Kornimate/medical-research-clean huggingface dataset:
a comparative study of kw-2246

Conditions: Cancer Related Pain (Breakthrough Pain)

Summary: this is a placebo-controlled, double blind, comparative study to evaluate the efficacy and safety of kw-2246 as rescue medication at an optimal dose, which is determined by dose titration in treating breakthrough pain episodes in adult cancer patients receiving strong opioid analgesic on a fixed-schedule as well as rescue medication for breakthrough pain.


Eligibility criteria:
inclusion criteria: * written informed consent * have been treated with opioid analgesic on a fixed-schedule at a stable daily dose * receiving at least 1 but not more than 4 doses of rescue medication per day in average and whose pain is controlled * ecog ps =\< 3 exclusion criteria: * currently suffered from intolerable opioid-specific adverse reactions due to opioid analgesics * severe respiratory dysfunction * asthma * severe bradyarrhythmia * severe hepatic function disorder * severe renal function disorder * severe psychoneurotic disorder * susceptibility to respiratory depression due to such conditions as increased intracranial pressure, head injury or brain tumor
diffusion-weighted mri for individualized radiation therapy planning of lung cancer

Conditions: Recurrent Non-small Cell Lung Cancer; Stage IIA Non-small Cell Lung Cancer; Stage IIB Non-small Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer

Summary: this clinical trial studies diffusion-weighted magnetic resonance imaging (mri) in identifying and localizing tumors in patients with non-small cell lung cancer undergoing radiation therapy. diagnostic procedures such as diffusion weighted mri may help identify where active cancer is to improve the targeting accuracy of radiotherapy. comparing results of diagnostic procedures done before, during, and after radiation therapy may help determine how the location and volume of tumors changes over time and predict how the tumor will respond to therapy.

primary objectives: i. assess diffusion-weighted mri as an early predictor for tumor response in patients with non-small cell lung cancer (nsclc). ii. establish the potential of individualized radiotherapy targeting of radioresistant tumor sub-volumes. outline: patients undergo diffusion-weighted mri within 4 weeks of radiation start (baseline), during the second week of radiation therapy, during the fourth week of radiation therapy, and at 3 months after radiation therapy (post-treatment). patients also undergo standard of care 4-dimensional (4d) computed tomography (ct) and fludeoxyglucose f 18 (fdg)-positron emission tomography (pet) at the same time points.

Eligibility criteria:
inclusion criteria: * patients must be able to undergo mri imaging; contrast application will be determined according to institutional guidelines; patients with lung cancer or locally recurrent lung cancer (following surgery) who are scheduled to receive external beam radiation therapy for at least 6 weeks * tumor visible on planning ct scan * negative pregnancy test for women of childbearing potential prior to study entry exclusion criteria: * patients requiring continuous supplemental oxygen * patients with metal implants including pace makers and defibrillators * patients with cerebral aneurysm clips or middle ear implant * patients with pain pump, a programmable shunt, or non-surgical metal (i.e. a foreign body) * claustrophobic patients * prior radiotherapy to body area under investigation * no vulnerable populations will be enrolled (prisoners, children, pregnant females, or institutionalized individuals)

Keywords: lung
objective assessment of the effects of shift work on drowsiness and driving impairment in hospital staff

Conditions: Impaired Driving; Sleep Driving

Summary: the purpose of this protocol is to assess the risk of drowsy driving amongst shift workers using objective measures of drowsiness and driving performance in an instrumented research vehicle.

specific aim 1. to test the hypothesis that on road (track) driving performance will deteriorate (variation in lateral lane position and the rate of out of lane driving events) and the frequency of episodes of severe sleepiness will increase ("microsleeps" on eeg and johns' drowsiness score \>4) in shift workers following an extended work shift or night shift compared to a rested state, following day shifts. specific aim 2. to test the hypothesis that ocular measures of alertness (percent of time with eyes closed, eye tracking and johns' drowsiness score) are related to abnormal driving performance (driving out of the lane) and "microsleeps" during on road (track) driving. specific aim 2a. to test the hypothesis that autonomic measures, ecg, respiration (measured with the bioharness), skin conductance level and peripheral blood flow (measured with the q sensor), are related to abnormal driving performance (driving out of the lane) and "microsleeps" during on road (track) driving specific aim 3. to test the hypothesis that self-reported sleepiness is related to on road (track) driving performance and episodes of severe sleepiness following extended working shifts or night shifts.

Eligibility criteria:
inclusion criteria: * participant must be a shift worker who undertakes extended duration shifts (16 hours or longer) or overnight shifts * participant must be between the ages of 18-65y * participant needs to have held a us driving license for two years previously or an international driving license for two years with 6-months regular (\>2/week) us driving experience * participants who wear corrective eye wear (i.e., glasses) are only eligible to participate if they have a valid prescription so we can fit the optalert glasses with their prescription lenses * resident physicians are only recruited if the combination of their time involvement in the study (i.e., any additional time beyond the time that it would ordinarily take them to commute home from work), together with their scheduled work hours, would fall within acgme standards for duty hours for resident physicians. exclusion criteria: exclusion criteria includes all parameters outside the inclusion criteria above.

Keywords: drowsy drive driving shift work disorder swd eeg ecg actiwatch diary bioharness q-sensor q sensor liberty mutual sleep impaired optalert tracker vehicle questionnaire survey
internet-based physical activity promotion and exercise prescription for people with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the aim of the study is to evaluate the effects of a 12-week internet-based exercise and physical activity promotion intervention on physical activity. furthermore, effects on symptoms of multiple sclerosis, physical activity-related health competence (pahco), self-concordance and basic needs satisfaction as well as usability and acceptability of the intervention will be investigated.


Eligibility criteria:
inclusion criteria: * diagnosed multiple sclerosis (mcdonald criteria) * expanded disability status scale between 0 - 6.5 * neurologically stable (no exacerbation within 30 days prior to enrollment) * internet access (wifi) * basic knowledge on handling personal computer and the internet * owning a smartphone with the operating system android or ios and with access to google play store or apple app score * basic computer and internet skills (e. g. using web browser and webcams) * ability to operate a smartphone (especially to install mobile applications) * ability to read, write and comprehend as well as communicate electronically exclusion criteria: * regularly physically active (more than 30 minutes twice a week with at least moderate intensity; includes aerobic training, resistance training and other sports e.g. tennis; excludes physiotherapy, physical activity during work or household, grocery shopping, gardening, walking the dog etc.) * clinically relevant cardiovascular diseases * cortisone therapy in the last 30 days * cognitive impairment that hampers study implementation * severe impairment of hand function (ataxia or paresis impeding the use of a smartphone app or smartwatch) * severe internal, orthopaedic and metabolic diseases that restrict mobility

Keywords: multiple sclerosis physical activity exercise behavior change internet-based intervention physical literacy self-determination theory
hed-o-shift: hedonic and neurocognitive processes in relation to dietary habits and weight status

Conditions: Neurocognitive Correlates of Eating Habits

Summary: this study includes an inclusion visit, 2 visits to the rennes university hospital and the filling of two on-line questionnaires. the first visit to the university-hospital of rennes, during which a blood sample will be taken, morpho-anatomic measures (height, weight, hip and size), impedancemetry and resting energy expenditure by indirect calorimetry will be carried out in the clinical investigation unit. during this visit, the volunteers will also have to bring a sample of urine and faeces previously collected at home. the two on-line questionnaires (hedonic and caloric evaluation of foods and beverages on photos) will have to be completed by the volunteers between the first and the second visit to the university-hospital. finally, the volunteers will go to the university-hospital of rennes for the second visit, on the neurinfo platform, during which they will be subjected to a cognitive two-choice test based on food and drink pictures, during fmri. before and after the fmri session, an assessment of the state of hunger, thirst, and general status of the volunteer will be carried out using a numerical scale ranging from 1 to 10.


Eligibility criteria:
inclusion criteria: * women aged 18-24, * presenting a normal bmi (18-25), * right-handers, * affiliated to a social security scheme * having given a free, informed and written consent. * having a low frequency of consumption of fatty and / or sugary / salty foods, or on the contrary, a high frequency of consumption of these foods. exclusion criteria: * related to the study: * high level athletes, (determined on the basis of the ricci \& gagnon questionnaire - excluded if score \> 32); * food abstinents for religious, ideological or health reasons (intolerance, vegetarianism, allergies, etc.); * family history of obesity or diabetes; * personal history of tca, anxiety or depressive disorder, or proven addictive behaviour; * excessive consumption of alcohol or other psychoactive substances (determined on the basis of the audit questionnaires - excluded if score \> 7 and craft - excluded if score\> 2 " yes "); * smoking daily or having stopped for less than 6 months; * history of bariatric surgery; * on-going treatment in the nutrition unit; * insufficient command of french; * pregnant or nursing women; * persons of full age who are subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty. * simultaneous participation in another research protocol involving the human person related to fmri: * implantable cardiac pacemaker or defibrillator; * neurosurgical clips; * cochlear implants; * neural or peripheral stimulator; * foreign orbital or brain metallic foreign bodies; * endoprostheses implanted for less than 4 weeks and osteosynthesis materials placed for less than 6 weeks; * claustrophobia.
study of the pharmacokinetics of daptomycin in children with renal disease

Conditions: Chronic Kidney Disease; Bacterial Infection

Summary: the purpose of this study is to: 1. study the pharmacokinetics and safety of daptomycin in children on hemodialysis (hd) and peritoneal dialysis (pd). 2. determine urine, hd and pd clearance of daptomycin.

infectious and sepsis events are one of the most common complications in children with chronic kidney disease. the incidence is highest in children with an access for dialysis, especially in those with catheters. staphylococcal species account for more than 50% of access infections (ranging from 58-77%). failure to clear the infection results in loss of dialysis access. daptomycin is a new antibiotic that provides coverage against most gram positive bacteria including methicillin-resistant staphylococci, vancomycin-intermediate staphylococcus aureus, and vancomycin-resistant enterococci. the pharmacokinetics of daptomycin in children on dialysis, a group of patients who may need the medication the most, remains unknown. children on hd or pd with suspected or confirmed infections due to gram-positive bacteria and who are concurrently treated with standard of care antibiotics will be considered for this study. each patient will be given a onetime dose of cubicin (daptomycin). after receiving daptomycin, serial blood samples along with dialysis effluent and urine (obtained from non-anuric patients) will be collected to evaluate the pharmacokinetic profile of the drug.

Eligibility criteria:
inclusion criteria: * children who are between 12-17 years of age who are either on hd or pd and whom the pediatric nephrology section of the ou children's physicians clinics provide care. * in addition to children on chronic hd and pd therapy, patients newly initiated on hd and pd will also be recruited for this study. * patients with suspected or confirmed cases of dialysis related infection from gram-positive bacteria and who are receiving standard of care antibiotics. * patients will be eligible for enrollment if they were admitted as an inpatient to the children's hospital or as an outpatient to the dialysis clinic exclusion criteria: * patients \> 17 years of age * patients \< 12 years of age * total amount of blood drawn as part of standard of care and for pharmacokinetic analysis exceeds 3 ml/kg over an 8 week period * taking an hmg coa reductase inhibitor within 7 days of daptomycin administration * having used daptomycin in the 30 days preceding study entry * participating in any experimental procedure in the 30 days preceding study * a history of muscular disease or neurological disease * baseline creatine phosphokinase (cpk) values equal to or greater than 1.5 times the upper limit of normal (normal range 65-370 iu/l) * hemoglobin \< 9 g/dl * hemodynamic instability within 72 hours before study enrollment * female subjects with a positive pregnancy test or failure to take a pregnancy test

Keywords: hemodialysis peritoneal dialysis daptomycin pharmacokinetics
computerized screening and brief physician advice to reduce teen drinking

Conditions: Alcohol Abuse; Risk Behavior

Summary: the goal of this project is to adapt a computerized screening and brief advice (sba) protocol that has demonstrated efficacy in reducing underage drinking among adolescent primary care patients and then to test it in a multi-site randomized controlled trial (rct).

the specific aims of the proposed multisite rct are: 1. to establish the efficacy of the computerized sba protocol on alcohol use, on dwi/rwid, and other alcohol-related health risk behaviors; 2. to test the effect of technological extenders (te) on prolonging the beneficial effects of the sba protocol; 3. to identify moderators, mediators, and optimal responders to the sba/te interventions; 4. to examine the association between cessation of underage drinking and other health-risk behaviors in an adolescent primary care sample.

Eligibility criteria:
inclusion criteria: * 12-21 years old * patients arriving for routine medical care * provide informed assent (for those \<18) or informed consent (for those 18-21) exclusion criteria: * medically or psychologically unstable at time of visit * receiving behavioral health services * cannot read or understand english at a 6th grade reading level * unavailable for follow-up assessments

Keywords: screening brief intervention underage drinking
multiple dose study of pf-05231023 in obese adult subjects

Conditions: Type 2 Diabetes Mellitus (T2DM)

Summary: this is a trial in obese subjects to study the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of pf-05231023.


Eligibility criteria:
inclusion criteria: * male and female subjects of non-childbearing potential between the ages of 21 and 70. * subjects with a bmi of 30 to 45.4 kg/m2 and total body weight \>110 lbs. exclusion criteria: * recent (6 months) unstable concurrent disease. * history of allergic disease or drug allergies. * any condition affecting food consumption or absorption.

Keywords: t2dm obesity safety multiple dose intravenous
excel clinical trial (universal registry)

Conditions: Chronic Coronary Occlusion; Left Main Coronary Artery Disease; Stent Thrombosis; Vascular Disease; Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Summary: the purpose of the universal registry is to assess the proportion and reasons for which subjects with angiographically significant ulmca disease requiring revascularization during the time course of this study are not randomized; to compare the baseline characteristics of subjects; and to assess the variability in randomization eligibility and treatment patterns.

approximately 100 consecutive subjects who otherwise meet all enrollment criteria, will be analyzed separately as intermediate lesion subjects, and will be followed through the time of initial treatment per standard of care with intended pci, cabg or medical treatment.

Eligibility criteria:
inclusion criteria: * subjects who are either not eligible for randomization or for other reasons are not randomized will be consented for the universal registry

Keywords: drug eluting stents stents angioplasty left main coronary artery disease
caudal vs. pudendal block in peds gu

Conditions: Hypospadias; Penile Torsion; Chordee; Phimosis

Summary: this study will compare two techniques to minimize pain during and after penile surgery in children undergoing certain urologic surgeries. these two approaches include the caudal nerve block and the pudendal nerve block.


Eligibility criteria:
inclusion criteria: * undergoing penile genitourinary surgery * asa class 1-3 exclusion criteria: * female patients * male children \ /= 3 years of age * asa class \>3 * surgery at satellite location (non-prentiss) * concurrent non-lower gu tract surgery * sacrospinal abnormality * history of chronic pain requiring opioid analgesics * inability to tolerate and receive acetaminophen, non-steroidal anti-inflammatory drugs (nsaids), alpha-2 agonists, or local anesthetics * history of malignant hyperthermia * history of coagulopathy

Keywords: caudal block pudendal block regional anesthesia
effects of high intensity focused electromagnetic therapy with pelvic floor muscle training on urine leakage and quality of life in primipara or multipara women with stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: this study aimed to evaluate the impact of high-intensity focused electromagnetic therapy (hifem) combined with pelvic floor muscle training (pfmt) versus pfmt alone on urine leakage and quality of life in primiparous and multiparous women with stress urinary incontinence. women aged 30 years or older exhibiting symptoms of stress urinary incontinence were randomized into two treatment groups. the experimental group received both hifem and pfmt, while the control group received only pfmt. the treatment continued for 6 weeks. evaluations measured at baseline and post-intervention included the 1-hour pad test, the international consultation on incontinence questionnaire-urinary incontinence short form (iciq-ui-sf), and sonography to assess bladder neck movement.


Eligibility criteria:
inclusion criteria: * primipara or multipara women aged 30 years or older with symptoms of stress urinary incontinence; exclusion criteria: * those who had any contraindication for high-intensity-focused-electromagnetic-therapy (hifem); * prior surgery for incontinence; * taking drugs for bladder dysfunction or diuretics; * hormone therapy; * urgent or mixed urinary incontinence; * incontinence associated with a neurologic condition; * inability to perform voluntary pelvic floor muscle contractions; * cognitive impairment or dementia, major neurological disorders (such as stroke, cerebral palsy, multiple sclerosis); * inability to carry out the treatment or evaluation; * uncontrolled hypertension.
validation of the french version of ask suicide-screening questions (asq) in adolescents managed in pediatric emergency unit

Conditions: Suicidal Ideation

Summary: the asq-fr study aims at validating the french version of ask suicide-screening questions composed of 5 items in adolescents managed in pediatric emergency department. therefore, use of this brief valid screening instrument could assess the risk for suicide in pediatric patients and then improve the prevention of suicidal tendencies in this population.

asq-fr is a prospective, cross-sectional instrument-validation study evaluated 5 candidate screening questions assessing suicide risk in adolescents between 10 and 18 years of age managed in two urban, pediatric emergency departments associated with tertiary care hospitals. asq-fr questionnaire is conducted by a psychologist before or after the french version of the siq/siq junior (suicidal ideation questionnaire), depending on the randomisation in the unit. siq is composed of 30 items and valid for adolescents aged 15 years or more. siq junior is composed of 15 items and valid for children up to 14 years old. questionnaires are followed by an interview in adolescents and parents separately by the psychologist to evaluate perceptions, feasibility and acceptability of questionnaires. it is planned a convenience sample of 200 patients aged 10 to 18 years who presented with either medical or surgical chief concerns to the emergency department.

Eligibility criteria:
inclusion criteria: * patient with informed consent of adolescents and at least one of parents or a guardian * patient with social protection cover * in adequation with emergency management exclusion criteria: * patients with mental disorder * minor without parent/gardian at the emergency unit

Keywords: psychiatry pediatrics suicide