Kornimate/medical-research-clean huggingface dataset:
absorption, distribution, metabolism and excretion of [14c]-labeled bia 9-1067 and metabolites

Conditions: Parkinson Disease

Summary: to determine the absorption, metabolism and excretion of bia 9-1067.

monocentre, open, non-placebo-controlled, single-group, single-dose study

Eligibility criteria:
inclusion criteria: * healthy caucasian male subjects, 40-55 years of age. * sitting blood pressure and pulse rate within a clinically acceptable range for the purposes of the study, i.e.: bp: 100 - 160 mmhg systolic, 50 - 95 mmhg diastolic and pulse rate: 50 - 100 bpm. blood pressure and pulse were to be measured after 3 minutes resting in a sitting position. * subject body mass index was to be between 18 and 28 kg/m2 * normal 12-lead ecg * ability to communicate well with the investigator and comply with the requirements of the entire study. * the subject had given his written informed consent to participate in the study. exclusion criteria: * history of serious adverse reactions or hypersensitivity to any drug. * presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis). * history of alcohol or drug abuse in the last 5 years. * abnormal physical findings of clinical significance at the screening examination or baseline which would interfere with the objectives of the study. * need of any prescription medication within 14 days prior to the administration of the drug and/or nonprescription medication within 7 days prior to the administration of the drug. * participation in other clinical trials during the previous month in which an investigational drug or a commercially available drug was tested. * loss of 500 ml blood or more during the 3 month period before the study, e.g., as a donor. * existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the drug, i.e., impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhoea or conditions associated with total or partial obstruction of the urinary tract. * symptoms of a significant somatic or mental illness in the 4 week period preceding drug administration. * history of hepatitis b and / or c and / or positive serology results which indicate the presence of hepatitis b and / or c. * positive results from the hiv serology. * clinically significant abnormal laboratory values (as determined by the principal investigator) at the screening evaluation, however, liver parameters (sgpt, sgot) values must be within the normal range. * positive results of the drug screening. * known hypersensitivity to bia 9-1067. * heavy smokers, i.e., more than 10 cigarettes per day * exposure to artificial ionizing radiation in the last 12 months (e.g., x-ray investigation) * subject who had more than 4 flights (with more than 2 hours flight time) within the last year prior to the administration of the drug.

Keywords: parkinson disease bia 9-1067
a study of safety and effectiveness of bendamustine hydrochloride in adult filipino patients with chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: the purpose of this study is to assess safety and effectiveness of extended bendamustine in the treatment of chronic lymphocytic leukemia (cll).

this is a phase iv, open label (all people know the identity of the intervention), multi-center, observational (a scientific study to make a clear and easy understanding of the cause and effect relationship) study of bendamustine. the study duration is of 24 weeks to coincide with the 4 weeks-6 cycles bendamustine treatment. the study will run for three years, and will enroll 10 percent of patient who would use this product, as a requirement of the philippine food and drug administration (fda). approximately fifty patients will be enrolled in this study. safety evaluations including adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * adult filipino patients with chronic lymphocytic leukemia * patients who are cytologically-diagnosed with chronic lymphocytic leukaemia (symptomatic binet stage b or c) and for whom fludarabine combination chemotherapy is not appropriate * world health organization performance status of 0, 1, or 2 * need-to-treat criteria in b-cell chronic lymphocytic leukemia exclusion criteria: * had received previous treatment with other cytotoxic drugs * had a history of a second malignancy (except cured basal cell carcinoma or cured cervical cancer) * concomitant illnesses such as overt heart failure, cardiomyopathy, myocardial infarction within the last 6 months, severe uncontrolled diabetes mellitus, severe uncontrolled hypertension, active infection that required systemic antibiotic treatment in an investigational drug study within 30 days prior to selection * patients with severe renal and hepatic impairment * patients with severe bone marrow suppression and severe blood count alterations * pregnant women and lactating mothers

Keywords: chronic lymphocytic leukemia bendamustine hydrochloride leukemia filipino
a 3-month clinical trial to assess the safety and efficacy of the ozurdex® intraocular implant in patients with diabetes mellitus

Conditions: Macular Edema; Diabetes Mellitus

Summary: there is a need to find an effective therapy for diabetic patients who develop macular edema after cataract surgery.

the objective of this study is to assess the safety and efficacy of the ozurdex® intraocular implant in patients with diabetes mellitus, who develop macular edema after cataract surgery

Eligibility criteria:
inclusion criteria: * patient has diagnosis of diabetes mellitus, type i or ii. * patient has experienced the development of macular edema following cataract surgery in at least one eye. * patient has had cataract surgery within 90 days prior to the screening visit. exclusion criteria: * patient has other significant ocular disease in study eye, including glaucoma. * patient has any active infection in the study eye. * patient has uncontrolled systemic illness (i.e., uncontrolled blood pressure, uncontrolled diabetes mellitus). * patient has experienced a significant increase in intraocular pressure following a prior treatment with topical or intravitreal steroidal medication. * patient has received the ozurdex® implant before in the study eye.
clinical impact of home oxygen saturation measurement (saturhome)

Conditions: Interstitial Lung Disease

Summary: the use of saturometry at home is more and more widespread in patients suffering from interstitial pulmonary diseases (ipd), the patients seeing it as reassurance and a concrete way to follow the evolution of their disease. however, there are no studies evaluating the real clinical benefit of taking saturation at home in this population. in addition, clinical experience seems rather to demonstrate an increase in the anxiety level and the number of clinically unnecessary consultations related to the use of this measure. the secondary objectives are to determine the impact of this measurement on: (1) the health care use (telephone calls, medical consultations and hospitalizations), (2) dyspnea score, (3) the anxiety and depression score (hads score) and (4) the physical activity level. the exploratory objectives will be to determine if the measurement of saturation at home makes it possible to (1) predict the occurrence of acute exacerbations of fibrosis, (2) effectively predict the decline in respiratory function tests and (3) 1-year mortality. the investigator will also assess whether this measure makes it possible to screen patients with oxygen therapy needs at home. the investigator hypothesize that measuring oxygen saturation at home will lead to a significant deterioration in quality of life, an increase in the use of health care, a significant increase in the rate of anxiety and depression, dyspnea and a decrease in the physical activity level.

measurement tools 1. quality of life: king's brief interstitial lung disease 2. anxiety and depression score: hads score 3. dyspnea score : ucsd questionnaire 4. physical activity level during 7 days: movemonitor by mcroberts 5. home base saturation: nonin ny vantagr 9590 6. disease evolution : complete lung function (plethymography, sprimoetry, dlco), 6-minute walking test (following the ats recommandation)

Eligibility criteria:
inclusion criteria: * fibrosing interstitial lung disease * saturation below 90% during the 6-minute walk test * clinically stable exclusion criteria: * oxygen dependent at rest

Keywords: saturometry at home quality of life heath care use physical activity level
intraoperative examination of sentinel node in endometrial cancer (trsgo-sln-003)

Conditions: Endometrial Cancer; Sentinel Lymph Node

Summary: more than half of the cases with macrometastatic sentinel lymph node (sln) have non-sln metastasis and leaving these nodes in-situ may impair the survival. this study assessed the diagnostic accuracy of intraoperative sln frozen section examination and scrape cytology as a possible solution for management of sln positive patients. clinical early stage endometrial cancer patients who underwent sln algorithm and intraoperative frozen section or scrape cytology to evaluate sln status for metastasis were analyzed retrospectively. intraoperative examination findings were compared with final pathology results and diagnostic accuracy of frozen section and scrape cytology were evaluated.

frozen section: lymph nodes up to 2 mm were embedded as a whole. lymph nodes between 2-5 mm were cut in half along their long axis and nodes larger than 5 mm were sliced in neat, parallel slices at 2-3 mm intervals-slicing was perpendicular to the long axis of the node. then whole of the slns were stained with hematoxylin and eosin (h\&e) and examined by frozen section. scrape cytology: slns were cut into 3-mm-thick pieces along their long axis. if the lymph node was smaller than 3 mm, it was cut in half. both sides of the pieces were scraped separately by an edge of a glass slide or a lancet gently. obtained materials were smeared immediately onto a slide and placed in ethanol for fixation. then, all slides were stained with h\&e and examined. the results were reported to the surgeon as positive (metastatic) or negative with the numbers of lymph nodes. after intraoperative examination, lymph nodes were put into formalin solution and sent for final pathologic examination. data analyses were performed using spss version 21.0 (ibm corporation, armonk, nyc, usa). shapiro-wilk test was performed to determine whether the data were normally distributed. descriptive statistics of continuous variables were compared between groups using mann-whitney u test. the chi-square test or fisher's exact test (when chi-square test assumptions do not hold due to low expected cell counts) were used to compare categorical variables between groups. continuous variables were presented as median and min-max values, whereas categorical variables were presented as number and percentage. a p value of \<0.05 was considered statistically significant. performance of each protocol to predict treatment success was assessed using confidence intervals with respect to sensitivity, specificity, positive predictive value, and negative predictive value.

Eligibility criteria:
inclusion criteria: * patients with apparently early stage endometrial cancer whose slns were evaluated intraoperatively were included to this study exclusion criteria: * patients with gross metastatic disease * patients who had contraindications to dyes (iodine allergy or hepatic impairments)
the solve-it national randomized trial

Conditions: HIV Infections

Summary: this study will evaluate the effectiveness of an interactive virtual environment computer game in reducing risky sexual behaviors among men who have sex with men.

hiv and sexually transmitted diseases (stds) are a major public health concern worldwide. although prevalent across all groups of people, hiv/stds have had a remarkable effect on men who have sex with men (msm), who accounted for 71% of all hiv infections among american males in 2005. after years of decline, the number of hiv diagnoses appears to have increased for msm, especially within the black msm population. thus, new approaches geared for hiv prevention and education and built on past hiv prevention methods are needed. new technologies, such as interactive computer games, delivered in a modern and appealing manner may gain or recapture the attention of msm who have disregarded more traditional hiv prevention and educational services. socially optimized learning in a virtual environment (solve)-it is an interactive virtual environment computer game, designed specifically for msms, that simulates the emotional, interpersonal, and contextual narrative of an actual sexual encounter and provides challenging decision-making opportunities. by promoting development of self-regulatory and behavioral skills, solve-it may be an effective approach to reduce sexual risk behaviors. this study will evaluate the effectiveness of solve-it in reducing risky sexual behaviors among msm. participation in this study will last 6 months from the beginning of treatment. all participants will first undergo baseline assessments that will include questionnaires about sexual behavior, drug use, health history, feelings, and beliefs. participants will then be assigned randomly to receive solve-it immediately or after a 6-month waitlist period. solve-it will include two 1-hour sessions conducted on a computer over the internet, occurring at baseline and 6 months later. during sessions, participants will play an interactive computer game that presents dating or sexual scenarios and allows participants to choose how the scenarios unfold. participants will repeat baseline questionnaires at months 3 and 6 of follow-up. participants in the waitlist group will be offered to receive solve-it after completion of the month 6 follow-up.

Eligibility criteria:
inclusion criteria: * self-identifies as latino, black, or caucasian * men who have sex with men * not hiv infected * engaged in unprotected anal sex at least twice in the 90 days before study entry with a nonprimary male partner * has broadband access during course of study * lives in united states * biological male exclusion criteria: * history of nonprescription drug injection use * has participated in solve-it at any phase

Keywords: hiv/aids prevention men who have sex with men (msm) risky sexual behavior socially optimized learning in a virtual environment (solve) hiv seronegativity
advanced mr imaging in sarcoma patients

Conditions: Sarcoma

Summary: we intend to investigate the clinical application of two emerging imaging modalities for which the technical capability is currently in place at mayo clinic. the treatment of ewing sarcoma (es), rhabdomyosarcoma (rms) and soft tissue sarcoma (sts) patients on this study will involve multi-disciplinary contributions from nationally recognized sarcoma experts in radiation oncology, radiology, orthopedic surgery, pediatric oncology, medical oncology and pathology. patients will undergo additional magnetic resonance (mr) imaging at the same time as the standard imaging. the ability to compare several imaging modalities within a single cohort of patients maximizes the potential of the study to impact the future management of sarcoma patients. the collaborative nature of this study, with essential contributions from many departments will undoubtedly improve the coordinated care of sarcoma patients and naturally disseminate the advanced imaging experience that is acquired.


Eligibility criteria:
inclusion criteria: * age ≥ 7 years. * histological confirmation of newly diagnosed localized or newly diagnosed with metastatic ewing sarcoma, rhabdomyosarcoma or soft tissue sarcoma. * tumors \> 5 cm in diameter. * planning to receive rt or surgery with or without adjuvant radiotherapy (rt) at mayo clinic rochester. * provide informed written consent if ≥ 18 years. if \< 18 years, provide informed written assent and parent or legal guardian provide informed written consent. * patients must have measurable disease as defined in section 11.0. * willingness to participate in mandatory imaging studies at mayo clinic rochester. * baseline mre information deemed as acceptable for assessment * baseline perfusion mri deemed as acceptable for assessment exclusion criteria: * co-morbid conditions that would result in expected survival to be less than 5 years
ai screening for diabetic retinopathy

Conditions: Diabetes Mellitus

Summary: the increasing prevalence of diabetes mellitus represents a major health problem, especially since around 40% of diabetic patients develop diabetic retinopathy, which severely impairs vision and can lead to blindness. this development could be prevented by annual check-ups and timely referral for treatment. however, there are major differences in the quality of examinations and bottlenecks in examination appointments. a solution to the problem could be the use of artificial intelligence (ai), especially deep learning. initial studies have shown that deep learning algorithms can be used successfully to detect diabetic retinopathy. however, it remains to be clarified whether the use of ai can achieve a sufficiently high level of accuracy in the detection of retinopathies. therefore, in the present study, the positive predictive value (ppv), the negative predictive value (npv), the sensitivity (sen) and the specificity (spez) of the ai algorithm 'mona-dr-model' in the detection of diabetic retinopathy should be measured. in addition, it is to be examined how well the classification into mild and severe retinopathy corresponds and how well this new examination method is accepted by the patients.

as part of the study, a 45-degree fundus image is taken for each eye and patient using the 'crystalvue nfc 600'. the fundus photographs are then analyzed using the 'mona-dr-mode'l and classified as "diabetic retinopathy according to ai present (k+)" or "diabetic retinopathy according to ai absent (k-)". these classifications are compared with the results ("diabetic retinopathy according to the doctor present (a+)" or "diabetic retinopathy according to the doctor absent (a-)") of the examinations routinely provided for in the disease management program (dmp) diabetes mellitus type 2 by resident ophthalmologists who work in the period 6 months before and after the fundus photography in the west german centre of diabetes and health (wdgz) were compared. all patients with the assessment "diabetic retinopathy according to ai present (k+)" or discrepancies with the ophthalmological dmp examination in the outpatient environment are offered a routine appointment at the marienhospital. there, an eye examination is then carried out by an ophthalmologist and, without knowledge of the previous findings, a reassessment and classification as "diabetic retinopathy according to the doctor present (a+)" or "diabetic retinopathy according to the doctor absent (a-)" is carried out by the ai.

Eligibility criteria:
inclusion criteria: * diagnosis of diabetes mellitus * diabetes duration ≥ 5 years * age \> 18 years old * patient is able to give informed consent * fluent in written and spoken german, or interpreter present exclusion criteria: * history of laser treatment * contraindication to the fundus imaging systems used in the study
stress adenosine cardiac magnetic resonance (mr) comparison with single photon emission computed tomography (spect) imaging

Conditions: Coronary Artery Disease; Cardiac Perfusion

Summary: this study is designed to determine the diagnostic value of adenosine cardiac magnetic resonance (cmr) when compared with spect. the investigators hypothesized that adenosine cmr could detect ischemia and is not inferior to spect imaging. in addition stress adenosine cardiac mri offers a "one stop shop" enabling evaluation of cardiac function, rest and stress perfusion and viability.


Eligibility criteria:
inclusion criteria: * suspected ischemia referred to spect stress imaging exclusion criteria: * standard contraindications to mri including (pacemaker/defibrillator, metallic clips on brain aneurysms, metal fragment in the eye, etc...) * congestive heart failure. * hemodynamic instability. * history of asthma or bronchospastic disease. * arrhythmia * creatinine \>1.4 * non compliant patient, not able to lie supine in the mri scanner for 1 hour. * pregnant patients * patients for whom the repeat stress might pose a significant risk.

Keywords: spect imaging stress adenosine cmr
study of obesity control by astragalus and notoginseng extrats

Conditions: Obesity

Summary: the effects of the astragalus and notoginseng extrats on obesity control was demonstrated in a randomized double-blind, and crossover human trial.

obesity refers to the body due to physiological or biochemical function of the change caused by excessive accumulation of body fat, resulting in weight gain. hence, the aim of this study was to evaluate the effects of the astragalus and notoginseng extrats on obesity control by a randomized double-blind and crossover human trial. subjects with simple obesity (body mass index (bmi) ≥ 27 or body fat ≥ 30%) ingested 5 extrats (n = 19) capsules or placebo (n = 19) perday for 12 weeks of a stage. anthropometric measurements (body weight, body fat, blood pressure) and blood biochemical markers including fasting blood glucose (fbg), albumin, total cholesterol (tc), triglyceride (tg), hdl-c, ldl-c, creatinine (cr), blood urea nitrogen (bun), ast, alt were examined every six weeks.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥ 27 or body fat ≥ 30%; * no history of serious diseases associated with heart, liver, kidney, endocrine systems or other organs; * no drugs consumption. exclusion criteria: * bmi \>35; * alcoholic; * us-controlled diabetics; * stoke in past one year; * high blood pressure; * mental diseases or melancholia; * pregency or breast-feeding a child.

Keywords: astragalus and notoginseng extrats body weight bmi triglyceride obese
high risk primitive neuroectodermal (pnet) brain tumors in childhood

Conditions: Medulloblastoma; Brain Tumors; Neuroectodermal Tumors, Primitive

Summary: the purpose of this study is to evaluate the efficacy of the combination of surgery, conventional chemotherapy, sequential high-dose chemotherapy with peripheral blood stem cell transplantation and reduced dose radiation therapy in high-risk pnet brain tumors.


Eligibility criteria:
inclusion criteria: * medulloblastoma in patients less than 5 years of age * brain pnet in patients less than 10 years of age * histologically documented diagnosis * body weight of \> 8 kg exclusion criteria: * parents' refusal

Keywords: brain pnet
effect of roux-en-y gastric bypass versus laparoscopic adjustable gastric band operations on resistin, apelin and visfatin peptides

Conditions: Morbid Obesity

Summary: this study aimed to measure, compare apelin, resistin, visfatin levels in patients underwent to rygbp, lagb and their relation with obesity.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of morbid obesity * being underwent lagb or rygbp exclusion criteria: * having prior abdominal surgery history

Keywords: visfatin resistin apelin roux-en-y gastric bypass laparoscopic adjustable gastric banding morbid obesity