Kornimate/medical-research-clean huggingface dataset:
dexmedetomidine and delirium in elderly patients

Conditions: Delirium, Dexmedetomidine, Postoperative PCA

Summary: investigators investigates the effect of perioperative dexmedetomidine 0.5 ug/kg/hr followed by a postoperative continuous infusion fentanyl-based pca(patient-controlled analgesia) drug mixed with dexmedetomidine 0.2ug/kg/hr for two days on reducing postoperative delirium and postoperative rescue analgesics in elderly patients who undergo hip surgery. the other half of patients received fentanyl-based pca only.

elderly patients are susceptible to postoperative delirium. delirium occurs in 10\~60% and is associated with longer hospital stays, increased costs, and morbidity. postoperative delirium usually occurs 2\~3 days after surgery. intraoperative infusion of dexmedetomidine lacks preventing postoperative delirium in elderly noncardiac major surgery. we hypothesized postoperative dexmedetomidine for two days as a mixture drug of fentanyl-based pca could reduce the incidence of postoperative delirium. we compared this effect with other control group who received fentanyl-based pca only. we also investigate eeg patterns of patients during emergence and compared the eeg patterns who developed delirium postoperatively in pacu(postanesthesia care unit) or general ward. dexmedetomidine has analgesic effect. we expected postoperative dexmedetomidine has benefits of opioid sparing effects.

Eligibility criteria:
inclusion criteria: over 65 yrs old elderly patient who undergo elective hip surgery and asa(the american society of anesthesiologists) physical status i-iii exclusion criteria: history of dementia, drug abuser, hypersensitivity to dexmedetomidine, fentanyl, propofol, disable to speech, reject the clinical study, hemodynamic instability during surgery, an illiterate, pregnancy
treatment of bv with first deqularum and then direkt after clindamycin

Conditions: Infection, Bacterial

Summary: treatment of bv with first deqularum cloride and then followed with clindamycin vaginal cream.

the hypoteses is that deqularum cloride takes away the biofilm so that clindamycin will kills the bacteria. cure rate will be followed up after 1 month and then after 6 month

Eligibility criteria:
inclusion criteria: * healthy women with bv exclusion criteria: * women treated with antibiotics within 1 month
duffy-null associated neutrphil count (danc) pediatric patients

Conditions: Neutropenia Autoimmune

Summary: there are currently no clinical and laboratory data that well characterize this neutropenia associated with the duffy-null phenotype, particularly for pediatric subjects. in particular there are no data on the frequency of immune neutropenia in danc neutropenic pediatric subjects. the goal of this study is to : * define the frequency of immune neutropenia within the cohort of danc subjects under study * evaluate the frequency of different degrees of neutropenia (mild-moderate-severe); * evaluate the possible association between different degrees of neutropenia and the presence of infections.


Eligibility criteria:
inclusion criteria: * presence of duffy-null phenotype exclusion criteria: * absence of duffy-null phenotype
prevention of breast cancer recurrence through weight control, diet, and physical activity intervention

Conditions: Breast Neoplasms; Recurrence

Summary: the main purpose of our study is to assess the effect of a lifestyle intervention combining weight control, diet and physical activity on the risk of recurrences among breast cancer patients with non-metastatic tumours in terms of 5-year cumulative incidence of recurences.

background/main objective: the main purpose of our study is to assess the effect of a lifestyle intervention combining weight control, diet and physical activity on the risk of recurrences among breast cancer patients with non-metastatic tumours. as secondary objectives we aim to assess whether the proposed intervention is able to improve the overall survival or the disease-free survival, as well as quality of life of breast cancer patients. methodology: this multicentric randomized controlled trial aims to include 2108 women (1054 per arm), aged up to 75 years, diagnosed with a non-metastatic breast cancer (stage i, ii, iiia) in the participating centres, whose standard treatment was completed within the last 3 months. participants will be assigned to either an intervention or a control group, and followed for five years. patients assigned to the control arm will continue with the usual care, including standard guidelines for weight control applied in the centre. patients in the intervention group will be involved in a lifestyle program with two components. the dietary part will aim to achieve a calorie reduction while maintaining nutritional quality; the physical activity part will include supervised sessions of moderate intensity. data will be analyzed on an intention to treat basis using time-toevent analysis. hypotheses: we expect a significant reduction in the 5-year cumulative incidence of recurrences (primary outcome) in the intervention group. furthermore, as secondary outcomes, we expect a significant increase in overall survival and an improvement of quality of life of patients included in the intervention arm.

Eligibility criteria:
inclusion criteria: * incident primary breast cancer (icd-o c50) * stage at diagnosis i, ii, iiia (or t1-3, n0-n2, m0) * age at diagnosis below 76 years * within 3 months since completion of standard treatment (excluding hormonal therapy) and within 15 months since the diagnosis of the disease exclusion criteria: * morbid obesity (bmi \>40kg/m²) or underweight (bmi \<18kg/m²) * ischemic heart disease (coronary syndrome, unstable angina or myocardial infarction) or cerebrovascular incident (ischemic or hemorrhagic) during the previous 12 months * diabetes (only if unstable - glycosylated haemoglobin \>9%) * current medical or surgical treatment to lose weight * mental illness that would prevent the patient from carrying out the intervention * logistical factors which would prevent the patient from carrying out the intervention (distance to travel, work or family commitments) * pregnant or planning pregnancy

Keywords: breast neoplasms recurrence motor activity diet quality of life
assessment of patient experience and needs for patients undergoing invasive inguinal lymph node procedures for penile cancer

Conditions: Penile Cancer

Summary: to learn more about the patient experience undergoing inguinal (in the groin) lymph node procedures for penile cancer during and after surgery.

objectives primary objective: to understand the lived experience of patients undergoing invasive inguinal lymph node procedures. secondary objective: to determine factors that influence decisions and improve experience for patients who need invasive inguinal lymph node procedures.

Eligibility criteria:
inclusion criteria: --patients diagnosed with penile cancer who have undergone invasive inguinal node procedures (ilnd and/or dsnb) and are at least 6 months post-procedure exclusion criteria: * patient's ≤18 years of age * patients who have not undergone invasive surgical procedures involving the inguinal lymph nodes * non-english-speaking patients for interviews: people who are physically and/or cognitively incapable of participating in a 60minute telephone interview as determined by a clinical provider or the patient.
diabetes toolkit at discharge

Conditions: Diabetes Mellitus, Type 2; Insulin Dependent Diabetes

Summary: the purpose of this randomized clinical trial is to implement the dm discharge toolkit into hospital discharge and assess the effect of the dm discharge toolkit on patients newly requiring insulin.

this study is a randomized controlled trial with a parallel group design of up to 120 study participants in a 1:1 ratio to receive either current standard of care discharge dm training (control) or current standard of care discharge dm training and the dm discharge toolkit (intervention) before or immediately after being sent home to assume self-dm care with insulin.

Eligibility criteria:
inclusion criteria: * english speaking patients * 18 years of age and older * expected survival \>90 days * need for new insulin at time of hospital discharge exclusion criteria: * patients with the inability to give informed consent * non-english speaking * not diagnosed with diabetes * not been newly prescribed insulin

Keywords: insulin hospital discharge transitions of care
a multicentre, randomised, open-label study to compare the efficacy and safety of azithromycin for 5 days with those of amoxicillin-clavulanic acid in patients with chronic bronchitis

Conditions: Bronchitis, Chronic

Summary: this study compared the clinical efficacy and safety of azithromycin with that of amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with an exacerbation of chronic bronchitis.


Eligibility criteria:
inclusion criteria: inclusion criteria: * outpatients presenting with an exacerbation of chronic bronchitis including: chronic bronchitis with obstructive respiratory disorders documented by a forced expiratory volume of below 80% and higher than 35% of the theoretical value, within the previous 12 months; and thought to be of infectious origin exclusion criteria: exclusion criteria: * patient not presenting with the associated signs of an exacerbation * patient presenting with clinical signs suggestive of pneumonopathy at inclusion * patient requiring hospitalisation in intensive care
progesterone vaginal pessary for prevention of preterm twin birth

Conditions: Preterm Birth

Summary: multiple pregnancies accounted for 1 - 6 % of all births in uk during 2007. more than 98% of these multiple births being twin births . preterm birth defined as birth occurring prior to 37 weeks of gestation and it was about 15 % of pregnancies in developed world and 12.7 % in the united states. preterm birth is the leading cause of infant and neonatal mortality. premature neonates are at increased risk of developing respiratory distress syndrome, sepsis, intraventricular hemorrhage, and necrotizing enterocolitis. twin pregnancy is considered one of the important risk factors of preterm birth. over distension of uterus may be one of the etiological factors for preterm birth. however, no definite effective interventions have been shown to prevent preterm delivery in twin pregnancy. three large randomized trials suggested that progesterone might prevent preterm delivery in high-risk singleton pregnancy especially those with previous preterm delivery or short cervix might be reduced by antenatal progesterone. fonseca et al (2007) concluded that women with short cervix are less likely to deliver preterm ≤34 weeks if they are treated with vaginal progesterone.


Eligibility criteria:
inclusion criteria: 1. diamniotic twin pregnancy 2. gestational age ± 28 weeks. exclusion criteria: 1. higher multiple pregnancy 2. iufd of one or both fetuses 3. any congenital anomalies 4. iugr or discordant twins 5. prom 6. if there is any contraindication to progesterone treatment 7. women who did performed cervical cerclage in the current pregnancy 8. difficult in follow up for the pregnant women as (living faraway area, or difficult transportion, etc). 9. threatened preterm labor. 10. polyhydromnis. 11. other medical disorder with pregnancy

Keywords: preterm birth twin pregnancy progesterone
sadbe for congenital melanocytic nevi

Conditions: Congenital Melanocytic Nevus

Summary: a study to evaluate the safety and efficacy topical squaric acid dibutylester (sadbe) for the neoadjuvant treatment of congenital melanocytic nevi (cmn).

patients with cmn and plans for elective surgical resection of their nevi will be enrolled in the study. two clinically similar areas within the planned excision site will be identified, marked and treated with sadbe or the placebo solution. following surgical resection, samples from the excised nevi will be taken and assessed for number of melanocytes. incidence of adverse events will also be collected.

Eligibility criteria:
inclusion criteria: * 18 years of age or older. * subject or parents willing and able to give informed consent, and assent as appropriate. * patients who have a clinical diagnosis of cmn with plans for elective non-urgent excision of part or all of their nevus, with nevus surface area of \> 6 cm2. exclusion criteria: * immunosuppressive therapy with glucocorticoid or other systemic immunosuppressant within 4 weeks of recruitment (except for inhaled corticosteroids for asthma). * history of malignancy. * history of organ transplantation. * known immunosuppressive disease, including infection with hiv. * severe medical comorbidities (diabetes mellitus requiring insulin, chf of any severity, mi, cva, or tia within 3 months of screening visit, unstable angina pectoris, oxygen-dependent severe pulmonary disease) * subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit. * subjects who have known hypersensitivity to sadbe or any of its components. * any condition judged by the investigator to cause this clinical trial to be detrimental to the patient.
pre-surgical evaluation for the quantra system in adult patients undergoing cardiac surgery

Conditions: Blood Loss, Surgical

Summary: this study will evaluate the performance of the quantra system comprised of the quantra hemostasis analyzer with the qplus cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.

the quantra system is a fully integrated and automated in vitro diagnostic device which uses seer sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. the quantra qplus cartridge was developed to monitor hemostasis during major surgical procedures in adult patients. the cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system. this single-site, prospective, observational study will evaluate the performance of the quantra system as compared to standard coagulation tests and comparable measures determined using teg in patients taking antiplatelet medication that are scheduled to undergo cardiac surgery.

Eligibility criteria:
inclusion criteria: * subject is scheduled for elective cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular assist device * subject was identified as taking antiplatelet medication, specifically a p2y12 inhibitor such that a teg platelet mapping test is prescribed prior to surgery to assess possible platelet inhibition * subject is ≥ 18 years * subject is willing to participate and he/she has signed a consent form exclusion criteria: * subject is younger that 18 years * subject is unable to provide written informed consent * subject is incarcerated at the time of the study * subject is pregnant * subject is currently enrolled in a distinct study that might confound the results of the proposed study * subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks.

Keywords: viscoelastic testing coagulation quantra hemostasis
red blood cell precursor formulation to determine increased production

Conditions: Anemia

Summary: the objective of this study is to measure the change in hemoglobin levels after the administration of an amino acid based, rbc precursor formulation.

medical foods are a distinct fda regulatory category different from single molecule chemical pharmaceuticals, and from dietary supplements. the fda has regulated amino acid preparations as drugs since the 1940s as they can elicit pharmacologic effects similar to conventional single molecule pharmaceuticals. the best known amino acid preparations are used to treat conditions such as maple syrup disease and phenylketonuria (pku). an official definition and categorization of medical foods was made in 1988 as part of the orphan drug act. medical foods are regulated similarly to drugs except they do not require pre-approval because all ingredients are found on the fda's generally recognized as safe (gras) (sections 201(s) and 409 of the federal food, drug, and cosmetic act) list and claims are confined to the nutritional management of a specific disease. medical food claims must be supported by recognized scientific data as determined by medical evaluation. a gras substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use. the standard for an ingredient to achieve gras status requires not only technical demonstration of non-toxicity and safety, but also general recognition of safety through widespread usage and agreement of that safety by experts in the field. many ingredients have been determined by the fda to be gras, and are listed as such by regulation, in volume 21 code of federal regulations (cfr) sections 182, 184, and 186.

Eligibility criteria:
inclusion criteria: 1. m/f patients 18 to 75 years old, non-pregnant/lactating 2. male patients with \< hemoglobin of 12.5 3. female patients with \< hemoglobin of 11 4. diagnosis of mild to moderate anemia by study physician exclusion criteria: 1. pregnant or unwilling to use adequate birth control for the duration of the study. 2. unwilling or unable to sign informed consent. 3. myocardial infarction within the last 6 months. 4. patients currently taking an erythropoietin medication and unable to discontinue for the duration of the study. 5. gi bleed in the last 6 months. 6. inflammatory bowel disease. 7. chronic liver disease.
ultrasonographic characterization of parametrial lesions in deep endometriosis: a diagnostic-accuracy study (ultra-parametrendo iii)

Conditions: Endometriosis

Summary: this is a single-center, prospective diagnostic-accuracy study. all women who will undergo surgery for de after preoperative ultrasound for six consecutive months will be included. anamnestic and preoperative (physical objective and ultrasonographic) data of these patients will be collected. surgical and pathological data will be analyzed to confirm the presence of parametrial de.

this is a single-center, prospective diagnostic-accuracy study. all women who will undergo surgery for de after preoperative ultrasound for six consecutive months will be included. anamnestic and preoperative (physical objective and ultrasonographic) data of these patients will be collected. surgical and pathological data will be analyzed to confirm the presence of parametrial de. all the study procedures are done according to our clinical practice. demographic and ultrasonographic data will be collected from the preoperative evaluation, which is routinely done at our institution by four ultrasonographic expert in diagnosing deep endometriosis. surgical and pathological data will be collected during surgical procedures and hospital stay.

Eligibility criteria:
inclusion criteria: * clinical suspicion of de, for which a preoperative transvaginal ultrasonographic assessment and laparoscopic surgical approach will be indicated; * age \> or equal to 18 years * informed consent for the participation in the study and for personal data treatment. exclusion criteria: * previous surgical diagnosis of parametrial de; * previous radiological diagnosis of parametrial de including techniques used to diagnose de (such as magnetic resonance \[mri\], computed tomography-based virtual colonoscopy \[ctc\] or double-contrast barium enema); * previous bilateral ovariectomy.
vr for pediatric burn dressing changes

Conditions: Pain; Burns

Summary: this study evaluated a smart phone virtual reality (vr) to manage pediatric burn dressing pain. a randomized controlled trial was conducted among 90 patients (6-17 years). active vr participants played the game, passive vr group were immersed in the same vr without interactions, and a standard care group served as the control. one researcher administered vr and observed pain while another researcher administered post-trial survey that measured child's perceived pain and vr experience. nurses were asked to report the clinical utility.


Eligibility criteria:
inclusion criteria: * children age 6-17 years (inclusive) * admitted or seen in the outpatient clinic for a burn injury * spoke english as primary language exclusion criteria: * a severe burn on the face or head that prevented the utilization of the vr * cognitive or motor impairment that prevented valid administration of study measures * visual or hearing impairments that prevented interaction with the vr environment * did not have a legal guardian present to give consent

Keywords: pediatrics burns pain virtual reality
application of prevena in reducing surgical site complications following reversal of ileostomy or colostomy

Conditions: Stoma Site Infection; Ileostomy - Stoma; Colostomy Stoma

Summary: surgical site infections (ssi) remain one of the most common complications associated with reversal of ileostomy and colostomy. in addition to having detrimental impacts on the patient's post-operative course, they also pose significant financial ramifications. there have been comparative studies in the use of negative pressure wound therapy in reducing surgical site infections. prevena incision management system is a type of disposable, customizable and powered negative pressure system designed to help manage and protect surgical incisions and their surrounding environment. it is now commonly used as a surgical wound dressings in the setting of vascular surgeries, post-cesarean infections and colorectal resections. our study is designed as a randomised controlled trial to examine if prevera therapy as a npwt is more superior than conventional dressings in reducing the rate of surgical site infections.

background: surgical site infections (ssi) remain one of the most common complications associated with reversal of ileostomy. in addition to having detrimental impacts on the patient's post-operative course, they also pose significant financial ramifications. the use of negative pressure wound therapy (npwt) is one strategy that has been extensively studied in reducing the rate of surgical site infections. prevena therapy is a form of incisional negative pressure wound therapy (inpwt) that has been widely used in the management of closed surgical incisions. they are delivered as prophylactic measures in preventing surgical complications such as surgical site infections. trial design: this study is designed as a randomized, controlled, open-label, multi-center superiority trial with 2 parallel groups and primary endpoint of surgical site infection at day 7 (after 7-day use of prevena) and day 30. study setting the trial will be conducted at two different hospitals located in dublin, ireland: st james hospital - ireland's largest acute academic teaching hospital (academic partner - trinity college dublin); tallaght university hospital - (academic partner - trinity college dublin)

Eligibility criteria:
inclusion criteria: * patients aged over 18 years old * patients undergoing elective reversal of ileostomy/colostomy * patients who agree to consent to inclusion and follow-up protocol exclusion criteria: * patients who do not fulfil study protocol * dressings being removed outside defined time periods * patients who do not attend for regular outpatient follow up appointments