Kornimate/medical-research-clean huggingface dataset:
vibration response imaging (vri) in patients who are potential candidates for surgical resection

Conditions: Lung Cancer

Summary: the primary purpose of the study is to investigate the use of vri to guide the selection of patients for lung surgery. perfusion scintigraphy is the current method to assess the fractional contribution of lung function of the remaining lung. the hypothesis is that vri can determine quantitative postoperative lung function equally accurately as a quantitative perfusion scan.

primarily, vri will be compared to perfusion (q) scan by predicted post-operative (ppo) fev1 and dlco as predicted by vri versus as predicted by q scan. secondary, the ppo as predicted by each test will be compared with the actual fev1 and dlco at 3 months post-operative; if these two methods provide similar results, vri will be deemed an acceptable alternative to q scan for determining patient selection for lung resection. finally, the patient outcomes (30 day mortality and pulmonary complications) for those patients falling within guideline parameters using the vri measurement will be analyzed to see if using vri in clinical practice would indeed allow prediction of satisfactory results (similar to literature benchmarks).

Eligibility criteria:
inclusion criteria: 1. able and willing to read, understand, and provide written informed consent; 2. age range of 18-90 years; 3. potential candidate for at least lobectomy due to lung cancer or other intrathoracic malignancy (either suspected or proven by biopsy). both open and minimally invasive (thoracoscopic) resections are acceptable. 4. bmi \> 19. exclusion criteria: 1. body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture); 2. there should be no active pulmonary infection (e.g. pneumonia) at the time of the recordings; 3. hirsutism unless patient is willing to have back shaved; 4. potentially contagious skin lesion on the back; 5. giant bulla (more than 1/3 of the hemithorax or \>10cm) 6. pregnant women

Keywords: lung cancer lung resection lobectomy pneumonectomy lung function perfusion
effect of remote preconditioning in patients undergoing off-pump coronary artery bypass graft surgery

Conditions: Ischemic Heart Disease

Summary: in recent several clinical trials, remote preconditioning showed very powerful myocardial protection. however, the myocardial protective effect by remote preconditioning was not evaluated on the patients undergoing off pump coronary artery bypass graft surgery (opcab). the investigators hypothesized that the lower limb remote preconditioning could protect the myocardium during the opcab. in this study, the investigators will try to evaluate whether remote preconditioning could induce myocardial protection on the opcab patients.

in recent two clinical trials on the patients undergoing cardiac surgery, remote preconditioning showed very powerful myocardial protection by simple and safe procedures such as the brief inflation of pneumatic tourniquet on the upper or lower limb. however, despite these impressive results, the clinical studies are lacking yet. moreover, two previous studies were done on the cardiac surgery with cardiopulmonary bypass. considering different mechanism, level of myocardial injury and the increasing popularity of opcab, we need the clinical study on remote preconditioning with the opcab patients. in this study, we will conduct randomized controlled clinical trials in which the remote preconditioning was induced by lower limb ischemia with double-blinded technique. myocardial injury will be assessed by postoperative serum troponin i levels and they will be compared with those of control group.

Eligibility criteria:
inclusion criteria: * adult patients undergoing elective off pump coronary artery bypass graft surgery exclusion criteria: * unstable angina * preoperative use of inotropics or mechanical assist device, * left ventricular ejection fraction less than 30%, * major combined operation such as aortic surgery or carotid endarterectomy, * severe liver, renal and pulmonary disease, * recent myocardial infarction (within 7 days), * recent systemic infection or sepsis (within 7 days) * peripheral vascular disease affecting lower limbs * amputation of the lower limbs

Keywords: opcab ripc
the mechanism of action of the unite biomatrix in diabetic foot ulcer

Conditions: Diabetic Foot Ulcers

Summary: the purpose of this study is to assess the mechanism of action of the unite biomatrix and compare its performance with the standard of care, saline moistened gauze, for the treatment of diabetic foot ulcers.


Eligibility criteria:
inclusion criteria: 1. a full thickness diabetic foot ulcer with a viable wound bed free of necrotic material (grade 1 on wagner scale). 2. diagnosis of diabetes mellitus (type i or ii) adequately controlled. 3. the ulcer is greater than 4 weeks duration. 4. three or fewer ulcers separated by \> 3.0 cm distance. 5. post-debridement, the ulcer size must be between 1 and 10 sq cm2. 6. ankle/brachial index is between 0.7 to 1.2 and or one of the following must be present: * transcutaneous partial pressure oxygen (tcpo2) \> 30 mmhg at the ankle * toe pressure of \>40mm hg or a doppler waveform consistent with adequate flow in the foot (biphasic or triphasic) 7. at least 18 years old. 8. able and willing to provide a voluntary written informed consent. 9. able and willing to wear an off-loading orthopedic shoe. 10. able and willing to attend scheduled follow-up visits and study related exams. exclusion criteria: 1. greater than 30% reduction in wound size during first week of observation by the investigator. 2. ulcer with exposed tendon or bone. 3. gross clinical infection at the study ulcer site including cellulitis and osteomyelitis. 4. gangrene. 5. active charcot's disease as determined by clinical and radiographic examination. 6. ulcer of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers). 7. known severe anemia. 8. known serum albumin \< 2.5. 9. renal failure with creatinine \> 2.5. 10. rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, hiv. 11. severe liver disease as defined by the treating physician or patient's primary care physician. 12. malignancy at or near the ulcer site. 13. any condition judged by the investigator that would cause the study to be detrimental to the patient. 14. presence of a hematology, clinical, chemistry or other test obtained within 7 days of screening that is outside the normal range for the laboratory and is determined to be clinically significant by the investigator. 15. received another investigational device or drug within 30 days of day 0. 16. radiation therapy, chemotherapy or immunosuppressive therapy within 30 days of enrollment. 17. received another allograft, autograft or xenograft within 30 days of the day 0. 18. known allergy to equine derived tissue. 19. alcohol or drug abuse, defined as current medical treatment for substance abuse. 20. pregnant or nursing women.
topical doxepin for radiation-induced dermatitis

Conditions: Breast Cancer

Summary: radiation dermatitis is one of the most common side effects of radiotherapy approximately occurring in about 95% of patients receiving radiotherapy . acute injury due to structural tissue damage, generation of free radicals, irreversible double-stranded breaks in nuclear and mitochondrial dna, and initiation of an inflammatory response in the epidermis and dermis occurs within hours to weeks after radiation exposure. radiation dermatitis due to pain and discomfort has an adverse impact on the quality of a patient's life.the radiation toxicities such as radiation dermatitis encountered in clinical practice are typically managed with a variety of topical agents such as water-based moisturizing creams or lotions, topical steroids, antiinflammatory emulsions, and wound dressings. pharmacologic interventions for the prevention and treatment of these toxicity can be used to protect skin against radiation damage.currently, there is no standard treatment for the prevention of radiation-induced dermatitis with demonstrated effectiveness.the aim of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of topical doxepin for the prevention and management of radiation-induced dermatitis during postoperative radiotherapy for breast cancer.

the patients who have undergone breast surgery and require radiotherapy and fulfill the inclusion criteria of the study will be entered the study. all the patients will be treated by 3d conformal radiation therapy using ct -based treatment planning and multi leaf linear accelerators. the patients will be treated by conventional fractionation regimens to a total dose of 5000 cgy (25 fractions of 200 cgy, 5 days per week). every week the patients will be visited by an experienced radiation oncologist and the skin reaction will be determined and recorded according to rtog acute radiation morbidity scoring criteria which scores from 0 to 4. the patients receive doxepin cream at the beginning of 5th week of radiotherapy and use it for a whole week. after acquiring written permission, the radiotherapy site will be photographed at the start and ending of the doxepin

Eligibility criteria:
inclusion criteria: * female with a diagnosis of, breast adenocarcinoma and be referred for post-operative radiotherapy with or without concurrent chemotherapy and with or without mastectomy * participants must not be pregnant. * participants treated with a total dose of 5000 cgy (25 fractions of 200 cgy, 5 days per week exclusion criteria: * patients who are not eligible * the presence of skin diseases in the radiation area * patients have constipation, xerostomia, blurred vision, urinary retention * hypersensitivity to doxepin
a microdose evaluation study of aby-029 in primary sarcoma

Conditions: Primary Soft-tissue Sarcoma

Summary: the primary study objective is to determine if microdoses of aby-029 (up to 6x) lead to detectable signals (defined as signal-to-noise ratio, snr ≥10, with the odyssey nir scanner in sampled tissues with an egfr pathology score ≥ 1 based on histological staining and compare snr to tissues with an egfr pathology score \< 1). the secondary study objective is to assess if the spatial patterns of egfr expression correlate with the tumor targeting of aby-029 detection by nir scanner relative to histopathology diagnosis, and other indicators (e.g. proliferation, infiltration, etc.) as the gold standard, and to measure the molecular uptake and concentration of aby-029 in resected specimens.

the investigators plan to enroll a minimum of 6 and a maximum of 12 adult patients with a diagnosis of primary soft-tissue sarcoma in this open label, single center, clinical trial of aby-029. the study will enroll patients with an egfr pathology score ≥ 1. initial diagnostic biopsy specimens will be analyzed for egfr positivity by immunohistochemistry following routine diagnostic processing by pathologist. patients will be administered a single intravenous dose of aby-029 1-3 hours before surgery. following tumor excision, the tumor will be transported to the pathologist and will be inked and sectioned. following sectioning the tumor will be imaged using near-infrared imaging systems. quantitative measurements of fluorophore concentration will be measured for tumors with egfr pathology score ≥ 1 and compared to those with egfr pathology score \< 1. quantitative mapping of fluorophore concentration will be correlated with local egfr concentration and blood vessel density. upon specimen analysis, fluorophore measurements will be taken from normal, marginal tissues (e.g. skeletal muscle, adipose) in addition to the tumor. average egfr concentration and blood vessel density will be determined for each tumor through histological analysis of sections by routine sarcoma protocol and analysis guided by regional variations in aby-029 concentration based upon near-infrared scan results. the protocol is not a safety study since no physiological effects are expected at microdose levels of aby-029. no diagnostic or therapeutic intent is proposed, and administration of the study drug is not intended to alter the extent of planned tumor resection during the surgical procedure.

Eligibility criteria:
inclusion criteria: 1. preoperative histological diagnosis of primary sarcoma. 2. tumor judged to be suitable for open surgical resection based on preoperative imaging studies. 3. valid informed consent by subject. 4. age ≥ 18 years old. exclusion criteria: 1. pregnant women or women who are breast feeding. 2. patients on any experimental anti-egfr targeted therapies, either investigational or fda approved.

Keywords: aby-029 affibody molecular fluorescence-guided surgery epidermal growth factor receptor (egfr)
exhaled breath particles in lung cancer

Conditions: Lung Cancer; Non-small Cell Lung Cancer; Lung Adenocarcinoma; Squamous Cell Lung Cancer

Summary: lung cancer (cap) is the leading cause of cancer related deaths on a global level. early diagnosis is vital for survival and life quality of the affected patients, yet lung cancer is often diagnosed at advanced stages, causing poor five-year survival rates. exhaled breath particles (ebp) and particle flow rate (pfr) collected by the particles in exhaled air (pexa) system is a safe and easily reproducible non-invasive method for gaining insight into the molecular environment of the distal airways. ebp and pfr have been found useful in detection of other airway diseases such as acute respiratory distress syndrome (ards), primary graft dysfunction (pgd) and bronchiolitis obliterans syndrome (bos). it has been shown that particles found in ebp reflect the general composition of respiratory tract lining fluid (rtlf) and that biomarkers found in ebp correlate to proteins that can be found in both bronchoalveolar lavage fluid (balf) and plasma. particle flow rate (pfr) has been found to differ between patients with lung cancer compared to control patients. in the present study the investigators aim to collect ebp samples and measure pfr from patients with primary lung cancer and from control patients. ebps are collected for molecular analysis. the investigators aim to identify biomarkers for diagnosing, predicting prognosis of and evaluating surgical treatment of non small cell lung cancer.

ebp samples and measurements of pfr will be collected from patients with primary non-small cell lung cancer (nsclc) at skåne university hospital (sus) lund. measurements will be done at 2 time points, before and after surgical resection for nsclc. ebp samples will be collected at one time point from a matched (by age and smoking history) control cohort. blood samples will be collected from both cohorts, at the same time points as the ebp/pfr measurements. tumor tissue and healthy adjacent lung tissue will be collected from lung cancer patients with tumors greater than 3 cm in diameter on preoperative computed tomography. the purpose of this clinical trial is to identify non-invasive means of diagnosing nsclc at earlier stages. the pexa method is not associated with any risks and has potential minimize hospitalization associated with more invasive methods that are in clinical practice today, such as bronchoscopy and biopsies.

Eligibility criteria:
inclusion criteria: * primary lung cancer with clinical tumor, node, metastasis (tnm) up to ct3n1m0 according to tnm 7th edition * able to take instructions and perform the standardized breathing maneuver exclusion criteria: * dementia * severe neurological disease * drug abuse * heart failure new york heart association (nyha) classification, nyha class iii or iv * ejection fraction \< 50 % * s-creatinine \> 140 µmol/l * poorly regulated diabetes mellitus

Keywords: exhaled breath particles pexa lung cancer non-small cell lung cancer
conbercept vs panretinal photocoagulation for the management of proliferative diabetic retinopathy

Conditions: Proliferative Diabetic Retinopathy

Summary: panretinal photocoagulation (prp) has been the standard treatment for proliferative diabetic retinopathy (pdr) since the diabetic retinopathy study demonstrated its benefit nearly 40 years ago,but prp has inevitable adverse effects on visual function. intravitreal injection of vascular endothelial growth factor(vegf) can induce short-term regression of retinal neovascularization(nv). the purpose is to assess and compare the efficacy and safety between intravitreal injection of conbercept and prp.

proliferative diabetic retinopathy (pdr) is a leading cause of vision loss in patients with diabetes mellitus,which of the initial manifestation of pdr is retinal neovascularization at the disc or elsewhere.panretinal photocoagulation (prp) has been the standard treatment for pdr since the diabetic retinopathy study demonstrated its benefit nearly 40 years ago,but prp has inevitable adverse effects on visual function including peripheral visual field defects, night vision loss, loss of contrast sensitivity.recent evidences have indicated that anti-vascular endothelial growth factor(vegf) treatment can reduce the severity and delay the progression of dr.however,the impact of this treatment on visual function and the effect of anti-vegf agents on retinal neovascularization compared with prp remain unclear. it is possible that a long-acting anti-vegf agent such as conbercept. so we design the study with is a prospective randomized controlled trial about intravitreal injection of conbercept versus prp on pdr.primary outcome is the change in bcva from screening to 12 months in the study eye measured in the etdrs letter score at 4 m

Eligibility criteria:
inclusion criteria: 1. participants of either sex aged 18 years or over. 2. diagnosis of diabetes mellitus (type 1 or 2). 3. best-corrected visual acuity (bcva) in the study eye better than or equal to 30 early treatment diabetic retinopathy study (etdrs) letters 4. pdr with no evidence of previous prp. 5. media clarity, pupillary dilation and participant cooperation sufficient for adequate fundus photographs. exclusion criteria: 1. a glycated haemoglobin (hba1c) level of more than 10%; 2. blood pressure \> 180/100 mmhg 3. myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months 4. dialysis or renal transplant 5. systemic anti-vegf or pro-vegf treatment within 6 months prior to randomization 6. for women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years 7. traction retinal detachment involving the macula 8. exam evidence of neovascularization of the angle 9. history of major ocular surgery or anticipated within the next 6 months following randomization

Keywords: conbercept anti-vegf agent panretinal photocoagulation
cpx-351 salvage therapy followed by haplo-cord transplant for relapsed/refractory leukemia or myelodysplastic syndrome

Conditions: Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Leukemia, Relapsed Adult Acute Myeloid; Myelodysplastic Syndromes, Previously Treated

Summary: this pilot study is designed to evaluate outcomes with the combination of cpx-351 salvage therapy and haplo-cord graft stem cell transplantation for subjects with relapsed or refractory aml or myelodysplastic syndrome.


Eligibility criteria:
inclusion criteria: 1. subject must have refractory or relapsed acute myeloid leukemia (aml) according to previously established criteria: 1. primary induction failure (pif) after ≥ 2 cycles of chemotherapy 2. first relapse 3. relapse refractory to salvage chemotherapy 4. second or subsequent relapse 2. subjects with myelodysplastic syndrome (mds): (a) either refractory anemia with excess blasts i or refractory anemia with excess blasts ii (raeb i or raeb ii) 3. karnofsky performance status ≥ 70 4. willing to participate as a research subject and sign an informed consent form 5. adequate physical function measured by: 1. cardiac: asymptomatic, or if symptomatic then left ventricular ejection fraction (lvef) at rest must be ≥ 45% and must improve with exercise 2. hepatic: ≤3 x upper limit of normal (uln) alanine aminotransferase (alt) and ≤ 1.5 total serum bilirubin, unless liver is involved with the disease or there is congenital benign hyperbilirubinemia 3. renal: serum creatinine within normal range, or if serum creatinine is outside the normal range, then calculated creatinine clearance ≥ 60 ml/min 4. pulmonary: asymptomatic, or if symptomatic, diffusing capacity of the lungs for carbon monoxide (dlco) ≥ 45% of predicted (corrected for hemoglobin) 6. if subject has prior malignancy, must be without any evidence of disease of that prior malignancy for at least 2 years (excludes skin cancers that may have been excised within that 2 year period). exclusion criteria: 1. serious active or uncontrolled infection or medical condition 2. women who are pregnant or breast feeding. women of childbearing age must use adequate contraception and have a negative pregnancy test. 3. prior daunorubicin therapy with a cumulative dose of more than 368 mg/m2 or equivalent 4. other systemic anticancer therapy or ongoing clinically relevant toxicities from such therapy (at discretion of the investigator) 5. history of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, congestive heart failure), resulting in heart failure by new york heart association class iii or iv staging. 6. subjects with wilson disease or other copper-related disorders.
a study of opd5 followed by autologous stem cell transplant for patients with relapsed refractory multiple myeloma

Conditions: Relapse Multiple Myeloma; Multiple Myeloma

Summary: the purpose of this study is to evaluate the safety and tolerability of a single infusion of opd5 before autologous stem cell transplant in patients with rrmm. the study will evaluate increasing doses of opd5 to find the best dose and to assess any side effects. each patient will be assigned to a dose cohort of 3-6 patients to receive one single dose of opd5. each patient will be hospitalized for about 14 days from the opd5 infusion and then have monthly visits to the clinic for 3 months and then every third month until disease progression or starting new myeloma treatment, maximum up to 2 years.


Eligibility criteria:
inclusion criteria: * male or female, between the ages of 18 years and 70 years at the planned time of study treatment; patients greater than 70 years of age may qualify on a case by case basis * diagnosis of multiple myeloma * received a previous autologous stem cell transplantation ( asct) (single or tandem) that resulted in disease progression within 24 months * received at least 2 prior lines of therapy * refractory to previous treatment with a proteasome inhibitor (pi), an immunomodulatory drug (imid) and an anti-cluster of differentiation 38 monoclonal antibody (anti-cd38 mab) * male and women of childbearing potential agrees to use contraception during the treatment period and during a specified time period after the last dose exclusion criteria: * prior treatment with melphalan flufenamide (melflufen) or opd5 * any medical condition that may interfere with safety or participation in this study * other malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast or very low and low risk prostate cancer in active surveillance * prior allogeneic stem cell transplantation or prior salvage asct