Kornimate/medical-research-clean huggingface dataset:
implementation of machine learning and hemodynamic profiles based clinical decision support systems for personalized guideline accordant antihypertensive regimens in primary care: a pragmatic cluster randomized controlled trial

Conditions: Hypertension

Summary: this trial is a prospective, multicenter, single-blind, three-arm parallel-group, cluster randomized controlled trial assessing the effectiveness and safety of two types of cdss in primary care settings in china. primary care sites are randomized to one of the intervention arms or the control arm (1:1:1 ratio) using computer-generated random numbers stratified by region and administrative categories of the primary healthcare institutions (including community health centers, community health stations, and township health centers). a total of 45 primary care sites are randomized to three groups, with 15 sites assigned to group a (use a cdss based on clinical guidelines and machine learning), 15 sites to group b (use a cdss based on guidelines, hemodynamic parameters and ml), and the remaining 15 sites to the control group.


Eligibility criteria:
inclusion criteria: 1. 35 ≤ age \< 80 years. 2. regularly attend the clinic for hypertension treatment during the study period, without plans of traveling during the study period. 3. diagnosed with hypertension, with sbp ≥140mmhg at screening. 4. currently taking 0 or 2 classes of antihypertensive medications (a/c/d), with or without concurrent use of class b. 5. willing to participate in the trial and capable of providing written informed consent. exclusion criteria: 1. physician-diagnosed or suspected secondary hypertension (e.g., hypertension caused by renal disease, renal artery stenosis, aortic stenosis, primary aldosteronism, pheochromocytoma/paraganglioma, cushing's syndrome, thyroid dysfunction, intracranial disease, drug-induced, or rare monogenic genetic disease). 2. sbp ≥180mmhg and/or dbp ≥110mmhg at the screening visit. 3. suspected or diagnosed white coat hypertension. 4. history of coronary heart disease. 5. history of heart failure. 6. intolerance to 2 or more classes of a, c,d antihypertensive medications. 7. currently taking antihypertensive medications other than class a,b,c and d. 8. diagnosed chronic kidney disease, estimating glomerular filtration rate (egfr)\< 60 ml/min·1.73m2, or receiving dialysis. 9. serious medical conditions (e.g., malignant cancer and hepatic dysfunction) 10. currently in an acute episode of disease (e.g, new-onset cardiovascular and cerebrovascular disease occurred within 3 months). 11. cognitive or communicative disorders. 12. currently pregnant or breastfeeding or planning a pregnant or breastfeeding during the study. 13. reluctant to take antihypertensive medications or have poor compliance with previous treatment. 14. participating in other clinical trials.

Keywords: hypertension cdss cluster randomized controlled trial
efficiency of an educational program for informal caregivers of hospitalized, dependent patients: cluster randomised trial

Conditions: Dependence, Dementias

Summary: the aim was to assess whether nursing interventions based on health educational programs for primary informal caregivers of dependent patients may improve their quality of life, decreasing emotional burden and increasing caregiving knowledge, in order to better meet patients' basic needs.


Eligibility criteria:
inclusion criteria: * primary informal caregivers of dependent patients, admitted in 30 hospital units, with expected hospital stays of at least one week. a dependent patient is understood to require the aid of someone else in order to carry out basic daily activities. exclusion criteria: * caregivers with cognitive deficits that could be an obstacle for adequate verbal understanding, illiteracy, persons taking part in other clinical trials or who had taken part in similar workshops in the previous two years, as well as health professionals.
effects of repetitive transcranial magnetic stimulation combined with sensory cueing on unilateral neglect in subacute patients with right hemispheric stroke

Conditions: Stroke

Summary: the objective was to compare the effects of repetitive transcranial magnetic stimulation (rtms) combined with sensory cueing (sc), rtms alone, and conventional rehabilitation on reducing unilateral neglect (un) and improving hemiplegic arm functions and performance of activities of daily living (adl). sixty subacute patients with left un after right-hemispheric stroke were randomly assigned to three groups; rtms combined with sc, rtms alone, and conventional rehabilitation. rtms at 1 hz was applied over p5 of the contralesional hemisphere while vibration cueing was emitted using a wristwatch device on the hemiplegic arm, five days per week for two weeks. the first two groups received the same dosage of conventional rehabilitation on top of their experimental interventions. blinded assessments were administered at baseline, 2 weeks postintervention, and four-week follow-up upon completion of training.


Eligibility criteria:
inclusion criteria: * diagnosis of right-hemispheric stroke * duration since onset of more than one week * presenting with unilateral neglect, confirmed by the conventional subtests of the bit with cutoff scores of 129 * first-ever stroke, or unilateral neglect as the consequence of the last stroke * being aged 18 or over * mini mental state examination score of ≥17 * giving written consent to participate. exclusion criteria: * duration since onset of stroke of more than six months * medically unstable * epileptic seizures, unconsciousness, or intracranial hypertension * serious heart disease * gravid * severe aphasia so as to have difficulty understanding the therapists' instructions * metal implants in vivo

Keywords: unilateral neglect right hemiplegia
direct to smoker outreach in a health care setting

Conditions: Tobacco Dependence

Summary: tobacco use is the leading preventable cause of death in the united states. effective treatment for tobacco dependence exists and includes counseling and pharmacotherapy with nicotine replacement, bupropion, or varenicline. the health care system is a key channel for delivering this treatment to smokers. brief clinical interventions delivered at office visits increase smoking cessation rates, are among the most cost-effective of medical interventions, and are recommended by u.s. public health service. however, physicians and other clinicians often fail to provide them. clinicians' rates of providing tobacco treatment in ambulatory care can be improved, but even when successful, clinicians can only reach smokers who make an office visit. a health care system might improve its delivery of tobacco treatment by supplementing visit-based efforts with a population-based strategy, using methods proven effective in public health settings. a population of smokers could be identified from electronic health records and offered treatment proactively in a way that maximizes convenience and minimizes barriers such the cost of pharmacotherapy. this study tests the effectiveness of a population-based direct-to-smoker (dts) outreach program provided to smokers in one community health center in revere, ma, that is part of an integrated health care system. it uses the system's population management tools to identify smokers and proactively offers them evidence-based tobacco treatment that is free and does require making an office visit. a randomized controlled trial will compare the effectiveness of the dts program to usual primary care. the hypothesis is that adding the dts program to usual primary care will increase the proportion of smokers who use tobacco dependence treatment and thereby stop smoking.


Eligibility criteria:
inclusion criteria: * adults (\>= 18 years) * made an office visit to a primary care physician (pcp) at revere health center in the year prior to may 2009 * has a telephone * listed as a smoker in the past 5 years in the electronic health record exclusion criteria: * severe psychiatric or neurologic diagnosis (e.g., psychosis, dementia) on problem list of electronic health record
targeted lower extremity joint training

Conditions: Multiple Sclerosis

Summary: the presence of foot drop limits normal gait. our prior data has suggested that approximately 30% of ms patients have foot drop. although we have observed that "task-specific" rehabilitation using the lokomat can improve ambulation in chronic ms patients, subjects with "foot drop" have difficulty translating task-specific training to normative gait patterns over ground, despite improving speed and endurance. one of the key limitations of the lokomat is a lack of robot-assisted training for the ankle joint. the anklebot, an mit-developed rehabilitation robot for the ankle, has the potential to address this. the device can move throughout three planes and train ankle flexion, extension, inversion and eversion; however, therapy with the anklebot alone does not train the knee or hip. we plan to test whether subject foot drop and overall gait benefit more from anklebot therapy alone or a combination of anklebot and lokomat.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of ms by mcdonald criteria (mcdonald, compston et al. 2001). edss level between 3.5-5.5, who report ambulation problems. 2. men and women between the ages 18-75 years. 3. presence of unilateral foot drop that is clinically apparent to the pi or pi designate. 4. must be able to ambulate 25 feet without an assisting device exclusion criteria: 1. cardiovascular: recent mi \ 190/110 mmhg, history of uncontrolled diabetes. 2. symptoms of orthostasis when standing up. 3. circulatory problems, history of vascular claudication or pitting edema. 4. unable to fully understand instructions in order to use the equipment or the process of the study. 5. body weight over 150 kg. 6. lower extremity injuries that limit range of motion or function. 7. joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment. 8. unstable fractures. 9. pressure sores with any skin breakdown in areas in contact with the body harness or lokomat apparatus. 10. chronic and ongoing alcohol or drug abuse. 11. pre-morbid, ongoing depression or psychosis. 12. ongoing physical therapy.

Keywords: ms rehabilitation treadmill robot foot-drop
dystonia treatment with injections supplemented by transcranial magnetic stimulation

Conditions: Cervical Dystonia

Summary: we applied 16 sessions of rtms over 4 consecutive days for adult patients suffering from cervical dystonia who received botulinum toxin (bont) injections on a regular basis. the tms protocol took place 9 weeks following their last bont injection. the primary outcome measure was improvement in cervical dystonia as measured by the twstrs scale. the secondary outcome measures included mood, cognition, and gait measures.

this was a crossover study design in which patients were randomized to active or sham stimulation during session 1 (s1) and then crossed over to the condition they were not randomized to at first during session 2 (s1). patients who were receiving bont injections for cervical dystonia on a regular basis but only noted benefit from bont for 9 weeks or less were eligible to participate. the total study protocol took place over 24 weeks. during week 1, patients had their regularly scheduled botox injections. during week 9, patients underwent either active or sham rtms, as detailed below. they had outcome measures obtained at week 9 (s1:t0; baseline/pre-tms), week 10 (s1:t1; post-tms), and week 12 (s1:t2; 2 weeks post-tms). at week 12, they underwent their regularly scheduled bont injections. during week 21, patients underwent either active or sham rtms, whichever condition they were not randomized into during the first session. they then had outcome measures obtained at week 21 (s2:t0; baseline/pre-tms), week 22 (s2:t1; post-tms), and week 24 (s2:t2; 2 weeks post-tms). the neurostimulation protocol was as follows: the dpmc target was defined as 1 cm medial and 2 cm anterior to the site of rmt acquisition. the rtms protocol was as follows: each session consisted of 1-hz rtms over the dpmc for 30 minutes (1800 pulses) at 90% of the rmt. patients received 4 sessions per day for 4 consecutive days with a 10-minute break between each session. the daily duration of the rtms protocol, including breaks, lasted approximately 160 minutes.

Eligibility criteria:
inclusion criteria: * patients 18-85 years of age who receive regular botulinum toxin (bont) scheduled every 12 weeks, on stable optimized doses but with reported benefits lasting ≤ 9 weeks for 2 consecutive cycles. patents followed at our center routinely fill out a self-reported form to document the duration of benefits perceived with bont therapy. participants will be allowed to continue oral medications that they are taking for dystonia concurrently but will not be allowed to change their concurrent medication regimen throughout the duration of the study. exclusion criteria: * presence of metallic objects or neurostimulators in the brain * pregnancy * history of active seizures or epilepsy * patients with severe scoliosis or other gait impairment that will preclude them from participating in gait evaluation.

Keywords: rtms cervical dystonia botulinum toxin
analysis of prognosis and risk factors of lal reconstruction procedure for patients with af of the lal: a prospective cohort study

Conditions: Avulsion Fracture of Lateral Ankle Ligament

Summary: to compare the clinical outcomes of cai patients with and without lateral ankle avulsion fracture after ligament repair/reconstruction, and to analyze the risk factors associated with the outcome.

80 patients with external ankle ligament injury without avulsion fracture and 40 patients with external ankle ligament injury combined with avulsion fracture were treated by surgery in our department. the outcomes included karlsson score, vas, aofas and tegner score. the outcomes were compared between the two groups, and the risk factors were analyzed.

Eligibility criteria:
inclusion criteria: 1. age 18-60 years old 2. chronic pain or instability in the ankle, injury to the lateral collateral ligament of the ankle determined by mri examination of the ankle, and distal avulsion fracture of the fibula indicated by ct examination. 3. patients with poor results after more than 3 months of conservative treatment with rest/topical/oral non-steroidal anti-inflammatory drugs 4. patients voluntarily participate in clinical trials, sign informed consent, and can cooperate with clinical follow-up exclusion criteria: 1. persons who have participated in clinical trials of other drugs or medical devices within the last 6 months 2. malalignment of ankle joint force (varus or valgus \&gt;5 degrees) 3. chronic specific synovitis (rheumatoid, pigmented villonodular synovitis, etc.) 4. patients with joint fibrosis, joint stiffness, and obvious limited movemente. moderate to severe osteoarthritis (takakura stage iii or iv) f. patients with contraindications to mri g. hemophiliacs h. patients with systemic conditions that cannot tolerate surgery
safety and immunogenicity study of a live francisella tularensis vaccine

Conditions: Tularemia

Summary: this study is designed to determine the safety and immunogenicity of a live francisella tularensis vaccine

study was designed as a continuation of previously published research and targets subjects who were at risk of occupational exposure to f tularensis virus. based on screening examinations; if a subject had a positive baseline titer (\ 1:20 and the subject had no lingering aes, the subjects participation was considered complete.

Eligibility criteria:
inclusion criteria:\> * at least 18 years old, or if on active military duty, 17 years old \> * females of childbearing potential must agree to have a urine pregnancy test immediately before vaccination (exception: documented hysterectomy or \> 3 years of menopause). the results must be negative. volunteers must agree not to become pregnant for 3 months after receipt of the vaccine.\> * subject must be actively enrolled in the sip \> * subjects must be considered at risk for exposure to f. tularensis.\> * subjects must have an up-to-date (within 1 year) medical history, physical examination, and laboratory tests on their charts and be medically cleared for participation by an investigator. examinations or tests may be repeated within 1 year at the discretion of the enrolling physician.\> * volunteer must be willing to return for all follow-up visits on days 1, 2, 7, once between days 12-16, and once between days 28-35, days 56-84 (if needed), all visits for serology, as well as an annual visit while enrolled in protocol.\> * volunteer must agree to report any adverse event which may or may not be associated with administration of the test article for at least 28 days after vaccination. all serious and unexpected adverse events will be reported for the duration of the volunteer's participation in the study. \> exclusion criteria:\> * clinically significant abnormal lab results including evidence of hepatitis c\*, hepatitis b\* carrier state, or elevated liver function tests (2x normal values or at discretion of pi).\> * personal history of an immunodeficiency or current treatment with an oral or intravenous immunosuppressive medication.\> * confirmed hiv\* infection.\> * any other medical condition at the discretion of the pi.\> * antibiotic therapy for 7 days before vaccination.\> * females must not be pregnant or lactating (females must agree to not become pregnant for 3 months after vaccination).\> * any known allergies to excipients of the vaccine\> * administration of another live vaccine within 4 weeks or an inactivated vaccine (generally) within 7 days of tularemia vaccination.\> * any unresolved adverse event resulting from a previous immunization. \>

Keywords: live vaccine strain (lvs), bacterial infections, ulceroglandular, oculoglandular
association of mood with risk for atherosclerosis

Conditions: Mood Disorders; Hypertension; Overweight and Obesity; Vascular Stiffness; Sleep; Elevated Blood Pressure

Summary: the investigators will aim to determine the association of mood disorders (mdo) with preclinical and clinical cardiovascular (cvd) risk factors among children. the investigators will also aim to identify traditional and non traditional predictors of cvd risk among children with mdo.

this research is being done to determine if mood disorders in children have an impact on stiffness of arteries and/or cause the arteries to not work as well and if mdos impact blood pressure over a 24 hour period of time.the investigators also want to determine if children with mood disorders have any risk factors or blood tests that can predict how stiff arteries are or how well arteries function and if these are associated with cardiovascular disease risk. the investigators also want to determine if children with mood disorders have greater adverse childhood experiences, worse emotional regulation and poorer quality of sleep. the investigators hope that information from this study could help in earlier detection of cardiovascular disease risk in children.

Eligibility criteria:
inclusion criteria: * children ages ≤ 22 years old * enrolled in the champion trial and have agreed to be contacted for future studies or children who visit pmp clinic and have mdo and a healthy weight or participants in the be-healthy cohort whose data indicate no history of mdo. exclusion criteria: * not able to speak english * unable to lie supine * significant arrhythmia * if participant has used vaso-active drugs the morning of the test (tobacco, caffeine decongestants, or asthma medications).
efficacy and safety of dkm420 in patients with osteoarthritis of knee

Conditions: Osteoarthritis of Knee

Summary: to prove the non-inferiority of dkm420 by evaluating the injecting efficacy and safety dkm 420 and control for patients who have osteoarthritis of knee.

a multi-center, randomized, double-blind, active-controlled, pivotal, non-inferiority clinical study

Eligibility criteria:
inclusion criteria: * men and women who is over 40 under 80 ages. * diagnosed as osteoarthritis of knee and satisfies the 3 of 6 acr(american college of rheumatology) conditions. * kellgren lawrence grade (ⅰ\~ⅲ) at visit 1 or within 24 weeks. * 100mm vas(visual analogue scale) over 40mm. * etc. exclusion criteria: - pregnancy and lactating women
study of multiple oral doses of pf-07081532 in adult participants with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: this is a phase 1, randomized, placebo-controlled, double-blind (investigator- and participant-blinded), sponsor-open study of pf-07081532. study participants will receive the investigational product or placebo every day for 42 days. the purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (pk) of multiple oral doses of pf-07081532 in participants with inadequately controlled type 2 diabetes mellitus, on metformin and optionally in non-diabetic participants with obesity.


Eligibility criteria:
inclusion criteria: * females of non childbearing potential; * patients with t2dm, inadequately controlled with metformin; * hba1c ≥7.0% to ≤10.5% (for t2dm); hba1c \<6.5% (for non-diabetic obese, if enrolled) * total body weight \>50 kg (110 lbs) * bmi ≥24.5 to ≤45.5 kg/m2 (t2dm), bmi \>30.5 to ≤45.5 kg/m2 (for non-diabetic obese) exclusion criteria * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, hepatic, psychiatric, neurological, dermatological, or allergic disease; * medical history of t2dm (for non-diabetic obese participants, if enrolled); * diagnosis of type 1 diabetes mellitus or secondary forms of diabetes; * evidence or history of clinically significant cardiovascular disease; * any malignancy not considered cured; * acute pancreatitis or history of chronic pancreatitis; * acute gallbladder disease; * any condition possibly affecting drug absorption; * personal or family history of mtc or men2; * medical or psychiatric condition that may increase the risk of study participation; * any vaccination within the 1 week prior to admission to the cru; * previous administration with an investigational drug within 30 days or 5 half-lives preceding first dose; * known prior participation in a trial involving pf-07081532; * a positive urine drug screen at screening or admission; * positive testing at screening for hiv, hbsag, hbcab, hbsab or hcvab; * positive covid-19 test at screening or admission; * supine bp ≥160 mm hg (systolic) or ≥100 mm hg (diastolic); * 12-lead ecg clinically relevant abnormalities that may affect participant safety or interpretation of study results; * participants with any of the following abnormalities in clinical laboratory tests: \*ast or alt level ≥1.5x uln; * total bilirubin level ≥1.5x uln; * tsh\> uln; * fasting c-peptide \<0.8 ng/ml; * serum calcitonin \> uln; * amylase \> uln; * lipase \> uln; * egfr \<60 ml/min/1.73m2 (per mdrd equation); * fpg \>270 mg/dl * history of alcohol abuse, binge drinking and/or any illicit drug use or dependence within 6 months of screening; * blood donation (excluding plasma donations) of approximately 1 pint (500 ml) or more within 60 days prior to dosing; * history of sensitivity to heparin or heparin induced thrombocytopenia; * known intolerance to any glp-1r agonist.

Keywords: type 2 diabetes mellitus obesity