Kornimate/medical-research-clean huggingface dataset:
evaluation of a virtual cardiology program to improve outcomes after acute decompensated heart failure

Conditions: Heart Failure; With Decompensation

Summary: the purpose of this study is to evaluate how safe and effective a remote, virtual, cardiology program is that provides heart failure education to patients, monitors for worsening heart failure, and quickly adjusts heart failure medications, compared to usual care medication use and adjustment, in participants with decompensated heart failure that are recently hospitalized.


Eligibility criteria:
inclusion criteria: * age ≥18 years of age * acute decompensated hf as a primary cause of hospitalization. hospitalizations for acute decompensated hf will be determined by local clinician-investigators but should include findings of acute hf (i.e., symptoms, signs, and/or laboratory/imaging abnormalities) and treatments aimed at acute hf (e.g., intravenous diuretics, vasodilators, or inotropes). participants with a new diagnosis of hf may be enrolled. the enrollment will be monitored to ensure no more than 2/3 of the total cohort has new-onset hf. * fluent in written and spoken english exclusion criteria: * optimized or nearly optimized on evidence-based medical therapies for hf as determined by local investigator * current pregnancy * chronic use of intravenous inotropic medications including milrinone, dobutamine, or dopamine * egfr of \<20 ml/min/1.73m2 ongoing chronic dialysis at screening. the egfr should be estimated using the 2021 chronic kidney disease epidemiology collaboration (2021 ckd-epi) creatinine equation. * history of prior heart transplant or currently listed for heart transplant * current left ventricular assist device or planned left ventricular assist device in the next 6 months * currently receiving hospice care * chronically resides in an assisted living or skilled nursing facility where medications are managed by facility personnel * terminal illness other than hf with a life expectancy of \<1 year as determined by the enrolling clinician-investigator
a survey of midazolam in people with status epilepticus

Conditions: Epilepsy

Summary: this study is a survey in japan of midazolam oromucosal solution used to treat people with status epilepticus. the study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. the main aim of the study is to check for side effects related from midazolam oromucosal solution and to check if midazolam oromucosal solution improves symptoms of status epilepticus. during the study, participants with status epilepticus will take midazolam oromucosal solution according to their clinic's standard practice. the study doctors will check for side effects from midazolam for 6 months.


Eligibility criteria:
inclusion criteria * participants with non-convulsive status epilepticus * participants treated with study drug outside the medical institution * participants receiving an additional dose of study drug exclusion criteria participants have any contraindication to midazolam.
study of m5049 in cle and sle participants

Conditions: Systemic Lupus Erythematosus; Cutaneous Lupus Erythematosus

Summary: this study is to evaluate the safety, tolerability and pharmacokinetics (pk) of orally administered m5049 in participants with systemic lupus erythematosus (sle) or cutaneous lupus erythematosus (cle).


Eligibility criteria:
inclusion criteria: * active systemic lupus erythematosus (sle) with a cutaneous lupus erythematosus disease area and activity index (clasi-a) greater than or equal to \[\>= \] 6 and/or at least one active sle clinical manifestation according to systemic lupus erythematosus disease activity index 2000 (sledai-2k) * active cutaneous lupus erythematosus (cle) (subacute cutaneous lupus erythematosus and/or discoid lupus erythematosus) with a clasi-a \>= 6 * other protocol defined inclusion criteria could apply exclusion criteria: * autoimmune or rheumatic disease other than sle or cle * dermatological diseases other than cutaneous manifestations of sle or cle * uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder * ongoing or active clinically significant viral, bacterial or fungal infection * history of uncontrolled seizures or other neurological disorder * history of or positive for human immunodeficiency virus, hepatitis c virus, or hepatitis b virus * history of malignancy * other protocol defined exclusion criteria could apply

Keywords: lupus erythematosus, systemic lupus erythematosus, cutaneous autoimmune diseases
using anesthetic gel patches to reduce pain of palatal injection

Conditions: Anesthesia, Dental

Summary: local anesthetic administration step is mandatory step for controlling pain before dental procedures. the aim of this study was to compare effectiveness of topical benzocaine 18% gel patch form and benzocaine 20% topical gel in reducing pain during injection of local anesthesia in children receiving dental treatment.

a sample of 50 children ranging in age from 6 to 8 years who need a bilateral dental treatment in the same arch participated in this study. they were healthy children rated 3 or 4 according to frankl behavioral rating scale. they were selected from the clinic of pediatric dentistry department, faculty of dentistry, alexandria university. a randomized split mouth design was done in which each child received both tested topical anesthetics on each side of the arch. the topical anesthetic gel patch or the topical gel application was randomly used at the first or second visits. pain or discomfort was evaluated during injection using sound, eye, motor (sem) scale, and after injection using faces pain scale- revised (fps-r).

Eligibility criteria:
inclusion criteria: 1. children ranging in age from 6 to 8 years. 2. healthy children with no contraindications of use of local anesthetics. 3. cooperative behavior according to frankl's scale scores 3 or 4. (appendix i) 4. patients needing dental interventions on both sides in the same arch that will require palatal or inferior alveolar nerve block injections. exclusion criteria: 1. uncooperative children or with intellectual or physical disabilities or medical conditions. 2. children with acute pain or emergency visits. 3. children with previous negative dental experience. 4. children receiving premedications or analgesics 48 hours before testing. 5. children/parents not willing to participate.

Keywords: benzocaine topical oral patch pain dental anesthesia children
gastroesophageal effect of indobufen versus aspirin in patients undergoing dual antiplatelet therapy

Conditions: Coronary Artery Disease; Gastroesophageal Reflux Disease

Summary: the dual antiplatelet therapy based on aspirin plays an important role in the treatment of patients with coronary heart disease. although aspirin is widely used and effective, it has many limitations in the long-term including increased risk of bleeding. in patients with coronary heart disease and gastroesophageal reflux disease, the symptoms of gastroesophageal reflux are usually aggravated after the application of aspirin. as an antiplatelet drug, indobufen can reversibly and selectively inhibit platelet cyclooxygenase-1 (cox-1), thereby blocking the synthesis of thromboxane b2 (txb2) and exerting its antiplatelet effect, and it does not affect the production of prostaglandins and endothelial prostacyclins in gastrointestinal mucosa. it has less gastrointestinal injury and lower risk of bleeding. this project is to study the effects of indobufen or aspirin on gastric acid secretion and gastroesophageal reflux in patients with coronary heart disease and gastroesophageal reflux disease treated with dual antiplatelet therapy.


Eligibility criteria:
inclusion criteria: * age 18-75 years * patients with stable and unstable angina pectoris receiving dual antiplatelet therapy (combined with clopidogrel) * coronary angiography indicating ≥50% stenosis in \>2.0 mm vessels * gastroesophageal reflux disease diagnostic questionnaire score (≥8) * signed informed consent exclusion criteria: * acute myocardial infarction within 1 month before admission * patients undergoing treatment related to gastroesophageal reflux disease (e.g. proton pump inhibitors, etc.) * patients receiving other antiplatelet drugs (such as cilostazol) and oral anticoagulants * patients with cardiogenic shock (systolic blood pressure \<90 mmhg and/or diastolic blood pressure \<60 mmhg), severe heart failure (killip grade ≥3), hepatic insufficiency (ast/alt more than twice the upper limit of normal value caused by non-cardiac diseases), prior stroke and renal dysfunction (gfr \<60 ml/min) * those with active hemorrhage, hemorrhagic diseases or tendency to bleeding, especially those with a history of cerebral hemorrhage * people who are known to be intolerant or allergic to aspirin, indobufen or clopidogrel * patients with malignant tumors or with life expectancy \<2 years * pregnant women, lactating women, women of childbearing age who do not take effective contraceptive measures, or those who plan to conceive during the trial, or those who have positive results of hcg examination before the trial * those who have participated in other clinical trials or are currently participating in other clinical trials within one month before the trial * according to the judgement of the researchers, patients could not complete the study or comply with the requirements of the study (e.g. memory or behavioral disorders, mental disorders, alcohol dependence, prior defaults)

Keywords: coronary heart disease gastroesophageal reflux disease indobufen aspirin
supporting use of ac through provider profiling of oral ac therapy for af

Conditions: Atrial Fibrillation; Prescribing Practices; Anticoagulants

Summary: the support-af study aims to improve rates of anticoagulation (ac) in atrial fibrillation (af) patients by developing and delivering supportive tools and educational materials to providers treating patients with af. the investigators hypothesize that ac percentage will increase among providers receiving tools and educational content.

nearly 1 million patients with atrial fibrillation (af) who meet guideline criteria for anticoagulation (ac) are being left untreated, often due to providers over-estimating risks of bleeding and falling and under-estimating risks of stroke. the objective of this project is to improve rates of adherence to ac guidelines by creating supportive and educational materials for cardiology as well as primary care providers to evaluate the risks and benefits of prescribing ac to patients with af. the investigators will email providers individual auto-updating reports containing their ac prescription rate compared to their peers and compared to practice level ac prescription goal. this report will also contain a list of the provider's af patients who are eligible to receive ac based on their cha2ds2-vasc stroke risk score ≥ 2 and a list of eligible af patients with upcoming appointments to focus providers on an actionable group of patients with whom they might review the use of ac. the investigators will also message providers through the ehr prior to an upcoming appointment with an eligible patient reminding them to discuss ac if they deem appropriate. in addition, the investigators will directly engage with providers through academic teledetailing to educate providers on ac and address misconceptions and barriers to initiating or resuming ac in af patients.

Eligibility criteria:
inclusion criteria: * university of massachusetts providers caring for patients aged 18 years and older with icd-10 diagnostic code consistent with af or atrial flutter who had a visit with a primary care provider or * cardiovascular medicine specialist in the previous one year with the diagnosis of af present as an active diagnosis in the electronic medical record (ehr). exclusion criteria: * university of massachusetts providers who do not care for patients aged 18 years and older with icd-10 diagnostic code consistent with af or atrial flutter who had a visit with a primary care provider or * cardiovascular medicine specialist in the previous one year with the diagnosis of af present as an active diagnosis in the ehr.
prognostic and predictive impact of upa/pai-1

Conditions: Breast Cancer

Summary: chemo-n0 (1993-1998) is the first prospective randomized multicenter trial in n0 bc designed to prospectively evaluate the clinical utility of a biomarker. it used upa/pai 1 as stratification criteria and randomized high-risk patients to chemotherapy versus observation; low-risk patients remained without any systemic therapy. the trial was designed to answer two principle questions: 1. can the reported prognostic impact of upa and pai 1 be validated in a prospective multicenter therapy trial? does low upa/pai 1 identify those low-risk n0 patients who are candidates for being spared necessity and burden of adjuvant chemotherapy? 2. do upa/pai 1 high-risk patients benefit from adjuvant cmf chemotherapy?


Eligibility criteria:
inclusion criteria: * n0 breast cancer patients tumor size \>/= 1 and \</= 5 cm in diameter undergoing standard loco-regional treatment exclusion criteria: * m1 status

Keywords: node-negative
the effect of adding auditory information on head movements in people with traumatic neck pain

Conditions: Whiplash; Healthy

Summary: this study sets out to investigate the potential effect of auditory disturbances on human movement

clinicians routinely investigate/test human movement but if/how this is effect by auditory disturbances is unclear. this study sets out to investigate the impact of auditory disturbances on head movements.

Eligibility criteria:
control group: inclusion criteria (control): * able to speak, read and understand danish/english exclusion criteria (control): * pain from the neck or shoulder area during the past 6 months * experience of delayed onset muscle soreness (doms) during the week leading up to the test session * former surgery in neck or shoulder * current or previous chronic or recurrent pain condition that could affect the results * pregnancy * drug addiction defined as the use of cannabis, opioids or other drugs * previous neurologic, musculoskeletal or mental illnesses that could affect the results * regular use of analgesics * abnormally disrupted sleep in the last 24 hours preceding the experiment * lack of ability to cooperate neck pain group: inclusion criteria (neck pain): * traumatic onset of neck pain * able to speak, read and understand danish/english * reduced/painful active range of motion of the head and/or painful reaction to palpation of the neck at the time of inclusion exclusion criteria (neck pain): * experience of doms during the week leading up to the test session * former surgery in neck or shoulder * pregnancy * drug addiction defined as the use of cannabis, opioids or other drugs * previous neurologic, musculoskeletal (other than neck pain) or mental illnesses that could affect the results * abnormally disrupted sleep in the 24 hours preceding the experiment * lack of ability to cooperate

Keywords: whiplash neck pain kinematics
primara: a prospective descriptive observational study to review mimpara (cinacalcet) use in patients with primary hyperparathyroidism in clinical practice

Conditions: Hyperparathyroidism, Primary

Summary: this is a multicentre, descriptive observational study of adult patients with primary hpt receiving cinacalcet in clinical practice in a number of countries in europe. patients will be enrolled within 1 month of initiating cinacalcet treatment, and data will be collected prospectively for up to 1 year from initiation. data will continue to be collected from patients discontinuing cinacalcet before the end of this period.


Eligibility criteria:
inclusion criteria: * at least 18 years of age at the time of first administration of cinacalcet * patients with primary hpt who have initiated cinacalcet within 1 month before enrolment in the study * provision of informed consent (if required) exclusion criteria: * previous use of cinacalcet (other than within 1 month before enrolment) * diagnosed secondary hpt * other known aetiology of hypercalcaemia (eg, sarcoidosis, tuberculosis)
effect of video-based game and aerobic exercise on knee osteoarthritis

Conditions: Osteoarthritis of Knee

Summary: this randomized controlled trial was conducted by the consort guidelines for non-pharmacological treatments. participants were randomly assigned to control, gaming, or aerobic groups using the closed-envelope randomization method. all groups received conventional physiotherapy for 8 weeks. in addition, the gaming group played active video games 3 days per week, while the aerobic group engaged in cycling-based aerobic exercise (20 minutes per session) 3 days per week. the control group received only conventional physiotherapy and continued their daily activities. evaluations were performed by the same assessor at the baseline and after eight weeks.


Eligibility criteria:
inclusion criteria: * participants, aged 30-65 years who were diagnosed with unilateral or bilateral osteoarthritis based on the clinical and radiological criteria of the american college of rheumatology. * the severity of osteoarthritis was classified as stage 2-3 according to the kellgren-lawrence grading system for gonarthrosis. * participants were required to be able to walk independently for at least 15 meters and to refrain from using non-steroidal anti-inflammatory drugs (nsaids) during the study period. exclusion criteria: * a history of lower extremity surgery within the past 6 months, * the presence of neurological or systemic diseases, * other inflammatory joint diseases, * getting classic physiotherapy and rehabilitation within the past month, * intra-articular corticosteroid injections within the past 3 months, * severe joint deformities or movement restrictions, * severe visual impairments.

Keywords: knee osteoarthritis video games aerobic exercise pain disabilitiy
study evaluating the safety of aab-003 (pf-05236812) in subjects with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this is a study to evaluate the safety of multiple doses of aab-003 (pf-05236812) in patients with mild to moderate alzheimer's disease. patients will receive either aab-003 (pf-05236812) or placebo. each patient's participation will last approximately 41 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of probable alzheimer's disease with mmse score of 16-26, and brain mri consistent with the diagnosis of alzheimer's disease * concurrent use of cholinesterase inhibitor or memantine allowed, if stable. * caregiver will participate and be able to attend clinic visits with patient exclusion criteria: * significant neurological disease other than alzheimer's disease * major psychiatric disorder * contraindication to undergo brain mri (e.g., pacemaker, csf shunt, or foreign metal objects in the body) * women of childbearing potential

Keywords: randomized safety study adaptive double blind
the comparison of low thoracic paravertebral block versus peritubal infiltration

Conditions: Percutaneous Nephrolithotomy

Summary: percutaneous nephrolithotomy (pcnl) is a safe and effective procedure that is considered the standard treatment for large and complex renal stones. although it has lower complication and morbidity rates than open surgery, the pain and discomfort related to a nephrostomy tube can cause distress for patients. managing this pain with opioids can lead to sedation, nausea, vomiting, and constipation, which defeat the purpose of this minimally invasive procedure. skin infiltration with bupivacaine around the nephrostomy tube is not effective. infiltration of renal capsule has shown to facilitate painless insertion of nephrostomy tube, suggesting the role of renal capsule in pain management. peritubal infiltration of bupivacaine from renal capsule to the skin along the nephrostomy tract may alleviate postoperative pain. a unilateral low thoracic paravertebral (pvb) block offers the option of providing extendable perioperative pain relief without the above side effects or the physiologic derangement associated with local anesthetics in the central neuraxial space. the aim of this study is to determine whether ultrasound guided low thoracic paravertebral block effective post-operative analgesia as compared to peritubal infiltration analgesia in patients undergoing percutaneous nephrolithotomy. main outcome measures: the primary endpoint is postoperative opioid consumption. secondary endpoints are visual analogue pain scores, opioid related side effects.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologist's physiologic state i-iii patients undergoing percutaneous nephrolithotomy exclusion criteria: * chronic pain * bleeding disorders * renal or hepatic insufficiency * patients on chronic non-steroidal anti-inflammatory medications * emergency cases

Keywords: postoperative analgesia peritubal infiltration ultrasound guided low thoracic paravertebral block percutaneous nephrolithotomy pain
a study of single-dose gabapentin in transient insomnia induced by a sleep phase advance

Conditions: Transient Insomnia

Summary: the purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a sleep phase advance.


Eligibility criteria:
inclusion criteria: * aged \>/= 18 years * females of child-bearing potential using medically-acceptable method of birth control \>/= 1 month prior to screening exclusion criteria: * current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition) * recreational drug use within past 30 days