Kornimate/medical-research-clean huggingface dataset:
a study to evaluate safety and efficacy of caelyx in combination with cyclophosphamide in the treatment of metastatic breast cancer (p02948)

Conditions: Breast Neoplasm

Summary: women with metastatic breast cancer are usually treated with anthracyclines (ie, doxorubicin or epirubicin) but cardiac toxicity limits their use. the aim of this study is to evaluate the safety and efficacy of caelyx in combination with cyclophosphamide in women with metastatic breast cancer who have received adjuvant anthracyclines with or without a taxane.


Eligibility criteria:
inclusion criteria: * female, aged \>=18 years. * subject must have histologic diagnosis of breast carcinoma. * subject must have documented measurable metastatic breast cancer by appropriate radiologic imaging. * subject must have previous anthracyclin-based adjuvant regimen and disease-free status for at least one year following the completion of adjuvant therapy. * subject must have ecog performance status 0, 1, or 2. * subject must have life expectancy \> 6 months * subject must have left ventricular ejection fraction \>=55% as determined by muga scan. * subject must have normal organ function, except if abnormal due to tumor involvement: * adequate bone marrow function (platelets \>=100 x 10\^9/l, hemoglobin \>=90 g/l, neutrophils \>=1.5 x 10\^9/l) * adequate renal function (serum creatinine \< 2 x the upper limit of normal (uln) * adequate liver function (bilirubin \< 2 times uln, ast or alt \< 2 times uln in the absence of liver metastasis, ast or alt \< 5 times uln in the presence of liver metastasis. * women of childbearing potential must be using adequate contraception and have a negative pregnancy test at the time of enrollment. * subject must be able to understand and give informed consent. exclusion criteria: * age \> 75 years old. * subject who is pregnant or breastfeeding or is unwilling to use adequate contraception. * subject who has had a previous chemotherapy for metastatic disease. * subject who has history of cardiac disease, with new york heart association class ii or greater with congestive heart failure. * subject who has clinically significant hepatic disease in regard to hepatitis b, hepatitis c, cirrhosis, or other liver diseases unrelated to the underlying metastatic breast cancer. * subject who has uncontrolled bacterial, viral, or fungal infection. * subject who exhibits confusion or disorientation. * subject with any condition which would prevent adequate follow-up. * subject who has received radiotherapy in the last 4 weeks. * subject with any other active primary tumor under treatment, except basal cell carcinoma of the skin, or carcinoma in situ of the cervix. * subject who has brain metastasis. * subject who is not able to give informed consent.
ceprotin treatment registry

Conditions: Protein C Deficiency

Summary: the overall objective is to collect and assess data on the treatment, safety, and treatment outcomes of subjects prescribed, receiving and participating in the ceprotin treatment registry.


Eligibility criteria:
inclusion criteria: participants for whom ceprotin therapy has been indicated and meeting the following criteria may be enrolled in this study: * signed and dated informed consent from either the participant or the participant's legally authorized representative prior to enrollment, as applicable * males and females of any age, including neonates, children, adolescents and adults * participant who received ceprotin or is initiating/receiving ceprotin treatment exclusion criteria: * none
elastography in the evaluation of major salivary gland lesions

Conditions: Salivary Gland Diseases

Summary: 2.2 aim(s) of the research (50 words max): to investigate the diagnostic accuracy of sonoelastography in the evaluation of major salivary gland lesions using histopathology as gold standard.

salivary gland diseases are ranging from the minor inflammatory conditions to a group of benign and malignant neoplasms. most of the salivary gland disorders manifest themselves as the enlargement of the gland which may be associated with pain or swelling. physical examination together with laboratory analyses may not be sufficient to discriminate these diseases . therefore, an accurate, non invasive diagnostic method is needed to discriminate these diseases (1). although ultrasound-guided fine-needle aspiration cytology (fnac) is considered the gold standard for preoperative diagnosis (2), it is an invasive method requiring significant experience to avoid complications like injury of the facial nerve as it courses within the parotid gland. this explains the continuing desire for further non-invasive diagnostic options (3). the current imaging modalities are ultrasonography, computed tomography (ct) and magnetic resonance imaging (mri). despite being highly sensitive, they lack the accuracy in differentiating benign and malignant lesions because of considerable overlap between the imaging features of benign and malignant salivary gland lesions. sonoelastography is a new technique that depends on the elastic properties of soft tissues, with the idea of malignant lesions being stiffer than benign or normal tissue. it may have a dependable role in diagnosing different salivary gland diseases, the same way it has been used in different parts of the body, such as the breast, lymph nodes, and thyroid (4). to the best of our knowledge, there are few studies concerning the role of elastography in the field of salivary gland disease.

Eligibility criteria:
inclusion criteria * all patients with clinically suspected lesions of parotid or submandibular glands . * an equal number of healthy volunteers will be included during the same period as control group . exclusion criteria: • a mass with ulcerated or raw surface, involvement of the whole gland by the lesion or previous surgical treatment
a study to evaluate the pharmacokinetic profiles of single 14 mg teriflunomide tablet in healthy chinese volunteers

Conditions: Multiple Sclerosis

Summary: primary objective: to assess the pharmacokinetic (pk) parameters of teriflunomide after a single oral dose of 14 mg administration in chinese healthy subjects secondary objective: to assess the safety and tolerability after a single oral dose of 14 mg teriflunomide in chinese healthy subjects

* screening: 2 to 21 days before inclusion (day -21 to day -2) * institutionalization period: 6 days including 1 treatment day (day -1 to day 6, treatment on day 1) * follow-up: 7-10 days (may be extended) * end of study: day 38 to day 41 (may be extended) * total study duration: maximum 9 weeks

Eligibility criteria:
inclusion criteria : male or female subjects, between 18 and 45 years of age, inclusive. body weight between 50.0 and 95.0 kg, inclusive, if male, and between 45.0 and 85.0 kg, inclusive, if female, body mass index between 19.0 and 24.0 kg/m2, inclusive. certified as healthy by a comprehensive clinical assessment and lab test. subject must use an appropriate contraception method. having given written informed consent prior to any procedure related to the study. exclusion criteria: blood donation, any volume, within 3 months before inclusion. symptomatic postural hypotension, whatever the decrease in blood pressure, or asymptomatic postural hypotension defined by a decrease in systolic blood pressure ≥20 mmhg within 3 minutes when changing from the supine to the standing position. excessive consumption of beverages with xanthine bases (\>4 cups or glasses per day). if female, pregnancy (defined as positive β-hcg blood test), breast-feeding. any medication (including st john's wort and traditional chinese herb medicine) within 14 days before the inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of that drug, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days. any consumption of citrus (grapefruit, orange, etc) or their juices within 5 days before inclusion. subject (both male and female) who disagrees to use an appropriate contraception method . the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
serum elafin and vascular affection in behcet disease

Conditions: Behcet Disease and Vascular Affection

Summary: to measure the level of serum elafin in patients with bd. to assess the relation between serum elafin levels and disease activity. to evaluate the vascular complications in bd and determine their relationship with disease activity. to assess the correlation between serum elafin and vascular affection and their relation with disease activity.

behçet's disease (bd) is a chronic, multisystemic, inflammatory disease characterized by recurrent oral and genital ulcers and multiple systemic involvements. elafin is a serine protease inhibitor produced mainly by epithelial cells. its expression is upregulated by proinflammatory cytokines such as il-1β and tnf-α that are potent stimulants of neutrophil activation, it counteracts the destructive effects of neutrophil elastase .interestingly, previous reports documented the role of serum elafin in the pathogenesis of bd.in fact, vascular complications may be one of the earliest manifestations leading to the diagnosis of bd. there is no reliable tool to identify vascular wall inflammation in bd, except for detecting intravascular thrombosis with ultrasonography (us). previous studies investigated arterial vessel wall thickness with us (mostly in carotid arteries) in bd . venous wall inflammation presents with deep vein thrombosis and superficial thrombophlebitis . it was stated that lower extremity vein wall thickness (vwts)was increased in bd patients independently of vascular activity and important in the diagnosis . however, studies in the literature evaluated only lower extremity vwts, whereas the relationship of vwt with disease activity has not been emphasized .

Eligibility criteria:
inclusion criteria: patients diagnosed as bd. age of all participants (20-45) years. exclusion criteria: age \ 45 years. other autoimmune diseases. cardiovascular diseases (heart failure, myocardial ischemia). possible related risk factors (e.g. diabetes, dyslipidemia, smoking). chronic conditions (e.g. chronic kidney disease, malignancy, autoimmune diseases).
use of music and voice stimulus on coma patients

Conditions: Coma

Summary: objectives: (1) to check music and voice message influence on vital signs and facial expressions of patients in physiological or induced comas; (2) to connect the existence of patient's responsiveness with the glasgow coma scale or with the ramsay sedation scale. method: this was a randomized controlled clinical trial with 30 patients, from two intensive care units, being divided in 2 groups (control and experimental). their relatives recorded a voice message and chose a song according to the patient's preference. the patients were submitted to 3 sessions for 3 consecutive days.

the relatives elaborated a voice recorded message and choose a music according to the patient preference, which were recorded in the same compact disc. two identical cd's were made at the same recorded time; one with and another one without stimulus in order to make the random division of the groups. the patients were evaluated according to one of the scales; they used earphones. during the sessions, the data relating to the vital signs and the face expression were recorded in a data collection instrument.

Eligibility criteria:
inclusion criteria: * to be in coma; * to be evaluated according to one of the scales and to have a score in the study range: in physiological comas, score between 3 to 8 glasgow coma scale (gcs); in induced coma, one of the last two scores of ramsay sedation scale (rss), r5 or r6; * to have hearing function preserved according to family; * to have written consent from the family or responsible party for the patient's participation in the research. exclusion criteria: * score between 9 to 15 in gcs or scores r1, r2, r3 or r4 in rss

Keywords: communication complementary therapies intensive care ethics
group acceptance and commitment training (act) with healthy older adults

Conditions: Aging; Quality of Life

Summary: the current study aims to explore the impact of a two-session group acceptance and commitment therapy (act) intervention compared to an assessment-only control on psychological outcomes in healthy older adults. the proposed study has two main objectives. 1. examine the impact the intervention on targeted act processes over time 2. examine the impact of the intervention on aspects of eudaimonic well-being over time

older adults are a growing segment of our population, and this period of life presents a variety of physical, emotional, environmental, and cognitive changes, even for healthy individuals. the current study aims to explore the impact of a two-session group acceptance and commitment therapy (act) intervention compared to an assessment-only control on psychological outcomes in healthy, community-dwelling older adults. participants will be randomly assigned (stratified by sex) to the act group condition or to an assessment-only control group. after randomization, those in the assessment-only control group will be asked to complete four assessments via mail (baseline, one-month, three-month, and six-month). the intervention group will participate in a brief group act intervention occurring over two sessions (90 minutes each, approximately one week apart). intervention participants will also complete assessments at baseline and at one-month, three-months, and six-months post-intervention. the specific aims and hypotheses of the current study are: specific aim #1: to examine longitudinal between-group differences in targeted act processes including psychological flexibility (openness to experience, behavioral awareness, and valued action) and satisfaction with social roles and activities from baseline to follow-up. we hypothesize that there will be significant time by group interaction, such that psychological flexibility and satisfaction with social roles and activities will increase significantly more in the intervention group relative to the assessment-only control group. specific aim #2: to examine longitudinal between-group differences in eudaimonic well-being (purpose in life and personal growth) from baseline to follow-up. we hypothesize that there will be significant time by group interactions, such that purpose in life and personal growth will increase significantly more in the intervention group relative to the assessment-only control group.

Eligibility criteria:
inclusion criteria: * healthy, community-dwelling older adult (age 65-99) exclusion criteria: * significant primary psychiatric disease * medications that have the potential to affect cognitive functioning * neurological events

Keywords: older adult psychological well-being acceptance and commitment therapy brief interventions psychological flexibility
20110165: study to evaluate the effect of amg 747 on schizophrenia negative symptoms (study 165)

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the effect of amg 747 on negative symptoms of schizophrenia in patients who are stable on current antipsychotic treatment. after a run-in period on their current antipsychotic treatment, patients will be randomized to one of the four treatment arms as add-on therapy for a treatment duration of up to 3 months.


Eligibility criteria:
inclusion criteria: * diagnosis of diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) schizophrenia * total score on the panss marder negative symptom factor scale (nsfs) ≥ 20 * total score on the panss marder positive symptom factor scale (psfs) ≤ 30 * receiving stable antipsychotic therapy for at least 8 weeks prior to screening * receiving a stable dose of other psychotropic agents for at least 8 weeks prior to screening * subject has had a stable residence or living arrangement for at least 8 weeks prior to screening and the residence or living arrangement is not anticipated to change for the duration of the study * the subject or subject's legally acceptable representative has provided informed consent. exclusion criteria: * current schizoaffective or bipolar disorder, panic disorder, obsessive compulsive disorder, evidence of mental retardation by history or clinical examination or known premorbid iq ≤ 70 * clinically significant suicidal ideation or suicide attempts, assaultive behavior or marked changes in mood within the 8 weeks prior to screening, or currently endorsing suicidal ideation in clinical exam * substance abuse (with the exception of nicotine or caffeine abuse) within the 8 weeks prior to screening, or during screening * substance dependence (with the exception of nicotine or caffeine dependence) within the 6 months prior to screening, or during screening * planning to initiate a smoking cessation therapy or otherwise substantially modify nicotine use during the study * positive urine drug test for substances of abuse (with the exception of positive screens for prescribed agents such as benzodiazepines). * other criteria may apply

Keywords: schizophrenia negative symptoms
serum levels of 25-hydroxy vitamin d in patients with moderate and severe erectile dysfunction

Conditions: Erectile Dysfunction

Summary: in present study, we aimed to investigate the association between erectile function severity of serum 25-hydroxyvitamin-d and cut-off level to treat men with erectile dysfunction.

investigators retrospectively analysed 130 patients admitted to the complaint of erectile dysfunction between aged between 18-80 years old from june 2017 to october 2018 at cigli region training hospital urology department and recep tayyip erdogan university urology department. international index of erectile function-5 (iief-5) turkish validated short form quesstionaire was performed to all patients. antropometric characteristics including weight, height, waist circumference, body mass index (bmi) and presence of comorbide diseases were recorded. after detailed history and physical examination performed all patients, overnight fasting in the morning between 08:00-10:00, blood samples from antecubital vein were performed and serum glucose, lipid profile, follicular stimulating hormon (fsh), luteinizing hormone (lh), total testosterone, prolactin, estradiol, 25(oh)d level were analysed. presence of uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled lipid metabolism disorders, neurological diseases, heamatological diseases, urinary tract infection, malignencies, chronic kidney failure, metabolic syndrome, psychiatric diseases and/or medical treatment, smoking, history of pelvic surgery, cardiac surgery and pelvic radiotherapy were accepted as exclusion criterias from the study. after iief-5 score adjust as 21 point, roc analyse was used to calculate the cut-off value of 25(oh)d and level of 27.32 ng/ml was calculated as cut-off value. patients were divided into two group according to 27.32 ng/ml level as a cut off value. serum 25(oh)d level was lower than 27.32 ng/ml in group 1 (severe and moderate symptomatic group) and higher than 27.32 ng/ml in group 2 (mild symptomatic group).

Eligibility criteria:
inclusion criteria: * presence of erectile dysfunction exclusion criteria: * presence of uncontrolled diabetes mellitus, * presence of uncontrolled hypertension, * presence of uncontrolled lipid metabolism disorders, * presence of neurological diseases, * presence of heamatological diseases, * urinary tract infection, * diagnosis of any malignencies, * chronic kidney failure, * presence of metabolic syndrome, * presence of psychiatric diseases and/or medical treatment, * smoking, * history of pelvic surgery, cardiac surgery and pelvic radiotherapy

Keywords: erectile dysfunction vitamin-d hypogonadism endothelial dysfunction nitric oxide
international registry and biorepository for tma(thrombotic microangiopathy)

Conditions: Thrombotic Microangiopathy; Hemolytic Uremic Syndrome; Thrombotic Thrombocytopenic Purpura

Summary: this registry will collect clinical data and store biosamples (seru, plasma, urine, and dna) annually from pediatric patients with thrombotic mcroangiopathy

children age, 6 months - 18 years, are eligible if they have one of the following categories of thrombotic microangiopathy (tma):(1) severe d+hus; (2) non-familial atypical hus; (3) familial atypical hus; or (4) ttp patients are seen intially and annually thereafter biosamples are collected for storage annually.

Eligibility criteria:
inclusion criteria: * severe hus, familial or non-familial atypical hus, ttp exclusion criteria: * none

Keywords: thrombotic microangiopathy (tma) hemolytic uremic syndrome (hus) thrombotic thrombocytopenic purpura (ttp)
treatment of extracorporeal membrane oxygenation in severe poisoning

Conditions: Poison;Medicinal; Extracorporeal Membrane Oxygenation

Summary: this is a prospective, multicentre clinical study to determine the value of the extracorporeal membrane oxygenation in the treatment of critically ill poisoning patients and whether there are significant differences in the prognosis of different types or doses of poison/drug poisoning. these conclusions may guide us on how to correctly perform extracorporeal membrane oxygenation, including whether or when should this treatment enabled, the mode of extracorporeal membrane oxygenation, whether to combine blood purification, treatment schedule and disembarkation time.

this study will be conducted in the affiliated hospital of nantong university, the sixth people's hospital of nantong university, the branch of affiliated hospital of nantong university, the people's hospital of qidong city, the people's hospital of rudong county, the people's hospital of rugao city, and the people's hospital of hai 'an city. it is expected that 60 patients with poisoning will be included, and the blood and urine samples of 60 patients will be collected and stored in the clinical trial sample database to evaluate and record the relevant indicators of the subjects. the relevant medical records in clinical treatment were analyzed and studied. each subject will be numbered and a separate medical record will be established. the purpose of this prospective multicenter observational clinical study was to 1) investigate the value of extracorporeal membrane oxygenation in the treatment of fatal poisoning; 2) to investigate the changes of patients' organ functions (heart, lung, liver, kidney, brain) during the extracorporeal membrane oxygenation operation and the influence on the removal of toxins. in order to obtain a more powerful clinical basis to guide the rational use of the extracorporeal membrane oxygenation technology in patients with fatal poisoning.

Eligibility criteria:
inclusion criteria: * severe intoxication resulting in cardiac arrest, refractory malignant arrhythmia, refractory shock, refractory heart failure, respiratory failure. * denying other available methods. * indications for the use of the extracorporeal membrane oxygenation exist. exclusion criteria: * severely impaired state of consciousness prior to cardiac arrest; * multiple organ dysfunction; * uncontrolled traumatic bleeding, massive gastrointestinal bleeding, and active intracranial hemorrhage; * left ventricular thrombosis; severe aortic insufficiency.

Keywords: severe poisoning extracorporeal membrane oxygenation emergency medical care