice pick scars or sinus tracts 5. treatment area per cheek is less than 9 cm x cm 6. unilateral or unbalanced acne scar distribution. 7. physical attributes which prevent the assessment or treatment of the acne scars. 8. treatment with an investigational product or procedure within 30 days prior to study enrollment or plans to participate in another clinical trial during the course of this study. 9. previous treatment with isolagen therapytm. 10. use of isotretinoin within one year of enrollment into study. 11. use of permanent or semi-permanent dermal fillers in the treatment areas within defined time frames. 12. disorders or drugs that increase bleeding or clotting. 13. pregnant or lactating women or women trying to become pregnant during the study. 14. excessive exposure to sun. 15. smoking more than ½ pack of cigarettes per day.

Keywords: acne
single dose escalation study of pf-04360365 in subjects with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to determine whether single doses of pf-04360365 is safe and well tolerated in patients with alzheimer's disease.


Eligibility criteria:
inclusion criteria: * male or female (of non-child bearing potential) subjects ages ≥50 years of age. * diagnosis of probable ad (of mild to moderate severity), consistent with criteria from both: nincds-alzheimer's disease and related disorders association (adrda) and dsm-iv-tr. * mmse score of 16-26 inclusive. * rosen-modified hachinski ischemia score ≤4. * on a stable dose of background cholinesterase inhibitors or memantine for at least 60 days prior to dosing. exclusion criteria: * diagnosis or history of other dementia or neurodegenerative disorders. * diagnosis or history of clinically significant cerebrovascular disease. * specific findings on magnetic resonance imaging (mri); cortical infarct, micro hemorrhage, multiple white matter lacunes. * history of allergic or anaphylactic reactions.

Keywords: antibody amyloid alzheimer's disease ad