Kornimate/medical-research-clean huggingface dataset:
flexibility of cognition and persistent pain

Conditions: Pain, Postoperative

Summary: this observational study aims to determine the association between preoperative cognitive flexibility and the risk of developing ppsp by preoperative administration of cognitive tests.

postoperative pain is a normal, physiologic, protective response to tissue injury that routinely resolves after healing of the surgical site. however, in some patients, pain persists long after surgery. ppsp is a diagnosis of exclusion that has most consistently been defined as pain that (1) developed after a surgical procedure, (2) is not residual from a preexisting condition, (3) has lasted for at least two months, and (4) is not attributable to other causes. one suggested risk factor for ppsp is poorer performance on tests of cognitive flexibility. two common tests of cognitive flexibility are the trail making tests (tmt) a and b and the color word matching stroop test (cwmst). three hundred patients undergoing either total knee arthroplasty or thoracotomy/mastectomy will be enrolled. during preoperative evaluation, participants will complete the tmt and cwmst. subjects will be followed prospectively and will complete surveys at one month, six months, and one year postoperatively to assess ppsp prevalence and intensity.

Eligibility criteria:
total knee arthroplasty (tka) patients - inclusion criteria: adults age 18 to 85 undergoing unilateral tka for osteoarthritis english as primary language - exclusion criteria: bilateral procedure unable to complete cognitive testing surgical indication for condition other than osteoarthritis (i.e. rheumatoid arthritis, spondylarthropathy) prior knee surgery _________________________________________________ thoracotomy/mastectomy patients - inclusion criteria: females age 18 to 85 undergoing mastectomy for breast cancer or adults age 18 to 85 undergoing unilateral open thoracotomy or video-assisted thoracoscopic surgery (vats) for any non-cardiac etiology english as primary language - exclusion criteria: bilateral procedure unable to complete cognitive testing plan for breast reconstruction prior breast/thoracic surgery

Keywords: total knee arthroplasty thoracotomy mastectomy video-assisted thoracoscopic surgery (vats) persistent pain cognitive flexibility
survival analysis of oral cancer patients

Conditions: Head and Neck Cancer

Summary: this study aims to assess the survival rate of oral squamous cell carcinoma (oscc) patients following immediate mandibular reconstruction with vascularized fibula flap (vff) and to identify risk factors influencing the overall survival rate and postoperative outcomes.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of stage iv oscc * follow-up period more than one year. exclusion criteria: * non-neoplastic diseases * two-staged reconstruction * presurgical distant metastasis

Keywords: squamous cell carcinoma free fibula flap prognosis survival mandibular reconstruction
safety and efficacy of gx-188e administered via ep plus gx-i7 or imiquimod.

Conditions: Cervical Intraepithelial Neoplasia 3

Summary: this is a study to investigate the safety and efficacy of gx-188e administered im plus local administration of gx-i7 or imiquimod at cervix in subjects with cervical intraepithelial neoplasia (cin) 3.


Eligibility criteria:
inclusion criteria: * able and willing to comply with all study procedures and voluntarily signs informed consent form. * female subjects age 19-50 years. * hpv 16 and/or 18 positive. * colposcopy is satisfactory based on visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected cin disease area * histopathologically diagnosed with cervical intraepithelial neoplasia 3, cin 3. exclusion criteria: * pregnancy or breastfeeding * history of previous therapeutic hpv vaccination (individuals who have been immunized with licensed prophylactic hpv vaccines are not excluded). * positive serological test for hepatitis c virus or hepatitis b virus surface antigen (hbsag) or human immunodeficiency virus (hiv). * any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study.

Keywords: investigator trial cervical intraepithelial neoplasia
bedtime potassium losartan on ckd with nocturnal hypertension patients with nondipping blood pressure pattern

Conditions: Chronic Kidney Disease Patients

Summary: nondipping blood pressure (bp) pattern is a potential independent risk factor for chronic kidney disease (ckd). whether bedtime administration of potassium losartan has benefit for anti-hypertension and the prognosis of ckd patients is not clear. patients with nondipping bp pattern or dipping bp pattern were enrolled in this study, and the patients with nondipping bp pattern were randomly divided into two groups and treated with bedtime or awakening doses of potassium losartan.

patients with nondipping bp pattern or dipping bp pattern were enrolled in this study, and the patients with nondipping bp pattern were randomly divided into two groups and treated with bedtime or awakening doses of potassium losartan. any patients who had any antihypertension medication at bedtime would withdrawal the drugs for 2 weeks before abpm. patients with nondipping bp were then randomly divided into two groups and received a bedtime or awakening dose of potassium losartan. patients with dipping bp were called the dipper group, while the patients with nondipping bp were called the awakening dose group or bedtime dose group, according to the time of drug administration.

Eligibility criteria:
inclusion criteria: * night bp is sbp≥120mmhg and/or dbp≥70mmhg； * presence of ckd; * estimated gfr (egfr)\ 30 ml⁄ min ⁄1.73 m2; * signed informed consent from participating patients. exclusion criteria: * pregnancy; * tumor; * infection; * renal replacement; * history of drug or alcohol abuse; * night- or shift-work employment; * treatment with steroids or hormonal therapy; * acute changes in egfr \>30% in the past 3 months; * presence of acquired immunodeficiency syndrome; * cv disorders (unstable angina pectoris, heart failure, life-threatening arrhythmia, atrial fibrillation, kidney failure,and grade iii or iv retinopathy); * intolerance to ambulatory bp monitoring (abpm); * inability to communicate and comply with all of the study requirements.

Keywords: potassium losartan, ckd, nondipping bp pattern
physical exam indicated cerclage in singleton gestation 24 weeks to 25 weeks and 6 days gestation

Conditions: Preterm Birth

Summary: rct assessing preterm delivery rate in singleton pregnancies having a physical-exam indicated cerclage placed between 24 weeks and 25 weeks and 6 days. patients randomized to either cerclage intervention or routine standard of care (no cerclage).


Eligibility criteria:
inclusion criteria: 1. pregnant women 18 years of age or older 2. nulliparous patient, has not had a preterm to term delivery 3. singleton pregnancy 4. english or spanish speaking 5. asymptomatic cervical dilation between 1- 2 cm, without visible membranes beyond the external cervical os and without any evidence of infection, active labor or active bleeding between 24 0/7 and 25 6/7 weeks gestation exclusion criteria: 1. twin or higher order multi-fetal gestation 2. multiparous patient, has had one or more preterm to term deliveries 3. cervical dilation more than 2 cm either at the beginning of the study or any time during the study 4. amniotic membranes prolapsed beyond the external os 5. fetal reduction procedure performed during current pregnancy 6. ruptured membranes prior to randomization 7. major fetal structural anomaly 8. fetal chromosomal abnormality, suspected or confirmed with additional genetic testing 9. cerclage already in place for other indication 10. active vaginal bleeding 11. suspicion of chorioamnionitis 12. placenta previa 13. painful regular uterine contractions 14. history of preterm birth before 37 weeks gestation 15. non-english or non-spanish speaking a. given that the study is explained in person and consent forms are written in english, there is no guarantee that the study will be explained correctly when using a phone translator. the same is true if the current english consent form were to be translated into a language other than english. there is no way to confirm that the integrity of the study is being upheld by using translating services. if the integrity of the study is not upheld, then this poses harm to the patient. 16. women under 18 years of age
hemodynamic monitoring and resuscitation in hip fractures

Conditions: Fracture of Hip

Summary: background: fracture of the hip is a potentially fatal event in an elderly, frail, highly comorbid patient group suffering from dehydration and hypovolemia, and it carries a risk that equals major trauma in young patients in regard of physiological insult and severity, yet no preoperative resuscitation and transfusion strategy is available. an important goal of hemodynamic monitoring and resuscitation is early detection of insufficient tissue perfusion and oxygenation. the peripheral perfusion index reflects changes in peripheral perfusion and blood volume and a decreased peripheral perfusion index predicts surgical complications and morbidity in acute surgical and septic shock patients. the research group hypothesize that elderly frail patients with a fracture of the hip suffer from hypovolemia and peripheral hypoperfusion of varying degrees and accordingly respond to controlled fluid resuscitation and that the non-invasive peripheral perfusion index will serve as an early predictor of a deteriorated circulation in reflection of stroke volume. methods: the main objective of this prospective observational study is to assess to what extend patients with fracture of the hip suffer from hypovolemia and respond to a fluid challenge. the secondary objectives are to evaluate correlation between the minimally-invasive measurements of stroke volume and blood volume and the non-invasive measurement of peripheral perfusion index and near-infrared spectroscopy, as well as prevalence of postoperative complications and mortality. fifty consecutive patients over the age of 65 years, presenting with a hip fracture, treated in a multimodal fast-track regimen, will be included when written informed consent is available. all patients will receive epidural analgesia and preoperative stroke volume-guided hemodynamic optimization. blood volume measurements are performed and all patients are monitored with peripheral perfusion index and near-infrared spectroscopy. discussion: this is likely the first study to address clinically applicable hemodynamic monitoring and resuscitation in patients with fracture of the hip where adequate resuscitation is easily missed. the study group aim to evaluate the feasibility of preoperative stroke volume-guided hemodynamic optimization in the context of minimally- and non-invasive monitoring of peripheral perfusion and blood volume measurements.


Eligibility criteria:
inclusion criteria: * primary acute hip fracture * age grater than 65 years * written informed consent exclusion criteria: - contraindications to epidural analgesia

Keywords: peripheral perfusion blood volume tissue prefusion near-infrared spectroscopy hemodynamic monitoring hemodynamic optimization preoperative resuscitation
nutritional status and hidradenitis suppurativa (acne inversa)

Conditions: Hidradenitis Suppurativa; Mediterranean Diet; Body Composition; Vitamin D Deficiency; Trimethylamine N-oxide (TMAO)

Summary: hidradenitis suppurativa (hs) is a chronic inflammatory, debilitating skin disorder. the exacerbating factors of hs include nutrition and adiposity. the objective of this study was to investigate the relationships between body composition and the adherence to the mediterranean diet (md) with the severity of hs in a sample of naïve-treatment patients with hs. in the wake of this evidence, in the study to investigate the relationships between nutritional status, the adherence to the md, body composition, and the severity of hs in a sample of naïve-treatment patients with hs compared to control group matched for sex, age, and body weight.


Eligibility criteria:
inclusion criteria: * healthy subjects of both gender * treatment-naïve patients * had hs diagnosed ≥6 months before study initiation wash out therapy for at least 3 months exclusion criteria: * occasional or current of use of drugs for hs, including topical antibiotics and systemic treatments (such as clindamycin-rifampicin, tetracycline, rifampicin-moxifloxacin-metronidazole, ertapenem, acitretin, cyclosporine a, dapsone, isotretinoin, biologics; * hypocaloric diet in the last three months or specific nutritional regimens; * vitamin/mineral or antioxidant supplementation; * occasional or current of use of drugs that could influence fluid balance, including non-steroidal anti-inflammatory drugs, hormone replacement therapy.
chest drain regular flushing in complicated parapneumonic effusions and empyemas

Conditions: Empyema, Pleural; Pleural Infection

Summary: infections of the pleural space are common, and patients require antibiotics and chest drain placement to evacuate the chest from the infected fluid. chest drains can get blocked by the drainage fluid and material. for this reason, it is thought that flushing the chest drain with saline solution, can help maintain the patency of the tube. this proposed study will evaluate the impact of regular chest drain flushing on the length of time to chest tube removal and total hospitalization as well as improvement in chest imaging and the need for additional interventions on the infected space.

there are no randomized controlled trials (rcts) evaluating the role of regular chest tube flushing in the setting of pleural space infection for optimal drainage and treatment outcomes. most studies of \<16 fr catheters have used both flushing and suction to decrease the likelihood of catheter blockage and improve drainage efficiency, however, this practice has never been studied prospectively or in rcts. regular flushing (e.g., 20-30 ml saline every 6 h via a three-way tap) is recommended for small chest drains by the british thoracic society (bts) 2010 guidelines. this practice is followed variably by some and not used by others. importantly, the role of this practice in successful drainage of infected fluid, and patient-centric outcomes has not been investigated. inconsistent flushing practices confound the interpretation of therapeutic modalities (such as intrapleural tissue plasminogen activator and deoxyribonuclease therapy) success or lack thereof and limit the execution of rcts and prospective studies of the pleural space in the setting of infection.

Eligibility criteria:
inclusion criteria: * patients with complicated parapneumonic pleural effusion and empyema requiring chest tube placement as standard of care for inpatient management of their pleural space infection with or without intrapleural tissue plasminogen activator and deoxyribonuclease therapy * age \> 18 years old. exclusion criteria: * patients who have surgical tubes that can't accommodate a three-way stopcock. * study subject has any disease or condition that interferes with the safe completion of the study. * inability to provide informed consent. * inability to undergo a chest x-ray. * if the managing clinician believes the chest tube will be placed for less than 24 hours. * patients with an indwelling pleural catheter (ipc)

Keywords: empyema pleural infection chest tube saline flush
gene-activated bone substitute for maxillofacial bone regeneration

Conditions: Bone Cysts; Bone Atrophy; Bone Deformity; Bone Fracture; Bone Loss; Tooth Loss

Summary: the purpose of this study is to evaluate the safety and efficacy of the gene-activated bone substitute consisting of octacalcium phosphate and plasmid dna encoding vascular endothelial growth factor (vegf) for maxillofacial bone regeneration. the patients with congenital and acquired maxillofacial bone defects and alveolar ridge atrophy will be enrolled.

all participants of the study will receive standard treatment according to the medical care standards for diseases and pathological conditions characterized by maxillofacial bone defects and/or alveolar ridge atrophy. bone grafting procedures as part of the surgical treatment will be performed with the use of investigated medical device. the safety and efficacy of the implanted gene-activated bone substitute will be evaluated by clinical examination, comprehensive laboratory tests, and computer tomography within 6 months after surgery.

Eligibility criteria:
inclusion criteria: * obtained voluntary informed consent for participation in the clinical study; * congenital and acquired maxillofacial bone defects (sockets of extracted teeth, bone defects after injuries, surgeries, removal of benign neoplasms and pseudotumors, etc.) or alveolar ridge atrophy. exclusion criteria: * not able or unwilling to give voluntary informed consent for the study or follow requirements of the clinical study; * decompensated chronic visceral diseases; * clinically significant laboratory abnormalities; * hiv, hbv and hcv antibodies in serum; * alcohol consumption within 4 days prior the study; * history of drug addiction; * participation in other clinical trials (or administration of study products) within 3 months prior the study; * conditions limiting study compliance (dementia, psycho-neurological diseases, drug addiction, alcoholism, etc.); * pregnancy or lactation; * malignancies including post-treatment period (surgical, chemotherapy, radiation therapy both alone and in different combinations) less than 5 years prior the study.

Keywords: gene-activated matrix bone substitute bone grafting dental implantation gene therapy plasmid dna vegf gene octacalcium phosphate
assessment of incidence of sars-cov-2 infection and covid-19 in brazil (avisa)

Conditions: COVID-19

Summary: this is an observational study, meaning that no interventions is tested, to determine incidence of sars-cov-2 infection and covid-19 in different clinical sites in brazil in several age groups. the study aims to assess baseline number of infected participants and perform a follow-up along two years to determine the new cases occurring among participants during the period. all participants will collect blood samples to get more details on the immune response.

this is an observational longitudinal study to assess incidence of sars-cov-2 infection in brazil. the study sample is stratified in nine age groups according decades of life, equally distributed in both sexes, with an expected incidence of 10%, at least, during the study period of 24 months. for the first age groups, (0-9, 10-19 and 20-29 years), sample was calculated with the minimum expected incidence of covid-19 among infected, regardless severity, is 10%. for the latest age groups (30-39, 40-49, 50-59, 60-69, 70-79 and 80+), the sample was calculated with the expected minimum incidence of hospitalization due to covid-19 according to estimates per age group reported by verity r et al. https://doi.org/10.1016/s1473-3099(20)30243-7 after the consent procedure, all participants will have a short interview, a igg/igm sars-cov-2 rapid test and a blood withdrawal to obtain serum for neutralizing antibodies. these procedures will be repeated every four weeks until the end of the study. individuals with symptoms compatible will be followed-up to confirm covid-19 diagnosis as well as to assess severity, need for hospitalization and assisted ventilation, sequels, and eventual reinfection. levels of neutralizing antibodies and other immune markers will be prospectively assessed in all infected participants, either asymptomatic and symptomatic.

Eligibility criteria:
inclusion criteria: * any sex or age * providing informed consent * agreement with all study visits, procedure and contacts exclusion criteria: * previous suspected or confirmed covid-19 * febrile illness in the latest 72 hours * olfactory or gustatory dysfunction in the last three months * healthcare worker in a service with routine attention to covid-19 patients * any conditions that can might hurdle participant's compliance to the study in tha opinion of the study team

Keywords: covid-19 sars-cov-2 infection asymptomatic infections antibodies, neutralizing immunity, humoral
occupational respiratory allergies and gene-environment interactions

Conditions: Work Related Asthma

Summary: the purpose is to compare clinical, functional, professional and socio-economical characteristics of patients with occupational asthma and work aggravated asthma. secondary purposes are: * to evaluate diagnostic value of new non-invasive techniques such as exhaled nitric oxide and cytology of induced expectoration; * to estimate medical-social becoming of diagnosed work-related asthma after one year; * to establish a biobank of blood samples of individuals with work related asthma for measurement of cytokines and search for genetic polymorphisms associated with asthma.

participants with work related asthma or suspected work related asthma will obtain a precise diagnosis concerning severity and control of respiratory disorder and also the possible effect of professional environment on the disorder. their medical care and medico-legal care, in case of recognition of occupational disease, could be ameliorated. in general, this study will allow the harmonization of diagnostic care and medical, medico-professional and medico-legal management of cases of work related asthma in specialized hospitals.

Eligibility criteria:
inclusion criteria: - patient consulting for suspected work-related asthma in one of hospitals participating to the study exclusion criteria: * patient refusing to participate * pregnant or breastfeeding women * individual in life-threatening emergency * hospitalized patient * patient in a health or social institution * person deprived of liberty * person with total occupational disability * retired person * person diagnosed as non-asthmatic * asthmatic person already enrolled in a clinical trial of bio-therapy to treat asthma
surgically resected crohn's disease patients: prognostic factors for re-operation and new score building

Conditions: Crohn Disease

Summary: the project will consist of a multicentre, prospective, observational study with a total duration of 24 months. clinical, endoscopic and ultrasound data will be collected in a dedicated database (on ig-ibd register), which will be used to identify potential clinical, endoscopic and ultrasound risk factors of re-operation. these data could be merged into a shared score, to stratify patients according to the risk of post-surgical re- operation and to define an optimal therapeutic management in the post- operative period. approximately 220 adult patients, with a defined diagnosis of cd, who underwent a surgery for cd in the previous 6 months will be enrolled.

patients will be consecutively enrolled in this prospective cross-sectional study, during the first 12 months, and then followed for 12 (minimum) up to 24(maximum) months, depending on date of patients' enrolment (total study length: 2 years). patients will be stratified according to risk factors and type of treatment carried out in that year

Eligibility criteria:
inclusion criteria: * male and female patients aged 18 to 65 years, inclusive * diagnosis of crohn's disease (cd) for at least 6 months prior to enrolment, by clinical, endoscopic and histopathologic evidence * first surgery for cd performed less than 6 months before enrolment (no second surgery allowed) * ability to provide written informed consent and to be compliant with the schedule of protocol assessments exclusion criteria: * diagnosis of ulcerative colitis or indeterminate colitis * crohn's disease isolated at stomach, duodenum, jejunum, or perianal region, without ileo-colonic involvement * more than one surgery for luminal cd * current stoma or need for ileostomy or colostomy * clinically relevant diseases making interpretation of the trial difficult or that would put the patient at risk of severe complications, in the opinion of the investigator * inability to provide written informed consent and poor compliance with the schedule of protocol assessments