Kornimate/medical-research-clean huggingface dataset:
a study of ibrf disorders of consciousness advanced care/multimodal care protocol in severe disorders of consciousness

Conditions: Brain Injury

Summary: this is a study to evaluate the safety and efficacy of the ibrf acp/mcp intervention protocol in patients with severe disorders of consciousness (sdoc).

currently, there are no empirically validated, evidence-based pharmacological interventions for the treatment of severe disorders of consciousness (sdoc). in addition, it is unclear why poly-pharmacological interventions, while more common in the treatment of other disorders (e.g., cancer, chronic pain), have not been embraced for the treatment sdoc; some of the lone agents used in treatment of sdoc patients are not "indicated" for combined treatment. in addition, the treatment of sdoc traditionally employs the use of single or small combinations of pharmacological agents, with no single pharmacological agent being identified as efficacious or effective. as such, a poly-pharmacological intervention may, inherently, involve pharmacological interactions that were not anticipated by the drug manufacturers or prescribing physicians. the purpose of this study is to document the safety of the ibrf acp/mcp and to establish its efficacy for those sdoc patients successfully completing treatment. the ibrf acp/mcp employs a poly-pharmacological approach aimed at studying arousal states and outcomes in sdoc patients beyond those rates documented in literature.

Eligibility criteria:
inclusion criteria: * age 18 years to ≤ 65 years * gcs rating of 3 to 9 (severe impairment) * evidence of an acquired brain injury that severely suppresses consciousness * coma, vegetative state, or minimally conscious state based on definitions of the mohonk report * if polytrauma, patient is medically stable exclusion criteria: * gcs of 10 or greater (moderate to mild impairment) * tracheostomies requiring ventilator support * medical condition that precludes objective assessment (e.g., concurrent guillain-barre or other severe peripheral neuropathy, severe critical illness myopathy/polyneuropathy) * onset of injury greater than 12 months post hypoxic ischemic injury (hii) * onset of injury greater than 24 months post traumatic brain injury (tbi) * emergence during the screening period * terminal illnesses, existing severe neuro-developmental disorders, existing chronic degenerative neurological conditions, prior moderate-to-severe tbi, or any stroke syndrome other than transient ischemic attack (tia), or a prior seizure disorder * patients with an uncontrolled seizure disorder, or seizure disorder can only be controlled with medication that is contra-indicated (e.g., dilantin or phenobarbitol), * in the opinion of the attending physician, the patient presents with a cardiac condition that would place them at unacceptable risk, or has a documented ejection fraction (ef) \<25%

Keywords: severe disorders of consciousness (sdoc) coma vegetative state minimally conscious state
technology-based eye care services (tecs) compare

Conditions: Cataract; Macular Degeneration; Glaucoma

Summary: the purpose of this study is to compare the technology-based eye care services (tecs) protocol to the standard face to face ophthalmologic exam.

patients will sign informed consent to enter the one visit study. they will undergo the study protocol and then see the face to face physician on the same day.

Eligibility criteria:
inclusion criteria: * patient at the atlanta va medical center (vamc) new comprehensive eye clinic exclusion criteria: * known acute or chronic ocular issues

Keywords: screening tele-ophthalmology
a pilot study to investigate biomarkers in anterior cruciate ligament (acl) patients and healthy controls

Conditions: Rupture of Anterior Cruciate Ligament

Summary: incident rates of acl rupture are greatest in 16-39 year olds at almost 1 in 1,000. performance based investigations (pbis) can be used to evaluate and select correct approaches to patient treatment, and biochemical, biomechanical and physiological biomarkers in other conditions are sensitive in distinguishing between disease state severities, type of injuries and responsiveness to treatment. despite the measurement sensitivity of pbis, these are not widely used possibly owing to their focus postoperatively where benefits are less worthwhile. this study aims to investigate novel biomarkers as performance based investigations (pbis) to improve surgical and treatment strategies in anterior cruciate ligament (acl) patients. the objectives are to identify whether biomarkers, collected before and after operations, can: 1) assist the surgeon in decision making; 2) lead to improved prognosis; 3) be used to predict the outcomes of prognosis, and; 4) correlate with disease signs/ smoking to help further understand acl injuries.


Eligibility criteria:
inclusion criteria: * unilateral acl rupture * 18 - 45 years old exclusion criteria: * combined posterior and acl rupture * multi-ligament instability including medial or lateral collateral ligament injury * other lower limb surgery \<3mths * current significant acute injury affecting other lower extremity joints, or other relevant neurological or musculoskeletal pathology.

Keywords: anterior cruciate ligament performance based investigations
non invasive extra-corporeal ecg signal analysis algorithm( nid algorithm) for myocardial ischemia

Conditions: Acute Coronary Syndrome; Myocardial Ischemia

Summary: the nia algorithm is similar to the traditional 12-lead ecg equipment. by analyzing patient data, nia algorithm provides more detailed results compared to traditional 12-lead ecg. patients with suspected coronary artery disease are conventionally diagnosed and treated by cardiac catheterization. however, cardiac catheterization is invasive procedure. unless clinical diagnosis is evident before cardiac catheterization, a treadmill exercise test, a nuclear medicine myocardial perfusion test, or a multi-direction coronary ct angiogram is usually performed to increase the accuracy of diagnosis. but these examinations are not accessible to all patients, and are time-consuming and costly.

in this project, the investigators hope to compare the data collected under this new technology of nia algorithm with results from final diagnoses of cardiac catheterization. as the nia algorithm is a fast and less costly, if it provides more sensitivity and specificity than does exercise ecg, nuclear myocardial perfusion test, and high-resolution coronary ct angiogram, it will expedite diagnosis for patients with coronary artery disease.

Eligibility criteria:
inclusion criteria: * patient with acute coronary syndrome who accepted percutaneous coronary intervention exclusion criteria: * no percutaneous coronary intervention
use of the enseal intrument for laparoscopic supracervical hysterectomy

Conditions: Indications for Laparoscopic Supracervical Hysterectomy

Summary: the use of the enseal® instrument for laparoscopic supracervical hysterectomy in a randomized, single-blinded comparison to the conventional procedure. the objective of the study is to investigate if the use of the enseal sealing instrument for supracervical hysterectomy leads to a shortening of the operation time.


Eligibility criteria:
inclusion criteria: * age \>18 years * indication for supracervical hysterectomy without additional surgical procedures (i. e. oophorectomy) * willingness and capability to comply with all study tests, procedures, and assessment tools * capability of providing informed consent. exclusion criteria: * history of, or evidence of, gynecologic malignancy within the past five years * pace maker, internal defibrilator/cardioconverter * impaired coagulation parameters * unwillingness to be randomized to treatment * history of median laparotomy * intraabdominal adhesions * requirement for open laparoscopy

Keywords: supracervical hysterectomy leiomyomas adenomyosis
clinical study of poss-pcu vascular grafts for vascular access

Conditions: Renal Insufficiency

Summary: this study evaluates the safety and performance of a new vascular graft made of poss-pcu as a vascular access conduit for haemodialysis. 30 patients requiring access for dialysis will be enrolled and monitored at regular intervals for 18 months.


Eligibility criteria:
inclusion criteria: * subjects requiring vascular access for haemodialysis * subjects with no suitable vein. * subjects aged 18 - 80 years old * subjects are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained * patients of child bearing potential, who are sexually active, must agree to the use of 2 highly effective forms of contraception throughout their participation in the study and for 6 months after completion of treatment: * condom with spermicide. and 1 of the following: * oral contraceptive or hormonal therapy (e.g. hormone implants). * placement of an intra-uterine device. exclusion criteria: * subjects with predicted short-term survival (less than 18 months) or poor prognosis (this will be on the discretion of the clinician in charge) * subjects with left ventricle ejection fraction (lvef) \<20% diagnosed on echo either pre-procedure or documented within the previous 3 months prior to consent. * pregnant or lactating * allergies to any constituents of the graft material * patients who are infected or colonized with methicillin resistant staphylococcus aureus (mrsa).
periarticular penetration of cefazolin and clindamycin in second stage revision arthroplasty of the hip

Conditions: PJI; Bone and Joint Infection; Pharmacokinetics

Summary: to prevent periprosthetic joint infection (pji), optimal penetration of antibiotics into the joint-space is needed. in revision arthroplasty, the incidence of pji is increased compared to primary arthroplasty. in this study, the penetration of antibiotic agents into the synovial fluid and bone will be analyzed. the concentration of antibiotics will be related tot the to the susceptibility (minimal inhibitory concentration; mic-90) of microorganisms that frequently cause pji.

periprosthetic joint infection (pji) is a feared complication of joint replacement, with an incidence of 0.5-1% after primary joint replacement and 3-5% after revision arthroplasty. for orthopaedic surgery involving a prosthesis, the administration of systemic antibiotic prophylaxis is strongly recommended to prevent pji. cefazolin is widely used as agent of choice in surgical antibiotic prophylaxis. previous studies, all performed in patients undergoing primary joint replacement, demonstrated that the concentration of cefazolin in bone and synovial fluid was dose-dependent and exceeds the mic90 for methicillin susceptible staphylococcus aureus (mssa), when given as 1 to 4 gram single dose shortly before incision. when a pji is already present, clindamycin is used as treatment option in pji caused by staphylococci (when combined with rifampicin) or cutibacteria. a limited number of studies have been performed to analyse the penetration of clindamycin into bone. these studies showed that clindamycin penetrates well into the bone and concentrations exceeded the mic90 for mssa. no studies have been performed to analyse the penetration of antibiotic agents into the periarticular tissue in patients who will undergo revision arthroplasty. in revision arthroplasty a foreign body (prosthesis) is in situ and periarticular tissue condition can be compromised due to previous surgical procedures and the presence of bone reaction to the prosthesis. it is not known whether the difference in pji incidence after primary and revision arthroplasty may be explained by different penetration of the surgical antibiotic prophylaxis. the aim of this explorative study is to analyse the penetration of cefazolin and clindamycin into synovial fluid and bone and whether the concentration of the agents exceeds the mic90 for micro-organisms frequently causing pji.

Eligibility criteria:
inclusion criteria: 1. age 16 years or older. 2. scheduled second stage revision arthroplasty (reimplantation) of the hip prosthesis during clindamycin 600mg three times a day orally for pji, started at least 3 days before reimplantation (steady state). exclusion criteria: 1. antibiotic prophylaxis other than cefazolin 2000mg i.v. 2. cefazolin use within 4 days previous to the reimplantation, other than the single dose administration of surgical prophylaxis just before incision. 3. clindamycin loaded bone cement in situ. 4. bmi more than 35 kg/m2.
lung cancer radiotherapy using realtime dynamic multileaf collimator (mlc) adaptation and radiofrequency tracking

Conditions: Neoplasms; Lung Neoplasms

Summary: a research study into a new technology for adjustment of the radiotherapy beam to account for movement of lung tumours as the patient breathes during radiotherapy.

twenty patients 18 years of age or more and undergoing stereotactic body radiotherapy (sbrt) at northern sydney cancer centre for lung cancer will receive the new treatment. participants will be physically able to undergo all aspects of treatment and intellectually able to provide written informed consent and complete questionnaires. beacons will be implanted in the patients' lung to allow the multi leaf collimator (mlc) tracking equipment to follow precisely the movement of the lung. the difference in ability to track tumour movement between mlc and the current standard method will be compared to identify changes in study outcomes. audiovisual (av) biofeedback will also be used to regulate patients' breathing during radiotherapy.

Eligibility criteria:
inclusion criteria: * aged 18 or older * has provided written informed consent for participation in this trial and is willing to comply with the study * patients undergoing external beam radiotherapy at northern sydney cancer centre * histologically proven stage i non small cell lung cancer (nsclc) oligometastatic lung metastases (3 or less). histological diagnosis will be obtained if clinically indicated. * mri/4d-ct prior to insertion of calypso beacons * patient must be able to have varian calypso beacons placed in the lung (if on anticoagulants, must be cleared by local medical officer (lmo) or cardiologist). * eastern cooperative oncology group (ecog) performance status 0-2 * body habitus enabling calypso tracking (as per calypso determining a patient's localisation designation \& orientation before implantation) * a maximum of three metastases to the lung from any non-haematological malignancy. multiple metastases will be treated separately. * tumour diameter ≤ = 5cm exclusion criteria: * previous high-dose thoracic radiotherapy. * less than two calypso beacons implanted in the lung. * calypso beacons are spaced by greater than 9cm or less than 1cm. * calypso beacons are less than 19cm from outer chest wall * cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. hormonal manipulation agents are allowable (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotropin releasing hormone receptor modulators) * targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, or concurrently with treatment * women who are pregnant or lactating. * unwilling or unable to give informed consent * unwilling or unable to complete quality of life questionnaires

Keywords: lung cancer stereotactic ablative radiotherapy (sabr) mlc tracking radiotherapy
a study of extended carfilzomib therapy for patients previously enrolled in carfilzomib treatment protocols

Conditions: Multiple Myeloma; Solid Tumors

Summary: this is a multi-center, open-label, phase 2 study of carfilzomib to monitor the safety and efficacy of long-term or continuing carfilzomib therapy for patients who previously completed a primary carfilzomib treatment study.


Eligibility criteria:
inclusion criteria: 1. previous completion of a carfilzomib study within 90 days prior to first dose of maintenance study drug. 2. disease assessments performed within 30 days prior to first dose of maintenance study drug. 3. written informed consent in accordance with federal, local, and institutional guidelines 4. females of childbearing potential (fcbp) must have a negative serum or urine pregnancy test, with a sensitivity of at least 50 miu/ml, within 3 days prior to first dose of maintenance study drug. 5. subjects must agree to adhere to the study visit schedule and other study requirements and receive outpatient treatment and laboratory monitoring at the institution that administers the drug. exclusion criteria: 1. administration of an intervening chemotherapy between the time of previous carfilzomib study termination and first dose of maintenance study drug. 2. pregnant or lactating females 3. diagnosis of a new malignancy of a different tumor type.

Keywords: multiple myeloma proteasome hematological carfilzomib pr-171
assessment of myocardial disease in man using novel non-invasive diagnostic tools

Conditions: Cardiovascular Diseases

Summary: this study will be testing two devices which are designed to detect cardiovascular disease in patients as early as possible. as there are now many therapies to prevent and treat this condition it is believed that detecting it early will help reduce the burden of the disease and permit more effective treatment. the two devices the investigators are testing are the viscope developed by hd medical and a device developed by csiro. both of these devices are simple, non-invasive and may provide useful information on how well the heart contracts and relaxes as well as valve function of the heart. the investigators are planning to enroll 100 healthy subjects, 100 participants with risk factors for heart failure and 300 patients with varying types of heart failure. the data collected from the experimental devices will be compared to the results from standard tests. patients will not have any of their therapies altered as part of this study.


Eligibility criteria:
inclusion criteria: * over 18 years * have provided consent risk factor patients also require: * hypertension \> 2 years * diabetes \> 2 years * known ischemia, tia, or stroke * arrhythmia; or reduced renal function (egfr\<50 ml/min) heart failure patients also require: * lvef \<40% * receiving standard medication for the treatment of symptomatic systolic heart failure with an nyha class of ii-iv. exclusion criteria: health patients (must not have any of the following): 1. cardiovascular disease 2. receiving cardiovascular medication 3. not in normal sinus rhythm (also required for hf patients)

Keywords: to assess two new diagnostic devices for detecting early heart failure.
continued efficacy of apomorphine after previous exposure of at least three months

Conditions: Parkinson Disease

Summary: the objective of this study was to measure the continued efficacy of apomorphine after previous exposure of at least three months duration.

this was a prospective, double-blind, randomized, placebo-controlled, crossover desigh, multicenter study of the safety and effectiveness of subcutaneous apomorphine treatment. patients received both apomorphine and placebo, in a randomized double-blind fashion

Eligibility criteria:
inclusion criteria: * patients diagnosed with idiopathic parkinson's disease and classified as stage ii-iv of the hoehn and yahr scale for staging the severity of parkinson's disease * patients must have been on an optimally maximized oral therapy regimen including levodopa/decarboxylase inhibitors in either immediate or delayed release forms, plus at least one direct acting oral dopamine agonist for at least 30 days prior to randomization * patients must have been receiving apomorphine subcutaneous injections for rescue therapy for "off" events for at least three months with an average dosing requirement of at least 2 doses per day over the week prior to enrollment with a dose of less than 11 mg exclusion criteria: * patients under medical therapy for clinically significant psychoses or dementia not related to ingestion of antiparkinson medications. (patients with hallucinations or other central adverse reactions associated solely with antiparkinson medications were not excluded.) * patients with a history of drug or alcohol dependency within one year prior to study enrollment * patients with unstable and clinically significant disease of cardiovascular (including orthostatic hypotension), hematologic (including coombs' positive hemolytic anemia), hepatic, renal, metabolic, respiratory, gastrointestinal or endocrinological systems or neoplasm within the threemonths before the start of the study. * patients with a history of allergy or intolerance to morphine or its derivatives, sulfur, sulfur containing medication, sulfites, domperidone, trimethobenzamide or other anticholinergics. * patients treated with experimental agents (other than apomorphine intermittent subcutaneous injections) within 3 months before study entry, experimental agents were defined on the basis of the regulatory status in the country of patient observation, or with other disallowed medications * patients whose apomorphine regimen was characterized by continuous infusion or by administration methods other than intermittent subcutaneous injection. * patients who could not or would not sign an informed consent form.
n-3 fatty acid effects in t2dm after acute high intensity exercise

Conditions: Type2 Diabetes Mellitus

Summary: the aim of this study was to verify the effect of a combined supplementation \[n-3 pufa (known to induce anti-inflammatory effects) plus vitamin e (known for its antioxidant properties)\] on lipidic, glycemic, redox status and inflammatory parameters in type 2 diabetic patients. in addition, considering that exercise, at high intensities, can induce a transient inflammatory state and increase oxidative stress (os) markers, the investigators tested if our nutritional intervention could attenuate this response within this population (thus, using high intensity exercise as inductor of acute inflammatory/os state).

herein the investigators tested the effect of eight weeks of omega-3 polyunsaturated fatty acid (n-3 pufa) and vitamin e supplementation before and after an acute high intensity exercise bout on lipid profile, glycemic, redox and inflammatory parameters in type 2 diabetic (t2dm) patients. thirty t2dm patients, without chronic complications, took part in this study. blood and urine samples were collected after 12 h-fasting state for baseline biochemical analysis. thereafter, subjects performed an incremental workload vo2max test on a cycle ergometer to determine the load of the high intensity submaximal exercise. on the following week, blood samples were collected before and immediately after the exercise test for measurements of oxidative stress (os) and high-sensitivity c-reactive protein (hs-crp). afterwards, participants were randomly allocated into two groups: placebo (gelatin) and n-3 pufa (capsules containing 180 mg of eicosapentaenoic acid, 120 mg of docosahexaenoic acid and 2 mg of vitamin e). three capsules were ingested daily for eight weeks. then, the examination protocol and the exercise test were repeated and the samples collected.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes * male and female * age between 40 and 60 years old. * must be able to do exercise exclusion criteria: * smoking; * clinical diagnosis of kidney, pulmonary or heart diseases