Kornimate/medical-research-clean huggingface dataset:
pain assessment during mandibular nerve block injection with the aid of dental vibe tool in pediatric dental patients

Conditions: Anesthesia, Local

Summary: the purpose of this study is to valuate the effectiveness of dentalvibe(dv) tool in pain reduction during local anesthetic injection compared to traditional injection without aid of dentalvibe in pediatric patients.

this study is a crossover randomized controlled clinical trial where (n=60 ) children will be selected from the outpatient clinic of pediatric dentistry and public health department, faculty of dentistry, alexandria university after securing necessary consents. these children will be selected based on a need for local anesthesia for pulpotomy treatment on both sides of the mandible. all selected children will be randomly allocated into 2 groups. group i (assigned to injection with the aid of dentalvibe tool), group ii(assigned to conventional injection). each group will receive 2 mandibular nerve block injections with two different injection techniques, with 1-2 weeks apart as a washing out period. mandibular nerve block injection will be either with vibration using dentalvibe at the injection side or topical analgesic (benzocaine 20%) gel will be applied before the injection of local anesthesia at first the appointment, and the alternative technique will be used at the second appointment . injection with the aid of dentalvibe tool will act as the experimental group while the control group will be the use of topical analgesic (benzocaine 20%).

Eligibility criteria:
inclusion criteria: * age range from 5-7 years. * patients who are in need of pulpotomy dental treatment requiring bilateral local anesthesia in the mandible. * children free of any systemic disease or special health care needs. * positive or definitely positive behavior during preoperative assessments according to the frankl scale. exclusion criteria: * having active sites of pathosis in the area of injection that could affect anesthetic assessment. * signs of irreversible pulpitis or pulp necrosis. * radiographs show periapical or bifurcation radiolucency. * patients allergic to local anesthesia or having a family history of allergy to local anesthesia. * patients with acute oral or facial infection (swelling and/or cellulitis). * patients refusing to participate.

Keywords: dentalvibe mandibular nerve block injection consolability scale
development and evaluation of thrive

Conditions: Oncology

Summary: investigators will test the feasibility and acceptability, as well as efficacy (exploratory aim) of a text messaging intervention for adolescents and young adults (aya) transitioning off active treatment for cancer. texting health resources to inform, motivate, and engage (thrive) is intended to improve knowledge about health promotion and health vulnerability and importance of continued engagement in care, while also providing support and improving efficacy to achieve health-related goals.

adolescents and young adults (aya) with cancer are recognized as an understudied and underserved population in oncology. aya engagement in ongoing disease management is compromised by lack of awareness of their continued health vulnerabilities and need for continued care, their desire to be "normal" and remove themselves from the cancer experience, and lack of aya-appropriate support and services. thus, aya with cancer, especially those completing active treatment, are extremely vulnerable and in need of support to maintain remission and assure optimal health into adulthood. to address the immediate need for innovative interventions targeting aya completing cancer treatment, the proposed study will test the efficacy, feasibility, and acceptability of a tailored text messaging intervention for aya transitioning off active treatment called thrive (texting health resources to inform, motivate, and engage). a pilot randomized controlled trial testing the acceptability and feasibility (primary) and initial efficacy (secondary) of a health promoting mobile health texting intervention with aya transitioning off active cancer treatment to follow-up care. the intervention compares a texting intervention to a receipt of an aya survivorship handbook. acceptability and feasibility are primary outcomes. efficacy outcomes include measures of knowledge, healthcare utilization, adherence, engagement in care, and psychosocial well-being measures.

Eligibility criteria:
inclusion criteria: 1. diagnosed with cancer 2. males or females between the ages of 12 and 25 3. in remission (per documentation in chart) 4. within 12 months of completing active treatment for cancer 5. cognitively capable to complete measures (per documentation in chart of impairment or parent or provider report). 6. able to read and speak english. 7. parent available to provide consent for those ages 12 to 17 exclusion criteria: 1)subjects that do not meet inclusion criteria described above will be excluded.

Keywords: texting mhealth adolescents and young adults transitioning of treatment
a study of bermekimab for the treatment of adult participants with moderate-to-severe atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: the purpose of this study is to evaluate the efficacy of bermekimab, compared with placebo, in participants with moderate-to-severe atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: * have atopic dermatitis (ad) for at least 1 year (365 days) prior to the first administration of study intervention as determined by the investigator through participant interview and/or review of the medical history * have a history of inadequate response to treatment for ad with topical medications or for whom topical treatments are otherwise medically inadvisable (example, due to important side effects or safety risks) * have an eczema area and severity index (easi) score greater than or equal to (\>=) 16 at screening and at baseline * must sign an informed consent form (icf) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study * must be willing to undergo 4 skin biopsies * have an investigator global assessment (iga) score \>=3 at screening and at baseline * have an involved body surface area (bsa) \>=10 percent (%) at screening and at baseline exclusion criteria: * has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances * has ever received any human interleukin-1 (il-1) antagonist (example, including but not limited to anakinra, rilonacept)
transverse abdominis plane block in laparoscopic ventral hernia repair

Conditions: Ventral Hernia

Summary: the current study aims to determine if transverse abdominis plane block using local anesthetic agents (bupivacaine 0.25% + ropivacaine 0.20%) decreases the post operative pain and helps in early mobilization or discharge from hospital in patients undergoing laparoscopic ventral hernia repair.

patients meeting inclusion criteria would be randomised after admission. those patients in experimental arm shall receive the tap block under usg guidance while those in control arm do not receive any block. surgery shall be proceeded in the usual manner in all the patients and assessment for pain starts in the immediate post operative or recovery room after the patient is completely conscious. the total amount of analgesic required by the patient is measured. pain assessment is done using the visual analog scale (vas) at regular intervals until follow up review.

Eligibility criteria:
inclusion criteria: * all patients undergoing laparoscopic ventral hernia repair during the study period exclusion criteria: * age \<15 or greater than 75 years * asa \> 3 * obstructed , recurrent or strangulated hernia * lap assisted open hernia repair * patients undergoing component separation * parastomal hernia, spigelian hernia, lumbar hernia * patients with chronic kidney disease, bronchial asthma * patients allergic to bupivacaine or nsaids * not willing to participate

Keywords: tap block laparoscopic ipom post operative pain
efficacy and safety study of abnoba viscum f 20mg in malignant pleural effusion patients

Conditions: Malignant Pleural Effusion

Summary: phase 3, non-randomized, multicenter, single arm study to assess efficacy and safety of abnoba viscum f 20mg in patients with malignant pleural effusion


Eligibility criteria:
inclusion criteria: * subject who need the pleurodesis among subjects diagnosed with a mlignant pleural effusion * full lung expansion must be achieved within 12 to 24 hours after drainage * expected survival time of at least 2 months * subject who score 50 or more on the karnofsky performance scale exclusion criteria: * subjects with previous attempts at pleurodesis with sclerosing agent * subjects with trapped lung or bronchial obstruction * subjects with adverse drug response to mistletoe agents * subjects who have participated in another clinical study other than the present study * subjects who is taking immune-suppressive agents * subjects with medical and psychiatric contraindications for the study drug * subjects who are not allowed to participate in the study by legal requirement * subjects who are not allowed to participate in the study by the investigator's discretion
role of asics in human inflammatory pain

Conditions: Arthritis; Osteoarthritis; Chondrocalcinosis; Gouty Arthritis; Rheumatoid Arthritis

Summary: in recent years, ion channels have emerged as new therapeutic targets for pain. among these channels, asics (acid sensing ion channels) are of particular interest because they are directly activated by extracellular acidity, which is a major cause of pain. indeed, many painful conditions such as ischemia, inflammation, tumor development or tissue incision are accompanied by tissue acidification. asic are excitatory ion channels that are expressed in neurons, including nociceptive sensory neurons. in humans, the use of amiloride, a nonspecific inhibitor of asics, has demonstrated their role in the perception of pain induced by subcutaneous injections of acidic solutions. asics thus appear as new candidates capable of mediating pain in humans. a growing number of data suggests that, in addition to protons, asics may also be activated by one or more endogenous compounds produced during inflammation. the purpose of this research project is to identify these compounds by testing the effects of human inflammatory exudates on asics activity. the discovery of such compounds would definitely validate asics as novel therapeutic targets for pain treatment in humans


Eligibility criteria:
inclusion criteria: * septic arthritis * gonarthrosis in push-inflammatory * microcrystalline arthropathies * chronic inflammatory rheumatism exclusion criteria: * refusal to participate in the protocol
pharmacogenomics registry to assess clinical utility

Conditions: Drug Side Effects

Summary: the preact registry aims to see whether data from pharmacogenomic testing (pgx) can help healthcare providers manage patient medication regimens and assess if the testing has an effect on reducing medication side effects, hospitalizations and emergency department visits. the way an individual processes a drug is in part determined by their genes, and there is known to be genetic variation between humans in the way drugs are metabolized. the study of the way genes affect a person's response to drugs is known as "pharmacogenomics."


Eligibility criteria:
inclusion criteria: * pharmacogenomic testing has been performed within 12-months prior to eligibility assessment for genes known to influence metabolism of at least one target drug * subject is 2 years of age or older * subject is not taking an investigational medication or in a clinical trial that would interfere with participation in the registry exclusion criteria: * subject's medical and medication history is unavailable over the 90-day period preceding the receipt of pharmacogenomic test results * subject (or subject's parent/guardian) is unable to provide an accurate history due to mental incapacity, in the investigator's opinion.

Keywords: pharmacogenomics adverse drug reactions pharmacogenetics
rivaroxaban vs warfarin for spaf in multi-morbid patients

Conditions: Nonvalvular Atrial Fibrillation

Summary: the overall goal of this study was to evaluate the comparative safety and effectiveness of rivaroxaban vs. vitamin k antagonist (vka) for stroke prevention in patients with nonvalvular atrial fibrillation (nvaf) across risk profiles and comorbidities that reflect everyday clinical practice. the primary objective in this study was to evaluate the combined end point of stroke or systemic embolism (sse), and major bleeding in nvaf patients treated with rivaroxaban vs. vka.


Eligibility criteria:
inclusion criteria: * be oral anticoagulant naive during the 365 days before the day of the first qualifying oral anticoagulant (rivaroxaban or vka) dispensing, and * have ≥365 days of continuous medical and prescription coverage before initiation of oral anticoagulation (which serves as the study's baseline period) exclusion criteria: * \<18 years of age * \<2 international classification of diseases, ninth/tenth revision, clinical modification diagnosis codes for atrial fibrillation * valvular heart disease * transient cause of nvaf * venous thromboembolism * hip or knee arthroplasty * malignant cancer * pregnancy * \>1 oral anticoagulant prescribed (on index date)
adapting a brief suicide intervention for pediatric primary care: enhancing uptake and impact

Conditions: Suicide Prevention

Summary: suicide is a leading cause of death among adolescents in the united states and improving access to high quality just-in-time suicide interventions to reduce risk has important public health implications. integrating such interventions into routinely accessed settings, such as pediatric primary care, holds promise; however, many clinicians in these settings fail to adequately screen or intervene in youth suicidal thoughts and behaviors, representing a key barrier to reducing suicide. the proposed study is a pre-post quasi-experimental pilot feasibility and preliminary efficacy trial of an adaptation of the safety-acute suicide prevention intervention implemented in 3 pediatric primary care clinics.

this project aims to take an innovative, user-centered design approach to adapt and optimize a brief, evidence-based suicide intervention, safety-acute (safety-a; formerly known as family intervention for suicide prevention -aka fisp), for use in primary care settings to support primary care management of adolescents with low to moderate risk suicidal thoughts and behaviors (stb). in this trial, the investigators will conduct a pre-post quasi-experimental pilot feasibility and preliminary efficacy trial of an adapted stb model of care based of the safety-acute intervention, compared to treatment as usual, with 3 primary care clinics. the trial will include 48 10-18-year-old patients with stb and their parents/caregivers (16 dyads per clinic). the investigators will assess acceptability and feasibility of the stb model of care, preliminary intervention impacts, and need for further adaptation.

Eligibility criteria:
inclusion criteria: * adolescent between the ages of 10 and 18 years old * speaks fluent english * current or past low to moderate suicide risk (denies current plan or intent to kill self) exclusion criteria: * high suicide risk (endorses current plan or intent or asq score =5, or prior attempt within last 3 months) * does not speak fluent english note: caregivers of 10-18 yr olds will also be included so age limits for participating samples include: 1. adolescents: ages 10-18 years old 2. parents/caregivers: ages 18 years and older
fluid filled lung oxygenation assistance trial

Conditions: Bronchopulmonary Dysplasia

Summary: the primary study objective is to assess the safety and feasibility of perfluorooctylbromide (pfob) partial liquid ventilation (plv) in infants with severe bronchopulmonary dysplasia (bpd).

the primary study objective is to assess the safety and feasibility of perfluorooctylbromide (pfob) partial liquid ventilation for up to ten days in infants with severe bpd as evaluated by: (1) no sustained oxygen desaturations (spo2 ≤ 80%) for greater than ten minutes without response to increased oxygen therapy, (2) no persistent hypotension without response to volume expansion and/or inotropic therapy, (3) no major mucus plugging events (defined as events that are unresolved after two bronchoscopes), (4) no pneumothoraces or pleural effusion with pfob, (5) and no evidence of increased carbon dioxide (co2) retention, renal insufficiency, hyperkalemia, or metabolic acidosis.

Eligibility criteria:
inclusion criteria 1. neonates with severe bpd as defined by 36 weeks post conception age and require positive pressure ventilation 2. infants born at less than 32 weeks post conception age 3. subjects may be up to 6 months corrected age 4. on conventional mechanical ventilation for chronic lung disease for at least two days prior to enrollment 5. on conventional mechanical ventilation at the time of enrollment and anticipated to continue for 14 days 6. off systemic steroids for lung disease for 72 hours (3 days) prior to t=0 7. hemoglobin value ≥8 g/dl: if less than 8 g/dl, transfusion is permitted. clinical blood transfusion should be administered prior to enrollment. 8. parental/guardian permission (informed consent) exclusion criteria 1. mechanical ventilation for acute disease, such as for infection or for post-operative complications 2. severe pulmonary hypertension (pah) (pulmonary pressure greater than 2/3 systemic) as defined by either echocardiogram (echo), or cardiac catheterizations or a ct-angiogram consistent with pah within the last 3 weeks. 3. pneumothorax (active air leak) requiring chest tube within 72 hours of t=0 4. active pulmonary hemorrhage within 72 hours of t=0 5. history of grade iii/iv interventricular hemorrhage without resolution or stability within 3 weeks of verifying eligibility 6. severe congenital heart disease compromising pulmonary circulation 7. other major congenital malformation (including but not limited to cdh) or known genetic syndromes at the discretion of the investigator 8. use of an investigational drug within 7 days prior to confirmation of eligibility. 9. the clinical attending physician believes it is not in the subject's and/or parents/guardians best interest to participate in the trial.

Keywords: bronchopulmonary dysplasia neonates
social-psychological intervention to improve adherence to haart

Conditions: AIDS; HIV Infections

Summary: all eligible patients will be invited to use electronic monitoring of medication (mems) during the next six months. after two months with mems the enrolled patients will be randomized to intervention group or to control group. the intervention group will be submitted to four social-psycho sessions with a pre-trained health professional. the control group will receive the usual care of the health service. the study will compare the rate of adherence to antiretroviral therapy between the intervention group and the control group. the duration of the study will be of six months. the analysis will be based on "intention-to-treat.


Eligibility criteria:
inclusion criteria: * patients aged more than 18 years old, with detectable viral load and more than six months under haart exclusion criteria: * pregnant women * patients participating in other trials * patients in treatment for hepatitis and for active opportunistic infection * patients with mental or physical condition which do not allow their attendance to the health service

Keywords: aids treatment haart adherence intervention
scalp cooling to prevent chemo-induced hair loss

Conditions: Breast Cancer; Alopecia

Summary: determine that the orbis paxman hair loss prevention system is safe and effective in reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy.

cooling the scalp during chemotherapy may help reduce the chances of losing hair during treatment. the investigators are hoping that using the paxman orbis scalp cooling device may stop patients who are undergoing chemotherapy from losing their hair.

Eligibility criteria:
inclusion criteria: * new diagnosis of breast cancer stage 1-2 * planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent * chemotherapy must be planned for at least 4 cycles of full-dose anthracycline or taxane based chemotherapy regimen, * defined as one of the following regimens: - adriamycin 60mg/m2 with cyclophosphamide 600mg/m2 - epirubicin 90-100mg/m2 with cyclophosphamide 600mg/m2 - doxorubicin 50mg/m2 with 5-fluroruacil 500mg/m2 and cyclophosphamide 500mg/m2 - paclitaxel 80mg-90/m2 weekly (every three weeks constitute a cycle), or 175 mg/m2 every 2-3 weeks as a single agent - docetaxel 100mg/m2 as a single agent - docetaxel 75mg/m2-100mg/m2 with pertuzumab and traztuzumab at standard doses - docetaxel 75mg/m2 with cyclophosphamide 600mg/m2 - docetaxel 75mg/m2 with carboplatin auc of 6 and trastuzumab at standard doses * concurrent traztuzumab at standard doses is allowed * concurrent pertuzumab at standard doses is allowed * administration of chemotherapy on a dose dense schedule is allowed as clinically indicated. * subjects must have tsh collected within 1 year prior to treatment and found within normal range. * if patient has a history of diabetes, hemoglobin a1c must be drawn within 3 months prior to treatment and found to be within normal limits. * cbc and cmp should be done within 4 weeks prior to treatment and found to be within acceptable limits. exclusion criteria: * stage 3 or 4 breast cancer or any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma) * baseline alopecia (defined ctcae v4.0 grade \> 0, see appendix b for ctcae v4.0 scale) * subjects with cold agglutinin disease or cold urticaria * subjects who are scheduled for bone marrow ablation chemotherapy * subjects receiving chemotherapy with concurrent anthracycline and taxane (at or tac) * male gender * age \>= 70 years

Keywords: breast cancer alopecia scalp cooling