Kornimate/medical-research-clean huggingface dataset:
accelerated theta burst in treatment-resistant depression: a dose finding and biomarker study

Conditions: Treatment Resistant Depression

Summary: this study evaluates the effectiveness of re-treatment using accelerated schedule of intermittent theta-burst stimulation for treatment-resistant depression. this is an open label study.

repetitive transcranial magnetic stimulation (rtms) is an established technology as therapy for treatment-resistant depression. the approved method for treatment is 10hz stimulation for 40 min over the left dorsolateral prefrontal cortex (l-dlpfc). this methodology has been very successful. the limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. this study will investigate the efficacy of a further modified protocol, creating a more rapid form of the treatment and look at the change in neuroimaging biomarkers. in particular, this study will determine the efficacy of re-treatment in individuals who have already experienced benefit of the accelerated protocol to ensure results can be repeated.

Eligibility criteria:
inclusion criteria: * male or female, 18 to 75 years of age. * able to provide informed consent. * diagnosed with major depressive disorder (mdd) or bipolar affective disorder 2 and currently experiencing a major depressive episode (mde). * prior exposure to rtms * participants must qualify as "moderate or severe treatment refractory" using the maudsley staging method. * participants may continue antidepressant regimen, but must be stable for 6 weeks prior to enrollment in the study. they must maintain that same antidepressant regimen throughout the study duration. * participants are required to have a stable psychiatrist for the duration of study enrollment. exclusion criteria: * history of mi, cabg, chf, or other cardiac history * any neurological conditions * history of epilepsy * ocd * independent sleep disorder * autism spectrum disorder
phase 3 study of alxn1850 versus placebo in adolescent and adult participants with hpp who have not previously been treated with asfotase alfa

Conditions: Hypophosphatasia

Summary: the primary objective of this study is to assess the efficacy of alxn1850 versus placebo on functional outcomes in adolescent and adult participants with hpp who have not previously been treated with asfotase alfa.


Eligibility criteria:
inclusion criteria: * diagnosis of hpp documented in the medical records * must meet 1 of the following criteria: 1. documented alpl gene variant (pathogenic, likely pathogenic, or variant of unknown significance) from a clinical laboratory improvement amendments (clia) or iso 15189 certified laboratory (section 8.7 ) 2. plasma plp above the upper limit of normal (uln) during the screening period (central or local laboratory results allowed per local regulations) * must meet 1 of the following criteria without a probably cause other than hpp: 1. serum alp activity below the age- and sex-adjusted normal range during the screening period as measured by the central laboratory 2. two documented serum alp activity results, at least 15 days apart, below the age- and sex-adjusted local laboratory normal range during the 24 months before the day 1 visit. note: local laboratories need to be clia or iso 15189 certified, or have other local equivalent laboratory certification with alexion's approval. * two separate 6mwts at below 85% of the predicted distance (for age, sex, weight, and height) during the screening period without a probable cause other than hpp exclusion criteria: * history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological disorders, or any other disorders that are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data as determined by the investigator * diagnosis of primary or secondary hyperparathyroidism * hypoparathyroidism, unless secondary to hpp * any new fracture within 12 weeks before day 1 (excluding pseudofractures) * planned surgical intervention which may impact the results of study assessments (in the opinion of the investigator) during the randomized evaluation period * history of allergy or hypersensitivity to any ingredient contained in alxn1850 or the placebo comparator (table 9)

Keywords: hypophosphatasia hpp asfotase alfa alxn1850
digital secondary prevention after atherosclerotic cardiovascular disease

Conditions: Atheroscleroses, Coronary; Atheroscleroses, Cerebral; Atherosclerotic Ischemic Disease

Summary: atherosclerotic cardiovascular disease (ascvd) remains a leading cause of morbidity and mortality worldwide and in norway. approximately 50% of the patients admitted to hospitals with an acute ascvd event has had a previous event. the high number of patients being readmitted to hospitals with new ascvd events is to a large degree explained by poor control of established risk factors such as high ldl-cholesterol, high blood pressure (bp), diabetes, obesity, smoking, and lack of physical activity, as well as poor adherence to evidence-based medication. this pragmatic, open-label proof-of-concept study conducted at three secondary care hospitals will randomly assign patients hospitalized with an ascvd event to either: (i) brief advice, tailored discharge information to general practitioners, and a nurse-led outpatient visit (control), or (ii) the same interventions as (i) plus a single in-hospital motivational counselling session and access to a digital platform for a 6 months period with patient information/videos and an individualized treatment plan and follow-up plan. the primary end point will be between-group differences in the proportion who report having attended follow-up visits in primary (primary care physicians and community-based healthy life centres) and specialist (cardiac rehabilitation programs, hospital outpatient visits) healthcare after 8 weeks and 6 months follow-up. secondary end points will be change in the smart2 risk score and cardiovascular risk factors between baseline and 6 and 12 months follow-up. exploratory end points will be changes in adherence to cardiovascular drugs, self-care behaviour, health literacy, patient activation, and quality of life.


Eligibility criteria:
inclusion criteria (all the following): * aged \>=18 years and signed informed consent and expected cooperation according to ich/gcp and national/local regulations * hospitalised with an planned or unplanned ascvd event and/or established atherosclerosis * access to a smartphone or tablet exclusion criteria (any of the following): -any condition or situation, that in the investigator's opinion could put the subject at significant risk, confound the study results, interfere significantly with the subject participation in the study, or rendering informed consent unfeasible not limited to: cognitive impairment, seizure disorders, active suicidal intent or plans, substance or alcohol dependence, psychotic disease, major depressive disorders or bipolar disorders, receiving concurrent psychological treatments, and ongoing night shift work. * short life expectancy (\<12 months) due to end-organ (i.e copd 4, ckd 4/5) or malignant diseases * clinically significant symptoms of anxiety and depression (hads a and/or hads-d score ≥8) * not being able to understand norwegian.
targeting cognition in ptsd: pregnenolone augmentation of ssris

Conditions: Stress Disorders, Post-Traumatic

Summary: this study will test the therapeutic potential of augmenting a stable ssri regimen with the neurosteroid pregnenolone to reduce cognitive symptoms and ptsd symptoms in patients diagnosed with ptsd.

see brief summary

Eligibility criteria:
inclusion criteria: 1. 18-65 years of age, any ethnic group, either sex 2. dsm-iv diagnosis of ptsd by mini (see schedule of events) 3. no change in ssri medications for \> 4 weeks. 4. no anticipated need to alter any psychotropic medications for the 10-week duration of the study. 5. ability to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process. exclusion criteria: 1. unstable medical or neurological illness, including seizures, cva, prostate or breast cancer 2. use of oral contraceptives or other hormonal supplementation such as estrogen. 3. significant suicidal or homicidal ideation. 4. concomitant medications for medical conditions will be addressed on a case-by-case base to determine if exclusionary. 5. current dsm-iv diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition; history of substance dependence within the last 3 months 6. female patients who are pregnant or breast-feeding. 7. known allergy to study medication. 8. drugs with a narrow therapeutic index (e.g. thioridazine, mesoridazine, ziprasidone, clozapine, etc.) will be excluded, as suggested by the fda; patients taking these agents will not be eligible for this study.

Keywords: ptsd pregnenolone cognition
the effect of ric on tia/stroke in children with moyamoya disease

Conditions: Moyamoya Disease; TIA; Children; Stroke

Summary: moyamoya disease is a common reason of transient ischemic attack (tia) and stroke in children. remote ischemic conditioning (ric) has been shown to prevent recurrent stroke in intracranial arterial stenosis, but it is unclear whether ric can prevent tia or stroke in children with moyamoya disease. this study aims to evaluate the effect of ric on tia/stroke in children with moyamoya disease.

this study will provide insights into the preliminary proof of principle, safety, and efficacy of ric in pediatric mmd patients, and this data will provide parameters for future larger scale clinical trials if efficacious

Eligibility criteria:
inclusion criteria: * age: ≥0 and ≤18 * all of the patients underwent digital subtraction angiography and met the current diagnostic criteria recommended by the research committee on mmd (spontaneous occlusion of the circle of willis) of the ministry of health and welfare of japan in 2012 * the cvr of patients detected by spect is not impaired severely * the patients didn't suffer stroke before. * informed consent obtained from patient or acceptable patient's surrogate exclusion criteria: * severe hepatic or renal dysfunction * severe hemostatic disorder or severe coagulation dysfunction * patients with unilateral mmd or the presence of secondary moyamoya phenomenon caused by autoimmune disease, down syndrome, neurofibromatosis, leptospiral infection, or previous skull-base radiation therapy * any of the following cardiac disease - rheumatic mitral and or aortic stenosis, prosthetic heart valves, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus or valvular vegetation, congestive heart failure, bacterial endocarditis, or any other cardiovascular condition interfering with participation * serious, advanced, or terminal illnesses with anticipated life expectancy of less than one year * patient participating in a study involving other drug or device trial study * patients with existing neurological or psychiatric disease that would confound the neurological or functional evaluations * unlikely to be available for follow-up for 3 months * contraindication for ric - severe soft-tissue injury, fracture, or peripheral vascular disease in the upper limbs.

Keywords: pediatric moyamoya disease tia stroke remote ischemic conditioning
treatment of impaired glucose tolerance in pregnancy

Conditions: Impaired Glucose Tolerance; Fetal Macrosomia

Summary: the purpose of this study is to evaluate if treatment (insulin or diet) of pregnant women with impaired glucose tolerance (75-g ogtt with a fasting p-gluc \ 10.0 and \<12.2 mmol/l) close to normoglycemia reduces children´s birth weight and neonatal morbidity. there will be a focus on treatment according to specific goals and separate follow-up regimes for the children and women post partum.


Eligibility criteria:
inclusion criteria: * women with 75g ogtt result : fasting capillary plasma \ = 12.2 mmol/l exclusion criteria: * multiple pregnancy * pregestational diabetes

Keywords: gestational diabetes mellitus impaired glucose tolerance pregnancy fetal macrosomia treatment perinatal morbidity
evaluation of clinical outcomes of ponto procedures performed in settings outside the main operating room (i.e. out-of-or)

Conditions: Hearing Loss; Bone Anchored Hearing Aids

Summary: this study is a combined retro- and prospective, single arm, multicentre investigation designed to follow clinical practice for ponto-implantations performed out of or. the overall objective is to investigate the complication rate for procedures performed out-of-or.

the study is observational and non interventional and follows clinical practice at participating clinics with the only exception of three questionnaires given to consenting patients after surgery and during follow-up, after loading of the sound processor. the study is a combined retro- and prospective study. the retrospective part consists of a chart review of patients who have undergone ponto-implantation out of or from 2019 and onwards. the prospectively recruited subjects are patients who are planned to undergo ponto-implantation surgery out-of-or.

Eligibility criteria:
inclusion criteria: * adult subjects (≥18 years old) undergoing ponto implantation in an out-of-or setting from 2019 and onwards * signed informed consent (applicable for subjects answering questionnaires) exclusion criteria: * no exclusion criteria have been set for this observational investigation
study of sequential high-dose chemotherapy in children with high risk medulloblastoma

Conditions: High-risk Medulloblastoma

Summary: the trial includes i) the evaluation of the efficacy of a treatment strategy, designed as a phase ii trial, and ii) a dose-finding part. the phase ii trial is an open label, non-randomized, multicentre trial without control group. a bayesian approach will be used to analyse the efs, assuming a cure model. we will use three prior distributions of the efs; (1) an enthusiastic prior distribution, (2) a pessimistic prior distribution, and (3) a non-informative prior distribution. as the patient outcomes in the trial will be recorded, the subsequent distribution of the outcome probability under experimental treatment will be computed by applying bayes' theorem, which yields an estimated efs probability with a 95% credibility interval (measure of bayesian precision). two interim analyses are planned to monitor the efficacy data (early stopping rules for futility or inefficacy). the final analysis of efficacy will be made on an intention to treat basis, including all recruited patients, 3 years after recruitment of the last patient. due to the uncertainty on the dose of cyclophosphamide that can be given in combination with busilvex for the last chemotherapy course in patients in complete response after intensification chemotherapy treatment, a dose-finding subtrial will be performed to address this issue (phase i part). the dose escalation of cyclophosphamide will be performed using the continual reassessment method in a bayesian framework.


Eligibility criteria:
inclusion criteria: * histological diagnosis of medulloblastoma with no ini-1 loss * high risk medulloblastoma defined by at least one of the following conditions: * newly diagnosed classical metastatic medulloblastoma * newly diagnosed anaplastic/large cell medulloblastoma or other unfavourable histology confirmed by review and coordinating investigator * newly diagnosed medulloblastoma with amplification of c-myc or n-myc * age at initial biopsy less or equal than 5 years * weight compatible with leukapheresis * ability to comply with requirements for submission of materials for central review * nutritional and general status compatible with this therapy, lansky play score \>/= 30% * estimated life expectancy \>/=3 months * no organ toxicity other than neurological symptoms (grade \>2 according to nci-common toxicity criteria v4.0 grading system) * no prior irradiation or chemotherapy (except vepesid - cbp) * written informed consent from parents or legal guardian * all patients must be affiliated to a social security regimen or be a beneficiary of the same in order to be included in the study. inclusion criteria for the phase i part of the study: * complete response after intensification phase confirmed by central review * adequate hepatic and renal function exclusion criteria: * desmoplastic medulloblastoma * atypical teratoid rhabdoid tumour * uncontrolled active or symptomatic intracranial hypertension * patient incapable of undergoing medical follow-up * relapse of medulloblastoma
neurocognitive predictors of health risk behaviors

Conditions: Substance Use

Summary: this study proposes to extend the ongoing longitudinal study of health risk behaviors and obtain new data from former adolescents (followed previously from ages 13-22; times 1-8) now from ages 23 to 28 (times 9-11). the goal of this study is to examine the contribution of developing neurocognitive markers to substance use in young adulthood by following a well-characterized longitudinal sample.

the main questions it aims to answer is: what are the long-term effects of valuation and control decision-making systems on health risk behaviors? participants will complete online surveys assessing their substance use behaviors and perform neurocognitive tasks related to risk processing and cognitive control across three time points.

Eligibility criteria:
inclusion criteria: - adolescents (now young adults) who participated in the original longitudinal project. exclusion criteria: * standard contraindications for magnetic resonance imaging at the study onset * history of seizures/stroke * a head injury with \> 10 min of unconsciousness or neurological sequelae
longitudinal pathogen-colonization in cystic fibrosis airways and ability to smell

Conditions: Cystic Fibrosis With Other Manifestations; Sinusitis

Summary: aim of the study is to detect the prevalence of chronic rhinosinusitis, pathogen colonization of the lower and upper airways and, in a sub-cohort the sense of smelling in patients with cystic fibrosis.

the sub-study on the sense of smelling in cf has been finalized in the meantime. results were published in 2012: smell in cystic fibrosis. lindig j, steger c, beiersdorf n, michl r, beck jf, hummel t, mainz jg. eur arch otorhinolaryngol. 2013 mar;270(3):915-21. doi: 10.1007/s00405-012-2124-2. epub 2012 aug 14.

Eligibility criteria:
inclusion criteria: * subject has a confirmed diagnosis of cystic fibrosis
sglt2i as anti arrhythmic therapy to prevent sudden cardiac deaths.

Conditions: Heart Failure; ICD; Diabetes Mellitus Type 2; SGLT2i

Summary: failing heart negative remodeling alterations might provide electrical heterogeneity and cardiac remodeling, thus potentially contributing to the occurrence of ventricular arrhythmia and subsequent sudden cardiac death (scd). in this study we have prospectively investigated whether sodium glucose transporte-2 inhibitors (sglt2i) could modulate serum markers of heart failure (ultra sensitive troponin , b type natriuretic peptide (bnp), c reactive protein (crp), the heart rate (hr) and serum catecholamines in patients with type 2 diabetes mellitus (t2dm), and be used as predictors for the occurrence of malignant ventricular arrhythmias (vtas) in patients who had received an implantable cardioverter defibrillator (icd) for primary prevention. in these t2dm patients with icd we investigated the functionality of devices, the appropriate and inappropriate shocks, and the hospitalizations for heart failure and the cardiac deaths.


Eligibility criteria:
inclusion criteria: * stable heart failure; indication for a icd and/or a crt-d system; nyha class ii-iii; left ventricle ejection fraction \<35%; patients receiving optimal medical therapy without controindications to receive sglt2i; diagnosis of t2dm. exclusion criteria: * nyha class i, and iv; co-morbidities which may limit life to \<6 months; history of cardiac surgery or intervention within the preceding 90 days; history of moderate to severe chronic obstructive pulmonary disease (copd), defined as needing chronic oxygen therapy, or recent (within 30 days) hospitalization for copd flare-up; pregnancy; history of primary pulmonary hypertension.
use of subtle vibration to improve walking ability by lower limb amputees

Conditions: Amputation; Diabetes Complications

Summary: the purpose of this study is to determine if subthreshold vibration, when applied to the residual limb of a lower limb amputee through their prosthetic socket, can sufficiently enhance peripheral sensation to result in an improved ability to balance and walk.

one of the many complications of diabetes is the loss of sensation in the feet. this sensory deficit can negatively impact the postural stability and mobility of non-amputees, since without feedback, it is simply more difficult to stand and walk. for lower limb amputees, the problem is compounded. these patients often have difficulty with prosthetic limb placement during maneuvering tasks, exhibit dramatic increases in the movement of their center of pressure during quiet standing, and both clinical and observational gait analysis reveal significant changes in their gait pattern relative to non-amputees. the investigators' work proposes to explore the use of a novel prosthetic intervention for diabetic lower limb amputees. the investigators hypothesize that the intervention will sufficiently enhance proprioception to result in measurably improved postural stability and locomotor function for these patients. the intervention is based on a phenomenon known as stochastic resonance, whereby the application of sub-threshold vibration enables mechano-receptors previously unable to respond to stimuli to become more susceptible to depolarization. for veterans with neuropathic proprioceptive losses, stochastic resonance may facilitate a functional response from subtle stimuli where gross inputs were formerly required.

Eligibility criteria:
inclusion criteria: amputee subjects: * unilateral transtibial amputee of diabetic etiology, * have been fit with a prosthesis and have used a prosthesis for at least one year, * wear the prosthesis at least 4 hours per day, * ambulate without upper extremity aids, * have no history of injurious falls within the previous six months, and * touch sensation measured by a 10 gauge semmes-weinstein monofilament in the dermatomes of their residual limb. exclusion criteria: subjects will be excluded if: * they have a significant lower extremity pain condition, musculoskeletal disorder, or neurological deficit that interferes with their ability to pursue typical daily activities or alters their gait characteristics, * their residual limb is ulcerated, or * are currently using anticonvulsant medications for the treatment of neuropathic pain.

Keywords: artificial limbs gait posture prosthesis vibration