Kornimate/medical-research-clean huggingface dataset:
double-blinded randomized controlled study investigating the efficacy of exparel (liposomal bupivacaine) for postoperative pain relief in mandibular third molar extractions

Conditions: Post Operative Pain

Summary: the most prevalent complaint after third molar extractions is pain. there have been many modalities and regimens developed to manage post-operative pain, such as modifications in surgical techniques, locally-applied medicaments, and oral analgesics. recently, liposomal bupivacaine (exparel) has been fda approved for single-dose infiltration in the oral cavity in adults and children (6 years or older) to produce extended postsurgical local anesthesia. we hypothesize that the administration of liposomal bupivacaine (exparel) at the end of third molar extractions will decrease postoperative pain and decrease narcotic use for pain management.

in this study, we will prospectively collect data from all patients receiving bilateral third molar extractions with exparel versus 0.5% bupivacaine 1:200,000 epinephrine (standard bupivacaine) injections to determine the efficacy of exparel in reducing postoperative pain. outcomes measured will be pain intensity based on a numeric scale, date and time when pain completely subsides for each side, adverse events, use of nsaid or acetaminophen outside of prescribed pain regimen, and use of narcotics. the purpose of this research project is to evaluate the use and efficacy of exparel in postoperative pain management in third molar extractions.

Eligibility criteria:
inclusion criteria: * patients receiving bilateral mandibular third molar extractions at the herman ostrow school of dentistry by an oral \& maxillofacial surgery resident. exclusion criteria: * patient unable to complete form for four days postoperatively. * patient with severe hepatic disease * patient with a history of allergy or contraindication to amide-type la or opioids * patient with recent history of antibiotic use within the past thirty days * patients with use of long-acting opioids, nsaids, aspirin, acetaminophen within 3 days prior to screening. * patients who are pregnant. * patients receiving additional mandibular teeth extractions.
leflunomide treatment for igg4-rd

Conditions: Autoimmune Disease

Summary: this study is an open-label randomized controlled trial aiming to investigate whether the efficacy and side effect of leflunpomide plus glucocorticoid.


Eligibility criteria:
inclusion criteria: * males and females * aged 18 to 70 years old with informed consent * all patients must meet the following diagnostic criteria of igg4rd (2011): 1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sialadenitis (mikulicz disease), sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions; 2. elevated serum igg4 (\>1.35 g/l); 3. histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and igg4+ plasma cells on immunohistology when performed). patients fulfill 1)+2)+3) are diagnosed as definite igd4rd, 1)+2): possible igg4rd; 1)+3): probable igg4rd; 4. exclusion of other diseases. exclusion criteria: * patients will not be included if meets any of the following criteria: 1. patients who were diagnosed as other autoimmune diseases; 2. patients who were diagnosed as malignant diseases; 3. pregnant and lactating women； 4. active infection: hiv, hcv, hbv, tb； 5. serious organ function failure, expected life time less than 6 months. 6. presenting with mikulicz disease without other manifestations.
improving utilization of lung cancer screening in underserved pa populations

Conditions: Lung Cancer

Summary: this study is an interventional study intended to assess the impact of a centralized outreach intervention that includes shared decision-making about lung cancer screening (lcs) in lcs-eligible primary care patients. the study's goal is to increase lcs rates compared to usual care and thus reduce lung cancer deaths.

the research team will select primary care practices included in areas where lung cancer mortality is high. an outreach registry of primary care patients obtaining care at participating practices who meet study eligibility criteria will be created from the electronic medical record. 500 primary care patients will be randomly selected for the outreach contact with decision counseling (ocdc) group from this outreach registry. patients targeted for inclusion in the study will have a scheduled primary care appointment 18-23 days after initial outreach contact.

Eligibility criteria:
inclusion criteria: * have an upcoming office visit with a primary care physician in one of the study practices * between the ages of 50 and 77 (inclusive) * history of smoking (current or former) in the electronic medical record (emr) exclusion criteria: * chest ct performed in the last 10 months before study initiation according to emr * diagnosis of lung cancer indicated in the problem list in the emr * current cancer treatment or other qualifying diagnoses that would make outreach inappropriate (e.g., dementia, hearing disability)

Keywords: screening utilization
amplatzer cardiac plug clinical trial

Conditions: Atrial Fibrillation; Ischemic Stroke; Peripheral Thromboembolism

Summary: the objective of this study is to evaluate the safety and effectiveness of the acp in subjects with nonvalvular atrial fibrillation by demonstrating that the device is non-inferior to optimal medical therapy (omt) with respect to the primary effectiveness endpoint and superior to omt with respect to primary safety endpoint.


Eligibility criteria:
inclusion criteria: * subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation * subject must be ≥18 years of age * subject must be on warfarin or dabigatran therapy * subject must be eligible for long term warfarin or dabigatran therapy * subject must have a chads(2) score of 2 or greater summary of exclusion criteria: * subject who requires warfarin or dabigatran for a condition other than af * subject who is on clopidogrel or another p2y12 platelet inhibitor such as prasugrel or ticagrelor * subject who has an absolute or relative contraindication to aspirin, or warfarin and dabigatran * subject with a new york heart association (nyha) classification equal to iv * subject with an implanted or surgical repair atrial septal defect (asd) device or patent foramen ovale (pfo) device * subject with aortic or mitral valve regurgitation of grade 2+ or greater * subject with left ventricular ejection fraction (lvef) ≤30 * subject with mitral or aortic prosthetic valve * subject with a history of hemorrhagic or aneurysmal stroke * subject with a history of previous radio frequency (rf) ablation for atrial fibrillation * subject with a body mass index (bmi) ≥40 * subject with a history of acute or recent mi, or unstable angina, or coronary artery bypass graft surgery (within 6 months) * subject who is on aspirin dose therapy greater than 81mg/day at time of enrollment

Keywords: acp atrial fibrillation af a fib stroke coumadin warfarin dabigatran pradaxa blood thinning medication left atrial appendage laa
18f-fluoroazomycin arabinoside (18f-faza) in lung cancer

Conditions: Lung Cancer

Summary: the purpose of this study is to look for low levels of oxygen (hypoxia) in lung cancer using a positron emission tomography (pet) scan. hypoxia can influence how lung cancer grows and responds to treatments like radiotherapy and chemotherapy. the use of pet scans to measure hypoxia may be better and simpler than the approaches used previously. this study will assess whether or not pet scans can provide useful information about hypoxia in lung cancer. in this study, a radiotracer called fluoroazomycin arabinoside (faza) will be used to measure hypoxia in the patient's tumour. faza has already been used in many cancers including lung cancer. patients who consent to participate in this trial will receive 1 faza pet scan prior to their first radiotherapy treatment


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. patients with stage ii or iii lung cancer (both nsclc and sclc) qualifying for radiotherapy to the primary tumor, with or without treatment of mediastinal or hilar lymph nodes 3. intention to treat using radiotherapy according to the current treatment policies of the pmh lung group 4. concurrent systemic therapy allowed 5. a negative serum pregnancy test within the two week interval immediately prior to pet-ct imaging, in women of child-bearing age 6. ability to provide written informed consent to participate in the study exclusion criteria: 1. previous radiotherapy to intended treatment volumes. 2. previous systemic therapy 3. active malignancy other than lung cancer 4. unable to remain supine for more than 60 minutes 5. pregnancy 6. age less than 18 years old 7. failure to provide written informed consent

Keywords: lung cancer faza pet imaging lung radiotherapy
efficacy and safety study of beclometasone/formoterol single inhaler in patients with copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: to evaluate the 1-year efficacy and safety of the fixed combination beclometasone/formoterol pmdi in a twice daily regimen in patients with stable severe copd.

the purpose of this study is to evaluate the long-term efficacy and safety of the fixed combination beclometasone/formoterol pmdi in a twice daily regimen in patients with stable severe copd. patients are randomised to receive either beclometasone/formoterol or budesonide/formoterol dpi or formoterol dpi during 48 weeks of treatment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of copd (according to gold guidelines) * fev1 \> or equal 30% and \< 50% of predicted normal post-bronchodilator (and at least 0.7 l absolute value) * copd symptoms for at least 2 years * at least 1 exacerbation requiring medical intervention (oral corticosteroid and/or antibiotic treatment and/or need for a visit to an emergency department and/or hospitalization) within 2-12 months before screening * current or previous smoker with a cumulative exposure to smoke of more than 20-pack year exclusion criteria: * current or past diagnosis of asthma, or any evidence suggestive of asthma * positive fev1 reversibility test * clinically significant or unstable concurrent diseases, including clinically significant laboratory abnormalities * acute copd exacerbation or lower tract infection and/or treatment with oral or injectable corticosteroids and antibiotics in the 2 months before screening or during run-in * long term oxygen therapy
the influence of postoperative analgesia on systemic inflammatory response and pocd after femoral fractures surgery

Conditions: Postoperative Cognitive Dysfunction

Summary: the purpose of this study is to determine whether epidural levobupivacaine applied for the purpose of post-operative analgesia compared to systemic analgesia with morphine leads to better pain control, stronger suppression of the inflammatory response and the production of inflammatory mediators, faster recovery of patients and consequently less incidence of postoperative cognitive dysfunction (pocd) in elderly patients after surgical treatment of femoral fractures.

the research will be carried out at the department of surgery at clinical hospital centre(chc) osijek after approval by the ethics committee of chc osijek and will be organized as a prospective randomized trial. respecting the including and excluding criteria for participation in the study, the research will include 70 patients aged 65 years and over who are undergoing surgery for proximal femur fractures and will be operated with the same operating technique (osteosynthesis with nail). all participants will receive the same type of anesthesia and one of two forms of post-operative analgesia, so it will be divided into two groups (35 patients) depending on which form of post-operative analgesia receive. randomization will be performed by drawing an envelope in which the specified one or other form of post-operative analgesia will be written. the study will be stopped in case of serious complications life-threatening (excessive sedation, respiratory insufficiency, hemodynamic instability and profound hypotension, heart rhythm disorders), which could possibly be related to the administration of drugs used for postoperative analgesia.

Eligibility criteria:
inclusion criteria: * patients age 65 and over * fracture of the proximal femur * preoperative assessment american society of anesthesiologists(asa) score i - asa iii * a written consent of the patient to participate in research exclusion criteria: * patient non-compliance * asa status iv and iv above * patients younger than 65 years * dementia, parkinson's disease, cerebrovascular accident history; simultaneous head injuries,the use of opioids and benzodiazepines longer than a month before the surgery; alcoholism; serious liver disease (class c according to child-pugh's classification); severe kidney disease that require dialysis * result of mmse test (mini-mental state examination) under 17 * the existence of any contraindications for the implementation of regional anesthesia and one or other form of post-operative analgesia.

Keywords: postoperative analgesia postoperative cognitive disfunction
a study assessing rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitors in adult participants with moderate-to-severe atopic dermatitis (ad)

Conditions: Atopic Dermatitis

Summary: the coprimary objectives of the study are to: * evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (tcs/tci), compared with placebo in combination with tcs/tci at week 24, assessed using validated investigator's global assessment for atopic dermatitis (viga-ad™). * evaluate the efficacy of rocatinlimab, in combination with tcs/tci, compared with placebo in combination with tcs/tci at week 24, assessed using eczema area and severity index (easi).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years with a diagnosis of ad according to the aad (american academy of dermatology) consensus criteria (2014) present for at least 12 months * history of inadequate response to tcs of medium or higher potency (with or without tci) * easi score ≥16 * viga-ad score ≥3 * ≥10% body surface area (bsa) of ad involvement * worst pruritus numerical rating scale ≥ 4 exclusion criteria: * treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 * treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to day 1: * systemic corticosteroids * nonbiologic, non-targeted systemic immunosuppressants * phototherapy * janus kinase inhibitors * treatment with any of the following medications or therapies within 1 week, prior to day 1: * tcs * tci * topical phosphodiesterase type 4 inhibitors * other topical immunosuppressive agents * combination topical agents including tcs of any potency or tci, pde4 inhibitors, or other topical immunosuppressive agents

Keywords: atopic dermatitis amg 451 eczema rocatinlimab khk4083
evaluation of the analgesic effect of transcranial direct current stimulation (tdcs) for sedated patients in intensive care unit.

Conditions: Transcranial Direct Current Stimulation (tDCS)

Summary: pain management for sedated icu patients is complex, partly because of the difficulty of assessing pain in non-communicative patients, and partly because of the side effects associated with excessive use of morphine. in this context, the use of another non-pharmacological approach, transcranial direct current stimulation (tdcs), could be of interest. with tdcs, neuronal activity is modulated by inducing a weak electric current through the cerebral cortex between two electrodes applied to the surface of the scalp. although the mechanisms of action of tdcs are not yet fully understood, the medium-term effects are thought to be linked to the activation of n-methyl-d-aspartate receptors, glutamate-activated receptors involved in cellular memory. the use of tdcs as an analgesic therapy for chronic pain has produced encouraging results in patients suffering from fibromyalgia, migraine and central pain following spinal cord injury, its use in sedated intensive care patients is unknown. to assess the possible analgesic effect of tdcs in these patients, we will use quantitative pupillometry, a technique already used in routine intensive care, to quantify nociception during a standardized nociceptive simulation.


Eligibility criteria:
inclusion criteria: * age from 18 to 80 years, * sedated patient in stable condition requiring mechanical ventilation for at least 72 hours with continuous administration of morphine. * person affiliated to the social security system or beneficiary of an assimilated regime. * close consent or emergency inclusion exclusion criteria: * history of epilepsy. * severe brain injury (head trauma, stroke, neuromeningeal infection, status epilepticus). * presence of intracranial ferromagnetic material. * presence of electronic stimulators or implants (e.g. pacemaker, spinal cord or intracranial stimulator). * facial trauma preventing eye opening. * patients who are blind and/or have eye damage. * protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons under legal protection. * subjects excluded from another study.

Keywords: pain management transcranial direct current stimulation (tdcs) analgesic therapy chronic pain sedated patient intensive care unit
the effect of exercises on pain and kinesiophobia in transplant patients

Conditions: Liver Transplantation

Summary: liver transplantation is a treatment method used in acute and chronic liver failure. progressive relaxation exercises, which are non-pharmacological methods aimed at minimizing complications and improving the quality of life after liver transplantation, have been reported to have many benefits such as reducing acute and chronic pain, reducing fatigue and reducing muscle tension. therefore, in this study, the effects of progressive relaxation exercises on pain and kinesiophobia in liver transplant patients were examined.

liver transplantation is a common treatment for acute and chronic liver failure, liver malignancy and complicated cirrhosis. although life expectancy increases after liver transplantation, some undesirable problems such as rejection, cardiovascular risk factors, hypertension, infection and malignancy occur. preferring non-pharmacological methods to minimise complications and improve quality of life accelerates the return of the individual to normal life. progressive relaxation exercises, one of these methods, can activate the parasympathetic nervous system, blood pressure, heart and respiratory rate can be kept within clinically normal limits due to vasodilatation in the blood vessels in the peripheral area and oxygen requirement is reduced. pge has been reported to have many benefits such as reducing the effects of anxiety and stress, reducing acute and chronic pain, nausea and vomiting, facilitating sleep, reducing fatigue, reducing respiration, blood pressure, heart rate and muscle tension. therefore, in this study, the effects of progressive relaxation exercises on pain and kinesiophobia in liver transplant patients were examined.

Eligibility criteria:
inclusion criteria: * patients over the age of 18 who agreed to participate in the study, * patients undergoing liver transplantation * patients without a disabling psychiatric disorder exclusion criteria: * patients under the age of 18 who do not agree to participate in the study. * those who have a psychiatric diagnosis that prevents communication.

Keywords: liver transplantation progressive relaxation exercises pain pain level kinesiophobia
adaptation and evaluation of bright horizons

Conditions: Alcohol Abuse; Substance Use

Summary: this study will test if a program called 'bright horizons' is effective at reducing binge substance use among adolescents. bright horizons is a culturally adapted intervention developed and tested through a partnership between the white mountain apache tribe and johns hopkins university. bright horizons is a brief intervention that teaches emotion regulation, coping skills, and problem solving. the intervention also uses goal setting to reduce alcohol and other substance use and to connect to individuals with treatment.

the goal of this study is to understand how bright horizons impacts adolescents who have a recent binge substance use event. participants will receive a lesson on binge substance use and answer questions at three different time points: when participants enroll in the study; 4 weeks later; and 4 weeks after that visit. evaluation questions will ask about participants' substance use, family and peer relationships, and other emotions and behaviors. control participants will receive the bright horizons intervention after enrollment of all intervention participants is complete.

Eligibility criteria:
inclusion criteria: * aged 12-17 * confirmed binge alcohol use event reported to the surveillance system within 90 days * self identify as native american * reside on or near the fort apache indian reservation * have parental or legal guardian consent/provide youth assent exclusion criteria: * unstable and severe medical, psychiatric or drug use problems that necessitates inpatient treatment * acute suicidal or homicidal ideation requiring immediate intervention * recent and severe stressful life events such as physical or sexual abuse, or violent crime victimization that requires specific and high intensity interventions or out of home placement * doesn't speak english * severally visually impaired