Kornimate/medical-research-clean huggingface dataset:
ezetimibe plus (+) simvastatin versus atorvastatin comparative study (0653a-092)(completed)

Conditions: Hypercholesterolemia

Summary: this is an efficacy and safety study of vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in korea. the primary hypothesis being tested is that daily administration of vytorin will result in a greater reduction of low density lipoprotein cholesterol (ldl-c) concentration from baseline after 6 weeks treatment compared to atorvastatin.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hypercholesterolemia * ldl-c \>/= 130 mg/dl but \</=250 mg/dl and triglyceride (tg) \</= 350 mg/dl * national cholesterol education program (ncep) adult treatment panel (atp) iii guideline exclusion criteria: * hypersensitivity to 3-hydroxy-3-methyl-glutaryl-coa reductase (hmg-coa reductase) inhibitors or ezetimibe
comparative study of ceftaroline vs. ceftriaxone in adult subjects with community-acquired pneumonia

Conditions: Bacterial Pneumonia

Summary: the purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of community-acquired pneumonia

the purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of community-acquired pneumonia. clinical trials for this study is held in many countries

Eligibility criteria:
inclusion criteria: subjects are required to meet the following inclusion criteria: * community-acquired pneumonia * initial hospitalization, or treatment in an emergency room or urgent care setting * infection would require initial treatment with iv antimicrobials. exclusion criteria: subjects must not meet any of the following exclusion criteria: * cap suitable for outpatient therapy with an oral antimicrobial agent * respiratory tract infections not due to community-acquired bacterial * non-infectious causes of pulmonary infiltrates * pleural empyema * infection with an atypical organism * history of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial * history of any hypersensitivity or allergic reaction to clarithromycin or any macrolide/ ketolide

Keywords: ceftaroline community-acquired pneumonia cap iv (intravenous) streptococcus pneumoniae haemophilus influenzae mycoplasma pneumoniae chlamydophila spp legionella spp multi-drug resistant streptococcus pneumoniae (mdrsp) antimicrobial resistance pneumococci ceftriaxone bacteria ß-lactam beta-lactam antibiotic
circulating factors in nephrotic syndrome

Conditions: Nephrotic Syndrome; Membranous Nephropathy; Minimal Change Disease; Primary Focal Segmental Glomerulosclerosis

Summary: a prospective observational study to investigate the treatment-associated changes of circulating factors associated with glomerular diseases among patients with de novo nephrotic syndrome admitted to hospital for a kidney biopsy.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * plasma albumin \< 36 g/l * urine protein \>3.5 g/day or urine protein/creatinine-ratio (upcr) \> 3.5 or urine albumin/creatinine-ratio (uacr) \>2200 mg/g * planned kidney biopsy * able to give written informed consent exclusion criteria: * kidney transplant recipient * previously undergone a kidney biopsy * unable to understand written information in danish
brinzolamide/brimonidine twice a day (bid) fixed combination (fc) vs brinzolamide bid plus brimonidine bid in patients with open angle glaucoma or ocular hypertension

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study was to evaluate the safety and efficacy of brinzolamide/brimonidine fixed combination in lowering intraocular pressure (iop) relative to each of its individual active constituents instilled concomitantly (brinzolamide+brimonidine) in patients with open-angle glaucoma or ocular hypertension.

this study consisted of 7 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and a treatment phase, which included 4 on-therapy visits conducted at week 2, week 6, month 3, and month 6 (or early exit). following washout of any iop-lowering medication, subjects who met all inclusion/exclusion criteria at both eligibility visits and who had iop measurements within the specified range during this period were randomized to 1 of 2 study drug groups: brinz/brim or brinz+brim.

Eligibility criteria:
inclusion criteria: * diagnosed with open-angle glaucoma or ocular hypertension and, in the opinion of the investigator, are insufficiently controlled on monotherapy or are currently on multiple iop-lowering medications. * meet qualifying iop entry criteria. * able to understand and sign an informed consent form. * other protocol-specified inclusion criteria may apply. exclusion criteria: * women of childbearing potential if pregnant, test positive for pregnancy at screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. * severe central visual field loss. * can not safely undergo the initial washout period and discontinue use of all iop-lowering ocular medication(s) for the minimum specified period prior to eligibility visit 1. * best corrected visual acuity (bcva) score worse than 55 etdrs letters (20/80 snellen equivalent). * chronic, recurrent or severe inflammatory eye disease. * ocular trauma within the preceding 6 months. * ocular infection or inflammation within the preceding 3 months. * clinically significant or progressive retinal disease. * other ocular pathology. * intraocular surgery within the 6 months prior to entry. * ocular laser surgery within the 3 months prior to entry. * any abnormality preventing reliable applanation tonometry. * any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study. * recent use of high-dose (\>1 gram daily) salicylate therapy. * recent, current, or anticipated treatment with any medication that augments adrenergic responses, or precludes use of an alpha-adrenergic agonist. * other protocol-specified exclusion criteria may apply.

Keywords: open-angle glaucoma ocular hypertension oag oht
study to assess the efficacy, safety, and tolerability of azd8529 in adult schizophrenia patients

Conditions: Schizophrenia

Summary: the purpose of this study is to determine whether treatment with daily oral dose of azd8529 40 mg administered over 28 days is safe, well tolerated and improves main symptoms of schizophrenia in adult schizophrenia patients.


Eligibility criteria:
inclusion criteria: * patient will need to read, understand and sign an informed consent prior to any study specific procedures * patient will have certain schizophrenia symptoms deemed by the investigator as appropriate for the study entry exclusion criteria: * patients will be excluded based on recent history of significant illness or current disease as assessed by the investigator during screening process (based on physical examination, laboratory studies and electrocardiogram studies) * patients will be excluded if urine drug screen test show positive results * smoking of more than 2 packs of cigarettes a day

Keywords: schizophrenia hallucinations paranoia inpatient schizophrenia clinical trial
management of grades 3-5 renal trauma in pediatrics

Conditions: Renal Trauma

Summary: comparing conservative management versus interventional management in hemodynamically stable paediatric patient with blunt renal trauma, evidence suggests that there is a reduced rate of renal loss and blood transfusion in patients managed conservatively.


Eligibility criteria:
inclusion criteria: * children ( age group 0-18) who are diagnosed to have renal tissue injury grade 3-5 by contrast ct exclusion criteria: * age group more than 18 years * low grade renal trauma 1-2 * patients who get explored due to extra urologic indication without proper urologic assessment
ph1 lobeline interaction study - 1

Conditions: Methamphetamine Dependence

Summary: the purpose of this study is to determine if there are significant cardiovascular or other interactions between sublingual lobeline and intravenous methamphetamine.


Eligibility criteria:
inclusion criteria: * be between the ages of 18 and 45 years of age * be in general good health with a history of methamphetamine (ma) abuse (but not dependence) * if female and of child bearing potential, agrees to use birth control * be able to understand and provide written informed consent * have a body mass index between 18 and 30 * have reported use of (ma) during the past three months without experiencing adverse consequence plus a life time ma or amphetamine use history of at least four occasions of use * have a negative drug test (barbiturates, benzodiazepines, amphetamines, opiates, cocaine, cannabinoids, ethanol) at screening and at the time of admission exclusion criteria: * please contact site for details
the effect of combined dulaglutide and dapagliflozin treatment vs dpp-4 inhibitors in endothelial and vascular function in patients with type 2 diabetes mellitus and albuminuria

Conditions: Urine Albumin (UAlb); Glycocalyx; Arterial Stiffness

Summary: patients with type 2 diabetes mellitus and albuminuria will be randomised eitheer to dulaglutide and dapagliflozin combination or dpp-4 inhibitor, as an add-on treatment to metformin. arterial stiffness, uacr, endothelial glycocalyx and global longitudinal strain will be assesed at baseline, 4 and 12 months.

patients with type 2 diabetes mellitus and albuminuria will be randomised eitheer to dulaglutide and dapagliflozin combination or dpp-4 inhibitor, as an add-on treatment to metformin. arterial stiffness via pulse wave velocity (pwv), uacr, endothelial glycocalyx via microscan camera, and global longitudinal strain via echocardiography will be assesed at baseline, 4 and 12 months after treatment.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus albuminuria hba1c: 7-10% egfr\&gt; 60 ml/min exclusion criteria: * type 1 diabetes mellitus inflammation, chronic or acute established cardiovascular disease malignancy within the last 5 years

Keywords: type 2 diabetes albuminuria arterial stiffness glycocalyx
to study safety, tolerability, pharmacokinetics and pharmacodynamics of azd1656 in japanese type 2 diabetes mellitus (t2dm) patients

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to assess the safety and tolerability of azd1656 after multiple repeated oral doses in japanese patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * male or female non-childbearing potential japanese t2dm patients, 30-75 years. * a body mass index (bmi) of 19 to 27 kg/m2. * diagnosed diabetes mellitus patients treated with diet and exercise or with up to two oral anti-diabetic drugs. stable glycemic control indicated by no changed treatment within 3 months prior to enrollment. exclusion criteria: * renal dysfunction gfr \< 60 ml/min. * systolic pressure (sbp) \> 160 mmhg or diastolic pressure (dbp) \> 95 mmhg * clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the ip. * history of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.

Keywords: azd1656 safety pharmacokinetics pharmacodynamic multiple ascending doses japanese t2dm
randomized controlled trial of health care to elderly patients.

Conditions: Congestive Heart Failure; Angina Pectoris; Asthma; Pneumonia; Fractures

Summary: to study the efficacy of multicomponent treatment and care for patients with acute illness or deterioration of a chronic disease at a nursing home in primary health care compared to traditional treatment at hospital.

managers at st. olavs university hospital and the city of trondheim local authority decided in 2001 to establish a reinforced department at a nursing home with a multicomponent approach to patient treatment. in the study treatment at a nursing home will be compared with conventional treatment in ordinary hospital beds in medical, surgical and orthopedic departments at a hospital. participating doctors at the hospital together with general practitioners shall develope inclusion criteria through delphi technique. eligible participants will be hospitalized from their ordinary home and expected to return to home after treatment. when an eligible patient is identified and accepted for inclusion, randomization will be performed by the clinical research department at the faculty of medicine.

Eligibility criteria:
inclusion criteria: * participating doctors at the hospital together with general practitioners shall develope inclusion criteria through delphi technique. exclusion criteria: * participating doctors at the hospital together with general practitioners shall develope exclusion criteria through delphi technique.

Keywords: treatment of elderly. nursing home. rehabilitation. readmissions.
alzheimer's disease and related disorders

Conditions: Alzheimer's Disease; Gait Apraxia; Impaired Cognition

Summary: the purpose of this study is to compare characteristics of gait and balance measured among patients with alzheimer's disease or related disorders separated into 3 groups according to the stage of disease (i.e., pre-dementia, mild and moderate dementia stages); to determine the effects of anti-dementia drugs and vitamin d on cognitive motor abnormalities; and to establish a database at angers university memory centre.

although gait disorders are frequently associated with alzheimer's disease and related disorders (adrd), few studies have focused on cognitive motor effects of anti-dementia drugs and vitamin d. the objectives of this study are to * compare characteristics of gait and balance measured among patients with adrd separated into 3 groups according to stages of disease (i.e., pre-dementia, mild and moderate dementia stages) * to determine the effects of anti-dementia drugs and vitamin d on cognitive motor abnormalities * to determine whether motor abnormalities could be associated with cognitive impairments, specifically executive dysfunctions * to establish a database at angers university memory center.

Eligibility criteria:
inclusion criteria: * all elderly patients from the university memory center of angers university hospital. * able to walk without any walking aid on 15 meters * mini-mental status examination score \> 10 * being affiliated to a social security regime exclusion criteria: * mini-mental status examination score ≤ 10 * subject suffering from pre-existing impellent disturbances * history of cerebrovascular accident or other cerebro-spinal pathology * poor workmanship of the written or oral french language * use of walking aid such as walking frame with wheels or tricycle. * acute medical or surgical disease in the past 3 months * refusal to participate (or trustworthy person) * near visual acuity \< 2/10
affect management for early adolescents

Conditions: HIV Infections

Summary: adolescents are at risk for hiv because of sexual and drug use behavior initiated during early adolescence, and those with mental health problems appear to be particularly susceptible. problems with managing emotions may make it difficult for early adolescents to make good decisions about sexual and substance use behaviors. this project will develop and evaluate interventions for early adolescents with mental health issues. an intervention focused on teaching affect management skills will be compared to an intervention addressing a variety of health topics to determine which intervention best reduces risk behavior among this at-risk population.


Eligibility criteria:
inclusion criteria: * seventh graders identified by counselors at participating public school. exclusion criteria: * adolescent is hiv positive. * adolescent is developmentally delayed. * adolescent is pregnant. * adolescent has a history of sexual crime.

Keywords: hiv prevention
efficacy and safety of sirolimus in combination with tacrolimus

Conditions: Kidney Transplantation

Summary: to study the efficacy and safety of the administration of tacrolimus in combination with sirolimus for the prevention of acute rejection in patients after renal transplantation

basic randomized clinical trial (multicentre) in primary ktx to assess the safety and efficacy of a tac/rapa vs a tac/mmf regimen. tac trough levels in accordance with current standards in both arms. steroids to be used to individual centre protocol. rapa trough levels will be adjusted to 5-10 ng/ml. up to now only few data (primate and clinical) on tac/rap combinations available.

Eligibility criteria:
inclusion criteria: * first kidney transplantation * re-transplantation * non-related living donor transplantation * patients \> 18 years * patients have given their written consent after being informed * female patients in the age of parity must consent to an effective birth control and submit a negative pregnancy test exclusion criteria: * related living donation * patients with known hiv-anamnesis * patients who need systemically administered immunosuppression for another indication than the prophylaxis of kidney graft rejection * patients with present malignant disease * patients with clinically significant, uncontrolled infectional disease and/or severe diarrhea, vomiting or active gastric ulcer * patients who haven taken part in a clinical study in the past 28 days and/or receive (received) medication which is not licensed by the responsible health authority * other reasons which depend on the assessment of the physician

Keywords: renal transplantation immunosuppression prevention of acute rejection
hepasphere interventional therapy using digital subtraction angiography（dsa）for lung cancer

Conditions: Lung Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of hepasphere interventional therapy using digital subtraction angiography（dsa）for lung cancer.

by enrolling patients with lung cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of hepasphere interventional therapy using digital subtraction angiography（dsa）for lung cancer.

Eligibility criteria:
inclusion criteria: 1. age:18-80 2. karnofsky performance status \>60 3. diagnosis of lung cancer based on histology or the current accepted radiological measures. 4. classification tumor,nodes,metastasis-classification(tnm) stage: ⅱ,ⅲ,ⅳ 5. will receive interventional therapy 6. life expectancy: greater than 3 months 7. patients' routine blood test, liver function and kidney function have no obvious abnormalities 8. ability to understand the study protocol and a willingness to sign a written informed consent document exclusion criteria: 1. patients with other primary tumor except lung cancer 2. history of coagulation disorders or anemia

Keywords: lung cancer hepasphere
the effects of acupressure applied to the primiparous during episiotomy

Conditions: Episiotomy Wound; Pain; Anxiety

Summary: this study was conducted to determine the effects of acupressure applied during episiotomy repair on pain and anxiety levels of the primiparous. the study was conducted as a randomized controlled trial with 126 pregnant women (63 women in the acupressure group and 63 women in the control) who applied to a maternity hospital between june and december 2023. acupressure was applied to the acupressure group twice (during internal suturing and skin suturing) by the researcher during the episiotomy repair. visual analog scale (vas) was used a total of four times, before and after the intervention, to assess the pain scores of the participants, while the spielberger manual for state-trait anxiety inventory (stai) was used after the second intervention to determine the anxiety levels of the participants.

introduction: this study was conducted to determine the effects of acupressure applied during episiotomy repair on pain and anxiety levels of the primiparous. methods: the study was conducted as a randomized controlled trial with 126 pregnant women (63 women in the acupressure group and 63 women in the control) who applied to a maternity hospital between june and december 2023. acupressure was applied to the acupressure group twice (during internal suturing and skin suturing) by the researcher during the episiotomy repair. visual analog scale (vas) was used a total of four times, before and after the intervention, to assess the pain scores of the participants, while the spielberger manual for state-trait anxiety inventory (stai) was used after the second intervention to determine the anxiety levels of the participants.

Eligibility criteria:
inclusion criteria: * being 18 or older, * having a single healthy newborn, * giving spontaneous birth through a medio-lateral episiotomy incision, * no signs of infection such as vaginal redness or swelling, * women with full and healthy tissue integrity in the area where acupressure will be applied. exclusion criteria: * the need to use unusual lidocaine during episiotomy repair (lidocaine 2% higher than 5 ml), * having any postpartum complications (such as bleeding, hypertension).

Keywords: acupressure episiotomy primiparous
a study to tailor advance directives

Conditions: Dementia; Persistent Vegetative State; Terminally Ill

Summary: in this study, hospitalized patients will first be surveyed regarding their interest in a traditional advanced directive (ad) and then in a modified ad.

the purpose of this study is to assess whether patients will execute an advance directive which offers a limited trial of life-sustaining therapy in non-terminal illness, declines life-sustaining therapy or artificial nutrition in advanced dementia, or declines life-sustaining therapy in general. advance directives (ads) as currently drafted have been questioned since they have not had much effect on end-of-life care. however, the reason for the lack of success may be simply that they rarely apply. traditional ads, which are limited to terminal illness or persistent vegetative states, are difficult to apply to the more common cases of critical illness in the setting of potentially reversible disease and advanced dementia, which are often not recognized as terminal. in addition, terminal ads are drafted too narrowly for patients who do not wish for life-sustaining therapy regardless of condition. patients may execute either ad at the conclusion of the survey. this research has the potential to demonstrate widely reproducible methods on which more precise advance planning can be based and thereby improve end-of-life care.

Eligibility criteria:
inclusion criteria: * hospitalized patients admitted to the general medical service at the university of chicago * previously enrolled in a study of hospitalized general medicine patients at the university of chicago exclusion criteria: * patients who score less than 17 out of 30 on the folstein mini-mental status examination or who have a proxy decision-maker * patients who are medically unstable based on two or more abnormal vital signs * patients who face a possible new diagnosis of cancer

Keywords: advance directive living will terminal illness