Kornimate/medical-research-clean huggingface dataset:
safe study - septal pacing for atrial fibrillation suppression evaluation

Conditions: Atrial Fibrillation

Summary: this is a randomized, parallel, single-blinded multi-center study. the objective is to compare the long term clinical outcomes among the site of atrial pacing and to compare the long term effect of the atrial fibrillation (af) suppression algorithm.


Eligibility criteria:
inclusion criteria: 1. have a history of paroxysmal af with documented af episode within the last 6 months; documentation of af is required. it can be documented by one of the following: * holter documentation and the strip must be at least 30 seconds; or * one page of 12-lead electrocardiogram (ecg); or * transtelephonic recording for more than 15 seconds. 2. have a conventional indication for a pacemaker due to either sinus or atrioventricular (av) node diseases. 3. provide written informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations. 4. be at least 18 years old. exclusion criteria: 1. already implanted with a pacemaker or implantable cardioverter defibrillator (icd). 2. are expected to have heart surgery within the next 6 months. 3. have angina pectoris, new york heart association (nyha) class iii or class iv. 4. are expected not to be able to tolerate high rate pacing. 5. have less than 12 months' life expectancy. 6. are on the cardiac transplantation list. 7. are in chronic af. 8. have a reversible aetiology of af (e.g., hyperthyroidism, acute post-cardiac surgery af, etc.).

Keywords: sinus node disease av node disease
a study of ly3841136 in healthy and overweight participants

Conditions: Obesity; Healthy

Summary: the main purpose of this study is to evaluate the safety and tolerability of ly3841136 in healthy and overweight participants. blood tests will be performed to check how much ly3841136 gets into the bloodstream and how long it takes the body to eliminate it. this is a 2-part study and may last up to 14 and 28 weeks for each participant and may include 7 and 19 visits in parts a and b, respectively.


Eligibility criteria:
inclusion criteria: * male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential * have had a stable weight for the last 3 months * have a body mass index (bmi) in the range of 18.5 to 32 kilogram per square meter (kg/m²), both inclusive (in part a) or a bmi in the range of 27 to 40 kg/m², both inclusive (in part b) exclusion criteria: * are women who are lactating * have known allergies to related compounds of ly3841136 or any components of the formulation * have a history of significant atopy (severe or multiple allergic manifestations), or clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions * have been diagnosed with type 1 or type 2 diabetes mellitus * have a history of chronic medical conditions involving the heart, liver, or kidneys
extracorporeal shock wave therapy and assessment strategy through a novel gait analysis tool for post-stroke spasticity

Conditions: Stroke, Ischemic; Stroke Hemorrhagic; Spasticity, Muscle; Spastic Gait

Summary: the aim of this study is to objectively evaluate the effectiveness of radial extracorporeal shock wave therapy (reswt) and conventional physical therapy program on the gait pattern through a new gait analysis system which encompasses spatiotemporal and kinematic parameters and to correlate the findings with the clinical evaluation.

the aim of this observational study was to objectively evaluate the effects of radial extracorporeal shock wave therapy and conventional physical therapy program on the gait pattern, spatiotemporal variables (step length, step cycle time, stance foot flexion-extension, foot stance pronation-supination, and foot swing flexion-extension), and kinematic parameters (trunk flexion-extension, trunk lateral flexion, hip flexion-extension, knee flexion-extension, ankle flexion-extension) through a new gait analysis system and correlate the findings with clinical outcomes such as modified ashworth scale (mas), passive range of motion (prom), clonus score, visual analogue scale (vas), tinetti assessment tool, functional ambulation categories (fac). the gait pattern of post-stroke patients before and after reswt delivery and conventional rehabilitation program will be assessed clinically and also through an instrumented treadmill (walker view) in terms of spatiotemporal and kinematic gait parameters.

Eligibility criteria:
inclusion criteria: * suffered from a hemorrhagic or ischemic stroke and they were in the subacute or chronic phase; * had no history of previous stroke; * had lower limb post- stroke spasticity and spasticity grade ≥1 on the modified ashworth scale (mas); * pain intensity measured on visual analogue scale (vas) ≥1; * ability to stand and walk unassisted for at least 30 seconds; * adult patients (\>18 years old). exclusion criteria: * other neurological, musculoskeletal, orthopaedic, or cardiovascular conditions; -- severe cognitive impairment, severe aphasia or inability to understand or execute instructions; * changes in antispastic medication and dose or changes in the analgesic medication; * myopathy; * severe spasticity grade; * visual field disorders or hemineglect; * anticoagulants or any contraindication to receive radial extracorporeal shock wave therapy (reswt), or any contraindication to receive physical therapy sessions.

Keywords: stroke spasticity neurological rehabilitation radial extracorporeal shock wave therapy gait analysis system
low dose aspirin alerts in high-risk pregnancies

Conditions: Preeclampsia; Aspirin; Clinical Decision Support Systems; Economics, Behavioral

Summary: the goal of this study is to assess the effect of an electronic health record (ehr) clinical decision support tool, also known as a best practice alert (bpa), on healthcare provider recommendations for low dose aspirin use in a high-risk pregnant patient population. the investigators hypothesize that the implementation of the ehr bpa tool will increase the healthcare provider's recommendation for low dose aspirin compared to current standard care.

low dose aspirin (lda) has been found to reduce the incidence of preeclampsia in high-risk pregnant patients. at a health system serving central and northeastern pennsylvania, electronic health record data reveal that clinicians recommend an lda regimen to only 60% of eligible high-risk pregnant patients, suggesting the need and opportunity for increased lda recommendation. this study will assess the efficacy of an electronic health record based clinician-facing interruptive clinical decision support tool/best practice alert (bpa) aimed at increasing lda recommendation for pregnant patients who are at high risk of preeclampsia. up to 704 patients will be randomized to account for possible 10% miscarriage and early termination rate as we require outcome data on a total of 640 patients for adequate power. eligible patients will be randomized to a control group, where the clinician receives no bpa, and one experimental group, where the provider receives a bpa noting the patient is at high-risk and recommend the provider order lda. if lda is not recommended, there will be a required acknowledgment reason from the provider noting a rationale for not initiating a lda regimen.

Eligibility criteria:
inclusion criteria: * receiving prenatal care within geisinger * initial prenatal visit prior to 28 weeks gestation * determined to be high risk for preeclampsia based on the modified united states preventive services task force and american college of obstetrics and gynecology criteria (at least 1 high risk factor) exclusion criteria: * not pregnant * no prenatal visit prior to 28 weeks gestation * maternal-fetal medicine only visits * not meeting the modified uspstf high-risk criteria * contraindication to aspirin, including allergy
evaluation of peripheral blood protein biomarkers for colorectal cancer screening

Conditions: Colorectal Cancer

Summary: the aim of the study is to validate the value of value of peripheral blood protein biomarkers in colorectal cancer screening, and to identify new ones


Eligibility criteria:
inclusion criteria: * patient aged 50 years or older referred for screening colonoscopy after a positive fit test or for endoscopic resection of a previously identified suspicious colorectal lesion exclusion criteria: * very high risk of colorectal cancer: lynch syndrome, familial adenomatous polyposis, peutz-jeghers syndrome, familial polyposis associated with a mutyh gene defect * other solid cancers or haematological malignancies that are progressive and/or undergoing treatment (apart from basal cell skin carcinoma) * contraindication to total colonoscopy

Keywords: biomarkers
fecal incontinence and rectal static disorder

Conditions: Fecal Continence Disorders; Posterior Pelvic Static Disorders

Summary: this study evaluate the rate of occurrence of fecal incontinence in patients who had surgery for posterior pelvic static disorder versus those with medical management. the aim is also to assess the natural history of constipation symptoms and quality of life in patients with posterior pelvic static disorder.

data of all patients with posterior pelvic static disorder are collected prospectively and consecutively in the fondamentum database since 2005, secured and hosted by the rennes university hospital. the data from initial functional assessment, carried out as part of routine care between 2005 and 2019, include a clinical examination of pelvic static disorders, anorectal manometry, defecography, collection of symptoms by questioning and by a systematic questionnaire completed by the patient during the routine care consultation. patients identified from this database and meeting the selection criteria will receive an information letter along with a questionnaire and a stamped envelope for returning the questionnaire. the self-questionnaires will focus on collecting symptoms related to static disorders (incontinence, constipation, quality of life). regarding the management of pelvic static disorder, we will detail whether it was operated or not, and what were the proposed medical care. upon receipt of the questionnaire, the new data will be entered into the research-specific database and will complete the clinical data resulting from the extraction of the care base the self-administered questionnaire sent to patients includes validated constipation (score of kess) and fecal incontinence (cleveland) questionnaires, and quality of life questions from the validated sf36 questionnaire. it also includes a visual scale ranging from -5 to +5.

Eligibility criteria:
inclusion criteria: * patient over 18 years of age * having a disorder of posterior pelvic statics * diagnosed during the period 2005 - 2019 * having a functional assessment in proctology between 2005 and 2019 in the proctology department of the rennes university hospital center (chu) * this complete functional assessment was carried out in consultation with proctology, as part of routine care, and included : * data from the interrogation * reported symptoms: incontinence, constipation and quality of life (collected through questioning and through a questionnaire systematically completed by the patient during the routine care consultation), * a clinical examination * anorectal manometry * a defecography * no one who does not object to participation in the research exclusion criteria: * persons of full age subject to legal protection (safeguard of justice, guardianship, trusteeship), persons deprived of liberty

Keywords: fecal incontinence pelvic static disorders
efficacy of sealants in cavitated enamel lesions on occlusal surfaces in children

Conditions: Fissure Sealants; Oral Hygiene Orientation

Summary: the aim of this study is to evaluate the efficacy of oral hygiene orientation singly, compared to resin-based sealants in controlling occlusal cavitated enamel lesions on primary and permanent molars. for this, 273 occlusal surfaces of primary molars and 273 occlusal surfaces of first permanent molars on 4-9 years-old children with an enamel cavitated lesion will be selected in 9 cities of brazil. the surfaces will be randomly divides into 2 groups: oral hygiene orientation and resin-based sealant. the surfaces will be evaluated after 6 and 12 months regarding clinical and radiographic lesions progression. the costs and cost-efficacy of these treatments, children's discomfort, parents'/guardians' satisfaction and impact on quality of life will also be investigated. poisson regression analysis will be performed in order to compare the groups, through clinical and radiographic criteria. this test will also be used to assess the association between the group and patient discomfort and parents' satisfaction. time, costs and impact on quality of life of the treatments will be compared by student's t test. for all analyses, the significance level will be set at 5%.


Eligibility criteria:
inclusion criteria: * parents or legal guardians accept and sign the informed consent form. * children must have at least one molar with caries lesion classified as icdas active score 3. exclusion criteria: * children with special needs and/or systemic diseases with oral impairment. * teeth with spontaneous painful symptoms or necrotized and teeth presenting restorations, sealants, cavitated caries lesions in dentin or other types of formation defects.

Keywords: dental caries primary tooth resin-based sealants
safety of adstem injection in patients with moderate to severe subacute and chronic atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this study aims to evaluate safety in subjects with over moderately subacute and chronic atopic dermatitis after an intravenous injection of adstem inj. since this is an observational study of patients participated in phase 1 clinical trials, no drug is administered in this study.

participants will be followed-up for adverse events on each visit. visits will be on 6, 12, 18, 24, 30, 36, 48, 60months after treatment of adstem inj. time perspective is both retrospective and prospective.

Eligibility criteria:
inclusion criteria: * patients who participated in phase i clinical trials * patients who voluntarily agreed to participate in the study exclusion criteria: * patients who can not follow-up from the end of the phase 1 clinical trial to the end of the study
rivaroxaban for thromboprophylaxis in high-risk cancer patients with totally implantable access ports

Conditions: Rivaroxaban; Thromboprophylaxis; Cancer

Summary: rivaroxaban has been developed in the various clinical settings.although cancer-associated dvt or pe was included in previously programs, limited patients of the total populations were cancer patients with totally implantable access ports in these studies. in this sense, investigators feel that new oral anticoagulants should be re-investigated in this highly specific patients group.therefore, investigators are planning to conduct a prospective study to estimate the efficacy and safety of rivaroxaban for thromboprophylaxis in high-risk cancer patients with totally implantable access ports.


Eligibility criteria:
eligibility criteria: 1. age 18-75 years; 2. patients with malignant tumors who received implantable access ports for treatment; 3. eastern cooperative oncology group (ecog) class 0-1; 4. will have a life expectancy \> 3 months; 5. expected survival of more than 6 months; 6. khorana score ≥2 point. exclusion criteria: 1. patients with a history of allergies to rivaroxaban; 2. history of recent major or clinically relevant bleeding within the previous 4 weeks. 3. patients with bleeding risks: thrombocytopenia (platelet count \< 50\*109/l), clinically significant active bleeding, active gastric ulcer disease, severe arterial hypertension, history of previous stroke; inadequate renal function; creatinine clearance \< 30 ml/min； 4. inadequate hepatic function: aminotransferase \> 3 times the upper limit of normal (uln) (if liver metastasis, alanine aminotransferase \> 5 times the uln 5. patients requiring strong cytochrome p450 3a4 (cyp3a4) inducers (rifampin, phenobarbital) or strong cyp3a4 inhibitors (hiv protease inhibitor, systemic ketoconazole) treatments. 6. plan of treatment with bevacizumab or other anti-cancer drugs known to increase the bleeding risk. 7. patients who have had anticoagulant drugs for any other reason. 8. women who are pregnant or breastfeeding.

Keywords: prophylactic anticoagulation rivaroxaban venous thrombosis totally implantable access ports cancer
compliance of thyroid fine needle aspiration biopsy and trucut biopsy results with tirads score and surgical pathology

Conditions: Thyroid Nodule

Summary: the investigators retrospectively reviewed the medical records of 760 patients with thyroid nodule biopsy and 88 patients who had thyroid surgery. the investigators evaluated patients' thyroid ultrasonography reports and determined thyroid imaging reporting and data system scores (tirads score: 1-benign, 2- very low malignant) risk, 3-low risk, 4-medium risk, 5 -malignant high risk). the investigators evaluated patients 'existing thyroid fine needle aspiration biopsy (fnab) reports and recorded the patients' cytology results (benign, malignant). documents of 88 patients who were included in the study and who underwent thyroidectomy were reviewed.pathology reports of these patients were evaluated and surgical pathology was determined as benign in 58 patients and malignant in 30 patients. then, a statistical study was performed between the cor needle biopsy (cnb) results of these participants and the surgical pathology and ti-rads scores.


Eligibility criteria:
inclusion criteria: * having a thyroid nodule * being both a thyroid needle and a core biopsy exclusion criteria: * child patients * pregnant patients * patients without a thyroid needle biopsy

Keywords: ti-rads score thyroid fine needle aspiration biopsy thyroid core needle biopsy surgical pathology
culturally optimized messages for latinos

Conditions: Diet, Healthy; Diet Habit; Obesity; Blood Pressure; Psychological

Summary: this project aims to redesign and optimize a deep-structure culturally-tailored healthy eating program and test its effectiveness in improving dietary outcomes, anthropometric, and blood pressure among 75 diverse latinos, compared to surface-level messages.

this project aims to redesign and optimize a deep-structure culturally-tailored healthy eating program and test its effectiveness in improving dietary outcomes, anthropometric, and blood pressure among 75 diverse latinos, compared to surface-level messages. the welcome study will be based on the re-aim framework with improved reach, adoption, implementation, and maintenance strategies. the intervention arm is a deep-structure cultural tailored text messages for distinct latino heritages (e.g., caribbean and non-caribbean) informed by mixed-methods formative research, compared to surface-level healthy eating messages based on the usda my plate spanish version. the program runs for 6 months: 2-months delivery phase + 2-months reinforcement phase + 2-months maintenance phase.

Eligibility criteria:
inclusion criteria: * age 25-65 y/o * self-reported hispanic/latino heritage * able to understand and answer questions in spanish or english * living in massachusetts for the past year and not planning to move in the next year * having a cellphone with the capacity of receiving and sending text messages and giving consent for the study to text this number as part of the intervention exclusion criteria: 1. self-reported diagnosis of cancer, diabetes or major stomach or heart condition (e.g.: gastrointestinal cancers, coronary heart disease, previous stroke or heart attack, severe dietary allergies or restrictions) 2. planning to move massachusetts in the next year 3. currently pregnant 4. institutionalized (i.e.: hospital, prison, etc.).
transcutaneous auricular vagus nerve stimulation for pediatric epilepsy

Conditions: Epilepsy

Summary: the purpose of this study is to determine whether transcutaneous auricular vagus nerve stimulation as a complementary therapy is effective in the treatment of pediatric epilepsy.


Eligibility criteria:
inclusion criteria: * diagnosed as epilepsy; * with age between 2-18 years old; * the number and dose of the medication was kept constant no less than eight weeks before intervention; * the patients or their guardians can count the frequency of the seizures and finish the study. exclusion criteria: * the patient is receiving the vns therapy; * accompanied with progressive central nervous system diseases; * have severe heart, liver ,kidney or blood diseases; * be pregnant or having the schedule of pregnancy in the study period.

Keywords: pediatric epilepsy transcutaneous vagus nerve stimulation
effect of eccentric exercise on spasticity, walking and balance in spastic cerebral palsy

Conditions: Cerebral Palsy, Spastic

Summary: our clinical research study is planned as a randomized controlled study and will use a stratified randomization method. the aim of this study is to investigate the effects of eccentric exercise training on spasticity, walking and balance in individuals with spastic cerebral palsy (cp). individuals with spastic unilateral sp (hemiparetic) and bilateral sp (diparetic) diagnosis, gross motor function classification system (gmfcs) level i, ii and iii, aged between 6-18 years will be included in the study.

as a result of the g-power analysis, it was revealed that a total of 42 individuals should be included in the control and study groups. in our study, a control group of 21 people (neurodevelopmental treatment group-ngt/2 days per week, 40 minutes) and an experimental group (neurodevelopmental treatment + eccentric exercise group-ngt+ee/2 sessions per week, 20 minutes ngt + 30 minutes eccentric exercise program) will be formed. after the initial evaluations, 2 physiotherapy sessions per week will be applied to both groups for 8 weeks and then the final evaluations will be made and the obtained data will be compared with the initial evaluation data to reveal the statistical effect of eccentric exercises on spasticity, walking and balance parameters. the hypotheses of the study are as follows: h1: eccentric exercise training for spastic lower extremity muscles in individuals with spastic cerebral palsy has an effect on spasticity severity. h2: eccentric exercise training for spastic lower extremity muscles in individuals with spastic cerebral palsy has an effect on gait parameters. h3: eccentric exercise training for spastic lower extremity muscles in individuals with spastic cerebral palsy has an effect on balance parameters. h4: eccentric exercise training for spastic lower extremity muscles in individuals with spastic cerebral palsy has an effect on quality of life, activities of daily living (adl), and participation.

Eligibility criteria:
inclusion criteria: * being between the ages of 6-18 and diagnosed with spastic hemiparetic or spastic diparetic cp, * being at level i, ii or iii according to gmfcs, * having increased muscle tone in hip flexor, hip adductor, knee flexor, knee extensor or ankle plantar flexor muscles according to mts, * giving informed consent including detailed information prepared for the study (by parent/guardian). exclusion criteria: * having received botox or surgery in the last 6 months. * not signing the consent form. * having limited cooperation regarding perception or performance of exercises required for the study. * having a systemic disease in addition to cp.

Keywords: gait analysis postural balance cerebral palsy eccentric exercise