Kornimate/medical-research-clean huggingface dataset:
antiretroviral therapy selection: comparing hiv clinical guidelines with hiv-assist, an online decision-support tool

Conditions: Hiv

Summary: hiv-assist is an online decision support tool created by johns hopkins faculty that utilizes standard patient variables, and provides treatment recommendations and tailored educational content to assist providers learn hiv treatment principles and support decision-making. the research goal is to determine the difference in percentage of appropriate antiretroviral therapy (art) selection (based upon a reference standard of hiv experts and guidelines) for a set of hypothetical patient scenarios, comparing a group of trainees with access to current national dhhs guidelines (control), and a group using hiv-assist (intervention) in addition to guidelines. the investigators proposed a randomized study design, in which an electronic survey/questionnaire with 10 hiv case vignettes are presented to study participants. medical and nursing students and internal medicine residents will be eligible to participate. participants providing informed consent will be randomized to receiving access to either online department of health and human services (dhhs) hiv guidelines, or the hiv-assist online tool to support participants' decision making. participants will be asked to indicate participants' art regimen of choice for each case scenario. the proportion of appropriate art selections will be evaluated comparing the intervention and control arms. the investigators will additionally report the time required for trainees to complete art selections for the presented clinical vignettes.


Eligibility criteria:
inclusion criteria: * students in the johns hopkins schools of medicine or nursing, and/or internal medicine residents exclusion criteria: * none

Keywords: decision analysis hiv education
effects of scapular proprioceptive neuromuscular facilitation on pain and range of motion in patients with adhesive capsulitis

Conditions: Adhesive Capsulitis

Summary: the term ''frozen shoulder'' is defined as a clinical condition with restricted active and passive range of motion (rom) in all directions, including flexion, abduction, and rotation.the objective of the study is to determine the effects of scapular proprioceptive neuromuscular facilitation and conventional physical therapy among patients with adhesive capsulitis.the study will be a randomized controlled trial (single-blinded parallel study), consisting of 2 groups- interventional group a and interventional group b.group a will be given conventional physical therapy and group b will be given conventional physical therapy alongwith scapular pnf.scapular pnf exercises are not included in our routine pt treatment programs and there is limited literature related to the pnf techniques. these techniques help develop muscular strength and endurance, joint stability, mobility, neuromuscular control and coordination all of which are aimed at improving the overall functional ability of patients.


Eligibility criteria:
inclusion criteria: * cases diagnosed with adhesive capsulitis, both primary and secondary origin. * stage two and stage three of adhesive capsulitis. * unilateral adhesive capsulitis. * both males and females of the age group 40 years and above. exclusion criteria: * history of shoulder surgery or manipulation under anesthesia, * local corticosteroid injection administration to the affected shoulder within the last 3 months. * severe musculoskeletal, neurological and cardiovascular conditions.
an extension study of abbv-8e12 in progressive supranuclear palsy (psp)

Conditions: Progressive Supranuclear Palsy (PSP)

Summary: the purpose of this study was to assess the long-term safety and efficacy of abbv-8e12 (tilavonemab) in participants with progressive supranuclear palsy (psp).

this study (m15-563) was a phase 2, randomized, double-blind, multiple-dose, multicenter, long-term extension of nct 02985879 (study m15-562) in participants with progressive supranuclear palsy (psp). those who completed the 52-week treatment period in study m15-562 and met all entry criteria were eligible for enrollment into this study. this study planned for a treatment period of up to 5 years and a post-treatment follow-up visit approximately 20 weeks after the last dose of study drug (including participants who prematurely discontinued treatment). all participants received abbv-8e12 as follows: those who received placebo in study m15-562 were randomized, in a 1:1 ratio, to either 2000 or 4000 mg; those who received abbv-8e12 at a dose of either 2000 or 4000 mg in study m15-562 continued on the same dose in this study. this study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy.

Eligibility criteria:
inclusion criteria: * participant completed the 52-week treatment period in study m15-562 (nct02985879) * in the opinion of the investigator, the participant was compliant during participation in study m15-562 (nct02985879) * participant has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend) exclusion criteria: * participants who weigh less than 44 kg (97 lbs) at the time of study entry * any contraindication or inability to tolerate brain magnetic resonance imaging (mri) * participant has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results * more than 8 weeks have elapsed since the participant received his/her last dose of study drug in study m15-562 (nct02985879) * participant is considered by the investigator, for any reason, to be an unsuitable candidate to receive abbv-8e12 or the participant is considered by the investigator to be unable or unlikely to comply with the dosing schedule or study evaluations

Keywords: tauopathy steele-richardson-olszewski syndrome psp
family nurture intervention, a group model in connecticut

Conditions: Behavior Problem; Development Delay; Emotional Disturbance; Family Conflict

Summary: the purpose of this current study is to investigate the efficacy of a group model of family nurture intervention in ameliorating behavioral problems in preschool-aged children. the behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral and developmental disorders. the investigator hypothesizes that the children who are treated with family nurture intervention (fni), which incorporates interactive touch with vocal soothing, and family practice in comforting, will show increased emotional connection and mother child co-regulation with better results in the outcome measures in the short term and long term.

there are several early intervention programs that are available for children with emotional, behavioral and developmental disorders, ranging from behavioral treatment and sensory exposure therapy to pharmaceutical treatments. although improvements in behavior have resulted from these interventions, they are limited in numerous ways. they are usually time-consuming, both for the child and the teacher or clinician providing the intervention. in order to see an effect of the intervention, most children must engage in the intervention procedure for several years. moreover, the effects of most current intervention procedures are minimal to moderate. pharmaceutical prescriptions are often accompanied by undesirable side effects that may modulate behavior, emotion, and physiological functions. the behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral and developmental disorders.

Eligibility criteria:
inclusion criteria: * child is a singleton * mother can speak in english or spanish * child is between the ages of 2 to 4 ½ years at date of enrollment * mother is 18 years of age or older at the time of consent * child demonstrates developmental deficit as measured by the sdq (cutoff of 13 or more on the total score excluding the pro-social questions; or 4 or less on the pro-social questions, which are reverse scored i.e. higher is better) * child must reside with mother exclusion criteria: * the child has severe congenital anomalies or chromosomal anomalies including downs syndrome and cerebral palsy * the child has a diagnosis of autism * the child has severe motor or physical disability * mother currently presents with psychosis or is currently taking antipsychotic medication * current maternal drug and/or alcohol abuse * mother has any current involvement with child protective services (department of children and families) * mother is pregnant * mother and/or infant has a medical condition or contagion that precludes intervention components

Keywords: family nurture intervention martha g. welch md randomized control trial pre-school intervention preschool intervention multiple family group intervention emotional connection co-regulation
exercise cardiac magnetic resonance imaging accuracy for cardiovascular stress testing

Conditions: Coronary Artery Disease

Summary: this study is being done to demonstrate a powerful new method for detecting heart disease that combines the proven prognostic capability of exercise stress testing with the superior image quality of cardiac magnetic resonance imaging (cmr). the investigators hope to demonstrate that exercise cmr has equivalent or superior diagnostic accuracy compared to exercise stress spect for detecting obstructive artery disease.


Eligibility criteria:
inclusion criteria: * any patient referred for stress spect * known or suspected ischemic heart disease * ability to perform adequate treadmill stress exclusion criteria: * any contraindication to mri (e.g. ferromagnetic foreign body, cerebral aneurysm clip, pacemaker/icd, severe claustrophobia) * renal insufficiency (gfr \< 40) * known allergy to gadolinium-based contrast or iodinated contrast (because of the research cta (computed tomography angiography) in patients not referred for cath after 2 weeks)
statin combined with amlodipine treats primary aldosteronism

Conditions: Primary Aldosteronism; Statin; Mineralocorticoid Receptor Antagonist; Hypertension

Summary: the drug treatment for primary aldosteronism (pa) is limited and difficult to improve long-term cardiovascular outcomes. this study plans to enroll patients with primary aldosteronism and randomly divide into 3 groups: scheme 1: statin combined with amlodipine besylate, scheme 2: statin combined with spironolactone and amlodipine besylate. scheme 3: amlodipine besylate combined with spironolactone , to observe the changes in plasma aldosterone level, 24-hour urinary aldosterone, blood pressure, and long-term cardiovascular risk.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of primary aldosteronism exclusion criteria: * allergy to drugs in this study * pregnancy * severe liver and kidney dysfunction * mental illness

Keywords: primary aldosteronism hypertension statin
a comparison of the effectiveness of pnf and mulligan mobilization techniques with neck pain

Conditions: Neck Pain

Summary: the aim of this study is to compare the effectiveness of pnf (proprioceptive neuromuscular facilitation) and mulligan mobilization techniques with classical physiotherapy modalities in individuals with neck pain.

forty individuals with neck pain aged between 18-55 years will be randomly divided into two groups, pnf and mulligan group. classical physiotherapy modalities will be applied to all individuals 5 days a week. pnf group will receive pnf techniques three days a week and mulligan group will receive mulligan mobilization techniques three days a week. participants will be treated for 4 weeks. the pain level of the patients whose demographic data were recorded; visual analog scale (vas), pressure pain threshold; algometer, range of motion (rom); universal goniometer, functionality; neck disability index, kinesiophobia; tampa kinesiophobia scale, quality of life; sf-36 quality of life scale, mood; beck depression inventory, cervical muscle performance level; cervical performance tests will be measured before and after treatment. post-treatment pain intensity, kinesiophobia and depression level; the effectiveness of pressure pain threshold, rom, functionality, quality of life and cervical muscle performance level will be compared within and between groups.

Eligibility criteria:
inclusion criteria: * complaint of neck pain for at least 3 months * volunteer between the ages of 18-55 * receiving a diagnosis of chronic neck pain by a physician exclusion criteria: * having undergone a surgical procedure for the spine * exercise therapy and/or physical therapy within the last 1 year * history of fracture in the cervical region * radiculopathy, myelopathy (motor and sensory loss), or neurological impairment * presence of cardiac pacemaker * positive vertebrobasilar artery test * having a blood clotting disorder * presence of cancer * being diagnosed with rheumatoid arthritis * those with systemic diseases targeting the cervical region * presence of active infection

Keywords: neck pain rehabilitation
low frequency subthalamic nucleus deep brain stimulation to improve verbal fluency

Conditions: Parkinson Disease

Summary: rationale: parkinson's disease patients with deep brain stimulation electrodes represent a unique opportunity to study the influence of basal ganglia on neurocognitive function. intervention: patients' deep brain stimulators will be turned off or on and the frequency will be changed to either theta or gamma. objectives: to identify differences in higher cognitive functions with stimulation "on" and "off" and theta versus gamma frequency stimulation. study population: 12 patients who had previously undergone bilateral stn deep brain stimulation implantation. study methodology: patients will undergo four sessions of neuropsychological testing (rngt, verbal fluency, d-kefs cwit) at baseline, no stimulation, theta stimulation and gamma stimulation, in random order over one day. study outcomes: test results of rngt, verbal fluency, d-kefs cwit. follow-up: none statistics: test results will be analyzed using within-subjects statistical tests.


Eligibility criteria:
inclusion criteria: 1. male or female patients who had previously undergone bilateral stn deep brain stimulation implantation 2. age \>18 years old 3. stable medication regimen for at least 3 months. 4. patient informed and able to give written consent 5. able to comply with all testing, follow-ups and study appointments and protocols exclusion criteria: 1. history of epilepsy or seizure 2. history of major substance abuse 3. patients with baseline settings at less than 1.5 v will be excluded from the study

Keywords: cognition hippocampus language memory neuromodulation randomized controlled trial
safety and reactogenicity of a monovalent conjugated vaccine against haemophilus influenzae type b

Conditions: Haemophilus Influenzae Type b

Summary: this study will investigate safety and reactogenicity of a monovalent conjugated vaccine against haemophilus influenzae type b in healthy children


Eligibility criteria:
inclusion criteria: * infants of either sex, aged 16 - 20 months / 2 - 4 months * in good health as determined by: medical history physical examination clinical judgment of the investigator; * available for all visits scheduled in the study and able to comply with all study regulations; * written informed consent obtained, from at least one parent or legal guardian exclusion criteria: * parent or legal guardian is unwilling or unable to give written informed consent to participate in study; * infants who presented a previous disease potentially related to haemophilus influenzae type b; * infants who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained haemophilus influenzae type b disease; * infants who have received any other haemophilus influenzae type b immunization dose before (for 16-20 months old children who have received a booster vaccination already); * premature (before 37th week of gestation) or birth weight less than 2500 g; * history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; * fever ≥38.0 °c (axillary body temperature) and/or significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment; * subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease; * known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder; * subjects with any neurological disorder, e.g., epilepsy or history of seizure disorder; * subjects with a clinically significant genetic anomaly; * treatment with corticosteroids or other immunosuppressive drugs; * treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives (or: within the past 3 months - applicable for children 16 - 20 months); * any vaccination administered within 2 weeks (14 days) before enrollment; * participation in any other investigational trial simultaneously; * planned surgery during the study period; * any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objective

Keywords: vaccine prevention haemophilus influenzae type b children
a phase 1, randomized, double-blind, placebo-controlled, single and multiple dose escalation study in healthy subjects

Conditions: Asthma

Summary: this is a single center, randomized, double-blind, placebo-controlled, single and multiple dose escalation phase 1 study. the objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous administered shr-1819 in healthy subjects


Eligibility criteria:
inclusion criteria: 1. ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent. 2. be able to comply with all the requirements and able to complete the study. 3. male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form. 4. no clinically significant abnormalities in medical history, general physical examination, vital signs, and laboratory tests. 5. men and women of childbearing potential (wocbp) must agree to take effective contraceptive methods and have no plan to have a child from signing the consent form to 16 weeks after ip administration. exclusion criteria: 1. positive hepatitis b virus (hbsag), hepatitis c virus (hcv-ab), human immunodeficiency virus (hiv-ab), or quantiferon-tb gold tests at screening; 2. participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening (according to the date of signed consent form), or in the follow-up period of a clinical study 3. severe injuries or surgeries within 6 months before screening or plan to do surgeries during the trial 4. any other circumstances that, in the investigator's judgment, may increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response
secondary versus tertiary wound closure in high risk gynecologic abdominal surgical incisions

Conditions: Surgical Incision

Summary: the purpose of this research study is to determine if closing a surgical wound differently is better than the procedure that is currently used. the wound will be closed with what is considered "tertiary intent." this means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery. the investigators also want to see how this new wound closure process affects your quality of life.

primary objective to compare the percentage of patients whose wound remained closed on postoperative day #30 after tertiary closure compared to historical controls who underwent secondary would closure. we are primarily looking at time to wound closure. we will be able to abstract this information from the postoperative clinic visit notes from patients in the "historical control" cohort. we will identify 20 patients with characteristics described in the inclusion criteria of this study who underwent laparotomy with secondary would closure during the calendar year 2018. secondary objectives to compare the proportion of acute and chronic wound infection in wounds closed with a tertiary closure technique to historical controls receiving a secondary wound closure. to compare the length of stay of patients receiving a tertiary wound closure to historical controls receiving a secondary wound closure. to describe the number of patients receiving a tertiary wound closure that return within 30 days of surgery as compared to historical controls receiving a secondary wound closure. to describe the quality of life in patients receiving a tertiary wound closure.

Eligibility criteria:
inclusion criteria: * patients with high risk class ii, class iii, class iv abdominal wounds * undergoing laparotomy for gynecologic related disorders * patients undergoing laparotomy for both benign and malignant diagnoses will be included in this study exclusion criteria: * pregnancy * allergy to triclosan * patients undergoing hipec
mpaacs: magnesium for the prevention of atrial arrhythmias after cardiac surgery

Conditions: Coronary Artery Disease; Valvular Heart Disease

Summary: the objective of our research is to determine whether treatment with magnesium will reduce the incidence of atrial fibrillation in patients undergoing cardiac surgery. several small studies of magnesium have already been conducted, but these studies were small and the results conflicting. a large, well-conducted study of magnesium treatment is required to definitively determine whether magnesium is effective in preventing this common complication after surgery. in addition, our study will include patients undergoing valvular surgery, a group previously excluded from research despite the fact that they are at increased risk of atrial fibrillation.

all patients referred for non-emergent cardiac surgery for isolated cabg, isolated valvular heart surgery, or combined valvular and cabg surgery are eligible for the study. subjects will be randomized prior to surgery (1:1) to receive 5 g magnesium or placebo (saline) bolus by the anaesthesiologist upon removal of the crossclamp. on postoperative days 1 through 4, subjects will receive either iv mgso4 (5g in 250 ml normal saline) or iv placebo (250 ml normal saline) infusion over 4 hours daily. atrial fibrillation (and other arrhythmias) will be detected by placing all subjects on continuous 24-hour ecg telemetry monitoring for postoperative days 0 through 4. the study is powered to detect at least a 30% relative reduction in postoperative atrial fibrillation in the cabg group; n=756. because of the higher incidence of atrial fibrillation in the valve +/- cabg group a total of 500 patients will be required to detect at least a 30% difference between treatment groups. these sample sizes are based on an alpha of 0.05 and 80% power.

Eligibility criteria:
inclusion criteria: * patient undergoing coronary artery bypass surgery with or without valve procedure * scheduled for on-pump or cardiopulmonary bypass protocol exclusion criteria: * existing atrial fibrillation/flutter in the past year or on antiarrhythmic medications * ventricular fibrillation * sustained ventricular tachycardia * 2nd or 3rd degree heart block * paroxysmal supraventricular tachycardia * major aortic repair planned during open-heart procedure * permanent atrial/ventricular pacemaker implanted * dialysis dependent or creatinine clearance \< 35 umoles/min or oliguric/anuric renal failure * patient intolerant of beta blockers * patient has reactive airways disease dependent on regular beta-adrenergic agents * patient is scheduled to undergo off-pump surgical protocol