Kornimate/medical-research-clean huggingface dataset:
preop cooled radiofrequency ablation for total knee replacement

Conditions: Postoperative Pain; Knee Osteoarthritis

Summary: total knee replacement surgery is commonly performed for patients suffering from severe knee osteoarthritis. however, 20% of patients continue to experience pain after surgery. there is currently no standardized pain management protocol for pain after total knee replacement. cooled radiofrequency ablation has been used successfully to alleviate spin-related pain and has recently been approved by the fda to treat chronic knee arthritic pain. this pilot study aims to collect preliminary data on the use of cooled radiofrequency ablation in patients undergoing total knee replacement.

the number of patients who undergo total knee replacement is rising significantly. however, many of these patients are dissatisfied with the results, because they continue to experience pain postoperatively. this pain can be debilitating and can also be associated with decreased quality of life. given the increasing number of patients undergoing total knee replacement and a dissatisfaction rate of 8-44%, improvements must be made in pain management protocols to help decrease pain in the immediate postoperative period following total knee replacement. cooled radiofrequency ablation is a procedure that uses water-cooled technology to denervate the sensory nerves. it is widely used in the spine and is increasingly being used in the knee to treat osteoarthritis. existing studies have shown that it can significantly reduce pain in patients with chronic osteoarthritis. in terms of its potential benefit as a preoperative measure to minimize postoperative pain, the literature is sparse. results from this study will be used to generate hypotheses and power for future studies.

Eligibility criteria:
inclusion criteria: * patients undergoing unilateral primary total knee replacement for osteoarthritis * pain \>6 (on a scale of 0-10) * body mass index: 21-35 kg/m2 exclusion criteria: * age \<65 years * patients who are wheelchair bound * history of inflammatory arthritis or rheumatic disease * body mass index \ 35 kg/m2 * chronic opioid use * pregnant women * non-english speaking
pain management intervention preparatory to a future pragmatic trial

Conditions: Non-Pharmacological Pain Management

Summary: researchers are promoting non-pharmacological pain management strategies for patients by assisting them in identifying post-surgical pain care preference following an operative procedure at mayo clinic.

this is a pilot study to test promoting non-pharmacological pain management strategies for patients by assisting them in identifying post-surgical pain care preference following an operative procedure. this pilot study will confirm the feasibility of patient-facing as well as clinician-facing decision support components of an electronic health record (ehr) imbedded evidence-based bundle.

Eligibility criteria:
inclusion criteria: * patients scheduled to receive a surgical spine procedure at mayo clinic * surgeons, physician pain specialists and allied health caring for patients meeting patient inclusion criteria exclusion criteria: * none
the diagnostic application of psmapet/mr in patients undergoing secondary prostate puncture

Conditions: PSMA PET/CT; Prostate Cancer; MpMRI

Summary: the present study is designed to explore the value of targeted puncture guided by psma pet/ct or mpmri in the diagnosis of patients with low psa and initial negative prostate biopsy


Eligibility criteria:
inclusion criteria: 1. age ≥40 years, male; 2. serum psa level 4-20 ng/ml; 3. serum psa level 4-20 ng/ml; 4. no contraindications to psma-pet/ct or mri; 5. signed informed consent. exclusion criteria: 1. serum psa \>20 ng/ml; 2. history of prostate surgery/radiotherapy; 3. acute prostatitis; 4. coagulation disorders or active infection; 5. severe internal/external hemorrhoids, perianal, rectal, or gluteal lesions; 6. allergy to local anesthetics; 7. inability to tolerate the biopsy procedure.

Keywords: prostate cancer psma pet/ct mpmri prostate biopsy
study of phenoptin to increase phenylalanine tolerance in phenylketonuric children on a phenylalanine-restricted diet

Conditions: Phenylketonurias

Summary: the primary objective of this trial is to evaluate the ability of phenoptin to increase phenylalanine (phe) tolerance in children with phenylketonuria who are following a phe-restricted diet.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of pku with hyperphenylalaninemia (hpa) documented by at least one blood phe measurement \>/=360 umol/l (6 mg/dl) * under dietary control with a phe-restricted diet as evidenced by:· estimated daily phe tolerance \</=1000 mg/day * at least 6 months of blood phe control (mean level of \</=480 μmol/l) prior to enrolling in the study * aged 4 to 12 years inclusive at screening * a blood phe level \</=480 μmol/l at screening * female subjects of childbearing potential (as determined by the principal investigator) must have a negative blood or urine pregnancy test at entry (prior to the first dose). note: all female subjects of childbearing potential and sexually mature male subjects must be advised to use a medically accepted method of contraception throughout the study. female subjects of childbearing potential must be willing to undergo periodic pregnancy tests during the course of the study * willing and able to comply with all study procedures * willing to provide written assent (if applicable) and written informed consent by a parent or legal guardian after the nature of the study has been explained and prior to any research-related procedures exclusion criteria: * any condition that, in the view of the pi, renders the subject at high risk from treatment compliance and/or completing the study * prior history of organ transplantation * perceived to be unreliable or unavailable for study participation or have parents or legal guardians who are perceived to be unreliable or unavailable * use of any investigational agent within 30 days prior to screening, or requirement for any investigational agent or vaccine prior to completion of all scheduled study assessments * alt \> 2 times the upper limit of normal (i.e., grade 1 or higher based on world health organization toxicity criteria) at screening * concurrent disease or condition that would interfere with study participation or safety (e.g., seizure disorder, oral steroid-dependent asthma or other condition requiring oral or parenteral corticosteroid administration, or insulin-dependent diabetes)
sildenafil iv bolus study

Conditions: Hypertension, Pulmonary

Summary: the objective of this study is to assess the safety, tolerability and pharmacokinetics of intravenous sildenafil (10 mg) administered as a bolus injection to patients with pulmonary arterial hypertension already receiving and stable on oral revatio 20 mg tid.


Eligibility criteria:
inclusion criteria: * subjects (≥18 years old) receiving oral revatio 20 mg tid for pah within the approved indication (eu summary of product characteristics) for a minimum of 1-month and who, in the investigator's opinion, have demonstrated good tolerability. subjects with pah who are nil by mouth for any reason (eg, elective surgery or medical procedure, tpn feeding, gastrointestinal disturbance etc) may also be included in the study provided they are haemodynamically stable (see inclusion criterion 4) and the 6 hour period of blood pressure and pulse monitoring in the study does not interfere with any planned medical or surgical intervention. * evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. * subjects who are willing and able to comply with scheduled visits, treatment plan and study tests and procedures. exclusion criteria: * any subject receiving revatio outside ('off-label') of the current summary of product characteristics (smpc). * other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. * introduction of potent cyp 3a4 inhibitors (eg, ketoconazole, itraconazole and ritonavir) within the previous 1 month of screening.

Keywords: sildenafil, revatio, pah, iv, bolus
gender differences and age related differences in emergency department admission

Conditions: Emergencies; Gender; Age Problem

Summary: the goal of this observational study is to learn about difference related to age and gender in patients admitted to emergency department.

objectives: medicine is progressively becoming aware of the clinical difference among patients who present different age, gender, and comorbidities. our goal is to examine how often different groups of patients access the emergency department and for which causes, as well as their different hospitalization and death rates. materials and methods: the investigators will collect and analyze data from all patients evaluated at the emergency department of "fondazione policlinico agostino gemelli" and "istituto clinico humanitas di milano" from january 2014 to december 2023, the sample obtained will be divided into four groups: younger than 50 years old, 50-65 years old, 66.75 years old, older than 75; each of these groups is divided between males, females and people who do not identify with either of those genders

Eligibility criteria:
inclusion criteria: * age over 18 y * admitted to emergency department exclusion criteria: * age under 18 y

Keywords: sex gender age emergency department
reduction and prevention of seizure occurrence from exposure to auditory stimulation in individuals with neurological handicaps

Conditions: Seizures; Epilepsy

Summary: neurologically-impaired individuals may have significant neurologic morbidity related to epilepsy and seizure disorders. finding safe, noninvasive methods of decreasing seizures, and potentially reversing the epileptogenic process, is of paramount importance in improving the lives of those with epilepsy.


Eligibility criteria:
inclusion criteria: * resident of thad e. saleeby center * epilepsy or seizure disorder * at least one year of detailed seizure reporting prior to study starting date exclusion criteria: * severe hearing impairment

Keywords: seizures epilepsy auditory stimulation music
a efficacy study of prx-00023 in patients with major depressive disorder

Conditions: Major Depressive Disorder (MDD)

Summary: the purpose of this randomized, double-blind, placebo-controlled study is to assess the safety and efficacy of prx-00023 in patients with major depressive disorder.

patients with major depressive disorder who meet all of the eligibility criteria will be randomly assigned to receive twice daily doses of either placebo or prx-00023. study drug will be taken for up to approximately 9 weeks. patients will have periodic office visits for the purpose of monitoring safety and tolerability, as well as efficacy assessments.

Eligibility criteria:
key inclusion criteria: * diagnosis of major depressive disorder key exclusion criteria: * females who are pregnant or nursing * electroconvulsive therapy within previous year * type 1 diabetes or uncontrolled type 2 diabetes * hiv, hepatitis b or hepatitis c * use of illegal drugs, history of drug abuse, and/or alcohol dependence * clinically significant abnormal lab results other protocol-defined eligibility criteria may apply.

Keywords: depression major depressive disorder major depression mdd
iit2023-09-chung-upfronttad: upfront tad/snb in patients with breast cancer with nodal metastases

Conditions: Breast Cancer; Axillary Nodal Disease; Female Breast Cancer; Axilla; Breast; Mastectomy; Lymphedema; Tumor, Breast

Summary: the purpose of the study is to determine the recurrence rates and survival of patients with clinical t1-2n0 er+/her2- invasive breast cancer who have biopsy proven image detected nodal disease treated with upfront lumpectomy or mastectomy with tad followed by adjuvant therapy. this is a prospective, single arm phase ii clinical trial. patients will be screened and enrolled per eligibility criteria. patient, tumor, and treatment data will be documented.


Eligibility criteria:
inclusion criteria: * women age ≥ 45 * clinical t1-2n0 er+ invasive breast cancer * us detected biopsy proven axillary nodal disease * written informed consent obtained from subject and ability for subject to comply with the requirements of the study. exclusion criteria: * palpable nodes on physical exam * her2+ or er- invasive breast cancer * extranodal extension \> 3 mm on nodal biopsy * more than 2 suspicious nodes on preoperative imaging

Keywords: t1-2n0 er+ invasive biopsy upfront lumpectomy
an open-labelled clinical trial of live attenuated varicella vaccines to evaluate the immunity persistence after primary immunization and safety and immunogenicity after the booster immunization

Conditions: Varicella

Summary: this is an open-labelled clinical trial of live attenuated varicella vaccines manufactured by sinovac (dalian) vaccine technology co., ltd .the purpose of this study is to evaluate the immunity persistence of the single-dose primary immunization of live attenuated varicella vaccine on different time points ,and the safety and immunogenicity after the booster immunization

this study is an open-labelled phase ⅲ clinical trial.the experimental vaccine manufactured by sinovac(dalian) vaccine technology co., ltd.a total of 1195 subjects who received vaccine in the phase ⅲ lot-consistency clinical trial were be enrolled .all subjects except c0243 and c0556 were divided into 3 groups according to the order of study number.subjects in 3 groups received a booster immunization of live attenuated varicella vaccines 1 year,2 years and 3 years after primary immunization,respectively.about 3.0ml of venous blood was collected from each enrolled subject at pre-booster immunization,30 days after booster immunization and the serum was separated for neutralizing antibody detection.the antibody levels were used to evaluate the immunity persistence and immunogenicity after booster immunization of live attenuated varicella vaccines .

Eligibility criteria:
inclusion criteria: * received one dose live attenuated varicella vaccine in the phase ⅲ lot-consistency clinical trial; * guardian(s) of the volunteer should be capable of understanding the written - consent form, and such form should be signed before the children being included into this study. exclusion criteria: * received one dose live attenuated varicella vaccine at the end of the phase ⅲ lot-consistency clinical trial; * according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
prophylaxis ephedrine or ondansetron prevents hypotension after spinal anesthesia for cesarean section

Conditions: Anesthesia; Adverse Effect, Spinal and Epidural

Summary: maternal hypotension after spinal anesthesia in parturients undergoing cesarean section is a very common problem leading to several complications to both patients and their babies. it can cause maternal discomfort, lightheadedness, nausea and vomiting. the most important complication is the decreasing blood flow to babies; which may lead to fetal acidosis. many interventions has been studied in order to prevent hypotension after spinal anesthesia in cesarean section e.g., fluid loading: colloid vs crystalloid, medications: ephedrine, phenylephrine, and metaraminol, etc. the recent study showed ondansetron (the antiemetic drug) can be effectively used to prevent hypotension after spinal anesthesia in normal patients or parturients. the action of ondansetron is believed to inhibit bezold-jarish reflex. this aim of this study is to compare the efficacy of ephedrine and ondansetron in the prevention of maternal hypotension after spinal anesthesia in cesarean section.


Eligibility criteria:
inclusion criteria: * age \> 18 years * elective cesarean section * patient accept spinal anesthesia * asa classification i-ii * term, singleton pregnancy * understand all process in this study exclusion criteria: * dm any type that not the gestational dm * hypertensive disorder * bmi\>40 * complicated pregnancy such as placenta previa, preeclampsia * allergic to study drugs * long qt syndrome * contraindication to spinal anesthesia

Keywords: prevention of hypotension spinal anesthesia cesarean section ephedrine ondansetron
population pharmacokinetics of fluconazole in the treatment of neonatal fungal infectious disease

Conditions: Fluconazole; Infection; Newborn; Pharmacokinetics

Summary: this study is based on the hypothesis that the pharmacokinetics of fluconazole in newborns and children are different from adults. we aim to study the population pharmacokinetics of newborns and children receiving the fluconazole for treatment of infectious diseases. in this study, we will detect fluconazole concentration in plasma by using residual blood samples of blood gas analysis and other clinical tests and employ computers for constructing population pharmacokinetic models. in addition, we also want to correlate use of fluconazole with treatment effectiveness and incidence of adverse effects in newborns and children. this novel knowledge will allow better and more rational approaches to the treatment of infectious diseases in newborns and children. it will also set the foundation for further studies to improve fluconazole therapies for newborns and children.

1. establish population pharmacokinetic (ppk) models of fluconazole in newborns and children by nonlinear mixed effect modeling (nonmem). at different timepoint after fluconazole administration, plasma samples of 50 newborns and children will be collected from neonatal intensive care unit (nicu) and pneumology department for fluconazole. the clinical information includes demography, medication, concentration data, blood biochemical parameters and so on . plasma samples will be tested by high performance liquid chromatography (hplc). ppk models of fluconazole will be established by nonmem program. the reliability and stability of the ppk model will be evaluated by 1000 times of bootstrap procedure and normalized predictive distribution error (npde). 2. evaluation of the clinical feasibility and safety of individualized dosing. according the results of ppk models, we will use dosages recommended in models to cure children infectious diseases in prospective studies. for fluconazole, 150 newborns and children will be collected. we will compare the therapeutic effects and safety between newborns and children with conventional therapies and those with individualized therapies, including proportions of newborns and children with effective fluconazole concentration, improvement speed of of newborns and children, liver and kidney functions, adverse reactions of drugs, and so on.

Eligibility criteria:
inclusion criteria: newborn （0-28d） with fluconazole against infectious diseases. the anti-infective therapy includes drugs commonly used in children infectious diseases. newborns infectious diseases include pneumonia, sepsis, purulent meningitis and other diseases with infection. informed consent signed by the parents and/or guardians. exclusion criteria: 1. allergic to any class of antibiotics; 2. receiving other experimental drugs; 3. there are other factors that clinicians consider unsuitable for inclusion in the study.
manage at work: addressing the challenge of chronic physical health conditions in the workplace

Conditions: Chronic Physical Health Conditions

Summary: the specific aim of the study is to evaluate the health benefits of a series of group workshops designed for workers with chronic physical health conditions. the facilitated workshops apply principles of pain and illness self-management to help workers deal with health-related challenges while at work. the workshops address issues of pain management, physical job demands, pacing of work, communication, problem solving, and coping. half of the participants in the study will be randomly assigned to attend workshop sessions (10 hours total), and all study participants will be followed for one year. the primary hypothesis is that workers who participate in these workshops will show improvements in work engagement and reductions in work limitation in the subsequent 12 months.

one significant trend in the us workforce is the advancing median age of workers and the growing prevalence of chronic medical conditions that contribute to workplace pain, fatigue, task limitations, and reduced productivity. the proposed multi-site study is a randomized, controlled trial of a multi-session group intervention program targeting workers with chronic health concerns (n = 300). the primary outcome measures will be self-report measures of work limitations and work engagement measured at baseline, 6 months, and 12 months follow-up. secondary outcomes will include turnover intention, sickness absence, job satisfaction, and healthcare utilization. process variables and covariates will include assessment of self-efficacy, work-related fatigue, emotional distress, work characteristics, general health status, and basic demographic variables. the study should provide an assessment of whether principles of symptom self-management can be successfully applied to workplace problems and delivered in a group workshop format to reduce the disabling effects of chronic medical conditions.

Eligibility criteria:
inclusion criteria: * workers with at least one chronic physical condition (\> 6 months). * working full time (at least 20 hours per week). * able to read and speak in english language. exclusion criteria: * impending retirement or major career change (next 12 months). * not available to attend group workshops after working hours.

Keywords: disability self-management chronic illness chronic pain occupation > 6 months