Kornimate/medical-research-clean huggingface dataset:
the optimal randomized controlled trial

Conditions: Left Main Coronary Artery Stenosis

Summary: the optimal study is a randomized, controlled, multicentre, international study. a total of 800 patients will be randomized in a 1:1 fashion to intravascular ultrasound (ivus)-guided pci versus qualitative angio(qca)-guided percutaneous coronary intervention (pci). patients will be consented prior to the pci procedure and then followed up to 2 years after the index procedure. patients will be followed-up at 1 month (telephone contact), 12 months (outpatient clinic visit or telephone call) and 24 months (outpatient clinic visit or telephone call) after the index procedure.


Eligibility criteria:
inclusion criteria: 1. the patient must be ≥ 18 years of age; 2. de novo lesion of the lm (ostial, shaft or distal) where pci is considered appropriate and feasible by the heart team\*. 3. stable or unstable angina, non-st segment myocardial infarction, documented silent ischemia or a positive functional study (e.g. by pressure or angiography derived indices). 4. any left-main medina classification 100, 110, 101, 011, 010, 111, 001 (left-main equivalent) can be included. 5. a patient with a previous coronary artery bypass graft (cabg) with no patent bypass on the lca may be included. 6. able to understand and provide informed consent and comply with all study procedures, including follow-up for at least 2 years. exclusion criteria: 1. patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential). 2. ongoing mi or recent mi with cardiac biomarker levels still elevated. 3. previous history of cabg with patent left internal mammary artery (lima) to lad and/or patent graft to the left circumflex coronary. 4. prior pci of the left-main or the ostium of the lad or the ostium of the lcx at any time prior to enrolment. 5. prior pci in lca (e.g. mid lad) within the previous 30 days. 6. known intolerance to any antiplatelet agent that would prevent a 12 month dual antiplatelet therapy (dapt) duration 7. patients requiring additional surgery (cardiac or non-cardiac) within 3 months post randomization. 8. non-cardiac co-morbidities with a life expectancy less than 2 years. 9. currently participating in another trial and not yet at its primary endpoint. the patient is not allowed to participate in another investigational device or drug study for at least 12 months after enrolment.

Keywords: ivus pci left main qca treatment strategy
angled-tip vs. straight-tip guidewire in biliary cannulation

Conditions: Bile Duct Diseases

Summary: the investigators aim is to compare outcomes between an angled-tip guidewire and a straight-tip guidewire in cannulation of the common bile duct during ercp. this is a randomized, controlled, single-blinded study. the primary outcome is success of cannulation and secondary outcomes are incidence of post-ercp pancreatitis, procedure duration, and rate of complication between the angled wire and straight wire.

wire-guided cannulation of the common bile duct is a standard technique utilized during endoscopic retrograde cholangio-pancreatography (ercp) to ensure safe and effective access to the common bile duct via the ampulla of vater. due to the anatomy of the ampulla, and the orientation of the biliary orifice, a guidewire with an angled tip may allow easier and safer access to the common bile duct without inadvertent manipulation of the pancreatic duct. the investigators aim to assess the technical and clinical outcomes between an angled-tip guidewire (gw) compared to a straight-tip guidewire in wire-guided cannulation of the common bile duct. the investigators hypothesize that an angled-tip gw is associated with increased rate of successful cannulation, decreased procedure time and decreased rate of post-ercp pancreatitis in wire-guided biliary cannulation during ercp.

Eligibility criteria:
inclusion criteria: * patients undergoing ercp for cholangiography, bile or tissue sampling from the gallbladder or bile duct * patients undergoing ercp for treatment of biliary diseases (removal of common bile duct stones, biliary stent placement) exclusion criteria: * patients who are less than 18 years old * pregnant patients * patients who have undergone previous bile duct cannulation or sphincterotomy * patients who have undergone prior endoscopic balloon dilation or needle-knife fistulotomy * patients who have undergone gastric surgery (billroth gastrectomy ii, roux-en-y gastric bypass) * patients with acute pancreatitis * patients who refuse endoscopic intervention * patients with ampullary tumor, duodenal stenosis, or pre-operatively proven pancreaticobiliary malunion

Keywords: ercp
predicting placental pathologies by ultrasound imaging

Conditions: Intrauterine Growth Restriction; Villitis; IUGR

Summary: intrauterine growth restriction (iugr) is caused when the placenta cannot provide enough nutrients to allow normal growth of the fetus during pregnancy. it is unclear why iugr happens, but an increase in inflammatory t cells in the placenta known as villitis of unknown etiology (vue) is observed in many iugr infants. the investigators aim to develop ultrasound methods for diagnosing vue to understand it's role in iugr.

intrauterine growth restriction (iugr) occurs in 3-10% of all pregnancies and is associated with significant morbidity and mortality during pregnancy, after birth and throughout the child's lifespan. iugr is caused by the inability of the placental vasculature to provide enough oxygen and nutrients to support the fetus; yet, the mechanisms leading to disruption of placental vasculature are unknown. the placenta of \~50% of iugr fetuses are infiltrated with inflammatory cells, specifically maternal t cells, which destroy placental blood vessels that support the fetus. this infiltration of t cells is known as villitis of unknown etiology (vue). the diagnosis of vue is problematic because it occurs without clinical signs and symptoms of maternal (or fetal) distress and puts the fetus at significant risk of demise. additionally, vue commonly recurs in subsequent pregnancies putting future offspring at risk. yet, the exact prevalence of vue and its significance in iugr pathogenesis and outcomes are poorly understood as vue is only diagnosed after the infant is outside the womb. therefore, the study aims to recognize risk factors and cellular mechanisms associated with vue and develop methods for diagnosing and treating vue in utero, in order to improve infant health.

Eligibility criteria:
inclusion criteria for iugr study cohort: * pregnancy \> 28 weeks gestation * diagnosis of intrauterine growth restriction (iugr) before admission for labor and delivery * weight \> 110 lbs (50 kg) * ability to understand and provide written informed consent inclusion criteria for control cohort: * pregnancy \> 28 weeks gestation * no known pregnancy complications at prenatal obstetrical visit (+/- 1 week gestational age of matched subject in iugr cohort) * weight \> 110 lbs (50 kg) * ability to understand and provide written informed consent exclusion criteria: * known immunodeficiency or pregnancy complication (i.e. preeclampsia or gestational diabetes) * known autoimmune disease (e.g., rheumatoid arthritis or systemic lupus erythematosus) or chronic hypertension * chronic, active viral infections, including hiv-1/2, htlv-1/2, hepatitis b or c * solid organ or transplant recipient * current smokers (tobacco exposure within 30 days of registration) * conceptions from assisted reproductive technology (prior clomid use is allowed) * multiple gestation * ruptured membranes * pregnancy \<28 weeks gestation * not planning on delivering at mayo clinic
a phase ii multicentre trial of needle based laser confocal endomicroscopy of cystic and solid tumours of the pancreas

Conditions: Pancreatic Cyst; Serous Cystadenoma; Intraductal Papillary Mucinous Neoplasm; Cystadenoma, Mucinous

Summary: a multicentre phase ii study to determine the safety and efficacy of eus-guided ncle in patients with suspected cystic tumours of the pancreas in whom endoscopic ultrasound-guided fine needle aspiration (eus-fna) is clinically indicated. patients will be recruited sequentially to undergo ncle as part of their routine diagnostic evaluation, followed by standard surveillance. this part of the study will recruit 60 patients.

a multicentre phase ii study to determine the safety and efficacy of eus-guided ncle in patients with suspected cystic tumours of the pancreas in whom endoscopic ultrasound-guided fine needle aspiration (eus-fna) is clinically indicated. patients will be recruited sequentially to undergo ncle as part of their routine diagnostic evaluation, followed by standard surveillance. this part of the study will recruit 60 patients. the study also includes a feasibility study to evaluate the role of intraoperative ncle in the diagnosis and staging of pancreatic tumours. this part of the study will recruit a further 20 patients. primary endpoint: assess the diagnostic performance of the cellvizio ncle system in the characterization of pancreatic cysts, compared to standard diagnostic modalities. secondary endpoints: * assess the safety and efficacy of eus-ncle. * assess the impact of the cellvizio ncle system on the management of patients with pancreatic cysts. * develop and validate interpretation criteria for ncle in the pancreas. * assess the diagnostic performance of ncle in characterising and staging pancreatic tumours intraoperatively.

Eligibility criteria:
inclusion criteria: 1. a diagnosis of a pancreatic cystic tumour based on multidisciplinary review of imaging for which eus-fna is indicated. 2. pancreatic cystic tumour \>1cm in size. 3. ecog performance status 0, 1 or 2. 4. estimated life expectancy of at least 12 weeks. 5. age \>18 years. 6. capable of giving written informed consent. 7. has not has pancreatitis within the previous 3 months. 8. women of child-bearing potential must have a negative pregnancy test in the week before ncle, and be using an adequate contraception method, which must be continued for at least 1 week after ncle. exclusion criteria: 1. acute pancreatitis in the last 3 months. 2. subject with multiple cysts 3. subjects for whom eus-fna or surgery are contraindicated 4. known allergy to fluorescein dye 5. any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial. 6. any psychiatric disorder making reliable informed consent impossible. 7. pregnancy or breast-feeding. 8. ecog performance status 3 or 4
evaluation of the efficiency of propioceptive study according to radiological stages in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: evaluation of the efficiency of propioceptive study according to radiological stages in patients with knee osteoarthritis

investigators divided patients with knee osteoarthritis into two groups. group 1 consisted of stage 1 and stage 2 patients. group 2 consisted of stage 3 and stage 4 patients. proprioceptive training was applied in both groups. investigators aim is to evaluate the effect of proprioceptive exercises on knee osteoarthritis according to the radiological level.

Eligibility criteria:
inclusion criteria: * diagnosed with knee osteoarthritis by a specialist physician using mri, us or radiography and physical examination. * being between the ages of 35-70 * stage 1-2-3-4 according to kellegran lawrence (k-l) in radiological examination exclusion criteria: having active synovitis * having received physical therapy in the last 6 months * those with neurological problems that affect walking * those with serious respiratory, central, peripheral, vascular and uncontrolled metabolic problems that will prevent exercise * has had lower extremity surgery in the past * intra-articular steroid injections within the last 6 months * using psychoactive drugs * those with serious vision, hearing and speech disorders * patients with vestibular dysfunction will not be included in the study

Keywords: knee osteoarthritis rehabilitation exercise physiotherapy propioception
omeprazole 20 mg in patients with laryngopharyngeal reﬂux and comorbid chronic rhinosinusitis

Conditions: Laryngopharyngeal Reflux; Chronic Rhinosinusitis (Diagnosis)

Summary: the hypothesis of this study is that a gastroesophageal reflux recommended treatment with proton pump inhibitor (dose and duration) compared to placebo significantly reduces both the signs and symptoms of laryngopharyngeal reﬂux and comorbid chronic rhinosinusitis. primary objective was to determine whether 8 weeks of treatment with omeprazole 20 mg ones daily (od) significantly reduces the signs and symptoms of laryngopharyngeal reﬂux when compared to placebo in patients with laryngopharyngeal reﬂux with comorbid chronic rhinosinusitis. secondary objectives were to determine whether 8 weeks of treatment with omeprazole 20 mg od significantly reduces the signs and symptoms of comorbid chronic rhinosinusitis in patients with laryngopharyngeal reﬂux when compared to matching placebo; and to investigate the association of the severity of signs and symptoms of laryngopharyngeal reﬂux with the ones of chronic rhinosinusitis in the same group of patients. the research was carried out as a double blind randomized placebo controlled trial. patients were randomized into two groups in an approximate 1:1 ratio using a concealed random sequence. after randomization and initial assessment treatment was initialized. patients on active treatment were given omeprazole 20 mg once daily half an hour before breakfast for 8 weeks, while those in the placebo group were given matching placebo tablets using the same regimen for 8 weeks as the group on the active treatment. patients were reassessed at the end of treatment for signs and symptoms of laryngopharyngeal reﬂux and comorbid chronic rhinosinusitis.


Eligibility criteria:
inclusion criteria: * laryngopharyngeal reﬂux * chronic rhinosinusitis exclusion criteria: * allergic rhinitis * asthma * cystic fibrosis * nasal polyposis * severe systemic diseases

Keywords: omeprazole placebo treatment adults
rivaroxaban for intracardiac thrombosis in the pediatric population

Conditions: Intracardiac Thrombus

Summary: the goal of this observational study is to determine the efficacy of rivaroxaban treatment for intracardiac thrombi resolution in pediatric patients (\< 16 years old) diagnosed with intracardiac thrombosis. the main question it aims to answer is: does rivaroxaban treatment resolve the thrombosis during a 3-month treatment? participants already taking rivaroxaban as part of their regular medical care for thrombosis resolution. they will undergo monthly visits to check that the treatment is progressing correctly and that no major bleeding has occurred. after 3 months of treatment, they will repeat the radiological imaging investigation to verify the actual resolution of the thrombosis.

the investigators will enroll all the consecutive pediatric patients (\< 16 years old) treated with rivaroxaban (dosage based on patient's body weight - 0.9 mg/kg/day) due to intracardiac thrombosis (ict) suspected by echocardiography and confirmed with cardiac computed tomography (cct) or magnetic resonance (cmr) imaging. all the participants will be treated with enoxaparin for 7 days before the rivaroxaban implementation. the treatment will last for 3 months. the participants will undergo monthly visits to check that the treatment is progressing correctly and that no major bleeding has occurred. bleeding severity will be assessed utilizing the bleeding assessment scale in critically ill children (basic). cct/cmr will be repeated to confirm the thrombosis resolution. after 3 months of treatment, they will repeat the radiological imaging investigation to verify the effective resolution of the thrombosis, or it will be continued for another 3 months if there is no resolution of the thrombosis.

Eligibility criteria:
inclusion criteria: * intracardiac thrombosis demonstration at echocardiography and cmr/cct confirmation * given informed consent from the parents or tutors exclusion criteria: * \< 38 weeks of gestational birth * \< 10 days of oral feeding and body weight * \< 2.6 kg * any major or clinically relevant bleeding event or abnormal coagulation test results within 10 days prior to the enrollment for the whole population
medical recovery and social reintegration for post-stroke patients using virtual reality

Conditions: Stroke Sequelae

Summary: application of virtual reality therapy and occupational therapy versus and standard physiotherapy and occupational therapy to patients with post-stroke sequelae, using specifical assessment tools, standard physiotherapy and occupational therapy programs.

1. initial and final clinical and functional evaluation of patients with post-stroke sequelae, storage and use of data obtained. 2. collection and access of demographic and clinical data of patients included in the study (respecting the principle of confidentiality and non-publication of personal data) only by staff involved in the research project and working in the clinical hospital of psychiatry and neurology in brasov. 3. application of virtual reality therapy and occupational therapy versus and standard physiotherapy and occupational therapy to patients who meet the criteria for inclusion in the study (scapulohumeral flexion and abduction of at least 20 degrees, elbow flexion of at least 20 degrees, hip and knee flexion of at least 20 degrees, without severe aphasia or severe behavioural/cognitive disorders). 4. use of data obtained from the application of virtual reality therapy at home, through telerehabilitation, if patients procure alone or through sponsorship/donation the equipment necessary to continue the virtual reality therapy program at home, taking into account that the technology purchased through the project allows this.

Eligibility criteria:
inclusion criteria: 1. stroke survivors after the acute phase, at least 6 weeks post-stroke; 2. stroke survivors within no more than 4 years after stroke, 3. at least 30-degree flexion and scapulohumeral abduction against gravity. 4. elbow flexion of at least 30 degrees 5. hip flexion of at least 30 degrees 6. knee flexion of at least 30 degrees exclusion criteria: 1. no severe cognitive impairments, 2. no global or transcortical sensory aphasia, 3. no other dysfunctions in the upper extremity such as surgery, fractures, shoulder arthritis or severe pain, 4. no other dysfunctions in the lower extremity such as surgery, fractures, arthritis or severe pain, 5. without anaemia 6. without atrial fibrillation 7. without nyha class iv heart failure

Keywords: virtual reality physiotherapy recovery
influence of hyperbilirubinaemia on two different near infrared spectroscopy devices

Conditions: Liver Transplant; Complications

Summary: protocol near infrared spectroscopy liver transplants: comparison of two monitoring of near infrared spectroscopy in pediatric liver transplant.

hyperbilirubinaemia may interfere with oximetry values as measured by near infrared spectroscopy devices. the number of wave lengths used by different devices can influence the oximetry values in adult patients. this has never been demonstrated in children with hyperbilirubinaemia scheduled for elective liver transplantation.the study will compare cerebral and somatic oximetry values measured by two different near infrared spectroscopy devices (foresight and invos) and analyse the influence of bilirubin levels on these differences.

Eligibility criteria:
inclusion criteria: * pediatric patients 0 to 18 years, with a liver transplant with living donor program of our institution * free, informed and written consent signed by the investigator or employees and by the legal guardians of minor patients in the days preceding the procedure exclusion criteria: * refusal of the patient or his parents to consent * known brain or neurological pathology
social cognition and turner syndrome

Conditions: Turner Syndrome

Summary: monocentric multidisciplinary study (psychologists, endocrinologists, psychiatrists, and molecular biologists) to characterize social cognition in adolescents with turner syndrome (ts). inclusion criteria: * turner syndrome with homogeneous 45,x karyotype. * age between 8 and 18 years. * somatic state compatible with the evaluation. * functional language and iq ≥ 80 for the transfer tests * informed consent signed by the holders of parental authority, the patient and the mother for her own participation (dna collection). * affiliation to social security (beneficiary or assignee). the primary endpoint will be the overall score to the aq (autism quotient) questionnaire and to the srs (social reciprocity scale), in comparison to the expected scores for the general population. for patients with scores above the threshold for srs or qa validation of a possible diagnosis of autism spectrum disorders will be performed with commonly used diagnostic tools (adir (lord et al, 1994), ados-g (lord et al, 1999) and diagnostic criteria of dsm iv-tr). secondary criteria will include the results of standardized tests to assess autistic features (aq, adi-r, ados, dsm iv-tr criteria), intellectual efficiency (wechsler scales), psychiatric comorbidities (kiddie-sads) and sociocognitive profile (spex test, social cognition, perception, executive functions). a dna sample will be collected from the patient and her mother. the observation period is 2 days for the patient and about 1 hour for the mother. the total duration of the study is 3 years.

patients will be recruited to the study by their pediatric endocrinologist during routine monitoring visits. they will then be contacted by phone or by mail for an appointment with their mother for more oral and written information consisting of an information notice and informed consent form. the recruitment of turner syndrome patients will be based on the reference centre for rare endocrine growth disorders (ap-hp, robert debré, armand trousseau and necker hospitals). the parental origin of the remaining x chromosome will be analyzed using microsatellite analysis and comparison of the profile of the patient and her mother. statistical analysis will be conducted under the supervision of professor c. alberti using commonly accepted standards. all tests will be bilateral. given the exploratory nature of the study, a significance threshold of 10% will be used. statistical analyzes will be performed using sas software v 9.2.

Eligibility criteria:
inclusion criteria: * turner syndrome with homogeneous 45,x karyotype. * age between 8 and 18 years. * somatic state compatible with the evaluation. * functional language and iq ≥ 80 for the transfer tests * informed consent signed by the holders of parental authority, the patient and the mother for her own participation (dna collection). * affiliation to social security (beneficiary or assignee). exclusion criteria: * additional condition associated with an autism spectrum disorder * turner syndrome not related to an homogeneous 45,x karyotype