Kornimate/medical-research-clean huggingface dataset:
acute application of antibiotic powder in open fracture wounds

Conditions: Fractures, Open; Wounds and Injuries--Infections; Anti-Bacterial Agents; Fractures, Bone; Extremity Fracture Lower; Extremity Fractures Upper

Summary: the purpose of this study is to help determine the best treatment for severe injures like open fracture wounds. some broken bone injuries can be more likely to get an infection. it is mostly due to the way they were injured. surgical site infection in the orthopedic surgery population is a big public health issue. wound infections result in both longer length of hospital stay and total cost of care. this study will be using an antibiotic called vancomycin or tobramycin in a powder form.

the investigators aim to investigate the effectiveness of preoperative intrawound antibiotic powder in preventing infection and reducing bacterial burden after open fracture. the investigators hypothesize that the participants who receive preoperative intrawound antibiotic powder will have fewer superficial and deep surgical site infections compared to participants who do not receive the antibiotic powder. the investigators also anticipate that the application of the antibiotic powder to open fracture wounds preoperatively will decrease the bacterial burden. sample swabs will be analyzed using the 16s metagenomics sequencing on the illumina platform. both rna and dna extracts will be utilized to identify and quantify the bacterial load in the wound bed at the time immediately prior to surgical debridement.

Eligibility criteria:
inclusion criteria: * subject or proxy willing and able to provide written informed consent. * age between 18 years and 80 years (inclusive), with an upper or lower extremity gustilo type ii, iiia, or iiib open fractures requiring debridement and internal fixation. * open extremity fractures * time from injury to study intervention 24 hours or less exclusion criteria: * individuals under the age of 18 years or over 80 years * type i or iiic open fractures * over 24 hours from time of injury * subjects who have received acute operative care of the open fracture at an outside facility prior to presenting at the emergency department. * open fractures distal to the wrist and midfoot * history of chronic infection in the extremity involved. * subjects who are currently pregnant * subjects who are prisoners * subjects with a known allergy to vancomycin or tobramycin * subjects with a condition or social circumstances that would reduce adherence and follow-up. * subjects participating in other clinical research involving investigational antimicrobial products within 30 days of randomization.

Keywords: open fractures antibiotic powder vancomycin tobramycin infection gustilo 16s
oral potentially malignant disorders: comparison between surgical treatment and wait and see approach

Conditions: Leukoplakia, Oral

Summary: this research protocol is comparing the effectiveness of surgical excision to the "wait and see" approach for the management of oral leukoplakia and erythroleukoplakia in prevention of oral squamous cell carcinoma onset.

different treatments have been proposed for the management of oral leukoplakia (ol) in order to prevent oral squamous cell carcinoma onset. however, there is still no consensus on the most effective approach for the patients affected by such oral potentially malignant disorders. surgery is often performed, but there is no randomized clinical trial which demonstrates its real effectiveness in preventing oral cancer onset. a recent rct compared surgical treatment with "wait and see approach" care in patients with nondysplastic ol, assuming that regular clinical follow-up could be considered a reliable standard of care among patients with nondysplastic oral leukoplakias. the purpose of this study is to evaluate effectiveness of surgical excision in treating ol and or reducing the onset of potential oral squamous cell carcinoma, with a follow-up of 5 years. this study will be the first rct comparing the effectiveness of surgery to "wait and see approach" in the management of both dysplastic and nondysplastic oral leukoplakias.

Eligibility criteria:
inclusion criteria: * ol diagnosis should be confirmed by incisional diagnostic biopsy and subsequent histopathological analysis * subjects' age: 18 years or older * lesions' size: 3 cm maximum longitudinal size of the single lesion * lesions's location: oral areas with no surgical risk of damages to important anatomical structures such as nerves, salivary ducts and/or arteries. * ability to understand and to sign a written informed consent document exclusion criteria: * previous oral cancer * head and neck radiotherapy * subjects under the age of 18 * subjects affected by pvl (proliferative verrucous leukoplakia) * high-risk of surgical damages to anatomical structures such as nerves, salivary ducts and/or arteries

Keywords: oral potentially malignant disorder oral carcinoma oral medicine cancer prevention
timing of complete revascularization for multivessel coronary artery disease in stemi

Conditions: Myocardial Infarction

Summary: the study will compare clinical outcomes between complete revascularization during hospitalization for st elevation myocardial infarction (stemi) and intervention after 30 days and intervention based on outpatient non-invasive ischemia testing in patients with multivessel coronary artery disease (mvd) presenting with first ever st elevation myocardial infarction.

this study is prospective, randomized, multicentre, open label study in patients with st elevation myocardial infarction (stemi) with multivessel coronary artery disease (mvd) defined as \>70% stenosis in a non-culprit vessel, initially treated with culprit only primary pci. the patients will be enrolled in four high volume pci centers after successful culprit only primary pci and then randomly assigned to one of three treatment arms:1. complete revascularization of all non-culprit significant lesions in a single session during initial hospitalization; 2. same revascularization in a single session after 30 days; 3.revascularization or it's deferral based on ischemia testing using dobutamin stress echocardiography. the study will explore differences in occurrence of major adverse cardio-cerebral events (cardiac death, repeated myocardial infarction, cerebrovascular accident and repeated revascularization) and complications of interventions during 12 months follow-up.

Eligibility criteria:
inclusion criteria: * clinical and electrocardiographic signs of first ever st elevation myocardial infarction (chest pain lasting less than 12 hours with persistent st elevation of ≥ 1mm in two contiguous leads on ecg recording) * multivessel coronary artery disease (mvd) on initial coronary angiogram, defined as visually assessed stenosis of more than 70% of any of the non-culprit vessels * treated with primary pci of infarct related artery (ira) only. exclusion criteria: * hemodynamically unstable patients defined as presence of cardiogenic shock, intraaortic balloon pump (iabp) implantation and mechanical ventilation prior, during and after primary pci; * presence of significant valvular disease; * decision that patient needs to be treated with coronary artery bypass graft (cabg) and/or valvular replacement or reconstruction surgery after initial culprit only pci; * myocardial infarction is caused by stent thrombosis: * chronic total occlusion of any of the coronary arteries on initial angiogram; * previously treated by cabg surgery; * estimated life expectancy less than one year.

Keywords: myocardial infarction percutaneous coronary intervention multivessel coronary artery disease dobutamine stress echocardiography
remission rate of newly diagnosed type 2 diabetes outpatients treated with short-term intensive insulin therapy

Conditions: Type2 Diabetes

Summary: to evaluate the long-term remission rate of short-term intensive insulin (stii) therapy in newly diagnosed type 2 diabetes outpatients and investigate the predictors contributing to the remission rate.


Eligibility criteria:
inclusion criteria: * newly diagnosed, insulin-naive type 2 diabetes outpatients * diabetes duration less than 1 year exclusion criteria: * various acute complications * hepatic transaminase \>2.5x normal reference value (glutamic-pyruvic transminase\>100u/l, glutamic-oxalacetic transaminase \> 100u/l) * abnormal renal functions (serum cretinine\>the normal reference value) * cardiac insufficiency (america nyha caediac function \>3) * type 1 diabetes mellitus * ongoing hormone therapy * women in gestation and lactation * patients with other endocrine disorders

Keywords: type 2 diabetes remission short-term intensive insulin therapy
effects of navicular mobilization in patients with planter fasciitis

Conditions: Plantar Fascitis

Summary: the significance of studying the effects of navicular mobilization in patients suffering from plantar fasciitis lies in its potential to provide valuable insights into non-invasive treatment approaches for a common and debilitating foot condition such as flat foot. understanding how this therapy impacts navicular height, pain and disability of the foot can lead to improved clinical outcomes and a better understanding of the biomechanical factors contributing to plantar fasciitis. ultimately, this research may help refine treatment strategies and enhance the quality of life for individuals suffering from this condition

the foot is a complex structure comprising numerous bones, muscles, and ligaments that work together to provide support and facilitate movement. it is supported by three arches: the medial longitudinal arch, the lateral longitudinal arch, and the transverse arch. the medial longitudinal arch plays a crucial role in absorbing weight, but issues like ligament laxity and muscle weakness can cause it to shorten, leading to conditions like plantar fasciitis. plantar fasciitis, a common overuse injury, occurs when the plantar fascia, a fibrous tissue that supports the arch of the foot, becomes inflamed due to repetitive strain, especially during activities that increase its stretch, such as barefoot walking or stair climbing. people with flat feet are more susceptible to plantar fasciitis due to the overstretching of the plantar fascia caused by the lack of arch support. navicular drop, a measure of the navicular bone height, also plays a significant role in foot biomechanics and the development of plantar fasciitis. high navicular height leads to increased foot pronation and tension on the plantar fascia, while low navicular height causes overpronation and arch collapse, both of which can result in inflammation of the plantar fascia. physiotherapists use techniques like navicular mobilization to address issues related to the navicular bone and improve blood circulation, healing, and pain relief in cases of plantar fasciitis. by understanding the biomechanics of the foot and employing targeted interventions, healthcare professionals can help manage and prevent conditions like plantar fasciitis, allowing individuals to maintain optimal foot health and functionality.

Eligibility criteria:
inclusion criteria: * plantar fasciitis with flat foot. * positive flat foot cases diagnosed with foot print measurement. * unilateral or bilateral involvement with chronic plantar fasciitis * diagnosed case of plantar fasciitis will be taken with navicular drop. * navicular drop (nd) of \> 10mm exclusion criteria: * patients with peripheral vascular diseases. * patients with history of fractures in the lower limb * patients with skin infections and wounds on the foot * patients with any neurological deficit involving foot. * patients with a history of foot or ankle surgery.

Keywords: planter fasciitis foot navicular bone mobilization, flat foot
correlation of several formulas to evaluate insulin sensitivity with the predicted m index

Conditions: Healthy Lifestyle

Summary: recently, an index based on the oral insulin sensitivity index with glucose (ogis) has been proposed in combination with anthropometric variables, called predicted m (predim), however, there is no evidence of the correlation of this with respect to the various indices (mcauley, belfiore, cederholm, avignon, matsuda, gutt, stumvoll, homa-ir (homeostatic model assessment for insulin resistance), isi (insulin sensitivity index), raynaud, quicki (the quantitative insulin sensitivity check index), firi (fasting insulin resistance index), bennett, tyg (triglycerides and glucose index)) in healthy patients.

analytical cross-sectional study with 25 healthy patients of both genders (male and female) from 30 to 60 years old, residents of the metropolitan area of guadalajara. they will be operated on for a 3-hour oral glucose tolerance test. the insulin sensitivity will be calculated with the predim, matsuda, mcauley, belfiore, cederholm, avignon, gutt, stumvoll, homa-ir, isi, raynaud, quicki, firi, bennett and tyg indexes. this protocol is already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers. the statistical analysis will be presented with measures of central tendency and dispersion, mean and standard deviation. the nominal variables in numbers and percentages. the kolmogorov-smirnov test will be performed to determine if the variables follow a normal distribution. to correlate the formulas used to evaluate the insulin sensitivity with the predicted m (predim) technique, the pearson or spearman correlation will be used according to the distribution.

Eligibility criteria:
inclusion criteria: * both genres * age 30 to 60 years * bmi \<25 kg / m2, * patients who are not sedentary or who participate in heavy physical activities * stable weight in the last 3 months exclusion criteria: * blood pressure \>120/80 mmhg * glucose \>100 mg/dl * postprandial glucose \>140 mg/dl * cholesterol \>200 mg/dl * triglycerides \>150 mg/dl * smoking * women with polycystic ovarian syndrome * history of metabolic, cardiovascular, thyroid, renal, pancreatic and/or arterial hypertension * use of medications that modify insulin sensitivity (corticosteroids) * previous surgery or infection * symptoms of vomiting and/or excessive nausea

Keywords: insulin sensitivity predim correlation healthy individuals
fusion rates of 3d printed porous titanium cages in three and four level acdfs

Conditions: Radiculopathy; Myelopathy Cervical; Foraminal Stenosis; Central Canal Stenosis

Summary: the purpose of this trial is to assess fusion rates in 3 and 4 level acdfs in patients implanted with depuy conduit 3d printed titanium cages supplemented with skyline anterior cervical plate system and 1 cc dbm. this will be a non-inferiority study, looking to show that synthes conduit 3d printed titanium cages fuse as well as cages.

this is a prospective, single arm study of clinical and radiological outcomes from anterior cervical discectomy and fusions for cervical spondylosis. 58 patients undergoing 3 to 4 level acdf procedures from c2-t1 will be enrolled. patients will be implanted with depuy conduit titanium acdf cage (depuy synthes, raynham, ma). a retrospective comparision group will be used. the retrospective group will include 58 consecutive patients undergoing 3-4 level acdfs with milled allograft. this single-centered study will enroll up to 58 subjects, with subjects followed for 24 months post-surgery. all subjects enrolled in the study will be recruited from a pool of subjects eligible for three or four level anterior cervical fusion surgeries. the inclusion/exclusion criteria are listed below.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * symptomatic multi-level degenerative cervical spondylosis necessitating anterior cervical arthrodesis in the subaxial cervical spine (between c2-t1). * surgery performed within the department of neurological surgery at the ohio state university wexner medical center (osuwmc) * cervical x-rays at 24 months (±60 days; retrospective comparison group only) exclusion criteria: * traumatic spinal fractures or spinal cord injury * previous cervical fusion surgery * co-morbidity requiring medication use that may interfere with bone or soft tissue healing (i.e., high dose oral or parenteral glucocorticoids, immunosuppressive agents, methotrexate) - at discretion of investigator * severe co-morbidities (e.g., heart, respiratory, or renal disease) * recent (\<3 yrs) or co-incident spinal tumor or infection * concurrent involvement in another investigational drug or device study that could confound study data (prospective exclusion only) * history of substance abuse (recreational drugs, prescription drugs or alcohol) that could interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up * subjects who are pregnant or plan to become pregnant in the next 24 months * prisoner * other contraindications for depuy conduit 3d printed titanium cage implant (prospective exclusion only)
letrozole and cdk 4/6 inhibitor for er positive, her2 negative breast cancer in postmenopausal women

Conditions: ER Positive, HER2 Negative Breast Cancer

Summary: this is a phase ii study evaluating the efficacy and safety of the pre-operative use of letrozole plus pd 0332991 (combination therapy)


Eligibility criteria:
inclusion criteria: * postmenopausal women * primary tumor greater than 2 cm in diameter * histologically proven invasive breast cancer * positive estrogen receptor * negative her-2 receptor * ecog performance status ≤ 1 or karnofsky performance status ≥ 70% * laboratory values must be follows: absolute neutrophil count ≥ 1,500/mm3; platelets ≥ 100,000/mm3; hemoglobin ≥ 9 g/dl; bilirubin ≤ 1.5 × institutional upper limit of normal (uln); serum creatinine ≤ 1.5 × uln; alkaline phosphatase ≤ 2 × uln; ast and alt ≤ 2 × uln; normal finding of ecg - qtc ≤ 470 msec (based on the mean value of the triplicate ecgs); left ventricular ejection fraction (lvef) ≥ 60%. * able to give written informed consent form * able to follow prescription instructions reasonably well exclusion criteria: * male * severe psychiatric disorder * prior history of other malignancy within 5 years of study entry, aside from basal cell carcinoma or the skin or carcinoma-in-situ of the uterine cervix * locally advanced breast cancer (t3n1 or any t4 or any n2, n3), or distant metastasis * multifocal or multicentric breast cancer except that the largest lesion is greater than 2cm * major surgery within 3 weeks of first study treatment * current use or anticipated need for: food or drugs that are known strong cyp3a4 inhibitors; drugs that are known strong cyp3a4 inducers * severe cardiovascular diseases in the previous 6 months * active inflammatory bowel disease or chronic diarrhea * renal impairment * poor adrenal function * hepatitis b and/or hepatitis c carriers (unless with normal hepatic function) * known human immunodeficiency virus infection * known hypersensitivity to anti-aromatase drugs or any cell cycle inhibitor * other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
amino acid tracer (facbc) positron emission tomography for lung nodule

Conditions: Lung Cancer

Summary: this study will look at how the \[18\]facbc goes into the lung nodules. this will hopefully lead to the development of better imaging techniques to look at lung nodules. \[18\]facbc is not approved by the fda (food and drug administration). this study will help to determine if it should be approved by the fda.

this is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. this substance has a natural tendency to go to tumor cells, as has been shown in the detection and staging of prostate cancer and for brain tumors. in this study we are going to test this new substance in patients with lung nodules. lung nodules are a common finding. it is very important to non-invasively determine whether the nodule is cancer or not, as early cancer detection and treatment may cure the disease. the substance is called \[18\]facbc and it is given in the form of an injection into a vein. after the substance reaches the lung nodules, scans called pet or positron emission tomography, are done. this is similar to having cat scans or x-rays. usually a compound called \[18\]fdg is used for pet scans but this substance often goes to inflammatory tissues as well. this new substance does not significantly go to inflammatory tissues, and may allow tumors in the lungs to be better identified.

Eligibility criteria:
inclusion criteria: 1. patients must be 18 years of age or older. 2. patients with a history of cancer who have a solitary pulmonary nodule between 1-3 cm in short axis with clinical and ct characteristics warranting surgical removal (see below). 3. clinical, laboratory, or diagnostic imaging findings on ct or 18f-fdg pet-ct do not suggest the possibility of the spn being part of a metastatic process. 4. ability to lie still for pet scanning 5. patients must be able to provide written informed consent. exclusion criteria: 1. age less than 18. 2. active carcinoma with known metastatic disease. 3. size of primary lesion less than 1 cm or greater than 3 cm 4. not a candidate for surgical resection or biopsy based upon clinical condition or discovery of metastatic disease which would preclude surgical therapy. 5. inability to lie still for pet scanning 6. cannot provide written informed consent

Keywords: pulmonary nodules
randomized phase iii study of exemestane (aromasin) for 5 years versus tamoxifen for 2.5 to 3 years followed by exemestane

Conditions: Breast Neoplasms

Summary: to compare the effects of exemestane for 5 years versus tamoxifen and exemestane given sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast cancer. this pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. this study is designed to be part of the larger team trial where the data from these 7 studies will be combined. a pre-specified analysis of the pooled data will be conducted.


Eligibility criteria:
inclusion criteria: * histologically/cytologically confirmed adenocarcinoma of the breast, followed by adequate surgical resection and/or radiotherapy, and/or adjuvant chemotherapy, if indicated. * stage t1-3 n0-2 mo, any tnm stage bc for whom adjuvant hormonal therapy is being considered. exclusion criteria: * those patients not deemed to have had potentially curative primary surgical treatment or one of the following criteria: * inflammatory breast cancer * histologically positive supraclavicular nodes * ulceration/infiltration of local skin metastasis * neoadjuvant chemotherapy * ductal carcinoma in situ (dcis) or lobular carcinoma in situ (lcis) without invasion * er and pr negative primary tumor or er/pr unknown status.