Kornimate/medical-research-clean huggingface dataset:
the rebif® vs glatiramer acetate in relapsing multiple sclerosis pharmacogenetics trial

Conditions: Relapsing Multiple Sclerosis

Summary: this study, rebif® vs glatiramer acetate in relapsing multiple sclerosis (ms) disease - pharmacogenetic(s) (regard-pgx) is a single blood sampling exploratory pharmacogenetic study of the regard trial. the aim of this trial is to provide additional data on the factors influencing interferon (ifn) beta response. this is a phase 4 trial involving subjects who previously participated in the regard trial. to address the trial objectives, a single visit follow-up trial will be performed during which a blood sample will be collected.


Eligibility criteria:
inclusion criteria: * was randomized in the regard 24735 study * is willing and able to comply with the protocol * has given written informed consent before performing any trial-related activities exclusion criteria: * is unwilling or unable to participate in the study * is already included in the initial regard 24735 pgx sub-study

Keywords: biomarkers genetic markers
physiological effects of nebulized salbutamol in acute respiratory failure patients on hfnc

Conditions: Acute Respiratory Failure; Pneumonia

Summary: this is a prospective physiological interventional study that assess the feasibility and safety of administering salbutamol using a vibrating mesh nebulizer during hfnc in patients with acute hypoxemic respiratory failure (ahrf). we evaluate whether this method of salbutamol delivery can reduce inspiratory effort and improve global and regional lung ventilation in ahrf patients. to achieve this, the study will record and analyze the following: esophageal pressure (pes) curves, global and regional tidal volumes, minute ventilation, and changes in global and regional lung ventilation assessed through electrical impedance tomography (eit).

to evaluate the patient's respiratory effort, the pressure-time product (ptpes) and the delta of pes oscillations during inspiration (∆ pes) will be obtained from the analysis of the pes curve. global and regional pulmonary tidal volumes will be evaluated with eit.

Eligibility criteria:
inclusion criteria: * • age \> 18, \< 90 years * non-intubated critically ill patients with ahrf due to pneumonia (diagnosis is based on the presence of infiltrates on chest x-ray and the onset of clinical signs of infection less than 7 days earlier) * pao2/fio2 ≤ 300 mmhg * patients receiving oxygen therapy exclusion criteria: * • age \< 18 years * hypercapnia (paco2 \> 50 mmhg) * hemodynamic instability (systolic blood pressure \< 90 mmhg or mean arterial pressure \< 60 or high dose of vasoactive drugs) * tachycardia or tachyarrhythmia (hr \> 130 b/min) * known allergy or intolerance to salbutamol * patient has received inhaled therapy with short-acting beta 2 agonists \< 8 hours before or with long-acting beta 2 agonists \< 24 hours before * acute exacerbation of copd or bronchial asthma * cardiogenic pulmonary edema * gcs ≤ 12 * contraindication for eit (e.g. icd) * pregnancy * patient refuses to participate

Keywords: salbutamol acute respiratory failure high flow nasal cannalae aerosol delivery
the star excursion balance test: analysis of children with cerebral palsy

Conditions: Search MeSH

Summary: purpose: the investigators estimated the reliability, standard error of measurement (sem), and minimum detectable change (mdc) of the star excursion balance test (sebt) in children with cerebral palsy (cp). methods: eight children with cp (four boys and four girls, sixteen legs) participated in this study. each child carried out the sebt and was assessed by two examiners. to determine intra-rater reliability, the investigators calculated the intra-class correlation coefficient (icc) model (3,3). the investigators also calculated the icc model (2,3) to determine the inter-rater reliability.


Eligibility criteria:
inclusion criteria: * were aged between 4 and 12 years, * had a status above level ii on the gross motor function classification system (gmfcs), * were able to understand instructions from the rater, and exclusion criteria: * had history of fracture or sprain of the lower limbs over the previous 12 months.
open-label surufatinib in european patients with net

Conditions: Neuroendocrine Tumours; Neuroendocrine Tumour of the Lung; Small Intestinal NET

Summary: this is a phase 2, open-label, multi-centre study of surufatinib in patients with low to intermediate grade (grade 1 or grade 2), well-differentiated neuroendocrine tumours (nets).

this is a phase 2, open-label, multi-centre study of surufatinib in patients with low- to intermediate-grade (grade 1 or grade 2), well-differentiated nets. the study will enroll 4 cohorts of varying nets, as follows: * cohort a - net of lung origin * cohort b - net of small bowel origin * cohort c - net of non-small bowel, non-pancreas, and non-lung origin * cohort d - net of any origin (ddi substudy) all patients will be treated with oral surufatinib 300 mg qd in treatment cycles of 28 days starting on cycle 1 day 1.

Eligibility criteria:
key inclusion criteria: 1. has histologically or cytologically documented, locally advanced, or metastatic net and has progressed on at least 1 prior line of therapy, but no more than 3 therapies; 2. has radiologic evidence of progressive tumour within 12 months of study enrolment 3. is willing and able to provide informed consent 4. is ≥18 years of age 5. has measurable lesions according to recist version 1.1 6. has an eastern cooperative oncology group (ecog) performance status of 0 or 1 7. female patients of childbearing potential and male patients with partners of childbearing potential agree to use a highly effective form(s) of contraception key exclusion criteria: 1. has an ae due to previous anti-tumour therapy that has not recovered to ≤ctcae grade 1, except alopecia and peripheral neurotoxicity with ≤ctcae grade 2 caused by platinum chemotherapy 2. major surgery within previous 4 weeks or radiation therapy within 2 weeks prior to the start of treatment. 3. prior vegf/vegfr-targeted therapy 4. uncontrollable hypertension, defined as systolic blood pressure ≥140 mmhg and/or diastolic blood pressure ≥90 mmhg, despite antihypertensive medication 5. gastrointestinal disease or condition within 6 months prior to first dose 6. has a history or presence of a serious haemorrhage (\>30 ml within 3 months) or haemoptysis (\>5 ml blood within 4 weeks) within 6 months of first dose of study drug. 7. clinically significant cardiovascular disease. 8. brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of stable disease (sd) for 14 days or longer; patients requiring steroids within 4 weeks prior to start of study treatment will be excluded. 9. a high risk of bleeding at screening due to tumour invasion into major vessels, such as pulmonary artery, the superior vena cava, or the inferior vena cava, as determined by investigators. 10. has arterial thrombosis or deep venous thrombosis within 6 months prior to first dosing, or thromboembolic events (including stroke and/or transient ischaemic attack) within 12 months. 11. has a clinically meaningful ongoing infection (eg, requiring intravenous treatment with anti-infective therapy)

Keywords: vegf
let's get organized feasibility study

Conditions: Neurodevelopmental Disorders; Mental Disorder

Summary: the aim of this study is to pilot test the let's get organized (lgo) occupational therapy intervention in a swedish context by exploring possible enhancements in time management skills, aspects of executive functioning, and satisfaction with daily occupations in persons with time-management difficulties due to neurodevelopmental and/or mental disorders. method: a pre-post design with 3 and 12-months follow-up is used. the lgo intervention is a manual-based group intervention aiming to enhance time-management, targeted to persons with mental or neurodevelopmental disorders. the lgo is conducted as 10 weekly 1.5-hour group sessions. two trained group leaders, lead each group of 6-8 participants. goal-directed and other learning strategies are used to train effective time management habits such as maintaining a calendar and wearing a watch. all group sessions follow the same format, and each session has a set theme. group sessions are structured with a slide presentation and a course manual, and information from the group leaders is intermixed with discussion among the participants and tasks to complete. the primary outcome of the study is self-reported time management measured by the assessment of time management skills (atms-s). secondary outcomes are executive functioning measured with the weekly calendar planning activity (wcpa) and satisfaction with daily occupations, which is measured with the interview-administered questionnaire satisfaction with daily occupations 13 items (sdo-13). data will be collected before intervention start (pre intervention), after intervention completion (post intervention) and 3 and 12 months post intervention completion. the atms will be collected at all four time points. the wcpa and sdo-13 will be collected pre, post and 12 months post intervention.


Eligibility criteria:
inclusion criteria: * confirmed or suspected diagnosis of a mental disorder, such as affective disorder or schizophrenia, or neurodevelopmental disorder, such as autism spectrum disorder or attention deficit hyperactivity disorder/attention deficit disorder * self-reported difficulties in time management in daily life to an extent that affects functioning in daily life negatively exclusion criteria: * intellectual disability

Keywords: time management group intervention executive function
adult double cord blood transplant study

Conditions: Cord Blood Stem Cell Transplantation; Hematologic Malignancies

Summary: the hypothesis of the study is double unit umbilical cord blood transplantation in adults will be associated with a one year survival rate of at least 40%.


Eligibility criteria:
inclusion criteria: * age 22 - 50 years * patients will have one of the following hematological malignancies: * acute myelogenous leukemia (aml): complete first remission (cr1) at high risk for relapse or complete second remission (cr2) * acute lymphoblastic leukemia (all): complete first remission (cr1) at high risk for relapse or complete second remission (cr2) * acute undifferentiated leukemia (aul) or biphenotypic leukemia: cr1 or cr2 * myelodysplastic syndrome (mds) with one of the following: low and intermediate-1 international prognostic scoring system (ipss) score with life-threatening neutropenia or thrombocytopenia; or platelet transfusion dependence intermediate-2 or high ipss score therapy-related disease: patient with history of chemotherapy and current evidence of mds * patients with adequate organ function and performance status criteria * two suitable umbilical cord blood units: a cryopreserved dose of at least 1.5 x 107 tnc/kg. if the unit contains red cells at time of cryopreservation, the cryopreserved dose must be at least 2.0 x 107 tnc/kg. each unit must be at least 4/6 hla-a and b antigen, and drb1 allele matched with the recipient. each unit must be at least 3/6 hla-a, b drb1 antigen matched to each other. exclusion criteria: * patient with suitable related donor * aml, all, aul, biphenotypic leukemia beyond cr2 * aml evolved from myelofibrosis * any acute leukemia with: * morphologic relapse or persistent disease in the bm * active extra-medullary leukemia including active cns leukemia * requiring greater than two cycles of chemotherapy to obtain present remission status * bone marrow aplasia (defined as bm cellularity \< 5% at transplant work-up) * mds with 10% or greater bone marrow blasts at pre-transplant workup * prior autologous or allogeneic hsc transplant at any time * prior radiation therapy rendering patient ineligible for tbi * any uncontrolled infection at time of study enrollment * seropositive or nat positive for hiv or htlv1 * females who are pregnant or breast feeding * patient unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research tests

Keywords: cord blood stem cell transplantation hematologic malignancies leukemia myelodysplastic syndrome
enhancing hepatitis c testing and treatment among people who inject drugs attending needle and syringe programs

Conditions: Hepatitis C; Hepatitis C, Chronic

Summary: this project aims to evaluate two strategies of hepatitis c virus (hcv) testing compared to standard of care among people who inject drugs at needle and syringe program (nsp) services in australia, to see if it can improve the number of people who start treatment following an hcv diagnosis: 1. hcv testing from collected dried blood spots sent to a central laboratory 2. hcv testing using a point-of-care device at the nsp site 3. hcv testing using standard of care at the nsp site

the tempo study will compare dried blood spot testing and point-of-care hcv rna testing to standard of care as strategies to enhance hcv treatment uptake among people with hcv and recent injecting drug use attending nsp services. peer support to enhance engagement and facilitate linkage to nursing care will be provided in the intervention arms of this study. the study is a cluster randomized controlled trial. the sites (clusters) will be primary nsps which provide services to people who inject drugs and have capacity to provide hepatitis c treatment services. the sites will be located in australia. eighteen nsps (the clusters) will be randomly allocated to receive point-of-care hcv rna testing (6 clusters), dried blood spot testing (6 clusters) or standard of care (6 clusters). at screening, participants will be tested for hcv infection with dried blood spot, point-of-care or standard of care, depending on cluster randomisation. screening will continue until a total of 150 hcv rna positive participants (\~25 participants per site) are enrolled in the dried blood spot arm, 150 hcv rna positive participants are enrolled in the point-of-care arm, and 150 participants are enrolled in the standard of care arm. hence a total of 450 hcv rna positive participants. hcv rna negative participants will have no further assessments or visits as part of the study protocol. participants who are hcv rna positive will be enrolled in the follow-up cohort and will be assessed for treatment eligibility. if eligible, they will be treated as per standard of care with a pharmaceutical benefits scheme (pbs) approved pan-genotypic hcv daa treatment. participants will be encouraged to take the first dose on the day of treatment work-up where possible. on-treatment and post-treatment testing and monitoring will be based on the site investigator as per standard clinical practice. all hcv rna positive participants will be followed up at 12 weeks, 24 weeks and 12 months post enrolment.

Eligibility criteria:
inclusion criteria for participants: attendees of the nsp service are eligible for inclusion if the following criteria are met: 1. provided written informed consent 2. ≥ 18 years of age 3. recent injecting drug use - defined as self-reported use within the previous six months. exclusion criteria for participants: a. is unable or unwilling to provide informed consent or abide by the requirements of the study.

Keywords: hepatitis c virus, needle and syringe programs
establishing a non-invasive method to measure your heart's performance

Conditions: Heart Failure

Summary: the purpose of the study is to evaluate a new way to examine cardiac function, using software developed at caltech. the experimental device is software loaded on an iphone. the iphone is used to capture a pulse (waveform) by simply placing the iphone lightly over the neck where the carotid pulse can be felt. in this study the information collected from the iphone app is compared to cardiac function data obtained from the current gold standard for measuring cardiac function, cardiac magnetic resonance imaging (mri). subjects referred from cardiologists will also generally have echocardiography information available for comparison with the iphone app. for the study, subjects will have completely non-invasive studies done in one setting: the iphone app to capture the waveforms (over carotid and radial (wrist) arteries), tonometry (another non-invasive method using a modified stethoscope), standard pulse oximetry, followed by a 30 minute mri examination of the heart. a second complete study will be done about 6 months after the first. the complete study session takes about 1.5 hours.

investigators at caltech have developed an iphone-based application that allows them to capture an arterial waveform using the iphone camera held over the skin. then based on the captured waveform and previous laboratory experiments and models, the investigators are able to calculate ejection fraction, the percentage of blood that goes out of the heart into the circulation with each beat. previous studies suggested that the iphone app measurements of ejection fraction were similar to those obtained with traditional cardiac echocardiography. in the current study the iphone app measures are being compared to ejection fraction obtained using cardiac mri. the iphone also measures other physical properties of the heart and aorta that the investigators call "intrinsic frequencies". using healthy subjects they have established the normal pattern/range of intrinsic frequencies, and in this study, a more diverse population of subjects (some with heart disease) will be studied, to determine how intrinsic frequency measures compare to traditional clinical measures of cardiac function.

Eligibility criteria:
inclusion criteria: * adult age 18-90, outpatients exclusion criteria: * inability to lie flat for 30 minutes with periodic breath holding * metal implants or other standard contraindications to mri * acute cardiac decompensation (active chest pain, shortness of breath) * hypotension (sbp\<90 mm hg) * claustrophobia * patient too large to fit in closed mri

Keywords: arterial waveform cardiac magnetic resonance imaging echocardiography intrinsic frequency measures of cardiac function
asian diabetes surgery study (adss): clinical predictor for the success of metabolic surgery

Conditions: Disease; Endocrine System Disease; Diabetes Mellitus

Summary: type 2 diabetes mellitus (t2dm) is a serious health problem that has increased dramatically worldwide due to the high and increasing prevalence of obesity. medical management of t2dm is of limited success. because not well controlled t2dm patients are in high risk of blindness, cardiovascular accident and end staged disease, t2dm has become a major health burden for society. recent data on the relative effectiveness of gastrointestinal metabolic surgery played as bariatric surgery in the remission of t2dm, suggests that it may be significantly more effective than current medical treatment. in considering that less than half of the t2dm patients can achieve satisfactory treatment goal under current medical treatment, gastrointestinal metabolic surgery shall play an important role in t2dm treatment in the future. however, the indication for metabolic surgery and clinical predictors of success are not clear now. these clinical predictors can help us to choose appropriate not-well controlled t2dm patients to receive metabolic surgery and reduce dverse health outcomes in those patients.

the present research proposal is designed to assess the clinical predictors of success in t2dm patients who receive metabolic surgery for the treatment of their diabetes. this study will recruit 200 obese t2dm patients who receive gastrointestinal metabolic surgery in our center and follow up them for one year. the inclusion criteria are those with t2dm more than 6 months, age between 18 to 65 and hba1c \> 8%. all the pre-operative clinical parameters will be collected prospectively, including c-peptide and stimulated c-peptide. the genetic polymorphism of these patients will also be analyzed and collected. the success of t2dm remission will be assessed at 12 months after metabolic surgery will be composite endpoint of cvd risk factor resolution; specifically, the proportion of patients with hba1c \< 6.5%. the clinical predictors will be analyzed by uni-vriate and muti-variate analysis. in the first year project, we will included 100 patients and will include another 100 patients at the second year. this project will apply for the budget of 1st year.

Eligibility criteria:
inclusion criteria: * age between 18 to 65. * type 2 dm \> 6 months, hba1c\>8.0% under treatment * body mass index \>25 kg/m2 * could follow up exclusion criteria: * age \ 65 * hba1c \< 7% * bmi \< 25 kg/m2
effect of motor imagery with virtual reality in patients with stroke

Conditions: Stroke

Summary: virtual reality applications in hemiplegia rehabilitation are gaining popularity. it is claimed that, apart from implementing a function, imagining that function can trigger synaptic connections.

although the effects of non-three-dimensional virtual reality and motor imagination on the brain have been investigated in a study, such comparison has not been made between the three-dimensional virtual reality and motor imagery. considering these situations, the aim of this study is to compare the effect of three-dimensional (immersive) virtual reality and motor imagery on upper extremity functional recovery after stroke.

Eligibility criteria:
inclusion criteria: * diagnosed as stroke patient. * speaks, reads and writes in turkish. * hand functions at 4, 5, 6 levels according to brunnstrom. * mini mental test score to be at least 24. * volunteer for participation. exclusion criteria: * neurological, orthopedic problems other than stroke. * to have motion sickness that cannot continue 3d application. * individuals neglecting the affected side

Keywords: virtual reality rehabilitation