Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics of nystatin lf i.v. in patients with acquired immune deficiency syndrome-related complex (arc)

Conditions: HIV Infections

Summary: to define the pharmacokinetic characteristics of nystatin lf iv (intravenous) in human subjects with aids-related complex (arc) after administration of a single iv dose at each of 4 dose levels.


Eligibility criteria:
inclusion criteria patients must have the following: * positive hiv antibody test. * diagnosis of aids-related complex (arc). * cd4+ cell count between 100 and 300 cells/mm3. * estimated life expectancy of at least 6 months. * normal neurological status. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * active opportunistic infection requiring ongoing therapy except patients being treated topically for oral thrush. patients with the following are excluded: * active opportunistic infection. * known hypersensitivity to polyene antibiotics. * unwillingness to sign an informed consent or to be in compliance of protocol requirements. prior medication: excluded within 72 hours of study entry: * biologic response modifier agents. * corticosteroids. * cytotoxic chemotherapeutic agents. * potential nephrotoxins. * potential neutropenic agents. * rifampin or rifampin derivatives. * systemic anti-infectives. * phenytoin or barbiturates (inducers of microsomal enzymes). * all systemic medications. prior treatment: excluded within 72 hours prior to study entry: * radiation therapy. active alcohol or drug abuse unless they have been off drugs and/or alcohol for two weeks prior to start of study.

Keywords: nystatin acquired immunodeficiency syndrome aids-related complex
efficacy of a novel in prevention of neonatal hypothermia

Conditions: Hypothermia; Newborn; Preterm Birth

Summary: the research was carried out to determine the effect of baby warmer swaddle, which has a heating system used after the birth of preterm babies, on the development of hypothermia. design: randomized controlled clinical trial setting: the research was carried out in the nicu of a training and research hospital in istanbul. method: a total of 65 babies between 32-37 weeks of gestation were included in the study. in accordance with the routine procedure of the clinic, preterm babies wrapped in polyethylene bags after birth formed the control group (n=33), while babies wrapped in polyethylene bags and placed in a swaddle with a heating system formed the experimental group (n=32).

although neonatal hypothermia has higher rates especially in underdeveloped and developing countries, it is a global health problem also seen in developed countries. in a meta-analysis study, the prevalence of neonatal hypothermia was reported as 57.2% in east africa. in a multicenter, prospective study, 79.6% of preterm newborns were admitted to nicus with hypothermia in ethiopia. in a study, the incidence of hypothermia to be 53% in the first 24 hours of life in preterm infants they conducted in a hospital in france. in a study, in 28 countries with upper-middle income status, admission temperature data of a total of 454,617 very low birth weight infants from 2009 to 2016 were analyzed. although these data showed an improvement in hypothermia rates ranging from 52.6% (2009) to 38.2% (2016), approximately 4 out of 10 infants experienced hypothermia when admitted to the nicu. similarly, in the united kingdom, the national neonatal monitoring program reported the prevalence of hypothermia as 28% and 25% for babies born in 2015 and 2016, respectively, emphasizing hypothermia as an ongoing problem.

Eligibility criteria:
inclusion criteria: preterms; * between 32-37 gh, * with an indication for hospitalization in the nicu, * with a body temperature of 36.4 °c and above in the axillary route immediately after birth, * with a maternal body temperature between 36.4 °c and 38 °c in the tympanic route are included in the study exclusion criteria: preterms; * with congenital anomalies, * who were transported to another hospital, or who were transported to the hospital where the research was conducted from an external center

Keywords: hypothermia newborn body temperature changes preterm birth
impact of statin therapy on muscle mitochondrial function and aerobic capacity

Conditions: Mitochondrial Diseases

Summary: the purpose of this study is to test how different doses of a statin, lipitor, affect muscle health and function, and cardiovascular fitness.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 25-43 * weight stable (no more than 5% change in body weight the previous 3 months) * \>5% risk for a cardiovascular event in the next 10 years according to the 2013 american college of cardiology/american heart association risk calculator and/or 2 out of 5 metabolic syndrome risk factors (triglycerides ≥ 150 mg/dl; hdl ≤ 40 mg/dl; glucose ≥ 100mg/dl; waist circumference ≥ 102cm for males, 88cm for females; blood pressure: ≥ 130mmhg systolic and/or 85mmhg diastolic or being treated for hypertension) and/or ldl-cholesterol \>120 mg/dl. * stable doses of medications for 90 days * willing to stop all nonsteroidal antiinflammatory drugs (nsaids) and aspirin for 7 days prior to muscle biopsy exclusion criteria: * smoking * previous use of statins * use of other medications or supplements that affect lipid profiles or body weight in the last 6 months (e.g., fibric acids, bile acid sequestrants, nicotinic acids, fish oil) * diagnosis of chronic diseases including cvd, other metabolic diseases (e.g., thyroid), current diagnosis and active treatment of cancer, hiv, or acquired immunodeficiency syndrome. * diagnosis of type 1 or type 2 diabetes at the time of screening (fasting blood glucose \>126mg/dl). if evidence of type 2 diabetes outcome measures is detected during the course of the study (fasting glucose \> 126 mg/dl or hba1c \> 6.5%) we will notify the participant to contact their physician. * history of abnormal bleeding problems * currently taking (within the last 10 days) anti-platelet medication (plavix), warfarin, and other anti-coagulants (eliquis, pradaxa, and xarelto) medications. * \>2 fold upper normal limit (unl) for alanine aminotransferase (alt) or creatinine * women who are pregnant or breastfeeding * individuals with polymorphisms (slco1b1 and gatm) known to be associated with susceptibility for statin induced myopathies (tested at screening) * currently enrolled in another research study

Keywords: insulin sensitivity cardiorespiratory fitness skeletal muscle mitochondrial function
patients with hidradenitis vs patients with psoriasis: psychological impact

Conditions: Psoriasis; Hidradenitis

Summary: the aim of this study is to evaluate the psychological impact of psoriasis or hidradenitis suppurativa on patients, in order to compare both pathologies.


Eligibility criteria:
inclusion criteria: * men and women at least 18 years old at the time of selection. * subjects diagnosed with psoriasis or hidradenitis suppurativa * subjects who had completed the questionnaires for psychological impact. * patients should be able to understand and communicate with the investigator. exclusion criteria: * subjects suffering from a serious concomitant illness. * subjects with a mental illness. * subjects who are performing psychiatric treatment. * patients who have alcohol dependence or drug abuse. * subjects that present legal incapacity or limited legal capacity. * subjects presenting illiteracy or language barriers.

Keywords: psoriasis hidradenitis psychological impact quality of life
diet and estrogen metabolism in postmenopausal women

Conditions: Breast Cancer

Summary: rationale: the amount of dietary fat or fiber may affect estrogen metabolism in postmenopausal women, and this may affect the risk of developing cancer. purpose: randomized dietary intervention to study the effectiveness of a low-fat diet combined with either high fiber or low fiber on estrogen metabolism in healthy postmenopausal women.

objectives: i. determine the effect of a low fat diet combined with either high fiber (25-35 grams per day) or low fiber (10-15 grams per day) intake on estrogen metabolism in healthy postmenopausal women. outline: this is a randomized study. patients are randomized to one of 2 arms (dietary fat reduction with and without increased fiber). all patient must successfully complete a dietary run-in phase for 4 weeks before randomization. during the run-in phase, patients are asked to maintain a food record for days 7-14. patients undergo radioisotopic infusion study of sex steroid metabolism on days 14, 21, and 28. patients are given 3 prepackaged meals a day for 12 weeks. patients must maintain a record of all food eaten and return all food containers to the center for documentation. patients undergo radioisotopic infusion study of sex steroid metabolism on days 70, 77, and 84. at the end of the 12 weeks, patients meet with the dietitian for 30 minutes to receive instructions on maintaining a low fat, high fiber diet for the second phase of the study. projected accrual: 40 women will be accrued over 4 years.

Eligibility criteria:
disease characteristics: healthy postmenopausal female between the ages of 50 and 69 with diet of greater than 32% of total calories from fat and less than 15 grams of fiber patient characteristics: age: 50 to 69 sex: female performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: at least 2 years since menopause in general good health increased body fat (125%-175% of ideal body weight) increased upper body fat (waist-to-hip circumference ratio greater than 0.85) serum estradiol greater than 13 picograms per milliliter prior concurrent therapy: no concurrent medication that can interfere with blood test results no hormone replacement therapy or thyroid hormones

Keywords: breast cancer
perioperative management of colorectal cancer patients infected with covid-19: a multicenter prospective cohort study.

Conditions: Colorectal Cancer; Surgical Procedure, Unspecified

Summary: this trial is a multicenter prospective cohort study to explore timing of colorectal cancer surgery after covid-19 infection so that can assist clinicians and patients. currently, there is less evidence on perioperative outcomes after covid-19 vaccination and the omicron variant. therefore, it is necessary to update previously published consensus which recommends that patients should avoid elective surgery within 7 weeks of covid-19 infection remain, unless the benefits of doing so exceed the risk of waiting. aiming at the above problems, we plan to carry out a multicenter prospective cohort study to develop perioperative management according patients' different conditions.


Eligibility criteria:
inclusion criteria: * undergoing colorectal cancer surgery * infected with covid-19 but nucleic acid test result is negative * the patients compliance is good * signed the consents voluntarily exclusion criteria: * undergoing emergency surgery(intestinal obstruction, intestinal perforation, intestinal hemorrhage, et al.) * the patients' situations which judged by situations is not suitable to participate in the clinical trial
bm collection from nicu infants for composition

Conditions: Diaper Dermatitis

Summary: the primary objective of this study is to collect feces from premature infants over a five weeks period to characterize its composition. metabolomics, proteomics, genomics and microbiome analyses and cell-based assays will be performed to identify individual components present in feces, which may contribute to the onset of irritation in the diapered area of premature infants.


Eligibility criteria:
inclusion criteria: * infant's parent(s)/legal guardian(s) must be fluent in english or spanish, willing and able to read, understand, and sign the informed consent form (icf). * infants (male or female) who are equal or less than a gestational age of 30 weeks + 4 days. exclusion criteria: * any medical condition which, in the opinion of the principal investigator, may compromise infant's safety. * any underlying chronic skin conditions. however, infants may participate in the study with a rash in the diapered area if, in the opinion of the principal investigator, this does not compromise infant's safety.
procollagen-3 driven corticosteroids for persistent acute respiratory distress syndrome

Conditions: Persistent ARDS

Summary: unresolved ards is defined by the persistence of ards criteria at the end of the first week of evolution despite an appropriate treatment of the cause of ards. a persistent ards is associated with an increased mortality and prolonged lengths of mechanical ventilation, icu stay and hospitalization. persistent ards is characterized by ongoing inflammation, parenchymal-cell proliferation, and fibroproliferation leading to disordered deposition of collagen. all of these pathways may be responsive to corticosteroid therapy. only two randomized controlled double-blinded trials assessed the use of corticosteroids for persistent ards. in 24 patients, meduri et al. reported an improvement of lung function and survival (1). in 180 patients, steinberg et al showed no effect of corticosteroids on survival (2). a lower risk of death was observed when corticosteroids were started before 14 days after the onset of ards (2). alveolar procollagen iii is validated as a biomarker of active fibroproliferation. alveolar procollagen iii \> 9 µg/l is associated to fibroproliferation (3). as mortality was lower in patients who received corticosteroids while presenting a high alveolar level of procollagen iii on inclusion, steinberg et al. showed that patients presenting with a low level of procollagen iii and treated with corticosteroids had an increased risk of death (2). investigatores hypothesize that the use of procollagen iii could improve personalized decision-making regarding steroid treatment in patients presenting with persistent ards. the future of anti-fibrotic treatment, including corticosteroids, in persistent ards might propose to individualize the therapy according to the presence of an active fibroproliferative phase (precision or personalized medicine).


Eligibility criteria:
inclusion criteria: * age \>= 18 years * continuous endotracheal ventilation * moderate - severe ards according to berlin definition with pao2/fio2 ≤ 200 with peep \>= 5 cm h2o * date of ards onset : \>= day 5 and ≤ day 14 after the onset of ards criteria (regardless of ards severity) * procollagen iii above 9 µg/l in a bronchoalveolar lavage performed by the attending physician between day 3 and day 13 after the onset of ards and realized within 5 days prior to randomization exclusion criteria: * known pregnancy or breast feeding * participation to another interventional trial within 30 days with mortality or ventilator free days as the main endpoint * clinical evidence of active untreated infection * a known, undrained abscess * intravascular nidus of infection * disseminated fungal infection
a motivation-enhancing app to retain patients with hay fever in a trial after treatment

Conditions: Grass Pollen Allergy; Rhinoconjunctivitis

Summary: the motivation-enhancing intervention is designed for participants in the ilit.nu trial. the participants are patients with hay fever who are treated with a vaccination in an inguinal lymph node. the motivation-enhancing intervention is a web-based app developed in collaboration with patient partners and is intended to increase retention and reporting in the ilit.nu trial.

the ilit.nu trial (eudract 2020-001060-28) investigates whether patient reported outcome measures compound symptom-medication score (csms) are relieved by intralymphatic immunotherapy (ilit). the participants are asked for a three-year period to attend annual consultations and to daily fill in an online questionnaire about their allergy symptoms and medication use during the grass pollen season (100 days). high attrition rates have been a problem in previous ilit trials. high attrition affects generalizability, validity and reliability of a trial. to increase retention and reporting in the ilit.nu trial, a motivation-enhancing web-based app has been developed. the web app is based on the self-determination theory and is developed in collaboration with patient partners and clinicians. participants are randomized across treatment group to either the motivation-enhancing web app or the standard reporting method. the project is conducted as a study within a trial (swat).

Eligibility criteria:
inclusion criteria: * participants enrolled in the ilit.nu trial exclusion criteria: * participants not enrolled in the ilit.nu trial, denmark

Keywords: retention motivation self-determination theory grass pollen allergic rhinoconjunctivitis intralymphatic immunotherapy patient and public involvement
perioperative factors and early postoperative kidney graft function recovery

Conditions: Heart Injuries; Kidney Transplant; Complications

Summary: divided into two groups based on acute kidney injury: non-acute kidney injury group vs. non-acute kidney injury group. acute kidney injury group, acute kidney injury network (akin), risk, injury, failure, loss of kidney function, and end-stage kidney disease (rifle), or kidney disease: improving global outcomes (kdigo) i would like to divide it according to the definition. after testing the normal distribution of patients, donors, grafts, types of immunosuppressants, surgery/anesthesia factors, and blood test findings between the two groups through the shapiro-wilk test, continuous data was tested using the student t-test or mann-whitney u test. sizes are compared using , and categorical data is compared with proportions using the χ2 test or fisher's exact test. analysis of factors related to acute kidney injury will be performed through univariate and multivariate logistic regression analysis.


Eligibility criteria:
inclusion criteria: * adult patients aged 19 years or older who underwent kidney transplant surgery in the operating room exclusion criteria: * pediatric patients under 19 years of age * patients with multiple organ transplants, including kidney transplants * patients undergoing re-kidney transplant surgery * patient examination findings missing from electronic medical record
multicenter phase iii trial of laparoscopic sentinel node biopsy

Conditions: Early Gastric Cancer

Summary: laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric cancer is less invasive method which can increase quality of life. for last two years, multicenter quality control study (phase ii) has been performed in korea and tolerable results were observed. based on these results, multicenter phase iii trial is required to validate the clinical role of laparoscopic sentinel lymph node biopsy.

the final analyses include the modified intention to treatment analysis (full analysis set) and per protocol analysis (including patients who underwent assigned surgery without agreement withdrawal). 1. injection of tracer and sentinel basin dissection * tracer: tc 99m hsa (human serum albumin, 2ml, 0.1mci/ml) + icg (indocyanine green, 2ml, 5mg/ml) * endoscopic injection of tracer on 4 sites around gastric cancer * identification of sentinel basin using laparoscopic probe (neoprobe) * laparoscopic sentinel basin dissection and identification of sentinel node at back table 2. surgical considerations * if positive sentinel nodes were diagnosed in frozen section, conventional gastrectomy is performed. * if micrometastasis or isolate tumor cells in sentinel basin lymph nodes were diagnosed in the permanent pathology, re-operation of conventional gastrectomy is not performed. * however, re-operation of converntional gastrectomy should be performed in case of macrometastasis, deep and lateral margin positive, more than pt2 lesion in the permanent pathology. 3. h.pylori eradication - there was no clear evidence that h.pylori eradication reduced development of metachronous gastric cancer. h.pylori eradication was planned to perform according to physician's decision or patient's need. however, recently, the effect of h.pylori eradication in development of metachronous gastric cancer was published in nejm (choi et al. 2018). therefore, from now on, h. pylori eradication will be recommended to enrolled patients with h.pylori.

Eligibility criteria:
inclusion criteria: * single lesion of adenocarcinoma in preoperative endoscopic biopsy * clinical stage t1n0 in the preoperative evaluation of endoscopy and computed tomography * tumor size: less than 3cm * location: 2cm far from the pylorus or cardia * aged 20 to 80 * ecog 0 or 1 * patient who signed the agreement * patient who is suspected to underwent laparoscopy assisted gastrectomy exclusion criteria: * indication of endoscopic submucosal resection * inoperable due to poor cardiac, pulmonary function * pregnant * having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen * diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer

Keywords: laparoscopic sentinel lymph node biopsy phase 3 early gastric cancer
seropositivity and adverse birth events in migrants from bilharzia-endemic areas

Conditions: Schistosomiasis

Summary: the study intends to examine the association between schistosomiasis seropositivity and adverse pregnancy outcomes. it aims at the verification of the hypothesis that in pregnant women originating from endemic areas for schistosomiasis, positive serology is associated with reduced infant birth weight.

schistosomiasis is a widespread helminthic infection, with an estimated 249 million people in 78 countries requiring preventive treatment each year. this infection has a significant association with morbidity worldwide. earlier studies performed in endemic areas showed that the reproductive tract was affected in more than 60% of the women who excreted s. haematobium ova in urine. transplacental transmission has not been observed, but schistosomiasis of the pregnant uterus has been reported and placental schistosomiasis has been associated with stillbirth. placental schistosomiasis (i.e. detection of schistosomiasis eggs in placental tissue) has been reported occasionally. schistosomiasis has been postulated to be associated with premature delivery and low birth weight; however, existing data are inconsistent. migration to the european union was estimated at 1.7 million people in 2012. migrants were predominantly from africa and asia. in these areas schistosomiasis has an estimated prevalence of 10-20%. while a large number of migrants from schistosomiasis-endemic areas enter europe and receive access to health care, many of them are unaware of helminthic infections they may have been exposed to, and their potential outcomes. treatment of schistosomiasis during pregnancy is a matter of debate. the german society for tropical medicine recommends treatment with praziquantel only after the completion of pregnancy. conversely, the south african medicines formulary suggests that pregnant women should be offered treatment individually and that they should not necessarily be excluded during treatment campaigns. by quantifying the effects of schistosoma infection on pregnancy outcomes this study will help clinicians in deciding on the question of treatment during pregnancy. the aim of the study is to examine the association of maternal schistosomiasis on adverse birth outcomes (as defined by low birth weight, premature delivery or stillbirth) in migrants to europe from schistosomiasis endemic areas.

Eligibility criteria:
inclusion criteria: * pregnancy * immigration from a country/geographic area with declared endemic schistosomiasis according to world health organization criteria * signed informed consent exclusion criteria: * placenta pathology of any cause * any medical condition affecting fetal growth