Kornimate/medical-research-clean huggingface dataset:
esophageal echo assessment of lv function during acute normovolemic hemodilution using crystalloid or hypertonic saline

Conditions: Acute Hypovolemia

Summary: the purpose of this study is to examine how the heart functions when a calculated amount of blood is removed and how two fluids, lactated ringer's (considered the standard replacement fluid) and hypertonic saline, re-expand the vascular system.

this investigator-initiated, single-center, prospective, randomized, clinical experimental design will enroll 30 patients scheduled for elective radical prostatectomy, cystectomy, or cystoprostatectomy, and anterior/posterior spinal fusions, which includes routine acute normovolemic hemodilution (anh) as a technique to decrease the need for banked blood transfusions. the purpose of this study is to compare two methods of volume replacement during the anh procedure. patients will be randomized to receive either standard crystalloid replacement with lactated ringers (lr) or 5% hypertonic saline. selected measurements will be obtained by transesophageal echocardiography (tee) for assessing changes in left ventricular volume and function associated with blood loss and replacement. this study will use the accuson cypress cardiovascular system and the v5m transesophageal echocardiography probe (siemens medical solutions, malvern, pa). the tee measurements will be recorded on magnetic optical discs and assessed off-line by the researcher after the data collection is completed using the proprietary software included in the ultrasound system. in addition, stroke volume variation measurement (svv), cardiac output (co), cardiac index (ci), and stroke volume index (svi) will be measured using the vigileo (tm) arterial pressure monitor with the flotrac (tm) sensor (edwards lifesciences, irvine, ca).

Eligibility criteria:
inclusion criteria: * elective surgical patients requiring acute normovolemic hemodilution exclusion criteria: * contraindication for hemodilution * contraindication for te echo

Keywords: te echo hemodilution hypertonic saline arterial pressure cardiac output
sexaffectivity in autistic spectrum disorder

Conditions: Autistic Disorders Spectrum; Sexual Behavior; Adolescent Development; Sexual Inadequacy

Summary: the who defines sexual health as a state of physical, emotional, mental and social well-being, related to sexuality, not only the absence of illness, dysfunction or disability. to acquire and maintain adequate sexual health, the sexual rights of all people must be respected, protected and fully exercised. people with autism spectrum disorder (asd) present difficulties in the development of social interaction skills, among other problems that directly affect their sexual health. the consolidated prejudices and social myths related to the sexual affectivity of people with asd, and in general to people with intellectual diversity, have meant that they do not pay any attention to the sexual health of this group in the assessment of their needs. main objectives: to understand the experience lived by young people with asd and their caregivers in relation to the affective needs during adolescence and to know the cognitive and behavioral expression of the affective dimension of adolescents with asd. mixed simultaneous design: qualitative based on the phenomenological paradigm, in order to establish the perceived needs of young adults with asd, their families and the professionals who attend them, with the realization of focus groups and in-depth interviews. the second quantitative part will be developed in adolescents (12-18 years) and their families, evaluating the habitual behaviors and difficulties of interaction in the affective expression, by means of questionnaires and self-administered scales. it will be necessary to sign the informed consent by all the participants, with the specific acceptance of the project by the ceic of the investigator's center.


Eligibility criteria:
inclusion criteria: * adolescents with asd. 12-18 years old exclusion criteria: * non defined
assessment of corneal topography and densitometry in rheumatoid patients

Conditions: Cornea

Summary: corneal transparency is a result of its unique ultrastructure with collagen fibrils regularity, integrity of connective tissue, and balanced keratocyte components. corneal densitometry is known to be altered in cases corneal haze or scar, but recently it is assumed to be altered earlies in presence of a systemic inflammatory disease, even before clinical manifestations take place. the aim of this study is to assess changes in corneal topography and corneal densitometry in ra patients with clinically clear corneas and to compare these results with those of healthy control subjects.


Eligibility criteria:
inclusion criteria: * patients diagnosed with rheumatoid arthritis exclusion criteria: * corneal opacity; severe dry eye; glaucoma; any inflammatory ocular disorder or infection including blepharitis, conjunctivitis, meibomitis and dacryocystitis; central or peripheral thinning evident in slit-lamp examination; history of ocular surgery, trauma, or contact lens use; and patients using any topical medication other than artificial tears will be excluded from the study.
a study of the safety and efficacy of risankizumab in adult participants with plaque psoriasis who have had a suboptimal response to secukinumab or ixekizumab

Conditions: Plaque Psoriasis

Summary: this study will evaluate whether adult participants with moderate to severe plaque psoriasis who have been treated with secukinumab or ixekizumab for at least 6 months and are experiencing a suboptimal response may benefit from switching to risankizumab with regard to skin symptoms, quality of life symptoms and psoriasis symptoms. study duration will last for up to 64 weeks with risankizumab given by subcutaneous injection at week 0, week 4, and then every 12 weeks for 52 weeks (with the last dose being administered at week 40). an additional visit will occur at week 8 for a physical exam and questionnaire collection. a final follow-up phone call will occur at week 60.


Eligibility criteria:
inclusion criteria: * diagnosed with moderate to severe chronic plaque psoriasis for at least 6 months before baseline (week 0). * participant must have been on labeled secukinumab or ixekizumab treatment for at least 6 months and are experiencing suboptimal response at time of screening and baseline visits. * participant must have a body surface area (bsa) 3%- \<10% and static physician global assessment (spga) 2/3 * participant must be eligible for continued biologic therapy as assessed by the investigator. exclusion criteria: * history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis, psoriatic arthritis. * participant with active skin disease other than plaque psoriasis that could interfere with the assessment of plaque psoriasis. * history of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (nmsc) or localized carcinoma in situ of the cervix. * history of major surgery within 12 weeks prior to baseline or planned to be performed during the conduct of the trial as assessed by the investigator. * participant with exposure to risankizumab or any il-23 inhibitors.

Keywords: plaque psoriasis risankizumab secukinumab ixekizumab psoriasis biologic
drug concentration monitoring of pembrolizumab in non-small cell lung cancer patients

Conditions: NSCLC

Summary: this observational study explores associations between drug trough-levels and clinical outcomes in non small cell lung cancer (nsclc) patients treated with immunotherapy (pembrolizumab) either alone or combined with chemotherapy. through-levels of pembrolizumab will be examined in blood samples collected during the first-line treatment period. in addition t-cell responses in peripheral blood and anti-drug antibodies will be monitored. results of drug trough-levels and t-cell responses will be linked to clinical outcome. 250 patients with nsclc will be enrolled in this trial.


Eligibility criteria:
inclusion criteria: * subjects must be \> 18 years and must voluntary sign an informed consent * treatment-naïve patients with advanced nsclc receiving immunotherapy alone (pembrolizumab) or combined with chemotherapy exclusion criteria: * any anti-cancer therapy \< 6 months prior to inclusion
laparoscopic peritoneal lavage vs laparoscopic sigmoidectomy in perforated acute diverticulitis: a multicenter prospective observational study (stella study)

Conditions: Acute Diverticulitis

Summary: laparoscopic peritoneal lavage (lpl) has recently been emerging as an effective alternative to laparoscopic sigmoidectomy (ls) in patients with complicated acute diverticulitis (cad) (modified hinchey's classification grade ii non-responder to conservative therapy and grade iii). aim of the study is to evaluate which surgical strategy, between lpl and ls, could give better results in patients with cad

in the literature, there is no consensus about the role of the laparoscopic peritoneal lavage in the management of complicated acute diverticulitis. recently, three important prospective randomized-control studies (scandiv, lola, dilala) have reported contradicting conclusions, as two of them (scandiv and lola) state that lpl is not superior to sigmoidectomy for the high reoperation rate and morbidity, while dilala confirms that lpl is feasible and safe in the short-term. to our knowledge, no international guidelines promote the use of lpl in complicated acute diverticulitis. we believe this technique could be safely used in a selected cohort of patients and, in some circumstances, could represent a "bridge" to a possible planned resection. the aim of the study is to collect and analyze the multicentric data of the lpl and ls and give a substantial contribution to the scientific community about this very debated topic.

Eligibility criteria:
inclusion criteria: * acute abdominal pain, * signs of localized or diffuse peritonitis * signs of suspected perforated diverticulitis (diagnostic imaging) * signed informed consent exclusion criteria: * septic shock * immunodepression * previous multiple abdominal surgical operations * modified hinchey's grade iv

Keywords: laparoscopic peritoneal lavage laparoscopic sigmoidectomy complicated acute diverticulitis d004238
msc and cyclophosphamide for acute graft-versus-host disease (agvhd) prophylaxis

Conditions: Leukemia; Multiple Myeloma

Summary: evaluating the effectiveness of the new protocol which replace the standard immunosuppressive therapy with use of mscs and cy in patients at high risk of relapse.

this trial try to find a new way of refractory hematological malignancies treatment. aim of this study evaluating the effectiveness of the new protocol which replace the standard immunosuppressive therapy with use of mscs and cy in patients at high risk of relapse.

Eligibility criteria:
inclusion criteria: * refractory forms of acute leukemia, but in complete remission (cr) * second and third remission of acute leukemia * 2nd and 3rd chronic phase chronic myelogenous leukemia (cml) (or ph + all) * relapsed multiple myeloma * advanced leukemia exclusion criteria: * icu * mechanical ventilation
endoscopic therapy of malignant bile duct strictures

Conditions: Obstruction of Biliary Tree; Biliary Tract Cancer; Biliary Tract Neoplasms

Summary: patients with malignant bile duct stenosis have poor prognosis and most of the patients are not good candidate for surgery at the time of diagnosis. placement of the stent is the palliative care for these patients. however over 50% of the stents get blocked within 6-8 months. use of the radiofrequency ablation before the stent placement may improve stent patency. heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent. the investigators are looking to see how safe and feasible rfa (radiofrequency ablation) catheter is in patient with malignant bile duct stenosis.

as part of medical care subjects will be undergoing an endoscopic procedure (ercp) in order to evaluate and stent a bile duct blockage. during the ecrp and just prior to the stent placement subjects will undergo the placement of a radiofrequency ablation catheter into the bile duct blockage. heat will be applied to the bile duct in order to open the blockage and prevent the re-growth of tissue into the stent; after the radiofrequency ablation, stent will be placed. three days after the procedure subjects will receive a phone call from the research coordinator to check any adverse or unwanted effects of the treatment. the study procedure (radiofrequency ablation) takes place over 10 minutes during ercp. the subjects will undergo routine follow up for their medical problems. no follow up visits are required as part of the study.

Eligibility criteria:
inclusion criteria: * documented malignant biliary obstruction requiring ercp guided stenting exclusion criteria: * coagulopathy (inr \> 2.0 or ptt \> 100 sec or platelet count \< 50,000) * evidence of high-grade symptomatic duodenal obstruction * poor performance status * active suppurative cholangitis * complex stenoses will not be eligible for the trial * patients without access to duodenum or ampulla are not candidates for ercp and stenting * candidates for a whipple resection * patients who do not speak english

Keywords: bile duct cholangiocarcinoma bile duct stenosis malignant bile duct obstruction malignant bile duct stricture radiofrequency ablation rfa endoscopic rfa catheter endohpb
single-session intervention targeting emotional awareness, clarity, and acceptance to reduce depression/anxiety

Conditions: Depression; Anxiety

Summary: two-arm, parallel group randomized clinical trial conducted via mturk comparing a single-session web-based intervention called visitor mindset versus a control intervention (nature videos with relaxing music) for adults with depression and/or anxiety symptoms

procedures include completing: (1) pre-intervention assessments; (2) one of two single-session web-based intervention (approximately 30 to 45 minutes each); (3) post-intervention assessments, including survey questions following a negative affect induction (brief film clip); and (4) a 2-week follow-up assessment.

Eligibility criteria:
inclusion criteria: * adults 18 years and older * english-speaking * at least mild anxiety and/or depression symptoms, as indicated by a score of 3 or greater on the 4-item patient health questionnaire (phq-4) exclusion criteria: * fail to meet above-listed inclusion criteria * exit the study prior to condition randomization * obvious lack of english fluency in open response questions * responding with random text in open response questions * respond with either copy/pasted responses from text earlier in the intervention to any of free response questions * participants with a completion time less than 180 seconds for the baseline survey assessment (taking about 1.5 seconds per question) or who fail all three attention check questions in the baseline survey, indicating very careless, random, inattentive and/or hasty responding
pretreatment aceclofenac effect on pain and analgesic intake after endodontic treatment

Conditions: Symptomatic Irreversible Pulpitis

Summary: the aim of this prospective, randomized, double-blind, clinical trial is to evaluate the effect of a preoperative, single, oral dose of aceclofenac (100 mg) on postendodontic pain at 6, 24 and 48 hours, postoperative pain at injection area at 6, 24 and 48 hours and analgesic intake after single-visit root canal treatment.

* patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured using heft-parker vas. eligible patients will be treated in one visit. * patients will be randomly assigned to one of 2 groups: experimental group (taking a 100 mg of aceclofenac) and the control group (taking a placebo tablet). each tablet will be taken one hour before the initiation of single-visit endodontic therapy. each participant will receive a standard inferior alveolar nerve block injection of 1.8 ml of 2% mepivacaine with 1:100,000 epinephrine. after endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 200 mg as rescue medication. * postendodontic pain intensity and incidence at the different pain categories (no, mild, moderate, severe) will be assessed 6, 24, and 48 hours postoperatively using heft-parker visual analogue scale (hp-vas). postoperative pain at injection area will be assessed at 6,24 and 48 hours using hp-vas. analgesic intake throughout the 48 hours will be recorded.

Eligibility criteria:
inclusion criteria: * patients in good health (american society of anesthesiologists class i or class ii). * patients having symptomatic irreversible pulpitis in one of their mandibular molars * age is 18 years or older. * patients who can understand heft- parker visual analogue scales. * patients able to sign informed consent. exclusion criteria: * patients allergic to aceclofenac or mepivacaine. * pregnant or nursing women. * patients having active pain in more than one molar in the same quadrant. * administration of analgesics within 12 h before the administration of the study drug.

Keywords: aceclofenac pain irreversible pulpitis
safety and feasibility of hyperkalemic cardioplegia with diazoxide in cardiac surgery (cpg-dzx) trial

Conditions: Myocardial Stunning

Summary: this study aims to confirm the safety and efficacy of diazoxide as an additive to hyperkalemic cardioplegia in patients undergoing cardiac surgery with cardiopulmonary bypass. the investigators hypothesize that diazoxide combined with hyperkalemic cardioplegia provides superior myocardial protection and reduced myocardial stunning compared with standard cardioplegia alone. thirty patients will receive treatment. safety will be assessed by comparing mean arterial blood pressure measurements, glucose levels and incidence of adverse events between the two groups. efficacy will be assessed by comparing right and left ventricular function in pre-operative vs post-operative transesophageal echocardiograms, need for mechanical circulatory support, ease of separation from bypass and vasoactive inotrope score (vis) between the two groups. the information gained could pave the way for the use of katp (potassium-atp) channel openers to prevent stunning, improve patient outcomes, and reduce health care costs related to myocardial stunning that requires inotropic and mechanical support following cardiac surgery.

this is a phase i clinical trial. thirty patients total will receive treatment (iv diazoxide added to cardioplegia). diazoxide will be added to the first dose of cardioplegia only. subsequent doses of cardioplegia will not contain additives.

Eligibility criteria:
inclusion criteria: * age 18 years or older * scheduled for cardiac surgery with cardiopulmonary bypass and cardioplegic arrest * patient scheduled for elective cardiac surgery * if female participant of childbearing potential, she must agree to and be able to use a highly effective method of birth control (eg, barrier contraceptives, hormonal contraceptives, intrauterine devices, or sexual abstinence) continuously for six days post- diazoxide dose exclusion criteria: * patient with diabetes mellitus on sulfonylurea medications * scheduled for left ventricular assist device (lvad) or heart transplant * left ventricular ejection fraction \< 30% * pre-operative placement or planned use of mechanical circulatory support during surgery * allergy to thiazide and its derivatives * history of gout * patient is pregnant or breastfeeding * patients with seizure disorders controlled by diphenylhydantoin * patients with a history of cold agglutinins
physical activity in pregnancy

Conditions: Pregnancy, Physical Activity

Summary: this prospective observational study assesses whether women who regularly exercise during pregnancy show reduced low grade inflammation, compared to women who are not regularly exercising. furthermore, the effects of regular physical activity in pregnancy on fetal and neonatal outcomes will be investigated. 3 groups of pregnant women will be formed (group 1: regularly physically active women; group 2: physically inactive women and group 3: women with a history of preeclampsia or positive history of metabolic conditions increasing the risk of hypertensive disorders in pregnancy).

pregnancy is a natural state of low grade inflammation in the mother and the feto-placental unit. the severity of this inflammation increases with higher pregravid body mass index (bmi). this is reflected by an increase in pro-inflammatory cytokines in the maternal circulation and in the placenta. it has been proposed that the pro-inflammatory maternal and fetal environment plays a role in mediating pregnancy outcomes. in non-pregnant individuals regular physical activity is associated with a reduced inflammatory state. the overall objective of the study is to investigate the interaction of maternal physical activity and pregnancy induced low-grade inflammation in the mother and feto-placental unit, and to assess th resulting effects on prenatal and postnatal development. specific research objective will be to study effects of maternal physical activity on: 1. low grade inflammation in the mother an feto-placental unit; 2. maternal and fetal lipid profiles, including high density lipoprotein (hdl) proteome; 3. fetal growth and infant body composition; 4. transcriptomic and epigenetic profile in the placenta; 5. biomarkers of nutritive status; 6. psychological assessment: cardiac awareness; assessment of arterial stiffness; stress-coping questionaire

Eligibility criteria:
inclusion criteria: * ongoing pregnancy no later than 14 weeks of gestation * giving informed consent exclusion criteria: * not wanting to give birth at the university hospital * gestational age \> 14 weeks of gestation * 3 or more consecutive miscarriages * increased risk to or above 1:200 after combined test (minimum parameters: maternal age, fetal crown-rump length (crl), nuchal translucency, nasal bone and maternal biochemistry) * fetal anomalies associated with possible growth or genetic anomalies * smoking * diagnosed with diabetes type 1 or 2 (t1d, t2d) * for groups 1 and 2: maternal metabolic risk factors (autoimmune conditions, increased risk for thromboembolic events needing anticoagulative therapy) * for groups 1 and 2: pre-pregnancy hypertension