Kornimate/medical-research-clean huggingface dataset:
a study of solanezumab (ly2062430) in participants with prodromal alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal alzheimer's disease (ad).


Eligibility criteria:
inclusion criteria: * has a diagnosis by the study investigator of a clinical syndrome of cognitive impairment consistent with prodromal ad per international working group (iwg) diagnostic criteria or mild cognitive impairment (mci) due to ad per national institute on aging-alzheimer's association (nia-aa) diagnostic criteria. * scores 17-28 on montreal cognitive assessment (moca) at screening. * scores \<27 on free recall cutoff score from the free and cued selective reminding test (fcsrt) (picture version) at screening. * scores ≤4 on modified hachinski ischemia scale (mhis). * scores \>0 on the functional activities questionnaire (faq). * has a florbetapir positron emission tomography (pet) scan or cerebrospinal fluid (csf) result at screening consistent with the presence of amyloid pathology. exclusion criteria: * has had mri or computerized tomography (ct) of brain within previous 2 years showing pathology that would be inconsistent with a diagnosis of ad. * has known allergy to humanized monoclonal antibodies. * has an ongoing clinically significant laboratory abnormality, as determined by the investigator. * has screening mri with results showing \>4 amyloid related imaging abnormalities h (aria-h) micro-hemorrhages or presence of aria-e. * has any contraindications for mri studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with mri. * has received treatment with a stable dose of an acetylcholinesterase (achei) inhibitor or memantine for less than 2 months before randomization. (if a participant has recently stopped acheis and/or memantine, he or she must have discontinued treatment at least 2 months before randomization.)

Keywords: anti-amyloid monoclonal antibody
observational,prospective study to develop and validate a prognostic tool to optimize therapy in patients with hcv g1/4

Conditions: Hepatitis C, Chronic

Summary: primary objective: • develop and validate a tool towards patients with chronic hepatitis c genotype 1 and 4 to allow optimize treatment.

this tool: 1. predicting the overall impact of prognostic factors (including the new factor of genetic polymorphism of the il28b) on sustained viral response (svr). 2. identify those patients most likely to respond. 3. therapy and therefore optimize resources the validation tool will check into clinical practice its predictive power (it will consider its ability to calibrate and discriminate) and make correct inferences and interpretations of the scores obtained when applying.

Eligibility criteria:
inclusion criteria: * patients with \> 18 years old. * patients diagnosed with chronic hepatitis c in the presence of hcv rna in plasma that meet criteria for initiating antiviral therapy in routine clinical practice conditions. * patients genotype 1 and 4. * patients with the results of all the factors evaluable at the time of inclusion. * patients who have accepted their participation in the study through informed consent. exclusion criteria: * patients previously treated with interferon (ifn) and ribavirin (rbv). * patients with genotype 2, 3, 5 and 6. * patients with co-infection with hepatitis b. * patients with other liver diseases. * patients with any contraindications to the drugs used in the treatment of hepatitis c.
physiological effects ketone ester in heart

Conditions: Heart Failure

Summary: the study is aimed to phenotype with cardiac mri the physiological effects of ketone esters on the heart. patients with heart failure will be recruited and given ketone esters or placebo in a randomized fashion. cardiac mri will be performed at baseline and after 12weeks follow up.


Eligibility criteria:
inclusion criteria: * heart failure ef \< 40% exclusion criteria: * claustrophobia * contraindicated implanted device
physiotherapy led community intervention for older adults discharged from the emergency department

Conditions: Old Age; Debility; Health Services for the Aged

Summary: ed plus emergency department discharge physiotherapy led community service is a pilot feasibility randomized controlled trial investigating the role of an integrated care intervention consisting of comprehensive geriatrics assessment in older adults in the emergency department and a physiotherapy-led community based intervention.

all patients who are aged 65 years and over will be screened using the identification of seniors at risk (isar) tool in the emergency department of a university teaching hospital. those with a score of 2 or above in the isar and suitable for discharge home will be randomised. the first treatment arm will undergo geriatric medicine item directed comprehensive geriatric assessment (cga) from admission to emergency department (ed). the non-treatment arm will under usual patient care. the second treatment arm will undergo geriatric medicine team directed cga from admission to ed and a physiotherapy led community based 6 week intervention in the patient's home. a dedicated multidisciplinary team of geriatric medicine trainee, occupational therapist, physiotherapist and medical social worker will carry out the assessment. for those randomised to the second treatment arm, a physiotherapist will assess and carry out a 6 week interventions that arise from that assessment and liaise with the patients general practitioner (gp), medical social worker and other health care professionals. the overall aims of ed plus are assess the feasibility of the 6 week physiotherapy led intervention. feasibility will be determined by the following outcomes: i) recruitment rate ii) adherence rate iii) acceptability of the programme iv) retention v) incidents the secondary aims are to improve function, reduce anxiety and depression, improve quality of life and prevent unnecessary ed admission.

Eligibility criteria:
the inclusion criteria for participants include: * adults aged ≥65 years with undifferentiated medical complaints presenting to an ed. * medically stable as deemed by the treating physician * display a score of ≥2 on the identification of seniors at risk (isar) screening tool. * be community dwelling * be discharged from the ed within 72 hours of index visit. exclusion criteria include: * individuals under the age of 65 years. * have a score of less than 2 on the isar. * older adults who present with acute myocardial infarction, stroke or non-medical problems e.g. surgical or psychiatric issues. * older adults who are medically unstable will be excluded. * if neither the patient nor carer can communicate in english sufficiently to complete consent or baseline assessment, they will be excluded. * older adults who are admitted to hospital from the ed will be excluded. * older adults who have a confirmed covid 19 diagnosis or those with symptoms highly suggestive of covid 19 will be excluded.

Keywords: older adults geriatric medicine integrated care emergency department feasibility
efficacy testing of a culturally relevant stigma intervention with wlwh in tanzania

Conditions: HIV; Stigma, Social; Self Efficacy; Self Esteem; Hope; Depressive Symptoms

Summary: this study will test a stigma reduction intervention with women living with hiv in tanzania.

this study will test a culturally and linguistically relevant stigma reduction intervention, labda siku moja, among women living with hiv in tanzania.

Eligibility criteria:
inclusion criteria: the inclusion criteria for this study are: * (1) women who are living with hiv; * (2) age 18 (age of adulthood as defined by the tanzanian government); * (3) able and willing to voluntarily consent to participate in the study; * (4) able to travel to a data collection in their local community (as described above); * (5) demonstrate mental competence at time of informed consent; * (6) verbally indicate that they plan to reside in their current community for at least 6 months after enrollment (necessary to prevent attrition); * (7) score at the median or higher level on the swahili version of the multidimensional measure of internalized hiv stigma scale. exclusion criteria: * (1) any acute psychological or physiological distress; if there is evidence of acute psychologic and/or physiologic, they will be excluded from this study and referred to an appropriate site for evaluation and treatment. * (2) transgender women living with hiv will not be eligible to participate in this study to reduce the potential for confounding sources of stigma recognizing that a transgender identity is highly stigmatized and culturally sensitive in tanzania. further, it would be exceedingly difficult to recruit a sufficient sample of transgender women living with hiv to conduct an appropriate analysis. * (3) participants may be enrolled in other hiv-related studies except cognitive-behavioral intervention studies addressing stigma, self-efficacy, self-esteem, and/or disclosure

Keywords: hiv women living with hiv clinical trial tanzania efficacy feasibility
mantra meditation in subjects that have chronically impaired attention after stroke

Conditions: Stroke Sequelae

Summary: there is an evidence gap on whether meditation may improve behaviorally measured attention after stroke, but preliminary research is promising. this study is the first-ever investigation of whether mantra meditation may improve chronic, severe impairment in attention after stroke.

the study is non-concurrent, multiple-baseline, across-subjects, single-case research design (scrd). the central hypothesis is that mantra meditation (independent variable) will be associated with improvement on 1 or more tests of behaviorally measured sustained attention (dependent variable). the mantra in this study is the syllable "um" and is not assigned any spiritual, religious, or affective meaning. the mantra is repeated aloud together by the subject and the pi for a duration of 30 minutes in each session. this procedure constitutes meditation for the purposes of this study. there are 9 session of meditation (3 times per week for 3 weeks). attention is measured in each of these sessions as well as in 3 separate testing sessions that precede the intervention period.

Eligibility criteria:
inclusion criteria. 1. adults between the ages of 18 and 70 2. chronic, non-lacunar, right-hemisphere stroke (i.e., sustained at \>12 months prior to date of clinical screen) 3. severely impaired attention defined as 5 or more errors of commission on the sartfixed 4. intact consent capacity with no evidence of dementia, defined as a score of 100% correct answer rate on university of california, san diego brief assessment of capacity to consent (ubacc). 5. right-handed dominance as well as sufficient movement and vision function for testing (use of computer mouse, keyboard, and monitor) 6. english language fluency and reading comprehension at least at 6th grade level exclusion criteria. 1. depression defined as a score of \>10 on beck depression inventory, short form (bdi-sf) 2. current or significant history of substance abuse 3. in the 3 months preceding enrollment, change in medications that impact neuroplasticity 4. current participation in any other research study, cognitive rehabilitation, meditation, or mental training program, including commercial brain-training programs 5. neurological disorder other than stroke (e.g., parkinson's disorder; multiple sclerosis; traumatic brain injury) 6. spatial attention deficit (unilateral neglect) defined as a score of 51 or fewer cancellations on the star cancellation test. 7. according to the clinical judgement of the pi or her authorized designee, any other functional impairment which would significantly deter comprehension and/or execution of the requirements of the trial, such as aphasia, hearing deficit, or mobility deficit restricting navigation to, from, and within the research site. subjects must be able to provide their own transportation to and from the study site. 8. uncontrolled or severe mental or cognitive disorder with low psychosocial functioning, such as untreated schizophrenia, bipolar disorder, or autism

Keywords: stroke
effects of wearing a face mask during crossfit exercise

Conditions: Dyspnea

Summary: face masks are important for prevention of transmission and contracting viruses such as covid-19. gymnasiums have been identified as being susceptible to virus transmission; therefore, wearing face masks during exercise is important during pandemics. this study will evaluate performance and physiological stress during high-intensity exercise while wearing a face mask during crossfit exercise training.

face masks are important for prevention of transmission and contracting viruses such as covid-19. gymnasiums have been identified as being susceptible to virus transmission; therefore, wearing face masks during exercise is important during pandemics. this study will evaluate performance and physiological stress during high-intensity exercise while wearing a face mask during crossfit exercise training. twenty-four men and women will be randomly assigned to perform exercise during crossfit exercise while wearing or not wearing a surgical face mask in a cross-over study. two types of exercise sessions will be assessed: a high intensity interval session and a continuous exercise session. there will therefore be four exercise sessions evaluated in our randomized cross-over design: 1) high intensity exercise while wearing a face mask; 2) high intensity exercise with no face mask; 3) continuous exercise while wearing a face mask; 4) continuous exercise with no face mask. outcome variables to be assessed include exercise performance during the sessions (total repetitions for pull-ups, push-ups, and squats during continuous exercise and total repetitions for box jumps during high-intensity exercise). heart rate, rating of perceived exertion, and dyspnea will also be assessed throughout the exercise sessions.

Eligibility criteria:
inclusion criteria: * experienced with crossfit exercise training exclusion criteria: * contra-indications to exercise as identified by a screening questionnaire (the "get active questionnaire")
modified t-stenting with szabo technique versus t-stenting for bifurcation lesions in coronary heart diseases

Conditions: Coronary Artery Disease

Summary: the study will compare clinical outcomes of modified t-stenting with szabo technique with t-stenting for bifurcation lesions in coronary heart diseases.

accurate deployment of stents in ostial lesions is difficult with traditional angiographic guidance. szabo technique, which used a second angioplasty guide wire to anchor the stent by passing the proximal end of the anchor wire through the last cell of the stent, demonstrated accurate placement of the stents in ostial locations. in bifurcation lesions, 2-stent strategy positioning with szabo technique was not investigated. modified t-stenting with szabo technique may improve prognosis of bifurcation lesions through reducing stents overlap. there is no clinical trial focuses on the effect and outcome of szabo technique for coronary artery bifurcation lesions in contrast with conventional strategy. in this study, the authors choose the closest 2-stent strategy, t-stenting, as control. we hope to determine whether a planned szabo 2-stent technique is superior to t-stenting for patients with bifurcation lesions. patients with bifurcation lesions will be randomly assigned to receive szabo 2-stent technique or t-stenting strategy. clinical outcomes and imaging assessment will be used to estimate their effects.

Eligibility criteria:
inclusion criteria: * patient must be at least ≥18 years of age. * lesions are eligible for percutaneous coronary intervention (pci). * patient has stable/unstable angina or myocardial infarction (mi). * bifurcation lesions (medina 1,1,1/0,1,1/1,0,1) without left main ostial lesions. * downstream lesions could be covered by two stents. * diameter of vessel ≥2.25mm * diameter stenosis in main vessel and side branch ≥ 50% by visual estimation. exclusion criteria: * severe tortuosity or calcification affected procedural success. * patient was allergic to the study stent or protocol-required concomitant medications. * patient is intolerable to dual anti-platelet therapy. * patient has any other serious medical illness that may reduce life expectancy to\<12 months. * patient is a woman who is pregnant or nursing. * patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation. * patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure. * coronary restenosis.

Keywords: bifurcation lesion percutaneous coronary intervention szabo t-stenting
a study for aggressive adult t-cell leukemia-lymphoma (atll)

Conditions: Adult T-cell Leukemia; Lymphoma

Summary: to test the superiority of vcap-amp-vecp regimen over biweekly-chop in aggressive atll in terms of survival benefit.

nothing to describe.

Eligibility criteria:
inclusion criteria: 1. diagnosis of atl was made based on seropositivity for htlv-i by either enzyme-linked immunosorbent assay or particle agglutination assay, and histologically- and/or cytologically-proven peripheral t-cell malignancy 2. aggressive atl, i.e., acute-, lymphoma- or unfavorable chronic-type atl 3. aged 15-69 years 4. no prior chemotherapy or radiotherapy 5. eastern cooperative oncology group (ecog) performance status (ps) 0-3 or 4 as a result of hypercalcemia 6. preserved organ (bone marrow, liver, kidney, heart and lung) functions 7. all patients were required to provide written informed consent exclusion criteria: 1. diabetes mellitus necessitating treatment with insulin 2. active systemic infection 3. cardiac disorders expected to become worse as a result of the dox-containing regimen 4. acute hepatitis, chronic hepatitis or liver cirrhosis 5. positive for hbs ag or anti-hcv ab 6. active concurrent malignancy 7. other serious medical or psychiatric conditions 8. pregnancy or breast feeding 9. central nervous system involvement by atl cells

Keywords: atll chemotherapy phase iii study vcap-amp-vecp biweekly-chop
a study comparing tazarotene cream 0.05% to tazorac® (tazarotene) cream 0.05% and both to a placebo control in the treatment of plaque psoriasis

Conditions: Plaque Psoriasis

Summary: a multi-center, double-blind, randomized, vehicle-controlled, parallel-group study comparing tazarotene cream 0.05% to tazorac® (tazarotene) cream 0.05% and both active treatments to a vehicle control in the treatment of stable plaque psoriasis


Eligibility criteria:
inclusion criteria: * have a definite clinical diagnosis of stable (at least 6 months) plaque psoriasis, involving at least 2% and no more than 20% of the body surface area (bsa) (not including the scalp and intertriginous areas) * have a minimum plaque elevation at the target lesion site of at least moderate severity (grade ≥ 3 on the psoriasis area severity index \[pasi\]). the most severe lesion at baseline should be identified as the target lesion * have an investigator's global assessment (iga) of disease severity of at least moderate (score ≥ 3) as an overall assessment of all lesions to be treated. exclusion criteria: * a female subject who is pregnant, nursing, planning a pregnancy, or does not agree to use an acceptable form of birth control within the study participation period * have a current diagnosis of unstable forms of psoriasis in the treatment area, including pustular, guttate, exfoliative or erythrodermic psoriasis * have a history of psoriasis unresponsive to topical treatments
multicenter cross sectional study of primary intestine lymphoma

Conditions: Non-Hodgkin Lymphoma of Intestine

Summary: the purpose of this study is to determine whether whether surgical resection followed by chemotherapy is superior to systemic chemotherapy alone in terms of treatment outcome and quality of life (qol) in patients with primary intestinal lymphoma.

intestine is the one of commonly involved extranodal sites of non-hodgkin's lymphoma (nhl). thus, small and large intestine account for approximately 30-40% of primary gastrointestinal tract lymphoma. more than 70% of intestinal lymphoma presents as localized disease, and surgery such as bowel resection is performed in many patients with intestinal lymphoma for diagnosis and treatment. however, it is still unclear whether surgical resection followed by chemotherapy is superior to systemic chemotherapy alone in terms of treatment outcome and quality of life (qol). thus, we analyze the clinical features and treatment outcome of patients with nhl of intestine, and at the same time perform a multicenter cross-sectional study about the qol in survivors of intestine nhl. we evaluates the treatment outcomes of patients with intestine nhl from hospitals affiliated with the consortium for improving survival of lymphoma (cisl) in korea. we assess the qol of survivors who completed their treatment using the eortc qlq-c30 questionnaire.

Eligibility criteria:
inclusion criteria: * primary intestine lymphoma. definition of primary intestine lymphoma: 1. dominant site should be small and large intestine with or without regional lymph node involvement 2. distant lymph node involvement can be allowed if the intestine lesion is the presenting site 3. contiguous involvement of other organs such as liver, spleen can be allowed exclusion criteria: * intestine involvement as a dissemination process in stage iv nodal lymphoma

Keywords: lymphoma, intestine, outcome, quality of life
prediction of cardiovascular events in vulnerable patients following acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the purpose of this study is to determine if testing patients for endothelial dysfunction will help identify which patients are more likely at risk to have another heart attack in the future. study participants will undergo mental stress testing while at the same time being connected to a device that measures endothelial function via the endopat device. these same participants will also undergo a sleep study via the watchpat device.


Eligibility criteria:
inclusion criteria: 1. patients undergoing revascularization by percutaneous intervention (pci) for acute coronary syndrome (acs) at mayo (stemi and nonstemi patients) 2. age greater than 18 exclusion criteria: 1. patients likely not to complete the study due to co-morbid conditions (end stage renal disease; liver failure; malignancies) 2. inability to sign a consent form or availability for follow up 3. patients unable to tolerate the blood pressure cuff inflation on both arms 4. patients with tremors 5. sustained non-sinus cardiac arrhythmias 6. acrylic finger nails 7. permanent pacemaker 8. color blindness 9. use of alpha blockers and short acting nitrates \< 3 hours before study 10. federal medical center inmates

Keywords: acute coronary syndrome (acs) percutaneous intervention (pci) coronary stent (cstent) percutaneous transluminal coronary angioplasty (ptca) stent placement balloon angioplasty