Kornimate/medical-research-clean huggingface dataset:
frequency of vascular events with short-term thromboprophylaxis in fast-track hip and knee-arthroplasty.

Conditions: Thromboembolic Events; Post-operative Bleeding

Summary: there are many different views regarding ideal duration and type of thromboprophylaxis after hip or knee surgery. an important factor in fast-track surgery is early mobilization, which in itself is thought to prevent clotting. the investigators hypothesize that there is no increase with regards to thrombosis in patients receiving fast-track surgery with early mobilization and chemical thrombosis prophylaxis only during hospitalization.

major orthopaedic surgery is related to development of thrombosis. it is well known that pharmacological prophylaxis reduces the risk of thrombosis after surgery but there are still doubt about the best type of prophylaxis and duration of treatment. the american college of chest physicians recommend thromboprophylaxis with either low molecular weight heparin, factor xa-inhibitors or vitamin-k-antagonists for up til 10 days after total knee replacement (tkr) and 35 days after total hip replacement(thr). however whether these recommendations are applicable in fast-track patients receiving early mobilisation is uncertain. studies on fast-track patients receiving early mobilisation and thrombosis prophylaxis only during hospitalisation showed very small incidence of symptomatic thromboembolic events. therefore we conduct a quality-cohort-study on all patients receiving fast-track tkr/thr with short-term anti-thrombotic treatment, in order to investigate frequency of symptomatical deep vein thrombosis, pulmonary embolus, acute myocardial infarction and stroke.

Eligibility criteria:
inclusion criteria: * primary uni/bilateral thr/tkr, revision thr/tkr or uni-kr in fast-track setup, discharged in 3 +-2 days. exclusion criteria: * not a danish citizen

Keywords: knee replacement, total hip replacement, total thromboembolism, venous prophylaxis enhanced recovery
vmat for dominant intraprostatic lesion

Conditions: Prostate Cancer

Summary: the aim of this study was to determine the efficacy and safety of the implementation of a program of " image-guided focal intensification dose to intraprostatic dominant lesion " in men with localized prostate cancer (pca) of intermediate and high risk (criteria nccn) eligible to receive radiotherapy in the department of radiation oncology of hup (hospital universitario de la princesa), within the established dose escalation protocol with intensity modulated image-guided radiotherapy (imrt / igrt).

the aim of this study was to determine the efficacy and safety of the implementation of a program of " image-guided focal intensification dose to intraprostatic dominant lesion " in men with localized prostate cancer (pca) of intermediate and high risk (criteria nccn) eligible to receive radiotherapy in the department of radiation oncology of hup (hospital universitario de la princesa), within the established dose escalation protocol with intensity modulated image-guided radiotherapy (imrt / igrt).

Eligibility criteria:
inclusion criteria: * male \> 18 years old with histologic diagnostic of prostate adenocarcinoma * clinical stage ct2a-t3b n0-1 m0 (ajcc 7 th edition) * psa (prostate-specific antigen) \< 100 ng/ml * gleason score 6-10 * life expectancy \> 5 years * patients who accept the radiotherapy treatment * patients provided written informed consent before participating in the trial exclusion criteria: * transurethral resection of the prostate or prior prostate surgery * previous pelvic radiotherapy * urethral stenosis with or without prior dilations * ipss\>15 * rectal diverticuli or rectal vascular malformations * metastatic disease * severe psychiatric or medical conditions that could hamper both treatment and follow-up

Keywords: prostate cancer vmat dominant intraprostatic lesion intensity modulated radiotherapy
abatacept pregnancy exposure registry

Conditions: Rheumatoid Arthritis

Summary: the purpose of the abatacept pregnancy registry is to monitor planned and unplanned pregnancies exposed to abatacept, to evaluate the possible teratogenic effects (that is, any abnormal development) of this medication in the pregnancy outcome and to follow live born infants for one year after birth.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * currently pregnant women who agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the physical examination of live born infants exclusion criteria: * women who come in first contact with the project after prenatal diagnosis of a fetal abnormality
validation of the san francisco syncope rule

Conditions: Syncope; Near Syncope

Summary: this study was designed to validate the "san francisco syncope rule". this set of rules was derived by quinn et. al. to help guide the treatment of patients evaluated in the emergency department who had an episode of syncope (passed out) or near syncope (almost passed out). a rule that considers patients with an abnormal ecg, a complaint of shortness of breath, hematocrit less than 30%, systolic blood pressure less than 90 mm hg, or a history of congestive heart failure was shown predict with a good degree of accuracy which patients would have an adverse event and require admission.

this study was designed to validate the "san francisco syncope rule". this set of rules was derived by quinn et. al. to help guide the treatment of patients evaluated in the emergency department who had an episode of syncope or near syncope. a rule that considers patients with an abnormal ecg, a complaint of shortness of breath, hematocrit less than 30%, systolic blood pressure less than 90 mm hg, or a history of congestive heart failure was shown predict with a good degree of accuracy which patients would have an adverse event/serious outcome and require admission. serious outcomes include the following: death,myocardial infarction, arrhythmia, pulmonary embolism, stroke, subarachnoid hemorrhage, significant hemorrhage, or any condition causing a return ed visit and hospitalization for a related event. in quinn's derivation trial, the sensitivity of the rule was 96%.

Eligibility criteria:
inclusion criteria: acute syncope or near syncope as a reason for the ed visit exclusion criteria: altered mental status, alcohol or illicit drug-related loss of consciousness, definite seizure, transient loss of consciousness caused by head trauma

Keywords: syncope near syncope san francisco syncope rule
the effects of circadian gene on sleep and associated symptoms in breast cancer patients under chemotherapy

Conditions: Breast Neoplasms

Summary: the purpose of this study is the evaluation of effect of circadian gene on sleep and other symptoms in breast cancer patients under chemotherapy.

in this study, the investigators are going to examine the effect of genetic polymorphism on sleep, anxiety, depression and other cancer-related symptoms in patients with breast cancer who have started chemotherapy after surgery. no intervention was intended and blood sample was taken with other routine laboratory tests.

Eligibility criteria:
inclusion criteria: * age: 18-70 * patient with breast cancer without metastasis * patient received cancer surgery and medically stable * patient will undergo chemotherapy for the first time in life * patient have signed on the informed consent, and well understood the objective and procedure of this study exclusion criteria: * patient received chemotherapy or radiotherapy * patient had another cancer before * patient have metastasis * patient with severe medical condition * patient had taken psychiatric medication more than 1 month in life * patient worked the night shift for more than 1 month in 6 months

Keywords: breast neoplasms sleep anxiety depression life quality
a study of trs01 in participants with post-surgical ocular inflammation

Conditions: Post Surgical Ocular Inflammation

Summary: the objective of this study is to evaluate the safety and preliminary efficacy of trs01 eye drops as compared to placebo on participants with ocular inflammation after cataract surgery.


Eligibility criteria:
inclusion criteria: pre-operatively, individuals of either gender or any race will be eligible for study participation if they are: * 18 years of age or older. * able to provide informed consent, follow instructions and complete all required study visits for the duration of the study. * scheduled for routine cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens (iol) implantation, and not combined with any other surgery. * have vision ≥ 20/200 in the non-study eye. * able to self-administer eye drops (tested during screening by self-administration of "artificial tears"), or have a care provider that can administer the drops. * have no known sensitivity /allergy to the trs01 or formulation excipients. * using adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol * randomization inclusion criteria as specified per protocol. exclusion criteria: * scheduled to undergo cataract surgery in the non-study eye for the duration of the study. * receiving specific medication/interventions as specified per protocol

Keywords: postoperative postsurgical ocular inflammation pain
is the bat inhibition able to replace sting challenges? (batirs)

Conditions: Vespid Venom Allergy

Summary: insect venom allergy is the major cause for severe allergic reactions in europe. wasps and honeybees are responsible for the majority of these allergic reactions. symptoms range from generalized skin symptoms (wheals, swellings) to respiratory or cardiovascular problems such as asthma, dizziness, loss of consciousness, or cardiac arrest. the regular administration of insect venom ('venom immunotherapy') over up to 5 years is a well-established therapy, providing long-term protection from further systemic sting reactions in the majority of patients. however, there is no laboratory test which is able to identify patients who will still react to an insect sting. the only reliable method available is stinging patients with living insects ('sting challenges'). the key issue is that only few centers in europe perform sting challenges and many patients have no access to these tests. therefore, it is of utmost importance to find a method which is able to identify patients who are still at risk for future allergic sting reactions. the inhibition of the basophil activation test (bat) could be a potential method to monitor the effectiveness of immunotherapy. basophils are cells which are activated in acute allergic reactions. the basophil activation of blood donors with vespid venom allergy can be measured after adding sera from allergic patients undergoing immunotherapy. in a preliminary study we found that the activation of basophils could be inhibited in all patients treated with vespid venom, however, results must be confirmed in a larger study. in this study, a total of 219 patients with vespid venom allergy will be included. those patients who are receiving or who have already finished venom immunotherapy will be sting challenged and blood samples will be taken to perform bat inhibition experiments. at the same time, donors with confirmed vespid venom allergy, who have not undergone immunotherapy, will be recruited for a blood donation, which is necessary for the bat inhibition tests. if results of the preliminary study could be confirmed, the bat inhibition will facilitate monitoring the effectiveness of venom immunotherapy and patients would benefit from an early detection of lacking tolerance and consequently from the increased venom dose preventing future life threatening systemic sting reactions.


Eligibility criteria:
inclusion criteria: * legally competent male and female subjects who are currently treated or who have been treated with vespid venom immunotherapy * age ≥18 and ≤70 years * written consent of the participant after being informed exclusion criteria: * pregnancy * autoimmune disease * uncontrolled cardiovascular disease * uncontrolled asthma
a study of bibr 1048 in prevention of venous thromboembolism in patients with tkr surgery.

Conditions: Arthroplasty, Replacement, Knee; Venous Thrombosis

Summary: the goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of bibr 1048 (dabigatran etexilate) orally, compared to placebo, in prevention of venous thromboembolism in patient with primary elective total knee replacement surgery, and to evaluate dose-response.


Eligibility criteria:
inclusion criteria inclusion criteria 1. patients scheduled to undergo a primary, unilateral elective total knee replacement 2. male or female 20 years of age or order 3. patients weighing at least 40 kg 4. written informed consent prior to the start of study participation exclusion criteria exclusion criteria 1. history of bleeding diathesis 2. constitutional or acquired coagulation disorders that in the investigator's judgment puts the patient at excessive risk for bleeding 3. major surgery or trauma (e.g. hip fracture) within the last 3 months 4. recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrollment (investigator's judgment) or history of myocardial infarction within the last 3 months 5. any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, av (arteriovenous) malformation or aneurysm or recent bleeding history 6. condition requiring anti-coagulant therapy 7. elevated ast(aspartate aminotransferase) , alt(alanine aminotransferase), or any history of clinically relevant liver disease 8. patients with a history of clinically significant renal diseases or with elevated creatinine values
study of sparc1103 in subjects with spasticity

Conditions: Spasticity

Summary: study of sparc1103 in subjects with spasticity


Eligibility criteria:
inclusion criteria: * men and women greater than or equal to 18 years of age * willing to sign the informed consent form * women of child bearing potential willing to practice an acceptable method of birth control * known history of spasticity due to ms exclusion criteria: * administration of an investigational drug or device within 30 days prior to screening visit 1 * unable to comply with trial procedures in the opinion of the investigator * concomitant neurologic conditions causing spasticity * any medical condition, including psychiatric disease or epilepsy, which would interfere with the interpretation of the trial results

Keywords: spasticity, multiple sclerosis
targeted hypoglossal neurostimulation study #2

Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiration Disorders; Signs and Symptoms, Respiratory; Syndrome, Obstructive Sleep Apnea

Summary: the objective of the study is to confirm the safety and efficacy in patients utilizing the aura6000 system for the treatment of obstructive sleep apnea (osa).


Eligibility criteria:
inclusion criteria: * ahi \>20 * noncompliant to cpap * willing to provide informed consent * willing to comply with all follow-up visits and evaluations exclusion criteria: * bmi limits * copd * central sleep apnea * anatomic variations interfering with device placement or stability.

Keywords: apnea respiration disorders signs and symptoms signs and symptoms, respiratory sleep apnea syndromes sleep apnea, obstructive respiratory tract diseases sleep disorders, intrinsic sleep disorders nervous system diseases
pfdd versus pfdrt in chiari decompression surgery

Conditions: Chiari Malformation Type I; Tonsillectomy

Summary: the purpose of this study is to determine whether a posterior fossa decompression and duraplasty with or without tonsil manipulation results in better patient outcomes with fewer complications and improved quality of life in those who have chiari malformation type i and syringomyelia.

participants with chiari malformation type i and syringomyelia will be randomized to either have a posterior fossa decompression and duraplasty with or without tonsil manipulation. the participant will then return to the neurosurgeon's office at the following time points which are consistent with standard of care practice: 3-6 months, 12 and 24 months. at these visits, the clinician will complete a physical exam and the participant will report on the prognosis of symptoms and complete questionnaires. a spine mri will be performed 3-6 months, 12 and 24 months after the decompression.

Eligibility criteria:
inclusion criteria: * age ≥14 years old * chiari malformation type i ≥5 mm tonsillar ectopia * a syrinx with a width \> 50% of the cross-sectional diameter of the spinal cord , and a length of at least 2 cervical and/or thoracic vertebral segments. * mri of the brain and cervical and thoracic spine are required prior to surgery and must be available to be shared with the data coordinating center exclusion criteria: * included one or more of the following preexisting conditions: hydrocephalus; tumor; brain trauma; stroke; meningitis; abscess; * other congenital anomalies of the brain or skull base; vertebral anomalies (i.e., klippel-feil, atlas assimilation, etc.); * degenerative or demyelinating disease; * cm-i without syringomyelia; * syringomyelia with cerebellar tonsils in a normal position; * fibromyalgia; * chronic fatigue syndrome; * prior posterior fossa surgery. * unable to share pre-decompression mri of the brain and spine patients who do not wish to participate

Keywords: posterior fossa decompression with duraplasty tonsillectomy fmdd
the association between parental anxiety and child behavior.

Conditions: Parental Anxiety,Child Behavior

Summary: parents' dental anxiety is demonstrated as a significant indicator for children's dental anxiety and parents play a key role in children's anxiety and fear development. studies have shown that parents who are fearful and anxious about dental treatments are associated with an increase in the occurrence of caries disease in their children, since they are more resistant to accompany their children to the dentist. people with a high level of dental anxiety, both children and adults, can be difficult to treat, take longer, and have behavioral issues, all of which can lead to a stressful and unpleasant experience for both the patient and the dental practitioner


Eligibility criteria:
inclusion criteria: * children, age ranging from 4 to 6 years old, of both sexes, have simple occlusal cavities attending the pediatric dental clinic. * parents of both genders exclusion criteria: * children who do not have the cognition to respond to the anxiety test or are not authorized by parents and medically compromised children. * parents who could not respond to the research tools.
virtual reality in the operating room

Conditions: Anesthesia, Intravenous; Pain, Postoperative; Delayed Recovery From Anesthesia; Satisfaction; Relaxation Therapy

Summary: this is a randomized, controlled trial designed to investigate whether the use of virtual reality immersive relaxation during hand/arm operations can allow for a relaxing operating room experience for patients while potentially reducing anesthesia requirements.

the proposed study is a randomized, controlled trial to evaluate the effectiveness of vr as an adjunct to standard anesthetic practice for upper extremity surgery. patients will be randomized to undergo immersion relaxation via the use of vr during their procedure or control. in both groups patients will undergo regional anesthesia preoperatively according to standard practice. patients will then be assessed postoperatively to assess the intraoperative propofol dose between groups, as well as secondary outcomes including patient satisfaction.

Eligibility criteria:
inclusion criteria: - patients undergoing upper extremity (hand, wrist, arm, and/or elbow) surgery at bidmc under mac exclusion criteria: * age \< 18 * open wounds or active infection of the face or eye area * history of seizures or other symptom linked to an epileptic condition * patients who plan to wear hearing aids during the procedure * patients with a pacemaker or other implanted medical device * droplet or airborne precautions (as determined by bidmc infection control policy) * non-english speaking * patients who require deep sedation * patients who are deemed ineligible to approach by the surgeon
difficult colon polypectomies

Conditions: Colon Polyps

Summary: the investigators aim to define the concept of difficult colonic polypectomy and investigate whether resection methods (hot/cold snare, endoscopic mucosal resection (emr), endoscopic submucosal dissection (esd)), adjuvant techniques (endoloop, prophylactic hemoclip placement, submucosal injection) and operator experience have an impact on polypectomy outcomes and complication rate.


Eligibility criteria:
inclusion criteria: * colonic polyps that are deemed difficult to resect by the endoscopist exclusion criteria: * patient refusal to participate in the trial
this study is about the efficacy of repetitive peripheral magnetic stimulation on the treatment of shoulder subluxation in subacute stroke patients.

Conditions: Shoulder Subluxation; Subacute Stroke; Magnetic Stimulation; Randomised Controlled Trial

Summary: the goal of this clinical trial is to study the efficacy of repetitive peripheral magnetic stimulation (rpms) on shoulder subluxation in subacute stroke patients. the main questions it aims to answer are could rpms reduce shoulder subluxation and improve upper-limb motor recovery in subacute stroke patients? researchers will compare real rpms to sham rpms to see if rpms works to improve shoulder subluxation and upper-limb motor recovery in subacute stroke patients. participants will: * get real rpms or sham rpms for 20 minutes, 5 days a week for 2 weeks * get conventional rehabilitation program 5 days a week for 2 weeks * follow-up at 2-, 4-, 8- and 12-weeks after first day of treatment


Eligibility criteria:
inclusion criteria: * subacute phase (seven days to six months) and first time of stroke patients * shoulder subluxation that measured half of a fingerbreadth or more * meet the criteria for admission to a comprehensive rehabilitation program * medically stable * intact skin on the hemiparetic arm exclusion criteria: * patients with contraindication for magnetic stimulation; cardiac pacemakers, magnetic materials near the intended stimulation site * patients with pregnancy * patients with severe aphasia or severe cognitive impairment * patients with previous shoulder pathology or limit shoulder function before stroke * patients with unstable vital signs