Kornimate/medical-research-clean huggingface dataset:
vitamin b12 supplementation in diabetic neuropathy

Conditions: Diabetes Mellitus; Diabetic Neuropathies; Diabetic Complication; Diabetic Foot

Summary: this prospective double-blind placebo-controlled trial aims to investigate the safety and efficacy of oral dispersible tablet of vitamin b12 for 1 year, in 90 patients with diabetes mellitus type 2 and neuropathy.

in this prospective, double-blind, placebo-controlled trial, 90 patients with type 2 diabetes on metformin treatment for at least four years, and both peripheral and autonomic diabetic neuropathy were randomized to an active treatment group (n=44) receiving b12, and a control group (n=46) receiving placebo. all patients had b12 levels less than 400 pmol/l. subjects underwent measurement of sural nerve conduction velocity and amplitude, vibration perception threshold, and performed cardiovascular autonomic reflex tests (carts: mean circular resultant, valsalva test, postural index and orthostatic hypotension\]). sudomotor function was assessed with the sudoscan that measures electrochemical skin conductance in hands and feet. the michigan neuropathy screening instrument questionnaire and examination and questionnaires to evaluate quality of life and level of pain were also used.

Eligibility criteria:
inclusion criteria: * adults (\>18 years old) with diabetes mellitus 2 * established diabetic neuropathy, both peripheral and autonomic (diabetic peripheral neuropathy and diabetic autonomic neuropathy). (diagnosis was made with a)two or more cardiovascular autonomic reflex tests abnormal, b)abnormal nerve conduction velocity, c)abnormal michigan neuropathy screening instrument questionnaire and michigan neuropathy screening instrument examination ). * good glycemic control (hba1c between 6.5 and 7.5 %), stable in the last year before participating in the study * metformin treatment for at least 4 years * low vitamin b12 levels according to suggested normal values for dm2 patients over 60 years old (\<400 pmol/l) exclusion criteria: * pernicious anemia, * alcoholism * gastrectomy * gastric bypass surgery * pancreatic insufficiency * malabsorption syndromes * chronic giardiasis * acute infection in the last 6 months * cardiovascular event in the last 6 months * surgery involving small intestine or human immunodeficiency virus infection. * patients with estimated glomerular filtration rate \<50 ml/min/1.73m2 * taking multivitamins or b12 supplements in the last 12 months

Keywords: diabetic neuropathy vitamin b12 sudoscan metformin diabetic foot diabetes mellitus autonomic neuropathy peripheral neuropathy painful neuropathy
a study evaluating the safety, tolerability and pharmacokinetics of gdc-0917 administered to patients with refractory solid tumors or lymphoma

Conditions: Solid Cancers

Summary: this is an open-label, multicenter, phase i dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics (pk) of gdc-0917 in patients with refractory solid tumors or lymphoma.


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented, locally advanced or metastatic solid tumors or lymphoma for which standard therapy either does not exist or has proven ineffective or intolerable * life expectancy \>/= 12 weeks * adequate hematologic and end organ function * for female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use an effective form of contraception and to continue its use for the duration of the study. exclusion criteria: * clinically significant history of chronic liver disease, active hepatic infection, evidence of hepatic cirrhosis or grade \>/= 2 liver dysfunction not due to hepatic metastases of cancer, current alcohol abuse, active infections with hepatitis b virus, or hepatitis c virus * grade \>/= 2 fever or associated constitutional symptoms, or a clinically significant systemic infection within the last month * autoimmune disease * history of clinically significant pulmonary disease * need for chronic and continuous systemic or topical corticosteroids or immunosuppressive therapy within 2 weeks prior to study entry or anticipated need of continuous systemic corticosteroids or immunosuppressive therapy during study participation. * allergy or hypersensitivity to components of the gdc-0917 formulation * palliative radiotherapy within 2 weeks prior to first dose of study drug treatment in cycle 1 * experimental therapy within 4 weeks prior to first dose of study drug treatment in cycle 1 * major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study drug treatment in cycle 1, or anticipation of the need for major surgery during the course of study treatment * prior anti-cancer therapy within 4 weeks before the first dose of study drug treatment in cycle 1 * all acute drug-related toxicities must have resolved prior to study entry, except for alopecia and grade 1 neuropathy * current severe, uncontrolled systemic disease excluding cancer * history of clinically significant cardiac dysfunction * history of malabsorption or other condition that would interfere with enteral absorption * any history of active gi bleeding within the past 6 months prior to screening * known hiv infection * uncontrolled ascites, due to diseases other than cancer, requiring weekly large-volume paracentesis for 3 consecutive weeks prior to enrollment * pregnancy, lactation, breastfeeding or unwillingness to use birth control during the study and for 3 months after the last dose of gdc-0917 * known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
intranasal ketamine for acute traumatic pain

Conditions: Acute Pain

Summary: introduction: ketamine has been well studied for its efficacy as an analgesic agent. however, intranasal (in) administration of ketamine has only recently been studied in the emergency setting. objective: to elucidate the efficacy and adverse effects of a sub-dissociative dose of in ketamine compared to iv and im morphine. methods: a single-center, randomized, prospective, parallel clinical trial of efficacy and safety of in ketamine compared to iv and im morphine for analgesia in the emergency department (ed). a convenience sample of 90 patients aged 18-70 experiencing moderate-severe acute traumatic pain (≥80mm on 100mm visual analog scale \[vas\]) were randomized to receive either 1.0mg/kg in ketamine, 0.1mg/kg iv mo or 0.15mg/kg im mo. pain relief and adverse effects were recorded for 1 hour post-administration. primary outcomes: the primary outcome was efficacy of in ketamine compared to iv and im mo, measured by "time-to-onset" (defined as a ≥15mm pain decrease on vas), as well as time to and degree of maximal pain reduction.


Eligibility criteria:
inclusion criteria: patients aged 18-70 years, with mild to moderate blunt trauma (sustained in road, workplace and home accidents) causing moderate to severe pain (≥ 80mm score on a 100mm visual analog scale=vas) were eligible for participation in the study. inclusion criteria also included a glasgow coma score (gcs) of 15, body weight of 50-110 kg, systolic blood pressure of 90-160 mmhg, heart rate \<100 bpm. patients were also required to have an american society of anesthesiologists (asa) score of 1 or 2, deny head injury, and deny regular use or use of opiates. exclusion criteria: any analgesia received within the prior 3 hours, allergic sensitivity to morphine or ketamine, a large meal ingested within the previous hour, pregnancy, deviated nasal septum or trauma to the nose, and a history of a psychiatric condition. despite evidence that ketamine does not exacerbate intracranial hemorrhage in patients with head trauma, patients with head injury complaining of loss of consciousness, dizziness, vomiting, or nausea were excluded as well.

Keywords: intranasal ketamine, analgesia, trauma, morphine, mass casualty
xpress et registry

Conditions: Eustachian Tube Dysfunction

Summary: a prospective, multicenter, registry of patients undergoing balloon dilation of the eustachian tubes (et).

this is a prospective, multicenter, single-arm, postmarket registry enrolling up to 300 participants who are planning to undergo balloon dilation of the eustachian tubes for treatment of chronic/persistent eustachian tube dysfunction (etd). procedural information will be collect as well as efficacy and safety data through 6 months post procedure.

Eligibility criteria:
inclusion criteria: * be at least 18 years old * have been diagnosed with persistent/chronic eustachian tube dysfunction (duration 3 months or more) * be a candidate for unilateral or bilateral eustachian tube balloon dilation using the xpress device * be able to read and understand english * be willing and able to provide informed consent * be willing to comply with the protocol requirements exclusion criteria: * have a history of patulous eustachian tube * require additional ear surgery (eg, myringotomy, tympanostomy) at the time of study procedure * have evidence of internal carotid artery dehiscence * be currently participating in any other drug or device clinical studies, excluding postapproval or marketing registry studies
thp hip fracture plating system study

Conditions: Femur Fracture; Femur Fracture Intertrochanteric; Garden Grade I Subcapital Fracture of Femoral Neck; Garden Grade II Subcapital Fracture of Femoral Neck; Garden Grade III Subcapital Fracture of Femoral Neck; Garden Grade IV Subcapital Fracture of Femoral Neck

Summary: the objective of this study is to systematically document the clinical outcomes of thp hip fracture plating system when used to treat intracapsular and intertrochanteric fractures.

primary endpoint: • revision rate due to device related complication(s) or non-union of the femur. secondary endpoints: • radiographic and clinical fracture healing of the proximal femur using standard scoring methods.

Eligibility criteria:
inclusion criteria: * patient must be 18 years of age or older. * patient must be eligible for an open reduction and internal fixation of the proximal femur. * patient must have an intracapsular or intertrochanteric fracture. * patient must have need for alignment, stabilization, and reduction of bone fractures. * patient must have ability and willingness to follow postoperative care instructions until healing is complete. * patient must be in good nutritional state. * patient must be able and willing to sign the irb/ec approved informed consent. exclusion criteria: * patient is a prisoner. * patient is a current alcohol or drug abuser. * patient is known to be pregnant or breastfeeding. * patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent. * infection. * patient conditions including bloody supply limitations, obesity or insufficient quantity or quality of bone. * patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions. * patient has foreign body sensitivity. where material sensitivity is suspected or unknown, testing is to be completed prior to implantation of the device. * patient is expected to be non-compliant with recommended post-operative weight-bearing instructions.

Keywords: cannulated screws lag screws compression screws telescoping lag screws cortical screws hip fracture plate
radiofrequency ablation using combined rf energy delivery mode and octopus electrodes for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma (HCC)

Summary: the purpose of this study is to evaluate, through a prospective multicenter trial, the procedural time, safety, technical success rate for achieving a safety margin of at least 5 mm around the tumor, and the clinical efficacy (local and remote recurrence rates: estimated local recurrence rate at 12 months) of radiofrequency ablation using the "no-touch" technique. this approach employs octopus electrodes and combined radiofrequency energy delivery (dual switching monopolar and bipolar mode) for the treatment of hepatocellular carcinoma.


Eligibility criteria:
\*\*inclusion criteria\*\* 1. agreement to the protocol requirements and provision of informed consent. 2. age between 20 and 85 years. 3. child-pugh class a or b7. 4. patients with liver cirrhosis who are candidates for radiofrequency ablation (rfa) based on multi-detector computed tomography (mdct) or multi-detector computed tomography (mri) within 60 days, with a suspected hepatocellular carcinoma (hcc) lesion of 1-3 cm. * \*\*hcc diagnostic criteria:\*\* a. presence of risk factors (e.g., hepatitis b virus (hbv) positive, hepatitis c virus (hcv) positive, liver cirrhosis). b. findings consistent with hcc on at least one imaging modality (mdct, dynamic mri, or primovist mri) according to the korean liver cancer association (klca) criteria. c. histological diagnosis of hcc. 5. no prior history of hcc treatment, or if previously treated, no recurrence confirmed for at least two years. \*\*exclusion criteria\*\* 1. presence of three or more malignant liver tumors. 2. diffuse infiltrative type tumors with unclear boundaries. 3. recurrent hcc within two years of previous treatment. 4. tumors adhered to major hepatic vessels or bile ducts by more than 5 mm. 5. poor tumor visibility even with contrast-enhanced ultrasound (ceus)-fusion image guidance. 6. vascular invasion by malignant liver tumors. 7. severe coagulopathy (platelets \ 50% prolongation). 8. presence of extrahepatic metastasis. 9. situations where obtaining appropriate data for the study is unlikely.
how to reduce unnecessary blood cultures: construction and validation of a predictive score for blood culture positivity in intensive care

Conditions: Infection, Bacterial; Infection, Fungal; Bacteremia

Summary: prospective observational cohort consisting of all adult patients admitted to participating critical care units (icu and ccu) during the study period, with blood cultures collected as part of their care, and who did not express any objection to participating. for each patient, data will be collected prospectively for each blood culture set collected.


Eligibility criteria:
inclusion criteria: * male or female, age 18 years or older * patient admitted to an icu or icu * patient with a blood culture sample as part of care exclusion criteria: * patient already included in this study during a previous hospitalisation * opposition expressed for participation in the study

Keywords: intensive care unit blood culture prediction score
effects of flavor modification for management of radiation induced dysgeusia

Conditions: Dysgeusia

Summary: intervention for dysgeusia in head and neck cancer patients undergoing radiation therapy. this research proposal aims to investigate potential benefits of mberry in improving quality of life and nutritional outcome in head and neck cancer patients' post-radiation therapy. our hypothesis is that cancer patients undergoing radiation therapy will benefit from use of miracle berry in treatment of dysgeusia.

dysgeusia, characterized by altered taste, is a common side effect of radiation used in oropharyngeal cancer treatment. radiation affects taste buds, leading to issues like loss of appetite, malnutrition, dependence on feeding tubes, dysphagia, and impacts social and overall quality of life. patients often report bitter, metallic or no taste with food after radiation. miracle berries, known for interacting with sweet taste receptors, could potentially transform acidic tastes into sweet ones. the aim is to explore mberry's potential in alleviating dysgeusia, aiding patients in achieving better nutritional status and quality of life.this study includes the use of mberry tablets, which contain protein within the miracle berry called miraculin, for the treatment of radiation-induced dysgeusia. mberry is not approved by the food and drug administration (fda) for the treatment of radiation-induced dysgeusia. it is being used as part of this research study to find out if mberry tablets improve taste outcomes among head and neck cancer patients after radiation therapy.

Eligibility criteria:
inclusion criteria: * over 18 years * diagnosis of mandibular cancer, tonsillar cancer, and lingual cancer * receiving primary or adjuvant radiation therapy exclusion criteria: * received a total glossectomy or total laryngectomy. * patients with allergies to peanut, latex, peach, or soy will be excluded as they are at increased risk of allergy to mberry. * diagnosis of diabetes as well as prediabetic patients and those that are taking metformin.
topik study: a study to report progressive multifocal leukoencephalopathy and other serious opportunistic infections in natalizumab treated participants

Conditions: Multiple Sclerosis

Summary: the primary objective of the study is to estimate the incidence of progressive multifocal leukoencephalopathy (pml) and serious adverse events (saes) of other opportunistic infections (ois) among all participants taking natalizumab. the secondary objectives of the study are to estimate the incidence of saes, to estimate the incidence of saes among participant subgroups defined by demographic and clinical factors (age, gender, duration of treatment, pregnancy, breastfeeding), to characterize and estimate incidences of malignancies, hypersensitivity reactions and john cunningham virus (jcv) positivity among all participants taking natalizumab, and to count and describe pregnancies and breastfeeding among participants previously exposed to natalizumab.


Eligibility criteria:
key inclusion criteria: * participants starting with natalizumab after 1st january 2019 and participating in the remus will be included in this study key exclusion criteria: * not applicable (na) note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: progressive multifocal leukoencephalopathy (pml)
use of hair to diagnose breast cancer

Conditions: Breast Cancer

Summary: this study aims to perform x-ray diffraction analysis of blinded hair samples from women with a documented health status, to validate the previous findings of james et al who described that x-ray diffraction patterns of human hair can distinguish samples from healthy subjects from those of diseased subjects, specifically those suffering from breast cancer. the primary hypothesis is that x-ray diffraction of hair can be used to distinguish hair from patients with confirmed breast cancer from subjects without detectable breast cancer.


Eligibility criteria:
inclusion criteria: * adult women (aged \>20) who are undergoing mammography, and * who are willing and able to provide informed consent; and * who have usable scalp hair exclusion criteria: * women with a history of breast cancer ever or other cancers (excluding non-melanoma skin cancer and cin: cervical intra-epithelial neoplasia) within 5 years.

Keywords: x-ray diffraction hair breast cancer synchrotron
coronary artery disease and its association with liver steatosis among hiv-infected persons

Conditions: HIV Infections; Coronary Artery Disease; Non-Alcoholic Fatty Liver Disease

Summary: the primary purpose of this study is to evaluate the association between nonalcoholic fatty liver disease (nafld) by computed tomography (ct) scan and coronary artery disease (cad) measured by the calcium (cac) score among hiv-infected persons.


Eligibility criteria:
inclusion criteria: * hiv patients who participated in our previous liver study, conducted at nmcsd, and hiv patients who did not participate in the liver study. exclusion criteria: * women who are pregnant or breastfeeding will be excluded.
can addition of doxycycline perioperatively reduce propionibacterium acnes in shoulder arthroplasty?

Conditions: Osteoarthritis

Summary: the purpose of this study is to investigate antibiotic treatment to target bacteria about the shoulder. this bacteria, propionibacterium acnes, is detected in many revision shoulder surgeries and is thought to contribute to periprosthetic joint infections, pain, and failure of total shoulder arthroplasty as well as other shoulder surgeries. this study is investigating adding an fda approved antibiotic that is commonly used for treatment of this bacteria and many common infections. the investigators will take intraoperative cultures to look for the presence or absence of specific bacteria. the investigators are conducting this trial to see if adding another antibiotic to specifically target this common bacteria found around the shoulder will be effective.

patients undergoing total and reverse shoulder arthroplasty for primary glenohumeral arthritis will be invited to participate in this study if patients meet inclusion and exclusion criteria. patients will be randomized to receive either standard perioperative antibiotics with cefazolin or to the treatment group to receive doxycycline in addition to cefazolin. patients will then undergo routine surgical treatment. 3 cultures from the superficial tissue, dermis, and glenohumeral joint will be taken and cultured for 14 days to detect any bacterial growth.

Eligibility criteria:
inclusion criteria: * patients undergoing primary total shoulder arthroplasty at rush university medical center exclusion criteria: * patients with prior shoulder surgery of any kind * patients with a known infection or history of infection with clinical signs such as elevated erythrocyte sedimentation rate, c-reactive protein, positive culture aspiration * patients with a known allergy to doxycycline * patients with a known allergy to cefazolin or penicillin