Kornimate/medical-research-clean huggingface dataset:
efficacy of music-based telerehabilitation after stroke

Conditions: Stroke

Summary: the goal of this clinical trial is to learn if a music-based telerehabilitation intervention implemented at home works to treat different kinds of neurological deficits caused by stroke. the main questions it aims to answer are: 1) can the music intervention improve recovery of cognitive, verbal, motor, and emotional deficits after stroke, 2) can the music intervention enhance structural and functional recovery of the brain, and (3) how different demographic, musical, and clinical background factors affect the way the music intervention works. researchers will compare the music intervention to standard (usual) care to see if the music intervention works to treat the deficits caused by stroke. subjects are stroke patients who will participate either in the music intervention 5 times/week for 10 weeks in addition to standard care or receive standard care only. during the trial, the subjects will undergo neuropsychological testing and magnetic resonance imaging (mri) three times: at baseline (before the intervention), at 3-month stage (immediately after the intervention), and at 6-month stage (3 months after the intervention).


Eligibility criteria:
inclusion criteria: * left or right hemisphere stroke which has occurred 3-12 months ago * at least mild cognitive deficit and mild aphasia / upper-extremity hemiparesis caused by the stroke * age 30-80 years * right-handed * finnish-speaking (or bilingual, able to participate in finnish) * understands the purpose of the study and is able to give informed consent exclusion criteria: * prior significant hearing or visual impairment * prior severe psychiatric illness (e.g., schizopheria, bipolar disorder, severe unipolar depression) * prior severe neurological illness (e.g., brain injury, dementia; can have prior tia or mild stroke)

Keywords: stroke music telerehabilitation attention executive function memory cognition language aphasia motor hemiparesis emotion depression anxiety quality of life magnetic resonance imaging neuroplasticity
a combination trial of copaxone plus estriol in relapsing remitting multiple sclerosis (rrms)

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: this is a double-blinded, placebo controlled study of estriol pills versus placebo pills in relapsing remitting multiple sclerosis. the study treatment will be an added on to copaxone injections in all subjects. the primary outcome measure is a reduction in relapses.

multiple sclerosis (ms) relapses are known to be significantly decreased during pregnancy. this proposal will establish whether oral treatment with estriol, the major estrogen of pregnancy, induces a decrease in relapses in relapsing remitting multiple sclerosis (rrms) subjects when used in combination with injectable copaxone. previously, in a pilot study, it has been demonstrated that treatment of rrms subjects with oral estriol for six months resulted in a significant reduction in gadolinium enhancing lesions on serial brain mris (annals of neurology, 2002; 52:421-428) and caused a favorable shift in immune responses (journal of immunology, 2003; 171:6267-6274). this is an add-on study aiming to extend these previous findings by treating longer and focusing on clinical outcomes. the combination of copaxone injection plus estriol pill (8 mg per day) will be compared to copaxone injection plus placebo pill in a double blind trial. the duration of treatment will be two years and the primary outcome measure will be relapse rate. other outcomes will include disability measures and brain mri outcomes. safety measures (blood tests and gynecologic evaluations) will also be followed and correlations will be made between serum estriol levels with efficacy and safety. the overall goal of this study will be the development of a new oral treatment, estriol, for rrms.

Eligibility criteria:
inclusion criteria: * diagnosis of relapsing remitting multiple sclerosis * at least one relapse in the last two years exclusion criteria: * patients treated in the past with total lymphoid irradiation, monoclonal antibody, t cell vaccination, cladribine, bone marrow transplantation, azathioprine, cyclophosphamide, methotrexate, mitoxantrone, cyclosporin or tysabri * clinically significant diseases other than multiple sclerosis

Keywords: multiple sclerosis estrogen estriol progesterone
evaluation of intermediate care clinics for diabetes

Conditions: Type 2 Diabetes

Summary: the aim of this trial is to assess the effectiveness of intermediate care clinics for diabetes, compared to usual care.

intermediate care clinics (icc) are suggested as one method of improving care for people with type 2 diabetes, but their effectiveness and cost effectiveness is not known. their aim is to provide a multidisciplinary community based service to support general practices in achieving good control of their patients. two local pcts (leicester city and warwickshire) have agreed to establish intermediate care clinics as part of a cluster randomised trial of their effectiveness. patients with type 2 diabetes in participating practices will be invited to take part. those that agree will attend a baseline assessment by a study nurse. this will include measurement of hba1c, body mass index, waist circumference, blood pressure, urine and lipids, as well as questionnaires about quality of life, satisfaction with current services and continuity of care. practices will then be randomised to either usual care or intervention arms, the latter having access to the new clinics. participating patients will be asked to attend a follow up assessment 18-24 months after the baseline assessments, when the same measurements will be repeated. we expect about 30% of patients in the intervention arm will have been referred to the icc. the primary outcome will be the percentage of patients achieving adequate control of hba1, blood pressure and cholesterol, comparing all participants in the intervention and control arms, whether or not those in the intervention arm attended icc. the study is powered to detect a 10% difference in this outcome, and will include 51 practices and 5100 patients. we will also examine the effect of the intervention on process measures, such as the number of contacts in hospital and general practice. in the intervention arm we will document in detail the inputs provided by icc, so that if successful the model can be adopted elsewhere. the economic evaluation will be undertaken from a societal perspective. a costing study will measure intervention and treatment costs in both groups. a comparative assessment of the marginal costs and outcomes of the intervention will be undertaken, to include cost-effectiveness ratios and cost-utility analysis. all findings will be subject to sensitivity analysis. additionally we will explore the views of patients in the intervention arm who attended icc using semi-structures interviews to identify positive and negative aspects of the patients' experiences. we will also hold focus groups to explore views of professional stakeholders.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes from participating practices across nhs leicester, warwickshire and coventry. exclusion criteria: * patients unable to give informed consent, * terminal cancer, or * pregnant.

Keywords: type 2 diabetes intermediate care primary care randomised controlled trial
knee steroid injection and blood sugar signatur

Conditions: Diabetes; Knee Osteoarthritis

Summary: a prospective, observational study assessing the relationship between hba1c level and the post-injection blood glucose signature. participants will be non-diabetic, pre-diabetic, non-insulin dependent and insulin dependent type 2 diabetic patients who will be receiving a knee steroid injection. all of them will be consented a week prior to the injection, when the cgm sensor will be applied to the back of the upper arm. this will be removed a week after the injection. koos survey as well as vas will be administered. adverse events (e.g., change in medication or hospitalization) will be monitored throughout the study.


Eligibility criteria:
inclusion criteria: * patients at the parkland outpatient clinic * indication for unilateral knee joint steroid injection for the treatment of knee joint osteoarthritis exclusion criteria: * less than 18 years old * hba1c \> 12.0% * steroid exposure in the 3 months prior to visit 1 * 3 or more steroid injections in the preceding 12 months * known contraindication to steroid injection (adverse reaction or allergy, active infection, inr \> 3.0) * lack of improvement with prior knee steroid injection * change in diabetic medication regimen in the last 1 month * significant change in diet within the last 1 month * current use of aspirin * allergy to adhesive * planned mri, xr, or ct during the 2-week study period
habituation's mechanisms in preterm and term infants

Conditions: Habituation, Psychophysiological; Preterm, Infant

Summary: each year in france, 7 % of newborns are born preterm (before 37 weeks of gestational age (ga)). the investigators called very preterm infants those who were born before 33 weeks of ga. these very preterm infants have a higher risk of developing neurological complications like developmental disabilities or cerebral palsy. to date, early assessment of these infants is difficult and not reliable enough to detect those who are at risks of developing neurological issues. now, the investigators need to identify earlier these infants to provide them interventions to improve their development (physical therapy for example). consequently, the investigators are examining a study whose aim is to assess preterm infants habituation. habituation is the newborn ability to become familiar with new environmental stimulations (noise, light...). this habituation allows the newborn to maintain his sleep even at onset of a noise or light. to study this phenomenon in infants born preterm near to corrected term (around 40 weeks of postnatal ga), will allow us to better understand neurological development of these infants. the investigators plan to compare habituation skills of preterm infants near to their theorical date of birth (40 weeks of ga) to a population of infants born at term. the investigators will also study the link between habituation abilities and sleep quality as well as neurodevelopmental outcome at the corrected age of two years old.


Eligibility criteria:
inclusion criteria: * preterm infants: preterm infants born from 25 weeks to 32 weeks + 6 days of gestation near to 36 weeks of gestation (corrected postnatal age) * term infants: term newborns with a gestational age between 39 and 41 weeks of gestation at day 3 with an apgar ≥ 1 at 1 minute of life * for both groups: normal neurological physical examination, written informed consent of the parents exclusion criteria: * no malformation or chromosomal abnormality, life threatening disease, administration of morphine or sedatives during the 24 hours before the study, context of maternal drug addiction, deafness, no psychoactive drug or anticonvulsivants during the last month of pregnancy for the term newborns, severe neurological disease

Keywords: preterm infant habituation apib
vein fitness system vs compressive therapy for venous ulcers: a bayesian adaptive trial

Conditions: Varicose Ulcer

Summary: the objective of this bayesian adaptive trial is to compare a control group versus a comprehensive ulcer healing protocol. the latter involves a combination of compressive therapy, miokinetic drainage and muscle strengthening for the entire lower extremity pump among patients with lower extremity venous ulcers. the investigators hypothesized that the combined therapy will have a higher closure rate as well as lower time to closure.

this is a bayesian adaptive, randomized, controlled, parallel, two-armed bayesian adaptive trial. patients diagnosed with varicose ulcers through doppler ultrasonography will be recruited at the pro circulation clinic of angiology and vascular surgery, brazil. the active group will be the vein fitness system, a multimodal intervention comprising exercise, lymphatic drainage, and compressive therapy, while the control group will be standard compressive therapy and regular wound care. the researchers will measure closure of the wounds and the closure rate as the primary outcomes. the study was designed in accordance with the consort statement.

Eligibility criteria:
inclusion criteria: * venous ulcers due to chronic venous disease assessed by color duplex scan (cds) examination in standing position. reflux will be assessed using cds over a longitudinal vein through the manual compression of the calf in a distant position from the examined area. reflux will be considered pathological if: \>0.5 seconds (s) in the superficial venous system, or \> 1.0 s in the deep system, or \> 0.35 s in a perforator vein. exclusion criteria: * investigators will exclude patients with ulcers from any other cause, including arterial insufficiency, with ankle-brachial pressure index (abpi) \< 0.8. also will be excluded patients who use immunosuppressive and chemotherapy drugs, who have allergies to compression materials, and wheelchair users (due to the impossibility of performing the exercises).

Keywords: varicose ulcer compressive therapy venous ulcer chronic venous disease
olfactory dysfunction of rhinosinusitis

Conditions: Rhinosinusitis

Summary: the purpose of this research is to improve understanding of the molecular and functional properties of the human olfactory system. the specific aims are: * to determine the location of ac3 and golf proteins in the human olfactory epithelium from freshly harvested nasal/sinus tissue of surgical patients * to perform objective functional studies on fresh human nasal/sinus tissue using an electro-olfactogram (eog) whic measures the electrical activity of olfactory sensory neurons in fresh biopsied tissue in response to odor or pheromone stimulation. an organotypic culture system for human tissue has been established to optimize the electrical signal acquisition. * to correlate the ac3 and golf expression profiles with pre-operative testing of human olfactory function * to correlate the eog findings with pre-operative testing of human olfactory function. * to systematically evaluate the role of individual intranasal agents on olfaction to further optimize the electrical signal acquisition from olfactory tissue.

this is a prospective cohort study. subjects will be recruited from the group of patients at the university of washington otolaryngology-head and neck surgery clinic who will undergo endoscopic sinus surgery for chronic sinusitis and other disorders of the nasal cavity and sinuses. subjects will sign consent and complete a subjective smell test (upsit--university of pennsylvania smell identification test), and the snot-20 (sinonasal outcome test-20) during their surgery, subjects will have two to four pieces of normally discarded tissue preserved for the study. subjects will also have two to four pieces of healthy tissue removed (total size approximately that of a pencil eraser tip)depending on the type of surgery involved. the following procedures will be performed on these tissues: * immunocytochemistry utilizing antibodies to ac3 and golf to determine the patterns and levels of expression of these proteins * two odorants, isoamyl acetate and citralva, to elicit odorant-induced activity from the human olfactory sensory neurons. the tissue will also be subjected to two putative human pheromones: 4,16-androstadiene-3-ol and 1,3,5(10),16-estrateraen-3-ol. * application of six commonly used intranasal agents: 0.9% saline, 1:1000,000 epinephrine, 0.05% oxymetazoline, 1% lidocaine, zicam (0.12% zinc gluconate) and nasocort aq (triamcinolone acetate).

Eligibility criteria:
inclusion criteria: * over 18 yrs. of age, scheduled for: a.) endoscopic sinus surgery for chronic sinusitis, b.) endoscopic transnasal approach to the pituitary for pituitary tumor removal, c.) endoscopic inferior turbinectomy for nasal congestion d.)endoscopic repair of cerebrospinal fluid leaks exclusion criteria: * unable to give informed consent or complete questionnaires due to language, cognitive impairment or sever medical conditions.

Keywords: olfactory dysfunction
a trial of famitinib in patients with failure of first-line treatment for intrahepatic cholangiocarcinoma

Conditions: Intrahepatic Cholangiocarcinoma

Summary: this is a single-arm, open-label, multi-center phase ii clinical trial intended to observe and evaluate the efficacy and safety of famitinib malate in treating icca(intrahepatic cholangiocarcinoma ) patients with fgfr2 genetic aberrations who failed first-line therapy.


Eligibility criteria:
inclusion criteria: 1. voluntary participation and written informed consent; 2. aged 18-75 years (inclusive), males and females; 3. those with histopathologically diagnosed icca, who had previously undergone but failed first-line systematic chemotherapy; 4. fgfr2 fusion/rearrangement confirmed by tests conducted in designated central laboratory; 5. at least one measurable lesion that has not been treated locally; 6. ecog score of 0-1; 7. expected survival ≥ 12 weeks; exclusion criteria: 1. presence of multiple factors affecting oral medications; 2. wounds unhealed over a long period of time, or fractures not completely healed; 3. known or suspected allergy to investigational drug or any drug related to this trial. 4. known cases of cns(central nervous system) metastasis; 5. uncontrolled cardiac diseases or symptoms; 6. patients with congenital or acquired immunodeficiency (such as hiv positive), or a history of organ transplants; 7. patients previously treated with fgfr inhibitors (such as erdafitinib)
a study of bispecific antibody mcla-145 in patients with advanced or metastatic malignancies

Conditions: Advanced Cancer; Solid Tumor, Adult; B-cell Lymphoma, Adult

Summary: this is an open-label, non-randomized, phase 1 study to determine the safety, tolerability, and preliminary efficacy of mcla-145 in adult patients with advanced metastatic solid tumors or b-cell lymphomas. the study will be conducted in 2 parts.

study design: this open label, multicenter, first in human study consists of 2 parts. part 1 is a dose escalation to find the recommended dose of mcla-145 in monotherapy or in combination with pembrolizumab. part 2 is a dose expansion to confirm the dose of mcla-145, alone or in combination through further evaluation of safety, tolerability, pk, preliminary antitumor activity, and functional target engagement. the study includes three periods: screening (up to 28 days prior to the first dose of study drug); treatment (first dose of study drug with treatment cycles of 28 days for patients treated q2w and 21 days for patients treated q3w); safety follow-up (30 and 90 days after the last dose) including survival follow-up checks every 2 months up to 12 months after the last dose.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed advanced or recurrent/metastatic solid tumors or b-cell lymphomas, that are considered non-amenable to surgery or other curative treatments or procedures (if applicable) * measureable disease per recist v1.1 or lugano criteria * eastern cooperative oncology group (ecog) performance status of 0 or 1. * received prior standard therapy for advanced or recurrent/metastatic disease as applicable to tumor type * received a maximum of 4 prior systemic treatment regimens (inclusive of chemotherapy, immunotherapy, and targeted therapy regimens) for advanced or recurrent/metastatic disease * life expectancy of ≥12 weeks, as per investigator judgement exclusion criteria: * the following b-cell neoplasms: burkitt lymphoma, lymphoblastic leukemia/lymphoma, lymphoplasmacytic lymphoma, chronic lymphocytic leukemia * prior therapy containing an anti-pd-l1 agent or t-cell agonist * current serious illness or medical condition including, but not limited to uncontrolled active infection * has not recovered to ≤ grade 1 or baseline from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting mcla-145 * prior ≥ grade 3 immune-mediated aes with anti-pd-1 therapy * history of any grade immune-mediated ocular aes. * known hypersensitivity or severe reaction to any component of mcla-145 or formulation components * participants who have active or inactive autoimmune disease or syndrome (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease) that has required systemic treatment in the past 2 years or who are receiving systemic therapy for an autoimmune or inflammatory disease (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs)

Keywords: first-in-human mcla-145 antibodies bispecific
height measurement in critically ill children

Conditions: Critically Ill Child; Nutritional Status; Height; Length

Summary: height/length has to be assessed accurately in critically ill children, as its value is required to assess nutritional status, to calculate nutritional requirements, to calculate body surface area (involved in drug prescriptions), and to assess pulmonary function. the who has standardized practices to perform height/length measurements, but this gold standard is not applicable in critically ill children (who cannot stand and are equipped with catheters, tubes and various devices). it is not accurate to rely on previous measurements as children are continuously growing. no height/length measurement tool or method has been validated so far in this population, neither any estimation nor extrapolation methods. the investigators aim to compare the who gold standard for height/length measurement to a list of other methods, validated in other children populations and currently used in the pediatric setting. we intend to compare each of them to the gold standard. the secondary objectives are to describe each height/length extrapolation or estimation method and to estimate the practical use of each method for critically ill children. a prospective observational study is planned. 140 critically ill children admitted to pediatric intensive care unit (picu) will be recruited. body segments (ulna, tibia, knee-heel, arm span) will be measured and length/height extrapolated from formulas used in different populations. previous length/height measurements will be collected to draw growth curves and extrapolate actual length/height. parents will be asked how tall their child is. after picu discharge, while the child meets who measurement standards, accurate length/height will be measured and compared to the results of the above mentioned techniques. comparison will be made in-between these results.


Eligibility criteria:
inclusion criteria: * age from 28 days to 18 years * admitted in pediatric intensive care * who standard not applicable * parent consent exclusion criteria: * expected death before discharge * expected that the child will not meet in the near future who standard criteria to measure height/length * growth \> 5% height before meeting the who criteria * limb abnormalities, scoliosis, retractions.