Kornimate/medical-research-clean huggingface dataset:
development of immunological assays for the evaluation of tumor antigen specific immunity

Conditions: Ovarian Serous Adenocarcinoma; Undifferentiated Carcinoma of Ovary; Cervical Cancer; Cervical Intraepithelial Neoplasia, Grade 3; Acute Myeloid Leukemia; Chronic Myeloid Leukemia

Summary: this study is a clinical study aiming at establishing immunological assays for the qualitative and quantitative evaluation of wt-1, survivin and hpv16 e7-specific immune responses in cancer patients. such a study will allow the development of suitable immunological tools to be used in assessing response in a subsequent phase i study aiming at evaluating therapeutic vaccine candidates targeting wt-1, survivin and/or hpv16 e7-expressing tumors. in addition, this study will help defining the baseline cancer-associated immune responses in the selected patient population. cervical and ovarian cancer patients, as well as leukemia patients, will be included in this study. wt-1, survivin and hpv-specific immune responses will be monitored in these patients by ex vivo and cultured ifng elispot as well as tetramer staining.


Eligibility criteria:
inclusion criteria: * specific inclusion criteria * for ovarian cancer patients: histologically confirmed surgical diagnosis of high-grade serous (or undifferentiated) ovarian cancer * for cin3 and cervical cancer patients: histologically confirmed diagnosis of cin3 or cervical cancer * for aml and cml patients: hla-a2 positivity and diagnosis of aml or cml confirmed by bone marrow biopsy or peripheral blood * shared inclusion criteria * no evidence of active progressive disease. for ovarian cancer patients, a woman with a rising ca125 and negative imaging is acceptable * age ≥ 18 yrs and \< 70 yrs * ecog 0-2 * adequate hematologic assessment (results from the previous standard of care visit): * absolute neutrophil count (anc) greater than or equal to 1.0 x 109/l * platelets greater than or equal to 100 x 109/l. * written informed consent exclusion criteria: * treatment with chemotherapy, radiation therapy, other immunotherapy or non-topical steroids within the past 3 weeks prior to initiation of the study. * immunosuppressive therapy (excluding topical steroids) for any other condition. * recurrent/progressive disease confirmed clinically, radiologically or histologically before entry into the study. (exclude versus inclusion criteria) * persistent fever (\>24 hours) documented by repeated measurement or active uncontrolled infection in the last 4 weeks. * active autoimmune disease, including, but not limited to, sle, ms, ankylosing spondylitis.

Keywords: ovarian cancer cervical cancer leukemia immunity wt-1 survivin hpv
evorpacept (alx148) in combination with pembrolizumab and chemotherapy in patients with advanced head and neck squamous cell carcinoma (aspen-04)

Conditions: Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma

Summary: a phase 2 study of evorpacept (alx148) in combination with pembrolizumab and chemotherapy in patients with advanced head and neck squamous cell carcinoma.

this is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (alx148) + pembrolizumab + 5fu + platinum and of pembrolizumab + 5fu + platinum in patients with metastatic or unresectable, recurrent hnscc who have not yet been treated for their advanced disease. the study comprises of an initial safety lead-in followed by a randomized portion.

Eligibility criteria:
inclusion criteria: * previously untreated metastatic or unresectable, recurrent head and neck squamous cell carcinoma. * adequate bone marrow function. * adequate renal and liver function. * adequate ecog performance status. exclusion criteria: * patients with known symptomatic cns metastases or leptomeningeal disease requiring steroids. * history of (non-infectious) pneumonitis that required steroids or current pneumonitis. * prior treatment with any anti-cd47 or anti-sirpα agent. * prior treatment with anti-pd-1 or pd-l1.

Keywords: alx148 cd47 sirpα hnscc pembrolizumab evorpacept
modulating stress-reactivity by real-time multimodal functional neuroimaging based neurofeedback

Conditions: Stress; Pituitary-Adrenal System

Summary: the overall goal of the outlined study is to establish a real-time (rt) functional magnetic resonance imaging (fmri) neurofeedback (nf) (rt-fmri-nf) protocol aiming at modulating neural, endocrine, and subjective reactivity to psychosocial stress.

the overall goal of the outlined study is to establish an rt-fmri-nf protocol aiming at modulating neural, endocrine, and subjective reactivity to psychosocial stress. more specifically, the investigators pursue the following goals: a) to evaluate whether neural and subjective stress-reactivity can be modified by training volitional control over targeted brain activity by means of rt-fmri-nf; b) to evaluate whether neuromodulation by means of rt-fmri-nf can be used as a new way to modulate hormone-release into the periphery; and c) to evaluate whether the efficacy of neuromodulation by rt-fmri-nf can also be reflected on eeg data as well as the autonomic nervous system (ans) measured by heart rate variability (hrv).

Eligibility criteria:
inclusion criteria: * sufficient spoken and written knowledge of english * right-handedness * ability to participate in study procedures exclusion criteria: * present or past psychological or psychiatric therapy * major or unstable general medical conditions * presence of cardiovascular disease * current intake of any medication interfering hormonal assessments * history of major cerebral injury * medical mri contraindication

Keywords: neurofeedback stress fmri real-time fmri neurofeedback anterior cingulate cortex hypothalamic-pituitary-adrenal axis cortisol eeg heart rate variability blood pressure simultaneous eeg/fmri
study comparing caspofungin to placebo for the treatment of icu intra-abdominal candidiasis

Conditions: ICU Yeast Intra-abdominal Infection

Summary: the incidence of intra-abdominal candidiasis is increasing, and it is now the leading indication for antifungal therapy, ahead of candidemia. prospective randomized trials of antifungal therapy have almost exclusively concerned patients with candidemia and did not include patients with intra-abdominal infections. the aim of this study is to demonstrate that caspofungin antifungal therapy for intra-abdominal candidiasis in icu patients is associated with lower failure rate compared to placebo.

the incidence of intra-abdominal candidiasis is increasing, and it is now the leading indication for antifungal therapy, ahead of candidemia. these infections are clearly associated with increased morbidity and mortality in both community-acquired and healthcare-associated infections. so far,prospective randomized trials of antifungal therapy have almost exclusively concerned patients with candidemia and did not include patients with intra-abdominal infections. no prospective randomized trial has been conducted on intra-abdominal candidiasis and most retrospective analyses have reported very conflicting results concerning the impact of treatment on outcome. the aim of this study is therefore to demonstrate that caspofungin antifungal therapy for intra-abdominal candidiasis in icu patients is associated with lower failure rate compared to placebo.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * covered by national health insurance * admitted to icu after surgery for intra-abdominal infection : * with suspected intra-abdominal candidiasis defined by a peritonitis score ≥ 3(1) * or with documented intra-abdominal candidiasis defined by positive direct examination or positive culture of peritoneal fluid collected intraoperatively. * with written and signed informed consent exclusion criteria: * allergy to caspofungin * life expectancy ≤ 48h * expected withdrawal of treatment * radiological drainage without surgery * severe hepatic impairment (child-pugh c score) * pregnant or lactating women * immunodepression (treatment including long-term corticosteroids, anti-tnf or disease including transplant patients) * infected acute pancreatitis * ascites fluid infection

Keywords: icu yeast intra abdominal infection candidiasis ß-d-glucan caspofungin
peng block combined to wound infiltration for hip replacement

Conditions: Postoperative Pain; Analgesia; Hip Arthropathy; Acute Pain; Pain; Postoperative Complications

Summary: this study analyze the effect of pericapsular nerve group (peng) block combined to wound infiltration for analgesia after elective hip replacement. half of participants will receive a peng block combined with wound infiltration, while the other half will receive wound infiltration alone.


Eligibility criteria:
inclusion criteria: * elective hip replacement surgery * asa physical status score \< 4 exclusion criteria: * contraindications to regional anesthesia * asa physical status score ≥ 4 * patient's refusal or inability to sing the informed consent * pre-operatively therapy with opioids * allergies to any drug provided by the study protocol

Keywords: regional anesthesia hip surgery peng
pulmonary surfactant(ps) therapy at high altitude area

Conditions: NRDS; Surfactant

Summary: the traditional concept believes that the etiology of neonatal respiratory distress syndrome (rds) is immature development of lung,especially the surfactant synthesis system,and rds is still one of the major causes of mortality and morbidity in newborns, especially premature infants\[1\].in recent years, using pulmonary surfactant replacement therapy (ps treatment) in the treatment of respiratory distress syndrome (rds) is a major breakthrough in neonatal medicine \[2\].combined with clinical practice and experience,and through meta analysis of related randomized controlled trials (rcts),it confirms that natural surfactant treatment can reduce mortality,the incidence of pulmonary air leaks (pneumothorax and interstitial lung emphysema),and the incidence of bronchopulmonary dysplasia (bpd) or 28-day-old mortality.for rds in preterm infants whose gestation is \<35 weeks ,surfactant replacement therapy is also more effective than in nearly term and full term infants.therefore, in the analysis of cases of different gestational age groups,the investigators should focus on the study of premature infants cases.due to less relevant research for using ps treatment to cure newborn rds in high altitude area,this retrospective study conducts statistics and analysis of recently three-year cases in some hospital of high altitude area,to explore the treatment effect of the high altitude region and the impact of altitude on the treatment.

in order to explore feasibility and efficacy for ps treatment of newborn rds in high-altitude area ,and its efficacy at different altitudes, the investigators conduct a multi-center retrospective study of rds cases in qinghai and tibet these two high-altitude area,and use rds cases under the unique conditions to do statistics and analysis.

Eligibility criteria:
inclusion criteria: * diagnosed with respiratory distress syndrome(rds) exclusion criteria: * major congenital abnormalities
positive end expiratory pressure with a t-piece resuscitator for near-term and term infants with respiratory distress

Conditions: Transient Tachypnea of the Newborn

Summary: evaluating the effect of early application of continuous positive airway pressure (cpap) via neopuff in cases of transient tachypnea of the newborn(ttn) and its role in decreasing the duration and complication of ttn.

the aim of the study is to determine whether positive end expiratory pressure therapy (peep) administered early via a t piece based infant resuscitator (neopuff) would safely reduce the incidence of ttn and the need for neonatal intensive care unit (nicu) admission of near term and term infants with respiratory distress.

Eligibility criteria:
inclusion criteria: * near term infants (36-37 weeks gestational age) and full term infants (38-41 weeks gestational age). * presence of signs of respiratory distress (tachypnea, intercostal and subcostal retractions, nasal flaring and grunting) evident shortly after birth. * cesarean section (cs) was defined as elective when surgery was performed before the onset of labor, with all other cases defined as secondary cs. exclusion criteria: * presence of any of the risk factors for neonatal sepsis such as prolonged rupture of membranes for ≥48 hours (prom), maternal fever, maternal chorioamnionitis or positive maternal gbs colonization. * presence of any other cause of respiratory distress, eg. * congenital malformations affecting the cardiorespiratory system , * chromosomal aberrations, * depression at birth (apgar score at 5 minutes of \< 7 or umbilical artery ph of \< 7.10), * fetal hydrops, * persistent pulmonary hypertension, * and meconium aspiration syndrome.
impact of self-monitoring blood glucose frequency on glycemic control in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: to determine if the frequency of blood glucose testing in patients with type 2 diabetes who are being treated with diet and exercise alone or diet and exercise plus oral agents will impact the hba1c level.

to determine the impact of smbg frequency on blood glucose control in patients receiving systematic diabetes management education through type 2 diabetes basics at international diabetes center.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * treatment with diet and exercise alone or with the addition of 1 or 2 oral agents * enrolled in type 2 basics program * a1c between 7.0 and 11%, inclusive * able to understand spoken english exclusion criteria: * insulin therapy * unable/unwilling to perform smbg * participating in another research study * currently performing smbg \>3 times/week

Keywords: referred to comprehensive diabetes education program
outcome of root canal treatments obturated with calcium silicate based sealers

Conditions: Endodontically Treated Teeth

Summary: the clinical use of a flowable premixed calcium-silicate bioceramic sealer used in association with warm carrier-based/single-cone technique will be compared with epoxy resin-based sealer with carrier-based technique.

healthy consecutive patients (n= 109) requiring 141 root canal treatments were enrolled in this study and divided in 3 groups (group 1: ceraseal + single cone cold technique n=47. group 2: ceraseal + carrier-based technique n=47. group 3 ah plus + carrier based technique n=47). periapical x-rays were taken preoperatively, after root canal filling and after 6, 12 and 24 months. two evaluators blindly assessed the periapical index (pai) and sealer extrusion in the 3 groups (k =0.90). healing rate and survival rate were also analysed. chi square tests was used to analyse significant differences among the groups. multilevel analysis was performed to analyse the factors associated to healing status and survival status.

Eligibility criteria:
inclusion criteria: 1. age 18-75 years 2. no use of antiresorptive or antiangiogenic drug 3. healthy status (asa 1 or 2). 4. needing one or more root canal treatment exclusion criteria: 1. teeth with less than 2 walls of structural integrity 2. wide apexes (\>40 diameter) 3. asa \> 3, 4. any pathology that could compromise bone healing or the immune response, 5. pregnancy or breast feeding 6. heavy smoking (\>15 cigarettes/day), (tverdal \& bjartveit 2006) 7. exposure to radiation therapy focussed on the head and neck region and malignant disease directly involving the jaws. 8. lacks of occlusal contacts

Keywords: root canal treatment healing rate warm obturation technique bioceramic sealer
orthodontic treatment impact on life experience of adolescents with fixed orthodontic appliances

Conditions: Orthodontic Appliance Complication

Summary: this cross-sectional study aimed to investigate the impact of different fixed orthodontic appliances on the day-to-day life experience of adolescent patients at any stage of their orthodontic treatment. a validated questionnaire was translated and used in the assessment, 364 patients (242 female and 122 male) were recruited, impact on the social and emotional well-being status of the participants was assessed as well as oral health, pain, and discomfort.

this cross-sectional study aimed to evaluate the impact of orthodontic treatment on the daily life experience of adolescents wearing fixed orthodontic appliances. we aimed to assess the impact of different fixed orthodontic appliances in a sample of 364 patients either having labial fixed orthodontic appliances only or combined with palatal anchorage appliances, combined with mini-screws, combined with both palatal anchorage appliances and mini-screws or having fixed retainers. the outcomes were the impact on the patient's social and emotional well-being status and the impact on the patient's oral health, pain, and discomfort. a questionnaire was distributed and the patient was asked to fill it in. the questionnaire is composed of 22 questions with a 3-point scale.

Eligibility criteria:
inclusion criteria: * male and female patients * patients wearing fixed orthodontic appliances at any stage of treatment (labial fixed appliance only - labial fixed appliance combined with any palatal or lingual appliance - labial fixed appliance combined with mini-screws) or fixed retainers either in the upper arch only, lower arch only, or in both arches. * age: 13-18 years old exclusion criteria: * patients who refused to participate in the study. * patients with cleft lip or palate. * illiterate patients. * patients who had a complicated medical history. * patients with severe skeletal discrepancy undergoing combined orthodontic and orthognathic surgical treatment.
acute salt handling in orthostatic intolerance

Conditions: Postural Tachycardia Syndrome; Orthostatic Tachycardia; Orthostatic Intolerance

Summary: the investigators will test the hypothesis that patients with chronic orthostatic intolerance or postural orthostatic tachycardia syndrome (oi or pots) will be unable to conserve urinary sodium as compared to healthy control subjects.

patients with chronic oi appear to be hypovolemic with abnormalities in hormones that regulate salt \& water handling. increases in dietary salt have salutary effects on orthostatic tolerance in a physiological laboratory. the infusion of intravenous saline acutely decreased heart rate in this patient population. preliminary data from vanderbilt suggests abnormal salt handling in patients with chronic oi in a few patients. these data need to be confirmed and a better understanding of sodium handling in response to acute salt loads is required in these patients.

Eligibility criteria:
inclusion criteria: * diagnosed with orthostatic intolerance by vanderbilt autonomic dysfunction center (or healthy control subject) exclusion criteria: * overt or acute cause for orthostatic tachycardia * hypertension (bp\>145/95 or need for anti-hypertensive medications) * qrs duration \> 120 msec on ekg * pregnancy

Keywords: saline sodium kidney tachycardia
the effects of angel sounds and guided imagery technique played to expectant couples

Conditions: Prenatal Anxiety; Prenatal Attachment; Sleep Quality

Summary: the study sample consisted of 177 pregnant women and their partners who met the inclusion criteria and participated in a prenatal education class. expectant couples were randomized into three groups: group 1 (fhs) listened to fetal heartbeat sounds, group 2 (git) received the guided imagery intervention, and group 3 served as the control group. each group consisted of 59 couples.

aim: this randomized controlled trial aimed to evaluate the effects of listening to angel sounds (fetal heartbeat) and applying the guided imagery technique on prenatal attachment, anxiety, and sleep quality among expectant couples. methods: the study included 177 pregnant women and their partners who attended a prenatal education class and met the inclusion criteria. expectant couples were randomly assigned into three equal groups. in group 1 (fhs), only fetal heartbeat sounds were listened to. in group 2 (git), the guided imagery technique was applied. group 3 served as the control group. each group consisted of 59 couples.

Eligibility criteria:
inclusion criteria: * having basic literacy skills, * owning a smartphone and having internet access, * having a singleton and viable pregnancy, * being between the 27th and 38th weeks of gestation, * not having any diagnosed pregnancy-related risks (e.g., preeclampsia, diabetes, placenta previa, oligohydramnios), * not having any diagnosed fetal health issues (e.g., fetal anomalies, intrauterine growth restriction), * pregnant individuals and their spouses with no current or prior psychiatric diagnoses. exclusion criteria: * not living with their spouse, * spouse working in shifts, * pregnancy via assisted reproductive techniques, * currently participating in childbirth education programs, * presence of communication difficulties or cognitive impairments in either the pregnant individual or the spouse. withdrawal criteria: * participated in the intervention for fewer than 3 nights, * unable to use the fetal heart rate monitoring device (fhrmd), * experiencing premature birth or pregnancy loss, * incomplete questionnaire data, * voluntary withdrawal from the study by the participant or their spouse. -

Keywords: fetal heart rate sounds guided imagery prenatal attachment anxiety, pregnancy sleep quality
postoperative delirium at heidelberg's intensive care unit -new diagnostic markers

Conditions: Postoperative Delirium

Summary: summary: postoperative delirium is a highly prevalent disease (10-30% prevalence) after surgery in intensive care unit, however, it is often misdiagnosed and mistreated. the aim of the present project is to investigate risk factors for postoperative delirium in more detail, to evaluate respective cognitive test systems and to measure eeg activity parallel to patients' serum anticholinergic activity. the pathophysiology of delirium is unknown up to now: a possible dysbalance between cerebral acetylcholine and dopamine concentrations is a likely hypothesis. therefore, the measurement of peripheral serum anticholinergic activity could be a new prognostic factor for evaluation of delirium. because delirium is also associated with higher postoperative mortality and morbidity, with delayed functional recovery, and postoperative delirium makes patient management much more difficult, increases costs, and, above all, causes severe discomfort to the patient new interdisciplinary diagnostic strategies are necessary to resolve this problem.


Eligibility criteria:
inclusion criteria: * all patients at intensive care unit over a defined time period * over 18 years old exclusion criteria: * elective heart and vascular patients

Keywords: postoperative delirium psychometric testing eeg serum markers
the utility of 18f-fluorocholine pet/ct in the imaging of parathyroid adenomas

Conditions: Hyperparathyroidism; Parathyroid Adenoma

Summary: we assessed sensitivity of 18f-fch pet/ct in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism (phpt).

we prospectively enrolled 65 consecutive patients with phpt who underwent neck ultrasound (us) and parathyroid scintigraphy (99mtc/99mtc-mibi dual phase). twenty-two patients had unsuccessful parathyroid surgery prior to the study. pet/ct scans were performed 65.0 ± 13.3 min after injection of 218.5 ± 31.9 mbq of 18f-fluorocholine (fch). three experienced nuclear medicine physicians assessed the detection rate of hyperfunctioning parathyroid tissue. response to parathyroidectomy and clinical follow-up served as a reference test. per-patient sensitivity and positive predictive value (ppv) were calculated for patients who underwent surgery.

Eligibility criteria:
inclusion criteria: * primary hyperparathyroidism and neck us and the dual-phase 99mtc/99mtc-mibi spect/ct scintigraphy performed prior to the pet/ct scan exclusion criteria: * pregnancy * patient's lack of consent to the examination

Keywords: pet/ct fluorocholine