Kornimate/medical-research-clean huggingface dataset:
prenatal alcohol biomarker study in uruguay

Conditions: Fetal Alcohol Syndrome

Summary: the purpose of this study is to examine the association between maternal alcohol use and newborn phosphatidylethanol (peth) levels in their newborn.

the goal of the proposed research study is to examine the association between maternal alcohol use and newborn phosphatidylethanol (peth) levels in their newborn children, in a country (uruguay) where significant alcohol use is common during pregnancy. maternal alcohol biomarker assays will include ethyl glucuronide (etg) in hair and nails and peth in blood obtained at the time of delivery. newborn umbilical cord and routine 48 hour heel stick blood will be collected to assess newborn peth levels. maternal biomarker levels will be compared to patient self-reported alcohol use. this proposed design is a cross-sectional study that will include 1,800 women 18 years and older and their newborns. women who are admitted to one of two selected public health care hospitals in montevideo, uruguay (hospital pereira rossell and servicio medico integral) for obstetrical care will be recruited to participate in the study. power estimates suggest that 1,800 maternal/infant pairs will give us sufficient power (\>90%) to estimate the predictive validity of this biomarker as a routine newborn screening test.

Eligibility criteria:
inclusion criteria: * inclusion criteria for experimental group (n=1,800) * pregnant women 18 years and older * admitted in active labor as well as their newborn child * well enough to participate in the research interview * able to provide fingernail, hair, and blood spot samples * all subjects must have given signed, informed consent prior to registration exclusion criteria: * not meeting the appropriate inclusion criteria or providing consent
safety and efficacy study of enzalutamide in patients with nonmetastatic castration-resistant prostate cancer

Conditions: Nonmetastatic Castration-Resistant Prostate Cancer; Prostate Cancer; Cancer of the Prostate

Summary: the purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features; * ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (gnrh) agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration); * testosterone ≤ 50 ng/dl (≤ 1.73 nmol/l) at screening; * progressive disease on androgen deprivation therapy at enrollment; * psa and the screening psa assessed by the central laboratory (central psa) should be ≥ 2 µg/l (2 ng/ml: * psa doubling time ≤ 10 months; * no prior or present evidence of metastatic disease; * asymptomatic prostate cancer; * eastern cooperative oncology group (ecog) performance status of 0 or 1; * estimated life expectancy ≥ 12 months. exclusion criteria: * prior cytotoxic chemotherapy; * use of hormonal therapy or biologic therapy for prostate cancer (other than approved bone targeting agents and gnrh agonist/antagonist therapy) or use of an investigational agent within 4 weeks of randomization; * known or suspected brain metastasis or active leptomeningeal disease; * history of another invasive cancer within 3 years of randomization; * absolute neutrophil count \< 1000/μl, platelet count \< 100,000/μl, or hemoglobin \< 10 g/dl (6.2 mmol/l) at screening; * total bilirubin ≥ 1.5 times the upper limit of normal; * creatinine \> 2 mg/dl (177 µmol/l) at screening; * albumin \< 3.0 g/dl (30 g/l) at screening; * history of seizure or any condition that may predispose to seizure; * clinically significant cardiovascular disease; * gastrointestinal disorder affecting absorption; * major surgery within 4 weeks of randomization; * hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including labrasol, butylated hydroxyanisole, and butylated hydroxytoluene; * any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.
effects of buspirone combined with clozapine

Conditions: Schizophrenia

Summary: this study aimed to evaluate the enhancing effects of different doses of buspirone on psychiatric symptoms and cognitive function in patients with schizophrenia. the investigators adopted a prospective, randomised, double-blind, placebo-controlled study design and included 46 patients with schizophrenia being treated at the fourth people's hospital of wuhu. the patients were randomly divided into three groups: the control group, the low-dose group and the high-dose group. the control group received clozapine monotherapy, while the experimental groups received additional buspirone at different doses in addition to clozapine. the positive and negative syndrome scale (panss) and the chinese version of the repeatable battery for the assessment of neuropsychological status were used to evaluate psychiatric symptoms and cognitive function.


Eligibility criteria:
inclusion criteria: * aged 18-65 years; * meeting the diagnostic criteria for chronic schizophrenia in the diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) * current remission of psychotic symptoms. the patients had a relatively stable mental state in the past 4 weeks, with a total score of ≤60 points and a score of ≤4 points on the positive and negative syndrome scale (panss)\[15\], and there were no signs of acute psychotic symptoms. to ensure that patients were included in the chronic phase, only patients who had been diagnosed with schizophrenia for ≥1 year were recruited, thus avoiding confusion with acute phase cases; * receiving monotherapy with antipsychotic drugs, such as clozapine. exclusion criteria: * pregnant or lactating women; * patients allergic to buspirone; * patients previously diagnosed with cognitive impairment, such as dementia or intellectual disability; * patients with a history of other brain injuries or diseases, such as stroke, traumatic brain injury, epilepsy or intracranial infection; * patients with severe liver or kidney insufficiency; * patients with severe physical diseases or other mental illnesses, such as bipolar disorder, major depressive disorder, alcohol or substance dependence; * patients with a history of using drugs that affect cognitive function during the study period or those who need to adjust the existing treatment regimen; * patients who are unable to cooperate with cognitive function tests or have poor treatment compliance.

Keywords: buspirone schizophrenia
clinical outcomes of micropure and podeye monofocal intraocular lenses

Conditions: Cataract; Lens Opacities

Summary: prospective, non-randomised, open, controlled, single-center post-market clinical follow study about micropure 1.2.3. and podeye intraocular lenses.

this clinical investigation is a prospective, non-randomised, open, controlled, single-center post-market clinical follow whereby study patients undergoing routine cataract surgery will have implantation of monofocal intraocular lens micropure 1.2.3. (physiol, liège, belgium) in one eye and implantation of monofocal intraocular lens podeye (physiol, liège, belgium) in the contralateral eye of the same patient. the study purpose is to obtain clinical data on visual acuity and contrast sensitivity on patients implanted with micropure 1.2.3. and podeye the devices under investigation (micropure 1.2.3. and podeye) are a monofocal glistening-free hydrophobic acrylic intraocular lenses (iols) manufactured by the sponsor of this study physiol sa/nv. the optical properties of the lenses are very comparable. the main difference is the mechanical design of the haptics, that is not expected to have an influence on the clinical outcomes. the iols will be implanted as part of the routine cataract surgery on patients suffering from cataract development. in total 76 patients will be recruited for this clinical study and receive the implantation of micropure 1.2.3. and popdeye intraocular lenses. subjects participating in the trial will attend study visits over a period of 12 months.

Eligibility criteria:
inclusion criteria: * cataractous eyes with no comorbidity * availability, willingness and sufficient cognitive awareness to comply with examination procedures * clear intraocular media other than cataract; * signed informed consent exclusion criteria: * age of patient \< 45 years; * irregular astigmatism; * regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120°; * difficulty for cooperation (distance from their home, general health condition); * previous intraocular or corneal surgery; * traumatic cataract; * any ocular comorbidity; * instability of keratometry or biometry measurements.

Keywords: intraocular lens monofocal hydrophobic
comparison of nodat in kidney transplant patients receiving belatacept versus standard immunosuppression

Conditions: New Onset Diabetes After Transplant; Kidney Transplantation

Summary: this study is being conducted to determine if belatacept is an appropriate alternative immunosuppressive medication (reducing the immune system's effect) when a kidney transplant patient develops new onset diabetes after transplant (nodat). patients who are diagnosed with nodat will be approached with the opportunity to participate in this study. if they agree to participate, they will be randomized one-to-one (like a coin flip) to the study arm (belatacept) or the control arm (their current medication regimen). if a patient is randomized to the study arm, they will be tapered off of their current regimen when they have started receiving their monthly belatacept infusions. the control arm will mean the patient will continue their current, standard of care medications, but following the tacrolimus trough levels indicated within the study protocol. different laboratory tests (i.e. fasting blood glucose) will be measured during the study to monitor the progression of nodat in all patients.


Eligibility criteria:
inclusion criteria: * written informed consent must be given by patient. * adult patients between age 18 and 65 * thymoglobulin induction at the time of transplant * patient must be epstein-barr virus seropositive exclusion criteria: * patient who received an blood type incompatible transplant, or with t-cell or b-cell positive crossmatch * patients with hepatitis b, hepatitis c, hiv or a clinically significant systemic infection within 30 days prior to transplant * history of stroke, severe cardiac disease or cardiac failure

Keywords: kidney transplant diabetes after transplant belatacept
the use of medical grade honey in the prevention of bone anchored hearing aid associated skin breakdown

Conditions: Skin Infection

Summary: postoperative medicinal grade honey in post-operative care may prevent bone anchored hearing aid associated skin breakdown better than standard care of bacitracin ointment alone in adult patients.

this is a prospective study. multiple surgeons will perform the bone anchored hearing aids (bahi) implantation surgery. patients will be randomized to either postoperative medicinal honey or postoperative standard care of bacitracin ointment alone using a random number generator. there will be a total of two patient groups. the type of bahi device used, laterally and the surgical technique will be recorded. treatment groups: group 1-patients undergoing bahi implantation who will be postoperatively treated with medicinal honey. group 2- patients undergoing bahi implantation who will be postoperatively treated with bacitracin ointment as standard care.

Eligibility criteria:
inclusion criteria: * patients undergoing bone-anchored hearing aid implantation surgery. exclusion criteria: * patients who are undergoing revision bone-anchored hearing surgery, history of radiation to the implantation site.
role of terminal warm blood cardioplegia as myocardial protection in the use of histidine-tryptophan-ketoglutarate cardioplegia in complex congenital heart surgery

Conditions: Congenital Heart Disease

Summary: terminal warm blood cardioplegia (twbc) has been shown to enhance myocardial protection in adult patients. even in pediatric patients, the use of cold blood cardioplegia followed by administration of twbc will provide cardioprotective effect similar to adult patients. histidine-tryptophan-ketoglutarate (htk), is attractive for cardiac surgeons because it is administered as a single dose and is claimed to offer myocardial protection for a period of up to 180 minutes allowing performance of complex procedures without interruption. merging the use of twbc on the use of htk cardioplegia, especially for pediatric cardiac cases, have not been investigated. this technique is expected to provide a longer ischemic time and a protective effect against reperfusion injury.

the design of this study is a randomized controlled trial in children younger than 5 years old undergoing heart surgery with cardiopulmonary bypass. the objective of this study is to assess the role of twbc in use of htk cardioplegia compared with the use of htk cardioplegia alone in open heart surgery of complex congenital heart disease. this study will be conducted at the national cardiac centre harapan kita hospital indonesia. surgery will be performed in the operating room of pediatric and congenital cardiac surgery unit. this study uses non-probability consecutive sampling. the samples are all pediatric patients with complex congenital heart disease who meet the inclusion criteria and not excluded by the exclusion criteria. patients will be divided into two groups, the treatment group who received htk cardioplegia and twbc, and the control group that only received htk cardioplegia alone. hearts will be arrested with htk solution during cardiac operation. htk cardioplegia will be given through the aortic root at a dose of 50-60 ml/kg after aortic cross-clamped. for the treatment group, twbc will be given shortly before the aortic cross clamp is removed at a dose of 10 to 15 ml/kg with temperature of 34 to 36 ocelcius. twbc is a mixture of blood and htk kardioplegia with a composition of four to one. the outcomes of this study are malondialdehyde as a marker of reperfusion injury due to oxidative stress, caspase-3 as a marker of apoptosis, ctn-i as a marker of myocardial cell damage and the incidence of low cardiac output syndrome.

Eligibility criteria:
inclusion criteria: * patient diagnosed with complex cyanotic congenital heart disease who scheduled for pediatric cardiac surgery * aristotle score is 8 and above * parents of patient have written informed consent and agree to follow the research procedures exclusion criteria: * patient diagnosed with an other congenital defect * patient diagnosed with rare congenital heart defect and high mortality rate (such as hypoplastic left heart syndrome)
latent tuberculosis infection in bone marrow transplant recipients

Conditions: Tuberculosis

Summary: the aim of this study is to estimate the usefulness of a t cell-based assay (i.e. quantiferon-gold in-tube assay) for diagnosis of latent tuberculosis infection (ltbi) in bone marrow transplant recipients. for this purpose, the investigators enrolled bone marrow transplant recipients and observed the developement of tuberculosis after the transplantation.

all adult bone marrow transplant recipients admitted to asan medical center will be enrolled. quantiferon-gold in-tube assay will be performed. isoniazid prophylaxis will be given only to patients with clinical risk factors (i.e. recent contact with active pulmonary tb patient or inadequate treatment history with abnormal cxr). however, isoniazid prophylaxis will be not given based on positive tst or positive quantiferon-gold in-tube assay.

Eligibility criteria:
inclusion criteria: * age 16 or more * bone marrow transplant recipients exclusion criteria: * recent contact of patients with active pulmonary tuberculosis * suspected active tuberculosis

Keywords: tuberculosis bone marrow transplant diagnosis
ag-013736 in combination with docetaxel versus docetaxel alone for patients with metastatic breast cancer

Conditions: Breast Neoplasms

Summary: the primary purpose of the study is to determine the time to progression of the combination of study drug (ag-013736) and docetaxel versus docetaxel alone in patients who have not received prior chemotherapy for metastatic breast cancer. the secondary purpose of the study is to determine the dose of study drug that can be given with docetaxel administered on an every 3 week schedule.


Eligibility criteria:
inclusion criteria: * female patients with histologically/cytologically proven metastatic breast carcinoma (stage iv, or recurrent with local or regional spread or distant metastatic disease) * adequate bone marrow, liver, and renal function exclusion criteria: * adjuvant chemotherapy given in the past 12 months * uncontrolled brain metastases

Keywords: metastatic breast cancer
both column fixation corridor in pelvic surgery

Conditions: Acetabular Fractures

Summary: the concepts of the both column fixation corridor (bcfc) and both column screws (bcs) have emerged as innovative approaches in orthopedic surgery yet have not been extensively explored in the literature. this study aims to evaluate the feasibility and potential advantages of this novel screw fixation technique, thereby filling the existing gap in knowledge and establishing standards for its application.

pelvic ct data will be collected from 400 healthy adults, including 200 males and 200 females. the synapse software will be utilized to simulate the placement of both anterior and posterior both column screws (bcs) in the both column fixation corridor (bcfc). screws will be virtually implanted into the bcfc using the "ozturk procedure," a technique developed based on clinical practice. measurements will include the thickness and length of each bcs for both anterior (abcs) and posterior (pbcs) placements, as well as the distances from the screw centers to the spina iliaca anterior superior (sias). additionally, the necessary caudo-cranial (cct) and centro-lateral tilts (clt) for achieving axial fluoroscopic visualization of the bcfc will be measured.

Eligibility criteria:
inclusion criteria: * adults aged 18 to 65 years. * both male and female participants. * participants with healthy pelvic anatomy as determined by ct imaging, without any previous fractures, deformities, or surgical interventions that could alter the pelvic structure. exclusion criteria: * history of pelvic or acetabular fractures. * previous pelvic surgeries that could alter the anatomical structure. * conditions significantly affecting bone quality, such as osteoporosis or metabolic bone diseases.

Keywords: both column screw percutaneous fixation acetabulum
pediatric preventative health screenings - obesity and family-centered outcomes

Conditions: Obesity; Overweight; Blood Pressure; Hypercholesteremia; Diabetes

Summary: in 2012, an expert panel of the national heart lung and blood institute published guidelines on cardiovascular health and risk reduction in children; among these guidelines were screening recommendations for obesity and obesity-related conditions. following publication of this report there was a call for caution and for increased patient (parent, child) input on implementing these guidelines. there are limited current studies evaluating patient-centered outcomes (pco) in the well-child setting, however, given the childhood obesity epidemic, there is a clear need for such an evaluation. the city of detroit, mi ranks first among 22 cities with data for the prevalence of overweight and obese youth (39.7%), making henry ford health system, which is located in detroit, mi, an ideal setting to study childhood obesity related research questions.

within this patient population, our specific aims therefore are to (1) examine current trends in screening and management of obesity and obesity-related conditions in a real-world urban practice setting; (2) examine the family (patient and parent/guardian) and clinician preferences for the identification and management of obesity and obesity-related conditions; and (3) design and conduct a phase ii pragmatic cluster randomized trial (pcrt) of an educational intervention in providers for guiding screening for obesity and obesity-related conditions during the well-child visit that incorporates and leverages pco. staff dedicated solely to this project will partner with the henry ford health system's proposed patient-centered outcomes research center's cores staff members to design, execute and disseminate study results in order to affect clinical care. by seeking to understand the current screening patterns in pediatrics and by creating an education intervention for providers aimed at taking a patient/family centered approach to these preventative health screenings, we may increase pcos which in turn may have meaningful implications for future adult health.

Eligibility criteria:
inclusion criteria: * between the ages of 2 and 18 * henry ford health system patient * well-child visit with participating provider * fluent in english exclusion criteria: * unable to provide consent
castle (clopidogrel and serum troponin level elevation)

Conditions: Thrombosis

Summary: primary objective: to test if 600 mg of clopidogrel loading dose administered ≥ 6 and ≤ 24 hours prior to pci produce a greater decrease of periprocedural release of biochemical markers (ck, ck-mb, and troponin-t and/or i) of myocardial necrosis, compared to 300 mg loading dose, given ≥ 6 and ≤ 24 hours prior to pci or 600 mg loading dose of clopidogrel, administered immediately (≤ 45 minutes) before pci.


Eligibility criteria:
inclusion criteria: * patients having symptomatic coronary artery disease with objective evidence of ischemia (eg, symptoms of angina pectoris, positive stress test results or dynamic electrocardiographic (ecg) changes). * patients undergoing stent implantation exclusion criteria: * any known contraindication to the use of aspirin or clopidogrel. * patients receiving clopidogrel within 10 days, thrombolytics within 24 hours or receiving oral anticoagulation therapy * elective administration of iib/iiia inhibitors. * cardiogenic shock * acute mi\< 24 hours * bp systolic \<100 mmhg * left ventricular ejection fraction \< 30% * heart failure, nyha class iii or iv * severe renal insufficiency (creatinine \> 3.0 mg/dl) * platelet count \<100,000/mm³ * target lesion in a venous bypass graft * target lesion in a chronic occlusion the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.