Kornimate/medical-research-clean huggingface dataset:
tonicity monitor for epilepsy and hypertonic disorders

Conditions: Epilepsy

Summary: epilepsy is an episodic disorder which can result in recurrent seizures often associated with hypertonia (muscle stiffening) and myoclonia (involuntary muscle jerking). hypertonia can often occur before full expression of the seizure and so detection of hypertonia could act as an alarm to epilepsy patients and carers in order to prepare for a seizure event. secondly, a recording device for seizure frequency and duration is a valuable clinical tool for collecting data for clinicians who manage the disorder in primary and tertiary care. the investigators have developed a portable prototype for hypertonia detection using a non-invasive, muscle activated, sensor that records seizure activity. the investigators now want to test this sensor system in patients identified by consultant clinician custodians within the wales epilepsy research network (wern). the epidetect® prototype has been developed by vikel ltd™ in collaboration with wern - a welsh assembly funded network.


Eligibility criteria:
inclusion criteria: for phase 1 of the trial; - admission to the neurophysiology department at morriston hospital for in patient video telemetry for phase 2 of the trial: 1. for pg-1 and pg-2 the persistence of intractable tonic-clonic epilepsy 2. for pg-3 the clinical suspicion of dissociative seizures 3. for pg-4 the clinical diagnosis of absence epilepsy 4. for cg-1 the absence of neurological, muscular-skeletal disorders 5. suitable circumstances for informed consent in all instances exclusion criteria: for phase 1 of the trial: - a diagnosis of a movement disorder for phase 2 of the trial 1. where learning difficulties in adult patients or carers prevents informed consent or proper home supervision in pg-2. 2. where neurological diagnosis is ambiguous or incomplete. 3. where topical application of the sensors causes discomfort or psychological distress.

Keywords: seizures
fmri assessment after radiofrequency in trigeminal neuralgia

Conditions: Trigeminal Neuralgia; Pain, Neuropathic

Summary: to investigate the brain activations related to tn, using fmri, and to evaluate changes in these activations following the application of pulsed and thermal radiofrequency lesioning to the gasserien ganglion.


Eligibility criteria:
inclusion criteria: * age 20 - 65 years * primary trigeminal neuralgia * maxillary and/or mandibular affection only * failure of medical treatment exclusion criteria: * 2ry trigeminal neuralgia * recurrent trigeminal neuralgia * ophthalmic branch affection * contraindication for intervention (sepsis, coagulopathy, infection at entery point, local anesthetic allergy,...) * pregnancy
lifeflight: fentanyl versus morphine

Conditions: Pain Relief; Adverse Events

Summary: the study is exempt from informed consent by the metrohealth medical center institutional review board (irb), because two standards of care are used and there is no increased clinical risk to the patient due to the study. the researchers randomize either fentanyl or morphine to be given to trauma patients and record how their pain scale is treated along with observing for adverse events. they are looking to see if the hypothesized benefits of fentanyl (which is much more expensive than morphine) actually exist.

periodic reports are made to the irb.

Eligibility criteria:
inclusion criteria: * trauma patient * able to speak/communicate a pain scale exclusion criteria: * age \<18 * age \>69 * initially or any time hypotensive * prisoner

Keywords: helicopter aeromedical pain relief analgesia fentanyl morphine adverse events
two phase extension trial of sp668 to investigate the safety and tolerability of sustained release fesoterodine in subjects with overactive bladder: a double-blind phase followed by an open-label extension phase

Conditions: Overactive Bladder

Summary: this extension trial of sp668 consists of two phases: double-blind treatment and open-label extension. the trial provides subjects the option of long-term treatment with sustained release (sr) fesoterodine (spm 907) and to assess long-term subject safety, tolerability and efficacy. double-blind: subjects remained on either fesoterodine 4mg, 8mg or 12mg depending on their dose assignment in sp668. previous sp668 placebo subjects received fesoterodine 4mg. open-label: subjects received fesoterodine 8mg with a one time option to reduce the dose to 4mg and a one time option to increase again to 8mg. the primary variables focus on long-term safety and tolerability and include the observation and assessment of adverse events, residual urinary volumes, laboratory parameters, changes in ecg, physical and urological examinations and subject's assessment of treatment tolerance. secondary efficacy variables include various parameters derived from micturition diaries, count of subjects and their dose choice throughout the trial and subject's assessment of treatment efficacy.


Eligibility criteria:
inclusion criteria: * overactive bladder
the effect of rimonabant on energy expenditure, fat metabolism and body composition

Conditions: Obesity

Summary: this study will determine in obese subjects the direct effects of the weight loss drug rimonabant (ie independent of weight loss) on energy expenditure, fat metabolism and and body fat distribution. we hypothesise that rimonabant will increase energy expenditure. the fuel for the increased energy expenditure will come from fat. as a result of burning more fat there will be a decrease in fat in blood and an improvement in the body's response to insulin.

in obese subjects (bmi 33-38kg/m2) completing 12 months of treatment with the cb1 antagonist rimonabant (sr141716) there was an average weight loss from baseline of approximately 8.5 kg. these studies also showed the weight loss was accompanied by a decrease in plasma triglyceride (tg), an increase in hdl cholesterol and an improvement in insulin sensitivity measured by homa-ir. when adjusted for weight loss 50% of the improvements in tg, hdl cholesterol, and insulin sensitivity was not attributable to weight loss. this suggests that rimonabant has direct effects on fat metabolism. this study will investigate the direct effects of rimonabant (ie independent of weight loss) in a 2 group randomised study. one group will receive rimonabant for 12 weeks and the other group will have a dietary intervention to match the weight loss in the rimonabant group. measurements of energy expenditure (using indirect calorimetry and actiheart monitors),fatty acid and triglyceride metabolism (using stable isotope techniques) and body fat distribution (by magnetic resonance imaging) will be made before and after the intervention. to determine the possible mechanisms of the changes in metabolism, gene expression of key regulators of fatty acid metabolism in adipose and muscle tissue and circulating levels of adipokines will be measured.

Eligibility criteria:
inclusion criteria: * healthy caucasian postmenopausal women * bmi 30-38 exclusion criteria: * not currently weight-stable * diagnosed with diabetes * cardiovascular disease * endocrine disease * hepatic and renal disorders * neurological/psychological illness/history of depression * previous surgical procedures for weight loss * medications known to alter body weight or appetite * β-blockers, fibrates and metformin * severe under-reporting of food intake based on a 4 day food diary

Keywords: obesity energy expenditure fatty acid triglyceride
pharmacokinetic evaluation of intranasal and intramuscular naloxone in healthy volunteers

Conditions: Drug Overdose; Opioid-Related Disorders

Summary: to determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg dose of naloxone administrated intramuscular and to identify an appropriate intranasal dose that could achieve systemic exposure comparable to an approved parenteral dose. to also determine the pharmacokinetics of two different concentrations of intranasal naloxone and finally, to determine the safety of intranasal naloxone with respect to nasal irritation.


Eligibility criteria:
inclusion criteria: * be able to provide written consent * must have a bmi ranging from 18 to 30kg/m2, inclusive * must have adequate venous access * must not have any clinically significant concurrent medical conditions determine by medical history, physical examination, vital signs, and 12-lead electrocardiogram. * must agree to use a reliable double-barrier method of birth control from the start of screening until one week after completing the study. oral contraceptives are prohibited. * must agree to not ingest alcohol, drinks containing xanthine greater than 500 mg/day (e.g., coca cola, coffee, tea, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study. exclusion criteria: * please contact clinical site directly for more information
delayed embryo transfer in poor responders

Conditions: Infertility

Summary: poor ovarian response indicates inadequate ovarian response to ovarian stimulation. in the current study the investigators will attempt to compare antagonist and short protocols regarding oocyte as well as embryo quantity and quality. frozen embryo transfer will be performed in order to abolish iatrogenic effect of stimulation drugs on implantation. still implantation and pregnancy rates are considered secondary outcomes.


Eligibility criteria:
inclusion criteria: * patient selection is based on the eshre consensus group 2011 definition of poor ovarian response (por) (bologna criteria): * at least two of the following three features must be present: 1. advanced maternal age (≥40 years) or any other risk factor for por; 2. a previous por (≤3 oocytes with a conventional stimulation protocol); 3. an abnormal ovarian reserve test (i.e. antral follicle count (afc) \<5-7 follicles or antimullerian hormone (amh) \<0.5-1.1 ng/ml). two episodes of por after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ovarian reserve test (ort). by definition, the term por refers to the ovarian response and, therefore, one stimulated cycle is considered essential for the diagnosis of por. however, patients over 40 years of age with an abnormal ort may be classified as poor responders since both advanced age and an abnormal ort may indicate reduced ovarian reserve and act as a surrogate of ovarian stimulation cycle. in this case, the patients should be more properly defined as expected pors. exclusion criteria: * women with endometriosis, endocrinal problems, uterine abnormalities as well as male azospermia.
effects of auricular vagus nerve stimulation on the pro-inflammatory cytokine response in healthy adults

Conditions: Cytokine Response to Vagus Nerve Stimulation

Summary: the autonomic (self-regulating) nervous system is important for the function of many organs in the body. the vagus nerve is part of the autonomic nervous system. the vagus nerve carries incoming information from the nervous system to the brain, providing information about what the body is doing, and it also transmits outgoing information which governs a range of reflex responses. it plays an important role in the immune system. a part of the vagus nerve is reachable for stimulation at specific locations in the ear. the purpose of this study is to better understand how different ways of stimulating the vagus nerve at the ear can affect a chemical marker of inflammation found in human blood that is associated with a variety of inflammatory diseases such as rheumatoid arthritis and lupus. this information may lead to in future studies to see if stimulation of the vagus nerve can improve inflammation in chronic inflammatory diseases.


Eligibility criteria:
inclusion criteria: * between 18 and 60 years old * currently healthy with no medical problems * non-smoker exclusion criteria: * history of any of the following: cardiac arrhythmia, coronary artery disease, chronic inflammatory disease, anemia, malignancy, depression, connective tissue disease (arthritis, vasculitis), neurologic disease, diabetes mellitus, renal disease, malignancy, dementia, psychiatric illness including active psychosis, or any other chronic medical condition * use of cholinergic, anti-cholinergic, or beta-blocking medications * family history of inflammatory disease * pregnancy * smoking * ear infection (otitis media or externa) * implanted vagus nerve stimulator

Keywords: cytokines inflammation vagus nerve tnf
prevention of oral malodor with an oral sticker containing herbal formula

Conditions: Halitosis; Oral Malodor; Bad Breath

Summary: the use of a herbal formulation containing sage, echinacea,lavender and mastic gum would prevent oral malodor if delivered in an appropriate delivery system to enable slow release of the active ingredients.

oral malodor (halitosis, fetor ex ora) is a common and disturbing condition, affecting according to some studies about one quarter of the population. this condition may start at any time from early childhood through adolescence, adulthood and old age and vary in character and severity.the bacteria responsible for malodor production are for the most part gram negative oral bacteria (2- 4) such as porphyromonas gingivalis, fusobacterium nucleatum and prevotella intermedia. these bacteria reside on various locations within the oral cavity (e.g. tongue dorsum, interdental space, periodontal pockets, tonsils) and breakdown salivary and oral proteins into their amino acid building blocks. some of these amino acids (e.g. methionine, cysteine, tryptophan, lysine) are further metabolized yielding malodorous volatile products such as methylmercaptan, hydrogen sulfide, indole, skatole and cadaverine (5-7). these are foul smelling compounds, which are released during exhalation and speech.in our study we intend to use an aprooved mucosal sticker containing carbopol and hydroxypropylcellulose mixed with the herbal ingredients and placed on the palatal mucosa.than mesure the volatile sulfur compounds to observe if the composition has antimalodor effect and for how long. the herbal ingredients are used for many years for medicinal and nutritional purposes. if our hypothesis is right we might have another formulation and method of application to prevent oral malodor

Eligibility criteria:
inclusion criteria: * random gender, age and healthy people exclusion criteria: * used antibiotics in the last three months or suffer from systemic disease

Keywords: malodor halitosis herbal formulation natural medicinals slow release delivery system
comparison of sirolimus vs paclitaxel drug eluting balloon for below-the-knee angioplasty in critical limb ischemia

Conditions: Critical Limb Ischemia; Drug Effect

Summary: the objective of this study is to compare the remote patency of paclitaxel versus sirolimus eluting balloons in patients with cli undergoing tibial artery revascularization. patients will be randomized 1:1 to paclitaxel eluting balloon (litos, acotec ltd) or sirolimus eluting balloon (magic touch, concept medical) after optimal balloon angioplasty. the primary endpoint of the study is the late luminal loss at 6 months angiography. secondary endpoint are major amputation, clinically driven target lesion revascularization and vessel reocclusion (duplex) at 12 months.

critical ischemia of the limb is considered one of the most severe clinical scenario of atherosclerotic disease involving the lower limb because it is associated with a high degree of mortality and morbidity. below the knee arterial disease is the basis of critical limb ischemia (cli). it is generally characterized by the involvement of multiple tibial arteries, long lesions and high rate of hronic total occlusions. percutaneous treatment of tibial arteriopathy is characterized by high restenosis (70%). the advent of the drug-eluting strategy has led to a reduction in the restenosis of the femoral and tibial district with paclitaxel eluting devices. data are not yet available on sirolimus eluting devices, both for the femoropopliteal and tibial districts. the objective of this study is to compare the remote patency of paclitaxel (lithos) vs. the sirolimus (magic touch) eluting balloons in patients with cli undergoing tibial artery revascularization. the study will enroll only patients with optimal balloon angioplasty defined by angiographic and ultrasound criteria in order to avoid biases related to potentially unbalanced suboptimal angioplasty results in both groups. the patients will be followed by either interventionalists as well as diabetic foot specialists in order to optimize their surveillance for lesion healings and vessel patency and reduced dropout. participating centers cardiovascular disease department (san donato hospital, arezzo, italy) o.u. cardiology (san iacopo hospital, pistoia, italy) o.u. cardiology (san giuseppe hospital, empoli, italy) o.u hemodynamics (a.o.u.c. careggi, florence, italy)

Eligibility criteria:
inclusion criteria: 1. age between 18 and 85 years 2. cli rutherford class 4-6. 3. stenosis or occlusion with length \>= 4 cm involving a tibial artery 4. presence of angiographic distal runoff to the foot (stage 1-2a-2b of the kawarada classification) 5. presence of optimal angioplasty result defined as residual stenosis \< 50%, absence of flow limiting dissection, absence of vessel perforation, absence of distal embolization by angiography and biphasic or triphasic flow at ultrasoud evaluation of the target vessel exclusion criteria: 1. known allergy to one of the drugs in the study 2. contraindications to antiplatelet therapy 3. life expectancy less than 1 year 4. major amputation planned before angiography 5. inability to obtain informed consent -

Keywords: cli
vitom study: a randomized, controlled trial.

Conditions: Pelvic Organ Prolapse; Prolapse of Vaginal Vault After Hysterectomy; Bulging of Vaginal Wall; Incontinence; Fistula

Summary: this is research in which students are queried by questionnaires on their satisfaction with and experience with certain educational practices (use of a camera image projecting during a live surgery) or with pre-recorded video. as data collection only involves survey data collection and satisfaction with an educational experience, and randomization/intervention is only involving use of one type of educational method versus another .

as better training in vaginal surgery is a priority of gynecologic safety and quality organizations, optimizing learner satisfaction with vaginal surgery learning experiences is of paramount importance. our purpose was to investigate if this unique camera system may have advantages in learner satisfaction both in the operating room and in video learning settings, therefore increasing the interest of the learner pool in vaginal surgery and optimizing their experience. this study has two main, non-dependent aims: aim 1: the investigators aim to perform a randomized, controlled trial that compares a vaginally-mounted high-definition telescopic camera system (vitom®) that can project live images in the operating room during vaginal surgery to traditional learner surgery observation practices, with the primary outcome of learner satisfaction as measured by validated adult learner satisfaction measures. aim 2: the investigators aim to investigate in a randomized, controlled trial whether learners watching videos acquired with the vitom® camera feel the video is more learner-friendly and optimal that videos acquired with traditional, tripod-mounted standard definition cameras.

Eligibility criteria:
inclusion criteria: * adult learners (age \>=18 years) * residents and medical students rotating in the field of gynecology at the university of louisville and within the group of learners who are available to observe and participate in surgeries with the urogynecologic team at any of the study sites. exclusion criteria: * adult learners will be excluded if they have participated in the study prior, are performing a role within the surgery that precludes their participating in one of the study arms. * if it is deemed by the surgical team that participation of the learner in the study or filming of the surgery would compromise the quality of surgery or patient safety in any manner.

Keywords: vitom adult learners medical students residents vaginal surgery medical education
a study of pet adapted therapy and non-invasive monitoring for previously untreated limited stage diffuse large b cell lymphoma

Conditions: DLBCL

Summary: the overarching goals of this study are to measure levels of circulating tumor dna (ctdna) in patients with early stage diffuse large b cell lymphoma (dlbcl), to assess the change in ctdna during treatment in order to prospectively identify markers of treatment failure, and to use ctdna as a future tool for response adapted therapy.

the long-term objective of this proposal is to determine the correlation between fdg-pet and mrd, as measured by ctdna in patients with early stage dlblc. patients will be treated with standard chemoimmunotherapy and radiation based on the recently completed swog s1001 study, however no radioimmunotherapy will be used (nct01359592). response to treatment will be determined by contemporary deauville criteria. assessment of ctdna (non-invasive disease monitoring) will be determined at diagnosis and will continue at pre-defined specific time points after therapy is complete.

Eligibility criteria:
inclusion criteria: * previously untreated limited stage non bulky dlbcl; defined as limited stage by routine staging criteria in lymphoma involving fdg-pet and bone marrow biopsies (the lugano criteria)\[21\] * patients with grade 3b follicular lymphoma and transformed indolent lymphoma are included * ages ≥ 18 * measurable disease, assessable by radiographic examination with fdg-pet showing involvement * access to archived or fresh/frozen tumor biopsies * no uncontrolled medical comorbidities * adequate cardiac function (ef \> or equal to 50%), no unstable angina * adequate renal function (gfr \> 60) * adequate liver function (liver function tests should be no greater than 2 x upper limit of normal) including normal bilirubin levels, no greater than 2 x upper limit of normal unless patient has a history of gilbert's disease * adequate marrow reserves as indicated by complete blood count in the judgment of the treating investigator exclusion criteria: * pregnancy, positive serum hcg within 28 days of enrollment, or breast-feeding * bulky disease greater than 10 cm in any dimension