Kornimate/medical-research-clean huggingface dataset:
effects of jet hydro dissection in breast augmentation postoperative pain

Conditions: Breast Augmentation

Summary: erbejet breast augmentation is a novel method of dissection of the subpectoral pocket. study is designed to differentiate parameters of pain between randomized laterality using no touch technique. this is not a free study. patients are required to pay the initial cost of surgery but will receive a refund of a partial payment. patients must undergo evaluation at consultation and surgical quote is provided.

breast augmentation in the subpectoral position has classically been associated with postoperative pain and discomfort within the first two weeks after the operation. minimizing this pain and discomfort and ability to return to normal function soon after the operation has been the goal of numerous interventions. minimal injury no touch dissection techniques have proven results regarding morbidity. erbejet is a novel dissection using a jet of local anesthetic infused saline fluid with a built in coagulation function used for dissection of soft tissues. the study is designed to randomly perform erbejet breast augmentation operation unilaterally on breast augmentation and mastopexy augmentation patients undergoing traditional sub pectoral dissection technique on the contralateral side. patient's record pain scores at regular intervals in the postoperative period. physical examination performed by blinded practitioners assess discomfort and tenderness scores within the two weeks after the operation.

Eligibility criteria:
inclusion criteria: * silicone breast implants candidate exclusion criteria: * history of breast cancer * inability to conform to post operative questionnaire and recovery follow up

Keywords: breast augmentation breast implants silicone implants breast surgery
immuno-regulatory profiling of t cells in gvhd treated with extracorporeal photopheresis

Conditions: GVHD

Summary: extracorporeal photopheresis (ecp) has been used as one of the treatments for graft versus host disease (gvhd). responses were observed in skin, liver, gi tract, mouth, eye and lung. ecp does not cause immune suppression and therefore less risk of infection or relapse of malignancy. however, the exact mechanism of action of this expensive procedure is not fully understood and no predictors of response to ecp are known so far. this reflects the need for a better understanding of gvhd and its response to ecp. blood samples from 15 patients who receive ecp as part of the treatment of gvhd at our institution will be collected. samples will be analyzed using flow cytometer


Eligibility criteria:
inclusion criteria: 1. patients who are recipients of allogeneic stem cell grafts. 2. patients with the diagnosis of gvhd according to established criteria and physician decides to treat using ecp 3. patient must have 100% chimerism with the donor 4. no recent donor lymphocyte infusion. 5. patients must be able to sustain a platelet count and a hematocrit \> 20,000/ml and \> 27% respectively, with or without transfusions. 6. the absolute wbc must be \>1500/ml 7. patient must be willing to comply with all study procedures. exclusion criteria: 1. patients who are unable to tolerate the volume shifts associated with ecp treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, severe asthma or chronic obstructive pulmonary disease, hepatorenal syndrome. 2. active bleeding. 3. international normalized ration (inr) \>2. 4. patients with known hypersensitivity or allergy to psoralen. 5. patients with known hypersensitivity or allergy to both citrate and heparin. 6. patients with co-existing photosensitive disease (e.g. porphyria, systemic lupus erythematosus, albinism) or coagulation disorders. 7. active, uncontrolled infection
trauma informed childhood obesity care for low-income minorities in primary care

Conditions: Childhood Obesity

Summary: the purpose of this pilot study is to examine changes in childhood obesity associated with the implementation of a trauma informed care approach with weight counseling and management among low-income minority children in a primary care setting.

prospective mixed methods pilot study, using both qualitative and quantitative measures. this study will be conducted in two phases. in phase 1 (year 1), the investigators plan to use a modified delphi procedure called the rand/ucla appropriateness method in which the investigators will form a multidisciplinary panel to develop a consensus of incorporating the tic practices based on focus into current best practices for childhood obesity prevention and treatment among low-income minorities to be facilitated by primary care providers. in phase 2 (year 2), the investigators will train and implement the primary care provider-mediated focus tic-com among providers for obese children and their caregivers / parents in the mlk opc family medicine clinic. during this phase, the investigators plan to examine the feasibility and acceptability of delivering the focus tic-com in the primary care setting at mlkopc through surveys and focus groups with both providers and the parents / caregivers of overweight / obese children. the investigators will also explore whether the focus tic-com impact on childhood obesity (as perceived by child's parent / caregiver) and increase linkages to behavioral health care regarding trauma / toxic stress. at 3 month intervals, the investigators will train a subset of providers in the intervention and they will implement the intervention immediately after training.

Eligibility criteria:
year 1: inclusion criteria: • adult experts (\>18 years old) in the fields of trauma informed care and childhood obesity among low-income minorities exclusion criteria: • individuals outside of the fields of trauma informed care or childhood obesity year 2: inclusion criteria: * parents / caregivers of overweight/obese children (ages 2-17 years old) in mlk-opc who speak english or spanish * primary care providers (\>18 years old) who work in the family medicine clinic of the mlk-opc exclusion criteria: * parents / caregivers of children that are not overweight/obese and/or under 2 years old * parent or caregiver that speaks a language other than english or spanish * primary care providers who do not work in the family medicine clinic of the mlk-opc

Keywords: trauma informed care
severe congenital hemostatic defects, cerebral microbleeds and cognition

Conditions: Cerebral Microbleeds, Congenital Haemophilia, Congenital Von Willebrand Disease

Summary: cerebral microbleeds (cmbs) are haemosiderin deposits, resulting from the leakage of erythrocytes from small cerebral vessels, which can be detected noninvasively using susceptibility-sensitive magnetic resonance imaging (mri) techniques. cmbs are commonly observed in daily practice: their prevalence range from five percent in healthy individuals over 65 years old to 50% in patients with a history of stroke. cmbs are associated with intracerebral hemorrhage (ich) and also cognitive impairment and dementia. the pathophysiology of cmbs is thought to primarily involve damage to brain microvasculature but the exact underlying cascade of events, including a potential role for haemostasis, has yet to be elucidated. haemostatic defects (congenital or acquired) may contribute to an increased number and importance of cmbs. congenital bleeding disorders such as haemophilia or von willebrand disease (vwd), populations at high risk of ich, are unique conditions that may give us further insights into a potential role of haemostatic defects in the pathophysiology of cmbs. cmbs might be the missing link between severe haemostatic defects, ich risk and cognitive function. we hypothesized that severe congenital haemostatic defects could contribute to an increased prevalence and number of cmbs, with an impact on cognition in adulthood.


Eligibility criteria:
inclusion criteria: * male or female, older than 18 years old, no upper age limit * adult patients with a severe congenital haemostatic defect * severe or moderate congenital haemophilia a (or b) defined as \<5 iu/dl (\<5%) endogenous fviii (fix) activity at screening * severe von willebrand disease defined as vwf: act ≤15iu/dl (\<15%) at screening * ability of the participant to provide signed and dated informed consent exclusion criteria: * contraindication for brain mri * hiv infection to avoid a bias towards severe multifactorial neurological complications * other known coagulation disorder(s) in addition to haemophilia or von willebrand disease * lack of informed consent

Keywords: cerebral microbleeds (cmbs) congenital haemophilia congenital von willebrand disease (vwd) cerebral small vessel disease (svd) cognition magnetic resonance imaging (mri)
catheter ablation for atrial fibrillation in patients with end-stage heart failure and eligibility for heart transplantation

Conditions: Heart Failure; Atrial Fibrillation

Summary: castle-htx will determine if af ablation has beneficial effects on mortality in patients with end stage hf who are eligible for htx

castle-htx is a randomized evaluation of ablative treatment of af in patients with severe left ventricular dysfunction who are candidates and eligible for htx. the primary endpoint is the composite of all-cause mortality, worsening of hf requiring a high urgent transplantation or lvad implantation. the secondary study endpoints are all-cause mortality, cardiovascular mortality, cerebrovascular accidents, worsening of hf requiring unplanned hospitalization, af burden reduction, unplanned hospitalization due to cardiovascular reason, all-cause hospitalization, qol, number of delivered implantable cardioverter-defibrillator (icd) therapies, time to first icd therapy, number of device-detected ventricular tachycardia/ventricular fibrillation episodes, lv function, exercise tolerance, and percentage of right ventricular pacing. ventricular myocardial tissue will be obtained from patients who will undergo lvad implantation or htx to assess the effect of catheter ablation on human hf myocardium.

Eligibility criteria:
inclusion criteria: 1. symptomatic paroxysmal or persistent af (paroxysmal: ≥2 symptomatic or one documented af episode lasting 30 seconds or more in the last 3 months; persistent: ≥1 documented episode in the last 3 months). 2. eligible for heart transplantation due to end-stage heart failure 3. lv dysfunction with left ventricular ejection fraction ≤ 35% (measured in the last 6 weeks prior to enrollment). 4. nyha class ≥ ii. 5. indication for icd therapy due to primary prevention. 6. dual chamber icd with home monitoring capabilities already implanted. 7. the patient is willing and able to comply with the protocol and has provided written informed consent. 8. sufficient gprs-network coverage in the patient's area. 9. age ≥ 18 years. exclusion criteria: 1. documented left atrial diameter \> 6 cm (parasternal long-axis view) 2. contraindication for chronic anticoagulation therapy or heparin 3. previous left heart ablation procedure for atrial fibrillation 4. acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrollment 5. untreated hypothyroidism or hyperthyroidism 6. enrollment in another investigational drug or device study 7. indication for cardiac resynchronization therapy 8. woman currently pregnant, breastfeeding, or not using reliable contraceptive measures during fertility age 9. mental or physical inability to participate in the study 10. listed as "high urgent" for heart transplantation 11. cardiac assist device implanted 12. planned cardiovascular intervention 13. life expectancy ≤ 12 month 14. uncontrolled hypertension 15. requirement for dialysis due to end-stage renal failure 16. participation in another telemonitoring concept
validation of child drawing hospital scale (cd: h) and the place of the drawing in the evaluation of dental anxiety

Conditions: Dental Anxiety; Dental Pain; Validation; Child Drawing Hospital Scale

Summary: objectives: our study aimed to perform a turkish validation study of the child drawing: hospital (cd:h) scale and evaluate the dental anxiety and pain experienced during the treatment by drawing. study design: pediatric patients between the ages of 4-13 who applied to the pediatric dentistry department between 2018-2020 were included in the study. following the translation of the cd:h scale into turkish and linguistic-cultural validation, the behaviors of pediatric patients during treatment were evaluated with the frankl behavior rating scale, the pain they experienced during treatment with the wong- baker face rating scale, and their anxiety levels were evaluated with the pictures drawn by the patients at the end of the treatment. the data were analyzed with statistical package for the social sciences v23, and the significance level was taken as p \<0.05. results: within the scope of the scale's reliability-validity study, the intra-class correlation coefficient (icc) was evaluated with test-retest consistency. for section a,b,c and total score reliability was found to be positive and strong level correlation. dental anxiety of boys was higher than girls. conclusions: the turkish version of the cd:h scale is a reliable and valid scale that can be used to evaluate the dental anxiety of turkish pediatric patients.


Eligibility criteria:
inclusion criteria: * patients who have toothache and who have undergone dental treatment (filling and root canal treatment) * patients with deep dentin caries who need local anesthesia * children between the ages of 4-13 * patients who are willing to paint and understand commands * patients without any mental or physical disability * patients whose parents agreed to participate in the study and signed their consent exclusion criteria: * children not aged 4-13 * patients with mild to moderate caries who do not need local anesthesia * patients who are not willing to paint * patients with inadequate hand coordination * patients with motor dysfunction * children with any systemic illness * patients with mental or physical disabilities * patients with any syndrome * patients with color blindness * children whose native language is not turkish * patients whose parents refused to participate in the study
effect of food on the pharmacokinetics of oral treprostinil

Conditions: Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Summary: the purpose of this study is to assess the pharmacokinetic and safety profile of a single dose of oral treprostinil following four different meals of varying caloric and fat content.


Eligibility criteria:
inclusion criteria: * subject is healthy and between the ages of 18 and 55 years, inclusive, at screening. * female subjects must weigh between 45 and 100 kg, inclusive, with a bmi between 19.0-29.9 kg/m2, inclusive at screening. male subjects must weigh between 50 and 120 kg, inclusive, with a bmi between 19.0-32.0 kg/m2, inclusive at screening. * subject has a medical history, physical examination, vital signs, ecg and clinical laboratory results within normal limits or considered not clinically significant by the investigator at screening. exclusion criteria: * subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ecg, or laboratory examinations. * subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug. * subject has a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.

Keywords: hypertension, pulmonary treprostinil pharmacokinetics treprostinil diethanolamine pulmonary arterial hypertension
remotely monitored, mobile health-supported high intensity interval training after covid-19 critical illness (remm-hiit-covid-19)

Conditions: Covid19; Critical Illness; High Intensity Interval Training; ICU; Intensive Care Units; Fitness Trackers

Summary: remotely monitored, mobile health-supported high intensity interval training after covid-19 critical illness (remm-hiit-covid-19)

remotely monitored, mhealth (remm) supported high intensity interval training (hiit to improve recovery after intensive care unit (icu) discharge in patients with covid-19 (remm-hiit-icu-covid) will evaluate the feasibility of clinical-, physiological- and patient-centered outcomes associated with a remotely monitored, mhealth-supported high intensity interval rehabilitation exercise training to improve the functional recovery of survivors who have experienced critical illness with covid-19 and have been discharged home from the hospital.

Eligibility criteria:
inclusion criteria: 1. age \>= 18 years 2. icu admission and subsequent discharge for primary diagnosis of covid-19 respiratory failure or infection requiring intubation and mechanical ventilation for \> 48 hours with an icu length of stay of ≥ 4 days. 3. ability to ambulate with or without a gait aid prior to hospital discharge 4. expected hospital discharge directly back to patient's residence (not to a skilled nursing facility, inpatient rehabilitation center, or long-term acute care hospital) exclusion criteria: 1. not ambulating independently prior to covid-19 illness (use of a gait aid permitted) 2. functional impairment resulting in inability to exercise at hospital discharge (including need for home oxygen requirement) 3. unable or unwilling to follow coaching via mobile-health iphone interaction 4. any absolute contraindications to exercise (as outlined in the american thoracic society guidelines for cardiopulmonary exercise testing), including but not limited to: 1. recent (\< 5 days) acute primary cardiac event 2. unstable angina 3. uncontrolled dysrhythmias causing symptoms or hemodynamic compromise 4. symptomatic aortic stenosis 5. uncontrolled symptomatic heart failure 6. acute myocarditis or pericarditis 7. suspected or known dissecting aneurysm

Keywords: critical care covid19 icu high intensity interval training intensive care unit critical illness fitness trackers
afs compared to ahc in treatment of necrotizing fasciitis nf

Conditions: Necrotizing Fasciitis

Summary: necrotizing fasciitis (nf) is a potentially life-threatening soft tissue infection. this study is comparing acellular fish skin graft (afs) to standard of care allograft (ahc) in the treatment of nf. the purpose of this study is to compare clinical outcomes and time until autograft take in patients that were treated with ahc or afs prior to permanent autografting to treat nf.

this will be a prospective, randomized, open-label, interventional, single-center study looking at time to autograft placement and time to full closure in subjects treated with acellular fish skin compared to subjects treated with acellular human cadaver skin to prepare the wound bed prior to grafting. subjects eligible to receive study treatment will be any adult patient (18 years of age or older) admitted to the joseph m. still burn center or advanced wound clinic at doctors hospital augusta with a diagnosis of nf that has been treated and is stable. prior wound excisions will be allowed until the surgeon has deemed the wound stable and free from necrotizing processes. exclusion criteria will be positive pregnancy test on admission, subject has active diagnosis of any autoimmune process, or cancer that in the opinion of the investigator would prevent the subject from successfully participating in the study.

Eligibility criteria:
inclusion criteria: * is ≥18 years of age. * has been admitted to the joseph m. still burn center at doctors hospital augusta or advanced wound clinic for treatment of nf which has been treated and is considered stable. exclusion criteria: * subject has been previously enrolled into this study or is currently participating in another drug or device study that has not reached its primary endpoint. * index wounds that due to anatomical location are unable to apply a npwt device.
role of ondansetron in spinal anaesthesia induced hypotension

Conditions: Spinal Anaesthesia Induced Hypotension

Summary: the objective of this study is to determine the effect of ondansetron on the total consumption of norepinephrine infusion needed to prevent spinal anaesthesia induced hypotension in cesarean section.

ondansetron has been reported to attenuate the incidence of spinal anaesthesia-induced hypotension (saih) and norepinephrine requirement during caesarean section. the mechanism of hypotension following spinal anaesthesia involves the reduction in vascular resistance caused by the sympathetic block and the activation of the bezold-jarisch reflex, leading to vasodilation and hypotension. peripheral serotonin receptors, 5-hydroxytryptamine3 (5ht3), are required for the activation of the bezold-jarisch reflex. in a rabbit model, a 5-ht3 receptor antagonist was reported to suppress bradycardia and hypotension by preventing the bezold-jarisch reflex.

Eligibility criteria:
inclusion criteria: * age from 19 to 40 years old. * singleton pregnancies with a gestational age of at least 37 weeks. * pregnant women are scheduled for elective caesarean delivery. * patients with stable vital signs. * patients with normal laboratory investigations. * patients undergoing spinal anaesthesia for caesarean delivery via pfannenstiel incision with exteriorizaion of the uterus. exclusion criteria: * patient's refusal. * age \ 40 years. * height\<150 cm, weight \< 60 kg, body mass index (bmi) ≥40 kg/m2. * contraindications to spinal anaesthesia (coagulopathy, increased intracranial pressure, or local skin infection). * patients with cardiac morbidities. * hypertensive disorders of pregnancy as pre-eclampsia. * peripartum bleeding. * patients with respiratory morbidities. * convulsions. * bleeding diathesis. * known allergy to any drugs used in this study.

Keywords: ondansetron spinal anaethesia hypotension norepinephrine