Kornimate/medical-research-clean huggingface dataset:
maintenance of remission with budesonide orodispersible tablets vs. placebo in eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: the purpose of this study is to prove the superiority of a 48-weeks treatment with budesonide orodispersible tablets versus placebo for the maintenance of clinico-pathological remission in patients with eosinophilic esophagitis.


Eligibility criteria:
inclusion criteria: * signed informed consent, * male or female patients, 18 to 75 years of age, * confirmed clinico-pathological diagnosis of eosinophilic esophagitis (eoe) according to established diagnostic criteria * clinico-pathological remission of eoe, * a documented trial with proton pump inhibitors (ppis) in order to rule out ppi-responsive esophageal eosinophilia, * negative pregnancy test in females of childbearing potential at baseline visit. exclusion criteria: * clinical and endoscopic signs of gastroesophageal reflux disease (gerd), * history of abnormal results in case of an optionally performed ph-monitoring of the distal esophagus, * patients with ppi-responsive esophageal eosinophilia * achalasia, scleroderma esophagus, or systemic sclerosis, * other clinically evident causes than eoe for esophageal eosinophilia, * any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection \[candida esophagitis\]), * any relevant systemic disease (e.g., aids, active tuberculosis), * if careful medical monitoring is not ensured: cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection, * liver cirrhosis or portal hypertension, * history of cancer in the last five years, * history of esophageal surgery at any time or of esophageal dilation procedures within the last 8 weeks prior to screening visit, * upper gastrointestinal bleeding within 8 weeks prior to baseline visit, * existing or intended pregnancy or breast-feeding.
insulin delivery using the dblg1 closed-loop on glycemic control and proms in adults living with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: to evaluate the impact of the dblg1 hybrid closed-loop system on glycemic control and patient-reported outcomes in adults living with type 1 diabetes under real-life conditions.

this is a multicenter real-world observational study analyzing data on the use of the dblg1 system in patients with t1d treated in the participating centers in belgium. data from patients with t1d who start(ed) with the dblg1 between may-01 2022 up to and including august-01 2023 will be analyzed. data will be collected during clinical routine follow-up from electronic medical records, questionnaires, standard of care laboratory tests and cgm-data. baseline data from before start (up to -12 months) of the dblg1 system and follow-up data at 4, 8, 12, 16, 20 and 24 months will be analyzed. there are no medical interventions, nor extra visits or laboratory tests planned outside normal clinical routine. glycemic control and patient-reported outcomes during follow-up will be compared with glycemic control and patient-reported outcome data at baseline.

Eligibility criteria:
inclusion criteria: * patients with type 1 diabetes * aged 18 years and older * starting with the dblg1 system in the participating centers * who signed the informed consent exclusion criteria: * patients who do not have type 1 diabetes * younger than 18 years * who do not start with the dblg1 system * who are not able to sign the informed consent * who do not want to sign the informed consent
effect of scapular stabilization exercise on breastfeeding women with non-specific neck pain

Conditions: Neck Pain

Summary: the purpose of this study is to determine whether scapular stabilization exercises can help breastfeeding women with non-specific neck pain by reducing their neck pain, cervical range of motion, and neck disability index.

the best infant feeding practice is breastfeeding, which has both immediate and long-term advantages for mothers, babies, the environment, the economy, and society as a whole. mothers who are nursing frequently experience neck pain. because the scapula and neck are closely related, scapular stabilization is becoming more and more popular for patients with neck pain.

Eligibility criteria:
inclusion criteria: 1. exclusive breastfeeding mothers with immediate to 6-month-old infants. 2. the bilateral cradle position is employed by patients when nursing. 3. patients had mechanical neck pain. 4. patients with a body mass index below 30 kg/m² 5. patients have moderate pain intensity, ranging from 3 to 7 on the visual analogue scale 6. the patients' scores on the neck disability index ranged from 10 to 40 out of 50. exclusion criteria: 1. patients had preterm babies or low-birth-weight babies. 2. pregnant patients 3. patients had postpartum complications. 4. patients had inflammation, infection, severe degeneration, congenital deformity, and trauma. 5. patients had sensory abnormalities or a positive motor reflex. 6. patients had cancer, metabolic, or systemic diseases.

Keywords: scapular stabilization exercise breast feeding women
comparison of cxr and mndct

Conditions: Acute Dyspnoea

Summary: a comparison of chest x-ray (cxr) and minimum dose ct (mndct) in the acutely ill patient. the hypothesis is that mndct is more sensitive than cxr in the detection of acute findings in the acutely ill patient.

a comparison of chest x-ray (cxr) and minimum dose ct (mndct) in a cohort of 100 patients admitted for acute respiratory distress. chest radiography (cxr) is compared to minimum dose ct (mndct) for the detection of consolidation;lung nodules, heart failure.

Eligibility criteria:
inclusion criteria: * all patients admitted for investigation of acute pulmonary embolus exclusion criteria: * none
a study to evaluate the use of the neotech ram nasal cannula for cpap and bi-pap application in infants 28-42 weeks gestation in a neonatal intensive care unit (nicu)

Conditions: Neonatal Respiratory Distress

Summary: this study will explore the ram nasal cannula as a means of providing cpap and bi-pap to infants 28-42 weeks gestation to prevent nasal septal erosion.


Eligibility criteria:
inclusion: * infants with birth weight \< 1500 grams and/or \<32 weeks gestational age * infants between 34-42 weeks gestational age and exclusive breastfeeding with no risk of nasal septal erosion or infants between 28-42 weeks gestational age at risk of nasal septal erosion exclusion: * infants with major congenital and upper airway anomalies * infants requiring ett (endotracheal tube) mechanical ventilation * infants receiving no respiratory support
standard neoadjuvant chemotherapy versus genomic driven chemotherapy in patients with breast cancer

Conditions: Breast Cancer

Summary: this randomized trial is comparing a standard neoadjuvant chemotherapy with a genomic driven chemotherapy in patients with breast cancer.

after a core biopsy, each tumor is profiled using affymetrix u133plus2 gene expression array. dld30 score (hess, jco, 2006) and top2a expression are quantified. patients are then either treated with 4fec followed by 4 docetaxel (standard arm) or by a genomic-driven regimen (experiemental arm). in the experimental arm, patients with high dld30 receive 3 months weekly paclitaxel followed by 4 fec, patients with high top2a receive 4fec then 4 docetaxel, patients with low dld30 and low top2a are treated with 6 cycles of docetaxel-capecitabine.

Eligibility criteria:
inclusion criteria: * invasive breast cancer not eligible for conservative surgery * her2 negative * amount of tumor cells \>30% on hes slides * rin\>6 and amount of rna\>1 ug * no metastases * subject, age \> 18 years and \<65 years old * signed written informed consent * ps 0-1 * no previous treatment for breast cancer * adequate organ function * fevg \>50% exclusion criteria: * in situ carcinoma * multifocal cancers * her2+ * presence of metastasis * genomic testing not feasible because of tumor cells \<30%, rin\<6, insufficient amount of rna * organ dysfunction that contraindicates chemotherapy

Keywords: genomic driven chemotherapy
necessity of anti-arrhythmic medication after surgical ablation for atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to determine whether anti arrhythmic medication, specifically amiodarone, is required during the first three months post surgical ablation. hypothesis: amiodarone will not be required during the first three months as verified by no increase in rehospitalizations for recurrent atrial fibrillation, and report of sinus rhythm at surgical follow up (approximately 3 weeks from date of surgery), 6 weeks and 12 weeks to include patients' first follow up with cardiologist at approximately 3 months post surgery.


Eligibility criteria:
inclusion criteria: * subject is ≥ 18 years of age * subject must be diagnosed with persistent and/or longstanding persistent atrial fibrillation as classified by the hrs guidelines 8 \[0\] * subject must be selected as a candidate to undergo the cox- maze procedure for ablation of atrial fibrillation * the cox maze procedure may be done as a stand alone procedure or combined with other cardiac surgical procedures either via a median sternotomy or a right thoracotomy: * subject has a left ventricular ejection fraction (lvef) ≥ 30% * subject would normally be prescribed amiodarone as an anti arrhythmic medication post surgical ablation * subject is able and willing to provide written informed consent and hipaa authorization * subject is able and willing to comply with all study requirements including attending all follow-up visits as deemed necessary by personal physician (cardiologist) * subject has a life expectancy of at least one year exclusion criteria: * subject has undergone previous attempts at surgical maze procedure or other af operation, including surgical or catheter ablation subject has an accessory pathways disorder (e.g. wolff-parkinson-white syndrome) * subject is in class iv nyha * subject has had a documented mi within 6 weeks prior to study enrollment * subject needs emergent cardiac surgery (i.e. cardiogenic shock) * subject has known carotid artery stenosis greater than 80% * subject has a current diagnosis of active systemic infection * subject is pregnant, planning to become pregnant within 12-14 months, or lactating * subject requires preoperative intra-aortic balloon pump or intravenous inotropes * subject has renal failure requiring dialysis * subject is diagnosed with hepatic failure * subject is on anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia * subject has a known connective tissue disorder * subject is incarcerated * subject has previous or current therapy that could compromise tissue integrity including thoracic radiation, chemotherapy, long-term oral or injected steroids * subject is an intravenous drug and/or alcohol abuser * subject is participating in concomitant research studies of investigational products ( e.g. appendage closure devices, atrial septal defect patches)

Keywords: atrial fibrillation anti-arrhythmic medication
sepsis institutional registry in hospital italiano de buenos aires

Conditions: Death; Severe Sepsis

Summary: the purpose of this study is to create an institutional registry of sepsis through a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.

the main goal is to describe the occurrence of sepsis and the characteristics of clinical presentation, evolution and predisposing factors within the population of the hospital italiano de buenos aires.

Eligibility criteria:
inclusion criteria: 1. over 17 years 2. two or more sirs criteria 3. active infection exclusion criteria: 1. refusal to register or to the informed consent process 2. ambulatory patients
physical activity a vital sign? 40 steps to safety test for patients with covid-19

Conditions: Covid19; Medical Emergencies

Summary: exertional desaturation is a feature of covid-19. the study will measure vital signs of patients discharge by practitioners in primary care, secondary care or by paramedic practitioners. patients will then undertake a 40-steps on the spot walk followed by measurements of heart rate and oxygen saturations for up to two minutes. association of desaturation with 30 days hospital admission and mortality will be reported.


Eligibility criteria:
inclusion criteria: * patients are being considered for discharge to independent care * participant is willing and able to give informed consent for participation in the study. * patient with independent, stable, gait * patient is alert, attentive, coherent, and calm * male or female, aged 18 years or above. exclusion criteria: * minor injuries * elective surgery patients * post-operative patients at discharge * requires supplemental oxygen * shortness of breath at rest (i.e. borg or numerical rating scale \>=2) * unstable angina * patients on long-term-oxygen therapy * pregnancy as stated by patient * oxygen saturations \< 95% on room air * resting heart rate \> 100 bpm * resting respiratory rate \> 25 bpm * ecg with signs of acute ischemia in patients where an ecg has been requested by the treating clinician * national early warning score of 5 or more * nursing home residents, or those being transferred to a nursing home or similar care facility

Keywords: exercise tolerance test vital signs readmission mortality
men1611 with trastuzumab (+/- fulvestrant) in metastatic breast cancer

Conditions: Advanced or Metastatic Breast Cancer

Summary: the main purpose of this open-label, dose-escalation, phase ib study is to identify the appropriate dose of men1611 to be used in combination with trastuzumab with/without fulvestrant for the treatment of advanced or metastatic her2-positive breast cancer

this phase ib study will investigate the safety and anti-tumor activity of daily oral doses men1611 in combination with trastuzumab with/without fulvestrant in female and male patients affected by advanced or metastatic her2-positive breast cancer. fulvestrant will be added to the post-menopausal patients with hormone-sensitive disease. men1611 is an investigational drug which blocks a protein called pi3k (phosphoinositide 3-kinase) involved in cancer cells growth. the maximum tolerated dose (mtd) of men1611 given as single agent was assessed in a phase i trial in patients with advanced solid tumors. this phase ib will start with a dose escalation part (step 1) to identify the mtd of men1611 given in combination with trastuzumab with/without fulvestrant. the study will continue with a cohort expansion (step 2) to investigate the anti-tumor activity of the selected men1611 dose level considered to be tolerable by a safety review committee.

Eligibility criteria:
main inclusion criteria: * histologically confirmed invasive adenocarcinoma of the breast * known her2+ breast cancer * advanced or metastatic breast cancer harbouring pik3ca mutation on tissue sample * \> 2 lines of anti-her2 based regimens with at least 1 regimen with trastuzumab * radiological documented evidence of progressive disease * life expectancy ≥ 12 weeks * eastern cooperative oncology group (ecog) performance status ≤ 2 main exclusion criteria: * previous treatment with pi3k inhibitors * brain metastases untreated, unless treated \> 4 weeks and only if clinically stable and not receiving corticosteroids * history of clinically significant bowel disease * ≥ grade 2 diarrhoea * history of significant, uncontrolled, or active cardiovascular disease * any serious and/or unstable pre-existing psychiatric or neurologic illness or other conditions that could interfere with patient's safety * not controlled diabetes mellitus (glycated haemoglobin \[hba1c\] \>7%) and fasting plasma glucose \>126 mg/dl * concurrent chronic treatment with steroids, as immunosuppressant, or another immunosuppressive agent

Keywords: advanced breast cancer metastatic breast cancer pi3k inhibitor her2-positive
inhaled beta-2 agonist versus epinephrine for treatment of transient tachypnea of newborn (ttn)

Conditions: Transient Tachypnea of the Newborn

Summary: inhaled beta-2 agonist versus epinephrine for treatment of transient tachypnea of newborn: randomized controlled trial to assess:

this is a randomized double-blind randomized controlled trial. it had been conducted at the neonatal intensive care unit (nicu) of mansoura university children's hospital, egypt written informed consent had been taken from all parents whose infants were recruited in the study. the ethics committee of the faculty of medicine has approved the study.

Eligibility criteria:
inclusion criteria: * babies with 35 weeks of gestation or more in the first 6 hours of life diagnosed with ttn according to the criteria of which are: * tachypnea (respiratory rate exceeding 60 breaths/ min) within 6 hours after birth * persistence of tachypnea for at least 12 hours * mild cyanosis, nasal flaring, or retractions. * chest radiograph indicating at least one of the following: * prominent central vascular markings * widened interlobar fissures * symmetrical perihilar congestion * hyperaeration is evidenced by flattening and depression of the diaphragmatic domes. exclusion criteria: * newborn infants with gestational age \< 35 weeks * meconium aspiration * respiratory distress syndrome * pneumonia * congenital heart diseases including persistent pulmonary hypertension of the neworn (pphn) * sepsis or suspected sepsis * polycythemia * newborn infants with congenital malformations and chromosomal anomalies * newborn infants with ventilatory support. * newborn infants with arrhythmia

Keywords: transient tachypnea of the newborn (ttn) epinephrine salbutamol respiratory distress newborn
intervention to improve the delivery of follow-up care for low-risk breast cancer

Conditions: Breast Cancer

Summary: this study tests a novel intervention designed to optimize needed survivorship care for low-risk breast cancer survivors while reducing burdensome care with limited health benefits. this study examines whether the intervention, titled reassure, improves survivors' preparedness for survivorship. up to 110 participants will be on study for up to 18 months.

the investigators plan a single site prospective, randomized, trial that will compare the effect of reassure on survivor preparedness against usual care. survivors will be identified from breast oncology clinics within uw health. reassure is comprised of three components: 1) the reassure pro assessment, which assesses survivors' symptoms and/or concerns, 2) a recommendation for or against a follow-up visit based on survivors reported symptoms /concerns using pre-established thresholds, and 3) reassure survivorship messaging. * primary objective * compare survivors' preparedness for survivorship with reassure versus usual care. * secondary objectives * determine the acceptability of reassure for survivors living in rural and non-rural areas. * assess changes in survivor reported symptoms and number of follow-up visits with reassure versus usual care.

Eligibility criteria:
inclusion criteria: * diagnosis of stage i, er and/or pr positive, her2neu negative breast cancer within the last 6-24 monoths * willing to complete study procedures using email exclusion criteria: * receipt of chemotherapy for the stage i er and/or pr positive, her2neu negative breast cancer diagnosed within the last 6-24 months * participants will be excluded if they are unable to read and write in english or if, in the opinion of a treating clinician, have cognitive impairment that would prevent completion of study procedures * pregnancy, based on patient self-report. if a patient becomes pregnant during the study period, they will be removed from the study at that time. * diagnosis of a er and pr negative, her2neu negative breast cancer or a her2neu positive breast cancer within the last 5 years

Keywords: follow up care low risk health care delivery
the accuracy of reconstruction of orbital walls fracture using prebent mesh versus patient specific implant

Conditions: Orbital Fractures

Summary: under ga, incision to access to orbital walls. then insertion of prebent titanium mesh or customized titanium implant and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.

under ga, incision to access to orbital walls. complete reflection of orbital floor to be constructed then insertion of customized orbital implant of patient or insertion of titanium mrsh after adaption on the model and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap.

Eligibility criteria:
inclusion criteria: * patient had fractured orbital walls suffering from enophthalmous, hypoglobus, diplopia exclusion criteria: * systemic disease interfere with bone healing enophthamous less than 2 mm

Keywords: orbital wall reconstruction prebent titanium mesh patient specific implant peek
role of oxytocin in myocardial infarction

Conditions: Myocardial Infarction

Summary: 60 patients admitted to this iccu at the sheba medical center will be randomly divided in to 2 groups. one group will receive the conventional treatment while the second group will receive the conventional treatment plus oxytocin infusion for 48 hours. all participants will undergo echo and cmri during hospitalization.


Eligibility criteria:
inclusion criteria: * age \> 18 years * current diagnosis of st elevation myocardial infarction * no previous episodes of acute coronary syndrome * agreed to enter research exclusion criteria: * age \< 18 years * congestive heart failure (acute or chronic) * cardiomyopathy * life threatening arrhythmia at presentation * previous lv dysfunction * hypotension (systolic \< 100mmhg, diastolic\<50mmhg, 15% less than patients normal values) * tachycardia - pulse \> 100bpm * bradycardia - pulse \< 55 ppm * killip 3 or 4 at presentation * current use of nitrates * pregnancy * females - history of pathological gu bleeding * inability to give consent