Kornimate/medical-research-clean huggingface dataset:
predicting bleeding risk on anticoagulant therapy for venous thromboembolism

Conditions: Venous Thromboembolism

Summary: the main objective of the study is to develop or validate a clinical prediction rule for major bleeding in patients on oral anticoagulant therapy who have been safely anticoagulated without bleeding or venous thromboembolism (vte) recurrence for at least 3 months since diagnosis and are being considered for long-term oral anticoagulant therapy.

oral anticoagulant therapy for patients who are at risk of developing blood clotting problems is used by between 400,000-600,000 canadians annually. the use of this drug represents the most common cause of patient adverse medical outcomes due to medical errors. furthermore, many patients have adverse outcomes using these drugs because physicians are not able to predict which patients are likely to have bleeding outcomes. much effort has gone into developing ways to predict which patients are at risk of clotting but almost no work has gone into ways of predicting which patients would be at high risk of bleeding. this information is required to balance off the risk-benefits and to enable physicians and patients to understand the risks and benefits of taking these medications. our study will develop a tool that can be used to predict bleeding risk in patients taking oral anticoagulant therapy. it will enable more informed decision making by both physicians and patients and will result in better control of the use of these drugs. in addition, patients who are at risk for being difficult to accurately dose on oral anticoagulants will be identified through our study.

Eligibility criteria:
inclusion criteria: * \>=18 years old * provoked or unprovoked venous thromboembolism * objectively confirmed venous thromboembolism * treated with an oral anticoagulant(vitamin k antagonist or new oral anticoagulant) for at least 3 months with plans to continue long-term * if taking a vitamin k antagonist; inr target is between 2.0-3.0 * if taking a vitamin k antagonist; must have taken it for the last 3 consecutive weeks (minimum) exclusion criteria: * major bleeding while taking oral anticoagulants * active bleeding at study enrollment * active cancer - current or at the time of vte diagnosis * unable to provide written informed consent * refusal to provide written informed consent

Keywords: venous thromboembolism long-term oral anticoagulant therapy warfarin bleeding risk clinical prediction rule predictors deep vein thrombosis pulmonary embolism vitamin k antagonist side effect
prospective study to validate the clinical accuracy of the norbert device to measure oxygen saturation

Conditions: Healthy; Hypoxia

Summary: the purpose of this study is to evaluate the spo2 accuracy and performance of the norbert device during non-motion conditions over the range of 70-100% sao2 as compared to arterial blood samples assessed by co-oximetry for spo2 validation.

the study is a single center, prospective, non-randomized study to measure the accuracy of an investigational device compared to blood reference values. the design of the study will be conducted in accordance with the recommendations of iso 80601-2-61:2011 annex ee.2 procedure for invasive laboratory testing on healthy volunteers. the purpose of this study is to evaluate the spo2 accuracy and performance of the norbert device during non-motion conditions over the range of 70-100% sao2 as compared to arterial blood samples assessed by co-oximetry for spo2 validation. the end goal is to show the spo2 accuracy performance of the norbert device. it is expected that the accuracy root mean square (arms) performance of pulse oximeters will meet a specification of 3.5 or better in non-motion conditions for the range of 70-100% sao2 thereby demonstrating an acceptable spo2 accuracy performance specification.

Eligibility criteria:
inclusion criteria: * healthy, male or female subjects between the ages of 18 to 50 years * completion of a health screening for a medical history by a licensed physician, nurse practitioner, or physician assistant * previously measured hemoglobin electrophoresis with normal result recorded in duke epic ehr * minimum weight 40kg; bmi within range 18.0 - 35.0 * assigned american society of anesthesiologists (asa) physical status 1 by principal investigator or delegate exclusion criteria: * prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., novocain) * prior known severe allergies to medical grade adhesive/tape (band-aid) * taking any medication other than birth control * is currently participating in, or has recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational interventional drug, device, or biologic study * has a negative allen's test to confirm non patency of the collateral artery * has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure * is female with a positive urine pregnancy test, or is female and is unwilling to use effective birth control between the time of screening and study procedure or is breast feeding * has anemia * has heparin allergy * has a history of sickle cell trait or thalassemia \[self-reported\] * has a positive urine cotinine test or urine drug screen or oral ethanol test * has a room air saturation less than 95% by pulse oximetry * has a clinically significant abnormal ekg * has a cohb greater than 3%, or methb greater than 2% * students and employees under the direct supervision of pi or sub-i

Keywords: medical device validation hypoxia spo2 oxygen saturation norbert device norbert health
effect of combination dexmedetomidine added to fentanyl-based intravenous patient-controlled analgesia on nausea vomiting in highly susceptible patients undergoing lumbar spinal surgery: prospective double blinded randomized controlled trial

Conditions: PONV

Summary: the aim of this study is to test the hypothesis that addition of dexmedetomidine to fentanyl-based intravenous patient controlled analgesia (pca) reduces requirement of fentanyl bolus and consequent postoperative nausea and vomiting in high-risk patients undergoing lumbar spine surgery.


Eligibility criteria:
inclusion criteria: 1. female, non-smoking patient who are 20-65 of age scheduled for elective lumbar spine surgery exclusion criteria: 1. bradycardia on ekg (45bpm) 2. atrioventricular conduction disorder 3. uncontrolled hypertension 4. angina history 5. obesity (bmi ≥ 30 kg/m2) 6. preoperative administration of opioid 7. preoperative administration of antiemetics 8. gastrointestinal disorder history 9. hepatic or renal disease 10. pregnant 11. foreigner

Keywords: ponv iv pca dexmedetomidine female non-smoking lumbar spine surgery
ultrasound-guided hydrodistension in patients with adhesive capsulitis

Conditions: Adhesive Capsulitis

Summary: the present study aims to compare the efficacy of assisted rehabilitation treatment, in terms of improvement of pain and shoulder articulation, in patients with stage 2 adhesive capsulitis compared with unassisted home rehabilitation treatment. this evaluation is performed following the glenohumeral capsular hydrodistension procedure performed under ultrasound monitoring.


Eligibility criteria:
inclusion criteria: * male or female patients, aged between 18 and 65 years; * stage 2 adhesive capsulitis of the shoulder, with diagnosis made by clinical, radiographic evaluation in two projections (antero-posterior, lateral) and ultrasound. exclusion criteria: * patients unable to give consent; * pregnant women; * patients with poly-drug allergies (anesthetics, corticosteroids); 3. * patients with other conditions with similar clinical picture (calcific tendinopathy, glenohumeral arthrosis, rotator cuff injury, etc...).

Keywords: shoulder adhesive capsulitis ultrasound
comparison among propofol, alfentanil and rocuronium as adjunct to sevoflurane anesthesia for endotracheal intubation in children with frenectomy

Conditions: Ankyloglossia

Summary: several methods have been demonstrated to improve intubating conditions during sevoflurane induction in children. these include opioids, propofol, and addition of neuromuscular blocking agents in pediatric patients. but the study about the comparison of these agents has been uncommon. frenectomy is common procedure to treat ankyloglossia. it is a short procedure performed under general anesthesia. the investigators aimed to compare intubating conditions among children with propofol, alfentanil or rocuronium after sevoflurane induction.


Eligibility criteria:
inclusion criteria: * children, 1-9 years old scheduled elective frenectomy under general anesthesia exclusion criteria: * patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period
effect of pressure biofeedback on deep cervical muscle training among university teachers.

Conditions: Neck Pain

Summary: the aim of this study is to investigate the effect of pressure biofeedback on deep cervical muscle in university teachers suffering from neck pain, functional disability and muscle endurance.

the purpose of this study will be to determine whether training of deep cervical flexor muscles with pressure biofeedback has any significant advantage over conventional training for pain and disability experienced by university teachers with neck pain. this study will be a randomized control trial with double blinded protocol. patient will be randomly allocated in two groups. the experimental group received deep cervical flexor muscles training with pressure biofeedback and conventional exercises. the control group received deep cervical flexor muscles training with only conventional exercises.

Eligibility criteria:
inclusion criteria: * both gender * age between 24 to 45 years * at least 4 years of teaching experience and average 8 hours of working per day * chronic neck pain score of more than 5 on numeric pain rating scale * mild to moderate disability score on neck disability index exclusion criteria: * participants with any ongoing treatment for neck pain * history of cervical spine surgery or reported any neurological signs. * history of any congenital or acquired postural deformity, spinal cord compression, tumour, instability, fracture, inflammatory disease or infection.

Keywords: neck pain disabilty muscle endurance pressure biofeedback teachers
quantification of myocardial blood flow by positron emission tomography in healthy volunteers

Conditions: Normal Healthy Volunteers Without Chronic Medical Conditions

Summary: to establish quantitative values of myocardial blood flow (mbf) in normal, healthy volunteers .

we seek to establish quantitative values of myocardial blood flow in 20 normal, healthy volunteers using our existing 2d pet camera (positron attrius) and invasively validated software package (heartsee) in order to 1) establish institutional values for which clinical patients can be compared to and 2) add to the collective data of the scientific community. values to be measured will be resting myocardial blood flow (mbf), stress mbf and coronary flow reserve.

Eligibility criteria:
inclusion criteria: * adults ≥18 and \<40 years old * participants must be able to give informed consent. * ability to abstain from caffeine for 48 hours exclusion criteria: * any chronic cardiac disease or condition (e.g. hypertension, hyperlipidemia) * any chronic systemic disease or condition (e.g. diabetes, systemic lupus, rheumatoid arthritis) * tobacco use * family history in a first degree relative with clinical coronary artery disease (history of myocardial infarctio, percutaneous intervention or coronary artery bypass grafting) in men \<55 years old or women \<65 years old * severe claustrophobia * positive urine pregnancy test * inability to give informed consent
rheumatic heart disease research and screening in nepal: a feasibility study

Conditions: Rheumatic Heart Disease

Summary: rheumatic heart disease (rhd) remains a significant public health problem in lower and middle-income countries, accounting for over 300,000 deaths world-wide. rhd is a sequela of acute rheumatic fever (arf) caused by group a streptococcus (gas). benzathine penicillin prophylaxis (bpp), through tri-weekly intramuscular injection of benzathine penicillin g, remains the mainstay of intervention to delay and prevent the sequelae among arf and rhd patients by preventing repeat gas infections. two major obstacles exist to the optimal utilization of this effort. first, despite proven benefits, bpp adherence remains low. unfortunately, there is very little knowledge on the factors associated with bpp adherence. even in countries like nepal, which has a nation-wide free bpp program serving about 6000 patients, there is absence of a robust system to prospectively track and study these patients. second, largely because rhd is initially asymptomatic, only a fraction of those who would benefit are enrolled in bpp programs. there is a dearth of information and evidence on potentially high-yield approaches like the screening of first-degree relatives (fdrs) of rhd patients to identify asymptomatic, early-stage rhd patients who may benefit from bpp. the investigators will combine the resources and expertise at the university of washington with those from existing partners at two leading nepali hospitals (manmohan cardiothoracic vascular and transplant center and dhulikhel hospital) to first create an easy to use, scalable, comprehensive electronic rhd registry and enroll bpp patients from these sites. in aim 1, the investigators will examine whether patient socio-demographic, clinical, and health services-related characteristics are associated with bpp adherence. investigators will use the bpp registry to collect important covariate information and adherence outcomes to address this aim. in aim 2, investigators will determine the feasibility of screening fdrs of known rhd patients. investigators will invite fdrs of known rhd patients (enrolled in the bpp registry) for echocardiographic screening for rhd. investigators will assess the prevalence of rhd in these fdrs. this proposal harnesses one of the largest rhd patient pools in the world for establishing a robust rhd-related quality improvement and research platform that serves as a solid foundation for conducting larger epidemiologic, interventional, and implementation studies on rhd risk, prevention, and treatment.


Eligibility criteria:
inclusion criteria: * rhd patients exclusion criteria: -
study of dermabond propen in closure of colectomy wounds

Conditions: Wound

Summary: 2-octylcyanoacrylate (2-oca) has been used extensively in clinical practice in trauma, plastic surgery, orthopaedic surgery, emergency medicine and paediatrics. most studies on 2-oca to date have focused on closure of short wounds, and only one has included closure of abdominal wounds in the context of general surgery. here, the investigators will look at the results of closure of abdominal wounds in patients undergoing elective colectomies with 2-oca, which is commercially available to us, versus closure with skin staples, which is the current standard technique of skin closure employed in the department of colorectal surgery, singapore general hospital. the primary objective was to measure effectiveness of 2-oca in 2 respects - the adequacy of wound healing and cosmesis, and the incidence of superficial wound infection.


Eligibility criteria:
inclusion criteria: * patients undergoing elective colectomies for benign or malignant conditions * midline vertical incisions or skin crease incisions * above the age of 21 years old * able to make own valid informed decisions exclusion criteria: * patients undergoing surgery for recurrent or metastatic disease * surgery for surgical emergencies such as acute abdomen or bleeding * known allergy to dermabond propen tissue adhesive or any of its constituents (cyanoacrylate or formaldehyde) * patients on immunosuppression

Keywords: colectomy closure wound dermabond propen
erbium-yag laser versus platelet rich plasma in the treatment of atrophic acne scars

Conditions: Acne Vulgaris; Scars

Summary: this study aim to assess the efficacy of er-yag laser 2940nm and prp as a single line of treatment in comparison with combined treatment in atrophic post acne scars.


Eligibility criteria:
inclusion criteria: * patients with atrophic post acne scars classified on the basis of goodman and baron's qualitative classification, no active acne lesions and patients with atrophic scars only exclusion criteria: * patients with positive history of keloidal tendency, positive history of bleeding tendency, platelet disorder, patients with any acute infection on face like, herpes, folliculitis, patients with hiv, hbsag, patients with a history of autoimmune diseases or patients on immunosuppressive drugs.

Keywords: acne scars erbium-yag laser platelet-rich plasma
hypothermia during intracranial aneurysm surgery trial

Conditions: Aneurysm; Hypothermia; Subarachnoid Hemorrhage

Summary: this is a large multi-center, prospective, randomized trial designed to determine whether mild intraoperative hypothermia results in improved neurological outcome in patients with an acute subarachnoid hemorrhage (sah) who are undergoing an open craniotomy to clip their aneurysms.

the purpose of this trial is to determine whether mild intraoperative body cooling (body temperature = 33 degrees celsius or 91.4 degrees fahrenheit) during open neurosurgical craniotomies for aneurysm clipping improves neurological outcome (measured as 3 months after surgery) in patients who have suffered an aneurismal sah. this may be the only nih-funded trial to examine the impact of an intraoperative intervention on neurological outcome following any neurosurgical procedure, and is certainly the largest trial of its kind yet undertaken. many methods have been proposed to "protect" neurosurgical patients from neurological complications that can occur during and after intracranial vascular procedures. however, no treatment targeted at the intraoperative period has ever been systematically tested. mild hypothermia was chosen as the treatment to be tested after an extensive review of medical literature and discussions with many anesthesiologists and neurosurgeons expert in the field suggested it was the intervention most likely to be beneficial. hypothermia is also easily produced in the operating room and most anesthesiologists are familiar with managing mild hypothermia. as a result, the investigators felt that a trial of hypothermia was practical and reasonably safe.

Eligibility criteria:
* adult greater than 18 years old * non-obese (body mass index less than 35kg/m2) * non-pregnant * world federation of neurologic surgeons preoperative grade i, ii, or iii patients with acute sah and scheduled to undergo open craniotomies for aneurysm clipping within 14 days of a documented sah. * there must be no contraindications to cooling (e.g., sickle cell anemia, cryoglobulinemia, or severe raynaud's disease). * patients must also have pre-sah rankin disability scores of 0 to 1 (i.e., no serious pre-existing functional disability of any kind), and a perioperative course of nimodipine (a calcium-channel blocker and the only drug known to improve outcome in patients with sah) must be planned. * each center must have approval from their local human subjects committee to participate in the trial and written informed consent from either the patient, next-of-kin, or legal guardian is required.

Keywords: aneurysm hypothermia subarachnoid intracranial hemorrhage
combination of chemoradiation therapy and epitope peptide vaccine therapy in treating patients with esophageal cancer

Conditions: Esophageal Cancer

Summary: the purpose of this study is to evaluate the safety and immune response of multiple peptides (urlc10, ttk, koc1 vegfr1, and vegfr2) emulsified with montanide isa51 in combination with chemotherapy (cddp, 5-fu) plus radiation therapy in treating patients with unresectable, advanced or recurrent esophageal cancer.

up-regulated ling cancer 10 (urlc10), ttk protein kinase (ttk) and k homology domain containing protein over expressed in cancer (koc1) were identified as new targets of tumor associated antigens using cdna microarray technologies combined with the expression profiles of normal and cancer tissues. furthermore, anti-angiogenic therapy is now considered to be one of promising approaches for treating cancer. vascular endothelial growth factor receptor 1 (vegfr1) and vascular endothelial growth factor receptor 2 (vegfr2) are essential targets for tumor angiogenesis. epitope peptides for these targets are able to induce cytotoxic t lymphocytes (ctl) restricted to hla-a \*2402 in vivo. on the other hand, chemotherapy (cddp, 5-fu) plus radiation therapy has been to be a standard treatment for unresectable advanced esophageal cancer. in this clinical trial, we evaluate the safety and immune responses of different doses of multiple peptides (urlc10, ttk, koc1, vegfr1, and vegfr 2) emulsified with montanide isa 51 in combination with chemotherapy (cddp, 5-fu) plus radiation therapy in treating patients with unresectable, advanced or recurrent esophageal cancer.

Eligibility criteria:
inclusion criteria: 1. patients must have unresectable, locally advanced, recurrent or metastatic disease of esophageal cancer. 2. measurable disease by ct scan 3. ecog performance status of 0 to 2 4. expected survival of at lease 3months 5. patients must be hla-a2402 6. laboratory values as follow: * wbc \> 2000/mm3, * platelet count \> 75000/mm3, * total bilirubin \< 1.5 x the institutional normal upper limits, * creatinine \< 1.5 x the institutional normal upper limits, * ast. alt. alp \< 2.5 x the institutional normal upper limits 7. able and willing to give valid written informed consent exclusion criteria: 1. pregnancy (women of childbearing potential:refusal or inability to use effective means of contraception) 2. breastfeeding 3. active or uncontrolled infection 4. prior chemotherapy,radiation therapy or immunotherapy within 4 weeks 5. concurrent treatment with steroid or immunosuppressing agent 6. patient with peptic ulcer disease 7. active or uncontrolled other malignancy 8. other malignancy within 5 years prior to entry into the study, expect for treated non-melanoma skin cancer and cervical carcinoma in situ 9. disease to the central nervous system 10. decision of unsuitableness by principal investigator or physician-in-charge

Keywords: epitope peptide vaccination chemoradiation esophageal cancer