Kornimate/medical-research-clean huggingface dataset:
myocardial fibrosis in repaired tetralogy of fallot- fifa study)

Conditions: Congenital Heart Disease; Congenital Heart Defect; Fallot Tetralogy

Summary: this study aims to study the correlation between biomarkers of myocardial fibrosis (extracellular volume fraction calculated by cardiac magnetic resonance imaging (mri) (t1-mapping) and levels of molecular biomarkers of fibrosis) and adverse events in a population of patients with repaired tetralogy of fallot.

the main causes of mortality in adults with repaired tetralogy of fallot (tf) are sudden death and heart failure. myocardial fibrosis has been linked to the appearance of arrhythmias and ventricular dysfunction in other patient populations, but this association is poorly studied in patients with tf, perhaps because research in congenital heart disease (chd) requires multicenter studies, difficult to carry out. interstitial myocardial fibrosis assessed by molecular and imaging biomarkers is associated with adverse events in patients with repaired fallot tetralogy.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older with repaired tetralogy of fallot or double outlet right ventricle fallot type exclusion criteria: * patients with pathologies that may interfere with the determination of the extracellular volume of myocardium (ischemic heart disease, storage diseases). * patients with pathologies that affect collagen metabolism (liver cirrhosis, stage ≥4 renal insufficiency, pulmonary fibrosis, metabolic bone disease, connective tissue diseases, active neoplasms, active treatment with corticosteroids and bone fractures or surgery in the previous 6 months). * pregnancy. * denial of informed consent. * patients with claustrophobia and pacemakers or defibrillators.

Keywords: fallot tetralogy myocardial fibrosis t1-mapping collagen turnover biomarkers
induce: a prospective 2-year spine registry

Conditions: Subjects Treated With NMP as Part of Their Spine Surgery; Degenerative Disc Disease (DDD)

Summary: the primary objective of this prospective, observational registry study is to evaluate the safety and effectiveness of natural matrix protein® (nmp®) when used to promote fusion in the cervical or lumbar spine. the secondary objective is to assess patient reported outcomes following the use of nmp in the treatment of the spine.

this is a multicenter, observational, prospective registry study of up to 1,000 patients across a maximum of 10 us sites. all subjects who meet study entrance criteria and planned to be treated with nmp fibers and/or micro particulates as part of their cervical or lumbar spinal surgery will be invited to participate in the study. primary endpoints * safety - freedom from product-related serious adverse events and subsequent surgical interventions at the treated level(s) * effectiveness - presence of fusion as measured by x-rays and if available ct. secondary endpoints beyond the primary endpoints, the following data may be collected and analyzed including, but not limited to, the following variables: * baseline demographics and medical history * duration of hospitalization * operative time * estimated blood loss * neurological status * subject patient reported outcomes as applicable including, but not limited to: * oswestry disability index (odi)/ neck disability index (ndi) * visual analog scale (vas) pain * veteran rand 12-item health survey (vr-12)

Eligibility criteria:
inclusion criteria: 1. implanted on-label with nmp in at least one vertebral level in the cervical (c1-c7) or lumbar (l1-s1) spine as part of their surgery 2. total volume of bone graft or bone graft substitute used in index surgery must contain at least 50% nmp by volume per treated level, where nmp is mixed with other graft material. 3. skeletally mature (age≥18 years of age) 4. be willing to sign the study-specific informed consent document prior to index surgery exclusion criteria: 1. not willing to sign the study-specific informed consent document prior to index surgery 2. use of allogenic growth factor extacts (i.e. osteofactor/proteios) or cell based allografts as part of the index surgery (use of autograft or bone marrow aspirate (bma) is allowed) 3. use of rhbmp-2 (i.e. infuse) or synthetic peptide enhanced graft (i.e. ifactor) as part of the index surgery 4. diagnosis of spinal deformity (greater than 20 degrees) or vertebral fracture including treated level 5. unable to comply with postoperative standard of care imaging (e.g. pregnant or nursing female) 6. did not complete baseline patient reported outcomes prior to index surgery 7. incarcerated at the time of surgery or preoperative evaluation

Keywords: degenerative spine nmp induce
evaluation of tibial and femoral tunnel position after arthroscopic reconstruction of the anterior cruciate ligament

Conditions: Anterior Cruciate Ligament Rupture

Summary: the purpose of this study is to evaluate the accuracy of tunnel positions in anterior cruciate ligament reconstruction

the tunnel placement in acl reconstruction is the most important predictor of clinical outcome and there is a high rate of inaccurate tunnel placements, even when performed by experienced surgeons.tibial and femoral tunnel positions are one of the major concerns in anterior cruciate ligament reconstruction which have a great impact on the final surgical results

Eligibility criteria:
inclusion criteria: * anterior cruciate ligament rupturing exclusion criteria: * none

Keywords: arthroscopy, anterior cruciate ligament, tibial tunnel.
efficacy and safety of two treatment regimens of 0.5 mg ranibizumab intravitreal injections guided by functional and/or anatomical criteria, in patients with neovascular age-related macular degeneration

Conditions: Neovascular Age-related Macular Degeneration

Summary: this study will evaluate and compare two individualized ranibizumab treatment regimens in patients with neovascular (wet) amd aiming to achieve and to maintain a maximum visual function benefit, while aiming to avoid unnecessary intravitreal injections. the results will be used to generate further recommendations on functional and anatomical monitoring of the disease and timing of treatment administration for patients with neovascular amd. in this context, the study will investigate the utility of optical coherence tomography (oct) to aid retreatment decisions with ranibizumab.

during the course of the study, the use of optical coherence tomography (oct)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (namd), novartis decided on 08-oct-2014 the early termination of the study. therefore the 12-month cutoff date was not reached and the related analyses were not performed.

Eligibility criteria:
inclusion criteria: * visual impairment predominantly due to neovascular age-related macular degeneration amd * active, newly diagnosed, untreated cnv due to amd * cnv involving the center of the retina * a qualifying vision score at study entry exclusion criteria: * stroke or myocardial infarction less than 3 months prior to study entry * active injection or inflammation of either eye at the time of study entry
assessing burnout in medical students in clerkship years in united arab emirates

Conditions: Burnout, Student; Burnout, Professional; Educational Problems

Summary: burnout syndrome is a medical condition caused by long-term job-related strain and is defined by presence of either one or more of the three states i.e. emotional exhaustion, depersonalization and lack of personal accomplishment. burnout has been shown to cause decreased work output and mental well being of employees and increase errors at workplace. burnout is observed in various lines of work and but has been found to be especially high among academic students undertaking professional studies as well as healthcare professionals. medical students in their clerkship years undergo high stake exams, while adapting from classroom and simulation learning to participate in clinical care of patients in hospital care setting with no prior experience, which much them vulnerable to developing burnout during medical school. burnout can effect medical students' well-being, which may continue into their internship and residency so greater emphasis in required on creating an awareness of burnout and identifying any factors associated to its development.

burnout syndrome can develop after a prolonged response to chronic emotional and interpersonal workplace stressors, and is defined by 3 dimensions - emotional exhaustion, depersonalization and lack of personal accomplishment. burnout syndrome can be prevalent in up to half the medical students and those studies have suggested poor mental health among them. various external and internal factors may contribute to burnout in medical students and little is known about the impact and mechanism of these factors in developing burnout. burnout can develop, persist or worsen in residency years and it has been found to frequent among diabetes specialty residents in united kingdom as well in emirati medical residents. burnout can affect overall wellbeing of medical students with health consequences as well as poor work engagement/ educational outcomes. to the best of authors knowledge no data exists on burnout in undergraduate medical students in clinical years (clerkship) in united arab emirates

Eligibility criteria:
inclusion criteria: 1. medical students (5th and 6th year) of college of medicine and health sciences in united arab emirates university 2. currently attending the college, not on sick leave or long-term absence. 3. agreed to participate after informed consent exclusion criteria: self-reported presence of active mental health illness or current treatment.

Keywords: medical student clerkship burnout syndrome medical education untied arab emirates
a study of the safety and pharmacokinetics of rhgaa in siblings with glycogen storage disease type ii

Conditions: Glycogen Storage Disease Type II; Pompe Disease; Acid Maltase Deficiency Disease; Glycogenosis 2

Summary: gsd-ii (also known as pompe disease) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (gaa). normally, gaa is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. in patients with gsd-ii, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. this study is being conducted to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of recombinant human acid alpha-glucosidase (rhgaa) as a potential enzyme replacement therapy for a pair of siblings with gsd-ii. to be eligible for this study, a patient must have a confirmed diagnosis of gsd-ii and have a sister or brother who also has a confirmed diagnosis of gsd-ii.


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained from the parent or guardian prior to performing any study related procedures; * patient must have a clinical diagnosis of gsd-ii confirmed by endogenous gaa activity below normal in at least one tissue; * patient must have a sibling with a clinical diagnosis of gsd-ii confirmed by an endogenous gaa activity below normal in at least one tissue, who is eligible for participation in this study; * patient must have a sibling with identical gaa mutations who is eligible for participation in this study; * patient must have a sibling with evidence of different progression of gsd-ii who is eligible for participation in this study; * the patient or his/her guardian(s) must have the ability to comply with the clinical protocol. exclusion criteria: * patient has significant organic disease (with the exception of symptoms relating to gsd-ii), including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, would preclude participation in the trial; * patient is participating in another investigational study.

Keywords: glycogen storage disease type ii gsd-ii pompe disease
a study evaluating the effectiveness and safety of risdiplam administered as an early intervention in pediatric participants with spinal muscular atrophy after gene therapy

Conditions: Muscular Atrophy, Spinal

Summary: this is an open-label, single-arm, multicenter clinical study to evaluate the effectiveness and safety of risdiplam administered as an early intervention in pediatric participants with spinal muscular atrophy (sma) and 2 smn2 copies who have previously received onasemnogene abeparvovec. participants are children \< 2 years of age genetically diagnosed with sma.


Eligibility criteria:
inclusion criteria: * \<2 years of age at the time of informed consent * confirmed diagnosis of 5q-autosomal recessive sma * confirmed presence of two smn2 gene copies * administration of onasemnogene abeparvovec pre-symptomatically or post-symptomatically * has received onasemnogene abeparvovec for sma no less than 3 months, but not more than 7 months, prior to enrollment * has, in the opinion of the investigator, not experienced clinically significant decline in function from the time of onasemnogene abeparvovec administration exclusion criteria: * treatment with investigational therapy prior to initiation of study treatment * any unresolved standard-of-care laboratory abnormalities per the onasemnogene abeparvovec prescribing information * concomitant or previous administration of a smn2-targeting antisense oligonucleotide or smn2 splicing modifier either in a clinical study or as part of medical care * requiring invasive ventilation or tracheostomy * requiring awake non-invasive ventilation or with awake hypoxemia (sao2 \<95%) with or without ventilator support * presence of feeding tube and an orsat score of 0 * hospitalization for pulmonary event within the last 2 months, or any planned hospitalization at the time of screening * any major illness requiring hospitalization within 1 month before the screening examination or any febrile illness within 1 week prior to screening and up to first dose administration.
detection in peripheral blood of circulating tumor cells in patient with head and neck squamous cell carcinoma

Conditions: Head and Neck Cancer

Summary: the dissemination of individual tumor cells is a common phenomenon in solid cancers. detection of tumor cells in peripheral blood circulating tumor cells (ctc) in nonmetastatic situation is of high prognostic significance. the objective of our study was to detect circulating tumor cells in two different method in patient with head and neck squamous cell carcinoma .


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient with head and neck squamous cell cancer stage iii or iv histologically proven * patient naive to any prior therapy * patient with operate cancer and resectable tumor * hemoglobin ≥ 10g / dl * performance status ≤ 2 * ability to provide written informed consent * patient's legal capacity to consent to study participation exclusion criteria: * other previous histology tumors * medical conditions or acute or chronic severe psychiatric disorders * deprived of liberty or under supervision

Keywords: circulating tumor cell cellsearch™ method rt-pcr
open label,phase ii trial of mab dose escalation of bicalutamide for biochemical failure in prostate cancer patients.

Conditions: Prostate Cancer

Summary: multi-centre one year trial for patients who have rising psa while on casodex 50mg daily dose. casodex dosage escalated to 150 mg tablet daily. treatment will be continued until patient demonstrates clinical benefit at one year, psa progression, toxicity, or withdrawal. treatment will be continued after one year if patient demonstrates continued clinical benefit.

the study will be a national, multicentre, open-label, phase ii trial. patients who have a rising psa on mab with bicalutamide 50 mg daily will be dose escalated to mab with 150 mg bicalutamide daily. subjects will receive trial treatment for 12 months, or until disease progression, unacceptable toxicity or withdrawal of consent. open label treatment will be offered thereafter if the subject demonstrates clinical benefit at the end of one year.

Eligibility criteria:
inclusion criteria: 1. provision of written informed consent. 2. men, over 18 years of age, with histologically-confirmed prostate cancer 3. treatment with zoladex (goserelin acetate) for greater than 3 months prior to day 1 4. serum testosterone level \< 50 ng/ml 5. current treatment with bicalutamide 50 mg daily.\*\* 6. two consecutive rises in psa above a nadir value, with the absolute value of the latest psa \> 2.0 ng/ml. 7. highest psa level no greater than or equal to 30 ng/ml. 8. life expectancy of greater than 1 year - exclusion criteria: 1. patients may not have received prolonged anti-androgen therapy other than with bicalutamide. patients who have received short term (2 months or less) non-steroidal anti-androgen therapy with an agent other than bicalutamide to block flare are not excluded.\* 2. psa level greater than 30 ng/ml. 3. in the opinion of the investigator, any evidence of severe or uncontrolled systemic disease which would make it undesirable for the patient to participate in the trial. 4. subjects who have received prior chemotherapy. 5. other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or superficial transitional cell carcinoma of the bladder. 6. absolute neutrophil count less than 1.5 x 109/l or platelets less than 100 x 109/l. 7. serum bilirubin greater than 1.25 times the upper limit of reference range (ulrr). 8. alanine aminotransferase (alt) or aspartate aminotransferase (ast) greater than 2.5 times the ulrr. 9. serum creatinine greater than 1.5 times -
effect of mental imagery training on brain plasticity and motor function in individuals with parkinson's disease

Conditions: Parkinson Disease

Summary: effect of mental imagery training on brain plasticity and motor function in individuals with parkinson's disease: a functional mri investigation.

this project will examine the effect of functional mri-based neurofeedback on brain plasticity and motor performance in patients with parkinson's disease (pd).

Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of idiopathic pd defined according to the uk brain bank diagnostic criteria and on a stable dopaminergic medication regimen will be included. exclusion criteria: * age \< 40 years * non-english speaking * pregnancy * breastfeeding * excessive alcohol consumption (\> 7 drinks per week for women, \> 14 drinks per week for men) or substance use * history of a neurological disorder such as a brain tumor, stroke, central nervous system infection, multiple sclerosis, movement disorder (other than pd), or seizures * history of schizophrenia, bipolar disorder, attention deficit disorder, or obsessive compulsive disorder * history of head injury with loss of consciousness * metallic surgical implants or traumatically implanted metallic foreign bodies * inability to lie flat for about an hour * discomfort being in small, enclosed spaces * dementia (montreal cognitive assessment score \< 21) * depression (beck depression inventory-ii score \> 19) * hoehn \& yahr stage \> 3 (i.e., able to stand and walk, but not fully independent) * focal neurological findings on exam that suggest cerebral pathology other than that associated with parkinsonism * motor symptoms that could potentially introduce too much motion artifact in the imaging data (e.g., mds-updrs resting tremor score \> 1 in limbs, head/chin tremor, or dyskinesia by history or exam).
effectiveness of habitworks and symptom tracking for anxiety and depression

Conditions: Anxiety; Depression, Anxiety

Summary: our objective is to conduct a randomized controlled trial (rct) that compares two digital interventions - symptom tracking and the habitworks app - in a sample of adults endorsing symptoms of anxiety or depression. we hope to obtain pilot data to support a fully powered rct to test moderators: 1. target engagement (improvement in interpretation bias) 2. feasibility and acceptability of symptom tracking and habitworks and procedures for a general community sample 3. symptom and functioning measures

habitworks is a personalized, transdiagnostic, smartphone-delivered interpretation bias intervention. our pilot studies of habitworks revealed good acceptability, feasibility, and target engagement in a variety of populations (beard, ramadurai, et al., 2021; beard, beckham, et al., 2021). our next step is to test effectiveness for anxiety and depression symptoms in a larger, community sample. results will provide pilot data to support an r01 effectiveness trial. we will randomize adults with anxiety or depression to habitworks or a credible control arm and examine effects on interpretation bias, symptoms, and functioning.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 at the time of consent (19 in nebraska, 21 in puerto rico based on age of consent) 2. current us resident 3. total score ≥ 3 on the patient health questionnaire-2 (kroenke et al., 2003) or generalized anxiety disorder-2 (spitzer et al., 2006), indicating at least mild depression and/or anxiety symptoms 4. 24-hour access to an iphone smartphone 5. ability to understand english exclusion criteria: 1. no current psychiatric symptoms that would prevent informed consent, understanding of research procedures, or ability to complete the study (e.g., active symptoms of psychosis, mania) 2. no medical symptoms that would prevent informed consent, understanding of research procedures, or ability to complete the study (e.g., physical disability)

Keywords: interpretation bias digital mental health
corticosteroid pulse after ablation

Conditions: Atrial Fibrillation

Summary: radiofrequency ablation is an effective treatment for atrial fibrillation. however, about 20% of the time the atrial fibrillation recurs. steroids given after the ablation may decrease inflammation caused by the ablation and thus improve healing and decrease the chance of recurrence of atrial fibrillation. in this study patients will be randomized to receive intravenous steroids or not immediately following the ablation.

atrial fibrillation, a common arrhythmia, is the source of considerable morbidity. prevalence of atrial fibrillation in adults is 0.5%, increasing to 10% in those patients over the age of seventy five. numbers are expected to increase nearly 2.5 fold over the next 50 years. radiofrequency (rf) ablation to cure atrial fibrillation has become an established and effective therapy in the many atrial fibrillation patients. however, approximately 20% return with recurrent atrial fibrillation after ablation. rf ablation directly targets the substrate for atrial fibrillation, cauterizing cardiac tissue through the application of radiofrequency energy , causing a myocardial lesion which effectively blocks the errant pathway. this process of rf ablation induces an inflammatory effect. as the lesion heals it often enlarges. this may contribute to recurrence of atrial fibrillation after ablation, as well as increased pain. there is some early evidence that a single dose of corticosteroids after ablation may improve the healing process, thus decreasing pain and incidence of recurrent atrial fibrillation. the aim of the study is to determine the usefulness of a one time dose of solumedrol following radiofrequency ablation for atrial fibrillation..

Eligibility criteria:
inclusion criteria: * age ≥ 18 * drug refractory, symptomatic paroxysmal atrial fibrillation exclusion criteria: * contraindication to solumedrol * persistent or permanent atrial fibrillation * previous history of radiofrequency ablation for atrial fibrillation

Keywords: atrial fibrillation corticosteroid radiofrequency catheter ablation for atrial fibrillation