Kornimate/medical-research-clean huggingface dataset:
very low dose oral anticoagulation and thromboembolic and bleeding complications

Conditions: Mechanical Heart Valve Recipients

Summary: we aim to investiagte whether very low dose self management of oral anticoagulation is superior to low dose oral anticoagulation in order to prevent bleeding events in patients undergoing mechanuical heart valve replacement.

in mechanical heart valve recipients, self-management of oral anticoagulation can reduce the risk of developing thromboembolic events and improves long-term survival compared with international normalized ratio (inr) control by a general practitioner. low-dose inr self-management (inr values of 1.8.-2.8 for aortic valve recipients and 2.5 - 3.5 for mitral or double valve recipients) does not increase the risk of thromboembolic events compared to conventional dose inr self-management. even in patients with a low inr target range, however, the risk of bleeding events is still higher than the risk of thromboembolism. we therefore perform a prospective, randomized trial in 1,800 patients with mechanical heart valve replacement. during the first six postoperative months, low dose inr self-management will be performed by all patients (inr measurement once a week). thereafter, 600 patients will continue with this treatment regimen, whereas the other 1,200 patients with perform very low dose oral anticoagulation. out of these 1,200 patients, 600 will perform inr measurement once a week and 600 patients will perform inr measurement twice a week. patients are followed up for 24 months.

Eligibility criteria:
inclusion criteria: * mechanical heart valve recipients exclusion criteria: * contra-indication to phenprocoumon * ulcerous disease with bleeding tendency, * hypo- or hypercoagulability * dementia * missing informed consent

Keywords: phenprocoumon inr self-management mechanical heart valve replacement bleeding thromboembolism
probiotic lozenge reduce streptococcus mutans in plaque in orthodontic bracket patients

Conditions: Malocclusion

Summary: advances in orthodontics have improved the quality of appliances and treatment protocols, raising the standard of patient care. however, enamel demineralization is still a problem associated with orthodontic treatment, leading to the formation of white spot lesions; this is a grave concern to orthodontists and patients. the overall prevalence of white spot lesions among orthodontic patients has been reported to be between 4.9% and 84%.1 when basic oral hygiene is poor, orthodontic appliances create areas of plaque stagnation, especially around brackets, bands, wires, and other attachments. levels of acidogenic bacteria, present in the plaque, notably streptococcus mutans (s mutans), are higher in orthodontic patients than in non-orthodontic patients. this causes demineralization around the brackets and leads to white spot lesions. they are most prevalent around the cervical region of bands in the posterior region, whereas in the anterior region, the lateral incisors in both arches, followed by the canines, are most commonly affected.


Eligibility criteria:
inclusion criteria: * orthodontic treatment with the straight wire appliance (mbt, 0.022-in slot; 3m unitek, monro- via, calif). * complete permanent dentition (excluding third molars). * no chewing gum or mouthwash used in the last week and during the study. * habit of brushing twice daily with fluoride toothpaste. exclusion criteria: * patient with poor periodontal condition. * patient with known medical condition e.g. subacute bacterial endocarditis, diabetes, valvular disease, anemia etc.

Keywords: misalignment of the two dental arches mal-align teeth
growth, tolerance in healthy infants fed a partially hydrolyzed rice protein

Conditions: Growth; Allergy

Summary: the purpose of this study is to assess growth and global tolerance in healthy new born infants with minor gastrointestinal troubles and/or allergic risk, fed an experimental partially hydrolyzed rice protein infant formula.

this objective will result in the study of non-inferiority of the experimental formula in terms of variation of weight compared with growth curves after 3 to 6 months of exclusive regime with the experimental formula. parents provide informed written consent. 4 visits are forecasted in pediatric surgeries: v1(inclusion), v2 (2 months), v3 (4 months) and v4 (6 months). the last visit corresponds to the beginning of the food diversification decided by the pediatrician. ideally it takes place at 6 months. if the food diversification starts at 4 months, then v3 and v4 constitute the same last visit.

Eligibility criteria:
inclusion criteria: * term health infants with gestational age ranging from 37 to 42 weeks * infants less than 1 month old * non breastfed children at the inclusion * growth parameter normal * apgar score \> 5 to 7 minutes * change in the formula because of digestive troubles (colics, gas, regurgitation) or risks of allergy * absence of metabolic, nervous or digestive troubles * absence of digestive haemorrhage, apnea or dizzy turn exclusion criteria: * partial breastfed children * infants presenting a cow's milk protein allergy * infants currently participating in another trial * infants presenting an organic disease involving medicinal or surgical treatment

Keywords: hydrolysed rice protein formula cow's milk protein allergy infant formula gastrointestinal tolerance
comparison between base and cover slide from endoscopic ultrasound guided fine needle aspiration for pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to determine whether there is a difference of diagnostic accuracy between cover slides and base slides from eus-fna cytopathologic sample in patients who were previously suspected of pancreatic cancer in radiologic test.

1. background 1. pancreatic cancer is the challenging malignancy in diagnosis and treatment. 2. recently, eus-fna has played a important role in diagnosing pancreatic cancer. 3. samples from eus-fna are sent to following three types of preparations. * cytologic smear (by pull apart method) * cell block * histologic biopsy 4. in cytologic smear method, endoscopists tend to send as many as slides, while pathologists want minimal slides if they warrant diagnostic accuracy. 5. therefore we are going to find a point of contact between high diagnostic yield and minimal overloading of pathologist. 2. method 1. we are going to enrolled the patients who were suspected of pancreatic cancer in previous radiologic test. 2. one identical and skilled endoscopist performs eus-fna with multiple punctures. 3. we get total 8 pairs of slides (= 8 covers + 8 bases). 4. all the cover slides are collected to the bottle-a, all the base slide to the bottle-b. 5. one identical and skilled pathologist inspects these slide in blind method. (she cannot show the label of bottle so that she does not know what bottle is a or b.) 6. she record the positive or negative in each bottle. (if there is only one slide is positive in malignant cell, the bottle is positive.) 7. in these manner, we collect the all subjects' cytopathologic results as a pair of outcome. all the possible combinations are following four examples: * (cover/base) = (positive/positive) = (+/+) * (cover/base) = (positive/negative) = (+/-) * (cover/base) = (negative/positive) = (-/+) * (cover/base) = (negative/negative) = (-/-) 8. then we are going to take a two-sided non-inferiority test of proportion using mcnemar's test.

Eligibility criteria:
inclusion criteria: * patients who were suspected of pancreatic cancer in previous radiologic test such as computed tomography, magnetic resonance imaging or positron emission tomography. exclusion criteria: * failed smear due to inexperienced assistant * loss of slide * patients who were diagnosed with other lesion far from pancreatic cancer in prospective confirmative tests. * patients who refuse to participate in this study * report of other pathologist who are not a previously-assigned pathologist

Keywords: eus-fna cytopathology slide smear
study comparing tigecycline versus ceftriaxone sodium plus metronidazole in complicated intra-abdominal infection (ciai)

Conditions: Appendicitis; Cholecystitis; Diverticulitis; Intra-Abdominal Abscess; Intra-Abdominal Infection; Peritonitis

Summary: this is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with ciai. subjects will be followed for efficacy through the test-of-cure assessment. safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours. * fever plus other symptoms such as nausea, vomiting, abdominal pain. exclusion criteria: * cancer * medicines that suppress the immune system * dialysis

Keywords: intra-abdominal infections abscess
phase 3 open-label study to evaluate the response and safety of kuvan® in subjects with phenylketonuria

Conditions: Phenylketonuria

Summary: this is an open-label, non-comparative, phase 3 study to evaluate the degree, frequency of response and safety of kuvan® (sapropterin dihydrochloride) in subjects aged 4 to 18 years who have phenylketonuria and with elevated blood phenylalanine level of greater than or equal to 450 micromole per liter.


Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent (for children under 18 years old the parent\[s\]/guardians give informed consent, subjects 14-17 years old give additionally their own written informed consent) * age of 4 - 18 years, inclusive * confirmed clinical and biochemical hyperphenylalaninemia due to phenylketonuria documented by past medical history with at least 2 blood phenylalanine level greater than or equal to 400 micromole per liter obtained in 2 separate occasions * blood phenylalanine level at screening greater than or equal to 450 micromole per liter (mean of two measurements) * for women of childbearing potential, a negative urine pregnancy test is required at screening and willingness to use a highly effective method of contraception is required while participating in the study * subject and/or the parent/guardian willing and able to comply with study procedures * subject and/or the parent/guardian willing to continue current diet unchanged during the 8 days response test and to adapt the diet according to phenylalanine therapeutic target range during the 6 week treatment period exclusion criteria: * subject already assessed for responsiveness to sapropterin dihydrochloride or other tetrahydrobiopterin (bh4) * used any investigational agent other than kuvan® (sapropterin dihydrochloride) within 30 days of screening, or required any investigational agent or vaccine prior to completion of all scheduled study assessments * pregnant or breastfeeding, or considering pregnancy * concurrent disease or conditions that would interfere with study participation or safety (for example, seizure disorder, asthma or other condition requiring oral or parenteral corticosteroid administration, insulin-dependent diabetes, or organ transplantation recipient) * concurrent use of required concomitant treatment with any drug known to inhibit folate synthesis (for example, methotrexate), levodopa, phosphodiesterase type-5 (pde-5) inhibitors (such as, sildenafil, vardenafil or tadalafil), medications that are known to affect nitric oxide synthesis metabolism or action * any conditions, that, in the view of the principal investigator renders the subject at high risk for failure to comply with treatment or to complete the study * clinical diagnosis of primary bh4 deficiency * known hypersensitivity to kuvan® (sapropterin dihydrochloride) or its excipients or to other approved or non-approved formulation of tetrabiopterin

Keywords: emr 700733_510, genetic disorder, phenylketonuria, phenylalanine, kuvan, sapropterin dihydrochloride
implementing the spotlight aq platform in adolescent/ young adult (16-25 years old) type 1 diabetics (t1d)

Conditions: Type 1 Diabetes Mellitus

Summary: the goal of this clinical trial is to compare the spotlight aq survey platform to the standard of care (soc) pre-clinic assessment in adolescents \& young adults (16-25 years old) with type 1 diabetes (t1d). the main questions it aims to answer are: * does using the spotlight aq survey in clinic decrease the a1c in the people who use it? * do patients and healthcare providers like using the spotlight aq survey? participants will use the spotlight aq survey before coming in to two standard of care t1d clinic visits participants will fill out surveys describing how they feel about using the spotlight aq survey. some participants may be asked to do an interview to talk about how they feel about the spotlight aq survey.


Eligibility criteria:
inclusion criteria: * 16-25 years old * patients diagnosed with t1d for at least 6 months * on any diabetes treatment * using a continuous glucose monitor (cgm) * willing/ able to use spotlight aq tool * able to give verbal assent * patients \& parents/caregiver speak english/ spanish fluently * patients in the children's mercy kansas city hospital or boston children's hospital network exclusion criteria: * \ 25 years old * mental illness that could seriously reduce their ability to participate in the study * lack of capacity * in another t1d intervention study
immunogenicity of fractional dose of the hpv vaccines

Conditions: HPV Infection; HPV Vaccine

Summary: this randomized phase iv trial compares intramuscular and intradermal fractional dose of bivalent hpv vaccine to fractional dose of nonavalent hpv vaccine among men and women aged 27-45 years in seattle, washington. participants will have immune response assessed at baseline, 4 weeks, 6 months, and 12 months


Eligibility criteria:
inclusion criteria: * age 27-45 years at enrollment * not intending to receive the hpv vaccine series for the duration of the study participation * willing and able to: provide written informed consent, undergo clinical evaluation, adhere to follow-up schedule exclusion criteria: * prior immunization with hpv-vaccine (cervarix, gardasil-4, gardasil-9) * currently pregnant or breastfeeding * immunedeficiency disease/condition or cancer that causes clinically significant immunosuppression * known hiv infection * chemotherapy (current or within 12 months) or currently taking a medication that causes clinically significant immunosuppression. * unstable medical condition (e.g., malignant hypertension, poorly controlled diabetes) * known allergy to vaccine components * prior history of hpv-associated cancer * any medical condition which, in the opinion of the investigator, may compromise the subject's ability to safely complete the study.

Keywords: hpv, vaccines
study of a melanoma vaccine in stage iib, iic, and iii melanoma patients

Conditions: Melanoma

Summary: the purpose of this study is to determine how safe and how well pol-103a works in preventing the relapse of melanoma after patients who have undergone surgery.


Eligibility criteria:
inclusion criteria: * histologically confirmed stage iib, iic, iii melanoma * surgical resection within 90 days of first dosing * persons with positive sentinel nodes must have a complete lymphadenectomy * ecog performance status 0 or 1 exclusion criteria: * any prior melanoma treatment other than surgery or regional irradiation * use of biologic response modifiers within 60 days of first dosing * subjects with history of other malignancy within past 5 years (with exceptions)
the physical and psychological benefits of yoga and breast cancer

Conditions: Breast Cancer

Summary: breast cancer is the most common cancer amongst canadian women. studies report that breast cancer patients are the most likely to use complementary medicine within the oncologic population. yoga has become especially popular with this group as it promises to improve the mind, body and soul holistically. the investigators yoga program specifically focuses on rebuilding physical strength, increasing flexibility and reducing the pain and stress associated with the post-operative period. this study will examine how yoga can help improve the overall quality of life and its effects on the physical well-being of women with breast cancer. with positive statistical results, the investigators hope to implement yoga as part of their rehabilitation services at the cedars breast clinic.

proposed intervention: 1-hour hatha yoga classes, once a week for a 12-week period. one class will be offered in french, another in english. the class will begin with approximately 10 minutes of pranayama (breathing exercises) and meditation, followed by 30 minutes of yoga poses and ending with 10 minutes of sivasana (rest period.) the first couple of classes in the 12 week series will begin with restorative postures and will gradually progress to more gentle exercises. if health permits, the last couple of classes will involve some strengthening poses. a small portion of the class will work with the physical body in general and there will be a specific emphasis on the physical difficulties faced by most breast cancer patients, i.e. neck, chest, shoulders arms and hands.

Eligibility criteria:
inclusion criteria: * ages between 18-70 * stage i to ii breast cancer * minimum of 6 weeks post operative status exclusion criteria: * previous/current psychiatric history * concurrently involved in a yoga program * inability to undergo yoga training secondary to physical/health limitations outlined by the treating team
remimazolam and scoliosis orthopedics

Conditions: Benzodiazepines

Summary: spinal cord injury is one of the most dangerous complications of scoliosis orthopedic surgery, and the stagnara awakening test has been used in orthopedic spine surgery and is considered the "gold standard" for detecting spinal cord injury. during the awakening test, the patient is awakened from anesthesia and, in conjunction with a neurological assessment, moves his or her fingers and toes to determine the integrity of spinal cord motor function in order to avoid spinal cord injury. during this procedure, the patient still requires a degree of sedation and analgesia to tolerate tracheal intubation and surgical pain. remazolam benzoate for injection is a new class of benzodiazepines that are ultra-short-acting sedative/anesthetic drugs. it has the advantages of rapid onset, rapid elimination, and no drug accumulation by continuous infusion, and has the advantage of being applied to wake up during spinal orthopedic surgery, but its effectiveness and safety are still unclear. this study aims to elucidate the safety and efficacy of rimazolam benzoate for injection for arousal in spinal orthopedic surgery through a single-center, randomized, single-blind, positive drug-controlled trial, with the aim of providing a basis for the development of a safe and effective anesthetic protocol for such surgery.


Eligibility criteria:
criteria: inclusion criteria: 1. age greater than 18 years and less than 60 years 2. elective scoliosis orthopaedic surgery under general anesthesia. 3. asa physical score i-iii 4. signed informed consent. exclusion criteria: 1. patients who cannot understand the method and requirements of the arousal test and cannot cooperate in completing the arousal test. 2. patients with limb sensory-motor dysfunction. 3. patients with a history of severe neurological disorders. 4. patients with psychiatric disorders. 5. patients who have taken benzodiazepines and/or opioids daily for one month or intermittently for the last three months. 6. patients with concomitant severe respiratory and circulatory disorders, including acute heart failure, unstable angina, resting ecg heart rate \<50 beats/min, qtc: ≥ 470ms in men and ≥ 480ms in women, third-degree av block, severe arrhythmia, moderate to severe heart valve disease, chronic obstructive pulmonary disease, and history of asthma. 7. abnormal liver and kidney function: alt and/or ast exceeding 2.5 times the upper limit of the medical reference range; urea or urea nitrogen ≥1.5 × uln, blood creatinine greater than the upper limit of normal values.
anxiety and cardiovascular autonomic control

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to evaluate the hypothesis that chronic anxiety and/or anxiety disorders resulted in hyperkinetic cardiovascular autonomic regulation, often associated with increased coronary risk.

background: prospective epidemiologic data indicate a strong relationship of chronic anxiety and/or anxiety disorders to risk of sudden cardiac death. other studies have shown that cardiac autonomic mechanisms are altered among stably anxious individuals in the direction of reduced parasympathetic and elevated sympathetic control. the latter investigations, however, have been based on very small clinic samples and have been incomplete in their assessment of cardiovascular regulation in anxiety. this investigation was the first large-scale population-based research examining the cardiovascular physiology of anxiety, and helped to increase understanding of the reported association between anxiety and sudden cardiac death. this study also helped to identify groups in the general population at increased risk of sudden death. design narrative: the study used an ongoing well-characterized cohort, the va normative aging study (nas), to recruit middle-aged and older community-dwelling men and women into the study. using a variety of validated psychological and psychiatric screening instruments--including the brief symptom inventory, the composite international diagnostic interview, the spielberger state-trait anxiety inventory, and the crown-crisp index--the study population was characterized in terms of symptoms of anxiety and diagnosis of anxiety disorders. cardiovascular autonomic control was then assessed among anxious and non-anxious individuals using non-invasive time-domain and power-spectral measures of heart rate and blood pressure variability. cardiac output, total peripheral resistance, and end-tidal pco2 were simultaneously assessed. 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:
no eligibility criteria
effectiveness of interactive augmented reality and electrical neuromodulation system in persons with stroke

Conditions: Stroke

Summary: this study is to investigate the effects of augmented reality (ar) combined with functional electrical stimulation (fes) intervention on cortical excitability, brain structure, lower limbs function, balance, and spasticity in individuals with stroke. twenty participants will be recruited in this study. they will be allocated to two group: ar and fes group (10), traditional physiotherapy group (10).

participants will be randomized allocated to two groups: augmented reality and functional electrical stimulation group , and traditional physiotherapy group. all participants will undergo 60 minutes per session, 3 sessions per week for 8 weeks training. functional magnetic resonance imaging (fmri) with diffusion tensor imaging (dti), time up go test (tug), berg balance scale (bbs), fugl-meyer assessment (fma), modified ashworth scale (mas), 10 meter walking test will be assessed before and after intervention in all participants.

Eligibility criteria:
inclusion criteria: 1. patients present with unilateral hemiplegia caused by a first-ever stroke 2. brunnstrom stage above stage ii, mental health was stable 3. cognitive ability is sufficient to understand the nature of study (mini-mental state examination score was above 23) exclusion criteria: 1. patients having other neurologic problems, which can affect balance and walking ability 2. intake of drugs or other medical condition that can affect function or can't tolerate rehabilitation 3. severe hearing or eye problem

Keywords: stroke augmented reality functional electrical stimulation