Kornimate/medical-research-clean huggingface dataset:
ulcers - electrical stimulation in diabetic foot ulceration

Conditions: Diabetes

Summary: the investigators hypothesise that use of a medical device, that increases blood flow to the foot, will speed up ulcer healing in symptomatic diabetes

diabetes affects approximately 347 million people worldwide, and by 2030 the who projects that diabetes will be the 7th leading cause of death. diabetic foot ulcers are estimated to occur in 15% of all patients with diabetes, often co-existing with neuropathy and peripheral vascular disease which compromise the limb's ability to heal. foot infections in this cohort are common, and diabetic foot ulcers serve as a portal for infective organisms to enter the body. unchecked, infection can spread contiguously to involve underlying tissues, including bone. a diabetic foot infection is often the pivotal event leading to gangrene and lower extremity amputation. diabetes accounts for over one million leg amputations every year, and represents 60% of all amputations in developed countries. due to the potential for rapid progression of infection, and the gravity of potential complications, diabetic foot problems are handled aggressively in the community, with a low threshold for referral to secondary care. out-patient clinics involve a multidisciplinary team of clinicians, podiatrists and vascular surgeons. good foot care is taught to all diabetic patients, and treatment with antibiotics, debridement and revascularisation should occur as a matter of urgency where appropriate. the device to be tested mimics the effect of walking by making the foot twitch- it increases blood flow to the limb and exercises the leg muscles. it is hypothesised that increasing blood flow to the limb, much as surgical revascularisation, will aid the legs ability to heal and fight infection. after training, it can be used by patients on themselves and is suitable for out-patient therapy. the investigators wish to evaluate both the short- and longer-term effects of a neuromuscular stimulator on diabetic foot ulceration as a therapeutic intervention.

Eligibility criteria:
inclusion criteria * 18+ years old * type 2 diabetes on best medical therapy * active foot ulceration, present \<3 months exclusion criteria * pregnancy * pacemaker * metal implants in the legs (below knee)

Keywords: diabetic foot ulcer healing medical device to increase blood flow in foot
radiation therapy to the brain or observation in preventing brain metastases in patients with advanced non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. it is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer. purpose: this randomized phase iii trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer.

objectives: primary * determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride. secondary * determine the progression-free survival in patients treated with this regimen. * determine the overall survival in patients treated with this regimen. * determine the safety and tolerability of this regimen in these patients. * determine the psycho-neurological effects of this regimen in these patients. * determine the quality of life of patients treated with this regimen. outline: this is a multicenter study. patients are stratified according to prior chemotherapy regimens (first line vs second line), and disease response status (complete response or partial response vs stable disease). patients are randomized to 1 of 2 treatment groups. * group 1: patients undergo prophylactic brain radiotherapy. * group 2: patients undergo observation. patients complete quality of life (hvlt, k-adl, eortc qlq-c30, and eortc-bn20) questionnaires periodically. after completion of study therapy, patients are followed up periodically.

Eligibility criteria:
disease characteristics: * histologically confirmed non-small cell lung cancer * stage iiib or iv disease * must have had ≥ 8 weeks of gefitinib or erlotinib hydrochloride therapy * at least 12 weeks of complete response or partial response since starting gefitinib or erlotinib hydrochloride * stable disease allowed provided 1 of the following criteria is met: * egfr mutation (exon 19 or 21) * having ≥ 2 of the following 3 factors: * female * never smoked * histologically confirmed adenocarcinoma of the lung * no evidence of brain metastases by ct scan or mri within the past 4 weeks patient characteristics: * ecog performance status 0-2 * anc ≥ 1,500/mm\^3 * platelet count ≥ 150,000/mm\^3 * bilirubin \< 1.5 mg/dl * serum creatinine \< 1.5 times upper limit of normal prior concurrent therapy: * see disease characteristics * received 1 or 2 prior systemic chemotherapy regimens

Keywords: adenocarcinoma of the lung adenosquamous cell lung cancer bronchoalveolar cell lung cancer large cell lung cancer squamous cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer
use of diffuse optical spectroscopy for evaluation of the trauma/critically care patients

Conditions: Trauma

Summary: trauma remains the leading cause of death and disability for americans age 1-44. trauma can cause internal bleeding, and this bleeding is often hard to detect without sophisticate tests that take time to complete and analyze. in addition, internal bleeding, including bleeding into the lung and chest cavity, as well as other blood loss, happens in many critically ill patients. for example, for hemorrhage, it is very difficult to detect active hemorrhage and to determine optimal rates of fluid and blood resuscitation. diffuse optical spectroscopy has the potential to accurately assess adequacy of tissue perfusion, oxygenation, tissue oxygen extraction, and cytochrome oxidation states that may be critical to optimal treatment, end- organ preservation, and survival.

the research' want to monitor tissue perfusion and indicators of tissue damage and viability in critically ill patients by using dos. non-invasive optical techniques dos,near-infrared diffuse optical spectroscopy (nir-dos. nir-dos provides functional physiologic tissue/organ information without ionizing radiation and without withdrawing any blood, in a cost-effective and rapid manner. the application of frequency-domain photon migration analysis (fdpm) to nirs allows independent measurements of tissue absorption and scattering properties at depths of 1 cm or more below the skin surface. such capabilities will improve early diagnosis, detection, optimization of therapy, assessment of adequacy of resuscitation, and alteration in management plans for all of these critical conditions.

Eligibility criteria:
inclusion criteria: * adult age 18 years or older, male or female * trauma/critical care patient exclusion criteria: * subject is not trauma/critical care patient

Keywords: internal bleeding changes in tissue perfusion
prediction of cognitive properties of new drug candidates for neurodegenerative diseases in early clinical development

Conditions: Alzheimer Disease; Battery

Summary: the early assessment of new drugs for alzheimer's disease remains difficult because of the lack of predictive end-point. the use of a battery including different parameters could improve this early development of new drugs. nevertheless, the interest of such a battery should previously be validated with the yet marketed ad drugs

the aim of the present study is to test the effect of a 15-day treatment with donepezil on a mixed battery associating cognitive assessment, imaging and neurophysiological tests in healthy volunteers. this multicenter, randomized, placebo-controlled, cross-over study is double-blind controlled and is conducted in 3 centers located in france (lille, marseille and toulouse). 18-30 years old, healthy volunteers, without any neurological or psychiatric impairment, will complete 2 test sessions in a randomized order: one with a 15-day treatment with donepezil, the other with placebo, and will be submitted to a mixed battery during the 14th and 15th day of the treatment. the primary outcome of the study will be based on cognitive assessment, imaging parameters and neurophysiological parameters.

Eligibility criteria:
inclusion criteria: * 18-30 year old male non-smoker subjects * subject without cognitive impairment or cognitive complaint (moca\>26, mac nair scale\<15) * subject without history of brain disease (severe brain trauma, stroke, cerebral tumor,...) * subject without major medical or surgical history * subject without current chronic disease * subject without current cerebral disease * subject without vascular or metabolic risk factor * subject without history or current mental disease or addiction (mini) * subject without lesion on mri * subject without abnormal electrical activities on eeg * subject without use of chronic treatment or psychotropic drugs or substances * french speaker subject and able to understand the test instructions exclusion criteria: * subject with age \ 30 years * subject with dementia or cognitive decline identified by moca \< 26 * subject with history of brain disease (brain trauma, stroke, cerebral tumor,...) * subject with major medical or surgical history * subject with current chronic disease * subject with current cerebral disease * subject with vascular or metabolic risk factor * subject with history or current mental disease or addiction * subject with family history of young-onset dementia * subject with family history of chronic or severe neurological or mental disease (first degree relatives) * subject with lesion on mri * subject with abnormal electrical activities on eeg * subject receiving a chronic treatment * subject using chronically or acutely psychotropic drugs or substances * subject with claustrophobia or contra-indication to mri * subject unable to understand the test instructions

Keywords: alzheimer donepezil biomarkers battery cognition imaging neurophysiological
web-based self-monitoring activity-restriction and relaxation training program for kids with mild traumatic brain injury

Conditions: Brain Injury Traumatic Mild

Summary: smart is an interactive web-based program that will allow youth with mild traumatic brain injuries (mtbi) to monitor their symptoms and receive education on problem-solving and coping strategies. this study will evaluate the effectiveness of smart as a means of improving symptom-management, coping skills, and general well-being during recovery from mtbi. half of participants will receive the smart intervention, while half will receive usual care.


Eligibility criteria:
inclusion criteria: * 11-18 years old * sustained mtbi within the past week exclusion criteria: * patient and/or family do not speak and read english * patient and/or family do not have internet access * patient experiencing more severe brain injury (glasgow coma score \<13) * patient with more than one moderate extracranial injury * patients with non-mtbi reasons for altered mental status * patients with severe pre-existing neurologic or cognitive disorders or other disorders that may impair ability to participate in the intervention.
radiotherapy with hyperthermia in recurrent and radiation-induced sarcomas

Conditions: Radiation Induced Neoplasms; Radiation-Induced Cancer; Recurrent Sarcoma; Recurrent Soft Tissue Sarcoma

Summary: after a screening, which consists of biopsy, physical examination, initial diffusion-weighted magnetic resonance imaging (dwi-mri) or body computed tomography (ct) scan, blood tests and case analysis on multidisciplinary team (mdt) meeting, a patient with radiation-induced or in-field recurrent sarcoma will receive the hypofractionated radiotherapy with deep hyperthermia (twice a week) within three weeks. the response analysis in ct or dwi-mri and toxicity assessment will be performed after 6 weeks. in resectable tumors, a patient will be referred to surgery. in the case of unresectability, the patient will followed-up.

due to the rarity of radiation-induced (ris) or previously irradiated recurrent (pirs) sarcomas, no guidelines nor randomized prospective clinical trials on this topic exist. thus the management of ris and pir is challenging. the only curable modality in non-metastatic ris/pirs is radical resection with wide negative margins. the role of secondary radiotherapy in locally advanced ris/pirs is unclear, mostly due to the concerns about possible severe side effects after re-irradiation. the addition of deep hyperthermia to irradiation and in the prolonged gap between the end of moderately hypofractionated radiotherapy (with or without integrated boost) and surgery may allow obtaining the long-term local control with the maintenance of a good treatment tolerance hyperthermia is a method of increasing the temperature in the tumor to damage cancer cells with minimum injury to the normal cells. it should be combined with another treatment modality (radio- or chemotherapy) rather than used alone. its efficacy was proven in clinical trials. treatment tolerance is usually very good.

Eligibility criteria:
inclusion criteria: * able to provide informed consent * eastern cooperative oncology group performance status 0 - 2 * age ≥18 years old * histologically-proven diagnosis of radiation-induced or recurrent soft tissue sarcoma * previous radiotherapy within the planned target volume exclusion criteria: * histologic diagnosis of rhabdomyosarcoma (except spindle cell and pleomorphic subtype), osteogenic sarcoma, ewing's sarcoma/pnet, aggressive fibromatosis * contraindications to radiotherapy or hyperthermia * predicted unacceptable high risk of reirradiation-related toxicity, in the investigator's judgment * unresectable metastases
a multi centre study to determine the feasibility of using an integrated consent model to compare standard of care administration schedules of g-csf (filgrastim) for primary prophylaxis of chemotherapy-induced febrile neutropenia in early stage breast cancer (react-g study)

Conditions: Early Stage Breast Cancer

Summary: in patients with early-stage breast cancer, chemotherapy has substantially improved survival rates for breast cancer patients. improvements in outcomes, however, are compromised by the considerable toxicities associated with chemotherapy, most notable being neutropenia. neutropenia is the presence of abnormally few white blood cells, leading to increased susceptibility to infection and can require hospitalization and need for intravenous antibiotics and is sometimes fatal. febrile neutropenia can also be associated with treatment delays and dose reductions, potentially compromising treatment efficacy. patients can receive medication to reduce the risk of febrile neutropenia, such as neupogen (filgrastim) as a daily injection for 5, 7, or 10 days. since there is genuine uncertainty amongst healthcare professionals as to which administration schedule of neupogen is better, investigators are performing a randomized study in which patients are put into a group by chance to give participants one of three standards of neupogen daily injection. neupogen can cost approximately $200 per injection, so if a physician prescribes 10 days for 8 cycles of treatment this can cost $16,000 compared to a 5 day prescription which would cost half this. in addition to cost savings, many patients are not able to give themselves injections on a daily basis and require nursing resources which are utilized at high-cost. this study will use an "integrated consent model" that involves an "oral consent" rather than a written informed consenting process in order to increase the number of patients who may participate while performing a study at a lower cost. while determining the optimal treatment will improve patient comfort and acceptability, using the minimal safe duration of administration may also offer cost savings.


Eligibility criteria:
inclusion criteria: * histologically confirmed primary breast cancer * planned to start docetaxel component of fec-d or ac-d, or first cycle of; dose-dense ac-t, tc, fec-d or tac chemotherapy * ≥19 years of age * able to provide verbal consent exclusion criteria: * contraindication to filgrastim
paracetamol versus ibuprofen in premature infants with hemodynamically significant patent ductus arteriosus

Conditions: Patent Ductus Arteriosus After Premature Birth

Summary: multicentric, double-blind clinical trial, which will evaluate the efficacy of iv paracetamol versus standard treatment with ibuprofen in the closure of patent ductus arteriosus in the preterm newborn. secondarily, we intend to compare the safety of both treatments, increase our knowledge about the pharmacokinetics, pharmacodynamics and pharmacogenetics of paracetamol and ibuprofen in the neonatal period and make a pharmacoeconomic assessment of the use of both drugs.

those newborns ≤ 30 weeks of gestational age who are diagnosed in the first 2 weeks of hemodynamically significant ductus arteriosus and who do not meet any exclusion criteria will be eligible to participate in the study. the paracetamol group will receive intravenous doses of 15 mg/kg administered every 6h for 3 days (up to a maximum of 2 courses, i.e. 6 days). the ibuprofen group (control group) will receive the usual treatment, this is an initial dose of 10 mg/kg followed by 5 mg/kg intravenously at 24 and 48 hours after the first (all three doses are considered a treatment course), up a maximum of 2 courses). a daily echocardiographic control will be performed to evaluate the closure of the ductus. if the ductus remains open and with significant clinical repercussion after completing a 3-day course of treatment, another batch of 3 doses of the same treatment will be administered. if medical treatment fails after two courses (6 days), the possibility of administering a batch of ibuprofen at usual doses in both groups with the intention of offering standard treatment to all patients will be considered. once the medical treatment with both drugs is completed if the ductus remains significant, the surgical closure will be carried out.

Eligibility criteria:
inclusion criteria: * written informed consent of parents/guardians * gestacional age ≤30 weeks * postnatal age ≤ 2 weeks * need for ventilatory support * born in participating hospital/arrival to them within the period of application of the treatment * 1 st episode of hemodynamically significant patent ductus arteriosus exclusion criteria: * major congenital malformations or chromosomopathies * refusal to participate and / or sign the informed consent. * impossibility or erroneous randomization * participation in another clinical trial with drugs * diuresis less than 1 ml / kg / h for 8 h prior to treatment * greater than 1.8 mg / dl creatinine * platelets below 50,000 / ul * active bleeding (tracheal, gastrointestinal and renal) * intraventricular hemorrhage recently (48h) (grades 3-4) * severe hyperbilirubinemia * liver failure or severe coagulopathy * active necrotizing enterocolitis or intestinal perforation * septic shock * imminent death
magnetic resonance elastography of cardiac transplant rejection

Conditions: Acute Graft Rejection

Summary: magnetic resonance elastography (mre) for cardiac transplant patients.

patient will undergo mre beginning 4-8 weeks post transplant, then with each scheduled cardiac biopsy through 7-8 months post transplant. results of the mre will be compared against results of the cardiac biopsy to determine if the non-invasive mre can predict cardiac transplant rejection.

Eligibility criteria:
inclusion criteria: * patients must have undergone cardiac transplantation at the ohio state university ross heart hospital. * patients must be able to lie flat on their back in the scanner for up to 60 minutes * patient must be able to hold their breath for up to 15 seconds at a time. exclusion criteria: * patients who are claustrophobic * patients who are pregnant, due to potential risks to the fetus. * patients with any unapproved, non-mri safe metal/devices in their bodies.
gait modifications and cutaneous stimulation

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to quantify differences in joint mechanics between different types of walking in healthy individuals and individuals with knee pathology. the investigators will determine how modifying gait through feedback and/or cutaneous stimulation changes joint loading.


Eligibility criteria:
inclusion criteria: * bmi \< 35 kg/m\^2 * for knee pathology subjects: diagnosis of knee pathology (e.g. knee osteoarthritis, acl injury, etc) and/or knee pain * full weight-bearing status exclusion criteria: * non-ambulatory * use of walking aid * for healthy volunteers - history of surgical intervention at any joint of the lower extremity * inability to cooperate with study protocol due to medical or psychiatric reasons * inability to provide informed consent * for healthy subjects: any diagnosis of knee osteoarthritis or knee pain

Keywords: knee pathology
reliability of pupil response to acute pain

Conditions: Pain; Osteoarthritis

Summary: the purpose of this research study is to test whether researchers can reliably measure the response pupils have when an acute painful stimulus is experienced. changes in the size of the pupil of the eye can be an indicator of brain activity in a region of the brain that is important for feeling pain.

there is strong rationale to support a role for locus coeruleus (lc) responsivity to acute painful stimuli in regulating speed of recovery after surgery and for lc responsivity as a mechanistic link explaining the risks for slow recovery from weak conditioned pain modulation (cpm), catastrophizing cognitive style, and low enzyme activity catecholamine-o-methyltransferase (comt) genotype. preliminary data show feasibility to perform the proposed study. primary hypothesis: an observational study of pupil responses to noxious stimuli shows strong intra-individual reliability over 8 weeks. key secondary hypotheses: compared to individuals homozygous for val at the val158met site of the catecholamine-o-methyltransferase (comt) gene, those homozygous for met will show smaller pupil responses to noxious stimuli and weaker cpm.

Eligibility criteria:
inclusion criteria: * adult (18-70) * pain from hip or knee arthritis of moderate intensity * american society of anesthesiologists physical status 1-3 exclusion criteria: * inability to complete study questionnaires * pregnancy * litigation or workers compensation related to hip or knee pain * taking \> 50 mg morphine equivalents/day * history of raynaud's disease of the feet * psychotic disorder or a recent psychiatric hospitalization * history of eye surgery or topical eye medications that would would directly affect pupil diameter