Kornimate/medical-research-clean huggingface dataset:
a study on safety and effectiveness of long-term treatment with vamorolone in boys with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: this study aims to assess safety and effectivness of long-term treatment with vamorolone in boys with duchenne muscular dystrophy (dmd) who have completed prior studies with vamorolone.

all subjects in this study have completed previous studies with vamorolone and continued to receive vamorolone under special programs: compassionate use program \[cup\], named patient program \[npp\] or expanded access protocol \[eap\]. all subjects will continue treatment with vamorolone under guardian protocol instead. the primary objective of this study is to evaluate the safety of long-term treatment with vamorolone in boys with duchenne muscular dystrophy regarding vertebral fractures. secondary study objectives will evaluate the safety of long-term treatment with vamorolone on non-vertebral fractures, cataracts, delayed puberty, overall safety as well as ambulatory and non-ambulatory function.

Eligibility criteria:
inclusion criteria: * subject and/or subject's parent(s) or legal guardian has provided written informed consent * subject has previously completed either the vbp15-lte or vbp15-004 study, and transitioned through the compassionate use program, named patient program or expanded acess protocol * subject is on vamorolone on day of enrolment * subject and parent / legal guardian are willing and able to comply with the protocol schedule, assessments and requirements exclusion criteria: * any medical condition, which in the opinion of the investigator, would affect study participation, performance or interpretation of study assessments * vamorolone treatment discontinued for ≥ 6 months within the year prior to enrolment for a non-safety reason, or vamorolone treatment previously discontinued at any time for a safety reason * severe hepatic impairment

Keywords: duchenne vamorolone santhera long-term safety
impact of physical activity on quality of life for chronic hemodialysis patients

Conditions: Chronic Hemodialysis

Summary: chronic end-stage renal disease has a significant impact on patients' quality of life. in 2005, a study evaluating the quality of life of patients with end-stage chronic kidney disease using the sf-36 and kdqol questionnaires showed that the proportion of patients with an altered quality of life varied from 20% to 50% in the physical component dimensions and from 12% to 47% in the mental component dimensions. more than 75% of dialysis patients had at least one of the 8 scores below the threshold that defines impaired quality of life. in 2011, the quavi-rein study involved 1251 dialysis patients showed a significant reduction of quality of life assessed using the generic sf36 questionnaire compared with the general population, in the physical and mental dimensions. moreover, in france, more than one senior citizens aged between 55 and 74 in three does not comply with the world health organisation's recommendations on the minimum level of physical activity required per day. a sedentary lifestyle is a major public health problem. it is the 4thrisk factor for mortality after hypertension, smoking and diabetes. this inactivity increases mortality and morbidity rates in humans, and consequently the risk of diseases such as cancer and type 2 diabetes. physical activity is recommended for patients with chronic kidney disease. in a survey of 505 nephrologists, 97% thought that physical activity is beneficial for dialysis patients, given that a sedentary lifestyle increases the death rate among dialysis patients. data from the international dopps registry, involving 20,920 patients, showed that patients who engage in physical activity have a better quality of life (physical, psychological and sleep quality components), as assessed by the kdqol-sf questionnaire.

the main objective is to study factors associated with the quality of life of hemodialysis patients, including physical activity.

Eligibility criteria:
inclusion criteria: * hemodialysis * major * agreeing to participate in the study exclusion criteria: * on peritoneal dialysis * on daily dialysis at home * minors * protected by law (guardianship, curatorship, safeguarding of justice) * refusing to participate in the study

Keywords: quality of life chronic hemodialysis patients factors associated physical activity
collection of circulating tumor cells from the peripheral blood of metastatic breast cancer patients

Conditions: Circulating Tumor Cells (CTCs)

Summary: to address the challenges of isolating and analyzing rare cells, this study aims to validate the instrumentation, the test protocols, and the analysis of patient's outcome to show the instrument's capability to reproducibly and accurately detect ctcs in cancer patients. in order to facilitate the validation process, investigators will only focus on metastatic patients for whom ctcs supposedly present at higher abundance. investigators propose to enroll cohorts of metastatic breast cancer patients. blood samples will be collected from these patients before they start any new line of therapy as determined by their doctors. the specific aims are to isolate, enumerate and analyze the number and/or molecular information of circulating tumor cells in patient blood using microfluidic chip-based sorting, imaging, and molecular profiling techniques. investigators will use this study to optimize diagnostic instrumentation, test blood processing protocols and ctc analysis algorithm. during this study investigators will collect patients' clinical information related to cancer, as well as the patients' survival status to validate the system's prognosis ability.


Eligibility criteria:
inclusion criteria: 1. provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study. 2. progressive and measurable metastatic breast cancer. 3. commencement of new anti-cancer chemotherapy or palliative care. 4. ecog performance status equal or less than grade 2. exclusion criteria: 1. subject has received any investigational agent, not explicitly approved by micareo, within last one year. 2. subject being identified with any blood borne infectious disease. 3. subject has received anticancer chemotherapy within last one month. (not including hormone therapy, or target therapy) 4. pregnancy.

Keywords: circulating tumor cells
ocs lung system expand ii trial

Conditions: Lung Transplantation

Summary: to evaluate the safety and effectiveness of the ocs™ lung system to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.

inclusion at least one of the following: * donor pao2/fio2 ≤ 300 mmhg at the time of the offer; or * expected cross-clamp time \> 6 hours for the second lung; or * donor after cardiac death (dcd donor); or * donor age ≥ 55 years old

Eligibility criteria:
inclusion criteria: * male or female primary double lung transplant candidate * age ≥ 18 years old * signed: 1) written informed consent document and 2) authorization to use and disclose protected health information exclusion criteria: * prior solid organ or bone marrow transplant * single lung recipient * chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal dysfunction requiring dialysis * participant in any other clinical or investigational trials/programs

Keywords: portable ex-vivo lung perfusion breathing lung transplant portable ocs lung system
a phase 1 study to investigate the pharmacokinetics, safety and tolerability of cp-601,927 in healthy japanese subjects

Conditions: Healthy

Summary: this phase 1 study is the first clinical trial to be conducted in japanese subjects. the pharmacokinetics, safety and tolerability of single and multiple doses of cp-601,927 will be evaluated in japanese, healthy, non-smoking subjects.


Eligibility criteria:
inclusion criteria: * healthy male and/or female japanese subjects between the ages of 18 and 55 years, inclusive. * japanese defined as being able to document that all 4 grandparents were japanese and were born in japan. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). * females of childbearing potential. * subjects with regular (daily or weekly) use of tobacco products or nicotine currently or within the past 6 months. subjects with urine cotinine concentrations \>100 ng/ml at any time during the study will be excluded.

Keywords: phase 1 pharmacokinetics healthy japanese non-smokers major depressive disorder cp-601 927
clinical outcomes of methicillin resistant staphylococcus aureus (mrsa) hospital-based pneumonia

Conditions: Pneumonia

Summary: the purpose of this non-interventional, retrospective study of existing data is to evaluate clinical outcomes related to methicillin-resistant staphylococcus aureus hospital based pneumonia by treatment and among subpopulations.

all patients meeting inclusion/exclusion criteria from inpatient database from 1/1/02-9/30/10.

Eligibility criteria:
inclusion criteria: * mrsa and pneumonia cases by icd-9 code identification. * diagnosis included during inpatient stay. * treatment initiation in hospital. exclusion criteria: * death of discharge within 3 days of treatment initiation. * exposure to other treatments with mrsa activity.

Keywords: mrsa. pneumonia outcomes
ischemic heart disease in male with prostate adenocarcinoma

Conditions: Ischemic Heart Disease; Prostate Adenocarcinoma

Summary: the purpose of the study: to increase the efficiency of diagnosis, treatment and prediction of the course of coronary heart disease in patients with adenocarcinoma of the prostate gland, depending on the hormonal status by determining the cardiovascular risk factors, factors of angiogenesis, structural and functional state of the heart, coronary vessels, kidney damage and their pharmacological correction.

research methods: 1. general-clinical examination 2. laboratory methods: * estimation of the generally accepted laboratory parameters * determination of blood lipid profile * determination of the level of highly sensitive crp by the method of immuno-enzyme analysis, * determination of the level of proteinuria, creatinine by the method of immuno-enzyme analysis with the subsequent calculation of gfr * determination of the level of insulin by the method of immuno-enzyme analysis with the subsequent calculation of indices of insulin resistance, * determination of the level of blood testosterone by the method of immuno-enzyme analysis, * determination of the levels of vascular-endothelial growth factor, angiosetamine by the immuno-enzyme assay, 3. echo-doppler examination of vessels (endothelium-dependent vasodilatation with reactive hyperemia, determination of the thickness of cim, gpi) 4. ultrasound examination of the main vessels of the head and neck 5. ecg 6. daily monitoring of bp 7. ct-angiographic examination of coronary vessels with the definition of the index of calcification 8. statistical methods

Eligibility criteria:
inclusion criteria: * men aged 45-75 years * presence of verified diagnosis of adenocarcinoma of the prostate gland, * stable antitumor therapy for 6 months, verified diagnosis of cad, * stable cardiological therapy for the past 3 months, * voluntary informed consent to participate in the study. exclusion criteria: * age older than 75 years, * female sex, * metastatic lesion, * chronic heart failure of the iii-iv functional class (fc), * arrhythmias that cause hemodynamic impairment and require antiarrhythmic correction (including ventricular arrhythmias of high gradation, atrial flutter , paroxysmal tachycardia, sinus node weakness syndrome, 2-3-degree av block), * ami, acute cerebrovascular accident, * diabetes mellitus (insulin-dependent diabetes mellitus) with a level of nva1s\> 7%, hyperthyroidism and hypothyroidism level of tsh\> 10 md / l, chronic renal failure (gfr \<30 ml / min / 1.73 m2), * acute cardiac and renal insufficiency, * obesity 4 degrees, * cachexia.

Keywords: atherosclerosis angiogenesis cardiooncology
effectiveness of a mobile neurofeedback for adhd youth

Conditions: Attention Deficit Hyperactivity Disorder

Summary: objective: verification of adhd treatment effectiveness of mobile neurofeedback to subjects of child and youth with adhd. method: mobile neurofeedback program is implemented for 165 adhd patients aged 8 to 15 to verify their effectiveness by conducting pre-post evaluation. prior to the implementation of the intervention, we conduct a survey with demographic information, behavioral characteristics, clinical global impression, neuropsychological test, brain mri, nirs and eeg. the drug naive subjects are randomly assigned to the mobile neurofeedback group or sham control group. the subjects on medication are randomly assigned to the mobile neurofeedback group or sham control group, in addition to the medication being administered. the intervention are conducted three times a week, twice a day, and 10-20 minutes for 12 weeks, and the effectiveness is assessed four times in advance, third month, sixth month and twelfth months. however, the sham control group were provided the same machines and programs as the neurofeedback exercise, but feedback is generated randomly regardless of ectroencephalogram change of the subjects.


Eligibility criteria:
inclusion criteria: * patient between the ages of 8 and 15 * patients diagnosed with adhd in accordance with dsm-5 diagnostic criteria and k-sads-pl ③ iq 80 or higher ④ neurofeedback or sham treatment group include patients who have not received methylphenidate/atomoxetine medication in the past or who have been treated with methylphenidate less than a year and not taken methylphenidate/atomoxetine within four weeks of starting point of this study. * medication+neurofeedback or medication+sham treatment group include adhd patients undergoing methylphenidate or atomoxetine medication over the past month without changes in capacity. and adhd patients whose cgi-s scale is 4 or higher. exclusion criteria: * patients diagnosed with congenital genetic disease * patients with a clear history of acquired brain damage, such as cerebral palsy. ③ patients with convulsions, other neurological disorders, or uncorrected sensory disorders * patients with a history of schizophrenia, other childhood psychosis ⑤ iq below 80 ⑥ patient with obsessive compulsive disorder, major depression or bipolar disorder
avatr - arteriovenous access thrombosis removal with capere thrombectomy system

Conditions: Arteriovenous Graft Thrombosis

Summary: a prospective, single-arm, non-blinded study, intending to treat and collect and evaluate data in up to ten (10) human subjects who are currently being treated with hemodialysis and who present with acute thrombosis in their arteriovenous (av) grafts, treated with the capere® thrombectomy system.


Eligibility criteria:
inclusion criteria: * dialysis patients who are ≥ 18 years of age * dialysis patients with clinical signs, symptoms and presentation consistent with acute thrombosis; onset of symptoms ≤ 14 days exclusion criteria: * dialysis patients who are ≤ 18 years of age. * grafts with aneurysmal degeneration * central venous occlusion * patients with infection of the vascular access * patients with active cancer under current therapy, myeloproliferative syndromes, hyperhomocysteinemia, and heparin-induced thrombocytopenia. * patients with pulmonary embolism (pe) with hemodynamic compromise * any contraindication to systemic or therapeutic doses of heparin or anticoagulants * known anaphylactic reaction of radiographic contrast agents that cannot be pre- treated * imaging evidence or other evidence that suggests the participant is not appropriate for mechanical thrombectomy intervention (e.g. recent access site creation where there are concerns of leak or disruption of the suture line) * female who is pregnant or nursing * concurrent participation in another investigational drug or device treatment study
vietnamese women's health project iii

Conditions: Cervical Cancer

Summary: the purpose of this protocol is to understand the extent of symptom perception and preventive care-seeking among vietnamese american women and their impact on cervical cancer screening from the perspectives and experiences of key informants including primary health care providers and vietnamese american women (vaw, foreign-born and united states-born). with this information, the investigators can better understand how to promote cervical cancer screening in the vietnamese community.

no further extensive description.

Eligibility criteria:
inclusion criteria: * primary health care providers are eligible to participate in the study if they meet the following criteria: * self-identify as currently practicing as a primary licensed independent practitioner including as a medical physician or nurse practitioner, * whose service populations include vietnamese american women, * and are able to understand and speak english or vietnamese. * vietnamese american women are eligible to participate in the study if they meet the following criteria: * self-identify as a vietnamese american woman (foreign-born women who have immigrated to the united states from other countries or are united states-born), * between ages 21 to 65 years old, * have not had a hysterectomy, * and are able to understand and speak english or vietnamese. exclusion criteria: * not a vietnamese american woman * not between the ages of 21 to 65 years old * had a hysterectomy

Keywords: screening
value of uric acid as early predictor of lupus nephritis

Conditions: Uric Acid

Summary: the aim of the present work is to determine the role of uric acid as a predictor and prognostic factor in the development of lupus nephritis.

systemic lupus erythematosus (sle) is a systemic autoimmune disorder identified by the production of autoantibodies and immune complex deposition \[1\]. it presents with a variety of unpredictable flares of disease activity and irreversible organ damage \[2\]. half or more (45%-85%) of patients with sle will develop lupus nephritis (ln) over the course of their lifetime, which is a major concern \[3,4\]. despite advanced immunosuppressive therapy, the 5-year survival rate of sle patients with severe renal damage (11%-33%) is usually very low \[5\]. hence, early prediction and diagnosis of ln are of great value. so far, renal biopsy remains to be the gold standard tool for diagnosis of ln \[6\] and assumes a vital role in its management and prognosis. however, renal biopsy can have various complications including hemorrhage and infection. besides, some patients have contraindications for renal biopsy, which indicates the requirement for noninvasive markers for evaluating renal dysfunction and its grade \[7\]. - elimination of serum uric acid (sua), the circulating endproduct of purine metabolism, occurs via both renal and extrarenal (gastrointestinal tract) pathways \[8\]. kang and colleagues \[9\] have reported that elevated serum uric acid may also be a risk factor for progression of renal disease, in spite of the fact that it is considered as one of the markers of renal dysfunction. elevated serum uric acid itself can lead to kidney damage without the deposition of uric acid crystals as reported in different studies \[10\]. other studies strongly suggest to consider the concept of asymptomaticity for chronic hyperuricemia and hence to check the normal level of serum uric acid levels \[11\]. hyperuricemia can be observed in patients with diabetic nephropathy , iga nephropathy , metabolic syndrome and cardiovascular diseases \[12,13,14,15\]. in addition, a noteworthy positive relationship was detected between serum level of uric acid and new onset lupus nephritis. elevated sua has been observed as an independent risk factor for the development of ln . the correlation between sua and the degree of renal dysfunction in ln patients was previously analyzed but in a few studies as in calich and colleagues study who reported an association between lupus nephritis and high serum ua . therefore the aim of the current study was to evaluate serum uric acid level and detect if hyperuricemia can independently predict and affect prognosis of ln among sle patients.

Eligibility criteria:
inclusion criteria: * all patients fulfilled the european league against rheumatism (eular) and the american college of rheumatology (acr) exclusion criteria: * exclusion criteria were the use of diuretics, aspirin, cyclosporine, or any drugs affect level of uric acid also exlude patients with hypertension, diabetes , dyslipidemia and obesity
study to evaluate the safety of nanoxel m inj.

Conditions: Breast Cancer; Non-small Cell Lung Cancer; Prostate Cancer; Ovarian Cancer; Head and Neck Cancer; Gastric Cancer; Esophageal Cancer

Summary: study to evaluate the safety of nanoxel m inj. administration in patients.

this is a multi-center, prospective observational study to observe the incidence of adverse events under actual clinical settings to test the safety of nanoxel-m inj. administration in patients with breast cancer, non-small cell lung cancer, prostate cancer, ovarian cancer, head \& neck cancer, gastric cancer or esophageal cancer.

Eligibility criteria:
inclusion criteria: 1. adults ≥18 years old 2. patients who have signed written consent form prior to participating in the clinical trial 3. patients who are assessed as adequate to administer nanoxel m injection. exclusion criteria: 1) patients who have shown severe hypersensitivity to docetaxel and concomitant drugs

Keywords: observational study, safety, nanoxel m, docetaxel
multidimensional measurement of psychopharmacological treatment response

Conditions: Autism Spectrum Disorders; Mood Disorders; Sleep Disorders; Attention Deficit Disorders

Summary: the study examines actigraphic, observational, psychometric and associated repeated measurements obtained prior to and during psychopharmacological treatment.

baseline actigraphic measurements, multi-symptom operationally defined observations and psychometric data will be established and repeated to measure treatment response. additional biological and biometric measures that have potential to further characterize the cohorts under study or treatment response will be collected as practical and when possible.

Eligibility criteria:
inclusion criteria: * diagnosis of: * autism spectrum disorder * mood disorder * attention deficit hyperactivity disorder * unaffected first degree relative of study subject * anticipation of pharmacological intervention or current pharmacological intervention exclusion criteria: inability to wear an actigraphy watch

Keywords: circadian disorders autism spectrum disorders mood disorders executive functioning pediatric mood disorders