Kornimate/medical-research-clean huggingface dataset:
a prospective post-market study to evaluate the clinical utility of iris, a three-dimensional (3-d) anatomical modeling software for pre-operative surgical planning and intra-operative navigation for nephrectomy

Conditions: Kidney Cancer

Summary: this is a prospective, multi-center, post-market study to evaluate the clinical utility of iris, a 3d anatomical modeling software, with standard ct scans during pre-operative planning and intra-operative navigation for nephrectomy. the study will be conducted over the course of 21-24 months and enroll approximately 60-120 subjects.


Eligibility criteria:
inclusion criteria: 1. subject is 18 years or older 2. subject is undergoing robotic-assisted partial or robotic-assisted radical nephrectomy being performed by participating surgeon 3. subjects who has had or plan to have a ct scan (with iv contrast medium) exclusion criteria: 1. subject has a solitary or horseshoe kidney 2. subject has more than two masses in the applicable kidney requiring multiple partial nephrectomies on the same kidney 3. subject with prior surgery (ex: partial nephrectomy etc.) on the affected kidney excluding endoscopic kidney stone surgery 4. subject with renal vein tumor thrombus 5. subjects planned to have a bilateral operation (ex: bilateral partial nephrectomies planned at the same time) 6. metastatic disease with life expectancy of less than 1 year 7. pregnant or suspect pregnancy 8. subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent 9. subject belonging to other vulnerable population, e.g, prisoner or ward of the state
perioperative analgesia for knee arthroplasty (paka)

Conditions: Knee Arthritis

Summary: peri-articular knee infiltration with levobupivicaine 150mg, morphine 10mg and ketorolac 30mg reduces postoperative pain following primary total knee replacement compared with the current standard treatment of femoral nerve blockade.


Eligibility criteria:
inclusion criteria: * all patients undergoing an elective primary unilateral total knee arthroplasty (tka) under the care of an orthopaedic consultant at university hospitals coventry and warwickshire nhs trust are potentially eligible for the trial. exclusion criteria: * those with sufficient cognitive impairment that they would be unable complete questionnaire (cognitive impairment). * those patients who lack capacity under the mental capacity act 2005 * those patients with a pre-operative history of neurological abnormality in the ipsilateral leg e.g. history of stroke, neurogenic pain or previous nerve injury. * those patients having spinal anaesthesia. * those patients with a specific contraindication to the analgesic agents used:morphine: hypersensitivity reaction ketorolac: active or previous peptic ulcer. history of upper gastrointestinal bleeding or perforation, related to previous nsaid therapy. * haemorrhagic diatheses, including coagulation disorders * hypersensitivity to ketorolac trometamol or other nsaids * moderate or severe renal impairment (serum creatinine \> 160 micromol/l) * levobupivicaine: levobupivacaine solutions are contra-indicated in patients with a known hypersensitivity to levobupivacaine, local anaesthetics of the amide type or any of the excipients * uncontrolled angina * 2nd/ 3rd degree heart block

Keywords: pain relief arthroplasty periarticular knee infiltration
carbetocin versus misoprostol in high risk patients for postpartum hemorrhage after c.s.

Conditions: Postpartum Hemorrhage

Summary: we will compare between carbitocin and misoprostol in prevention of postpartum hemorrhage in high risk patients after c.s.

* postpartum hemorrhage was traditionally defined as blood loss in excess of 500 ml from a vaginal delivery or 1000 ml at cesarean section. it can result from uterine atony, retained placental tissue including that from abnormal placentation, maternal genital tract trauma and coagulopathies. (almog et al, 2011) * uterotonic agents (e.g. ergometrine, misoprostol) should be easily accessible. many units of an oxytocin infusion and/or rectal misoprostol during and after cesarean deliveries used to reduce the incidence of atony. -misoprostol has been widely recommended for the prevention of post-partum hemorrhage when other methods are not available. the most common regimen reported for the treatment of post-partum hemorrhage is rectally. (oladapo et al., 2012) * misoprostol is a prostaglandin e1 analogue. it has been investigated in the prevention of postpartum hemorrhage, using either the oral or rectal route of administration. (hofmeyr et al, 2009) * carbetocin is a long-acting oxytocin studied by dansereau et al.; 1999.they found that the carbetocin group of patients had a decreased incidence of pph and of the need for therapeutic oxytocics. the recommended dose of carbetocin is 100 mg given either im or slowly (over 1 minute). * risk factors may present antenatally or intrapartum; care plans must be modified when risk factors present. clinicians must be aware of risk factors for pph and should take these into account for the wellbeing and safety of both the mother and the baby.rcog guidlin table 1: risk factors for pph * suspected or proven placental abruption * known placenta praevia * multiple pregnancy * pre-eclampsia/gestational hypertension * previous pph . * obesity (bmi \>35) * anaemia (\<9 g/dl) * delivery by elective caesarean section * induction of labour * retained placenta tissue * prolonged labour (\> 12 hours) . * big baby (\> 4 kg) royal college of obstetrics and gynecology.green-top guideline no. 52 may 2009 minor revisions november 2009 and april 2011. prevention and management of postpartum hemorrhage. thus our aim is to compare the effeciency and cost effectiveness of carbitocin and misoprostol in patients at high risk of pph after c.s. in prevention of pph.

Eligibility criteria:
inclusion criteria: * women with a singleton pregnancy undergoing cesarean section after 37 weeks of gestation. any medical disorder with pregnancy that carries a risk factor for pph. exclusion criteria: * women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only. * women undergoing cesarean section at less than 37 weeks of gestation.

Keywords: pph
testing a wellness app for first responders, military personnel and veterans

Conditions: Mental Health Wellness

Summary: the purpose of the research study is to trial a smart phone application, the guide app, to better understand its impact on social connectedness, personal growth and mental health/wellness among first responders, soldiers, and veterans. the research team will also investigate workplace metrics (e.g., engagement and burnout), implementation outcomes and technical merit. the investigators plan to run a three-armed randomized waitlist pilot feasibility trial with up to 150 participants.

there is an urgent need to address mental wellbeing, isolation, and burnout among first responders, military personnel and veterans. research shows that these groups are at a greater risk for suicide, depression, and post-traumatic stress disorder (ptsd) than the general civilian population, and that their occupations make them more likely to feel isolation and burnout. despite these risks, first responders, soldiers and veterans tend not to seek help due to stigma, time burden and other barriers to entry. the guide app was designed with this population in mind. the lessons and exercises take only minutes to complete, and the group chats are anonymous, so users can share their thoughts with likeminded peers, without the stigma. in a 4-week pilot study with 16 participants from the wilkes barre police department, the guide app showed promising results in promoting wellbeing, reducing anxiety and encouraging personal growth. this clinical trial builds off the pilot study. the investigators will use a three-armed randomized waitlist pilot feasibility trial with 150 participants (first responders, soldiers, and veterans) to test whether use of the guide app will lead to increased social connectedness, personal growth, and mental health/wellbeing; and whether these outcomes will in turn increase work engagement and reduce burnout. the investigators will also investigate implementation outcomes (e.g., the feasibility of using the app) and technical merit (e.g., how user-friendly the app is).

Eligibility criteria:
inclusion criteria: * law enforcement, military personnel, or veteran. * employed (part-time, full-time, self-employed). * owns compatible smartphone. * not paid by the guide app/nlyten corp. * no previous use of guide app. exclusion criteria: * not law enforcement, military personnel, or veteran. * not employed. * paid by guide app/nlyten corp. * previous use of guide app.

Keywords: first responders veterans soldiers social connectedness burnout wellbeing
cohort study of the clinical course of macular diseases in kagawa

Conditions: Macular Disease

Summary: macular diseases often cases severe visual impairment. recent clinical introduction of anti-vascular endothelial growth factor agents may change the clinical course of various macular diseases, including age-related macular degeneration (amd), polypoidal choroidal vasculopathy (pcv), retinal angiomatous proliferation (rap), central serous chorioretinopathy (csc), myopic choroidal neovascularization (cnv), retinal vein occlusion (rvo), diabetic macular edema (dme), and so forth. the advance in vitrectomy improve visual outcomes in some maculae diseases, including epiretinal membrane (erm), macular hole (mh), vitreomacular traction syndrome (vmts). patients with such macular diseases are registered and are followed up for 5 years with appropriate treatment for each patient. by the analysis of the correlation between initial examinations and final visual acuity, factors associated with good visual prognosis will be elucidated.


Eligibility criteria:
inclusion criteria: * patients who visit department of ophthalmology, kagawa university hospital with macular diseases, such as amd, pcv, rap, rvo, dme, erm, mh, vmts. * patients who are agreed with the participation of this study. exclusion criteria: * none

Keywords: amd pcv rap rvo dme erm mh mcnv
study of zoledronic acid for patients with hormone-sensitive bone metastases from prostate cancer

Conditions: Prostate Cancer

Summary: this study aims to determine whether early treatment with zoledronic acid, that is given during the early phase of advanced prostate cancer, will be more efficacious than delayed treatment


Eligibility criteria:
inclusion criteria: * prostate cancer * at least one bone metastasis * receiving or about to receive androgen deprivation therapy (adt) exclusion criteria: * previous adt failure * previous or current treatment with another bone-protecting agent, chemotherapy or targeted therapy * abnormal renal function other protocol-defined inclusion/exclusion criteria may apply.

Keywords: zoledronic acid bone metastases prostate cancer hormone-sensitive
the effect of sleep deprivation on passive and active functions and distance modulation of the vestibulo-ocular reflex

Conditions: Healthy

Summary: the goal of this cross-over clinical trial is to evaluate the effect of 24 hours sleep deprivation on the vestibulo-ocular reflex (vor) in healthy participants. the main questions it aims to answer are: 1. the effect of sleep deprivation on vestibular function. 2. the difference between passive and active vor function following sleep deprivation. 3. the vergence mediated modulation ability of the vor following sleep deprivation. 4. the effect of sleep deprivation on behavioral vor function. participants will be tested before and after a normal night sleep and during 24 hours of sleep deprivation.

the study will include two sleep protocols: normal sleep and 24h sleep deprivation. the participants will be informed and will sign a consent form. participants will then be randomly divided to begin with one of the sleep protocols. to avoid major changes in participants lifestyle, that might intervene with the basic measurements, both nights will take place within a maximum of one month and a minimum of one week for recovery between them. one week prior to each condition, participants will fill a sleep diary which will include their sleep duration to ensure that a routine sleep pattern will be maintained prior to each of the tests. participants will be instructed not to consume alcoholic drinks or mind-altering substances for 24h prior, and during both conditions, and caffeine for 12h prior and during both conditions. to enable normal sleep as possible, the normal sleep protocol will take place in each of the participants home. matching environmental conditions will be kept to those of the clinic (lighting, white background) where the sleep deprivation protocol will be held. the participants will be tested using the video head impulse test (vhit) and the computerized dynamic visual acuity test (c-dva) during both nights. the participants will be equipped with an actigraph watch wgt3x-bt to assure sleeping conditions.

Eligibility criteria:
inclusion criteria: * age 30-60 years old * healthy * persons who are not night shift workers * persons who are not used to but can keep awake for 24 hours exclusion criteria: * night shift workers * vestibular system deficiency in vhit test * active neurological disease * any orthopedic deficit in the cervical area preventing a proper vhit examination * a diagnosed sleep disorder or \>5 score in the pittsburgh sleep quality questionnaire hebrew version (psqi)

Keywords: vor,vergence modulation,sleep deprivation,adaptation
retroperitoneal tunneling versus dissection technique during sacrocolpopexy

Conditions: Pelvic Organ Prolapse

Summary: the purpose of this study is to compare operative time, patient reported outcomes, surgical complications, and surgical outcomes between the tunneling versus dissection technique during robotic assisted sacrocolpopexy (ra scp).

women with symptomatic, stage ii to iv pop who plan ra scp at utmb health will be approached to participate. using the study protocol inclusion and exclusion criteria, patient's eligibility will be determined. all eligible subjects will provide the written informed consent before any research data is collected. all screening assessments will be completed at a preoperative, in-person, clinic visit, and within 60 days of surgery. the subject will then undergo randomization to tunneling versus dissection technique during ra scp with the total sample size of 40 female subjects (20 per group). concomitant procedures for pop or urinary incontinence are permitted and will be based upon the operating surgeons' standard clinical practice and best clinical judgement. subsequently, the subject will have postoperative follow up at 2 weeks, 6 weeks and 3 months

Eligibility criteria:
inclusion criteria: 1. females at least 18 years of age at the time of consent. 2. able to understand and read english 3. able and willing to provide written informed consent 4. able to comply with the follow-up study protocol, per clinician judgment 5. symptomatic pop (bulge or pressure) evidenced with vaginal prolapse with pop-q measurement consistent with stage ii-iv. 6. ra scp as desired surgical approach to correct apical prolapse exclusion criteria: 1. females who are pregnant, or intend to become pregnant during the study 2. texas department of criminal justice prisoners 3. a known history of sensitivity to propylene mesh 4. prior prolapse repair surgery using mesh (abdominal, vaginal or rectal) 5. active or chronic systemic infection including any pelvic infection, abscess 6. has had history of primary pelvic organ cancer (uterine, ovarian, endometrial, cervical, bladder) or any cancer that is metastatic to the pelvis 7. prior or current pelvic radiation, or chemotherapy. 8. not a candidate for general anesthesia 9. history of systemic connective tissue or musculoskeletal disorders (scleroderma, sle, marfan's syndrome, ehlers danlos, polymyositis, lambert eaton syndrome etc) 10. history of neurologic condition affecting bladder function (multiple sclerosis, spinal cord injury, stroke with neurologic deficit)

Keywords: pelvic organ prolapse sacrocolpopexy
postoperative analgesia after total knee arthroplasty

Conditions: Arthroplasty, Replacement, Knee

Summary: total knee arthroplasty (tka) is associated with moderate to severe postoperative pain. although epidural treatment provides good and reliable postoperative pain relief after tha, it may cause urinary retention, nausea, hypotension, diminished muscle control, and delayed mobilization. the challenge of new analgesic regimes is to reduce the occurrence of side effects while maintaining adequate pain relief and maximum muscle control. a relatively new method to provide postoperative pain relief after tka is local infiltration analgesia combined with single-shot injection(s) or continuous infusion of local anesthetics into the surgical site. as local infiltration analgesia combined with continuous intraarticular infusion compared with continuous epidural infusion has not been evaluated, our study was designed to determine whether this technique could enhance analgesia and improve patient outcome after tka. this study compares continuous epidural infusion of ropivacaine and intravenous ketorolac with local infiltration analgesia with ropivacaine, ketorolac and adrenaline combined with continuous intraarticular infusion of ropivacaine and ketorolac.


Eligibility criteria:
inclusion criteria: * patients admitted consecutively to primary total knee arthroplasty. * provided informed consent exclusion criteria: * fertile women with positive pregnancy test, nursing mothers, fertile women who do not use safe contraception * severe chronic neurogenic pain * medical treated diabetes * contraindications for spinal aesthesia and epidural analgesia * known hypersensitivity towards study drugs * rheumatoid arthritis * treatment with narcotics * treatment with antidepressants * severe obesity bmi\>35 * treatment with antacid * not able to speak and understand danish

Keywords: postoperative pain
pharmacovigilance in gerontopsychiatric patients

Conditions: Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders

Summary: the purpose of this multicenter-study is to investigate safety of psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric inpatients. elderly people are at higher risk for developing side effects under pharmacological treatment due to an altered metabolic situation, higher comorbidity rates and often polypharmacy. furthermore gerontopsychiatric patients can often not articulate their symptoms clearly, for example due to pronounced cognitive impairment. the aim of the study is to gain valid data of possible adverse drug reaction rates, their potential risk factors and outcome, as well as medical prescription practises. to assess these outcomes an intensive pharmacovigilance-monitoring will be conducted at the five participating study sites. at baseline demographic data, previous and present disorders, use of drugs, previous and present medication, quality of life, cognitive function, physical examination results, laboratory results and ecg will be assessed. afterwards patients are visited weekly and screened for possible adverse drug reactions. all adverse drug reactions will be coded in the meddra-system. in case of a possible serious adverse drug reaction serum levels of all psychotropic substances applicated will be assessed. drug combinations will be analysed using an established advanced bioinformatic tool (mediq). diagnosis, medication intake and possible adverse drug reactions are documented continually. 2 weeks after discharge from the ward, patients will be contacted by phone to assess catamnestic data.


Eligibility criteria:
inclusion criteria: * age 65+ years old * inpatients treated at one of the geriatric psychiatry study sites. * signed consent form ( patient and/or legally authorized custodian) exclusion criteria: * patients that are incapable to give their informed consent and are not under legally authorized custodianship. * parallel participation in another clinical trial.

Keywords: geriatric psychiatry pharmacovigilance
study on the effects of intravenous dexmedetomidine on pain in patients undergoing elective spinal surgery

Conditions: Chronic Pain

Summary: this is a randomized, prospective, double-blind , placebo-controlled trial examining the effects of intraoperative dexmedetomidine infusion on pain in patients undergoing lumbar spinal fusion surgery. one hundred ten subjects (55 in each arm) will be enrolled. subjects, over the age of 18, undergoing lumbar spinal fusion will be considered eligible for enrollment. subjects will receive either intraoperative dexmedetomidine or placebo of normal saline infusion. they will be followed for approximately six weeks postoperatively.


Eligibility criteria:
inclusion criteria: * adults who will undergo lumbar spinal fusion, including surgeries extending into thoracic and sacral segments * subject is non-lactating and is either: * not of childbearing potential * of childbearing potential but is not pregnant at time of surgery as determined by pre-surgical pregnancy testing * subject is asa physical status 1, 2, or 3. exclusion criteria: * subject is pregnant or breastfeeding * any subject whom the investigators deem unable to complete any/all research related tasks * subjects who are cognitively impaired (by history) * subject requires antipsychotic medications * subject has received treatment with alpha-2 agonists or antagonists within 2 weeks prior to surgery * subject has known allergy to dexmedetomidine * subjects with impaired renal or hepatic function * subjects with advanced heart block * subjects with severe ventricular dysfunction
classic and sham massage on psychological and physical functional variables in athletes

Conditions: Hamstring Contractures

Summary: in this study we intend to apply a treatment protocol for hamstrings that can be beneficial for a good recovery. initially, a sample of athletes with hamstring shortening was chosen. once the sample is chosen, it will be divided into two groups: group 1 (g.1) who will receives a sham massage, group 2 (g.2) that receives the classic massage. to finalize the study comparing the results of the two groups to observe the experimental protocol obtains better results. material and methods the sample of an athletic club. recruiting subjects between 18 and 45 years old without other injuries of the lower limb. subjects with shortening of the hamstring muscles are available through the specific shortening test. this is a randomized controlled trial. subjects were randomly assigned to two intervention groups (1 treatment and 1 placebo control). the intervention consists of 4 sessions for 1 month. the sessions have a duration of 45 minutes. evaluations are performed at the beginning of treatment, at the end of treatment. participants also perform strengthening exercises three days a week, a total of 3 sets with 15 repetitions each. group 1 receives a sham massage of the quadriceps and hamstrings. group 2 receives a classic massage of the quadriceps and hamstrings. the assessments consist of knee and hip goniometry, lumbar and hamstring flexibility by finger-to-floor testing, and complete the questionnaire mood status profile (poms), which evaluates the states of mind.


Eligibility criteria:
inclusion criteria: * the sample comes from two athletic clubs of valencia with subjects between 18 and 30 years old without lower limb injuries, with shortening of the hamstring muscles selected by the specific shortening test. exclusion criteria: * muscle-skeletal injuries in any part of the body are excluded from the study.