Kornimate/medical-research-clean huggingface dataset:
nutritional intervention in a cross-sector model for the rehabilitation of geriatric patients

Conditions: Malnutrition

Summary: based on an established follow-home-programme offered at discharge from hospital the aim of this study is to test a model of how nutritional intervention in elderly patients can be systematized and quality assured in the transition between sectors. furthermore the aim is to demonstrate that this model has a positive effect on the functioning and well-being of the elderly patient. the purpose of the follow-home-programme is to facilitate the transition of the elderly patient between hospital and private home in order to follow-up on any medical, nursing- or retraining-related intervention necessary to the rehabilitation of the patient. however this offer does not focus on nutrition in particular. this is a problem as many elderly patients are known to develop a poor nutritional status due to low appetite, disease etc. our hypothesis is that adding a systematic nutritional focus to the follow-home intervention programme will promote the rehabilitation of the elderly patient further. the nutritional intervention in our study will focus on improving energy- and protein intake and we will measure the effect on the patient's functional abilities, quality of life and rate of hospital readmissions. the intervention model will be based on individualized nutritional counselling by a registered dietician in the patients home.

the study is designed as a 12 week randomized, controlled intervention study. the study sample will consist of 80 geriatric patients admitted to a medical ward at herlev university hospital in copenhagen, denmark. the patients will be equally distributed into the control and the intervention group. the control group will follow the usual follow-home programme. the intervention group will also follow this programme, but will additionally be offered 3 home visits by a registered dietician. interdisciplinary information exchange will take place through established communication channels eg. patient records, visitations. before and after the intervention data on the patient eg. hand-grip strength, nutritional status, dietary intake, functional abilities, well-being and activities of daily living will be gathered.

Eligibility criteria:
inclusion criteria: * geriatric medical patients * age +70 years * nutritional risk according to the level 1 screen in nutritional risk screening 2002 (nrs2002) * nutritional therapy for at least 3 days and at least in two daily meals during the hospitalization period * participation in the standard follow-home programme exclusion criteria: * dementia * expected readmissions * terminal disease * non-danish speaking * not able to perform hand grip test * planning weight reducing diet

Keywords: nutrition rehabilitation weightloss
noninvasive vagal nerve stimulation and cognitive rehabilitation

Conditions: Traumatic Brain Injury

Summary: the purpose of this study is to examine the feasibility and preliminary efficacy of using transcutaneous auricular vagus nerve stimulation (tvns) to enhance cognitive recovery in patients with mild-moderate traumatic brain injury (tbi).

eligible participants will be invited to two sessions, 2-7 days apart. in each session, either active tvns or sham stimulation will be administered while the participants are performing tasks of executive functions. the order of the sessions (tvns vs sham) will be counterbalanced across participants.

Eligibility criteria:
inclusion criteria: in inpatient rehabilitation due to recent traumatic brain injury, ages 18-65 years. ability to independently use a keyboard. able to understand and communicate in english (according to clinical judgment). able to independently provide consent to participate. orientation to place, time, and situation (two consecutive scores of 25 or more on the orientation log(o-log)40. this scale is routinely administered during acute rehabilitation stay. exclusion criteria: acute medical issues requiring close physician or nursing monitoring. bioelectrical implants, including pacemakers. pregnancy or persons who are lactating. significant gross or fine motor weakness. significant, ongoing communication or comprehension impairments (such as aphasia) that would affect an individual's ability to complete the required assessments. acute agitation or behavioral issues, as defined by a last agitated behavior scale score greater than 21 (routinely administered during acute rehabilitation stay, that would affect an individual's ability to participate in the required assessments. severely impaired memory retention (score lower than 3 in the 3 word delayed recall test, routinely administered during acute rehabilitation stay. diagnosis of depression. active substance abuse.
balancing lupus experiences with stress strategies

Conditions: Systemic Lupus Erythematosus

Summary: linking a psychosocial stress intervention with clinical measures of stress in african american lupus patients will assess the utility of this method in reducing perceived stress, and provide the necessary preliminary steps toward future investigations of potential mechanisms.

to begin to fill this research void, a stress intervention will be piloted and both biological specimens and questionnaire responses collected to assess changes in stress state following the intervention in patients who participated in the intervention compared to those who did not participate in the intervention.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * african american * diagnosis of lupus exclusion criteria: * previous participation in a disease self management program

Keywords: lupus stress
facioscapulohumeral dystrophy in children

Conditions: Neurological Observations; Facioscapulohumeral Muscular Dystrophy; Pediatric Disorder

Summary: this study will focus on the symptoms, natural history and clinical impact of facioscapulohumeral muscular dystrophy (fshd) in children. symptoms of classical fshd start in adulthood. however, a small subgroup of fshd patients have an early, childhood onset. this early onset is associated with faster progression and other symptoms like hearing loss and epilepsy. the symptoms, natural history and clinical impact of fshd in children are largely unknown. the results of this study will be vital for adequate symptomatic management and trial-readiness.

fshd is a hereditary muscle disease with slowly progressive muscle weakness. in children it is a very heterogenic disease ranging from severely affected infants to mildly affected adolescents. symptoms can include muscle weakness, pain, fatigue, epilepsy, hearing loss, vision loss, mental retardation and spinal deformities. the prevalence of these symptoms and the adequate follow-up of these symptoms is unknown. moreover the clinical impact and social functioning of children with fshd is under exposed. therefore this study will focus on the total spectrum of fshd in children. in addition, an extensive genetic screening will be conducted, searching for (epi)genetic disease modifiers and severity predictors.

Eligibility criteria:
inclusion criteria: * aged 0-17 years * symptoms of facial, scapulohumeral or peroneal weakness * genetically proven fshd1 or fshd2 * living in the netherlands exclusion criteria: * no informed consent

Keywords: muscular dystrophy natural history genetic profilling
predictive value of cognitive tests performed for the diagnosis of alzheimer's disease and related disorders

Conditions: Alzheimer's Disease; Impaired Cognition; Memory Disorders

Summary: the purpose of this study is to determine the predictive value of standardized cognitive tests performed in health examination centres for the diagnosis of alzheimer's disease and related disorders among adults aged 65 years and older with a subjective memory complaint.

the main objective of this study is to determine the predictive value of standardized cognitive tests performed in health examination centres for the diagnosis of alzheimer's disease and related disorders among adults aged 65 years and older with a subjective memory complaint.

Eligibility criteria:
inclusion criteria: * age ≥ 65 years * community-dwellers * volunteers receiving a free medical examination in health examination centre * subjective memory complaint exclusion criteria: * known dementia * sensory deficit compromising the cognitive evaluation * poor workmanship of the written or oral french language
a study of vedolizumab in adults with ulcerative colitis (uc) or crohn's disease (cd) in real-world practice

Conditions: Inflammatory Bowel Diseases; Crohns Disease; Colitis, Ulcerative

Summary: vedolizumab is a medicine that helps to reduce symptoms of ibd and the associated inflammation in the digestive system for participants with ulcerative colitis or crohn's disease. in this study, participants with ulcerative colitis or crohn's disease will be treated with vedolizumab according to their clinic's standard practice. participants will receive vedolizumab as either an infusion or an injection just under the skin (subcutaneous). the main aim of the study is to observe real-world treatment patterns in participants treated with vedolizumab. the study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

this is a non-interventional, prospective study of participants with moderately to severely active ibd (uc or cd) who are initiating or currently ongoing induction or maintenance treatment with vedolizumab in the real world setting. the study will enroll approximately 100 participants. the data will be collected prospectively at the study sites and will be recorded into electronic case report forms (e-crfs). all the participants will be assigned to a single observational cohort: * participants with ibd this multi-center study will be conducted in austria at specialized gastroenterology centers. the overall duration of the study will be 24 months. data will be collected at baseline, at 3 months after induction, and every 6 months after induction, and at the time of switch, discontinuation and/or at routine follow-up visits up to 12 months.

Eligibility criteria:
inclusion criteria: 1. has moderately to severely active ibd (uc or cd), initiating or ongoing iv induction treatment with vedolizumab in accordance with the current smpc at baseline or ibd participants receiving ongoing/maintenance iv vedolizumab treatment, with the option to switch to sc vedolizumab maintenance treatment. exclusion criteria: 1. prior history of intolerability, hypersensitivity, or other contraindications (active severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as progressive multifocal leukoencephalopathy) to vedolizumab therapy as defined in the current smpc. 2. current or planned participation in an interventional clinical trial for cd or uc. 3. cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Keywords: drug therapy
a clinical trial designed to evaluate the safety and efficacy study of luminate® in inducing pvd (posterior vitreous detachment) in non-proliferative diabetic retinopathy

Conditions: Non-Proliferative Diabetic Retinopathy

Summary: a phase 2, randomized, double-masked, placebo-controlled multicenter clinical trial designed to evaluate the safety and efficacy of luminate in inducing pvd in subjects with non-proliferative diabetic retinopathy.


Eligibility criteria:
inclusion criteria: 1. non-proliferative diabetic retinopathy subjects of any grade 2. subjects with either a) no pvd, b) stage 1 pvd or c) stage 2 pvd at baseline by b-scan in the study eye 3. subjects that are at least 45 years of age 4. subjects that are free of other significant retinal pathologies that could interfere with the measurements or conduct of this study 5. intraocular pressure under control, iop 30 mm or less 6. male or female subjects 7. signed informed consent - exclusion criteria: 1. no media opacities or abnormalities that would preclude observation of the retina or performance of any study related imaging tests 2. history of prior vitrectomy in the study eye 3. subjects with epiretinal membranes, vitreomacular adhesion, vitreomacular traction, or macular holes in the study eye at baseline 4. subjects with proliferative dr, neovascular amd, or retinal vascular occlusion in the study eye 5. subjects with clinically significant macular edema in the study eye 6. subjects with a history of focal/grid or pan-retinal laser photocoagulation in the study eye 7. subjects likely to need intraocular surgery, laser treatment, or non-study intravitreal injections in the study eye during the study period. 8. subjects with history of retinal detachment in the study eye 9. high myopes with a spherical equivalent of \> -8.00 d spectacle correction in the study eye 10. subjects with systolic bp\> 180 at screening 11. subjects with hga1c \>12.0 within 90 days preceding enrollment 12. subjects that have chronic or recurrent uveitis 13. subjects that have ongoing ocular infection or inflammation 14. subjects with uncontrolled glaucoma, ie iop \> 25mm with or without iop lowering agents 15. subjects that have contraindications to the study medication 16. subjects who are unable to meet the extensive post-op evaluation regimen 17. pregnant or nursing women 18. subjects with a history of penetrating ocular trauma in the study eye 19. subjects that are participating in another clinical research study

Keywords: vitreolysis of the vitreous
metagenomics for ocular inflammation

Conditions: Uveitis; Aqueous Humor; Infection

Summary: the aim of this study is to apply a diagnostic test called 'metagenomic sequencing' to identify the involvement of potential infections in patients with ocular inflammation, where this hasn't been detected by currently available standard testing. for many people with ocular inflammation, no cause is ever found for their disease. in some cases, an infection or infectious trigger is suspected, but currently available tests are inadequate. metagenomic sequencing can identify almost every globally known infection (bacteria, virus, fungi, parasites) in a sample. therefore, it has the potential to identify an infection that has caused or triggered ocular inflammation, and as a consequence may help to identify specific treatments. it has the potential to improve our understanding of how to diagnose and treat people with this problem. this study will allow us to test the technique that has been previously optimised for brain infections, on ocular fluids. participants will be 18 years of age or over and have active ocular inflammation which is suspected to be due to an infection, or an autoimmune process which has been triggered by an infection, but identification of this infection has not been possible using the investigations available as part of standard nhs care. participants will be identified by the treating clinical team as requiring a sample of fluid from inside of the eye, and some of this fluid will be sent for metagenomic sequencing alongside standard testing. this study will be conducted at moorfields eye hospital, london and will last for approximately a year. participants will undergo additional non-invasive ocular imaging on the day of their clinic visit, but will not have to attend any additional research visits.


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older with the capacity to consent 2. standard of care has not determined a clinical diagnosis 3. active ocular inflammation with risk of visual loss 4. clinically suspected infectious or para-infectious cause of ocular inflammation exclusion criteria: 1. contraindication to ocular fluid sampling 2. where an urgent result within 5 days is clinically required

Keywords: metagenomics uveitis aqueous humor ophthalmology
study of spr001 in adults with classic congenital adrenal hyperplasia

Conditions: Congenital Adrenal Hyperplasia; CAH - Congenital Adrenal Hyperplasia

Summary: this is a multicenter phase 2, multiple dose, dose escalation study to evaluate the safety, pharmacokinetics (pk), pharmacodynamics (pd), and efficacy of spr001 in adult patients with classic congenital adrenal hyperplasia (cah).

this is a 6-week, multiple-dose, dose escalation study of spr001 for the treatment of adults with classic cah. after screening, eligible patients will be enrolled into a 6-week treatment period followed by a 4-week washout/safety follow-up period. it is initially planned that up to approximately 18 patients in 2 dose cohorts will be enrolled. additional patients or dose groups may be considered based upon specific safety, pk/pd, and/or efficacy findings, or if an active dose has not yet been reached. spr001 will be administered as an oral daily dose. patients will undergo titration of spr001 through three escalating dosage strengths at 2-week intervals. patients will have overnight pk/pd assessments performed at baseline, which include an pre-dose overnight assessment and a post-dose overnight assessment for pk/pd following administration of the first dose. at the end of each 2-week dosing period, patients will return for single overnight visits for steady-state pk/pd assessments. a follow-up outpatient visit will occur 30 days after their last dose.

Eligibility criteria:
inclusion criteria: * male and female patients age 18 or older. * documented diagnosis of classic cah due to 21-hydroxylase deficiency * elevated 17-ohp at screening * on a stable glucocorticoid replacement regimen for a minimum of 30 days exclusion criteria: * clinically significant unstable medical condition, illness, or chronic disease * clinically significant psychiatric disorder. * clinically significant abnormal laboratory finding or assessment * history of bilateral adrenalectomy or hypopituitarism * pregnant or nursing females * use of any other investigational drug within 30 days * unable to understand and comply with the study procedures, understand the risks, and/or unwilling to provide written informed consent.

Keywords: 17-hydroxyprogesterone
acurate enhance post market study

Conditions: Aortic Valve Stenosis; Aortic Valve Calcification; Aortic Diseases

Summary: the objective of the acurate enhance study is to assess valve frame expansion and hemodynamics in a routine clinical setting when optimized procedural steps for valve implantation are followed.

acurate enhance is a prospective, open-label, single-arm, multicenter, post-market study in patients implanted with the acurate neo2™ aortic valve system (or future commercially available iteration) for the treatment of severe calcific aortic stenosis in a routine clinical setting. a subject who provides an informed consent form (icf) approved by the independent ethics committee (iec) and signed by the subject or the subject's legally authorized representative is considered enrolled once an attempt is made to insert the acurate neo2 delivery system. up to 150 subjects will be enrolled. follow-up will occur at pre-discharge, 30 days, 6 months and 1 year post index procedure per standard of care. visits are in-person at 30 days and 1 year. the 6 month visits is in-person (preferred) or via telephone interview.

Eligibility criteria:
inclusion criteria: * subject has documented severe aortic stenosis and an aortic annulus size compatible with the acurate neo2 valve per the commercial ifu based on the center's assessment of pre-procedure diagnostic imaging, and is deemed suitable for treatment with the acurate neo2™ aortic valve system (or future commercially available iteration) as confirmed by the case review committee \[crc\]. * subject (or legal representative) understands the study requirements and provides written informed consent (eg, iec-approved icf). * subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all study required follow-up visits. exclusion criteria: * subject has a previously implanted bioprosthesis in the aortic position. * subject has a unicuspid or bicuspid aortic valve. * subject has either of the following: * severe vascular disease that would preclude safe access (e.g., aneurysm with thrombus that cannot be crossed safely; marked tortuosity; significant narrowing of the abdominal aorta; severe unfolding of the thoracic aorta; or thick, protruding, ulcerated atheroma in the aortic arch), or * severe/eccentric calcification of the aortic annulus that would prevent safe implantation of the tavi prosthesis. * subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated or to the individual components of the study valve (nickel, titanium, processed porcine pericardium, polyethylene terephthalate \[pet\]). * subject has egfr \<30 ml/min (chronic kidney disease stage iv or stage v). * subject is unwilling or unable to undergo study required follow-up visits.
modified mrcukallⅻ/ecoge2993 regimen for all

Conditions: Leukaemia,Lymphoblastic

Summary: this prospective study was conducted to evaluate the efficacy and safety profiles of modified mrcukallⅻ/ecoge2993 regimen in young adults with newly diagnosed, low-risk, philadelphia chromosome negative acute lymphoblastic leukaemia.

all patients received a modified bfm regimen which was derived from the mrcukallⅻ/ecoge2993 regimen.the differences were as follows:(1) cranial prophylactic radiotherapy was omitted (2) pegaspargase was used instead of l- asparaginase for patient.(3)two additional pegaspargase treatments were added into consolidation therapy.

Eligibility criteria:
inclusion criteria: * newly diagnosed all * age:18-35years * wbc count below 30×109/l(b lineage)；wbc count below 100×109/l(t lineage) * absence of t(9;22), t(1;19), t(4;11) or any other 11q23 rearrangements * receive no chemotherapy or radiotherapy before * adequate renal function (eg, serum creatinine≤1.5 mg/dl and creatinine clearance ≥50 ml minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal) exclusion criteria: * mismatch the inclusion criteria * systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.