Kornimate/medical-research-clean huggingface dataset:
computer-aided breast cancer detection in women undergoing screening mammography

Conditions: Breast Cancer

Summary: rationale: a computer-aided detection program may help doctors find breast cancer sooner, when it may be easier to treat, in women undergoing screening mammography. purpose: this randomized clinical trial is studying how well computer-aided breast cancer detection works in women undergoing screening mammography.

objectives: * compare, prospectively, the breast cancer detection rate and recall rate of single reading using computer-aided detection vs standard double reading in women undergoing screening mammography. outline: this is a prospective, randomized, multicenter study. participants are randomized to 1 of 3 screening arms. * arm i (double reading): screening mammograms are independently reviewed by two readers (i.e., radiologist or radiographer), each of whom reports on any abnormalities and decides whether a participant is recalled for further assessment or returned home to routine screening. in the event there is disagreement between the readers' findings, a third reader acts as an arbitrator by rendering an interpretation of the mammogram and making the final decision to recall the participant or return to routine screening. * arm ii (single reading with computer-aided detection \[cad\]): screening mammograms are reviewed initially by a single reader who reports on any abnormalities. the reader then re-examines the mammogram with the aid of cad, a system that uses computer prompts to recall suspicious features or abnormalities that may have been overlooked or previously dismissed as being normal. based on these evaluations, a recommendation is made by the reader to either recall the participant for further assessment or return home to routine screening. if there is a discrepancy between the reader's interpretation and the cad findings, another reader may be consulted to review the mammogram. * arm iii (double reading followed by single reading with cad): screening mammograms are reviewed by double reading as in arm i followed by single reading with cad as in arm ii. peer reviewed and funded or endorsed by cancer research uk projected accrual: a total of 30,000 participants will be accrued for this study.

Eligibility criteria:
disease characteristics: * currently undergoing 2-view mammography for routine breast cancer screening at any of the following participating national health services breast cancer screening program centers: * manchester * coventry * nottingham * hormone receptor status not specified patient characteristics: * female * menopausal status not specified prior concurrent therapy: * not specified

Keywords: breast cancer
short cycle therapy in art regimens containing rilpivirine: assessment of patients' satisfaction

Conditions: HIV-1-infection

Summary: with this study the investigators propose to evaluate the satisfaction of the patients receiving antiretroviral treatment for hiv infection with standard everyday scheme, compared to patients receiving the same treatment with short-cycles of 4 days a week.

the aim of this study is to evaluate the impact of sct on the quality of life of hiv infected adults by administering hiv treatment satisfaction questionnaires (hiv-tsqs) to patients receiving sct for at least 48 weeks and by comparing their answers to those of patients receiving standard 7-days-a-week art with comparable therapeutic regimens. this is an interventional study performed at the hiv outpatients clinics of the infectious and tropical diseases department in azienda ospedaliera universitaria integrata of verona (italy). during standard visits and after collecting their informed consent, the investigators will administer hiv-tsqs to 30 patients receiving 4-days-a-week of rilpivirine-containing regimens (either rilpivrine/emtricitabine/tenofovir alafenamide or rilpivirine + lamivudine/abacavir) and to 30 patients receiving the same regimens but 7-days-a-week. for the first group, the investigators will consider patients who have switched to a sct at least 48 weeks before administration of the questionnaire, and data on their viro-immunological status (hiv-rna, cd4+ cells count and cd4+/cd8+ ratio) after the switch to sct will be retrospectively collected as well.

Eligibility criteria:
inclusion criteria: * hiv-1 chronic infection; * therapy with three-drugs and standard dosage art containing rilpivirine: either rilpivirine/emtricitabine/tenofovir alafenamide (odefsey) or rilpivirine/lamivudine/abacavir; * virological suppression (vl\<50 copies/ml) for at least 12 months before switching to sct. one viral blip with vl\<200 copies/ml, followed by a second deterrmination after 30 days \<20 copies/ml is admitted; * cd4+ cells count \>200/mmc; * no evidence or history of viral resistances against nnrtis, tenofovir, emtricitabine, abacavir and lamivudine; no history of previous failures with their art regimens; * ability to provide written informed consent. exclusion criteria: * evidence or history of viral resistances against nnrtis, tenofovir, emtricitabine, abacavir and lamivudine; history of previous failures with their art regimen; * diagnosis of any opportunistic infection in the 2 weeks before enrollment; * for women, ongoing pregnancy and lactation; * history of hbv infection (positive anti-hbc antibodies, with negative anti-hbs antibodies); * therapy with experimental drugs/chemotherapy/radiotherapy in the 12 weeks before enrolment; * current abuse of drugs or alcohol.

Keywords: short-cycle therapy sct rilpivirine hivtsqs patients' satisfaction
treatment of dilated blood vessels on the cheeks with a new yellow laser and a traditional green laser

Conditions: Telangiectasia; Rosacea

Summary: the goal is to compare a novel yellow laser, based on semiconductor technology, with traditional green laser, in the treatment of cheek telangiectasias. the trial design is randomized split-face double-blinded study with 20-30 volunteers. the improvement will be assessed using a 7-point telangiectasia grading scale.

trial design: the study is a comparative randomized split-face double-blinded study without a control group. it enables a comparison between two lasers; namely the ktp laser and the investigational photolase laser. the split-face design eliminates the individual biases and the randomization eliminates the possible small variations in the symmetry of the telangiectasias on the face. the double-blinded assessment eliminates the physicians' and the subjects' subjective and objective bias. methods: the subjects will be treated with a 532-nm green ktp laser and a 585-nm yellow photolase laser; different laser on each side of a face. a total of one or two treatments will be given based on the response of the first treatment. the improvement of subjects' telangiectasia will be graded after the final treatment according to a 7-point telangiectasia grading scale (tgs) by a blinded physician using images taken with visia imaging system. the usability, reliability and treatment characteristics of photolase laser will be qualitatively assessed by the treating physicians (not blinded). objectives: the primary objective is to assess how the photolase laser compares to the ktp laser in the treatment of facial telangiectasia in terms of the treatment outcomes. the secondary objective is to assess the usability, reliability and treatment characteristics of the photolase laser from the perspective of the user.

Eligibility criteria:
inclusion criteria: * the subjects are required to be finnish speaking adults with symmetrical facial telangiectasia, volunteering to participate in the clinical trial. * the subjects have to have a fitzpatrick skin phototype i-iv. exclusion criteria: * pregnancy * lactation * hemophilic condition * fitzpatrick skin phototype v-vi * drug or alcohol abuse * subjects who are under guardianship * subjects with significant tanning less than 6 weeks prior to the treatment day. * unbalanced basic diseases, such as diabetes, heart disease, cancer etc.

Keywords: laser lasers ktp semiconductor tgs rosacea telangiectasia
midodrine as novel treatment of post-cardiopulmonary bypass vasoplegic syndrome

Conditions: Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome

Summary: vasoplegic syndrome (vs) is a common and serious complication of cardiopulmonary bypass (cpb) procedures associated with a significant increase in morbidity and mortality. vs is defined as significant hypotension, high or normal cardiac outputs, low systemic vascular resistance, low cardiac filling pressures, and vasopressor requirement despite adequate fluid resuscitation following cpb. extensive research has been performed regarding the pathophysiologic response to cpb and risk factors associated with vs. no safe and effective preventive strategy has gained widespread use. supportive care with intravenous (iv) vasopressors has thus been adopted as standard of care. the use of these medications, while effective in the majority of patients, generally necessitates close monitoring in an intensive care unit (icu) setting. these patients are subject to prolonged icu and hospital stays, as well as the potential complications of prolonged use of central venous lines (cvl) required to give these medications. recent studies suggest midodrine, a generic oral vasopressor, may accelerate the decline in iv vasopressor requirements in select icu patients. at our institution, the addition of midodrine to iv vasopressors for the treatment of vs has been observed to be effective in reducing iv vasopressor duration. no literature exists describing the use of midodrine in this patient population. the goal of this study is to investigate the novel use of midodrine in cpb surgery complicated by vs. ultimately, we hope to produce literature supporting its use that may be applied on a global scale to improve patient care


Eligibility criteria:
inclusion criteria: * post-cardiopulmonary bypass surgery * vasoplegic syndrome criteria 1. map \< 65mmhg 2. cardiac index\>/=2.4 l/min/m\^2, as determined by swan- 3. systemic vascular resistance index \</=1400 dynes s/cm\^5/m\^2 4. adequate fluid resuscitation as determined by treating critical care team * vasopressor requirement 1. norepinephrine 0.05-0.5 mcg/kg/min with/without 2. vasopressin any dose exclusion criteria: * allergy to midodrine * pregnancy * midodrine or cardiac glycoside as preadmission medication * history of orthostatic hypotension, thyrotoxicosis, or pheochromocytoma * severe organic heart disease (endocarditis, untreated congenital or rheumatic heart disease) * liver failure/cirrhosis * chronic kidney disease (gfr \<30ml/hr) * ventricular assist device implantation procedure, intra-aortic balloon pump placement, or heart transplantion * unresolved post-operative acute kidney injury (rise in serum creatinine by \>/= 0.5mg/dl from baseline * inadequate tissue oxygenation (lactate \> 2 mmol/l) * inability to take oral medications
brief assessment of impaired cognition

Conditions: Dementia

Summary: the aim is to develop and validate a new brief and accurate case-finding instrument for dementia and cognitive impairment - basic

the case-finding instrument consists of four components: a. patient-directed questions, b. supermarket fluency, c. category-cued memory test, d. informant-directed questions. the data collection was carried out at five outpatient memory clinics in denmark

Eligibility criteria:
inclusion criteria: * fluent in danish exclusion criteria: * impaired eyesight or hearing

Keywords: validation casefinding tool
physiotherapy for arthrofibrosis following knee replacement.

Conditions: Arthroplasty Complications; Fibrosis; Knee Joint Contracture

Summary: this research aims to develop an optimal physiotherapy intervention for people with arthrofibrosis (stiffness due to scar tissue) after total knee replacement (tkr). we will develop an optimal intervention by conducting: 1. a review of the evidence to identify what components could be included in the intervention, how effective they are and what outcomes have been measured by the research. 2. interviews with patients with arthrofibrosis to understand the impact it has on their life and what outcomes are important to them and interviews with healthcare professionals (hcps) to understand their experiences of treating patients with arthrofibrosis. 3. a delphi study with a larger group of hcps and patients to reach a consensus on what the optimal intervention should include. this involves a series of anonymous voting on a range of items that have been generated by the group and the results of the evidence review. 4. a workshop with patients, hcps and health-care commissioners to finalise the intervention. during the workshop we will present our findings and work in small groups to agree the intervention


Eligibility criteria:
inclusion criteria for patients: * adults (aged 18 and over) of any age who have undergone elective tkr with post- operative arthrofibrosis/stiffness who have undergone manipulation under anaesthetic (mua) in the previous 24 months or are currently listed for a mua. * ability to give informed consent exclusion criteria: * patients with neurological or blood disorders for hcp participants : * at least 5 years of experience working with joint arthroplasty including the management of patients with arthrofibrosis or 3 years in the case of orthopaedic surgeons.

Keywords: knee stiffness
transcranial alternating current stimulation (tacs) for the recovery of phonological short-term memory in patients with aphasia after stroke

Conditions: Stroke; Aphasia

Summary: this study will assess the effects of transcranial alternating current stimulation (tacs) on language recovery after stroke.

aphasia is a debilitating disorder, typically resulting from damage to the left hemisphere, that can impair a range of communication abilities, including language production and comprehension, reading, and writing. approximately 180,000 new cases of aphasia are identified per year, and approximately 1 million or 1 in 250 are living with aphasia in the united states. treatments are limited and provide modest benefits at best. the current emphasis in aphasia rehabilitation is to formulate intensive speech and language therapies and augment therapeutic benefits, potentially with brain stimulation concurrent with therapies. the current study will investigate the efficacy of high-definition tacs (hd-tacs) to help restore neural oscillatory activity in stroke survivors with aphasia. tacs differs from trancranial direct current stimulation (tdcs), a widely used brain stimulation paradigm, in that sinusoidal or alternating currents are delivered rather than direct currents. tacs is shown to manipulate ongoing oscillatory brain activity and also to modulate synchronization (or connectivity) between targeted brain areas. this feature of tacs is quite attractive, given the new body of evidence suggesting that language impairments stem from diminished brain connectivity and ensuing disruptions in the language network due to stroke. the study will employ high-definition tacs (hd-tacs) in a parallel, double-blinded, sham-controlled design combined with language therapy targeting phonological short-term memory (stm) function in stroke survivors with aphasia. magnetoencephalography (meg) and fmri bold data collection will occur to determine tacs parameters and to evaluate stimulation-induced neural changes, respectively. the investigators plan to recruit 120 stroke survivors with aphasia in a 2-group tacs study design.

Eligibility criteria:
inclusion criteria: * diagnosed with left hemisphere stroke/aphasia * consent date \>= 1 month after stroke onset * fluent in english * 18 years of age or older exclusion criteria: * severe cognitive, auditory or visual impairments that would preclude cognitive and language testing * presence of major untreated or unstable psychiatric disease * a chronic medical condition that is not treated or is unstable * the presence of cardiac stimulators or pacemakers * contraindications to mri or tacs, e.g. patients with metallic implants, and/or history of skull fractures, pregnancy, skin diseases * history of ongoing or unmanaged seizures * history of dyslexia or other developmental learning disabilities
psychological effects of a set of essential oils

Conditions: Stress; Anxiety; Well-Being, Psychological; Mood

Summary: the goal of this clinical trial is to test the effectiveness of an intervention designed to improve wellness through aromatherapy. the main question it aims to answer is whether this intervention can deliver beneficial psychological effects on stress, anxiety and mood, as well as overall well-being. participants will receive a bottle with a no/neutral odor or an essential oil (or a blend of essential oils) for home administration and will be asked to complete a series of scales pre and post self-administration twice one week apart.

the potential beneficial effects of a set of essential oils (eo) are being tested in the form of a randomized clinical trial (rct). there are five conditions: a control (receiving a neutral/no-odor stimulus) and four active groups (receiving one of the four eo). the study is a within-subjects/between-subjects design with five arms and involves comparisons between pre-intervention and post-intervention between: (a) initial psychological states of the participants, and (b) after inhalation of the stimuli. participants will be randomly allocated to one of the five experimental arms. for medium effect sizes assumed (f = 0.25), 5 groups and two measurements in time (pre and post stimulus administration) a minimum of 80 subjects total sample size is needed. affective states (relaxation, contentment, happiness, motivation, tension), as well as data on mood; depression, anxiety, and stress will be assessed. data about familiarity, pleasantness and intensity of the stimuli will also be collected.

Eligibility criteria:
inclusion criteria: * adults (at least 18 years old) exclusion criteria: * allergies to essential oils * medical conditions that could have an effect on sense of smell

Keywords: fragrances essential oils well-being psychological effects anxiety stress depression
the clinical safety of alcoholic extract sahastara remedy of extract capsule in healthy volunteers

Conditions: Osteoarthritis

Summary: the clinical safety of sahastara remedy alcoholic extract in healthy volunteers. investigators will investigate safety of 100 and 200 mg of sahastara remedy extract capsule in healthy volunteers. this is clinical trial phase i.

the sahastara remedy (sht) is a thai traditional medicine that is use to relieve pain of musculoskeletal problem. there is study shown that sht extract was not found acute and chronic toxicity in rat. however, there is no study regarding safety in human. thus, this study is a clinical trial phase i that investigate clinical safety of sht alcoholic extract in healthy volunteers. the clinical safety will monitor for 28 days in continuously use of 100 and 200 mg sht extraction 3 time a day and after stop intervention for 14 days.

Eligibility criteria:
inclusion criteria: * no pregnancy * no serious medical condition evaluated by physical examination and laboratory results in 1 month before study * no supplementary food and/or vitamin during the study * able to follow suggestion during the study exclusion criteria: * uncontrolled hypertension (bp\>140/90 mm.hg.) * bmi \> 30 * have serious medical condition including severe peptic ulcer, congestive heart disease, liver and renal dysfunction. * on during use medicine including rifampicin, phenytoin, propranolol, theophylline
primary care prevention of stimulant diversion by high school students with adhd

Conditions: ADHD

Summary: the purpose of this study is to test clinical strategies that pediatric providers may use to prevent misuse and diversion of stimulants by their adolescent patients with adhd.

this study addresses the increase in diversion (selling, sharing, loaning, or trading) of prescription stimulant medications by adolescents with attention-deficit/hyperactivity disorder (adhd). in the absence of any standardized, empirically evaluated clinical strategies or interventions to prevent or decrease stimulant diversion, this project will test the effect of a brief provider-led intervention for stimulant diversion prevention among adolescents being prescribed stimulant medication in pediatric care. the investigators hypothesize that adolescents treated in pediatric practices randomized to the intervention will report decreased diversion, increased perceived risk of harm, and decreased intentions to divert compared to adolescents treated in pediatric practices randomized to treatment-as-usual. secondary analyses will examine the effect of the intervention on additional contributing variables (e.g., patient, parent, and provider attitude and behavior change).

Eligibility criteria:
inclusion criteria: * diagnosis of adhd * treatment with stimulant medication * enrolled in or attending middle school or high school * parent/guardian willing to participate * receiving treatment at one of the 7 pediatric practices participating in the protocol exclusion criteria: * not diagnosed with adhd * not treated with stimulant medication * not enrolled or attending middle school or high school * parent/guardian unwilling to participate * not receiving treatment at one of the 7 pediatric practices participating in the protocol

Keywords: adhd stimulant misuse stimulant diversion
a study to evaluate subcutaneous zilucoplan in pediatric participants with generalized myasthenia gravis

Conditions: Generalized Myasthenia Gravis

Summary: the purpose of this study is to assess the pharmacokinetics, pharmacodynamics, safety, tolerability, immunogenicity and activity of zilucoplan (zlp) in pediatric study participants with generalized myasthenia gravis (gmg).


Eligibility criteria:
inclusion criteria: united states of america (usa) specific inclusion criterion: - participant must be 12 to \<18 years of age at the time of signing the informed consent/assent according to local regulation rest of world (row) specific inclusion criterion: - participant must be 2 to \<18 years of age at the time of signing the informed consent/assent according to local regulation global inclusion criteria: * participant has a diagnosis of generalized myasthenia gravis (gmg) confirmed by a prior positive serologic test result to acetylcholine receptor (achr) prior to screening * participant meets the criteria as defined by the myasthenia gravis foundation of america (mgfa) clinical classification ii to iv at screening * participants with gmg, including: * an mg-activities of daily living (mg-adl) total score of 6 or more in adolescents from 12 years to \<18 years of age at screening * documented weakness in at least 1 limb, neck, or bulbar muscle in children from 2 years to \<12 years of age at screening (does not apply to us) * documented vaccination against meningococcal infections within 3 years prior to study start. if not fully vaccinated, participants must receive appropriate prophylactic antibiotic treatment until at least 2 weeks after the initial dose of vaccine(s) exclusion criteria: * participant has known positive serology for muscle-specific kinase * participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the participant's ability to participate in this study * participant has had a thymectomy within 6 months prior to baseline * participant has minimal manifestation status of mg based on the clinical judgement of the investigator * current or recent systemic infection within 2 weeks prior to baseline or infection requiring intravenous antibiotics within 4 weeks prior to baseline

Keywords: ra101495 gmg generalized myasthenia gravis zilucoplan pediatric mg0014