Kornimate/medical-research-clean huggingface dataset:
temperature and injury in radiotherapy radiation skin injury

Conditions: Breast Neoplasm Female; Radiation Toxicity

Summary: the main purpose of the present study was threefold: (1) to describe the thermographic response after radiation; (2) to investigate whether there was a significant temperature change over time and among the different radiation-dermatitis score; and (3) to test if temperature change could be used to predict the development of radiation-induced skin injury in the incipient stage.

radiation skin injury (rsi) is a frequent adverse reaction reported encountered by patients undergoing radiotherapy, occurring in about 87%-95% of irradiated patients and is characterized by swelling, redness, pigmentation, ulceration, fibrosis, pain, warmth, burning and itching of the skin. rsi has an effect on the level of discomfort experienced and the quality of life of patients, and may require interfering with radiation schedule and complex surgical reconstruction especially when combined with molecular targeted therapy. however, evaluation of rsi is not straightforward. there is no standard instrument for objective clinical evaluation of the severity of radiation skin injury. previous studies have shown that radiation leads to the development of cutaneous vasculature and generation of an inflammatory response, which will increased skin temperature. the skin temperature change due to laser or thermal injury has been measured in many studies with temperature and time as predictors of skin damage. the most frequent method of skin temperature measurement has been the infrared thermography. consequently, the changes in the difference of skin temperature (dst) may be used as an objective, quantitative, and functional surrogate measure to determine and predict rsi.

Eligibility criteria:
inclusion criteria: * a pathologically proven breast cancer receiving three dimensional conformal radiated therapy followed by modified radical mastectomy * ecog ps≤1 * normal organ function * no prior radiotherapy * no concurrent chemotherapy exclusion criteria: * rash or unhealed wound in the radiation field, * pregnancy or lactation * the presence of connective tissue disorder
chemotherapy with dna damaging agents in colorectal cancer

Conditions: Colorectal Cancer

Summary: chemotherapy treatment alone with dna damaging drugs might be as effective as chemotherapy combined with surgery in colorectal cancer (crc) avoiding surgery complications.


Eligibility criteria:
inclusion criteria: - patients that did not underwent surgery exclusion criteria: - patients that underwent surgery

Keywords: dna damaging agents
intraoperative anaesthesia awareness following induction of anaesthesia

Conditions: Anaesthesia

Summary: a primary aim of anaesthesia is to prevent awareness of surgery; ablation of the experience of surgery is the most secure way to prevent awareness with recall. fortunately the incidence of awareness with recall (the patient can spontaneously remember the intraoperative event) is very rare (0.1-0.2%). however the investigators systematic review suggests that consciousness of intraoperative events may occur in approximately 37% of patients in experimental studies (as identified by the validated clinical procedure the isolated forearm test that does not require postoperative recall of the event). in this international cohort study, recruiting a minimum sample of 200 patients, the investigators will investigate the incidence of anaesthesia awareness (as identified by the isolated forearm test) following the induction of anaesthesia and before surgery.


Eligibility criteria:
inclusion criteria: * adult patients clinically requiring intubation will be included in this cohort. * patients must be able to follow the isolated forearm technique commands when awake and prior to their operation will be included in this cohort. exclusion criteria: * contraindication to isolated forearm technique test such as unable to have tourniquet on arm for the isolated forearm technique (e.g. lymphedema or operative site).

Keywords: anaesthesia isolated forearm test responsiveness laryngoscopy intubation
laser atherectomy versus angioplasty for the treatment of critical limb ischemia

Conditions: Critical Limb Ischemia

Summary: the reason the investigators are doing this study is to compare the results of laser atherectomy versus angioplasty with or without the placement of a stent in the artery. a stent is a metal tube used to open up narrow arteries in the body.

people with peripheral artery disease that has severely reduced blood flow in their lower leg are usually treated with surgical bypass. this condition is known as critical limb ischemia or cli. over the last decade, advances in techniques and tools have allowed surgeons to more aggressively treat complex cases. studies have shown successful treatment of cli with endovascular techniques (less invasive surgical procedures through a small incision for the treatment of vascular disease), including laser atherectomy and angioplasty. surgical guidelines are not clear as to the best procedure to use for cli. to the best of our knowledge, a study comparing laser atherectomy and angioplasty has not been done. laser atherectomy works by releasing ultraviolet light which is absorbed by the plaque in the arteries. this will then get rid of the plaque. angioplasty is a procedure used to open blocked or narrowed arteries. currently, it is not known if laser atherectomy has better results than angioplasty.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * male or female (non-pregnant females) * patients with peripheral artery disease that has progressed to critical limb ischemia (cli) * patients undergoing angiography with possible intervention for rutherford class 4-6 limb ischemia that may benefit from revascularization

Keywords: laser atherectomy critical limb ischemia angioplasty
cardiac surgery as a means of reversing frailty

Conditions: Frailty

Summary: frailty is a multifactorial condition associated with older age, which leads to increased vulnerability to external stressors, such as infections or surgical procedures. key features of frailty are unintentional weight loss, reduced strength and physical activity as well as the feeling of exhaustion. when selecting patients for surgery, frailty can play an important part in resource planning and prognostication. multiple studies have shown frailty to have a negative impact on mortality, perioperative adverse events, hospital length of stay as well as postoperative quality of life and functional status. despite it being an important patient-centered outcome, postoperative quality of life tends to be overlooked when selecting patients for surgery. cardiac surgery presents a massive stressor to the frail patient, but on the other hand might have the ability to reduce disease burden and improve functional status, thus reducing frailty. this prospective observational cohort study aims to assess frailty, as well as functional status and quality of life in cardiosurgical patients pre- and postoperatively, and evaluate its impact on postoperative clinical and functional outcomes. the primary endpoint of this study is the change in postoperative level of frailty.


Eligibility criteria:
inclusion criteria: * age ≥ 60 years * elective cardiac surgery exclusion criteria: * age \< 60 years * emergency procedures * pulmonary thromboendarterectomy * declined informed consent * pregnant women

Keywords: frailty cardiac surgery
maraviroc 300 mg twice daily in hiv negative male volunteers

Conditions: HIV Infections

Summary: a placebo controlled study of the impact on insulin sensitivity and lipid profile of maraviroc 300 mg twice daily in hiv negative male volunteers.


Eligibility criteria:
inclusion criteria: * subjects must have documented negative hiv serology by elisa and p24 antigen * subjects must be clinically well males aged between 18 to 60 years. * fasting blood glucose, total cholesterol and triglycerides within normal limits * hepatic transaminases (ast and alt) ≤ 3 × upper limit of normal (uln) * adequate hematologic function (absolute neutrophil count ≥ 1,000/mm3; platelets ≥ 50,000/mm3; hemoglobin ≥ 8.0 g/dl) * serum amylase ≤ 1.5 × uln * sexually active males must use condoms during the course of the study * life expectancy ≥ 1 year * willing and able to provide informed consent exclusion criteria: * subjects with a waist hip ratio \> 0.97 or bmi \> 28 kg/m2 will be excluded * acute or chronic hepatitis b infection (determined by positive hepatitis b surface antigen result at the screening visit) * acute or chronic hepatitis c infection (determined by positive hepatitis c antibody result at the screening visit) * other metabolic syndrome or disease process in the opinion of the investigator likely to cause marked disturbance in glucose and lipid homeostasis including hypertension. * receiving on-going therapy with any of the following: * metabolically active medications * any lipid-lowering medication * hormonal agents (oestrogens or androgens) * glucocorticoids * beta-blockers * thiazide diuretics * thyroid preparations * psychotropic agents * anabolic steroids * megestrol acetate
therapeutic effects of hippotherapy in children with prader-willi syndrome

Conditions: Prader-Willi Syndrome

Summary: this study evaluates the therapeutic effects of hippotherapy in children with prader-willi syndrome. half of children will participate in hippotherapy for 15 weeks (30 minutes per sessions, twice a week, total 30 sessions, private lesson), while the other half will not receive hippotherapy.

this study evaluates the therapeutic effects of hippotherapy in children with prader-willi syndrome. half of children will participate in hippotherapy for 15 weeks (30 minutes per sessions, twice a week, total 30 sessions, private lesson), while the other half will not receive hippotherapy. the primary purpose of this study is to investigate effect of hippotherapy on motor function of prader-willi syndrome patients. the secondary purpose is to compare motor function, obesity, and behavior of the children after the intervention with those parameters before the intervention.

Eligibility criteria:
inclusion criteria: * can sit upright on the static surface * can follow one step command exclusion criteria: * body wight \> 35 kg * serious medical conditions such as cardiac disease, pulmonary disease, uncontrolled epilepsy * visual impairment, hearing impairment * bleeding tendency, anticoagulation * fracture within 6 months, major orthopedic surgery within 1 year

Keywords: hippotherapy gross motor balance behavior
efficacy of cart-19 cell therapy in b cell acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: this is a single arm, open-label, multi-center study to determine the efficacy and safety of an experimental therapy called cart-19 in patients with chemo-refractory and relapsed b-cell all.

this is a single arm, open-label, multi-center, phase i study to determine the efficacy of ctl019 in patients with r/r b-cell all. the study will have the following sequential phases: screening, pre-treatment (cell product preparation \& lymphodepleting chemotherapy), treatment and primary follow-up, secondary follow-up (if applicable) and survival follow-up.

Eligibility criteria:
inclusion criteria: * male and female subjects with cd 19+ b cell acute lymphoblastic leukemia in patients with no available curative treatment options (such as autologous or allogeneic sct) who have limited prognosis (several months to \<2 year survival) with currently available therapies will be enrolled 1. age 1 to 60 years. 2. expected survival \> 12 weeks 3. creatinine \< 2.5 mg/dl and less than 2.5x normal for age 4. alt ≤ 5x normal 5. bilirubin \<2.0 mg/dl 6. any relapse after prior sct will make patient eligible regardless of other prior therapy 7. patients with relapsed disease after prior allogeneic sct (myeloablative or non-myeloablative) will be eligible if they meet all other inclusion criteria and ①. have no active gvhd and require no immunosuppression ②. are more than 4 months from transplant 8. for those patients who require leukapheresis for t cell collection (i.e. no previously collected product exists), adequate venous access for apheresis or eligible for appropriate catheter placement, and no other contraindications for leukapheresis 9. voluntary informed consent is given 10. patients with cns3 disease will be eligible if cns disease is responsive to therapy (at infusion) exclusion criteria: 1. pregnant or lactating women. the safety of this therapy on unborn children is not known. female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion 2. uncontrolled active infection 3. active hepatitis b or hepatitis c infection 4. concurrent use of systemic steroids at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy during collection or after infusion. steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. use of inhaled steroids, or hydrocortisone for physiological replacement in patients with adrenal insufficiency are permitted as well 5. presence of grade 2-4 acute or extensive chronic gvhd 6. under treatment for gvhd 7. previous treatment with any gene therapy products 8. any uncontrolled active medical disorder that would preclude participation as outlined. 9. hiv infection. 10. cns3 disease that is progressive on therapy, or with cns parenchymal lesions that might increase the risk of cns toxicity
surgical hand antisepsis with propan-ol-1 60% per rubbing and scrubbing

Conditions: Skin Diseases; Surgical Site Infection

Summary: the present study evaluates the effects of to compare bactericidal efficacy using the reference antiseptic product propan-ol-1 60% using the hand rub method versus hand scrub method in order to test if pass the standard european norm 12791.

the investigators conducted a crossover clinical trial to evaluate the antiseptic effectiveness of preoperative surgical scrubbing using propan-ol-1 60% by rub and scrub. samples will be taken from the hands of each volunteer after a surgical hands antiseptic.

Eligibility criteria:
inclusion criteria: * participants without systemic pathologies, with healthy skin of the hands and short fingernails. * they do not use substances with antibacterial action. exclusion criteria: * taken antibiotics before 10 days of the intervention. * wear any jewellery on the hands.

Keywords: hand antisepsis
a study to evaluate glpg2222 in ivacaftor-treated subjects with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this clinical study is a phase iia, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate two doses of orally administered glpg2222 in adult subjects with a confirmed diagnosis of cf harbouring one f508del cftr mutation and a second gating (class iii) mutation and on stable treatment with ivacaftor. up to 35 evaluable subjects are planned to be included in the study. eligible subjects must be on stable treatment with physician prescribed ivacaftor (kalydeco®) for at least 28 days at the baseline visit. they will be randomized in a 2:2:1 ratio to receive one of two active doses of glpg2222 (150 mg q.d. or 300 mg q.d.) or placebo q.d. administered for 29 days. subjects will be in the study for a minimum of 6 weeks and a maximum of 10 weeks, from screening until the follow-up visit.


Eligibility criteria:
inclusion criteria: 1. male or female subject ≥ 18 years of age, on the day of signing the informed consent form (icf). 2. a confirmed clinical diagnosis of cf. 3. one f508del mutation on one allele in the cftr gene, a gating (class iii) mutation (one of the following: g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n, or s549r) on the 2nd allele in the cftr gene (documented in the subject's medical record or cf registry). 4. weight ≥ 40 kg. 5. stable concomitant treatment for at least 4 weeks (28 days) prior to baseline (including physician prescribed ivacaftor (kalydeco®) 150 mg b.i.d.). 6. forced expiratory volume in 1 second (fev1) ≥ 40% of predicted normal for age, gender and height at screening (pre- or postbronchodilator). exclusion criteria: 1. history of clinically meaningful unstable or uncontrolled chronic disease that makes the subject unsuitable for inclusion in the study in the opinion of the investigator. 2. unstable pulmonary status or respiratory tract infection (including rhinosinusitis) requiring a change in therapy within 4 weeks of baseline. 3. need for supplemental oxygen during the day, and \>2 liters per minute (lpm) while sleeping. 4. history of hepatic cirrhosis with portal hypertension (e.g., signs/symptoms of splenomegaly, esophageal varices, etc). 5. abnormal liver function test at screening; defined as aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) and/or alkaline phosphatase and/or total bilirubin (\>1.5 times uln (ctcae grade 2) and/or gamma-glutamyl transferase (ggt) ≥ 3x the upper limit of normal (uln), and/or total bilirubin (\>1.5 times uln (ctcae grade 2). 6. estimated creatinine clearance \< 60ml/min using the cockroft-gault formula at screening.
a prospective study to evaluate the impact of maximal urethral length preservation technique during robotic laparoscopic prostatectomy on the stretched flaccid penile length and continence

Conditions: Prostate Adenocarcinoma; Incontinence Stress; Erectile Dysfunction Following Radical Prostatectomy

Summary: after robotic prostatectomy, besides erectile function and achievement of oncological control, staying dry is also a very important desire expressed frequently by the patients. this has led to the concept of trifecta achievement after robotic prostatectomies. hence, continence preserving prostatectomies are the order of the day today. patient acceptance to surgery is low if the continence cannot be assured preoperatively. many techniques have been promulgated in the last two decades. the investigators present a novel technique of maximal urethral length preservation during surgery as an effective method of continence preservation. the investigators hypothesize that maximal preservation of urethra would lead to improved and early continence after robotic prostatectomy. the investigators also hypothesize that urethral preservation spares penile length shortening. the investigators therefore propose to prospectively evaluate penile length shortening. while penile length change after radical prostatectomy has been studied in the past, the investigators like to assess the penile morphometric assessment following the novel technique of maximal urethral length preservation radical prostatectomy.


Eligibility criteria:
inclusion criteria: all men undergoing robot assisted laparoscopic radical prostatectomy (ralp). - exclusion criteria: 1. exposure to androgen deprivation therapy 2. prior treatment for prostate cancer 3. metastatic prostate cancer 4. history of hypospadias or urethral reconstruction 5. history of penile implant, intracorporal injections, intraurethral suppositories 6. prior pelvic surgery. -
predicting outcomes of cardiac surgery-associated acute kidney injury using biomarkers at initiation of rrt

Conditions: Acute Kidney Injury

Summary: the aim of this study was to verify the prognostic value of functional kidney biomarkers on survival and renal function recovery in cardiac surgery patients with acute kidney injury.

cardiac surgery-associated acute kidney injury (csa-aki) is the second most common type of aki after septic aki and is associated with increased mortality and morbidity. few biomarkers were validated as outcome-specific biomarkers in patients developing aki after cardiac surgery at initiation of rrt. this study was designed to not only verify the prognostic value of functional kidney biomarkers on survival, but also predict it severity in order to optimize clinical decision making with respect to dialysis initiation and discontinuation.

Eligibility criteria:
inclusion criteria: * patients undergoing cardiac surgery who required renal replacement therapy. exclusion criteria: * history of end stage renal disease or on dialysis * prior kidney transplantation * patients with a dnr order or "do not escalate care" order

Keywords: acute kidney injury renal replacement treatment biomarker
combined anesthesia for laparoscopy surgery in gynecology

Conditions: Pain

Summary: the purpose of this study is to determine whether combined anesthesia will provide better pain control for the postoperative period following gynecological laparoscopy surgery.

following signing an informed consent patients who are scheduled for gynecological laparoscopy surgery for benign disease will randomized to general vs. combined general and spinal anesthesia. during the postoperative period data regarding pain level as evaluated by visual analogue scale (vas), number of doses of pain relief drugs, satisfaction and number of day in hospitalization will be collected from patient charts.

Eligibility criteria:
inclusion criteria: 1. american society of anesthesiology (asa) physical status classification system:asa i-iii. 2. benign gynecological laparoscopy surgery exclusion criteria: 1. patients who are not capable to sign the consent form. 2. women with known allergy to the medication used in spinal analgesia. 3. patients who are pregnant or lactating. 4. patients with contraindication to spinal analgesia. 5. patients who use opioid on a regular base.

Keywords: visual analogue scale pain level analgesia combined anesthesia
ed tracking sheet implementation

Conditions: Sepsis; Severe Sepsis; Systemic Inflammatory Response Syndrome

Summary: the purpose of this study is to assess whether implementation of an ed sepsis tracking sheet effects the percentage of goal-directed sepsis criteria met in a tertiary care academic emergency department.

sepsis remains a common cause of morbidity and mortality in the hospital setting. accurate diagnosis and timely initiation of therapy are important drivers of patient-centered outcomes in sepsis management. compliance with the core measures listed in the surviving sepsis campaign guidelines has been variable. an ed-specific sepsis tracking sheet (sts) - a tool for implementing and documenting critical actions in sepsis management - was created at our institution by a team of physicians, nurses, and ed pharmacists. dedicated ed pharmacists were instructed to fill this sheet within one hour of the sepsis-specific best practice advisory (bpa) being activated in the ed. core measures associated with the one hour and three hour sepsis bundles were tracked and outcomes were compared pre- and post-implementation of the sts.

Eligibility criteria:
inclusion criteria: * over 18 years old * initially evaluated in the dhmc lebanon emergency department * activated sepsis bpa upon initial presentation (triage history consistent with infection combined with 2 or more sirs criteria? are these the criteria that trigger our sepsis bpa?) exclusion criteria: * patients who are transferred to the dhmc lebanon emergency department from another facility * patients with absent data regarding one or more of the goal-directed sepsis criteria * patients who did not initially meet criteria to trigger the sepsis bpa, but developed sepsis later in their hospital course

Keywords: cms compliance ed pharmacist