Kornimate/medical-research-clean huggingface dataset:
safety and tolerability study of oral ns-018 in patients with primary myelofibrosis (mf), post-polycythemia vera mf or post-essential thrombocythemia mf

Conditions: Primary Myelofibrosis; Post-Polycythemia Vera Myelofibrosis; Post-Essential Thrombocythemia Myelofibrosis

Summary: the purpose of this study is to determine the safety and tolerability of orally administered ns-018 in patients with primary myelofibrosis (pmf), post-polycythemia vera myelofibrosis (post-pv mf), or post-essential thrombocythemia myelofibrosis (post-et mf)

this is a phase 1/2 study that is currently enrolling janus kinase 2 (jak2) failures into the phase 2 portion of the study.

Eligibility criteria:
inclusion criteria: * primary myelofibrosis, post-pv mf, or post-et mf that requires therapy * mf patients must have received prior jak2 inhibitor therapy, and been found to be intolerant, or refractory/relapsed from prior jak2 inhibitor therapy, based on investigator assessment * ≥18 years old * ecog performance status of ≤ 3 * estimated life expectancy of ≥12 weeks * male or non-pregnant, non-lactating female patients * serum creatinine of ≤1.5 × the upper limit of normal (uln)or estimated creatinine clearance (crcl) ≥ 40 ml/min/1.73 m2 * aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤3 × the upper limit of normal (uln) and total bilirubin ≤1.5 × uln. if the total bilirubin is elevated between 1.5 x and 3 x uln, patients with a direct bilirubin ≤ 1.5 x uln are eligible during the phase ii portion. * absolute neutrophil count (anc) \>1000/μl and platelet count \> 25,000/μl * qtcb ≤ 480 msec * no mf-directed treatment for at least 2 weeks prior to initiation of ns-018, including any use of corticosteroids for myelofibrosis symptom or blood count management. low dose corticosteroids ≤ 10 mg/day prednisone or equivalent is allowed for non-myelofibrosis purposes. exclusion criteria: * active, uncontrolled systemic infection * patients with any unresolved toxicity greater than grade 1 from previous anticancer therapy * potentially curative therapy is available * currently taking medication that is substantially metabolized by cytochrome p450 (cyp) 1a2 or cyp3a4 or taking medication known to be strong inhibitors or inducers of cyp3a4 * patients with a serious cardiac condition within the past 6 months * pregnant or lactating * radiation therapy for splenomegaly within 6 months prior to study entry * splenectomy (phase 2 portion of the study only) * known hiv positive status * known active hepatitis, a history of viral hepatitis b or hepatitis c

Keywords: keywords provided by ns pharma, inc.: jak2 kinase inhibitor ns-018 myeloproliferative neoplasms primary myelofibrosis post-polycythemia vera myelofibrosis post-essential thrombocythemia myelofibrosis additional relevant mesh terms: bone marrow diseases hematologic diseases polycythemia vera thrombocythemia, essential pmf post-pv mf post-et mf
application of specific frequencies to stimulate the spinocerebellar tract in subjects with unilateral dysafferentation

Conditions: Somatosensory Disorders

Summary: the purpose of this study is to determine the effects of power plate vibration therapy on balance as measured by the neurocom balance master.

acute and chronic equilibrium disorders result in over five million patient visits per year in the united states with unknown additional individuals not seeking care. symptoms of dizziness, vertigo, and lack of balance are among the most common symptoms reported to physicians. equilibrium disorders not exclusively due to visual or vestibular conditions are typically due to problems in proprioception. proprioception is the specialized sensory modality that informs the body as to movement, position, and spatial orientation through mechanisms that track sensations accompanying joint movement and position. mechanoreceptors in joints, along with vestibular, visual, muscle spindle, golgi tendon organ, ligament and tendon sensory receptors, comprise the propriosensory system, which conveys information to the motor system to maintain equilibrium on a reflexive, automatic basis. alterations in somatosensory input from mechanoreceptors have been identified as causing aberrant muscle firing patterns. the neurocom balance master is an fda approved device designed to both measure and treat balance problems and evaluate the neuromuscular control by quantifying the ability to maintain dynamic postural stability. the neurocom unit is a microprocessor controlled balance unit that provides quantitative data regarding the patient's ability to control the platform. this unit is widely used throughout the country in both university and clinical settings to help patients restore their balance.

Eligibility criteria:
inclusion criteria: * logan student, staff, or faculty with no history of ankle injury * ages 18 - 60 years old * logan student, staff, or faculty with no history of ankle surgery * no visual or vestibular condition that would affect balance exclusion criteria: * systemic illnesses that have an adverse effect on balance * local infection, injury, or other malignancy affecting the lower extremity * any unstable joints of the lower extremity * any spinal manipulation within 48 hours * prescription or herbal muscle stimulants, relaxants, etc. that could affect balance * pregnancy

Keywords: somatosensory dysfunction
investigation of activation of latissimus dorsi muscle segments during functional reach activity in chronic stroke patients

Conditions: Stroke

Summary: latissimus dorsi (ld); medial sacrum, lumbar vertebrae and lower thoracic vertebrae 10-12 lateral to the spinous processus. it is a fan-like wide muscle that connects to the inferior angle of the scapula and ribs, adheres to the anterior surface of the proximal humerus and continues with aponeurosis of the contralateral gluteus maximus below. the activation of the ld muscle during the functional reach activity, which we use most frequently in daily living activities, affects the upper extremity and trunk movements. therefore it is important muscle that affects the quality of movement. the study include individuals with stroke that diagnosed by the neurologist and include healthy subjects. during sitting activity, they will be required to reach three different distances in the sagittal and scapular plane: arm length, 125% of the arm length and end point where it can reach the modified functional reach test. during the activity, electromyography (emg) activation of latissimus dorsi, anterior deltoid and erector spina muscles will be examined with electromyographic device. hypothesis originating from the investigation: h1: latissimus dorsi muscle segments show different activation during functional reach activity. h2: activation of latissimus dorsi muscle segments is affected by reaching direction during functional reach activity. h3: activation of latissimus dorsi muscle segments is affected by reaching distance during functional reach activity.

measurements will be made during the sitting activity of the individuals included in the study. individuals will be asked to reach midsternal height cups in two separate planes, sagittal and scapular, at arm's end, 125% of arm's distance and end point where it can reach according to modified functional reach test. muscle activation of latissimus dorsi, erector spina and anterior deltoid muscles will be measured by superficial electromyographic measurement. muscle activation according to seniam for erector spina and anterior deltoid will be evaluated. for latissimus dorsi, activation will be measured in six segments separated according to anatomic dissection. reach activity will be performed 3 times on each side and at 1 minute intervals.

Eligibility criteria:
inclusion criteria: * diagnosed with stroke by a neurologist * least 6 mounts after stroke * fugl meyer upper extremity motor rating scale with a value of 40 and above, * independent sitting, * mini mental status scale (mmse)\> 24, * 30-67 age. exclusion criteria: * neurodegenerative disease other than stroke * presence of neglect * presence of apraxia * uncorrected visual impairment * neuromusculoskeletal pathologies * neck and shoulder pain lasting more than 3 months

Keywords: latissimus dorsi stroke electromyography reaching activity muscle activation
an open-label treatment protocol with ux003 rhgus enzyme replacement therapy for an advanced stage mps 7 patient

Conditions: Mucopolysaccharidosis Type 7

Summary: emergency access granted to treat a single patient with advanced mucopolysaccharidosis type 7 with ux003 recombinant human beta-glucuronidase (rhgus) enzyme replacement therapy via iv administration every other week (qow) for up to 144 weeks.


Eligibility criteria:
inclusion criteria: * 1 specific patient * confirmed diagnosis of mps 7 based on leukocyte or fibroblast glucuronidase enzyme assay or genetic testing confirming diagnosis. * written informed consent of parent(s) or legal guardian(s)

Keywords: mucopolysaccharidosis type 7 sly syndrome ux003 enzyme replacement therapy rare disease lysosomal storage disease metabolic disorder
non-inferiority clinical trial of dexchlorpheniramine (cream versus lotion) in the relief of sunburn related symptoms

Conditions: Sunburn

Summary: topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by anvisa in brazil for the relief of skin irritation and pruritus, including the ones caused by sunburn. the aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% lotion) with the standard preparation (1% cream) for the relief of sunburn related symptoms and to demonstrate the safety of both preparations.


Eligibility criteria:
inclusion criteria: * signs of solar erythema of mild to moderate intensity resulting from voluntary exposure to sun within the last 72 hours * presence of lesions with some degree of symmetry to allow comparison between both pharmaceutical formulations * compliance of the subject to the treatment protocol * agreement with the terms of the informed consent by the participants or their legal guardians when younger than 18 years old exclusion criteria: * pregnancy or risk of pregnancy * lactation * signs of solar erythema of severe intensity * use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study * history of atopy or allergic diseases * history of allergy to any component of the formulations * other conditions considered by the investigator as reasonable for non-eligibility

Keywords: sunburn dexchlorpheniramine lotion cream
home-based telerehabilitation for people with alzheimer disease

Conditions: Alzheimer Disease

Summary: the aim of this study is to investigate the effect of a physical exercise program with cognitive tasks to be applied with telerehabilitation in alzheimer's disease, on cognitive and physical function, ability to perform daily living activities, depression and anxiety. secondary aim is to examine the effect of the exercise application on the care burden and well-being of caregivers.

exercise application in the study will take 6 weeks. evaluations will be made twice, at the beginning and end of the exercise application. functional mobility was measured with the 5-times sit-and-stand test (5xsts) and timed up and go test (tug); static balance with one-leg stand test; functional independence level with functional independence scale (fim); daily living activities will be evaluated with the katz activities of daily living scale. the general cognitive level of the cases was determined by mini-mental state examination; depressive symptoms will be measured with the geriatric depression scale-short form, and anxiety levels will be measured with the beck anxiety scale. the care burden of caregivers will be assessed with the zarit care burden scale, and caregiver's well-being will be assessed with the warwick-edinburgh mental well-being scale. primary outcome measures are mini mental test, timed up\&go test, and the 5-times sit-and-stand test .

Eligibility criteria:
inclusion criteria: 1. over 65 years old, 2. diagnosed with alzheimer's disease according to the national institute of neurological and communicative disorders and stroke and the alzheimer's disease (nincds-adrda) criteria, 3. scoring between 0-2 points according to the clinical dementia rating scale (with mild-moderate dementia-related symptoms), 4. have used any dementia medication such as cholinesterase inhibitors and memantine for at least the last month, 5. mini mental test score between 13-24 points, 6. the caregiver living with is sufficient in the use of technology, 7. cases who could understand the instructions given in turkish were included in the study. exclusion criteria: 1. dementia with lewy bodies, frontotemporal dementia and one of the other types of dementia, 2. having a pulmonary, neurological, musculoskeletal or rheumatological disease that may prevent exercise, 3. unstable medical condition (uncontrolled diabetes or hypertension, deep vein thrombosis, etc.), 4. modified charlson comorbidity index score greater than 6, 5. receiving any rehabilitation service from an institution or person, 6. having regular exercise habits, 7. subjects with visual or auditory deficits or behavioral problems that would make communication difficult were not included in the study.

Keywords: exercise training cognition telemedicine telehealth
dose escalation study to evaluate the safety/tolerability and efficacy of ea-2353 in subjects with retinitis pigmentosa

Conditions: Retinitis Pigmentosa; Retinitis Pigmentosa Syndrome

Summary: this is an open-label, multiple ascending dose study to evaluate the safety, tolerability, and efficacy of ea-2353 in subjects with rp. unilateral intravitreal injections (ivt) will be administered into the subject's study eye. there will be up to 4 cohorts.

this is an open-label, multiple ascending dose study to evaluate the safety, tolerability, and efficacy of ea-2353 in subjects with rp. there will be up to 4 cohorts. each of the first three cohorts will treat 3 subjects with 4 weekly injections of ea-2353. unilateral intravitreal injections (ivt) will be administered into the subject's study eye, which is determined as the eye with worse vision based on the bcva. eligible subjects will be enrolled into one of the following three cohorts in an ascending sequential fashion: * cohort 1 (low dose) * cohort 2 (mid dose) * cohort 3 (high dose) * cohort 4 (maximum tolerated dose) patient participation will last for approximately 25 months.

Eligibility criteria:
inclusion criteria: 1. male or female, ≥ 18 years of age. 2. have a clinical and molecular diagnosis of rp. 3. understand the language of the informed consent and are willing and able to provide written informed consent prior to any study procedures. 4. are willing to comply with the protocol and follow the instructions including attendance at all scheduled study visits. 5. bcva in the worse eye between 20/50 and able to count fingers (cf) 6. have clear ocular media. 7. have pupillary dilation sufficient to allow for quality images. exclusion criteria: 1. subjects who are pregnant or suspected to be pregnant and subjects who are lactating or intend to breastfeed. female subjects of childbearing potential are required to have a negative urine pregnancy test at screening and prior to each injection, and must agree to use an acceptable method of contraception from the time of signing informed consent until the end of the study. 2. have any uncontrolled systemic disease or non-ocular disorder which would put the subject at risk due to study treatment or procedures, influence the results of the study, or impact the subject's ability to participate in the study (e.g., infection, uncontrolled elevated blood pressure, cardiovascular disease, and inability to maintain glycemic control). 3. presence of a significant ocular disease or disorder in the study eye. 4. have a history of any vitreoretinal surgery ever in the study eye. 5. have received any prior cell or gene therapy for rp. 6. have history or current abuse of alcohol and/or drugs.

Keywords: rp retinitis pigmentosa ea-2353 inherited retinal disease ird
pelvic alignment in relation to standing balance and selective motor control in children with spastic diplegia

Conditions: Cerebral Palsy; Spastic Diplegia

Summary: this study will be conducted to identify the relation between pelvic alignment and standing balance and also the relation between pelvic alignment and selective motor control in children with spastic diplegic cerebral palsy.

in this study, pelvic alignment of children with diplegia will be evaluated using the formetric instrument system. their standing balance will be evaluated using the biodex balance system, while selective voluntary motor control of lower extremities will be assessed using the selective control assessment of the lower extremity scale (scale). results will be compared to find the correlation between pelvic alignment and standing balance and the correlation between pelvic alignment and selective motor control. results can help clinicians to better address the problems of pelvic asymmetry in children with spastic diplegia to improve their overall balance and functional abilities.

Eligibility criteria:
forty children with spastic diplegia of both sexes will be selected with the following criteria: inclusion criteria: 1. their age will be ranged from 6 to 8 years. 2. the degree of their spasticity will be ranged from 1 to 1+ according to modified ashworth' scale. 3. they will be on level ⅰ or ⅱ on growth motor function classification system (gmfcs). exclusion criteria: the children will be excluded if they have one of the following: 1. severe visual or hearing impairment. 2. fixed deformities or surgical interventions in the lower extremities. 3. botulinum toxin injections in the last 6 months.

Keywords: pelvic alignment pelvic tilt, torsion, inclination formetric biodex dynamic balance selective motor control scale
evaluation of outcomes following surf therapy

Conditions: Depression; Posttraumatic Stress Disorder

Summary: the current study evaluates psychological and physical health outcomes for active-duty service members following participation in an established surf therapy program. participants complete assessments before and after the surf therapy program, as well as brief assessments before and after each surf therapy session.

the proposed study would evaluate whether an existing surf therapy program that is part of the wounded, ill, and injured (wii) wellness program at naval medical center san diego (nmcsd), significantly reduces both psychological symptoms (e.g., ptsd, depression, anxiety, negative affect, lack of positive affect) and physical symptoms (e.g., pain, sleep) among active-duty service members. psychological and physical symptoms will be assessed before beginning the surf program and at program completion. in addition, brief assessments of mood and symptoms will be completed before and after each individual surf therapy session.

Eligibility criteria:
inclusion criteria: * active-duty military service members seeking surf therapy at nmcsd and have been medically cleared to participate * diagnosis of either a psychological (e.g., ptsd, depression) or physical (e.g., amputated limb; traumatic brain injury) condition that served as a reason for referral exclusion criteria: * service members who cannot receive medical clearance to participate in the nmcsd surf therapy program * service members who have previously participated in the nmcsd surf therapy program

Keywords: depression ptsd anxiety surf therapy
a multicenter study to compare multiple doses of intravitreal microplasmin versus sham injection for treatment of patients with diabetic macular edema (dme)

Conditions: Diabetic Macular Edema

Summary: a multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical pvd induction for treatment of patients with dme.


Eligibility criteria:
inclusion criteria include: * patients \>18 years of age with diabetic macular edema exclusion criteria include: * pvd present at baseline * vitreous hemorrhage * certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (pvr) * patients who have had a vitrectomy in the study eye at any time

Keywords: diabetic macular edema pvd dme diabetic retinopathy
nurse-led alcohol brief intervention plus mobile personalized chat-based support on reducing alcohol use in university students

Conditions: Alcohol Misuse

Summary: this study aims to assess the effect of personalized support using instant messaging application on alcohol drinking reduction in university students proactively recruited from universities in hong kong.

the government has promoted hong kong as the asian's wine hub with zero alcohol tax (ethanol ≤30%) since 2008, which causes dramatic increases in alcohol drinking and binge drinking rates. alcohol use in youth is the leading cause of disability adjusted life-years loss. most adult drinkers start drinking at age 18-21. evidence shows that alcohol brief intervention (abi) is effective reducing hazardous and harmful alcohol use in university students. the proposed trial aims to enhance the abi by incorporating information communication technologies (icts) such as instant messaging (im) apps (e.g. whatsapp and wechat) to provide personalized, real-time chat-based support led by nurses. the aims of study are as follows: 1. to determine the main effect of the intervention vs. control group on alcohol consumption per week at 6-month (primary) 2. to assess the effects on alcohol consumption per week at 12-month, audit scores at 6 and 12-month, perceived usefulness of im app at 12-month, intention to use im app to reduce/quit drinking at 12-month, number of standard drinks, episode of binge drinking, episode of heavy drinking, planned drinking, academic role expectation and alcohol scale, alcohol problems scale, patient health questionnaire 4-item, perceived stress scale 4-item, covid-19 related drinking behavioral changes, and self-efficacy to reduce/quit drinking at 6-month and 12-month 3. to identify mediators between intervention and outcomes to inform the potential mechanisms 4. to qualitatively explore experience on the interventions for reducing alcohol use and related harms

Eligibility criteria:
inclusion criteria: * student aged ≥18 years from local universities in hong kong * able to read and communicate in chinese (cantonese or mandarin) * likely to stay in hong kong for most of the time in the next 12 months * using im apps (whatsapp or wechat) installed on a smartphone * baseline audit screening score ≥8 exclusion criteria: * having a history of psychiatric/psychological disease or currently on regular psychotropic medications * currently participating in treatments or programmes on reducing alcohol use

Keywords: chat-based im alcohol brief intervention alcohol misuse university students