Kornimate/medical-research-clean huggingface dataset:
multi-scale modeling of breast conserving therapy

Conditions: Breast Cancer

Summary: the proposed study is a single-center, prospective, pilot, observation study to tabulate and measure the changes that occur during treatment and healing for breast conserving therapy (bct) in women with non-metastatic breast cancer for comparison to the multiscale model of breast lumpectomy and healing in order to identify targets for improving bct. the study will be comprised of 12 de novo breast cancer patients with non-metastatic breast cancer undergoing bct. subjects will be enrolled in the study during the 3 weeks prior to receiving their bct surgery and will be followed for six months after the bct surgery. a total of 6 visits (not including the surgery) are planned.

this is a single-center, prospective, pilot observation study. eligible subjects who enroll in this study will begin at the time of informed consent, which will occur during the pre-operative, surgical evaluation time. once consented, a 3-dimensional 180° camera surface image will be taken and a pain-scale score will be completed. data from the medical history will be recorded. as standard of care, the surgery will be scheduled and performed. following surgery, a series of 5 standard of care visits will occur over the subsequent 6 months, that will include research measures of local ultrasound x5 and 3-dimensional surface imaging x3. the pain scale score will be administered pre and post ultrasound on the 5 post-operative visits. a judging of the cosmesis will take place at weeks 10 and 26 by independent surgeons. the participant's role in the study will be completed after the week 24 visit.

Eligibility criteria:
inclusion criteria: 1. adult females ≥ age 30 years 2. have early stage (stage i, ii), non-metastatic breast cancer 3. planned to receive bct 4. have received a pre-operative mammogram within 30 days of surgery 5. have received pre-operative magnetic resonance imaging (mri) within 30 days of surgery 6. planned to receive post-surgery radiotherapy by whole breast radiotherapy 7. signed informed consent form prior to any research assessment exclusion criteria: 1. adult females younger than 30 years of age 2. previous breast cancer 3. neo-adjuvant therapy for breast cancer 4. pregnant or nursing females 5. participation in a study of investigational drug in the previous 30 days or 5 half-lives of the investigational drug

Keywords: breast mastectomy lumpectomy breast therapy
ciliary neurotrophic factor (cntf) safety trial in patients with macular telangiectasia (mactel)

Conditions: Idiopathic Juxtafoveal Telangiectasia

Summary: this study is a phase 1, open label, non-randomized, multi-center, pilot study to evaluate the safety and tolerability of nt-501 implants in 5-7 study participants with mactel.

protocol for extended follow-up of a phase 1 multicenter open label safety and tolerability clinical trial of ciliary neurotrophic factor (cntf) in patients with macular telangiectasia type 2 (mactel)

Eligibility criteria:
inclusion criteria: * the participant must be offered sufficient opportunity to review the informed consent form, agree to the form's contents and sign the protocol's informed consent; * the participant must have bilateral mactel; * women of childbearing potential and all men must agree to use an effective form of birth control during the study; * participant must be medically able to undergo ophthalmic surgery for ect implant; * the participant's best-corrected visual acuity 64 letters or better (20/50 or better) in the study eye; exclusion criteria: * participant is \< 21 years of age; * participant is medically unable to comply with study procedures or follow- up visits; * participant has evidence of ocular disease other than mactel that may confound the outcome of the study (e.g., diabetic retinopathy with manifest macular edema, uveitis, etc.); * participant has a chronic requirement (e.g., ≥ 4 weeks at a time) for ocular medications and/or has a diagnosed disease, that in the judgment of the examining physician, may be vision threatening or may affect the primary outcome (artificial tears are permitted); * participant has evidence of subretinal neovascularization in either eye; * participant has evidence of central serous chorio-retinopathy (csr) in either eye; * participant has evidence of pathologic myopia in either eye; * participant has had a vitrectomy, penetrating keratoplasty, trabeculectomy or trabeculoplasty;

Keywords: mactel macular telangiectasia type 2
anatomic outcomes following ozurdex injections

Conditions: Retinal Vein Occlusions

Summary: ozurdex(tm) has recently been fda approved for use in macular edema secondary to retinal vein occlusion. it remains unclear how quickly the drug works and for how long as the initial studies did not have frequent anatomic monitoring. this study will utilize frequent spectral domain oct imaging to better understand the onset of treatment effectiveness and duration of action on the anatomic thickness of the retina, in addition to distinguishing structural abnormalities of responders from non-responders.

focal laser therapy has been the gold standard for the treatment of macular edema secondary to branch vein occlusion (brvo), though it has not been shown to be effective for central vein occlusion (crvo). intravitreal corticosteroids have been shown in many case series to be effective at diminishing macular edema secondary to both brvo and crvo. sustained drug delivery models have been sought after to relieve the need for frequent injections. ozurdex has recently been found to be effective for the treatment of macular edema following brvo or crvo and has been approved by the fda for these indications. the onset of effectiveness and duration of action on the anatomic thickness of the retina have not yet been demonstrated. in addition, it is uncertain as to when the clinician can label the patient as a responder or nonresponder. we also believe this study will help identify patients that may need more frequent dosing schedules.

Eligibility criteria:
inclusion criteria: * patients diagnosed with brvo/crvo who are otherwise eligible to receive treatment with ozurdex (tm) exclusion criteria: * patients younger than 21 years of age, unwilling or unable to grant informed consent, participation in a clinical trial within the 30 days prior to enrollment. patients receiving any other ocular therapy.
correlation of hospital stay length with the glucose levels after cardiac surgery

Conditions: Stress Hyperglycemia

Summary: the study is designed to test if there is any correlation between the glucose levels in the postoperatory period and the length of hospital stay.

the stress hyperglycemia commonly observed in the postoperatory period, there have been several studies to assess if there is benefit of having a strict glucose control or not. this study will assess if there is correlation between the glucose levels measured continuously with the length of the stay in the hospital.

Eligibility criteria:
inclusion criteria: * physical status classification of the american society of anesthesiologists (asa) ii-iv * patients programmed for cardiac surgery * any body mass index exclusion criteria: * pregnant women * chronic kidney disease (ckd) stage 2 or higher

Keywords: hyperglycemia
comparison of esophageal manometry and ct scan measurements

Conditions: Morbid Obesity; Respiratory Failure

Summary: the goal of this study is to determine the relationship between esophageal pressure (pes) and superimposed pressure (sp) in subjects with morbid obesity.

in the clinical setting, pes is a surrogate for pleural pressure, while sp is measured by means of chest ct scan images. the sp highly approximates the vertical pleural pressure gradient both in normal lungs and injured lungs in lean subjects. it is known that in the healthy obese patient the pes is higher than that in normal lean patients, but there is no information about the relationship between high pes with the sp in subjects with morbid obesity. the investigators hypothesized that factors other than superimposed pressure determine the high pes in subjects with morbid obesity. hence, pes should be high despite the low sp found in healthy obese individuals. the investigators will test this hypothesis in a prospective observational cohort study. in 12 subjects (6 with body mass index \> 40kg/m2, and 6 with body mass index \< 30kg/m2 ) with scheduled chest ct scan for clinical purposes: 1. the pes will be measured during spontaneous breathing (baseline values at end-expiration and variations during tidal breathing). to achieve this purpose, an esophageal balloon (aveatm ventilator esophageal pressure monitoring tube set, 8 fr, carefusion, yorba linda, ca, usa) will be inserted after administration of local anesthesia (lidocaine spray 2%). 2. the sp will be determined by lung computed tomography imaging and the pleural pressure will be calculated in non-dependent lung regions as the difference between pes and sp. for this purpose, an additional low-dose ct scan at the end-expiration will be taken after the scheduled ct scan. during the research procedure, the pes during the whole respiratory cycle, the ct image at the end-expiration, demographics, past and current medical history will be recorded. there will be no follow-up phase in this study.

Eligibility criteria:
inclusion criteria: * patients who are scheduled to take a chest ct scan for the clinical purpose at mgh radiology department * 6 adult subjects with bmi more than 40kg/m2 * 6 adult subjects with bmi less than 30kg/m2 * more than 18 years old exclusion criteria: * presence of pneumothorax * history of spontaneous pneumothorax * severe coagulopathy (inr ≥ 4) * severe thrombocytopenia (platelets count ≤ 5,000/mm3) * usage of any devices with electric current generation such as pacemakers or internal cardiac defibrillator * recent esophageal trauma or surgery * other esophageal diseases, such as esophageal cancer, leak, varices, and hernia * presence of hypoxemia, short of breath and dysphagia. * presence or suspicion of pneumonia or lung fibrosis.

Keywords: esophageal manometry superimposed pressure pleural pressure chest ct scan
progression of atherosclerotic plaque determined by computed tomographic angiography imaging(paradigm)

Conditions: Coronary Heart Disease

Summary: to describe the natural history of the coronary atherosclerotic plaque development and progression over time by ccta with demographic and laboratory data for refinement of risk stratification of patients referred for ccta.

all paradigm study patients underwent initial and follow-up ccta based on order from their primary physician. demographic data, targeted medical history, cardiovascular risk factors, and laboratory data was prospectively collected in electronic case report forms (ecrfs) at the time of the initial ccta and at the time of follow-up ccta.

Eligibility criteria:
inclusion criteria: * patients underwent two or more clinically indicated ccta with 64-detector rows or greater for cad evaluation * patients underwent at least 2 year interval between the baseline and follow-up ccta exclusion criteria: * poor image quality of ccta

Keywords: coronary heart disease coronary computed tomography angiography (ccta) coronary atherosclerotic plaque coronary atherosclerosis
effects of coordinated care for disabled medicaid recipients

Conditions: Chronic Conditions Faced by Medicaid Recipients With Disabilities

Summary: the purpose of this study is to improve the quality of care for individuals with multiple chronic conditions, health care systems have begun turning to coordinated care. although coordinated care can refer to many different things, it usually includes activities such as assessing patients' needs, referring them to the right doctors, helping them make and keep appointments, and helping them comply with medical or dietary recommendations. to understand the effects of coordinated care for high-needs medicaid recipients, mdrc is conducting a randomized trial of a pilot coordinated care program run by kaiser permanente for blind and disabled medicaid recipients in the denver area.


Eligibility criteria:
inclusion criteria: * disabled, in fee-for-service medicaid exclusion criteria: * under age 18, over age 64

Keywords: all conditions faced by disabled medicaid recipients
clinical application of a self stabilizing atlantoaxial fusion cage

Conditions: Atlantoaxial Dislocation

Summary: conventional open surgery often requires extensive dissection of the muscle insertion points of the suboccipital muscle group during the insertion position and direction of the atlas axis screw, resulting in sustained postoperative occipital neck pain and movement dysfunction. in order to overcome the shortcomings of the prior art mentioned above, the present invention provides a self stabilizing fusion cage with a wing plate. during surgery, a thinner and smaller screw through the wing plate is used to achieve a secure connection between the atlas axis and the fusion cage. due to the smaller screw size, the screw placement has higher safety. the purpose of this study is to compare the advantages of using this new fusion cage compared to traditional surgical instruments.


Eligibility criteria:
inclusion criteria: 1. atlantoaxial dislocation 2. agree to use a new self stabilizing atlantoaxial fusion cage for surgery where feasible 3. sign an informed consent form; exclusion criteria: 1. atlantoaxial dislocation without surgical treatment 2. patients who refuse to participate in this project
sacroiliac (si) screws: the effect of si screw removal on patient-reported pain and functional outcomes

Conditions: Sacroiliac Joint; Pain; Pelvis

Summary: chronic pain following surgical stabilization of a pelvic fracture is very prominent and can have a major affect on a patient's quality of life. persistent pain after radiographic evidence of fracture union commonly leads to implant removal. but, the routine removal of orthopaedic fixation devices after fracture healing remains an issue of debate.

many surgeons remember patients whose intractable, hardly explainable local symptoms and complaints of pain resolved quickly after a hardware-removal procedure. however, implant removal requires a second surgical procedure in scarred tissue, poses a risk for nerve damage, infection and re-fractures, and is not a guarantee of pain relief. rates of implant removal vary based on anatomic location and implant selection. many studies have introduced and assessed the outcomes of hardware removal in the ankle, tibia and femur. but, there is currently no controlled trial that assesses the benefits and harms of sacroiliac (si) screw removal in pelvic fracture patients. reports in literature are not consistent concerning the incidence of painful hardware and the outcome and pain relief after hardware removal. there is conflicting evidence that removing hardware decreases acute pain in ankle, tibia, and femur fractures but there is a need to explore the effect of si screw removal in pelvic fracture patients. the investigators propose to prospectively randomize patients with a pelvic fracture requiring the use of si screws for stabilization to removal versus non-removal of si screws and track which group has less pain and need for narcotic pain medications.

Eligibility criteria:
inclusion criteria: * the patient is between 18 and 80 years of age, inclusive * the patient has a pelvic fracture that required si screw stabilization * the patient has reached skeletal maturity * the patient's pelvic fracture was the result of trauma (includes polytraumatized patients) * the patient is english-speaking * the patient's pelvic fracture was initially treated at shock trauma * the patient is currently experiencing pain associated with his/her pelvic fracture * the patient's surgeon agrees to randomization (the patient is amendable to either si screw removal or non-screw removal treatment) * the patient is able to be randomized between 4 and 8 months post-si screw stabilization surgery at an orthopaedic follow-up appointment exclusion criteria: * the patient is non-ambulatory due to an associated spinal cord injury * the patient was non-ambulatory pre-injury * the patient is currently pregnant * the patient is enrolled in another study that does not allow co-enrollment * the patient is likely to have severe problems with maintaining follow-up

Keywords: screw removal vs. non-screw removal complications si screw stabilization
high-intensity interval versus combined exercise training in chf

Conditions: Heart Failure

Summary: chronic heart failure (chf) is a clinical syndrome presented with central, cardiac deterioration as well as peripheral vascular and muscular abnormalities, resulting finally to reduced exercise tolerance, quality of life and mortality rates. exercise training is a major component of rehabilitation / secondary prevention interventions, inducing significant beneficial changes in mechanisms of pathophysiology, exercise tolerance, functional capacity and quality of life, while a positive impact on hospitalization and mortality reduction should not be also excluded. there has been growing interest in the characteristics and modalities of exercise training able to induce optimal benefits. high intensity and interval mode have been shown to induce greater benefits than moderate intensity and continuous mode regimes. additionally, there has been sound rationale for the inclusion of strength training, which has been also shown able to yield benefits in terms of exercise capacity and quality of life. however, there haven't been much data on the so called combined regimes, which include both aerobic exercise and strength training. this study aims at investigating the effects of combined high-intensity interval and strength training compared to high-intensity interval exercise alone in chf.


Eligibility criteria:
inclusion criteria: * stable heart failure * ejection fraction \<=45% * optimal medical treatment * nyha class \<=iii exclusion criteria: * contraindications for maximal cardiopulmonary exercise testing (cpet) * moderate to severe copd * inability to follow exercise programs due to orthopaedic problems

Keywords: heart failure aerobic exercise strength training cardiopulmonary rehabilitation high-intensity exercise training
the efficacy of purse-string skin closure with negative pressure wound therapy (npwt) after ileostomy reversal

Conditions: Surgical Site Infection; Wound Heal

Summary: evaluating the effectiveness of the existing 'linear suture + wound drain placement' and 'purse-string suture + negative pressure wound therapy' through a prospective comparative study


Eligibility criteria:
inclusion criteria: * patients experiencing ileostomy repair at multicenter exclusion criteria: * active bacterial infection needing antibiotics before surgery * parastomal infection before surgery * uncontrolled diabetes mellitus * emergency repair of stoma (ex. stoma prolapse, high output stoma etc...) * inflammatory bowel disease
iron deficiency and anemia in cardiac surgery

Conditions: Anemia; Cardiac Surgery

Summary: anemia and preoperative iron deficit in cardiac surgery are associated by an increased volume of transfusion and an increase in complications and/or mortality. recent studies have shown that epo and iron administration the days preceding the operation results in a reduction of perioperative transfusion for patients with preoperative anemia.


Eligibility criteria:
inclusion criteria: * patient with cardiac surgery * with iron deficiency with or without anemia exclusion criteria: * anemia without iron deficiency * iron overload * jehovah's witnesses * endocarditis * treating neoplasia * uncontrolled hypertension * with infection * alfa-epoetin hypersensitivity * hypersensitivity of hamster's protein * erythroblastopenia induced by erythropoietin * ferinject or mannitol allergy
intraoperative administration of intravenous morphine in patients undergoing laparoscopic cholecystectomy

Conditions: Postoperative Pain; Morphine; Laparoscopic Cholecystectomy

Summary: the goal of this observational, quality improvement study is to compare the effect of a dose of morphine given during gall-bladder removal surgery. the main questions to answer are: * do participants, who are given given a dose of morphine during gall-bladder removal surgery, experience less pain after surgery? * does a dose of morphine during gall-bladder removal surgery cause more side effects? the investigators will compare the effects of two types of anesthesia: a) anesthesia without morphine during surgery, and b) anesthesia with morphine during surgery.

the investigators will use redcap secure web application (via open patient data explorative network, a subsidiary under university hospital of odense, denmark) for data collection and data management. no sample size has been collected as per the observational design. the investigators expect to include an equal number in each study arm, as there has been no indication of change in indications for surgery type. the investigators expect to use students t-test for comparison of groups. if possible logistic regression analyses will be undertaken.

Eligibility criteria:
inclusion criteria: * patients who have had elective laparoscopic cholecystectomy/planned gall-bladder removal surgery exclusion criteria: * age limit as above * patients unable to give consent to anesthesia * patients unable to participate in pain scoring * patients with chronic pain syndromes, characterized by patients receiving regular analgesic treatment and patients with active or previous contact to pain clinic) * patients with active or previous substance abuse * emergency surgery

Keywords: intraoperative morphine for laparoscopic cholecystectomy
wound treatment with 3% sodium pentaborate pentahydrate

Conditions: Wound Healing

Summary: chronic foot wounds which is very difficult to treat are common especially in diabetic and peripheral arterial or venous insufficiency patients. this research is aim to observe the foot wound's recovery with 3% sodium pentaborate pentahydrate hydrogel.

chronic foot wounds which is very difficult to treat are common especially in diabetic and peripheral arterial or venous insufficiency patients. for these reason we prepared a hydrogel formulations. gel preparation: hydrogel formulations were prepared by dispersing 1%(w/v) carbopol polymer (carbopol ultrez-21, lubrizol, usa) in distilled water. neutralization buffer (1.6g of 1m sodium hydroxide solution for 1l polymer-water suspension) was used for the gelation of the polymer. sodium pentaborate pentahydrate (3% w/v), f68 (2% w/v) and f127 (2% w/v) were mixed into the blank hydrogel and stored at 4 °c until it completely dissolved (approximately 24 h). ph of the hydrogel formulation was set to 6.5-7.0 using 1m sodium hydroxide. the hydrogel without any active ingredient was used as negative control (vehicle). for the first group after wound dressing we applied hydrogel with 3% sodium pentaborate pentahydrate, and for the control group after wound dressing we applied hydrogel without any active ingredient everyday for two months. the same doctor observed and took photo of the wounds every week in the outpatients clinic.

Eligibility criteria:
inclusion criteria: diabetic foot wounds exclusion criteria: child

Keywords: diabetic foot wound sodium pentaborate pentahydrate hydrogel