Kornimate/medical-research-clean huggingface dataset:
semi-elemental versus polymeric een in the preoperative optimization for patients with cd

Conditions: Crohn Disease; Nutrition Disorders; Surgery

Summary: growing evidence has shown that exclusive enteral nutrition (een) plays an important role in the preoperative optimization for patients with crohn's disease (cd). however, the efficacy and safety of different types of enteral feeds including semi-elemental and polymeric enteral nutrition on cd have not been investigated. the aim of this study was to compare the role of semi-elemental and polymeric enteral nutrition on cd.

growing evidence has shown that exclusive enteral nutrition (een) plays an important role in the preoperative optimization for patients with crohn's disease (cd). however, the efficacy and safety of different types of enteral feeds including semi-elemental and polymeric enteral nutrition on cd have not been investigated. the aim of this study was to compare the role of semi-elemental and polymeric enteral nutrition on cd. the primary outcome: the reduction rate of crp/alb after exclusive enteral nutrition in crohn's disease. the other outcomes: (1) the changes in crohn's disease activity index; (2) the tolerance of enteral nutrition; (3) the changes in body mass index; (4) postoperative complications and the incidence of stoma; (5) the rate of surgery; (6) other adverse reactions.

Eligibility criteria:
inclusion criteria: 1. elective bowel resection for crohn's disease; 2. preoperative diagnosis of crohn's disease; 3. age between 18 to 65 years old; 4. malnutrition; 5. the crohn's disease activity index over 150; 6. nasal feeding. exclusion criteria: 1. emergency surgery; 2. preoperative exclusive enteral nutrition before three months; 3. can not tolerate enteral nutrition; 4. less than 6 weeks of exclusive enteral nutrition; 5. preoperative corticosteroids within 3 months; 6. history of gastrointestinal surgery; 7. isolated colon disease; 8. metabolic disease (diabetes, hyperthyroidism).

Keywords: crohn's disease exclusive enteral nutrition surgery
preoperative nerve block for rhinoplasty/septoplasty

Conditions: Nasal Fracture; Deviated Nasal Septum

Summary: addiction is an inherent risk when prescribing opiates for pain relief, and methods to reduce its use or amount prescribed can help mitigate this risk for addiction. patients undergoing rhinoplasty are often prescribed a short course of opiates during the acute post surgical phase. studies have shown intraoperative sphenopalatine ganglion (spg) nerve block in endoscopic sinus surgery can reduce post operative narcotic use. the purpose of this study is to determine if use of spg block can be used to reduce narcotic use in the acute post operative phase of rhinoplasty/septoplasty.

with the current opioid epidemic, more than 40,000 deaths can be attributed to prescription and illicit opioid use per year. there is inherent risk for patients to develop addiction when prescribing opiates for pain relief, and methods to reduce its use or the amount prescribed can help mitigate this risk. surgery is one of the leading causes for prescribing narcotics to control pain. patients undergoing rhinoplasty are often prescribed a short course of opiates during the acute post surgical phase. intraoperative sphenopalatine ganglion (spg) block has been successfully and safely used in endoscopic sinus surgery, and has been shown to decrease narcotic use and inpatient hospital stay time. the investigators are interested in determining if use of spg block may offer an improved strategy to reducing the use of narcotics for post rhinoplasty/septoplasty pain relief. the investigators hypothesize that spg block will reduce the amount of post operative opiates required for pain control. the study population will include patients undergoing rhinoplasty/septoplasty at keck medical center of usc who are able to provide consent. the study will include two arms: spg block (experimental) and placebo saline injection (control). patients' post operative pain scale and narcotic use will be recorded until first follow-up visit (2 weeks). patient demographics, surgical indication, and intraoperative analgesia will be recorded. t-tests will be conducted between patient groups. anova will be used to analyze other factors that may be associated with decreased narcotic use.

Eligibility criteria:
inclusion criteria: 1. any patient requiring rhinoplasty/septoplasty and able to provide consent. 2. must be willing to participate. 3. must be able to complete consent in english or spanish. exclusion criteria: 1. history of opioid substance abuse disorder. 2. \<18 years old 3. currently pregnant
fungal biomarkers to reduce duration of empirical antifungal therapy: a randomized comparative study (stafe)

Conditions: Fungal Infection; Critical Illness

Summary: the investigators hypothesized that the use of biomarkers of invasive fungal infections would increase the percentage of early discontinuation of empirical antifungal therapy and thus reduce the duration of treatment in icu patients.

the duration of empirical/preemptive anti fungal treatment will be based in the intervention group on biomarker results. biomarkers of fungal disease will performed before starting anti fungal treatment and at day 4.

Eligibility criteria:
inclusion criteria: * age \> or = 18 years * patients requiring empiric antifungal therapy the first time in the icu * predictable duration of hospitalization in the icu ≥ 6 days exclusion criteria: * neutropenia (wbc \<1000 or neutrophils \<500/mm3) * immunosuppressive therapy (chemotherapy within 3 months prior to the icu admission, solid organ graft under immunosuppressive therapy) * invasive fungal infection documented in the three previous months * antifungal treatment in the three previous months * pregnant or lactating women

Keywords: empiric antifungal therapy biomarkers invasive fungal infection candida
the role of osteopathic manipulative medicine in recovery from concussions

Conditions: Concussion, Brain

Summary: this project aims to study whether adding osteopathic manipulative treatment (omt) to usual care of concussed patients will enhance their recovery.


Eligibility criteria:
inclusion criteria: * age between 13-55 years * concussion sustained within the last 12 days exclusion criteria: * contraindications to omt, such as skull fracture, cervical fracture, signs of intracranial bleeding, or stroke * neck surgery within the last 6 months * any conditions recognized by a physician as contraindicating or impeding protocol implementation * will not be under the care of a healthcare professional * any active (or pending) worker's compensation, disability, or personal injury claims related to their concussion injury

Keywords: concussion sport-related osteopathic manipulative treatment
bioavailability of the polyphenols contained in a red grape extract-based drink and their metabolic effects

Conditions: Healthy

Summary: randomized placebo-controlled crossover study during which participants undergo two different experimental days. the participants consume a red grape based- drink (polyphenols: 300 mg/100 ml and sugar: 9.8g/100 ml) or a placebo (no polyphenols and sugar: 9.8g/100 ml). after 3 hours they consume a test meal (905 kcal, 15% protein, 46% fat, 39% cho). blood samples are taken at fasting, over 3 hours after drink consumption and over 5 hours after the test meal to evaluate metabolic response. fasting and 48h-urine are collected to evaluate bioavailability.


Eligibility criteria:
inclusion criteria: * bmi \>25 and \<35 kg/m2 * total cholesterol \<250 mg/dl * triglyceride \< 200 mg/dl. * fasting glucose \<100 mg/dl exclusion criteria: * cardiovascular events (ima or stroke) in the 6 months prior to the study * kidney or liver failure * anemia (hb \<12 g/dl) * any chronic disease * intense physical activity * dietary supplements
to determine the ability of a new product formulation to remineralize an early caries lesion by an in-situ study

Conditions: Dental Caries

Summary: this is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to evaluate remineralization of early caries lesions.


Eligibility criteria:
inclusion criteria: 1. male and/or female subjects 18 to 50 years inclusive 2. minimum of 20 natural uncrowned teeth (excluding third molars) must be present 3. willing to wear retainer 24 hours per day 4. no active, unrestored cavities 5. have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥ 0.2 ml/min respectively) ascertained from a preliminary sialometry 6. available throughout entire study 7. willing to use only assigned products for oral hygiene throughout the duration of the study 8. must give written informed consent 9. must be in good general health 10. no known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study exclusion criteria: 1. advanced periodontal disease 2. medical condition which requires premedication prior to dental visits/procedures 3. not enough teeth to secure the oral retainer 4. diseases of the soft or hard oral tissues 5. wear an orthodontic appliances 6. impaired salivary function 7. current use drugs that can affect salivary flow 8. use antibiotics one (1) month prior to or during this study 9. pregnant or breastfeeding 10. participate in another clinical study one (1) week prior to the start of the washout period or during this 9-week study period 11. use tobacco products 12. allergic to common toothpaste ingredients 13. allergic to amino acids 14. immune compromised individuals (hiv, aids, immuno-suppressive drug therapy)
otl38 injection (otl38) for intra-operative imaging of folate receptor positive ovarian cancer

Conditions: Ovarian Cancer

Summary: the primary objective of the study is to compare the performance of different camera imaging systems in assessing the positive predictive values and sensitivity of otl38 to detect folate positive ovarian cancer cancers using the gold standard of pathologic review.

patients will be seen in the ovarian cancer clinic. patients that have or are suspected to have ovarian cancer, and are candidates for debulking surgery based on the clinician evaluation, may be considered candidates for this study. as over 90% of ovarian epithelial cancers express folate receptor, we would expect a high percentage of these patients scheduled for surgery, to have eligible cancer types for entry into the study. these patients will be prospectively consented to participate in this trial. there will be no randomization or control group and only patients previously scheduled to undergo surgery will be eligible to participate. we anticipate a 2-year period will be necessary to reach our accrual goal of up to 10 patients. after obtaining informed consent, patients will receive a one-time dose of 0.025 mg/kg of otl38, infused over approximately 60 minutes and completed at least 1 hour prior to intraoperative imaging. as a prophylactic measure, we recommend 25mg of iv benadryl to the patient prior to the infusion of otl38 to decrease the possibility of a hypersensitivity reaction. the duration of surgical procedures to resect ovarian cancers varies substantially, anywhere from 3- 8 hours or more. during the phase 2 study, the median time spent imaging the patients with a single camera was 14 minutes. utilizing two cameras to complete imaging would not overly increase the duration of time patients spend under anesthesia. however, there is a chance that being under anesthesia for the additional 25-35 minutes could put the patient at an increased risk of having of a common side effect associated with anesthesia. these common side effects include, but are not limited to: nausea and vomiting after surgery, sore throat and hoarseness, shivering/chills, confusion, and muscle aches

Eligibility criteria:
inclusion criteria: * female patients \> 18 years of age * have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary surgical cytoreduction, interval debulking, or have recurrent ovarian cancer * good operative candidate as determined by clinical presentation and laboratory assessments * subject capable of giving informed consent and participating in the process of consent. exclusion criteria: * pregnant women as determined by urinary or serum beta hcg. * patients with a history of allergy to any of the components of otl38, including folic acid * known fr-negative ovarian cancer * patients with a known allergy to benadryl * previous exposure to otl38 * vulnerable populations: the homeless, prisoners or not capable of participating in the consent process
effects of insulin in perceived mood symptoms in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this study investigates the influence of two different insulin regimens, twice-daily insulin lispro low mix (lm) and once-daily insulin glargine, on perceived physical, mood, and cognitive symptoms as well as cognitive-motor task performance in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * diagnosed as having type 2 diabetes mellitus, as defined by the world health organization * are being treated with metformin therapy alone, metformin therapy plus once-daily insulin, or metformin plus one or more other oral antihyperglycemic agents at the time of study entry * female patients not breastfeeding and female patients of childbearing potential must test negative for pregnancy at time of study entry based on a urine pregnancy test and do not intend to become pregnant during the study and agree to use a reliable form of birth control during the study * hemoglobin a1c greater than or equal to 7.0% and less than or equal to 10% within 3 months prior to visit 1 * have given informed consent to participate in the study in accordance with local regulations exclusion criteria: * are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry * have previously been diagnosed with clinical depression or have been treated with a central nervous system stimulant, antidepressant, antipsychotic, or anxiolytic agent within 30 days prior to study entry * have a known allergy to insulin lispro low mixture, insulin glargine, metformin hydrochloride, or excipients contained in these products * have known hypersensitivity or contraindication to metformin hydrochloride
local ablative therapy for patients with multiple (4-10) brain metastases

Conditions: Brain Metastases, Adult

Summary: to observe the quality of life (qol) and to report on toxicity and outcome parameters after the (repeated) use of local ablative therapy (lat) i.e. stereotactic radiotherapy (srt) for patients with multiple (4-10) brain metastases

phase iv prospective non-randomized observational trial (registry trial) for patients with a ds-gpa \> 1.5 or an estimated life expectancy of \>3 months and an established diagnosis on dedicated brain mri of 4-10 bm of any solid primary tumor. we plan to deliver a local ablative therapy (lat) i.e. srt in 1 to 5 fractions on visible bm and post-surgical cavities if applicable. our primary aim is to provide quality of life (qol) data and our secondary aim is to report on several toxicity and outcome parameters for this patient cohort.

Eligibility criteria:
inclusion criteria: 1. male or female, ≥ 18 years of age 2. minimal 4 and up to a maximum of 10 synchronous bm diagnosed on a high resolution contrast-enhanced mri scan (t1 gadolinium) not dated more than 4 weeks prior to inclusion. 3. maximal lesion diameter of single gross tumor volume (gtv) of 3 cm 4. maximal cumulative gtv (+ctv for cavity) of 30cm3 5. karnofsky performance status ≥ 70 6. ds-gpa or expected overall survival (if no ds-gpa applicable) of ≥ 1.5 or \>3 months respectively. 7. any solid primary tumour. lymphoma, germ cell tumor, small cell lung carcinoma and multiple myeloma are excluded. 8. ability to provide written informed consent and to participate in the procedure of the questionnaires. exclusion criteria: 1. bm not amenable to srt 2. previous srt or surgery on the same lesion 3. co-morbidities considered clinically precluding the safe use of an mri examination or srt 4. any psychological, sociological or geographical issue potentially hampering compliance with the study 5. pregnancy 6. concurrent use of systemic therapy 7. more than 10 bm on planning-mri 8. maximum cumulative gtv (+ctv for cavity) of more than 30cm3 on planning-mri 9. a brainstem metastasis with a ptv of more than 20 cm3 10. leptomeningeal disease

Keywords: stereotactic radiotherapy brain metastases multiple (4-10)
catheter orifice configuration (six-hole versus end-hole) on post-operative analgesia after total knee arthroplasty.

Conditions: Pain

Summary: multiorifice catheters have been shown to provide superior analgesia and significantly reduce local anesthetic consumption compared with end-hole catheters in epidural studies. this prospective, blinded, randomized study tested the hypothesis that, in continuous femoral nerve block (cfnb) under ultrasound guidance, multiorifice catheter would reduce local anesthetic consumption at 24h compared with end-hole catheter.

eighty adult patients (aged ≥18 years) scheduled to undergo primary total knee arthroplasty under a combination of continuous femoral nerve block (cfnb), sciatic nerve block and general anesthesia were randomized to cfnb using either a 3-pair micro-hole (contiplex, braun®, 20g - 400 mm) or an end-hole (silverstim vygon®, 20g - 500 mm) catheter. once the femoral catheter was sited, a bolus of 20 ml lidocaine 1% was injected. an electronic pump then delivered an automated 5 ml bolus of ropivacaine 0.2% hourly, with 10 ml self-administered patient controlled analgesia boluses.

Eligibility criteria:
inclusion criteria: * every patient accepting a conitnuous femoral nerve catheter exclusion criteria: * pregnancy, * any contraindication to peripheral nerve blockade, * pre-existing peripheral nerve neuropathy, * allergy to la (study medications), * asa score ≥4, * neurologic or neuromuscular disease, * psychiatric disease, * renal failure, * hepatic failure, * chronic opioid therapy, * nsaid contraindication, * inability to use a patient controlled analgesia (pca) device, g * enu valgum, * infection at the injection site or * withdrawal of consent.

Keywords: multiorifice or endhole femoral nerve catheter
the effect of different force magnitudes on maxillary posterior segment intrusion

Conditions: Orthodontics

Summary: a randomized clinical trial comparing two different force magnitudes in maxillary posterior segment intrusion in adult patients with skeletal open bite malocclusion

this randomized controlled trial is aiming to study the effect of the different force magnitude on maxillary posterior segment intrusion. two groups are going to be allocated and the amount and rate of intrusion will be measured and compared.

Eligibility criteria:
inclusion criteria: * adult patients with an age range from 17 to 25. * skeletal open bite. * dental open bite that is due to overgrowth of maxillary posterior segment as seen clinically and that can be corrected without surgical intervention (a minimum of 3 mm and a maximum of 8 mm). * skeletal class i or mild to moderate skeletal class ii that enables camouflage treatment. * normal incisor show on smiling (that makes the case indicated for molar intrusion and not for incisor extrusion). * full set of maxillary posterior dentition (first and second premolars, first molars at least). * no previous orthodontic treatment. exclusion criteria: * medically compromised patients. * patients suffering from any congenital or hereditary diseases. * smoking or any systemic diseases. * chronic use of any medications including antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroids, and calcium channel blockers.

Keywords: skelatal open bite, posterior intrusion
tender loving care for recurrent pregnancy loss

Conditions: Recurrent Pregnancy Loss

Summary: the goal of this investigational study is to evaluate participation in a weekly, interactive, tender loving care messaging platform impact on pregnancy outcomes in patients with recurrent pregnancy loss. the main questions it aims to answer are: (1) does participation in weekly, interactive tender loving care messages increase live birth rates in patients with recurrent pregnancy loss? (2) does participation in weekly, interactive tender loving care messages increase patients' quality of life? does participation in weekly, interactive tender loving care messages decrease patients' depressive symptoms? participants will be asked to interact with weekly messages providing prenatal counseling and support. additionally, patients will be asked to complete the fertility quality of life survey several times over the course of the pregnancy.

participants will be asked to interact with weekly messages providing prenatal counseling and support. additionally, patients will be asked to complete the fertility quality of life survey several times over the course of the pregnancy.

Eligibility criteria:
inclusion criteria: * pregnant individuals receiving their prenatal care at wrnmmc * able to speak and understand english * less than or equal to 10+0 weeks gestation by last menstrual period (lmp) or dating ultrasound at the time of enrollment * at least two prior pregnancy losses. pregnancy losses must be confirmed with laboratory criteria confirming a positive pregnancy test in the military electronic medical record with subsequent resolution (resolution may be reported by patient), or with ultrasound criteria demonstrating an intrauterine gestational sac with subsequent resolution (resolution may be reported by patient). exclusion criteria: * age less than 18 years and older than 44 at time of enrollment * unable to speak or understand english * current smoker or tobacco use within 30 days * history of uterine anomaly, coagulopathy, balanced translocation, endometrial polyps, submucosal fibroids, pathology confirmed acute or chronic endometritis, hydrosalpinx, history of asherman syndrome, poorly controlled endocrinopathies, hiv infection * history of gonadotoxic therapy or cancerous condition of the female reproductive tract * suspicion for or confirmation of an ectopic pregnancy

Keywords: recurrent pregnancy loss
stiripentol for the treatment of refractory status epilepticus

Conditions: Status Epilepticus

Summary: the investigators retrospectively analyzed all patients who were admitted to the department of neurology at marburg university hospital between 2013 and 2023 with a diagnosis of (super)-refractory status epilepticus and who received additional treatment of se with stp. all patients who received stp during the se were included, regardless of previous medication.

the investigators retrospectively analyzed all patients who were admitted to the department of neurology, university hospital marburg, germany, between 2013 and 2023 with a diagnosis of status epilepticus, who received additional treatment of se with stp. they were able to identify 25 patients who received stp as add on therapy. all these patients suffered from rse or srse. since there was no sop or treatment algorithm available, they have listed the individual treatment regimens in table 2. 5 of these patients were previously published in a case series (strzelczyk et al. 2015). treatment success was defined as continuous interruption of the se. descriptive statistics are reported as absolute numbers and percentages, mean ± standard deviation (sd) or median ± median absolute deviation. the study was approved by the local irb.

Eligibility criteria:
inclusion criteria: * adult patients who suffered from rse or srse and received stp as add on therapy. exclusion criteria: * children

Keywords: status epilepticus epilepsy stiripentol