Kornimate/medical-research-clean huggingface dataset:
pediatric atorvastatin in diabetes intervention trial (padit)

Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Summary: the purpose of this study is to determine if atorvastatin can improve blood vessel stiffness and blood vessel function in children 10-18 years old with type 1 and type 2 diabetes. subjects will receive atorvastatin 20mg or placebo daily for 3 months and will then switch therapies for the next 3 months. hypothesis: atorvastatin will improve blood vessel function by decreasing arterial stiffness and improving blood flow.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus (t1dm) or type 2 diabetes mellitus (t2dm) for more than 1 year * age 10-18 years. exclusion criteria: * cardiovascular disease (cvd) * liver disease * pregnancy * use of cholesterol or triglyceride lowering drugs * perceived inability to comply with the study protocol * endocrinopathy other than diabetes

Keywords: diabetes children adolescents arterial compliance physiology cardiovascular endothelium
patient navigation to improve surgical access in primary hyperparathyroidism

Conditions: Hyperparathyroidism, Primary

Summary: the goal of this study is to address surgical health equity in historically marginalized participants with primary hyperparathyroidism (phpt). the main questions that this study aims to answer are, how does patient navigation impact: * the proportion of phpt participants undergo parathyroidectomy? * the proportion of phpt participants who complete surgical consultation? * time to surgical consultation? * time to surgery?

patients historically marginalized in medicine are at increased risk of delayed care and undertreatment of phpt, which can result in end-organ damage and reduced quality of life due to fatigue, brain fog, pain and other constitutional symptoms due to imbalances in calcium levels. it can be easily treated with a highly curative, cost-effective, and low risk surgery but less than 40% of patients who qualify for surgery undergo treatment. patients from historically marginalized populations such as black/hispanic/asian race, underinsurance, and older age are disproportionately impacted by lower rates of surgery and longer delays to surgery. this pragmatic pilot trial aims to address surgical health equity in historically marginalized patients with phpt by assessing the impact of navigation, specifically direct outreach and appointment scheduling, on conversion of surgical referral to consultation and conversion of surgical consultation to treatment in two dimensions, timeliness and clinical outcomes. participants will be randomized to receive or not receive scheduling navigation at time of recruitment with a crossover design at 3 months for those who do not receive scheduling navigation at time of recruitment and have yet to complete surgical consultation.

Eligibility criteria:
inclusion criteria: * diagnosed with phpt and not yet had parathyroidectomy who meet criteria for surgical treatment of phpt (osteoporosis, fragility fracture, or evidence of vertebral compression fracture on spine imaging, renal involvement \[renal stone, silent nephrolithiasis on renal imaging, nephrocalcinosis, hypercalciuria (24-hour urine calcium level 400 mg/dl) with increased stone risk, or impaired renal function (glomerular filtration rate 60 ml/min)\], calcium 1 mg/dl above upper limit of normal, age less than 50) * qualify as a member of a racial or ethnic minority group (black, hispanic, asian and pacific islander, native american), lower socioeconomic neighborhoods (by zipcode), socially vulnerable (social determinants of health indicating financial strain, social vulnerability index in the top quartile 75%+ by zip code), or with underinsurance (medicaid, medicare, dual eligible, uninsured) exclusion criteria: * prior parathyroidectomy * end-stage renal disease * renal transplant * vitamin d deficiency * metastatic disease * familial hypocalciuric hypercalcemia * no indication for surgery * unable/unwilling to provide consent

Keywords: parathyroidectomy barriers and challenges to surgical health equity
evaluation of a primary care based lifestyle medicine clinic at uab

Conditions: Obesity and Obesity-related Medical Conditions

Summary: this is a randomized quality improvement project (i.e., not a research study) that will test the implementation and effectiveness of a lifestyle medicine clinic at the university of alabama at birmingham.

this is a randomized quality improvement project that has received a non-human subjects research determination from the irb at the university of alabama at birmingham. this study will use a randomized encouragement trial design to test whether a lifestyle medicine clinic at uab (flow: fitness, lifestyle, and optimum wellness) is implementable and effective for improving cardiometabolic health (e.g., body weight, body composition, blood pressure, blood glucose, and blood lipids). only patients of the uab family and community clinic are included in this project (i.e., no outside recruitment/enrollment).

Eligibility criteria:
inclusion criteria: * current patient of the uab family \& community medicine clinic * bmi: greater than or equal to 25 kg/m2 * previous diagnosis of at least one of the following conditions: * prediabetes or type 2 diabetes * prehypertension or hypertension * dyslipidemia exclusion criteria: * not a current patient of the uab family \& community medicine clinic

Keywords: quality improvement project implementation clinical effectiveness encouragement design
predictive value of soluble cd146 in glioblastoma patients

Conditions: Glioblastoma

Summary: glioblastoma is the most common malignant primary brain tumor with poor prognosis because of its diffusive and infiltrative nature. the fda approved the use of the anti-vegf antibody bevacizumab in recurrent gbm. however, resistance to this anti-angiogenic reagent is frequent and fails to enhance patients' overall survival. the investigators previously identified one novel mechanism responsible for bevacizumab-resistance in cd146-positive glioblastoma (joshkon et al. acta neuropathol commun, 2022). now, the investigators objective is to prospectively monitor the soluble cd146 value in plasma from patients treated by bevacizumab for recurrent glioblastoma. the investigators will collect plasma at baseline, before the first bevacizumab administration, before the second administration, at the time of first mri evaluation and at progression. plasma cd146 value will be analyzed by elisa. the investigators expect to confirm the correlation between soluble cd146 value in plasma and patient response to bevacizumab.


Eligibility criteria:
inclusion criteria: * - adult patients with recurrent idhwt glioblastoma * relapse after standard first line treatment (radio-chemotherapy) * candidate for bevacizumab treatment * able to be monitored by mri * kps ≥ 60% * written signed consent form exclusion criteria: * pregnancy or breast feeding * life expectancy less than 3 months * bevacizumab in first line treatment * other concomitant life-threatening disease * under legal protection

Keywords: glioblastoma cd146 bevacizumab
impact of early mobility on post-surgery recovery in patients undergoing oncologic surgeries

Conditions: Malignant Neoplasm

Summary: this trial studies the impact of early mobility tracked with a 3-dimensional (3d) motion tracking technology (xsens) on post-surgery recovery in patients undergoing oncologic surgeries. xsens uses wireless measurements which could be used in clinical settings to objectively measure movement patterns (the joint range of movement and the distance of movement) during functional activities. post-surgery mobility tracking may help doctors to identify the minimum required level of mobility after inpatient oncologic surgeries to enhance early post-surgery recovery and decrease early post-surgery complications.

primary objectives: i. to investigate objectively using evidence based randomized controlled trial the impact of early mobility (first day after the surgery) after any inpatient oncologic procedures on early recovery of postoperative course. ii. try to find out the minimum level of postoperative mobility that needed for early postoperative course recovery by objective assessment of range of movement for each participant using 3d motion tracking system (xsens). outline: patients are randomized to 1 of 2 arms. arm i: patients walk one to two laps around the ward twice per day, and have mobility tracked with xsens over 5-10 minutes, until discharge from hospital. patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows. arm ii: patients walk for minimum 30 minutes per day and mobility is tracked with xsens over 5-10 minutes up to discharge from hospital. patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows. after completion of study, patients are followed up for 30 days post discharge.

Eligibility criteria:
inclusion criteria: * ambulant inpatient with a stay of \>= 2 days after any inpatient oncologic surgery * eastern cooperative oncology group (ecog) scale of performance status of less than 3 * american society of anesthesiologist score (asa) 3 or less * participants who do not engage in regular exercise regimen before the surgery (other than regular occupational physical therapy) * participant or legal representative must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure exclusion criteria: * patients with altered mental status * patients with psychiatric illness * ecog scale performance status 3 or more * asa score of 4 * participants who engage in regular exercise regimen before surgery (at least one session per week) * patients with restricted movement due to other diseases * patients who require continuous monitoring
effectiveness of microcurrents therapy in pressure ulcers in elderly people

Conditions: Electric Stimulation Therapy

Summary: the purpose of this study is to investigate the effect on the healing of pressure ulcers in elderly people using a care protocol plus the application of microcurrent patches during 12 hours per day compared to the effect of the same protocol plus placebo electric stimulation.

the design of this study is a multicentric, parallel, randomised, triple blind clinical trial with placebo control. the size of the sample will be 30 participants older than 60 years old who are institutionalized in some nursing homes in spain.they will be randomized in two groups: control or experimental. the variables of the study will be collected at three time points: before the intervention, 14 days after the start of the intervention and at the end of the intervention. the statistical analysis will be an intention-to-treat analysis. for the main outcomes variables a two-factor anova will-be performed (intervention-time) with a post-hoc analysis with bonferroni correction

Eligibility criteria:
inclusion criteria: * adults over 60 institutionalized in nursing homes. * participants presenting pressure ulcers in phase ii, iii and iv according to the north american national pressure ulcer advisory panel system and the european pressure ulcer advisory panel system. * time of evolution of the pressure ulcer greater than 1 month and less than 24 months. * ulcer size greater than 1 cm2. * less than 14 points on the braden scale. exclusion criteria: * presence of a pacemaker or any implanted electrical device. * metal implants in the pressure ulcer area. * pressure ulcer in occipital area. * cancer. * osteomyelitis. * 3 or more abnormal blood values at the beginning of the study that indicate a limited healing potential (anemia, iron deficiency, protein deficiency, dehydration, uncontrolled diabetes or hypothyroidism) * allergies to the usual cures protocol established. * systemic infection * recent history (minimum of 30 days) of treatment with growth factors or vacuum-assisted treatment.

Keywords: electric stimulation therapy pressure ulcer aged
evaluation of atelectasis formation with electrical impedance tomography during anesthesia for mri in children

Conditions: Anesthesia

Summary: this study investigates under controlled conditions the variation of poorly ventilated lung units (silent spaces) in children between 1 and 6 years of age measured by electrical impedance tomography during intravenous anaesthesia in a day-hospital setting and before discharge to help further raise safety standards in paediatric anaesthesia

eligible, children, with parental written informed consent, scheduled for a cerebral magnetic resonance image (mri) will receive an intravenous anaesthesia using a propofol infusion of 10 mg/kg/h. at the bern children's hospital all children will be premedicated with midazolam rectal/oral 0.5 mg/kg or dexmedetomidine nasal 2 mcg/kg 20 minutes before the beginning of the procedure eligible children will be prepared for procedure according to the local sops of the paediatric anaesthesia departments. mandatory monitoring will consist of: spo2, hr, nibp. an iv-line for drugs injection will be placed. induction of anaesthesia: after iv-line placement a bolus of propofol of 2 mg/kg followed by a continuous infusion of 10 mg/kg/h will be applied. administration of low-flow oxygen for all children (0.3 l/kg/min) via microstream® smart capnoline® paediatric cannula (philips healthcare, amsterdam, netherlands). this cannula allows to measure the etco2. in case of extremely agitated child an inhalative induction may be performed. this technique represent the actual standard of care and is not associated with increased risks because of the study. before induction of the anaesthesia, before the radiological procedure when the induction is terminated, after the termination of the radiological procedure, before transport to the post anaesthesia care unite (pacu), and before the discharge from the pacu after 2 hours of monitoring ventilation distribution changes by thoracic electrical impedance tomography are measured (each measurement will last 1 min).

Eligibility criteria:
inclusion criteria: * asa physical status 1 to 3, * 1 to 6 years of age with legal guardians providing written informed consent. exclusion criteria: * exclusion criteria are necessity to intubate the child, * contraindication for propofol administration, * congenital heart or lung disease with oxygen * dependency and high aspiration risk (requiring rapid sequence induction intubation).

Keywords: children electrical impedance tomography
study in healthy adults to evaluate pharmacokinetics, safety and tolerability of abt-450 with ritonavir

Conditions: HCV Infection

Summary: the purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of multiple doses of an experimental hepatitis c virus (hcv) protease inhibitor with ritonavir in healthy volunteers.

this is a multiple ascending dose, non-fasting, open label, randomized study.

Eligibility criteria:
inclusion criteria: * overall healthy subjects * non-childbearing potential females included exclusion criteria: * history of significant sensitivity to any drug * positive test for hav igm, hbsag, anti-hcv ab or anti-hiv ab * history of gastrointestinal issues or procedures * history of seizures, diabetes or cancer (except basal cell carcinoma) * clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder * use of tobacco or nicotine-containing products within the 6-month period prior to study drug administration * donation or loss of 550ml or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration * abnormal screening laboratory results that are considered clinically significant by the investigator * current enrollment in another clinical study * previous enrollment in this study * recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol * pregnant or breastfeeding female * requirement for any otc and/or prescription medication, vitamins and/or herbal supplements on a regular basis

Keywords: multiple ascending doses
a prospective comparison of alcon ladarvision wavefront-guided lasik enhancement and conventional lasik enhancement for the correction of residual refractive errors following lasik procedures

Conditions: Refractive Errors

Summary: the purpose of this study is to conduct a prospective clinical trial to compare conventional and wfg lasik for enhancements on post-lasik patients. differences in safety, efficacy, visual quality, and refractive stability will also be compared during this study.


Eligibility criteria:
inclusion criteria: * male or female, of any race, and at least 21 years old at the time of the preoperative exam, and have signed an informed consent. the lower age limit of 21 years is intended to ensure documentation of refractive stability. * at least 6 months from original lasik surgery. * stable refraction with more than 0.75d of spherical equivalent from the desired correction and have less than 1.50d of cylinder in the manifest refraction. * both eyes must be within 1.00d spherical equivalent of each other on the manifest refraction test. * the eye to be treated with wavefront-guided enhancement must have at least a 9.5mm flap. * manifest refraction and ladarwave™ refractions must be within 1.00d. * at least 3 lines potential improvement in ucva. * bscva of 20/20 or better. * good corneal flap and interface. * adequate corneal thickness for surgery (residual stromal bed \> 280 microns). * able and willing to give informed consent. * located in the greater washington dc area for a 12-month period. * access to transportation to meet follow-up requirements. exclusion criteria: * female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. pregnancy will be ruled out with a urine pregnancy test. * concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin, as determined by history. * medical condition(s), which, in the judgement of the investigator, may impair healing, including but not limited to: collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex (as determined by history). * active ophthalmic disease, neovascularization of the cornea within 1mm of the intended ablation zone, or clinically significant lens opacity. * evidence of glaucoma or an intraocular pressure greater than 22mm hg at baseline. * evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye. * flap irregularity(striae, interface debris, scarring, or epithelium). * calculated residual stroma bed less than 280. * stable refraction with less than 0.75d of spherical equivalent from the desired correction and more than 1.5d of cylinder in the manifest refraction.

Keywords: residual refractive error left over from initial lasik correction. higher order aberrations measured using a wavefront analyzer.
the effect of non-surgical periodontal treatment in the renal function of patients with chronic kidney disease: rct

Conditions: Chronic Kidney Disease; Periodontitis

Summary: periodontal disease is a bacterially-induced inflammation. as such, it can become a point of entry of bacteria, toxins and cytokines into the systemic blood circulation, thus adversely affecting the function of kidneys. this is turn can aggravate the condition of patients with ckd. the study hypothesis is that periodontal therapy can improve renal function in patients with ckd and lower the blood levels of markers for systemic inflammation.


Eligibility criteria:
inclusion criteria: * chronic kidney disease (stage i, ii, iii, iv) * at least 12 teeth present in the oral cavity * moderate to severe chronic periodontitis, which is defined as: at least 8 surfaces with periodontal pocket depth (ppd) ≥5mm and at least 4 surfaces with clinical attachment loss (cal) ≥4mm, distributed in at least two quadrants. exclusion criteria: * patients that have had a renal transplant or undergoing dialysis * acute infections or use of antibiotics in the past 3 months. * auto-immune diseases, conditions that cause immunosuppression or use of immunosuppressant medication. * systemic conditions that require antibiotic prophylaxis for routine periodontal therapy. * non-surgical periodontal therapy in the past 6 months or surgical periodontal therapy in the past 12 months. * use of medication that can cause gingival hyperplasia such as cyclosporine or fenintoin. * myocardial infarction or cerebral vascular incident in the past 12 months or uncontrolled angina.

Keywords: ckd, renal, chronic kidney disease, periodontitis, perio
ranibizumab versus low-fluence photodynamic therapy in the treatment of chronic central serous chorioretinopathy

Conditions: Chronic Central Serous Chorioretinopathy

Summary: the purpose of this study is to compare the efficacy and safety of intravitreal ranibizumab injection versus low-fluence pdt in the treatment of chronic csc.

central serous chorioretinopathy (csc) is characterized by serous detachment of the neurosensory retina. the pathophysiology of csc is not certain and various theories are proposed including impaired function of retinal pigment epithelium (rpe), choroidal ischemia and choroidal hyperpermeability leading to rpe damage. acute csc with monofocal or paucifocal changes of rpe usually shows spontaneous resolution and has a favorable visual outcome. chronic csc is characterized by multifocal or diffuse decompensation of rpe associated with persistent detachment of neurosensory retina. this might lead to cystoid macular degeneration, foveal atrophy and damage to the foveal photoreceptor layer, consequently resulting in irreversible significant visual loss. photodynamic therapy (pdt) was proposed for the treatment of chronic csc. modified parameters of pdt such as shortening of the time of laser emission and reduction of a total light energy have been suggested to reduce the irreversible damages induced by conventional pdt. recently, intravitreal injection of antibody to vascular endothelial growth factor(vegf) was proposed as a new treatment option based on the effect of anti-permeability. several reports demonstrated acceptable outcomes after intravitreal bevacizumab injection, one of anti-vegf agent. but the clinical results with ranibizumab are not reported yet. the purpose of this study is to compare the efficacy and safety of intravitreal ranibizumab injection versus low-fluence pdt in the treatment of chronic csc.

Eligibility criteria:
inclusion criteria: 1. best-corrected visual acuity (bcva) between 0.0 and 1.0 logarithm of the minimal angle of resolution (logmar) 2. presence of subfoveal fluid persisting for 3 months or more on optical coherence tomography (oct) 3. presence of leakage and multifocal/diffuse rpe decompensation on fluorescein angiography (fa) 4. choroidal vascular hyperpermeability and abnormal dilation of choroidal vasculature on indocyanine angiography (icga) exclusion criteria: 1. previous treatment, such as laser photocoagulation, pdt, intravitreal injection of steroid or anti-vegf agent 2. evidence of choroidal neovascularization 3. any other ocular diseases that could affect visual acuity 4. systemic steroid treatment in the previous 12 months 5. media opacity such as cataract that could interfere with adequate acquisition of oct, fa and icga images

Keywords: chronic central serous chorioretinopathy ranibizumab photodynamic therapy