Kornimate/medical-research-clean huggingface dataset:
use of a peptide-based formula in an adult population

Conditions: Malabsorption

Summary: the study is designed to observe the use of a peptide-based oral nutrition supplement in adults with chronic malabsorption or maldigestion who require supplemental nutrition as assessed by a clinician.


Eligibility criteria:
inclusion criteria: * subject is ≥ 18 years of age. * subject has chronic malabsorption or maldigestion. * subject requires supplemental nutrition as assessed by a clinician. * subject agrees to consume 2 servings of the study product a day for at least 16 consecutive days during treatment period. exclusion criteria: * subject is currently taking or has taken antibiotics within 2 weeks prior to enrollment in the study. * subject has current active malignant disease or was treated within the last 6 months for cancer. * subject has a history of diabetes mellitus. * subject is pregnant as demonstrated by a urine pregnancy test. * subject has severe auto immune disease and is on immuno-modulating therapy. * subject has a history of allergy to any of the ingredients in the study product. * subject has active hiv. * subject has a known aversion to flavor of product being tested. * subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption. * subject has an obstruction of the gastrointestinal tract precluding ingestion or absorption of the study product. * subject is taking part in another non-sponsor approved clinical trial.
validation of human papillomavirus assays and collection devices for self-samples and urine samples

Conditions: Cervical Intraepithelial Neoplasia Grade 2/3

Summary: the valhudes study is a diagnostic test accuracy study that aims to document the clinical accuracy of hrhpv testing on urine samples, collected under standardised and optimised conditions, and on two types of vaginal self-samples and compare results with those from matching samples taken by a clinician.

the samples are collected from patients referred to colposcopy because of prior cervical abnormalities. the patient takes at home two urine samples with the colli-pee device (a device that allows to collect first-void urine), the day before the visit to the colposcopy centre. at the colposcopy centre, two vaginal self-samples are taken by the patient herself: one with a cotton swab and a second with a plastic brush. finally, the gynecologist takes a cervical pap smear with a cervex-brush combi. a real-time pcr test will be used to detect dna of high-risk hpv types. it is possible that in the future also other tests will be validated on these samples. the colposcopy and histological findings will be used as the gold standard. the main purpose of the study is to assess the relative diagnostic tests accuracy of hrhpv testing on self- and urine samples compared to hrhpv testing on cervical samples taken by a clinician. furthermore, the participating women will receive also a questionnaire which can give insights into the attitudes and preferences of the women with regard to the self-sampling devices.

Eligibility criteria:
inclusion criteria: * women with previous abnormal cervical cancer screening test results * women between the ages of 25 and 64 exclusion criteria: * hysterectomised women * women with known pregnancy * non-consenting women * women that are not able to understand and to sign the informed consent

Keywords: self-sampling hpv testing diagnostic test accuracy cervical intraepithelial neoplasia urine cervical cancer screening
confirmation of tube placement in newborns

Conditions: Respiratory Distress Syndrome; Apnea of Newborn

Summary: tracheal intubation remains a common procedure in the neonatal intensive care unit (nicu) and the delivery room (dr). current guidelines recommend estimation of correct endotracheal tube (ett) insertion our hospital policy recommends to estimate the correct depth (cm) of tube placement by measuring the nasal-ear-tragus length using the "7-8-9 rule" when the endotracheal tube is placed orally. using this formula an infant weighing 1kg would be intubated to a depth of 7cm, a 2kg infant to a depth of 8cm, and a 3kg infant to a depth of 9cm from the upper lip. with the new 2015 guidelines, ett depth is determined by measuring the newborn's nasal septum-tragus length (ntl) and adding 1cm or by using the "initial endotracheal tube insertion depth" table. the ntl is described as the distance from the base of the nasal septum to the tragus of the ear. however, studies using ntl reported that using this technique only resulted in correct ett placement in 56% of cases. every ett has markings on the tube, which are called vocal cord markings, which are to be used to provide a guidance to how deep to place the ett into the trachea. there has been npc study to compare the vocal cord markings with the current approach of ntl. the current study aims to determine if the use of vocal cord markings during intubation increases percentage of correct endotracheal tube placement compared to ntl in preterm and term infants.


Eligibility criteria:
inclusion criteria: * all infants (term and preterm) born at the royal alexandra hospital who require endotracheal intubation in the delivery room or/and neonatal intensive care unit will be eligible. exclusion criteria: * infants will be excluded if their parents refuse to give consent to this study.
low dose calcium to prevent preeclampsia

Conditions: Pre-Eclampsia; Hypertension, Pregnancy-Induced; Dietary Calcium Deficiency

Summary: the purpose of this study is to assess, in pregnant women with calcium-poor diets, what is the effectiveness of low-dose (500 mg/day) calcium supplements associated with an educational intervention, compared to the educational intervention alone, in the prevention of preeclampsia and hypertensive disorders during pregnancy.


Eligibility criteria:
inclusion criteria: * capacity to understand verbal and visual instructions * gestational age 16 - 20 weeks * live fetus exclusion criteria: * hyperparathyroidism or other contra-indication to calcium supplementation * gastrointestinal diseases or conditions that may interfere with calcium absorption (e.g. bariatric surgery, cancer, chronic colitis) * use of medications that may interfere with calcium absorption (e.g. corticosteroids, thiazides, thyroid hormones) * women already taking calcium supplements or daily antacids at recruitment

Keywords: calcium dietary supplements hypertension, pregnancy-induced pre-eclampsia nutritional education diet therapy diet records hospitalization maternal mortality
a multiple dose study investigating pharmacokinetics and pharmacodynamics of subcutaneous nnc0363-0845 in participants with type 1 diabetes pharmacokinetics and pharmacodynamics: how insulin nnc0363-0845 is transported throughout the body and how it works

Conditions: Diabetes Mellitus, Type 1

Summary: this study is designed to investigate the movement of insulin nnc0363-0845 throughout the body and how it works for the treatment of type 1 diabetes mellitus. the aim of the study is to improve clinical outcomes for patients with type 1 diabetes mellitus by better controlling the blood sugar levels. participants will get insulin nnc0363-0845 as well as insulin detemir (levemir®). nnc0363-0845 is a new insulin molecule designed to provide blood sugar-dependent insulin action, while insulin detemir is commonly used and prescribed by doctors. participants will get subcutaneous (under your skin) injections of insulin nnc0363-0845 (study medicine) up to 6 times daily for 3 days, and of insulin detemir up to 6 times daily for another 3 days. which medication participants receive first and which second, insulin nnc0363-0845 or insulin detemir, is decided by chance. the study will last for about 6 weeks up to a maximum of 14 weeks. participants will have 2 in-house visits (where participants will stay at the site for 4 nights) and 5 outpatient visits with the study doctor. participants will have frequent contact with the study doctor during the study. during the in-house visits, two intravenous catheters (a thin tube inserted into a vein) will be inserted for blood sampling and infusions. interested parties may not participate in the study if the study doctor believes it will affect their health negatively. women cannot take part if they are of childbearing potential.


Eligibility criteria:
key inclusion criteria: * male participant or female participant of non-childbearing potential. non-child-bearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening. * aged 18-64 years (both inclusive) at the time of signing informed consent. * diagnosed with type 1 diabetes mellitus 1 year or more before screening. * current daily basal insulin treatment greater than 0.2 and below or equal to 0.5 (i)u/kg/day. * current total daily insulin treatment between 0.4 and 0.8 (i)u/kg/day (both inclusive). * body mass index between 18.5-29.9 kg/m\^2 (both inclusive). * hba1c (glycated haemoglobin) below or equal to 8.0%. key exclusion criteria: * male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice). adequate contraceptive measures include that the male participant uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%). in addition, participants must not donate sperm for the duration of the study.
a comparison of traditional and moses laser enucleation of the prostate (molep): a prospective, randomized, double-blinded control trial a comparison of traditional and moses laser enucleation of the prostate (molep): a prospective, randomized, double-blinded control trial

Conditions: Benign Prostatic Hyperplasia

Summary: holmium laser enucleation of the prostate (holep) has proven to be efficacious and safe for the treatment of benign prostatic hypertrophy (bph). new laser technologies such as the moses pulse laser system provide for improved energy delivery which may decrease blood loss and operative time. we seek to evaluate moses technology for enucleation of the prostate in the setting of bph.

this is a single-center, prospective, double-blinded, randomized controlled trial comparing molep to holep. inclusion criteria included all symptomatic bph patients desiring enucleation with prostate sizes \> 80ccs based on cross-sectional imaging. patients are randomized in a 1:1 fashion and the study is powered to evaluate for a difference in operative time (i.e. alpha=0.05,n=21 per group). all surgeries will be performed with a 550 μm fiber. at the start of each case, a laser technician would be notified of randomization via envelope and randomize the settings to either moses or traditional mode. the surgeons and patients were blinded to which mode was used. all surgeries will be performed using a two lobe technique and laser settings between 2j and 20-40hz. further recorded endpoints include change in blood loss, reduction in international prostate symptom score (ipss), improvement in uroflow parameters, and complications postoperatively at 6 weeks.

Eligibility criteria:
inclusion criteria: * any man with clinical symptoms fo bph requiring surgery who has a prostate sized at greater than 80 grams exclusion criteria: * anyone actively on anticoagulation perioperatively
impact advanced recovery® for radical cystectomy (rc) patients: a pilot study

Conditions: Bladder Cancer; Radical Cystectomy; Urinary Bladder Neoplasms; Surgery

Summary: the purpose of this study is determine if using impact advanced recovery® before and after rc surgery helps reduce surgical complications.

radical cystectomy (rc) is the removal of the entire bladder and nearby organs that may contain cancer cells. it is a major surgery that can lead to breakdown of proteins in the body and a decreased immune response, both of which increase the risk of illness and death. poor nutrition status before rc surgery is linked to a higher rate of death after surgery. therefore, it is important to eat a balanced diet before and after rc surgery to avoid negative outcomes. studies show that patients who drink a nutritional supplement that may enhance the immune system before and after gastro-intestinal surgery may have fewer infections and shorter hospital stays after surgery. patients with cancer of the colon/rectum, stomach, and pancreas who drank a similar immune-enhancing nutritional supplement before and after surgery also had fewer infections. the purpose of this study is to attain pilot data for a larger trial.

Eligibility criteria:
inclusion criteria: * men undergoing rc surgery for primary bladder cancer exclusion criteria: * patients with swallowing difficulties or unable to tolerate oral intake * evidence of metastatic disease * weight loss ≥ 10% (with respect to usual body weight) in the 6 months prior to surgery or bmi ≤ 18.5 * patients undergoing cystectomy for non-bladder primary malignancy or cancer type other than urothelial * active viral infections such as human immunodeficiency virus (hiv) positive, hepatitis, or who have a known immunodeficient state * prior history of gouty arthritis or uric acid stones * patients with milk, soy, or fish allergies

Keywords: nutritional supplement immune system rc surgery
pet ct with hx4 in cervix cancer

Conditions: Cervix Cancer

Summary: the aim of this study is: 1. to determine if tumor hypoxia can be accurately visualised with \[18f\]hx4 pet imaging in cervix cancer, 2. to correlate the \[18f\]hx4 pet images with blood and tissue markers, 3. to investigate the quality and optimal timing of \[18f\]hx4 pet images, 4. to compare \[18f\]hx4 pet uptake with \[18f\]fdg pet uptake before and after treatment and 5. analyze correlation with responses

tumor hypoxia is the situation where tumor cells are or have been deprived of oxygen. hypoxic tumor cells are usually more resistant to radiotherapy and chemotherapy and more likely to develop metastasis. in cervix cancer, tumor hypoxia is known to be an important prognostic factor for long term survival. \[18f\]hx4 is being developed as a diagnostic radiopharmaceutical for pet imaging to find a marker for hypoxia that can be used in standard clinical practice. current hypoxia tracers lack reliable image quality and kinetics. because of the short half life and clearance, the investigators expect that \[18f\]hx4 will have a higher tumor to background ratio than current nitro-imidazole hypoxia markers such as \[18f\]-misonidazole. in a recent phase 1 clinical study from van loon et al, pet-imaging with \[18f\]hx4 was feasible without any toxicity. the clinical use of a reliable, non-invasive and easy to use hypoxia imaging agent could allow selection of patients most likely to benefit from hypoxia modifying therapies.

Eligibility criteria:
inclusion criteria * histologically confirmed cervix carcinoma (squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma) * tumor stages figo ib - iva * who performance status 0 to 2 * scheduled for primary curative radiotherapy (either or not combined with chemotherapy or hyperthermia) * no previous surgery to the cervix * no previous radiation to the cervix * the patient is willing and capable to comply with study procedures * 18 years or older * written informed consent before patient registration exclusion criteria * recent (\< 3 months) myocardial infarction * uncontrolled infectious disease * pregnant or breast feeding and/or not willing to take adequate contraceptive measures during the study

Keywords: cervix cancer [18f] hx4 pet imaging hypoxia phase ii trial
the effect of ultra-low-dose naloxone on remifentanil-induced postoperative hyperalgesia - a randomized controlled study

Conditions: Pain

Summary: high-dose remifentanil infused intraoperative ironically results in postoperative hyperalgesia. ultra-low dose nalxone is demonstrated to prevent these opioid-induced hyperalgesia in animal model. in this clinical trial in patients undergoing general anesthesia with remifentanil, we evaluate the effects of ultra-low-dose naloxone on remifentanil-induced hyperalgesia

we enrolled adult patients undergoing thyroidectomy under general anesthesia with desflurane and remifentanil. remifentanil was administered via target-controlled infusion and anesthetic depth was maintained keeping the bis between 40 and 60. patients were randomized into one of three groups depending on intraoperative doses of remifentanil and naloxone: effect-site concentrations of remifentanil 1 ng/ml (control group), 4 ng/ml (remifentanil group), and 4 ng/ml combined with infusion rate 0.8 ng/kg/min of naloxone (remifentanil and naloxone group). postoperative mechanical pain thresholds, pain intensity, and analgesic consumption were examined during 48 h of postoperative period. the primary outcome was mechanical pain threshold measured on the peri-incisional area 24 h after surgery.

Eligibility criteria:
inclusion criteria: * patients who are scheduled to undergo elective thyroidectomy exclusion criteria: * consent refusal, obesity, pregnancy, hx. of thyroid surgery, neurological disorders, psychiatric disorders, hx. of drug abuse or chronic use of opioids or sedative drugs, intake of any analgesic drug within 12h before surgery.

Keywords: acute pain postoperative surgery
study of tissue and blood samples from patients with high-grade glioma

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment. purpose: this research study is looking at tissue and blood samples from patients with high-grade glioma.

objectives: * to evaluate the diagnostic and prognostic relevance of various molecular, cytogenetic, and other tumor markers in high-grade glioma in paraffin-embedded tissue collected from patients enrolled in the mayo clinic or north central cancer treatment group (ncctg) high-grade glioma trials conducted since 1979. * to evaluate alterations of specific chromosomes and chromosomal regions including 7, 9p, 10p, 10q, 13q, 17p, 17q, 19q, 22q, x, and y using pcr analysis of microsatellite repeats and fish. * to determine dna ploidy by flow cytometric analysis. * to examine various markers of cellular proliferation and cellular function including flow cytometric determination of %s-phase, %g2m, and immunohistochemical evaluation of pcna, ki-67, and p53. * to evaluate additional markers identified by the glioma markers network. * to compare the incidence of markers in the major histologic subtypes (anaplastic astrocytoma \[aa\], anaplastic oligoastrocytoma \[aoa\], glioblastoma multiforme \[gbm\]) and to assess their correlation in the total group, as well as within each of these subtypes. * to compare the ploidy determinations by fish and flow cytometry. outline: paraffin-embedded tissue and peripheral blood samples, previously or currently collected from clinical trials participants at the time she/he enrolled in the trial, are evaluated for as many markers as possible, changes in cytogenic and molecular genetic tumor markers, frequency distributions of all tumor markers and histological and clinical variables by polymerase chain reaction, ihc, flow cytometry, and fish analysis.

Eligibility criteria:
* patients with newly diagnosed high-grade gliomas * patients participating in ncctg/alliance or mayo protocols * willing to provide mandatory blood and tissue samples for research purposes; note: 15 unstained slides may be submitted in place of a tissue block

Keywords: adult anaplastic astrocytoma adult giant cell glioblastoma adult gliosarcoma childhood high-grade cerebellar astrocytoma childhood high-grade cerebral astrocytoma
associations of pre- and intraoperative endoscopic findings of middle ear status in cholesteatoma

Conditions: Middle Ear Cholesteatoma

Summary: the aim of this study is to assess the accuracy of preoperative hrct of the temporal bone combined with the preoperative audiologic assessment compared with the intraoperative endoscopic middle ear finding.

the information of the preoperative hrct scanning of the middle ear cavity in cholesteatoma combined with the preoperative audiologic assessment could be informed the intraoperative middle ear finding in the patients who were diagnosed with chronic otitis media with cholesteatoma, which influence the plan of surgical management. whether these preoperative assessments can predict the intraoperative finding is unclear. the aim of this study is to assess the accuracy of preoperative hrct of the temporal bone combined with the preoperative audiologic assessment compared with the intraoperative endoscopic middle ear finding.

Eligibility criteria:
inclusion criteria: * the patients included in this study had otorrhea, hearing loss, or aural fullness that last more than 3 months. otological examination revealed tympanic membrane perforation or retraction, along with cholesteatoma. exclusion criteria: * patients who had a previous temporal bone fracture, concomitant with congenital craniofacial anomalies, or underwent previous otologic surgery were excluded.

Keywords: endoscopic,cholesteatoma,audiogram, air-bone gap
eeg in resuscitated in-hospital patients

Conditions: Sudden Cardiac Arrest; Seizures

Summary: in kuopio university hospital department of clinical neurophysiology there have been designed a fast eeg electrode, that is suitable for acute emergency use. this study will address the clinical use of acute eeg with this fast eeg electrode in in- hospital patients who have been resuscitated due to cardiac arest. after resuscitation patients will be treated in icu and eeg will be recorded for 24 hours.


Eligibility criteria:
inclusion criteria: * resuscitated in-hospital patients exclusion criteria: * patients with do not attempt to resuscitate-decision * patients who are not going to be treated in icu after resuscitation

Keywords: eeg cardiac arrest resuscitation seizures