Kornimate/medical-research-clean huggingface dataset:
the u.k. northstar clinical network

Conditions: Duchenne Muscular Dystrophy

Summary: the goal of this natural history study is to capture the natural history of duchenne muscular dystrophy (dmd) in children and adults in the united kingdom. children and adults with dmd will be invited to join. the primary objective of the study is to collect longitudinal data on motor and respiratory function in dmd patients from childhood to adulthood. the secondary objectives of the study include collection of longitudinal data on other aspects of natural history on dmd, including respiratory, cardiac and endocrine complications, neurodiversity (cognitive impairment, neuro-behavioural disorders such as adhd and autism), changes to bone density and occurrence of fractures, changes to puberty, incidence of scoliosis, unplanned hospital admissions, and quality of life. the study will also collect information on ethnicity. participants will attend an annual or bi-annual neuromuscular clinic, and will have a series of assessments and questionnaires with the study team. these include: key medical data, physiotherapy data, respiratory assessments, quality of life questionnaires, and dmd questionnaires. following assessments and questionnaire completion, data is input into the study's tailor-made national neuromuscular database.

this study will make use of the existing northstar network to collect a wider range of clinically relevant data from paediatric and adult dmd patients, to describe more completely the natural history of the disease in different domains and across different life stages and disease phases. data will be collected using assessment techniques and outcome measures appropriate to the major phases of the disease, and which are in some cases not currently part of the standard of care for dmd in the uk. the national neuromuscular database will continue to be used to collect and store these data. this study will allow the network to continue to describe the current natural history in dmd prospectively, with more robust subject ascertainment and completeness. this will help meet the current need for contemporary natural history data for the evaluation of new therapies, and further research in dmd.

Eligibility criteria:
inclusion criteria: * all patients with genetically confirmed diagnosis of duchenne muscular dystrophy in the united kingdom. recruitment will also be possible in cases in whom the dmd diagnosis is made after a muscle biopsy even if the dystrophin gene variant is still being investigated. exclusion criteria: * involvement in clinical trials is not an exclusion criterion nor having had surgical procedures, as this is an observational research study. the regular clinical data of patients in clinical trials will be acquired as part of the clinical follow up. * patients based outside of the united kingdom.

Keywords: dmd duchenne muscular dystrophy northstar clinical network northstar standards of care in dmd
brief eclectic psychotherapy for ptsd - a randomized controlled trial

Conditions: Chronic Posttraumatic Stress Disorder

Summary: participants are randomly assigned to either 16 sessions of brief eclectic psychotherapy (gersons et al. (2000) journal trauma stress 13: 333-348), comprising psychoeducation, exposure, mementos and writing assignments, domain of meaning and integration, farewell ritual, or a minimal attention control group that will be offered 16 sessions of bep after a waiting time of four months. participants in the minimal attention control group receive monthly telephone calls and complete a symptom self monitoring diary (tarrier, n. et al. (1999) behavior therapy 30: 597-605) for three weeks.


Eligibility criteria:
inclusion criteria: * clear memory of an "index" traumatic event (sufficient for constructing a scene to be used in exposure) that occurred no less than six months prior to entering the trial (montgomery and bech 2000) * ptsd according to the dsm-iv, related to the index traumatic event, as measured with the caps: frequency ≥ 1 and intensity ≥ 2 for a symptom to be counted plus a minimum level of overall severity ≥ 50 * not receiving other psychotherapy for ptsd during the 16 weeks of active treatment; psychotherapy for other problems, brief check-ins with an existing therapist, and attendance at self-help groups will be allowed * if on psychoactive medication: on a stable medication regimen for a minimum of two months prior to entering the trial * aged between 18 and 70 years * sufficient proficiency in the german language to participate in bep * consent to be randomized into the trial exclusion criteria: * current psychotic, bipolar, substance-related, or severe personality disorder * current severe depressive disorder * severe cognitive impairment or a history of organic mental disorder * evidence of ptsd or depression immediately prior to the index trauma * ongoing threat of traumatic exposure * prominent current suicidal or homicidal ideation * asylum seeking status
a study of 2 doses of map0010 and placebo in asthmatic children

Conditions: Asthma

Summary: the purpose of this study is to examine the safety and efficacy of two doses of map0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment period.


Eligibility criteria:
inclusion criteria: * male or female asthmatic children with mild to moderate persistent asthma. * 12 months to 8 years of age. * for children age 4 to 8 years: documented diagnosis of asthma at least 3 months prior to visit 1, per nih (epr-3) criteria. * for infants age 12 to \ 1 day and affected sleep. * and with at least one major or two minor risk factors. exclusion criteria: * any other significant childhood illness/abnormality or chronic lung disease * any history of upper or lower respiratory tract infection, within 2 weeks of screening. * any history of acute or severe asthma attack requiring icu admission or ventilatory support. * use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening. * any use of oral corticosteroids within 30 days of screening or prolonged use (\>10 consecutive days) of oral corticosteroids, within 12 weeks of screening.

Keywords: asthmatic children
the impact of covid-19 infection on the symptoms of functional dyspepsia

Conditions: Dyspepsia

Summary: although respiratory symptoms were predominant in patients infected with covid-19, gastrointestinal symptoms were always reported in about 10% patients. previous studies demonstrated that the sars-cov-2 virus still persists in stool samples for a long time after initial infection. moreover, some patients had a longer duration of covid-19-related gastrointestinal symptoms, which was defined as "post-acute covid-19 syndrome". previous studies have shown that functional gastrointestinal disorders may occur after acute gastroenteritis. functional dyspepsia (fd) is one of the most common functional gastrointestinal disorders. fd was reported to be correlated with multiple pathophysiological mechanisms, including gi bacterial imbalance, disordered gut microbiota, and disturbed barrier and immune function. it is unknown whether covid-19 infection could exacerbate the symptoms of fd. therefore, we followed up a group of fd patients before and after covid-19 and investigate the impact of covid-19 infection on the symptoms of fd.


Eligibility criteria:
inclusion criteria: 1. aged ≥18 years old 2. patients who met broad criteria of dyspepsia before infection exclusion criteria: 1. organ failure defined by marshall standard 2. severe psychiatric illnesses 3. suspected or identified bowel obstruction 4. known malignancy 5. pregnancy or lactation 6. unable to provide consent

Keywords: functional dyspepsia covid-19
liver transplantation versus alternative therapies for patients with pugh b alcoholic cirrhosis

Conditions: Cirrhosis

Summary: liver transplantation has been universally recognized to improve survival of patients suffering from end-stage (pugh c) alcoholic cirrhosis. however, for pugh b patients, the benefit of liver transplantation remains to be demonstrated. the aim of the present study was to compare the outcome of pugh b patients with alcoholic cirrhosis randomly assigned for immediate liver transplantation (group 1) or standard treatments (group 2).

120 patients (60 per group) were included. the therapeutic strategy defined by randomization was achieved in 68% of group 1 patients and 75% of group 2 patients (ns). all-causes death and cirrhosis-related death were not different in group 1 and group 2 patients: the five-year survival rate was 58% in group 1 and 69% in group 2 patients (ns). through multivariate analysis, the independent predictors of long-term survival were absence of ongoing alcohol consumption (p\<0.001), recovery from pugh c (p=0.046), and baseline pugh score\<8 (p=0.029). liver transplantation was associated with a higher rate of de novo malignancies (30.4% vs. 7.8%, or=5.1, p=0.001).

Eligibility criteria:
inclusion criteria: * cirrhosis * age 18-65yrs * pugh b * written consent exclusion criteria: * hiv, hbv or hcv infection * hepatocellular carcinoma * pugh a or pugh c cirrhosis * creatinin \>200µmol/l * sepsis * psychiatric disorders * extrahepatic neoplasia

Keywords: cirrhosis transplantation
effect of ginkgo biloba special extract li 1370 on dual-tasking in patients with mci

Conditions: Mild Cognitive Impairment

Summary: the aim of this study is to evaluate the effects of ginkgo biloba extract (gbe) in executive function-impaired mild cognitive impairment (mci) patients by assessing gait while walking alone as well as under differing dual-task conditions. the primary endpoint in the evaluation of gbe efficacy is gait speed. the secondary endpoint is cycle time variability under dual-task conditions.


Eligibility criteria:
inclusion criteria: * age 50-85 years * swiss german or german speaker * completed elementary school * impaired executive function (gait speed reduction ≥ 10% under dual-task as compared to normal walking) * no dementia according to international classifications of diseases (icd)-10 and diagnostic and statistical manual of mental disorders (dsm)-iv. * cognitive decline (self/informant report or objective task) * preserved basic activities of daily living and minimal impairment in complex instrumental functions * written informed consent and nihil obstat exclusion criteria: * current drug treatment with warfarin-like drugs (coumarins or clopidogrel), however, acetylsalicylic acid 100mg and 300mg is permitted * current intake of gbe or during the last 6 months * known hypersensitivity to gbe or its constituents * regular intake of antipsychotic, anxiolytic or sedative drugs(allowed if clinically stable for at least the past 3 months while under treatment) * concomitant gait-relevant disorders: severe cardio/pulmonary/cerebron -vascular disorders, bleeding diathesis, polyneuropathy and severe orthopedic disorders, organic cerebral disease epilepsy, low vision * severe medical conditions (e.g. chronic renal insufficiency, severe hepatic disorders,cardio-vascular disease, uncontrolled hypertension, peptic ulcer, malignoma) * participation in another clinical intervention study within the last 2 months * use of walking aid * normal walking speed is \< 100cm/s

Keywords: gait, ginkgo biloba, mild cognitive impairment
magnetic resonance imaging of aortic aneurysm instability

Conditions: Aortic Aneurysm

Summary: abdominal aortic aneurysm (aaa) is a progressive enlargement of the aorta, the largest blood vessel in the body. it is at risk of bursting when it is usually fatal. currently the risk of the aaa bursting is estimated from its diameter. in this study, the investigators hope to develop a new type of aneurysm scan involving magnetic resonance imaging (mri). it is hoped that this scan will be better at determining which aaas are at risk of bursting and therefore require an operation to prevent this.

abdominal aortic aneurysms (aaa) have a prevalence of \~5% and when ruptured carry a mortality rate of \~90%. the pathophysiology of aaa encompasses a range of poorly understood biomechanical and biological processes. currently the diameter of the aneurysm is used as a surrogate for the risk of rupture and patients with an aneurysm diameter greater than 55 mm are considered for elective surgical repair. however, this reliance on a single surrogate measure is too simplistic and does not take into account other physical and biological aspects of the aaa. we propose to evaluate the role of inflammation, proteolysis and neovascularisation in patients with aaa disease. we will compare novel magnetic resonance imaging techniques with blood and tissue measures of inflammation (c-reactive protein, cytokines, macrophage and leucocyte density), proteolytic activity (matrix metalloproteinases, tissue inhibitors of metalloproteinases) and neovascularisation (vessel density, endothelial progenitor cells). by comparing findings between patients with symptomatic and asymptomatic disease, this study will inform our understanding of the disease process as well as potentially identify risk markers of aaa instability that could be used to follow-up patients with asymptomatic disease.

Eligibility criteria:
inclusion criteria: * aaa measuring \>40mm in ap diameter on ultrasound scanning * age \>40 years (patients younger than this with aaa may have a connective tissue disorder and a different aetiology to their disease) * considered to be suitable for standard infra-renal open surgical repair exclusion criteria: * patients who are not deemed to be fit for open surgical repair * patients who are deemed to be suitable for a stent graft performed by the radiologists rather than the standard operation * contraindication to mri scanning identified from mri safety questionnaire (see attached)or claustrophobia * age \<40 years * patients requiring emergent repair such that there is insufficient time available to complete the protocol * patients refusing to give consent * patients unable to give consent * pregnant women (contrast is teratogenic in animals) * intercurrent illness (may confound the results) * patients with a systemic inflammatory disorder or underlying malignancy * patients who require an emergency operation such that there is insufficient time to complete the study protocol * renal dysfunction (creat \>250 or egfr\<25) * hepatic dysfunction (child's grade b or c)
effectiveness of intensive training in upper limb rehabilitation after stroke.

Conditions: Stroke

Summary: the aim of the study is to analyse the effect of intensive training on upper limb function in stroke patients. 16 stroke patients were randomly divided into two groups: the intensive group and the control group. the control group will be trained with robotic exoskeleton for upper limbs and task specific training, 3 sessions per week for 4 weeks, for 1 hour per day. the intensive group will do robotic exoskeleton for upper limbs and task specific training, 5 sessions a week for 4 weeks, for 2 hours a day.

abtract aim: the aim of the study is to analyze the effect of intensive training on upper limb function in stroke patients. methods: the control group will be trained with robotic exoskeleton for upper limbs and task specific training, 3 sessions per week for 4 weeks, for 1 hour per day. the intensive group will do robotic exoskeleton for upper limbs and task specific training, 5 sessions a week for 4 weeks, for 2 hours a day. the primary outcome measure include is the fugl meyer assessment (fma).secondary measures include the box and blocks test (bbt), dynamometer, motor activity log (mal), stroke impact scale (sis), functional independence measure (fim) and canadian occupational performance measure (copm). assessments occur at baseline, after 4 weeks of intervention, and at 1 month after intervention commencement. analysis will be intention to treat using a generalised linear mixed model to report estimated mean differences in scores between the two groups at each timepoint with 95% confidence interval and value p. hypothesis: if an intensive training programme is effective in improving upper limb motor function, its implementation for clinical practice could be beneficial for improving upper limb motor function and quality of life in people who have suffered a stroke.

Eligibility criteria:
inclusion criteria: * people diagnosed with stroke (ischaemic or haemorrhagic). * patients in a subacute or chronic state. * patients must be over 18 years of age and under 80 years of age. * patients with impaired functionality of the upper limb. exclusion criteria: * persons diagnosed with other pathologies, other than those indicated in the inclusion criteria. * mini-mental state examination (mmse), the minimum score to be achieved will be 22 points. * severe difficulties in understanding language (aphasia). * behavioural or behavioural disturbance. * treatment with botulinum toxin 3 months prior to the intervention.

Keywords: stroke intensive training upper limb occupational therapy
ultrasound to facilitate stone passage

Conditions: Urinary Stone; Urinary Calculi

Summary: this is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.

this is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia. subjects will be included across three phases: phase 1: 20 subjects to demonstrate initial feasibility phase 2a: 100 subjects for a two-arm (50:50) randomized control trial (rct) phase 2b: 20 subjects to demonstrate feasibility in individuals with spinal cord injury (sci) this study is currently in phase 1. phase 2a and 2b are intended to be conducted in parallel and will not be initiated until after review of the phase 1 results and approval to proceed to phase 2 by the fda. up to 3 distinct targets may be treated per subject. the maximum total dose exposure is 30 minutes for one session. subjects may return after at least 21 days and after all aes have resolved for an additional session on the same side. subjects may return after imaging follow-up for inclusion of their contralateral side.

Eligibility criteria:
inclusion criteria: * individuals presenting with at least one kidney stone * stone with maximum dimension \> 2 mm and ≤ 7 mm as determined by clinical imaging * individuals with sci - (phase 2b only) exclusion criteria: * individuals under 18 years of age * individuals who are pregnant or who are trying to get pregnant * prisoners * with cognitive impairment that would limit their ability to comprehend their role in consent or participation. * individuals who are unable to read or understand english * individuals who are unable or unwilling to participate in follow up activities * individuals who cannot be positioned for ultrasound imaging * individuals with uncorrected bleeding disorders or coagulopathies * individuals receiving anticoagulants and who are unable or not willing to temporarily cease the medication for the investigational procedure * individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm ipsilateral to the renal stone targeted by the investigational procedure * individuals with a solitary kidney * individuals with an uncorrected urinary tract obstruction * individuals with an untreated infection * individuals with a comorbidity risk which, at the discretion of the physician, would make the patient a poor candidate for the investigational procedure * individuals who have received two previous investigational procedures for the same stone target * individuals who have undergone the investigational procedure within the last 21 days or still have unresolved aes from a previous investigational procedure.
lifitegrast 5% for the treatment of dry eye in habitual soft contact lens wearers

Conditions: Dry Eye

Summary: this is a prospective, single site, randomized, double masked, comparator-controlled study designed to evaluate the efficacy of lifitegrast ophthalmic solution 5% in treating the symptoms of dry eye in soft contact lens wearers as compared to control. we hypothesize that there will be a significant improvement in dry eye symptoms in contact lens wearers using lifitegrast as compared to those being treated with control (lifitegrast vehicle).


Eligibility criteria:
inclusion criteria: 1. subjects must read, understand and sign the statement of informed consent 2. subjects must be at least 18 years of age 3. subjects must be habitual soft contact lens (cl) wearers, with a daily, weekly, bi- weekly or monthly replacement schedule 4. habitual contact lenses must have a suitable fit as determined by the investigator 5. subjects must report a history of dry eye symptoms, for which they have used rewetting drops or artificial tears (ats) in the past 30 days 6. subjects must be willing to discontinue the use of artificial tears (ats) and rewetting drops for the duration of the study 7. subjects must have a score of 12 or higher on the cldeq (contact lens dry eye questionnaire-8) at baseline 8. subjects must have at least 2 of the following signs of dry eye disease: 1. high tear osmolarity \> 308 mosm/l, (milliosmoles per liter) or a difference greater than 8 mosm/l between eyes 2. any corneal staining 3. any bulbar conjunctival staining 4. low tbut (tear break up time) (\<10s) 5. schirmer \<10mm in either eye 9. subjects must be able to read at least half of the 20/25 (via entrance snellen visual acuity) or better in each eye in their current contact lens prescription. 10. subjects currently wearing reusable contact lenses must be willing to use clear care solution for cleaning and disinfecting throughout the study. exclusion criteria: 1. currently pregnant or breastfeeding by self-report 2. allergy to lifitegrast ophthalmic solution 5% (xiidra) 3. habitual extended wear contact lens schedule 4. any active ocular disease that may affect the ocular surface other than dry eye (significant blepharitis, allergic conjunctivitis, lagophthalmos, chalazia, hordeolum etc.) 5. any meibomian gland dysfunction, blepharitis, corneal neovascularization or papillary conjunctivitis that is grade 3 or higher using the efron grading scale. 6. excessive corneal staining, that in the opinion of the investigator, is a contraindication to contact lens use. 7. history of ocular surgery 8. any active ocular infection 9. use of any topical ophthalmic medications other than artificial tears or rewetting drops 10. inability to perform necessary visual function assessments 11. punctal plug insertion in the last 3 months, or presence of punctal plugs at the time of the exam.

Keywords: dry eye soft contact lenses