Kornimate/medical-research-clean huggingface dataset:
intercontinental cooperative non-hodgkin t-cell lymphoma prospective registry study

Conditions: Non-Hodgkin T-cell Lymphoma

Summary: the better understanding of non-hodgkin t-cell lymphoma is essential for establishing effective treatment strategy for non-hodgkin t-cell lymphoma. therefore, the data about conical features and treatment outcomes of each subtype should be accumulated to establish treatment strategy. however, the majority of previous data for non-hodgkin t-cell lymphoma was from small case series of single institute. furthermore, as novel drugs were developed for the treatment of relapsed or refractory t-cell lymphoma, the date from patients who were treated with those novel drugs are especially required because their outcomes may reflect the outcomes of currently available treatments. thus, a multinational, multicenter prospective registry study is needed to provide information useful for establishing treatment strategies for t-cell lymphoma.


Eligibility criteria:
inclusion criteria: * pathologically diagnosed mature t-cell non-hodgkin lymphoma based on the world health organization classification 2008 * newly diagnosed patients without a previous treatment history for t-cell lymphoma or relapsed/refractory t-cell lymphoma patients * age ≥19 years * written informed consent exclusion criteria: * hodgkin lymphoma * non-hodgkin b-cell lymphoma * immature non-hodgkin t-cell lymphoma: precursor t-lymphoblastic lymphoma/leukemia * not understanding informed consent
study of ruxolitinib (incb018424) sustained release formulation in myelofibrosis patients

Conditions: Myelofibrosis

Summary: the purpose of this study is to determine the safety and tolerability of ruxolitinib (incb018424) sustained release (sr) formulation in participants with primary myelofibrosis (pmf), post-polycythemia vera mf (ppv-mf), and post-essential thrombocythemia mf (pet-mf).

the study will enroll approximately 40 participants with pmf, ppv-mf or pet-mf. participants will take ruxolitinib sr once daily for 16 consecutive weeks and then transition to a comparable twice daily dose regimen of ruxolitinib using the immediate release (ir) tablets which have been under investigation in controlled phase 1, 2, and 3 clinical trials. participants receiving benefit from treatment with ruxolitinib may continue further participation with ir tablets up to the time when the last participant completed week 36 or the commercial availability of ruxolitinib ir, whichever was earlier. follow-up will occur at least 30 days following the last dose of ruxolitinib.

Eligibility criteria:
inclusion criteria: * participants 18 years of age or older. * participants must be diagnosed with primary myelofibrosis (pmf), post-essential thrombocythemia myelofibrosis (ppv-mf), or post-polycythemia vera myelofibrosis (pet-mf). * participants with myelofibrosis requiring therapy must be classified as high risk (3 or more prognostic factors), intermediate risk level 2 (2 prognostic factors), or intermediate risk level 1 (1 prognostic factor)defined by international working group for myelofibrosis research and treatment (iwg-mrt). * participants must have a palpable spleen measuring 5 cm or greater below the costal margin. exclusion criteria: * participants with a life expectancy of less than 6 months. * participants of childbearing potential who are unwilling to take appropriate precautions to avoid pregnancy or fathering a child. * participants with inadequate bone marrow reserve. * participants with history of platelet counts \< 50,000/μl, platelet transfusion(s), or an absolute neutrophil count \< 500/μl in the month prior to screening. * participants with inadequate liver or renal function at screening and baseline visits.

Keywords: myelofibrosis myeloproliferative neoplasms pmf pet-mf ppv-mf
study of music therapy in pain rehabilitation programs

Conditions: Music Therapy

Summary: the purpose of this study is to measure changes in mood, symptom burden, pain level, and stress scores in patients before and after a 20-minute music therapy intervention.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * patients that are enrolled in the pain rehabilitation center, mayo florida exclusion criteria: - ≤ 18 years of age.
ultrasonic neuromodulation for treatment of cognitive impairment

Conditions: Alzheimer Disease; Dementia; Cognitive Impairment

Summary: this study will evaluate a new form of non-invasive deep brain therapy for individuals with alzheimer's disease. low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. a well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. the trial will evaluate brain target engagement using magnetic resonance imaging, pet imaging, and numerical scales of cognitive performance.


Eligibility criteria:
inclusion criteria: * mild cognitive impairment or mild dementia due to alzheimer's disase (ad) with confirmed ad biomarkers (amyloid pet or csf) * age 65-80 * moca \> 18 exclusion criteria: * evidence of cerebral amyloid angiopathy or stroke within 1 year * clinical symptoms or findings suggestive of alternative diagnosis or co-pathology * inability to complete mri * suicidal ideation
anterior segment optical coherence tomography microstent positioning

Conditions: Glaucoma; Stent Migration; Stent Dislodgement; Intraocular Pressure

Summary: the goal of this observational study is to learn about the long-term results of glaucoma stent surgery in men and women 18 or older who have had cataract and microstent surgery in the past 2 years at the moran eye center. the main questions the study aims to answer are: 1. how often are microstents mispositioned? 2. what effect does microstent positioning have on intraocular pressure after surgery? participants will have a one-time clinic visit for an eye exam and optical coherence tomography (oct) . from the eye exam and oct, researchers will assess and categorize the position of the microstents and assess the schlemm's canal dilation. researchers will review the participants' medical records to acquire 2-year data for the following: 1. surgeon type and level of experience (resident, fellow, attending ophthalmologist) 2. proportions of proper gonioscopic placement intraoperatively for each surgeon group 3. effectiveness of surgery, based on change in intraocular pressure (iop) from baseline medicated iop, number of iop-lowering medications the patient was able to discontinue, and rate of need for additional glaucoma surgery.


Eligibility criteria:
inclusion criteria: * any adult glaucoma patient (age 18+) who underwent hydrus microstent or istent inject placement at the moran eye center. exclusion criteria: * any patient who subsequently had to have their stent removed for any reason, any patient with a history of trauma to the anterior segment or reconstruction altering typical anatomy.
study to evaluate impact of school-based influenza vaccination on school populations

Conditions: Influenza

Summary: rates of confirmed influenza illness in vaccinated and non-vaccinated children will be compared between schools with and without vaccination programs. the investigators hypothesize that in addition to lowering rates of influenza in vaccinated children, raising vaccination rates by 30-40% through school-based vaccination programs will decrease incidence of influenza in non-vaccinated children attending those schools compared to non-vaccinated children in schools with low vaccination rates.

this prospective cohort study will evaluate rates of virologically confirmed influenza in children attending schools with and without school-based vaccination programs. eight schools (4455 students) in two school districts matched for size, race/ethnicity, socioeconomic status, and location will serve as intervention and control schools. during influenza season defined by local surveillance data, nasal/throat swabs will be obtained for rapid influenza detection assays from all children with fever and respiratory symptoms identified by teachers for evaluation in the school nurse's office. absent children will be offered testing at a central location within the schools' communities.rates of confirmed influenza illness in vaccinated and non-vaccinated children will be compared between schools with and without vaccination programs. rates of absenteeism also will be evaluated. the investigators hypothesize that in addition to lowering rates of influenza in vaccinated children, raising vaccination rates by 30-40% through school-based vaccination programs will decrease incidence of influenza in non-vaccinated children attending those schools compared to non-vaccinated children in schools with low vaccination rates.

Eligibility criteria:
inclusion criteria: * children enrolled in target schools exclusion criteria: none

Keywords: influenza influenza vaccination school-based vaccination
static muscular stretching for treatment of pad

Conditions: Peripheral Artery Disease

Summary: patients with peripheral arterial disease (pad) often have walking impairment due to insufficient oxygen supply to skeletal muscle. the investigator's pilot study in pad patients has shown that endothelial function and walking distance improve with regular static muscle stretching. therefore, the purpose of this study is to determine whether prescriptive muscle stretching improves muscle oxygenation and walking ability in pad patients. this is a single-blinded study in 40 patients with stable symptomatic pad. patients assigned to the stretch group will use ankle splints (both legs) to perform static muscle stretching for 4 weeks (ankle dorsiflexion applied 30 min/d, 5 days/wk). patients assigned to the control group will also wear the ankle splints daily but without invoking any dorsiflexion, i.e., without stretching. measurements will consist of ankle-brachial index (abi) at rest and post-exercise, skeletal muscle oxygenation (evaluated with near-infrared spectroscopy (nirs)), and 6 minute walk test (6mwt), performed at baseline and after 4 weeks of stretching (or control splint placement). in addition, nirs will be used to evaluate muscle oxygenation while patients are wearing the splint device in order to quantitatively prescribe the angle of dorsiflexion that provides optimum stretch and deoxygenation of the calf muscles without causing pain. primary outcomes include increased muscle oxygenation during exercise and walking distance after 4 weeks of static muscle stretching. results from this study will be used to support funding applications for a larger efficacy trial.


Eligibility criteria:
inclusion criteria: * age 40+ * a resting ankle-brachial index (abi) of 0.90 or less in either leg * stable disease (pad) for a minimum of 3-months exclusion criteria: * habitual exercise (30 minutes of continuous activity for 3 or more days per week) * cardiovascular rehabilitation program during the past 3 months * below or above-knee amputation, critical limb ischemia (ulceration or gangrene) * leg pain at rest * cardiorespiratory disease * diabetes * major surgery or lower extremity revascularization during the previous 3 months * major medical illness treatment during the prior 12 months * central neurological disease * limited ankle or knee joint range of motion * requirement of oxygen with activity or exercise * more than a class ii new york heart association level of heart failure * wheelchair confinement, or inability to walk * cognitive disorder * vasculitis problem including takayasu's arteritis, buerger's disease, collagen disease or raynaud's disease
evaluation of a oncology day care unit programme with two different focuses

Conditions: Cancer

Summary: the aim of this study is to investigate the effects of a nature-centred integrative oncology day care unit programme ("outdoor concept") compared with an already established integrative oncology day care unit programme ("indoor concept").


Eligibility criteria:
inclusion criteria: - cancer diagnosis exclusion criteria: * cognitive impairment that would interfere with questionnaire replies or the intervention * pregnancy or lactation * known serious mental illness * participation in another study

Keywords: nature mind-body therapies mindfulness yoga meditation
efficacy, safety and underlying mechanisms of sphenopalatine ganglion acupuncture for perennial allergic rhinitis

Conditions: Perennial Allergic Rhinitis

Summary: in recent years, a number of randomized controlled trials have confirmed the efficacy and safety of acupuncture in the treatment of allergic rhinitis (ar). indeed, the latest american clinical guidelines recommended acupuncture treatment for ar patients who are interested in non-pharmacological treatment. in conventional acupuncture treatment for ar, needles are inserted at specific acupoints in the body; with several studies demonstrating acupuncture of sphenopalatine ganglion (spg) to improve nasal symptoms and quality of life in nasal inflammatory diseases. the investigators hypothesize that, compared with sham acupuncture and rescue medication (rm), active spg acupuncture combined with rm would lead to greater improvements in symptoms score and reduction in overall need for antihistamines. to test this hypothesis the investigators design a randomized, double blind, controlled trial to evaluate the efficacy of spg acupuncture in perennial ar patients (allergic to indoor allergens, including house dust mite, fungi, animal dander and so one) and to explore the potential underlying mechanisms.


Eligibility criteria:
inclusion criteria: * 1. history of physician-diagnosed par with at least 2 years of typical symptoms * 2. course on each onset lasting at least 4 weeks * 3. skin prick test and/or serum antigen specific ige positive to indoor allergens(sige≥0.7ku/l,≥class 2) * 4. good patient compliance on acupuncture treatment * 5. total nasal symptom scores(tnss)\>6 at v0 exclusion criteria: * 1. oral steroids within 4 weeks prior to recruitment * 2. nasal steroids and/or antihistamine 2 weeks prior to recruitment * 3. seasonal ar * 4. any respiratory infection within the previous 4 weeks prior to recruitment * 5. history of nasal polyps, nasal septum deviation, asthma or autoimmune disorders * 6. previously received acupuncture therapy for ar within 1 month prior to recruitment * 7. women during pregnancy or lactation

Keywords: acupuncture sphenopalatine ganglion perennial allergic rhinitis neuropeptides inflammatory cytokines neuro-immune interactions
study of physical and mental health of older patients with newly diagnosed cancer

Conditions: Cognitive/Functional Effects; Depression; Hematopoietic/Lymphoid Cancer; Malnutrition; Pain; Psychosocial Effects of Cancer and Its Treatment; Unspecified Adult Solid Tumor, Protocol Specific; Weight Changes

Summary: rationale: gathering information from older patients with newly diagnosed cancer may help doctors learn more about the risks of functional decline. purpose: this studying is looking at the physical and mental health of older patients with newly diagnosed cancer.

objectives: * to create a geriatric-oncology database of patients 65 years of age and older with newly diagnosed cancer who have been identified as being at increased risk of functional decline and mortality within a year. * to enhance the geriatric-oncology database by linking it to the central medicare services (cms) database and the ohio death files. outline: this is a multicenter study. patients undergo a 1-hour comprehensive geriatric assessment at baseline and periodically during the study as part of routine care. the assessments include the lawton's nine-item instrumental activities of daily living (iadl); the katz's activity of daily living (adl); the timed up and go test; the karnofsky physician-rated performance rating scale (kps); the number of falls in the past 6 months; the mini nutritional assessment (mna); the body mass index; the percent of unintentional weight loss in the past 6 months; the medical outcomes study (mos) social support subscale (emotional/information and tangible subscales); the mos social activity limitations measures; the charlson comorbidity index; the cumulative index rating scale geriatrics (cirs-g); the ace-27; the folstein's mini-mental state examination (mmse); the geriatric depression scale (gds); the functional pain scale; and a list of medications. data will be obtained from patients medical records at baseline, 6 months, 1 year, and 3 years. at completion of 1 and 3 years of follow up, the geriatric-oncology database will be linked to the central medicare and medicaid services (cms) database and the ohio death files.

Eligibility criteria:
disease characteristics: * histologically confirmed newly diagnosed cancer * any stage disease * at increased risk for functional decline and mortality within the next year as per the vulnerable elders survey (ves-13) screening tool (score ≥ 3) * seeking care at the ireland cancer center (university hospitals and all other satellite sites) * patients with a pre-existing cancer diagnosis and a geriatric syndrome referred directly to the senior adult oncology program by their providers for a geriatric-oncology consultative evaluation are not eligible patient characteristics: * able to speak and comprehend english * able to understand and willing to sign a written informed consent prior concurrent therapy: * not specified

Keywords: pain depression weight changes cognitive/functional effects malnutrition psychosocial effects of cancer and its treatment unspecified adult solid tumor, protocol specific hematopoietic/lymphoid cancer
the effect of lying position on hemodynamic parameters in patients with mechanical ventilated and spontaneously breathing.

Conditions: Position Sense Disorders; Hemodynamic Instability

Summary: aim: the study was carried out to examine the effect of lying positions on hemodynamic parameters in patients with mechanical ventilation (mv) and spontaneous breathing. material and methods: the research was carried out semi-experimentally with a single-group posttest design, between november 2021 and may 2022 in the internal medicine intensive care (icu) unit a university hospital. the study of the sample consisted of 60 patients in the icu. data were collected with the patient identification form and the hemodynamic parameters follow-up form. the patients were given different lying positions for 3 days. hemodynamic parameters were measured and recorded at the 10th minute, 1st hour and 2nd hour after position changes. the measurement results obtained were compared with one-way anova test.

aim: the study was carried out to examine the effect of lying positions on hemodynamic parameters in patients with mechanical ventilation (mv) and spontaneous breathing. material and methods: the research was carried out semi-experimentally with a single-group posttest design, between the dates of 15.11.2021 and 15.05.2022 in the internal medicine intensive care (icu) unit a university hospital. since repeated measurements were planned in the study when determining the sample, a-priori power analysis was performed based on anova repeated measures analysis and the effect size was calculated according to the etasquared value (abd el-aziz et al., 2021). accordingly, the sample of the study was calculated as 34 patients to reach at least 80% power within a 95% confidence interval. the research was completed with a total of 60 patients who were spontaneously breathing (n=30) and mechanically ventilated (n=30). data were collected with the patient identification form and the hemodynamic parameters follow-up form. right lateral, semi fowler's, left lateral and supine positions were applied to the patients every 2 hours between 9 am 5 pm for 3 days and then pulse rate, respiratory rate, systolic blood pressure (sbp), diastolic blood pressure (dbp) and oxygen saturation (spo₂) were measured at 10th minute, 1st hour and 2nd hour. in data analysis, number, arithmetic mean, standard deviation, chi-square, independent groups t test and one-way anova test were used.

Eligibility criteria:
inclusion criteria: * hospitalized in intensive care for at least 3 days * over 18 years of age * monitored * spontaneously breathing or connected to a mechanical ventilator, * conscious or unconscious, * receiving or not receiving oxygen support, * with or without a tracheostomy, * hemoglobin level of 8g/dl. exclusion criteria: * patients with movement restrictions * inotropic/vasopressor and sedative group medications * body temperature of 38˚c and above * patients receiving cpap (continuous positive airway pressure) treatment

Keywords: patient position nurse hemodynamic parameter intensive care unit
a phase 2 study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of vx-135 and daclatasvir in subjects with genotype 1 chronic hepatitis c chronic hepatitis c

Conditions: Chronic Hepatitis C; CHC; HCV; Hepatitis C

Summary: a phase 2 study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of vx-135 and daclatasvir in treatment-naïve adult subjects with genotype 1 chronic hepatitis c


Eligibility criteria:
inclusion criteria: * subjects must have genotype 1 chc and evidence of hcv infection at least 6 months before screening * subjects must be treatment-naïve and have not received prior treatment with any interferon, immunomodulatory agent, or daa for hcv exclusion criteria: * evidence of cirrhosis * history or other clinical evidence of significant or unstable cardiac disease * any other cause of significant liver disease in addition to hepatitis c * creatinine clearance ≤50 ml/min using the cockcroft-gault equation at screening * female subjects who are pregnant or nursing
a long-term follow-up study of participants who received delandistrogene moxeparvovec (srp-9001) in a previous clinical study

Conditions: Duchenne Muscular Dystrophy

Summary: the purpose of this study is to provide a single clinical study with a uniform approach to monitoring long-term safety and efficacy in participants who received delandistrogene moxeparvovec in a previous clinical study. no study drug will be administered as part of this study. pre-infusion baseline will be defined as the timepoint just prior to infusion of delandistrogene moxeparvovec from a previous clinical study. each participant will be followed for a minimum of 5 years post-infusion of delandistrogene moxeparvovec from a previous clinical study. the duration of participation in this study is dependent on the length of follow-up the participant completed post-infusion of delandistrogene moxeparvovec from a previous clinical study.


Eligibility criteria:
inclusion criteria: * received delandistrogene moxeparvovec for duchenne muscular dystrophy in a previous clinical study. * has (a) parent(s) or legal caregiver(s) or is ≥18 years of age and able to understand and comply with the study visit schedule and all other protocol requirements. exclusion criteria: * participant or family does not want to disclose participation with general practitioner/primary care physician and other medical providers. other inclusion/exclusion criteria may apply.

Keywords: duchenne muscular dystrophy dmd pediatric long-term follow-up safety efficacy