Kornimate/medical-research-clean huggingface dataset:
serial magnetic resonance imaging for the prediction of radiation-induced changes in normal tissue of patients with oral cavity or skull base tumors

Conditions: Malignant Oral Cavity Neoplasm; Malignant Skull Base Neoplasm; Osteoradionecrosis

Summary: this phase iv trial studies how well serial magnetic resonance imaging (mri) after radiation therapy works in predicting radiation-induced changes in the normal tissue of patients with oral cavity or skull base tumors. performing mris after radiation therapy for patients with oral cavity or skull base tumors may help to predict osteoradionecrosis (a change in non-cancerous tissue).

primary objectives: i. demonstrate the feasibility of serial magnetic resonance (mr) imaging biomarkers for assessment of early, intermediate, and late radiotherapy-attributable physiologic alteration of tumor and normal tissues and the kinetics thereof. ii. develop mr-biomarker inclusive predictive models for development of radiotherapy-attributable normal tissue injury. iii. define dose-response relationships between imaging biomarkers and subsequent radiation-induced effects. outline: patients are assigned to 1 of 2 cohorts. cohort i: patients may receive a contrast agent intravenously (iv) and then undergo an mri over 45-60 minutes at baseline, 3-5 weeks after starting standard of care radiation therapy, and then at 2 months, 6 months, 12 months, and 3 years after completing radiation therapy. cohort ii: patients may receive a contrast agent iv and then undergo an mri over 45-60 minutes at baseline, and at 5-10 weeks and 12 months after standard of care surgery.

Eligibility criteria:
inclusion criteria: * patients with histologically proven malignant neoplasms of the oral cavity and skull base * patients whom, currently or previously, dispositioned to treatment with radiotherapy * patients with good performance status (eastern cooperative oncology group \[ecog\] score 0-2) * patients willing to give written informed consent exclusion criteria: * patients unable to tolerate diffusion weighted (dw)-mri or dynamic contrast-enhanced (dce)-mri or having an estimated glomerular filtration rate (gfr) \< 60 ml/min/1.73m\^2 * patients with contraindication to mri (e.g. non-mri compatible metallic implants)
anterior segment spectral-domain optical coherence tomography in patients with closed globe injury

Conditions: Eye Injuries

Summary: this study use anterior segment spectral-domain optical coherence tomography (sd-oct) to exam patients with closed globe injury, and compared with slit lamp examination. the results showed that oct can identify features of closed globe injury that were otherwise not visible on slit lamp biomicroscopy.

the anterior segment architecture changes of closed globe injury patients include corneal damage, hyphema, angle recession and lens dislocation, which can be showed with oct. oct was superior to slit lamp biomicroscopy examination in detecting anterior segment architecture changes, especially in the presence of media opacities.

Eligibility criteria:
inclusion criteria: * patients with closed globe injury were recruited; had hyphema at least 1/3 of anterior chamber volume exclusion criteria: * can not cooperate with examination
mhealth intervention to prevent type 2 diabetes mellitus (phase ii study)

Conditions: Prediabetic State

Summary: the aim of this study is to develop and evaluate a low intensity, multifaceted, digital health intervention to prevent t2dm based on: i) the use of a system comprising mobile health (mhealth) technology integrated with electronic health records to send tailored text messages (smss) promoting lifestyle changes in people at risk of t2dm, and, ii) the provision of online education to primary healthcare workers about prediabetes management.

the prediabetext project will involve five workpackages (wp). in wp1-4 we will develop and pilot-test the different components of the intervention (wp1 will develop the brief text messages targeted to patients; wp2 will adapt our existing technology system to deliver the messages; wp3 will develop an educational intervention targeted to primary healthcare workers, and; wp4 will pilot-test and optimise both interventions). in wp5 we will conduct a phase ii, six-month, three-arm, cluster randomised, clinical trial with 42 primary care workers and 420 patients at risk of t2dm (hba1c from 6% to 6.4% or fasting plasma glucose 110-125mg/dl, or both) registered in primary care centres from mallorca. patients will be allocated to a control (usual care) group, intervention a (patient messaging intervention), or intervention b (patient messaging intervention plus online education to their primary healthcare workers). the primary outcome will be hba1c. secondary outcomes will include additional clinical outcomes, and physiological, behavioural and psychological outcomes.

Eligibility criteria:
eligibility criteria for primary healthcare workers: we will include physicians and nurses from primary care centres in mallorca. we will exclude those anticipating moving to a different centre during the study period. eligibility criteria for patients: inclusion criteria: * registered in the public health service of the balearic islands * at risk of t2dm (hba1c from 6% to 6.4% within the last 3 months or two consecutive values of fasting plasma glucose 110-125mg/dl within the last 12 months, or both) * with access to a mobile device able to receive text messages. exclusion criteria: * people not able to read messages in spanish * patients with severe mental conditions. * patients on an antidiabetic medication regime * pregnancy: currently or during the previous 12 months * people planning to change healthcare centre during the intervention period

Keywords: prediabetic state glycemic control telemedicine
oto-104 for meniere's disease

Conditions: Meniere's Disease

Summary: the purpose of this study is to evaluate the safety of oto-104 in subjects with unilateral meniere's disease. the effectiveness of oto-104 to reduce the symptoms of meniere's disease will also be evaluated.

meniere's disease is a debilitating disorder of the inner ear which includes symptoms such as vertigo, tinnitus, hearing loss and aural fullness. meniere's disease may result from an imbalance of fluid in the inner ear. several studies have shown that corticosteroids may help manage this imbalance yet the effect does not last very long. oto-104 is a longer lasting corticosteroid which could provide significant benefit to patients with meniere's disease.

Eligibility criteria:
inclusion criteria: 1. subject has a diagnosis of unilateral meniere's disease by 1995 american academy of otolaryngology - head and neck surgery (aaohns) criteria and reports active vertigo for the 2 months prior to the study lead-in period. 2. subject has experienced active vertigo during the lead-in period. 3. subject has asymmetric low frequency sensorineural hearing loss. 4. subject agrees to maintain their current treatments for meniere's disease while on-study. 5. subjects not currently on a low-salt diet or diuretic should have a medical history of having used one or both of these treatments for at least 1 month without relief of symptoms. 6. subjects currently on a low-salt diet and/or diuretic at the time of screening agree to continue this treatment throughout the study. exclusion criteria: 1. subject has an infection in the ear, sinuses, or upper respiratory system. 2. subject is pregnant or lactating. 3. subject has a history of immunodeficiency disease. 4. subject has a history of previous endolymphatic sac surgery. 5. subject has a history of previous use of intratympanic (it) gentamicin in the affected ear. 6. subject has a history of tympanostomy tubes with evidence of perforation or lack of closure. 7. subject has experienced an adverse reaction to it injection of steroids. 8. subject has used an investigational drug or device in the 3 months prior to screening. 9. subject has had a duration of meniere's disease of \>20 years.

Keywords: meniere's disease vertigo definitive vertigo vertigo episodes vertigo frequency tinnitus hearing loss aural fullness
circulating cancer cells/macrophage hybrid cells in patients with breast cancer.

Conditions: Breast Cancer

Summary: pilot, prospective, monocentric study aimed at evaluating the rate of patients with circulating cancer cell/macrophage hybrid cells in the peripheral blood. the study will be conducted on a population of patients with breast cancer (regardless of stage of the disease and the immunohistochemical subtype). for each included patient, blood samples will be taken and tumor specimens will be collected for the study. at the end of the blood collection, the patient will have completed his participation in the study.


Eligibility criteria:
inclusion criteria: 1. patient with breast cancer of any stage (stage i, ii, iii or iv) and any immunohistochemical subtype (triple-negative, hr+/her2-negative or her2-positive). 2. patient not yet initiated on specific treatment for the stage of breast cancer at inclusion. 3. available tumor sample (archived tumor block) : initial tumor or metastasis depending on the stage of the disease and availability. 4. age ≥ 18 years old. 5. patient affiliated to a social health insurance in france. 6. patient having signed informed consent prior to inclusion in the study and prior to any specific study procedure. exclusion criteria: 1. associated pathology(ies) that may prevent the proper conduct of the procedure under consideration. 2. pregnant or breastfeeding woman. 3. any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol. 4. patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship protection of justice). 5. patient who has presented another solid tumor (except breast or cervix carcinoma in situ) within 5 years.

Keywords: breast cancer cancer cell/macrophage hybrid cells hybrid cells
study of cetuximab with and without weekly paclitaxel for patients with previously treated advanced urothelial cancer

Conditions: Urologic Neoplasm

Summary: the purpose of this research study is to determine whether the investigational drug cetuximab, (erbitux) alone or with paclitaxel (taxol) can stabilize the growth of urothelial cancer.

this research study is being done to find out if cetuximab, alone or with paclitaxel will slow the growth of urothelial cancers. cetuximab is an antibody that blocks a protein called epidermal growth factor receptor (egfr). egfr sits on the outside of tumor cells and controls tumor cell growth. this agent has been looked at alone and with other chemotherapy drugs including paclitaxel. it has been found to be safe and can shrink other types of cancer. this research study is also being done to find out if cetuximab, alone or with paclitaxel shrinks urothelial tumors. if it extends the time the tumors shrink. if it helps people live longer. the purpose of this research study is to find out what effects (good and bad) these treatments have on you and your cancer. we do not know if you will benefit from this research study. it is possible that your condition will get better, but it is also possible that there will be no effect on your condition or that your condition will get worse. we can use what we learn from this research study to help other people with the same disease.

Eligibility criteria:
inclusion criteria: * histologically confirmed carcinoma of the urothelium (bladder,renal pelvis, ureter) * measurable disease by recist * patients who received only one prior systemic non-taxane regimen for urothelial cancer. may have received this in the adjuvant or neoadjuvant setting or for advanced disease. * signed irb approved consent * must have tissue available for egfr assessment and additional correlative studies * ecog ps 0-2 * 18 years of age or older * not of child bearing potential or negative pregnancy test within 7 days of treatment * anc greater than or equal to 1,500/ul * platelets greater than or equal to 100,00/ul * creatinine less than or equal to 2x institutional uln or create. clearance greater than or equal to 30, bilirubin less than or equal to 1.5x uln, ast\&alt less than or equal to 5x uln exclusion criteria: * received more than one prior regimen for advanced disease * prior radiation to more than 30% of marrow containing skeleton * prior therapy that specifically and directly targets the egfr pathway * prior severe infusion reaction to a monoclonal antibody, pre-existing neuropathy greater than or equal to grade 2 * prior reaction to cremophor el * known acute hepatitis b or c or known hiv * active or uncontrolled infection * significant history of uncontrolled cardiac disease * any concurrent chemotherapy not indicated in this study; or * any other investigational agents

Keywords: urothelial urologic neoplasm advanced metastatic
does epidural anesthesia reduce postoperative ileus following colorectal surgery?

Conditions: Colorectal Disorders; Postoperative Ileus

Summary: the use of epidural analgesia (ea) has been suggested as an integral part of an enhanced recovery program for colorectal surgery. however, the effects of ea on postoperative ileus remain controversial. some authors suggest that ea has beneficial effects for postoperative outcome and hospital stay, whereas others have reported that the role of ea in the modern perioperative care of patients undergoing open colorectal surgery has been limited. therefore, the investigators aimed to investigate the effect of ea on postoperative outcome, particularly postoperative ileus and hospital stay in patients with colorectal surgery.

in 2016, results of cochrane review of 22 trials on the efficacy of ea in patients undergoing abdominal surgery showed that an epidural containing a local anesthetic, with or without the addition of an opioid, accelerated the return of gastrointestinal transit (high quality of evidence) and no difference in the incidence of vomiting or anastomotic leak (low quality of evidence). for open surgery, an epidural containing a local anaesthetic would reduce the length of hospital stay (very low quality of evidence). however, in a recent analysis from american college of surgeons revealed that the use of ea did not improve postoperative recovery after elective colectomy in their analysis and was associated with increased postoperative ileus and prolonged hospital stay after open colectomy. in this study, the investigators aimed to compare the efficacy of ea to reduce the postoperative ileus and hospital stay, as well in the patients undergoing colorectal surgery. this prospective randomized study planned to include 100 consecutive patients with colorectal disorders.

Eligibility criteria:
inclusion criteria: * undergoing colorectal surgery due to both benign and malign disorders * no contraindication for epidural anesthesia exclusion criteria: * drug use (psychotropic drugs etc) that may cause paralytic ileus * immobile patients that eras protocol can not be applied on * anticoagulated patients with the risk of epidural hematoma,

Keywords: colorectal surgery postoperative ileus epidural anesthesia enhanced recovery after surgery
continuous infusion versus intermittent boluses of cisatracurium in the early management of pediatric ards

Conditions: Respiratory Distress Syndrome, Pediatric; Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

Summary: the aim of this work is to compare continuous infusion vs on need intermittent boluses of cisatracurium in the early management of pediatric acute respiratory distress syndrome

in the pediatric population, acute respiratory distress syndrome (ards) has a high mortality rate of approximately 24%. in addition, there is a lack of high-quality data to guide the use of non-depolarizing neuromuscular blocking agents (nmbas) in mechanically ventilated children. hence, there is a need to evaluate its use in pediatrics.

Eligibility criteria:
inclusion criteria: 1. children with mild, moderate, and severe ards diagnosed according to criteria of pediatric acute lung injury consensus conference (palicc) in 2015. 2. children of both sexes aged from one month to 18 years. 3. children diagnosed with ards \<48 hours before enrollment exclusion criteria: 1. continuous neuromuscular blockade at enrollment 2. children on phenytoin and carbamazepine 3. severe liver cirrhosis 4. high-risk medical illness (bone marrow transplantation within the last one-year, diffuse alveolar hemorrhage from vasculitis, chronic respiratory failure, burns \> 70% total body surface) 5. previous hypersensitivity or anaphylactic reaction to cisatracurium 6. neuromuscular conditions that may potentiate neuromuscular blockade and/or impair effective spontaneous ventilation

Keywords: cisatracurium pards
surgical management of gastroschisis

Conditions: Gastroschisis; Neonatal Disease; Hernia, Umbilical; Complication,Postoperative

Summary: the investigators aim to analyze the management of children born with gastroschisis between january 2009 and december 2023, i.e. to evaluate post-operative follow-up, hospitalization costs, the risk of post-operative umbilical hernia, and the parents' and the child's appreciation of the scar.

gastroschisis is an abdominal wall anomaly that affects 3 in 10,000 live births, and in over 90% of cases is diagnosed before birth. in fetuses with gastroschisis, the intestine protrudes through a defect in the abdominal wall, usually to the right of the umbilical cord. although the survival rate of live newborns with gastroschisis is over 90%, the risk of intrauterine fetal death is still 7.5 times higher than in the normal population, and gastroschisis can cause significant morbidity during the neonatal period. the scientific literature suggests multiple options for each stage in the care of children with gastroschisis, both pre- and postnatally. heterogeneity of practice exists even within the same geographical area, and deserves to be analyzed. in this context, the investigators wish to analyze the management of children born with gastroschisis between january 2009 and december 2023, i.e. to evaluate post-operative follow-up, hospitalization costs, the risk of post-operative umbilical hernia, and the parents' and the child's appreciation of the scar.

Eligibility criteria:
inclusion criteria: * patients born with gastroschisis between january 2009 and december 2023 exclusion criteria: * patients born with gastroschisis before january 2009 or after december 2023 patients without gastroschisis

Keywords: gastroschisis hospitalization costs neonate management
oral lactoferrin versus iron supplementation during pregnancy

Conditions: Iron-deficiency

Summary: iron deficiency anemia (ida) is the condition in which there is anemia due to a lack of iron. the oral route is preferred to the parenteral route to replace iron stores \[sharma jb; et al., 2004\]. inorganic iron has poor bio-availability in addition to many side effects, including gastrointestinal discomfort, nausea, vomiting, diarrhea and constipation and it may sometimes increase susceptibility to infection \[ so¨lvell l; et al., 1970\].

iron deficiency anemia (ida) is the condition in which there is anemia due to a lack of iron. the oral route is preferred to the parenteral route to replace iron stores. this allows the normal mechanism of absorption to be used, in addition to being an inexpensive and effective treatment \[sharma jb; et al., 2004\]. inorganic iron has poor bio-availability in addition to many side effects, including gastrointestinal discomfort, nausea, vomiting, diarrhea and constipation and it may sometimes increase susceptibility to infection \[ so¨lvell l; et al., 1970\]. furthermore, routine iron supplementation has recently been challenged. the british society for hematology, obstetric hematology group (bsh ohg) and the british committee for standards in hematology (bcsh) recommend screening by full blood count (fbc) at booking and at 28 weeks instead of universal iron supplementation \[pavord s. 2012\]. lactoferrin is a high-affinity cationic iron binding glycoprotein \[baker en, 2005\]. bovine lactoferrin is currently available pharmaceutical preparation. it is in to safe and effective in treating pregnant women suffering from id and ida \[mohamed rezk, et al. 2015\]. this study will compare the efficacy of these three available options.

Eligibility criteria:
inclusion criteria: • pregnant women (aged 20-40 yrs.) with single fetus, in the second trimester, with normal haemoglobin level (hb level ≥10.5 gm /dl) will be enrolled. exclusion criteria: * women with anaemia (hb level ≤10.5 gm. /dl) due to any causes, such as chronic blood loss, haemolytic anaemia and thalassemia (including thalassemia trait). * history of peptic ulcer. * medical complications with pregnancy (such as cardiovascular, thyroid, pituitary, nutritional, renal, liver diseases, diabetes mellitus (dm) and hypertension (htn). * fetal abnormalities such as microcephaly, intrauterine growth restriction (iugr).

Keywords: iron deficiency
effect of one week self-management program in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study is to explore the effect of one week inpatient self-management program (smp) in patients with fibromyalgia. the smp is delivered as group education/activities by allied health professionals.

this study will determine if one week inpatient smp can reduce fm symptoms and increase patients self-efficacy, health status, quality of life and being active health consumers. the one-week smp is designed to help people manage their rheumatic disease and challenges in daily life. the program has the same core concepts as outpatient programmes and comprises information, discussions on how to cope with the disease and daily life, cognitive management skills, exercise, engagement in self-care and interactions with healthcare professionals. during the program, the inpatient education unit takes up to 16 patients and 5 relatives per week within one diagnostic group. each educational session lasts for 1.5-2.5 hours and the physical activity sessions for 0.5-1 hour. in the evening group sessions, the patients are divided into small groups of approximately five participants. they talk together for one hour under leadership of one health professional who is educated in coaching. the focus is on coping with the disease and daily life. for the intervention group there will be a one year follow up study.

Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia outlined by the american college of rheumatology for one year or more * between 20 and 70 years old * native norwegian speaking * own wishes about participating the self-management program exclusion criteria: * participated in the hospitals' smp before * cognitive dysfunction * problems with sight and hearing that not can be compensated * mental disorders except light or treated depressions

Keywords: self-management self-efficacy coping health consumer patient education health related quality of life