Kornimate/medical-research-clean huggingface dataset:
stretta in reflux uncontrolled by ipp

Conditions: Gastroesophageal Reflux Disease

Summary: the aim of the study is to compare the stretta procedure and the sham procedure efficiency 6months post-procedure in reflux uncontrolled by intake of inhibitors of protons pump (ipp) patients.

the study is over a period of 1 year. after checking eligibility, the patient will be randomised in double blind : stretta procedure /sham procedure. control visits will take place after 4 weeks (on site), 8 weeks (by phone), 12 weeks (by phone), 18 weeks(on site) and 24 weeks(on site).during the 24 weeks visit, the therapeutic success will be evaluated. in case of success, endoscopic control will be performed and the patient will come back on site at week 36 and 48 (end of study). in case of therapeutic failure, the stretta procedure will be proposed to the patient without breaking the blind for the 1st procedure. the procedure will be scheduled between week 24 and week 27. the patient will come back for a visit on site at weeks 31, 36 and 48 (end of visit)

Eligibility criteria:
inclusion criteria: * age ≥ 18 ans * severe or moderate heartburn (at least 3 heartburn times per week), persistent under treatment with ipp exclusion criteria: * recent oeso-gastro-duodenal endoscopy(\< 3 months) * oesophagitis \> grade a * endobrachyoesophagus \> c0m1 * hiatal hernia \> 2 cm * symptoms insufficiently relieved with continued intake of ipp or with intake of ipp according to needs * predominant symptom of gastrooesophageal reflux disease other than heartburn * patients contra-indicated for radiofrequency technique * pregnant women
virtual reality biofeedback for postpartum anxiety and depression

Conditions: Anxiety and Depression; Postpartum Depression; Pregnancy Related

Summary: the purpose of this study is to test patient feasibility and acceptability of virtual reality biofeedback program in postpartum women for anxiety and depression outcomes.

in an open-label pilot trial, women will undergo a single session using the virtual reality biofeedback program. the objective of this study is to assess feasibility and acceptability of virtual reality biofeedback program in postpartum women with specific assessments of anxiety and depression outcomes.

Eligibility criteria:
inclusion criteria: * currently pregnant or postpartum (delivery within 3 months) * 18 years or older exclusion criteria: * unable to participate in study procedures * english illiterate (surveys validated in english)
explainable ocular fundus diseases report generation system

Conditions: Ophthalmological Disorder; Image, Body

Summary: to establish a deep learning system of various ocular fundus disease analytics based on the results of multimodal examination images. the system can analyze multimodal ocular fundus images, make diagnoses and generate corresponding reports.

the ocular fundus is the only part of the human body that can directly see the blood vessel microcirculation and nerve tissue. through various imaging tests, including color fundus photograph (cfp), optical coherence tomography (oct), fluorescein fundus angiography (ffa) and indocyanine green angiography (icga), etc., it is possible to statically overview or dynamically observe the retina and choroid, the condition of blood vessels and nerves, and comprehensive diagnosis of the disease. the screening, interpreting and accurate diagnosis of ocular fundus diseases are crucial for disease prevention, control and precise treatment. however, due to the variety of fundus examination methods, and the complexity and professionalism of the examination, there is a lack of fundus specialists who have sufficient clinical experience and knowledge to interpret fundus examinations. with the continuous development of artificial intelligence (ai) in diagnosing fundus diseases, various modalities of imaging examination methods are gradually applied to the development of fundus disease diagnosis systems. moreover, medical images often come with corresponding reports, which are mostly generated by clinicians' or radiologists' experience. here, we are establishing a fundus disease diagnosis and report-generating system based on cross-modal ocular fundus imaging examinations, and fundus lesions were visualized at the same time. multi-center data verification will also be conducted. the results of the research will assist in fundus lesions diagnosis and imaging reports generation. we hope this could popularize more complex fundus imaging examination methods to society, and help improve the early diagnosis and treatment of fundus lesions that cause blindness.

Eligibility criteria:
inclusion criteria: * the quality of multimodal ocular fundus disease examination images and corresponding reports should be clinically acceptable. exclusion criteria: * reports with key information missing. * images with severe image resolution reductions, blur or artifacts were excluded from further analysis.

Keywords: retinal disease choroidal disease deep learning
variability of tinnitus characterization tools and investigation of audiovisual integration in tinnitus perception

Conditions: Tinnitus

Summary: characterizing the nature and severity of tinnitus in individuals presents a particular challenge. the nature of the sound (loudness and pitch) is not necessarily indicative of the effect on quality of life. different methods are used to measure each parameter. loudness is measured using a technique called "minimum masking," in which the subject is presented with a broadband white noise and asked to adjust the loudness level until they can no longer hear their tinnitus. severity of tinnitus is commonly characterized using two questionnaires: the tinnitus handicap inventory (thi) and the tinnitus functional index (tfi). these questionnaires assess the perceived severity of the tinnitus and the effect on everyday activities and quality of life. a visual analog scale (a scale from 0-10) is used as a general subjective measurement of tinnitus severity. in the first part of this study, we will measure each of these parameters over a series of sessions to establish a baseline variability for each individual. the second part will look at the influence of context-specific visual information on auditory perception. this involves watching silent videos of a person speaking, with and without an additional tone designed to match the subject's tinnitus. the effect of this audiovisual feedback on the subject's perception of tinnitus will be assessed using a subjective rating scale and the minimum masking task.

this study is not specifically seeking to treat tinnitus, but is designed to investigate various parameters that can alter the tinnitus percept. findings from this study will help identify parameters that can be more effective at decreasing or fully suppressing the tinnitus percept that will be systematically explored in a follow-up study.

Eligibility criteria:
inclusion criteria: * have subjective, non-pulsatile and bothersome tinnitus * ability to give informed consent and understand study objectives and procedures in english * willing and able to understand and comply with all study-related procedures * will not start any new tinnitus treatment during the study exclusion criteria: * substantial hearing loss or hyperacusis that may interfere with the study * medical history of other ear or brain disorders * pregnant or currently breast-feeding (we need to give all female subjects a pregnancy test because pregnant females and unborn children require extra protection for their safety) * any handicap that prevents the subject from reliably performing the tests, such as blindness.

Keywords: neuromodulation noninvasive plasticity hearing hyperacusis
dexamethasone vs. dexmedetomidine for popliteal nerve block in pain management after pediatric ankle and foot surgery

Conditions: Foot Injuries and Disorders; Ankle Injuries and Disorders

Summary: effect of perineurial dexamethasone and dexmedetomidine on popliteal nerve block duration for pediatric, ankle or foot surgery

this study is proposed to explore the effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery. after scoliosis surgery, children need good analgesia. peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe. the safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. an effective adjuvant, such as dexamethasone or dexmedetomidine, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect. there is considerable research where intravenous and perineural dexamethasone and dexmedetomidine use has been compared in adults. however, there is a massive lack of research regarding children. in this study, investigators compare perineural dexamethasone and dexmedetomidine. group 2 has dexamethasone doses of 0.1mg/kg, and group 3 has 0,1ug/kg dexmedetomidine added to the local anesthetic. the investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.

Eligibility criteria:
inclusion criteria: * all children scheduled for ankle or foot surgery * aged \> 3 months \< 7 years exclusion criteria: * age \< 3 months * age \> 7 years * infection at the site of the regional blockade * coagulation disorders * immunodeficiency * asa= or \>4 * steroid medication in regular use * chronic pain
verification study and reactivity study for the validity of ququ scale

Conditions: Alzheimer's Disease Dementia; Cognitive Concern Without Dementia

Summary: examine the construct validity, the test-retest reliability, the concurrent validity with the standard dementia rating scales and the reactivity of a novel dementia rating scale "ququ scale: quick question scale" final for the evaluation of patients with alzheimer's disease dementia and mild cognitive impairment.


Eligibility criteria:
inclusion criteria: 1. alzheimer's disease dementia and patients with cognitive concern without dementia 2. written informed consent by each subject and/or a legal representative, and study informant. if the doctor decides that the patient has no trouble in understanding this study, the written informed consent of a legal representative may be exempted. if not, this study needs a written informed consent by a legal representative and the patient except the case where the consent is hardly obtained due to the progression of the disease. exclusion criteria: 1. patients with other types of dementia (e.g. vascular dementia, levy body dementia, frontotemporal dementia) 2. patients with other diseases which cause secondary dementia prior to alzheimer's disease dementia 3. patients with other severe neurological disease or psychiatric disorder without alzheimer's disease dementia 4. patients with other medical conditions where the investigators determine that it is inappropriate for the subject of this study (e.g. inappropriate for the evaluation of dementia rating scale)

Keywords: alzheimer's disease dementia
asia pacific menopause federation menopause consensus

Conditions: Menopause; Menopause Related Conditions

Summary: the aim of this study is to achieve expert consensus on the management of menopause in the asia-pacific

the aim of this study is to achieve expert consensus on the management of menopause in the asia-pacific. the experience of the menopause is deeply rooted in sociocultural perceptions unique to each population. thus, the management of menopausal symptoms and other conditions related to the menopause also vary from region to region. the investigators will use a modified delphi method involving the participation of experts from various countries in the asia-pacific. the objective of this study is to achieve consensus on various aspects of the management of the menopause in the asia-pacific. this study will involve several rounds of delphi surveys, administered via google forms, microsoft word or pdf. each survey questionnaire contains 1. questions on basic demographic information 2. statements on areas of concern in the management of the menopause; each participants vote on to what extent they agree or disagree with the statement on a likert scale. 3. questions on the participants' usual clinical practice in treating menopause multiple survey rounds will be held until agreement on the statements and stability is achieved.

Eligibility criteria:
inclusion criteria: experience in treating menopause
glidescope versus direct laryngoscope for emergency intubation

Conditions: Oral Intubation

Summary: the purpose of this study is to assess if the glidescope video laryngoscope is superior to the macintosh direct laryngoscope for definitive airway management in acutely-injured patients.

on admission to the emergency department following traumatic injury, many patients require placement of an artificial airway to support their breathing, provide oxygen and protect their airway. this procedure is accomplished through a number of different techniques and few studies have compared these techniques in order to establish the best method. we will compare an older technique using a metal handle and blade that allows for direct visualization of the vocal cords (direct laryngoscopy) to a newer technique that employs a fiberoptic bundle imbedded in a handle that allows indirect visualization of the vocal cords during placement of the artificial airway. the newer technique has the theoretical advantage of being more useful in patients with abnormal airways which are frequently encountered in trauma patients. since both techniques are currently employed routinely in our institution, we will randomize all trauma admission to have an initial attempt with one of the two techniques in order to perform a randomized, unblinded trial.

Eligibility criteria:
inclusion criteria: * require emergency intubation exclusion criteria: * age \< 18 * require surgical airway on initial assessment * have known or strongly suspected spinal cord injury

Keywords: airway management trauma intubation
virtual reality for anxiety in interventional radiology procedures

Conditions: Preoperative Anxiety

Summary: the goal of this clinical trial is to learn if virtual reality works to reduce anxiety in patients undergoing interventional radiology procedures. the main questions it aims to answer are: does virtual reality lower anxiety in patients undegoing minimally invasive procedures? can it help the platient's compliance and operators' satisfaction? researchers will compare virtual reality to usual preoperative care to see if virtual reality is effective. participants will: use virtual reality for 20 minutes before the intervention starts. complete questionnaires before and after the procedure.

patients enrolled and assigned to group 1 will wear the virtual reality visor in the induction room, before entering the angio suite in which the procedure will take place. the study requires that before and at the end of the procedure, a measurement of blood pressure and heart rate in order to measure the change in the patient's anxiety state. at the end of the procedure, they will be administered satisfaction tests to interventional radiologists and patients. the viewers in question are meta quest 2. through the use of these viewers, the patient will will watch a vr video containing music and natural images that can promote relaxation in preparation for the procedure.

Eligibility criteria:
inclusion criteria: * indication to ct-guided biopsy in local anesthesia * informed consent signature exclusion criteria: * lack of patient consent to trial. * lack of eligibility to perform ct-guided needle biopsy, or eligibility to perform the procedure but with administration of general anesthesia or sedation. * patients who do not speak italian or english will be excluded; * patients with visual and/or hearing impairment; * patients on analgesics or anxiolytics; * patients with the following conditions: dementia, psychiatric disorders; headache, dizziness, recent head injury, epilepsy, and other conditions in which the application of vr glasses has been judged to be potentially harmful; and when the topical anesthetic (lidocaine and prilocaine \[eutectic mixture of local anesthetic (emla)\]) or tetracaine (ametop) was not properly applied before surgery.

Keywords: virtual reality preoperative care
phase i study evaluating tolerability, safety, pharmacokinetics, and efficacy of combined ono-4059 and r-mpv therapy for pcnsl

Conditions: Primary Central Nervous System Lymphoma

Summary: to confirm the tolerability and safety of combined administration of ono-4059 and r-mpv therapy in untreated pcnsl patients.


Eligibility criteria:
inclusion criteria: * patients diagnosed with pcnsl * patients who have not received treatment for pcnsl in the past * patients with ecog performance status 0-2 * patients expected to survive for 6 months or more exclusion criteria: * patients with intraocular pcnsl without brain lesions * patients are unable to swallow oral medications
closed-loop control of glucose levels (artificial pancreas) for 15 weeks in adolescents and adults with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. a dual-hormone closed loop strategy regulates glucose levels through the infusion of two hormones: insulin and glucagon. the objective of this study is to compare, in a randomized multicenter trial, the effectiveness of single-hormone closed-loop, dual-hormone closed-loop, and sensor-augmented pump therapy with low-glucose suspend in regulating day-and-night glucose levels in outpatient settings for 15 weeks in adolescents and adults. the investigators hypothesize that dual-hormone closed-loop will reduce time spent in hypoglycemia compared to single-hormone closed-loop, which in turn will be more effective than sensor-augmented pump therapy with low-glucose suspend.


Eligibility criteria:
inclusion criteria: 1. males and females ≥ 12 years of old. 2. clinical diagnosis of type 1 diabetes for at least one year. 3. the subject will have been on insulin pump therapy for at least 3 months. 4. hba1c ≤ 11%. exclusion criteria: 1. clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator. 2. recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery. 3. history of pheochromocytoma or insulinoma (glucagon could induce a hormonal response of these tumors) 4. beta-blockers at high dose based on investigator's evaluation of dosage interference with glucagon (glucagon can modify effect of beta-blockers, mostly evident at very high doses) 5. chronic indometacin treatment (can prevent glucagon effect on liver thus its ability to raise glucose) 6. chronic acetaminophen treatment (can interfere with glucose sensor measurements) 7. warfarin chronic treatment if inr monitoring cannot be evaluated (can increase the risk of bleeding) 8. anticholinergic drug (risk of interaction) 9. pregnancy. 10. severe hypoglycemic episode within two weeks of screening. 11. current use of glucocorticoid medication (except low stable dose and inhaled steroids). 12. known or suspected allergy to the trial products 13. other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator. 14. anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport). 15. treatments that could interfere with glucagon

Keywords: closed-loop system artificial pancreas type 1 diabetes hypoglycemia insulin glucagon
carboplatin combined with paclitaxel in treating patients with advanced thymoma

Conditions: Thymoma; Thymic Carcinoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one chemotherapy drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of carboplatin combined with paclitaxel in treating patients who have advanced thymoma.

objectives: * determine the objective response rate in patients with advanced thymoma or thymic carcinoma treated with carboplatin and paclitaxel. * determine the duration of response in these patients treated with this regimen. * determine the toxicity of this regimen in these patients. outline: patients receive paclitaxel by intravenous (iv) infusion over 3 hours followed by carboplatin iv over 30 minutes on day 1. treatment repeats every 21 days for 2 courses in the absence of disease progression. patients achieving complete or partial remission or stable disease receive 4 additional courses of therapy for a maximum of 6 courses. further treatment may be given at the discretion of the treating physician. patients were followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. projected accrual: a total of 35-68 patients were to be accrued for this study within 3.8-4.6 years.

Eligibility criteria:
inclusion criteria: * histologically confirmed invasive, recurrent, or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery * extensive disease (distant disease, pleural disease, pulmonary with or without mediastinal disease, or recurrent progressive disease in site of prior radiotherapy) * advanced limited disease allowed if ineligible for primary radiotherapy or surgery * measurable disease * age 18 and over * ecog performance status 0-1 * granulocyte count at least 1,500 cells/mm\^3 * platelet count at least 100,000 cells/mm\^3 * bilirubin no greater than 1.5 mg/dl * creatinine no greater than 2.0 mg/dl * concurrent corticosteroids for myasthenia gravis or other chronic conditions allowed exclusion criteria: * acute concurrent complications such as infection or post-surgical complications * other prior malignancy within the past 5 years unless curatively treated with no evidence of recurrence * pregnant or nursing. a negative pregnancy test was required, and fertile patients must use effective contraception * prior chemotherapy for metastatic disease. prior preoperative or adjuvant chemotherapy allowed if disease-free survival prior to recurrence was more than 1 year

Keywords: thymoma thymic carcinoma
the effect of spinal anesthesia on heart rate variability in diabetic patients

Conditions: Heart Rate Variability; Diabetes; Spinal Anesthesia

Summary: cardiac autonomic neuropathy is a common complication of diabetes and is associated with resting tachycardia. regional anesthesia could interrupt normal autonomic activity by central sympathetic blockade. the investigators evaluate the relation of severity of diabetes and heart rate variability, also the impact of spinal anesthesia on the change of heart rate variability.


Eligibility criteria:
inclusion criteria: * patients undergoing lower limb surgery with spinal anesthesia (asa class 1,2,3) exclusion criteria: * severe coagulopathy, short height, arrhythmia patients, patients taken medication which could affect autonomic nervus system (bata- blocker or alpha-blocker)

Keywords: heart rate variability spinal anesthesia dm cardiac autonomic dysfunction