Kornimate/medical-research-clean huggingface dataset:
peri-operative aspirin continuation versus discontinuation

Conditions: Hematuria; Urinary Bladder Neoplasms

Summary: this study evaluates the continuation (non-discontinuation) of aspirin during turbt. half of participants will continue their usual low-dose aspirin regimen during turbt and throughout the perioperative period, while the other half will discontinue aspirin use ten days prior to surgery (standard recommendation) and restart therapy two weeks post-discharge.

recently, the american college of chest physicians in their 2012 clinical guidelines on perioperative anti-thrombotic therapy associated tur of bladder tumour (turbt) with an increased risk of bleeding associated with anti-thrombotic therapy. despite this, contemporary series of turbt identify the rate of significant in-hospital postoperative bleeding at only 2-3.4%. previous prospective work by our group demonstrated no increase in postoperative hemorrhagic complications with early initiation of aspirin following turbt. these findings are supported by a recent retrospective work on turbt showing a similar complication profile between continued perioperative antiplatelet therapy and antiplatelet naive patients. the risk associated with aspirin withdrawal prior to surgery, including increased thrombogenicity, has been extensively studied. following cessation of aspirin, full platelet recovery is expected within 12-14 days, however, hemostasis may be regained with as little as 20% of normal platelet activity. further, evidence supports a platelet rebound phenomenon in the setting of acute aspirin withdrawal and a resultant clinical prothrombotic state, with thrombotic events peaking ten days following drug cessation. finally, the acute stress response postoperatively is well known; one component being hypercoagulability which lasts at least seven days after major and uneventful abdominal surgery, predominantly caused by increased platelet activity. whereas turbt generally carries a low overall risk of cardiac morbidity, the general requirement to discontinue aspirin pre-operatively potentially increases certain patients' cerebrovascular or cardiac risk (eg. post-coronary stent placement). as shown above, the risk of significant post-operative hematuria is minimal, and as such, aspirin withdrawal may be unnecessary. we will perform a prospective, randomized controlled trial to address the safety and tolerability of continued aspirin use during turbt.

Eligibility criteria:
inclusion criteria: * adults aged 18 years and older with the ability for self-consent, * referred for elective turbt, * receiving low-dose daily aspirin prophylaxis. exclusion criteria: * known coagulopathy or abnormal coagulation profile (prothrombin time, partial thromboplastin time, or platelet count), * receiving other anti-thrombotic, anti-coagulant, or non-steroidal anti-inflammatory medication (nsaids), * pregnancy.

Keywords: aspirin usage transurethral resection of bladder tumor (turbt)
biospecimen biorepository for the study of als, als-ftd and similar neurodegenerative disorders

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of this study is to collect csf and blood samples that can be used in future research studies to identify potential biomarkers in blood and cerebrospinal fluid (csf) collected in amyotrophic lateral sclerosis (als) patients.

biomarkers are non-genetic elements in your blood and csf that may help diagnose and monitor als more easily. there are no readily available sources of longitudinal csf, plasma or serum samples from people with als, als-ftd or similar neurodegenerative disorders or their family members for use in the identification of potential als biomarkers. future research will examine potential biomarkers in blood and csf collected over time to see if they change over time and can be used to diagnose and monitor people with als.

Eligibility criteria:
inclusion criteria - patient with als, als-ftd or similar neurodegenerative disease: * clinical diagnosis of possible, laboratory-supported probable, probable or definite als according to modified el escorial criteria, suspected als according to original el escorial criteria, or diagnosis of a similar neurodegenerative disorder. * willing to provide consent, or assent, if physically unable to consent owing to disease-related muscle weakness. inclusion criteria - spouse/domestic partner of patients with als/als-ftd and similar neurodegenerative disorder or subject with family history of als, als-ftd or similar neurodegenerative disease: * no personal history of als, als-ftd or other motor neuron disease. * subjects with family history of als, als-ftd the affected family member needs to be a first, second, or third degree blood relative. * willing to provide consent. exclusion criteria - subject with als/als-ftd or similar neurodegenerative disease: * history of medical disorder that leaves in question whether neurological signs and symptoms potentially related to a neurodegenerative disease may be caused by another unrelated disorder. * limited mental capacity rendering the subject unable to comply with lumbar puncture or standard phlebotomy procedures. * for lumbar puncture, an increased risk of bleeding complications or allergy to local anesthetic administered or skin antiseptic used for lumbar puncture. exclusion criteria - spouse/domestic partner of patients with als/als-ftd and similar neurodegenerative disorder or subject with family history of als, als-ftd or similar neurodegenerative disease: * limited mental capacity rendering the subject unable to comply with lumbar puncture or standard phlebotomy procedures. * for lumbar puncture, an increased risk of bleeding complications or allergy to local anesthetic administered or skin antiseptic used for lumbar puncture.
the ddi study of sp2086 and simvastatin

Conditions: Type 2 Diabetes

Summary: the purpose of the study is to investigate the potential interaction between multiple oral doses of sp2086 and a single oral dose of simvastatin in healthy adult volunteers.

this is an open-label (volunteers will know the names of treatments they are assigned) single-center study of sp2086 and simvastatin in healthy adult volunteers. sp2086 will be administered orally (by mouth) as 100 mg on days 4, 5, 6, 7, and 8 and simvastatin will be administered orally as two 20mg tablets on days 1 and 8. both sp2086 and simvastatin tablets will be taken with 8 ounces (240 ml) of water.

Eligibility criteria:
inclusion criteria: * healthy volunteers with a body mass index (bmi, a measure of a person's weight in relation to height) between 19 and 26 kg/m2 exclusion criteria: * history of diabetes * history of heart failure or renal insufficiency * urinary tract infections, or vulvovaginal mycotic infections * history of or current clinically significant medical illness as determined by the investigator * history of clinically significant allergies, especially known hypersensitivity or intolerance to lactose * known allergy to sp2086 or metformin or any of the excipients of the formulation of sp2086 or simvastatin
the value of the canadian ct head rule and the new orleans criteria in minor head trauma

Conditions: Minor Head Injury

Summary: the new orleans criteria (noc) and the canadian ct head rules (cchr) have been developed to decrease the number of normal computed tomography (ct) in mild head injury (mhi). the aim is to compare the clinical performance of these 2 decision rules for indentifying patients with intracranial traumatic lesions and those who required an emergent neurosurgical intervention following mhi.

a multicenter external validation study in 7 tunisian teaching and non teaching hospitals including patients with mhi defined as a blunt trauma to the head within 24 hours with a glasgow coma scale (gcs) score of 13 to 15 and at least one of the following: history of loss of consciousness, short-term memory deficit, amnesia for the traumatic event, post-traumatic seizure, vomiting, headache, external evidence of injury above the clavicles, confusion, and neurologic deficit. primary outcome was need for neurosurgical intervention defined as either death or craniotomy, or the need of endotracheal intubation within 30 days of the traumatic event. secondary outcome was the presence of traumatic lesions on head ct scan. comparaision of both decision rules using sensitivity specifications, positive and negative predictive value.

Eligibility criteria:
inclusion criteria: * patient with acute mhi was defined as a patient having a blunt trauma to the head within 24 hours with a glasgow coma scale (gcs) of 13 to 15 and at least 1 of the following risk factors: history of loss of consciousness, short-term memory deficit, amnesia for the traumatic event, post-traumatic seizure, vomiting, headache, external evidence of injury above the clavicles, confusion, and neurologic deficit. exclusion criteria: * patients are excluded from the study if they are younger than 10 years, had gcs score of less than 13 or instable vital signs, came to the ed more than 24 hours after head trauma, were pregnant, were taking warfarin or had bleeding disorder, had an obvious penetrating skull injury or had contraindications for ct.

Keywords: minor head injury ct scan canadian ct head rules the new orleans criteria
effect of calcium and vitamin d on bone loss from the hip

Conditions: Osteoporosis

Summary: the primary aim of this study is to determine the effects of supplementation with both calcium and vitamin d on changes in bone density of the hip in men and women age 65 and older.

in this study 445 men and women age 65 and older were enrolled for three years each. subjects were randomized to treatment with 500 mg of calcium s calcium citrate malate plus 700 iu of vitamin d daily or placebo. subjects came to the research center every six months for biochemical and bone mineral density measurements. changes in these measures over the three years were determined in each group and compared.

Eligibility criteria:
inclusion criteria: \>65 years calcium intake \< 1500 mg/day willing to discontinue calcium and vitamin d pills for 2 months prior to enrollment exclusion criteria: mentally incompetent, femoral neck bmd greater than 2 sd above/below age/sex-matched reference mean, 24-hr urine calcium/creatinine \> 300 mg/d women or \>350 mg/d men terminal illness, renal disease requiring treatment, kidney stone in the past 10 years, current hyperparathyroidism, treated with glucocorticoids, estrogen or androgen, fluoride, calcitonin, bisphosphonate, or any other treatment for osteoporosis.

Keywords: calcium vitamin d bone loss
a study to assess the impact of pneumococcal conjugate vaccination programme on the carriage of pneumococci

Conditions: Pneumococcal Disease

Summary: a study taking swabs from the back of the nose (nasopharynx) to look at carriage of pneumococci.


Eligibility criteria:
inclusion criteria: * born in a cohort eligible for routine or catch up pneumococcal conjugate vaccination (i.e. date of birth since 4th september 2004) or a family member where a child is eligible and has been enrolled * written informed consent given by the subject's parent/ legal guardian as well as assent from the child after the nature of the study has been explained to them or * written informed consent given by the subject after the nature of the study has been explained to them exclusion criteria: * moderate to severe disability. * cerebral palsy, syndromes and neurological disorders affecting swallowing. * ear nose and throat disorders affecting the anatomy of the ear,i.e.malformed ears. * confirmed or suspected immunodeficiency (congenital or acquired). * on immunosuppressive therapy.

Keywords: pneumococci streptococcus pneumoniae
oral calcium in pregnant women with hypertension

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension; Pre-Eclampsia; Pregnancy Toxemias; Vascular Diseases

Summary: to determine of providing calcium supplementation to women with pre-existing hypertension reduces the level of blood pressure, requirement for antihypertensive drugs, and incidence of pre-eclampsia.

background: maternal and fetal complications are more likely to occur in pregnant women with preexisting hypertension. alterations in calcium metabolism, the renin angiotensin system, and intracellular free calcium concentration have been identified in this high risk population. the beneficial effects of calcium supplementation on blood pressure and the incidence of superimposed pre-eclampsia may be due to correction of the hormonal and cellular basis for vasoconstriction. the trial sought to prove that oral calcium lowered parathyroid hormone, reduced intracellular free calcium, and decreased vascular endothelin production, resulting in vasodilation and compensatory stimulation of the renin-angiotensin system. design narrative: randomized. double blind. in this observational study, subjects were assigned to two grams of supplemental elemental calcium or to placebo at 13 to 15 weeks gestation. the trial determined the effect of oral calcium supplementation on: the level of blood pressure; the need for antihypertensive drugs; forearm and peripheral vascular resistance; the incidence of maternal complications, including pre-eclampsia and eclampsia; and plasma levels of vitamin d3, ionized calcium, parathyroid, renin activity, angiotensin ii, endothelin, nitrate/nitrite, prostacyclins, and intracellular calcium concentrations in lymphocytes and platelets. these variables were measured prior to randomization and every two months throughout pregnancy and the postpartum. support ended in july 1999. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
pregnant women with chronic hypertension.
the biomechanical mechanism for gait and plantar pressure changes after posterior cruciate ligament rupture and reconstruction

Conditions: Posterior Cruciate Ligament Tear

Summary: investigating the biomechanics for the pcl ruptured or reconstructed patients during walking, jogging, cutting, jumping. to establish a knee joint biomechanical evaluation model to quantify and evaluate the plantar pressure information under dynamic load-bearing state after pcl fracture. provide a precise basis for the biomechanical state of the knee, and establish a clinically practical automatic analysis of plantar pressure information and an expert diagnostic system.

background: the posterior cruciate ligament (pcl) is an essential structure in knee stabilization. knee cartilage degeneration after a pcl injury has been reported in several studies. understanding the changes in movement patterns of patients with pcl ruptures could help clinicians make specific treatment protocols to restore patients' sporting ability and prevent joint degeneration. however, the kinematics and kinetics of the lower limb in patients with pcl injuries are still not clear. methods: three-dimensional gait analysis system, force plate, electromyography will be used for 55 healthy male participants (control group) and 55 male patients with isolated pcl-deficiency (pcl-d group) during walking, jogging, cutting, jumping. repeated measurement two-factor analysis of variance will be performed to determine differences between involved and uninvolved legs in the pcl-d group and control group at different rehabilitation times (prior reconstruction surgery, 6 months, and 1-year post pcl reconstruction surgery). three-dimensional gait analysis and computer-aided analysis technology of plantar pressure information were used to study the changes of pcl after fracture and reconstruction. based on the plantar pressure information, the movement parameters, and individual attribute parameters, establish a knee joint biomechanical evaluation model to quantify and evaluate the plantar pressure information under dynamic load-bearing state after pcl fracture. provide a precise basis for the biomechanical state of the knee, and establish a clinically practical automatic analysis of plantar pressure information and an expert diagnostic system.

Eligibility criteria:
inclusion criteria: * age of 18-45 years old * isolated pcl rupture patients: the inclusion criteria included an isolated pcl rupture of at least 3 months' duration. * healthy volunteers: no history of neuro or musculoskeletal system injury that may affect the movements. exclusion criteria: * additional knee ligament or meniscal damage * severe damage to the ipsilateral hip, ankle joint, or contralateral lower limb (ligament ruptures or bone fractures) * age \>50 years (to avoid age-induced osteoarthritis interference) * any cartilage injury grade \>2 according to the outerbridge classification * tegner score18 \<3

Keywords: posterior cruciate ligament knee hip ankle biomechanics walking jogging cutting jumping
acute achilles repair with or without orthadapt augmentation

Conditions: Achilles Tendon Tear

Summary: the purpose of this study is to assess the clinical performance of the orthadapt bioimplant in patients with acute mid-substance achilles tendon tears requiring surgical repair.


Eligibility criteria:
inclusion criteria: * a transverse, full thickness, acute mid-substance achilles tendon tear that requires surgical repair * achilles tendon tear is repairable by surgery using primary means as determined by intra-operative assessment * achilles tendon rupture with viable ends of the tendon that are suitable for primary repair * isolated achilles tendon rupture without poly trauma * patient must be 18 to 70 years of age * life expectancy greater than or equal to 12 months * patient is able to provide voluntary informed consent * patient is willing and able to return for all follow-up visits and study related exams * patient is willing to comply with prescribed physical therapy regimen exclusion criteria: * emergency, poly trauma patients * previous achilles tendon surgical procedure on that tendon * deficit in the contralateral extremity that prevents a comparison with the treated extremity * repair requires tendon lengthening, gap filling or tendon transfer * bmi greater than 40 * peripheral arterial disease * uncontrolled diabetes mellitis * patients whose injury is known to involve litigation * known allergy to equine derived product * systemic collagen disease * neurological disease * active infection - systemic or at the intended surgical site * acute use of immunosuppressive agents * rupture resulting from fluoroquinolone induced tendinopathy * alcohol or drug abuse * participant in another investigational drug or device trial * pathologic soft tissue conditions that would prevent secure surgical fixation * patients who are unwilling or unable to return for follow-up visits and study related exams * pregnant women * cancer patients * decisionally impaired patients * institutionalized patients * prisoners

Keywords: acute achilles tendon tear acute achilles tendon repair
efficacy and safety of the liquid embolic system (tonbridge) for endovascular treatment of cerebrovascular malformations

Conditions: Intracranial Arteriovenous Malformations

Summary: the purpose of this study is to verify the efficacy and safety of the liquid embolic system (tonbridge medical tech. co., ltd. (suzhou)) for the treatment of cerebrovascular malformations.

this is a prospective, multi-center, randomized, parallel positive controlled, non-inferiority trial. this clinical trial is conducted at more than 2 centers in china, and patients who intend to be treated with liquid embolic system for cerebrovascular malformations are enrolled. eligible patients are randomized into experimental group using liquid embolic system (tonbridge) or control group using onyx liquid embolic system (medtronic) in a 1:1 ratio. the purpose of this study is to evaluate the effectiveness and safety of the liquid embolic system (tonbridge).

Eligibility criteria:
inclusion criteria: * age 18 to 80 years, any gender; * subject is suitable for endovascular treatment of cerebrovascular malformations; * subject is able to understand the purpose of the study, shows sufficient compliance with the study protocol and provides a signed informed consent form. exclusion criteria: * intracranial hemorrhage within 1 month prior to treatment; * the targeted embolization area needs to receive other treatments (surgical resection, srs, other embolic materials) at the same time; * combination of other cerebrovascular malformations, such as cavernous vascular malformation; * severe stenosis or occlusion of cerebral feeding artery requiring surgical intervention; * intracranial tumor requiring surgical intervention; * mrs score≥3; * heart, lung, liver and renal failure or other severe diseases; * known bleeding tendency, such as coagulation dysfunction (inr\>1.5); * known allergy to dmso and contrast media, or contraindication to anticoagulant therapy; * pregnant or breastfeeding women, or who plan to become pregnant during the study; * subject is participating in other drug or medical device clinical trials at the time of signing informed consent; * other conditions judged by the investigators as unsuitable for enrollment.
the effects of virtual reality greenspace on stress among adults with mobility impairments

Conditions: Mobility Impairments

Summary: the purpose of this project is to examine the effects of virtual reality greenspace exposure on physiological and affective acute stress responses among adults with mobility impairments.

exposure to greenspace is known to yield numerous mental and physical health benefits such as improved mood, decreased stress, and increased levels of physical activity. regular access to greenspace however is difficult for various segments of the population including individuals with disabilities or chronic health conditions. numerous factors contribute to this difficulty including architectural barriers, shortage of accessible trails, and limited transportation options. these challenges have led to a growing interest in exploring the use of virtual reality (vr) greenspace environments. studies have demonstrated that vr greenspace exposure can reduce stress and improve mood and mental well-being in various populations but has not been tested among individuals with mobility impairments who experience high levels of stress. during a single lab visit, participants will be randomized to vr greenspace activity or control, undergo the trier social stress test. the vr group will then engage in a series of nature-based vr activities. the control group will sit quietly. assessments will be collected at 4 timepoints. physiological stress responses will be measured via changes in bp, hr, and two saliva measures (salivary alpha-amylase, salivary cortisol). affective response (stress, affect, anxiety) will be assessed using self-report surveys. this study will provide insight into the influence of vr greenspace exposure on stress recovery (physiological and affective responses), among individuals with mobility impairments.

Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * a self-reported lower extremity mobility impairment (e.g., cerebral palsy, spinal cord injury, multiple sclerosis, stroke) with partial or full use of the upper extremities. exclusion criteria: * impairment in visual acuity as measured by a snellen eye chart \<20/70 after correction * regular engagement (\>20 minutes/week) in virtual reality greenspace activity * having an endocrine disorder (that can affect cortisol levels) * taking oral corticosteroids * score below 24 on the mini mental state exam

Keywords: stress mobility impairment virtual reality greenspace