Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of aclidinium bromide for treatment of moderate to severe chronic obstructive pulmonary disease (copd) (las-md-33)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive pulmonary disease. the study will be 16 weeks in duration; 2-week run-in period, 12-week double-blind treatment, and 2-week follow-up phone visit.


Eligibility criteria:
inclusion criteria: * a diagnosis of stable moderate to severe copd as defined by the global initiative for chronic obstructive lung disease (gold) guidelines, 2009; postbronchodilator fev1/fvc \< 70%, and postbronchodilator fev1 ≥ 30% and \< 80% predicted * current or former cigarette smokers exclusion criteria: * patients who have been hospitalized for an acute copd exacerbation within 3 months before the first visit * respiratory tract infection or copd exacerbation in the 6 weeks before visit 1 * patient with any clinically significant respiratory conditions other than copd, cardiovascular conditions or mental illness * history or presence of asthma verified from medical records * chronic use of oxygen therapy greater than or equal to 15 hours per day * patient with uncontrolled infection due to hiv and/or active hepatitis * patients with a history of hypersensitivity reaction to inhaled anticholinergics * patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.

Keywords: copd chronic obstructive pulmonary disease chronic bronchitis emphysema airflow obstruction, chronic chronic airflow obstruction chronic obstructive airway disease chronic obstructive lung disease
effect of ultrasound therapy on bilateral masseter myalgia: comparison of 1 megahertz versus 3 megahertz

Conditions: Adult Females; Bilateral Masseter Myalgia

Summary: temporomandibular disorders (tmd) are a group of musculoskeletal and neuromuscular conditions that involve the temporomandibular joints, the masticatory muscles, and all associated tissues. these disorders are characterized by regional pain and limitation of mandibular range of motion. pain-related tmd affects approximately 5% to 12% of the population and can affect individual's quality of life. the incidence is about 4 percent. therapeutic ultrasound is a type of physical therapy that delivers energy via propagation of ultrasonic waves. one gap in knowledge is whether 1 megahertz (mhz) treating frequency has the same efficacy as treating with 3 mhz. this research proposes to test that.

see brief summary.

Eligibility criteria:
inclusion criteria: * adult females * bilateral myalgia based on diagnostic criteria for tmd (dc-tmd) criteria * an average pain of 5 or more on a 0 to 10 scale over the last 30 days. exclusion criteria: * a history or diagnosis of systemic musculoskeletal disorders or rheumatologic diseases (e.g. fibromyalgia, muscular atrophy). * certain conditions such as neoplasms or fractures. * neuropathies or neurological disorders. * currently taking muscle relaxants or analgesics. * undergone any form of physical therapy within the last 60 days. * severe bruxism requiring mouth-guard treatment.

Keywords: temporomandibular disorders masseter myalgia adult female
prevalence of multidrug resistant micro-organism carriage in patients undergoing an ercp in four different countries

Conditions: Drug Resistance, Multiple, Bacterial; Cholangiopancreatography, Endoscopic Retrograde

Summary: the duodenoscopes currently used for endoscopic retrograde cholangio - and pancreaticography (ercp) examinations are reusable and are therefore washed and disinfected after each use. despite this, these endoscopes sometimes remain contaminated with bacteria. several reports of outbreaks linked to contaminated duodenoscopes have been published worldwide. recently, the food and drug administration (fda) advised manufacturers and health care professionals to transition away from fixed endcap duodenoscopes and instead focus more on the use of duodenoscopes with disposable components or fully disposable duodenoscopes. single-use endoscopes have been developed, but they are not yet widely used, partly because of the extra costs that these endoscopes add to the examination. a possible interim solution, is to only use these disposable endoscopes in patients who carry multi-resistant bacteria in order to prevent the spread of these bacteria. for this, it is important to know how many people who undergo an ercp carry multi-resistant bacteria. the primary objective of this study is to measure the prevalence of multi-resistant bacteria in patients undergoing ercp in four different countries: india, the netherlands, italy and the united states. in the netherlands, some secondary outcomes will be investigated with regard to the prevalence of duodenoscope contamination, the risk of bacterial transmission via a contaminated duodenoscope and the presence of multi-resistant bacteria in the duodenum.


Eligibility criteria:
inclusion criteria: * the subject is planned to undergo an ercp procedure, either through an outpatient department or an inpatient department * the subject is capable to understand the information required to give informed consent exclusion criteria: * in case the inclusion criteria were not met

Keywords: cholangiopancreatography, endoscopic retrograde drug resistance, multiple, bacterial equipment contamination duodenoscope associated infection
the transcriptomic study of thai patients with atopic dermatitis by tape strips

Conditions: Atopic Dermatitis

Summary: this study will be use the tape strip technique to evaluate the skin biomarkers of atopic dermatitis among thai patients to differentiate clinical phenotype.

the patients will be enrolled in this study if they have been diagnosed with atopic dermatitis. all participants (ad patients and controls) will be evaluated their skin biomarkers by using tape stripping. the tape strips will be applied to the antecubital fossa to collect the epithelial samples. then rna was extracted from the tape strips for mrna profiling to identify the immune and epidermal barrier genes.

Eligibility criteria:
inclusion criteria: * children (age 1-18 years old) with mild atopic dermatitis * children (age 1-18 years old) with moderate to severe atopic dermatitis * children (age 1-18 years old) with moderate to severe atopic dermatitis and food allergy * adult (age 18-60 years old) with atopic dermatitis * healthy individuals (1-60 years old) * patients with asthma (1-60 years old) exclusion criteria: * active skin infections * used systemic immunosuppressants within 4 weeks * used topical steroids or immunomodulators within 1 week * used moisturizers within 12 hours before evaluation

Keywords: tape strips endotype
evaluation of a standardised orientation and mobility training in older adults with low vision

Conditions: Low Vision; Aged

Summary: the purpose of this study is: 1. to develop a standardised orientation and mobility training (o\&m-training) in the use of an identification/symbol cane by older adults with low vision, and; 2. to evaluate this newly developed standardised o\&m-training with respect to effectiveness and feasibility in a randomised controlled trial.


Eligibility criteria:
inclusion criteria: * aged 55 years or over * low vision * living independently in the community or in a home for older people * able to see large obstacles and to go outside for a short walk or doing groceries * one of the following: 1. experiencing difficulties with safely crossing a street 2. experiencing difficulties with recognising acquaintances outdoors 3. willing to become recognisable as being partially sighted by using the identification cane * written informed consent * orientation and mobility training (o\&m-training) in the use of an identification cane exclusion criteria: * cognitive impairment (a score of less than 4 on the abbreviated mental test 4) * language or hearing problems that impede completing an interview by telephone * confinement to bed or possible nursing home admission that impede completion of the o\&m-training * permanent use of a walking aid incompatible with the use of an identification cane * having recently received an o\&m-training in the use of an identification cane and permanent use of this cane

Keywords: low vision ophthalmology randomised controlled trial mobility orientation cane aged
forodesine hydrochloride (bcx-1777) for b-cell acute lymphoblastic leukemia

Conditions: B-cell Acute Lymphoblastic Leukemia

Summary: a phase i/ii, multi-center, open-label, repeat-dose study of forodesine hydrochloride infusion in patients with b-cell acute lymphoblastic leukemia with an option of extended use of forodesine hydrochloride


Eligibility criteria:
inclusion criteria: * documented b-cell acute lymphoblastic leukemia (b-all), which under who guidelines is now referred to as precursor b-lymphoblastic leukemia/lymphoma * must have failed at least 1 treatment regimen for b-all, which under who guidelines is now referred to as precursor b-lymphoblastic leukemia/lymphoma * performance status of ≤2 by eastern cooperative oncology group (ecog) criteria * any age is allowed * life expectancy of at least 3 months * adequate liver function (aspartate transaminase \[ast\] and/or alanine transaminase \[alt\] not \>3 times upper limits of normal \[uln\]) * adequate kidney function (calculated creatinine clearance \>40 ml/min) * negative serum or urine pregnancy test within 2 to 7 days prior to the start of study treatment in females of childbearing potential * females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study in such a manner that the risk of pregnancy is minimized. acceptable contraceptives include intra-uterine devices (iuds), hormonal contraceptives (oral, depot, patch, or injectable) and double barrier methods such as condoms or diaphragms with spermicidal gel or foam. * signed informed consent form (icf), minor assent form (if applicable), prior to start of any study-specific procedures exclusion criteria: * active serious infection not controlled by oral or intravenous antibiotics * treatment with any investigational antileukemic agent or chemotherapy agent in the last 7 days prior to study entry and lack of full recovery from side effects due to prior therapy independent of when that therapy was given * rapidly progressive disease with compromised organ function judged to be life-threatening by the investigator * patients with clinical evidence of active central nervous system (cns) disease * concurrent treatment with other anticancer agents * pregnant and/or lactating female * patients with known human immunodeficiency virus (hiv) infection hiv testing will be performed at the screening visit for patients who have not been tested within 6 months of receiving study drug, as well as those patients who have had exposure or have been transfused with blood products that were not appropriately screened. * patients with known active hepatitis b and/or hepatitis c infection hepatitis testing will be performed at the screening visit for patients who have not been tested within 6 months of receiving study drug, as well as those patients who have had exposure or have been transfused with blood products that were not appropriately screened. * hypersensitive or intolerant to any component of the study drug formulation

Keywords: b-cell leukemia b-lymphoblastic leukemia lymphoma b-all
heartfulness meditation to improve resilience among health care students: a 90 day program

Conditions: Mental Health Wellness 1; Stress, Psychological; Depression; Anxiety

Summary: this investigation will examine the feasibility of delivery and effect on resilience, depression and anxiety of a 90-day heartfulness practice delivered virtually for health care students. it is hypothesized that by providing this program on-line, students will be able to attend easily and complete the sessions. it is also hypothesized that those students who participate in the meditation program will increase resilience.

this investigation will examine the feasibility of delivery and effect on resilience, depression and anxiety of a 90-day heartfulness practice delivered virtually for health care students. specific aims (sa) sa1: determine feasibility and acceptability of delivering the 90-day heartfulness meditation program virtually. feasibility will be assessed by participant compliance, retention, and acceptability to the participants. criteria: feasibility will be achieved by compliance with average of at least 3 trainer led meditations / week retention of 75% of participants at the end of 45 days (intermediate point) and 90 days (primary end point). criterion: acceptability will be indicated by a csq8 score \> 17. sa2: examine the benefits of heartfulness meditation on improving resilience, decreasing depression, and decreasing anxiety of health care students. h2: at the end of 90 days (primary end point), students who participate in the heartfulness resilience training (heart) will have better resilience (cd-risc) compared with students who do not participate and will have less anxiety and depression (hads). sa3: examine the association between the number of sessions completed and changes in resilience, depression, and anxiety at 45 and 90 (primary end point) days. h3: changes in resilience, depression, and anxiety will be significantly correlated (pearson correlation coefficients) with total number of sessions completed (h3a) and with number of one-on-one sessions with a trainer (h3b).

Eligibility criteria:
inclusion criteria: * men and women ages 20-70 * student in one of the health care programs on the anschutz medical campus at the university of colorado. exclusion criteria: * students who are currently engaged in any formal meditation practice (e.g., transcendental meditation, mindfulness based stress reduction, (mbsr) more than once per week * unable to use the technology without special accommodations.

Keywords: resiliency meditation health care student heartfulness
quetiapine extended release depression symptoms

Conditions: Schizophrenia; Depression

Summary: aim of the study is to assess if the new compound seroquel xr™ is non-inferior to risperidone, considered as the reference drug for the treatment of depressive symptoms of schizophrenia. please note: seroquel sr and seroquel xr refer to the same formulation. the sr designation was changed to xr after consultation with fda.


Eligibility criteria:
inclusion criteria: * provision of written informed consent * patients who satisfy the criteria for diagnosis of schizophrenia or schizoaffective disorder according to dsm-ivtr * baseline depressive symptoms, assessed by means of ham-d (21-item) score ≥20, and ham-d item 1 score ≥2 exclusion criteria: * any dsm-iv axis i disorder other than schizophrenia and schizoaffective disorder * patients treated with depot antipsychotic medications within 1 dosing interval before day 0; patients treated with other ap oral medications during the trial except for the switch period * use of clozapine within 28 days prior to enrollment or clozapine non responders * any significant clinical disorder that, in the opinion of the investigator, made the subject unsuitable to be given treatment with an investigational drug * an absolute neutrophil count (anc) of ≤1.5 x 109 per liter * patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.

Keywords: schizophrenia depression quetiapine
exploration of the utility of dental-dedicated mri for dentistry

Conditions: Dental Crowding; Dental Occlusion, Traumatic; Dental Pain; TMD/Orofacial Pain; TMD; Orthodontics; Endodontic Disease; Orthodontic Treatment

Summary: this description observational research is comparative in design, that is comparing existing standard clinical dental images, not obtained in this study, to test (i.e., ddmri) images. the standard clinical dental images consist of radiographs, such as bitewings, periapical, panoramic, cone-beam ct, and medical ct, as well medical mris of the temporomandibular joints (tmj).the conceptualization of research questions, study designing, and interpretation of imaging data has and will involve content expertise in all ddmri research.

patients recruited from dental clinics at the university of minnesota school of dentistry will be screened for eligibility and asked to complete an mri safety screening questionnaire. eligible individuals will be invited to participate in at least one study visit, during which an mri scan will be performed. at the end of the session, participants will complete a short questionnaire about their experience during the scan.

Eligibility criteria:
inclusion criteria: 1. patient age: 18 years old or older 2. receiving imaging for routine dental care 3. does not have a serious medical condition 4. is not pregnant or is not potentially pregnant 5. is willing and able to give consent in english 6. has the ability to manage their own calendar and schedule appointments 7. willing to have a separate 2-hour appointment to have an mri exclusion criteria: 1. unable to consent to participant in english 2. serious health condition, which includes but not limited to renal failure/on dialysis, unstable heart disease (uncontrolled arrhythmia, cardiomyopathy and/or unable to lay flat, within 1 month of cardiac catheterization or myocardial infarction), unstable cerebral vascular disease (within 1 month of stroke and/or stent placement), diabetes (type i or ii) not controlled by medication or diet, uncontrolled seizures, uncontrolled hyperthyroidism, non-allergic bronchospasm (chronic obstructive pulmonary disease and emphysema), uncontrolled movement disorder, and liver failure 3. pregnant and/or intending to become pregnant, 4. prisoner and/or not able to manage their own scheduling 5. screen positive on mr safety questionnaire, specifically including people that have worked with or otherwise been exposure to metal particles and have the potential for such particles to be embed within them.

Keywords: diagnosis magnetic resounance imaging
study comparing reduced versus standard dose post-transplantation cyclophosphamide in combination with post-engraftment anti-thymoglobin as graft versus host disease prophylaxis in alternative donor peripheral stem cell transplantation

Conditions: Allogeneic Hematopoietic Cell Transplant; Graft Versus Host Disease

Summary: this is a multi-center randomized study to compare the reduced-dose of post-transplantation cyclophosphamide (ptcy) at 35mg.kg to standard dose at 50mg/kg combined with tacrolimus and post-engraftment low dose anti-thymoglobin (atg) as graft versus host disease (gvhd) prophylaxis in patients undergoing allogeneic stem cell transplantation from alternative donor.

this is a multi-center randomized study in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-hsct) from alternative donors (9-10/10 matched unrelated donor or haplo-identical donors). the aim is to evaluate to the efficacy and feasibly of reduced-dose of ptcy at 35mg/kg as gvhd prophylaxis. patients will be assigned to study group receiving ptcy at 35mg/kg on day +3 and +4 together with tacrolimus starting from day +5 and single dose anti-thymoglobin at 2.5mg/kg as gvhd prophylaxis or to the control group with standard dose of ptcy at 50mg/kg on day +3 and +4 with same dose of tacrolimus and atg as the study group.

Eligibility criteria:
inclusion criteria: 1. patients undergo allo-hsct with matched unrelated donor or haplo-identical donor; 2. normal organ function (creatinine clearance ≥ 50ml/min/1.73m2 or creatinine ≤2mg/d(or 177μmol/l); no hepatic abnormal (alt or ast≤2.5xn; tbil≤1.5xn); normal pulmonary function (fev1、 fvc、dlco≥80%); normal cardiac function (efs ≥50%); 3. ecog: 0-2; 4. life expectation ≥3 months; 5. informed consent provided. exclusion criteria: 1. pregnancies 2. active hepatitis (hbv-dna≥1×103 copies/ml); 3. active infection require anti-biotics; 4. hiv infection

Keywords: post-transplantation cyclophosphamide prophylaxis reduced dose graft versus host disease
partnership-based nursing practice for lung patients and their families

Conditions: Chronic Obstructive Pulmonary Disease; Family; Chronic Disease

Summary: this study aims to describe and measure the effectiveness of partnership-based nursing care for people with chronic obstructive pulmonary disease (copd) and their families. investigators hypothesize that an holistic, inclusive -taking account of the challenge of multi-morbidity and the long-term relationship that patients with copd and their families have with the nurses along with the open structure of whatever kind of services is needed in each patient-family case, often in interdisciplinary and inter-institutional collaboration- , is beneficial as regards use of healthcare, health characteristics, hrql, use of inhaler medications, sense of security in care and illness intrusiveness.

growing number of people with chronic lung diseases, particularly chronic obstructive pulmonary disease (copd), and the wide ranging burden that the disease induces to individuals, families and societies, has spurred concerted efforts to develop new healthcare for these people. outpatient clinics are receiving increasing recognition, particularly those managed by nurses. an out-patient nursing clinic based on theoretical premises of partnership as practice has been established at landspitali university hospital. initial research has shown effectiveness of the practice on the use of healthcare, health status, health related quality of life as well as increased capacity of families to live a meaningful life with the disease. there is a need to substantiate knowledge of the effectiveness of the partnership-based practice by focusing on use of healthcare resources, health and the experience of patients and families, as well as developing educational material for nurses. investigators hypothesize that the holistic, inclusive -taking account of the challenge of multi-morbidity and the long-term relationship that patients with copd and their families have with the nurses along with the open structure of whatever kind of services is needed in each patient-family case, often in interdisciplinary and inter-institutional collaboration- , is beneficial as regards use of healthcare, health characteristics, hrql, use of inhaler medications, sense of security in care and illness intrusiveness. the experience of patients with copd and their families of living with the disease and receiving the care will substantiate the previously indicated variables. to this study a multi-dimensional approach is needed which includes both a holistic evaluation (qualitatively studying the experience of participants) and which measures variables prevalent in studies on self-management and palliative care (quantitative use of instruments and demographic variables).

Eligibility criteria:
inclusion criteria: * clinical icd 10 diagnosis of j40 to j44 and j96 * currently receiving the partnership-based nursing care exclusion criteria: • not speaking icelandic

Keywords: chronic obstructive pulmonary disease self-management palliative care family chronic disease nursing practice