Kornimate/medical-research-clean huggingface dataset:
adolescent, caregiver, and young adult perspectives of the transition from pediatric to adult care for sickle cell disease: a preliminary evaluation of the sickle cell disease transition program

Conditions: Sickle Cell Disease

Summary: sickle cell disease (scd) is a debilitating genetic disorder affecting 70,000-100,000 americans. it is frequently associated with very serious medical complications. for children with scd, successfully transitioning to adult care is a vital step in ensuring continuity of care, managing their disease, and improving their health outcomes. transition programs have been created to facilitate the transition process. however, few studies have assessed transition readiness and whether transition program components meet the transition needs of patients and families. the purpose of this study is to explore transitioning from pediatric care to adult care and to assess components of the sjcrh scd transition program from three perspectives: adolescents with scd, their caregivers, and young adults with scd who have transitioned to adult care. data collection methods will include focus groups, questionnaires, and checklists. qualitative data analysis procedures will be used to examine the data.

in this study, through the use of focus groups and questionnaires, we will identify perceptions of transition from pediatric to adult care, transition readiness, disease knowledge, and self-management skills, and assess components of the st. jude children's research hospital (sjcrh) sickle cell disease transition program. participants will participate in focus groups to discuss transition and transition-related concepts and evaluate components of the transition program. additionally, participants will complete questionnaires about specific aspects of the transition program and about current disease knowledge and management skills.

Eligibility criteria:
inclusion criteria: * adolescents with scd (all genotypes) ages ≥ 12 years old and ≤ 18 years old and currently receiving services through the sjcrh sickle cell disease transition program. * caregivers who have resided with the adolescent with scd for at least 2 years prior. * young adults with scd (all genotypes) ages ≥ 18 years old and ≤ 30 years old who have transitioned to adult care exclusion criteria: * non-english speakers. * adolescents and young adults with sickle cell trait.

Keywords: transition program perspectives
epidemiology of acute phase protein and chd

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Atherosclerosis

Summary: to use the multiple risk factor intervention trial (mrfit) stored serum bank to do nested case-control studies of various serum risk factors in coronary heart disease incidence and mortality.

background: the use of stored serum from the mrfit cohort contributed additional information on how various lipid fractions and other serum constituents interact to produce atherosclerotic disease. the cost of performing such studies on a new cohort would be many times greater. design narrative: the case-control study evaluated: 1) the relationship between acute phase reactants, albumin, alpha 1 glycoprotein c-reactive protein and sialic acid; 2) oxidized low density lipoprotein cholesterol (ldlc) measured by thiobarbituric acid reactive substances (tbars), and risk of myocardial infarction or coronary heart disease death; 3) lp(a); 4) antioxidized vitamin e and carotene. the study was done in one year because of the need to analyze the specimens shortly after they were thawed. the statistical analysis was done in collaboration with university of minnesota coordinating center. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
retrospective evaluation of thrombo-embolic complication in pelvic fracture surgery

Conditions: Venous Thromboembolism; Pelvic Fracture

Summary: pelvic fracture are very often treated by surgery ; however there are a high level of thrombotic risk during the surgery (venous thrombo embolic events represent about 10% to 50%. the aim of our study is to report the number of these events and identify the risk factor associated to these events regarding greenfield risk assessment profile .


Eligibility criteria:
inclusion criteria: * indication to pelvic fracture surgery * age above 18 years exclusion criteria: * pelvic fracture without surgery indication.
maternal choline supplementation and cannabis use during pregnancy: impact on early brain development

Conditions: Child Development; Cannabis Use

Summary: the goal of this study is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women who have used cannabis products during the current pregnancy improves the offspring\&#39;s brain-related development during the first 3 months. participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. the primary outcomes are the child\&#39;s brain responses to sound at 4 weeks corrected age and infant behaviors at 3 months corrected age as reported by the primary caregiver. secondary outcomes include motor, socio-emotional, language and cognitive development.

phosphatidylcholine (pc) is a form of choline, a nutrient that is sometimes referred to as vitamin b4 or vitamin j. choline is for normal growth everywhere in the body, including in the brain. pc is a naturally occurring substance and can be found in many different kinds of food including milk, liver, and eggs so most people get enough choline. however, when a woman is pregnant and her baby is growing many new cells, more pc may be needed. research has suggested that the presence of adequate amounts of choline during pregnancy and breastfeeding can help ensure healthy fetal brain development and may have long-lasting positive effects on cognitive function. problems in behavioral and cognitive development into childhood have been reported in children of mothers who used cannabis during gestation. alternatively, two studies of maternal choline levels during pregnancy have reported beneficial effects of higher levels on childhood behavioral and cognitive development. this study assesses whether a higher dose of choline taken during pregnancy will have positive results on offspring development. participants in this double-blind study will be randomly assigned to receive either placebo or 1028 mg of choline daily throughout pregnancy, until delivery. vital signs will be taken, potential side effects will be assessed, and study medication will be given at each visit. blood samples will be taken at enrollment, and approximately at weeks 16, 22, 28, 34. children will be followed and assessed until 3 months of age.

Eligibility criteria:
inclusion criteria: * pregnant women who report cannabis use during current pregnancy exclusion criteria: * pregnancies complicated by fetal anomaly, including neural tube defect or chromosomal abnormality, or multiple gestations due to increased obstetrical risks * women with major preexisting maternal medical morbidities * women with a prior history of fetal death * current personal history of chronic infections, including hiv * current personal or family history out to first-degree relatives of trimethylaminuria or homocystinuria * primary language other than english or spanish * evidence of noncompliance

Keywords: phosphatidylcholine choline
clinical and healthcare outcomes from real-world use in the united states of a companion ai during af ablation

Conditions: Atrial Fibrillation

Summary: observational, multi-center, clinical device registry for us patients with a primary goal to observe the clinical outcomes in patients who are mapped with volta medical's vx1 or af-explorer systems during af ablation procedures.


Eligibility criteria:
inclusion criteria: 1. patients 21 years of age or older who is: * indicated for af ablation or * who has received an af-ablation with the past 24 months where vx1 was used or 2. patients are receiving or received a catheter ablation procedure for af according to current guidelines 3. patients must be able and willing to provide written informed consent to participate in the clinical trial exclusion criteria: 1. patients not indicated or were not indicated for catheter ablation according to current guidelines 2. patients with af secondary to an obvious reversible cause 3. patients who are or may potentially be pregnant 4. enrollment in an investigational study evaluating another non-vx1 investigational device, biologic, or drug
gait analysis following knee viscosupplementation

Conditions: Gait; Knee Osteoarthritis; Injection

Summary: this is a pilot, double-blind, randomised trial that investigates which gait parameters are more sensitive following a single bolus injection of hyaluronic acid with mannitol, hyaluronic acid with sorbitol, or saline placebo for knee osteoarthritis. outcome measures are gait analysis through a inertial sensors (physilog), knee society score (kss), university of california los angeles (ucla) activity-scale and euroqol 5dimensions. follow-up will be of 4 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of primary knee oa ahlbäck ii-iii and signed consent forms. exclusion criteria: * recent history of infection, diabetes, neurological impairment, chronic venous or lymphatic stasis, pain medication of level 2 or 3, psychiatric conditions, contraindications for ha joint injection and previous ha or steroid injections in the last six months.
car-t cell therapy in patients with hematological malignancies

Conditions: CART Therapy

Summary: the prognosis of relapsed or refractory lymphoblastic leukaemia (all) and diffuse large b-cell lymphoma (dlbcl) is poor with conventional treatment with complete response rates around 25-30% with a median progression-free survival (pfs) of around 2 months and 7 months, respectively, despite the use of allogeneic and autologous haematopoietic stem cell transplantation. the recent introduction of car-t (chimeric antigen receptor t-cells) therapy as a therapeutic option has been a breakthrough in the management of these entities.

information on baseline patient characteristics, haematological disease, comorbidities and car-t therapy procedure (lymphodepletion schedule, infused product) will be collected. early post-infusion toxicity and recurrence data will be collected. the grading of adverse effects will follow the ebmt and astct guidelines. finally, data will be collected to analyse survival and, in case of death, cause of death).

Eligibility criteria:
inclusion criteria: * adult patients \>18 y/o * patients receiving car-t cell therapy in spain, since 2018. exclusion criteria: t * patients receiving cart therapy as part of a clinical trial.
magnetic resonance imaging (mri) for early diagnosis of cystic fibrosis (cf)

Conditions: Cystic Fibrosis; Lung Disease

Summary: in patients with cystic fibrosis (cf) the clinical course of lung disease is crucial for individual prognosis and life expectancy. imaging modalities are important in the assessment of follow up of structural lung changes and monitoring of pulmonary complications in cf. although high resolution computed tomography (hrct) is the accepted gold standard for evaluation of morphological lung changes in cf, chest-x-ray is widely used as standard imaging procedure for assessment and follow up in these young patients due to less radiation exposure. magnetic resonance imaging (mri) has not been used for lung imaging in cf so far. studies from the 80's and early 90's were not able to show any impact for the use of mri in cf. due to recent technical developments mri of the lung became possible. our study group was able to show that mri is a competitive imaging modality for evaluating changes of the cf-lung in comparison to the gold standard (hrct). so far only patients from the age of 6-7 years were examined. according to recent studies cf is a disease which starts in utero. therefore it can lead to extensive pulmonary changes even in infants and young children. in this age group lung function testing is difficult and not broadly available. an early optimized therapy is crucial for the long term course and outcome of the pulmonary disease. the aim of this study is to evaluate morphological and functional mri for early diagnosis of lung changes in children (0-6 years) with cf.

month 1-2: protocol adaptation for infants and small children month 3-14: patient examinations (20 patients with sedation) month 15-18: data evaluation

Eligibility criteria:
inclusion criteria: * informed consent signed by the parents or a legal guardian * sedation as necessary * conventional clinical indicated diagnostic procedures (lung function test, chest-x-ray, ct) exclusion criteria: * study exclusion in case of contra indications for mri: * patients with cardiac pace maker, metallic implants (e.g. cerebral vessel clips) as well as other conditions that prohibit the exposition of a patient to a strong magnetic field. * no informed consent * dyspnea, which disables the patient to follow breathing instructions during the study.

Keywords: cystic fibrosis, lung disease, mri, morphology, function morphological mri functional mri correlation to clinical data
lowering caloric density of the diet

Conditions: Obesity; Feeding Behavior

Summary: for weight loss to occur, energy intake needs to be reduced to incur an energy deficit. one dietary strategy that may facilitate reducing energy intake and enhancing weight loss is consuming a diet low in dietary energy density (ed). the ed of a given food, defined as the ratio of energy of the food to the weight of the food (kcal/g), is largely determined by water content, but is also affected by fat and fiber. although the 2010 dietary guidelines encourage an eating pattern low in energy density (ed) to manage weight, it is currently not known what the best strategy is for reducing ed in the diet. eating a greater number of foods low in ed or reducing the number of foods high in ed may reduce overall dietary ed. as ed is believed to reduce intake by allowing a greater weight of food relative to total energy consumed assisting with enhancing feelings of fullness, it is anticipated that either increasing consumption of low-ed foods in the diet alone or combining an increase in consumption of low-ed foods with a decrease in consumption of high-ed foods may be the best strategies for reducing overall dietary ed for weight loss.


Eligibility criteria:
inclusion criteria: * 1) age between 18 and 65 years and 2) a body mass index (bmi)7 between 27 and 45 kg/m2. exclusion criteria: 1. report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the physical activity readiness questionnaire (par-q)8 (medical conditions that could limit exercise for safety reasons will be required to obtain written physician consent before participating in the investigation) 2. report being unable to walk for 2 blocks (1/4 mile) without stopping 3. are currently participating in a weight loss program and/or taking weight loss medication or lost \> 5% of body weight during the past 6 months 4. report major psychiatric diseases or organic brain syndromes 5. have had bariatric surgery or are planning to have bariatric surgery within the next 4 months 6. intend to move outside of the metropolitan area within the time frame of the investigation 7. are pregnant, lactating, \< 6 months post-partum, or plan to become pregnant during the investigation.
conservative versus operative - first time patella dislocations

Conditions: Patella Dislocation

Summary: there is no consensus regarding whether rehabilitation or surgical management is best for the management of a primary patellar dislocation. consequently this prospective randomized controlled aims to compare the incidence of recurrent knee dislocations and patient reported outcomes of patients with primary patellar dislocations managed with surgery (medial patellofemoral ligament reconstruction) compared to non-operative management (a standardized rehabilitation protocol, control group).

long term sequalae of first-time patellar dislocations include recurrent knee instability, osteoarthritis, and a decreased quality of life, and yet there is no consensus on the best management for these patients. despite an increasing trend toward investigating operative vs non-operative management of primary patellar dislocations, scarce level-1 evidence exists comparing the two treatment modalities. indeed, the few meta-analyses suggesting improved outcomes of operative treatment for first time patellar dislocations mainly utilize retrospective cohort studies. a randomized-controlled trial of 39 patients with primary patellar dislocations with a mean age of 24 (21 operative vs 18 non-operative), found decreased rates of recurrent knee instability after a mean follow up of 44 months (0% in operative vs 35% in non-operative), and a higher kujala knee score (88.9 in operative vs 70.8 in non-operative; p=0.001). a controlled but non-randomized prospective controlled trial among 69 patients with a mean age of 18, (30 operative vs 39 non-operative), found lower rates of recurrent knee instability after a mean follow up of 24 months (0% in operative vs 20.5% in non-operative and a higher kujala knee score (86.3 in operative group vs 80.03 in non-operative; p \<0.05).the scarce randomized, prospective data investigating the appropriate management in primary patellar dislocations underscores the importance of the current study in providing high-quality evidence to the debate of how to best manage primary patellar dislocations. this study aims to compare the incidence of recurrent knee dislocations and patient reported outcomes of patients with primary patellar dislocations managed with surgery (medial patellofemoral ligament reconstruction) compared to non-operative management (a standardized rehabilitation protocol, control group).

Eligibility criteria:
inclusion criteria: * age 12 and older * patients seen by the columbia university shoulder elbow and sports medicine service * patients who experience a first-time patella dislocation exclusion criteria: * coexistent ligament injury or osteochondral fracture necessitating acute surgical intervention * previous knee surgery * knee instability prior to injury * inability or unwillingness to adhere to study participate * lost to follow up
comparison of alignment achieved using the velys robotic-assisted solution versus manual instrumentation in total knee arthroplasty

Conditions: Osteo Arthritis Knee; Osteoarthritis

Summary: the purpose of this post-market research study is to gather clinical and radiographic (x-ray) information about total knee replacement surgeries completed with the velys robotic-assisted solution and with standard manual instrumentation. the velys robotic-assisted solution helps the surgeon to plan bone cuts and then accurately achieve the planned cuts during the total knee replacement surgery. the study aims to compare how well the velys robotic-assisted system enables the surgeon to position the implants exactly as planned compared to manual instrumentation.


Eligibility criteria:
inclusion criteria: 1. subject is male or female and between the ages of 22 and 85 years at the time of consent, inclusive. 2. subject has a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis or rheumatoid arthritis and in the opinion of the investigator, is a suitable candidate for primary tka using the devices described in this cip with either resurfaced or non-resurfaced patellae. 3. subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the sponsor 4. subject is currently not permanently bedridden, as determined by the investigator 5. subject, in the opinion of the investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow-up visits and co-operate with investigational procedures. 6. subject is able to read and comprehend the informed consent document as well as complete the required pros in english. 7. subject's pre-operative alignment is such that (in the opinion of the investigator) it is appropriate for it to be adjusted to mechanical long leg alignment during surgery. exclusion criteria: 1. the subject is a woman who is pregnant or lactating. 2. contralateral knee has already been enrolled in this study. 3. subject had a contralateral amputation. 4. previous partial knee replacement (unicompartmental, bicompartamental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary tka in affected knee. 5. subject has an active local or systemic infection 6. subject has loss of bone or musculature, osteoporosis, neuromuscular compromise or vascular deficiency in the affected limb in sufficient degree to render the procedure unjustifiable in the opinion of the investigator (e.g. absence of musculo-ligamentous supporting structures, joint neuropathy) 7. subject has severe instability secondary to advanced loss of osteochondral structure or the absence of collateral ligament integrity. 8. subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months. 9. subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.

Keywords: arthroplasty knee robotic-assisted velys accuracy
fractionated stereotactic radiotherapy in patients with acromegaly

Conditions: Acromegaly

Summary: hypothesis: fractionated stereotactic radiotherapy is a safe therapy for treatment of patients with acromegaly in terms of both tumour control and biochemical remission

an audit was done on 34 patients with acromegaly (consecutive cohorte) treated with fractionated stereotactic radiotherapy in rigshospitalet/national university hospital, copenhagen, denmark. all patients had mr control regularly to monitor tunour control, and biochemical control assessed by growth hormone measurements during an oral glucose tolerance test. furthermore all other pituitary axes were tested for sufficiency and concomitant medication likewise registered. the 7 year interim analysis demonstrated an acceptable tumour control and biochemical remission profile, and most patient had subsequent withdrawal of somatostatin analogue- and growth hormone receptor antagonis therapy. the observational study will continue with a new update in approx 2 years

Eligibility criteria:
inclusion criteria: adults active acromegaly pituitary tumour on mri biochemical activity - exclusion criteria: pregnancy no visible tumour on mri -

Keywords: acromegaly irradiation remission pituitary function