Kornimate/medical-research-clean huggingface dataset:
burst suppression anesthesia for treatment of severe depression

Conditions: Major Depressive Disorder

Summary: this study is designed to determine if the antidepressant effects of deep anesthesia via propofol are related to eeg burst suppression.

ten individuals with treatment resistant major depressive disorder will undergo 10 treatments of deep anesthesia via propofol over a 3-week period. depression will be evaluated before and after treatment.

Eligibility criteria:
inclusion criteria: * • diagnosis of major depressive disorder (mdd) or bipolar disorder (i or ii, most recent episode must be depression * failed at least 2 anti-depressant treatments and no ect in past 6 months * age between 18-55 years * bmi \< 35 * hamilton rating scale for depression (hsrd) score \> 18 * quick inventory of depression scale (qids) score \> 10. exclusion criteria: * • diagnosis of primary psychotic disorder, dysthymia, or personality disorder * significant pre-morbid cognitive impairment * hypertension and current use of ace inhibitor or ar blocker medications * symptomatic coronary artery disease or congestive heart failure * history of transient ischemic or neurologic signs during the past year * history of or susceptibility to malignant hyperthermia * contraindication to isoflurane or propofol anesthesia (as determined by anesthesiologist) * diabetes requiring insulin * poor kidney function * chronic use of benzodiazepines or opioids * individuals incompetent to provide consent (e.g. catatonic, psychotic).
can transcutaneous electrical acupoint stimulation improve the quality of recovery after thyroidectomy?

Conditions: Postoperative Complications

Summary: the effect of transcutaneous electric acupoint stimulation (teas) on the quality of recovery in patients undergoing thyroidectomy surgery remains unclear. therefore, the investigators conducted this prospective, randomized, double-blind study to verify the hypothesis that pre-operative teas could improve the quality of recovery (qor) after thyroidectomy surgery.

transcutaneous electric acupoint stimulation (teas) is a form of non-invasive electrical stimulation that produces a perceptible sensation via electrodes attached to the skin. it has no risk of infections and can potentially be applied by medical personnel with minimal training. clinical trials have demonstrated that teas reduces the consumption of intra-operative anesthetics and general anesthesia related side-effects.

Eligibility criteria:
inclusion criteria: * consecutive female patients aged 18 to 60 with american society of anesthesiologists physical status (asa) physical status i or ii, who underwent general anesthesia for elective thyroidectomy surgery exclusion criteria: * potentially difficult airway, * a history of chronic pain, * drug or alcohol abuse, * mental disorder, * intake of any analgesic drug within 48 h before surgery, and * previous experience with acupuncture treatment
preoperative anti-pd-1 antibody combined with chemoradiotherapy for locally advanced squamous cell carcinoma of esophagus

Conditions: Esophageal Squamous Cell Carcinoma

Summary: this study will evaluate the safety and feasibility of preoperative immune checkpoint therapy with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma. and this study will provide valuable information for further clinical trials of preoperative pembrolizumab and other immune checkpoint therapy in esophageal cancer treatment.

esophageal cancer ranks the eighth most common cancer (the fifth most common cancer in china), while escc is the most common subtype in asia (more than 90 % in china). radical resection is thought to be the mainstay of esophageal cancer treatment and preoperative crt is well applied in treating locally advanced esophageal cancer. in a multicohort, phase ib study, pembrolizumab was used in 23 unresectable esophageal cancer patients. in this clinical trial, the incidence of grade 3 treatment-related adverse events was 39 % without the appearance of grade 4 and higher-grade adverse event, while the overall response rate reached 30 %. the safety of immune checkpoint therapy for unresected esophageal cancers using nivolumab, a different pd-1 monoclonal antibody, has also been confirmed by high quality clinical trials. this study will evaluate the safety and feasibility of preoperative immune checkpoint therapy using pembrolizumab with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma. and this study will provide valuable information for further clinical trials of preoperative pembrolizumab and other immune checkpoint therapy in esophageal cancer.

Eligibility criteria:
inclusion criteria: * a patient will be eligible for inclusion in this study only if all of the following criteria apply: 1. histologically confirmed ct2-t4a,n0-n+,m0 resectable esophageal squamous cell carcinoma 2. eastern cooperative oncology group (ecog) performance status 0-1 3. patients approve and sign the informed consent exclusion criteria: * 1. patients with active autoimmune disease or history of autoimmune disease 2. patients who have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications 3. subjects with a history of symptomatic interstitial lung disease 4. history of allergy to study drug components 5. women must not be pregnant or breast-feeding 6. men with female partners (wocbp) that are not willing to use contraception 7. patient has received prior chemotherapy, radiotherapy, target therapy and immune therapy for this malignancy or for any other past malignancy 8. underlying medical conditions that, in the investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events

Keywords: esophageal squamous cell carcinoma neoadjuvant chemoradiotherapy pembrolizumab immune therapy checkpoint inhibitor
yi jin jing tiger roaring speech rehabilitation with real-time feedback technique for pd

Conditions: Speech Disorders; Parkinson Disease

Summary: speech disorders affect more than 90% of patients with parkinson's disease (pd). neither of conventional drugs nor surgery can effectively improve speech function. western speech rehabilitation is effective for speech disorders, but the domestic use of those methods used is limited. our preliminary results revealed that traditional chinese yi jin jing tiger roaring speech rehabilitation is effectively in the treatment of speech disorders in pd, however, high-quality clinical evidence is still scarce. in order to solve this problem, we will conduct a prospective cohort study to explore the effects of yi jin jing tiger roaring speech rehabilitation with real-time feedback technique on speech disorders in pd patients. this study will help to establish a set of chinese medicine treatment and objective evaluation methods for pd speech disorders.


Eligibility criteria:
inclusion criteria: * patients with idiopathic parkinson's disease * native language is chinese * vhi-10 score more than 10 * informed consent exclusion criteria: * previous or concurrent medical history affecting swallowing function (laryngeal diseases such as vocal nodules, gastroesophageal reflux, and laryngeal cancer). * history of serious psychosis * diagnosed by the investigators that patients with severe cardiac, liver and kidney diseases, or other serious health conditions * dementia (a mini-mental state examination (mmse) score of \< 24), inability to comprehend the experimental protocol or voluntarily provide informed consent * lack of cooperation * additional reasons for exclusion at the discretion of the clinical investigator
myotonic dystrophy type 1 and resistance exercise

Conditions: Myotonic Dystrophy 1

Summary: the purpose of this study is to investigate the response after one bout of moderate-heavy resistance exercise in patients suffering from myotonic dystrophy type 1. there is still doubt about if these patients could benefit from resistance exercise, or if this mode of exercise is detrimental to their mobility and health. we aim to monitor the subjects during the recovery phase and investigate recovery in several ways.

myotonic dystrophy type 1 (dm1) is an autosomal, dominantly inherited, muscular disease and the most common muscular dystrophy amongst adults. the disease is characterized by progressive myopathy and myotonia, first evident in the distal parts of the body: calves and forearms, further progressing towards proximal parts. a recent review by voet and co-workers (2013) concludes that exercise is safe for dm1-patients, and based on our current knowledge, dm1-patients should be able to gain positive adaptations from exercise. however, the physiological outcomes of an exercise stimulus are not well studied in this population and because of alterations in important ca2+ handling systems the recovery processes might be significantly different from healthy muscles. the aim of this study is to investigate the acute responses to moderate-heavy resistance exercise in dm1-patients. we aim to establish a timeline for recovery of muscle strength, measured as maximal voluntary contraction. in line with this, we want to investigate if any muscular damage has occurred with both direct and indirect measures, and possible mechanisms leading to muscle damage, i.e. impaired ca2+ handling.

Eligibility criteria:
inclusion criteria: * confirmed myotonic dystrophy type 1-diagnosis exclusion criteria: * non-ambulatory * injuries to muscle-skeletal-system that prevents resistance exercise * severe affection of the cardiovascular system * cognitive affection * lives more than one hour from test site

Keywords: resistance exercise recovery muscle protein synthesis muscle protein breakdown muscle function
arrhythmogenic substrate in primary cardiomyopathies and/or channellopathies

Conditions: Cardiomyopathy

Summary: this study assesses the value of arrhythmogenic substrate identification and elimination by catheter ablation to prevent recurrent ventricular arrhythmias and sudden cardiac death in a series of selected patients with primary cardiomyopathy and/or channellopaties with icd implantation.

the present study is designed as a prospective single center study. all selected patients with implanted icd to prevent vt/vf recurrence who are referred to the arrhythmology department of san donato milanese hospital, for the management of a primary cardiomyopathy fulfilling the inclusion criteria will be enrolled. primary cardiomyopathies include: - dilated cardiomyopathy (dcm), - arrhythmogenic right ventricular cardiomyopathy (arvc), - left ventricular non-compaction (lvnc), - early repolarization syndrome (er), and - hypertrophic cardiomyopathy (hcm).channellopaties incude - long qt syndrome and j-wave syndrome) patients with or without a family history of brs, will also be included. endo-epicardial electroanatomical 3dmapping and rfa ablation will be systematically performed according to a standardized procedure. patients will be monitored for at least 3 days after rf ablation. before hospital discharge, echocardiography and 12-lead ecg will be performed. patients will be followed-up clinically after the procedure as per normal clinical practice. follow-up visits will be systematically scheduled at 3, 6, 12, 18 and 24 months. 12-lead ecg and icd interrogation will be performed at each follow-up visit. patients will be instructed to immediately contact the center in case of symptoms suggestive of ventricular arrhythmias. documentation for intercurrent events will be requested and collected. the maximal duration of study participation for the individual patients is two years.

Eligibility criteria:
inclusion criteria: * patients affected by cardiomyopathies and/or channellopaties (long qt syndrome and j-wave syndrome) with and without documented family history of brs; * presence of symptoms attributable to va and/or presenting documented arrhythmic episodes; * patients with an icd already implanted; * patients referred to the centre for an electrophysiological study and indication for a potential concomitant radio-frequency catheter ablation (rfa) of ventricular tachycardia (vt) or ventricular fibrillation (vf); * age ≥ 18; * willingness to attend follow-up examinations; * written informed consent for the participation in the trial exclusion criteria: * pregnancy or breast-feeding; * life expectancy \< 12 months
characteristics of subjects with overweight or obesity at the onset of hypertension

Conditions: Hypertension; Obesity

Summary: the study aims to investigate the characteristics of subjects with hypertension at onset among a cohort of apparently healthy subjects, with overweight or obesity (bmi ≥ 25 kg / m2), and free of any drug treatment at the baseline. the evaluation includes anthropometric (weight, height, bmi, waist circumference), haematochemical (hormones, metabolic and routine) parameters and the screening for hypertension with abpm. the diagnosis of hypertension is made in accordance with the 2017 guidelines of the american college of cardiology / american heart association acc / aha.


Eligibility criteria:
inclusion criteria: * overweight or obesity (bmi\> 25 kg/m2) exclusion criteria: * any kind of drug * hypertension * endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.), * chronic inflammatory diseases * renal failure * liver failure * angina pectoris * myocardial infarction and heart failure * genetic heart diseases * thrombocytopenias
intraoperative versus ct guided celiac plexus neurolysis in unresectable pancreatic cancer

Conditions: Pain, Chronic

Summary: many studies had stated that the coeliac plexus neurolysis (cpn) is a safe and effective treatment method of pain associated with pancreatic cancer. the neurolytic injectate is usually alcohol 50-100%; however, phenol \>5% is also possible to use. nowadays, there are several techniques to access the coeliac plexus (per cutaneous using fluoroscopy or computed tomographic imaging (ct), surgical and endoscopic ultrasound). however, the percutaneous computed tomography guided technique is the gold standard technique, it has multiple drawbacks as availability and cost of imaging modality, exposure to radiation and multiple complications.surgical technique in spite of being easy, cheap but there is a controversy about its efficacy. also there is no head to head comparison between the surgical technique and the percutaneous technique.in this study we hypothesized that intraoperative technique has the same efficacy of percutaneous celiac block technique with less complication and cost

this study aimed to compare the efficacy of the surgical technique versus the per cutaneous computed tomographic guided technique of celiac plexus neurolysis for pain management in unresectable pancreatic cancer . all patients suffering from pain of pancreatic cancer with vas≥5 undergoing laparotomy and proved to be unresectable either undergoing biopsy or bypass surgery will receive celiac plexus neurolysis either intraoperative or post operative ct guided . all patients will be managed by systemic analgesic if the block not sufficient . in this study we will give the patient the analgesic according to who recommendation as starting by non steroidal anti inflammatory drugs as diclofenac sodium, if it is not sufficient we will give them opioids as tramadol, and for neuropathic pain gabapentin. all drugs will be given with escalating dose . failed block defined as change in vas between vas baseline and one month ≤ 3 may need to repeat the block by percutaneous technique .

Eligibility criteria:
inclusion criteria: * adult patients suffering of pain from pancreatic cancer with baseline vas≥5, scheduled for surgical assessment * patients proven histololgically to be unresectable * patients undergoing either biopsy or bypass surgery exclusion criteria: * patient with resectable tumour will be excluded. * patient with coagulopathy. * patient with aortic aneurysm. * patient with any disease contraindicating any sympathetic blockade as advanced cardiac disease .
improvement to perform thoracocentesis after a specific training in medical students with the supervised use of an augmented reality simulator

Conditions: Pleural Effusion; Frist Time Indication to Perform a Thoracentesis; Medical Student Training

Summary: monocentric study, aiming to assess the improvement of medical students to perform a first-time thoracentesis after training using a specific training using an augmented virtual reality simulator, versus standard training. study population: medical students from the department of respirology (university hospital of strasbourg), performing their first thoracocentesis in patients having an indication for a first-time thoracocentesis. this is not an interventional study, no change in patient course being induced because of the study. after the procedure: use of specific surveys for the patient and for medical students to assess the patient's pain, the patient and the medical student level of anxiety, and the student ability during the procedure.


Eligibility criteria:
medical students : inclusion criteria: * medical students between the 4th and 6th year of their medical course, working in the department of respirology at the university hospital of strasbourg, france, without any prior experience of thoracocentesis. * older than 18 years old * no opposition to participate to the study (signed consent form). exclusion criteria: - student with a prior experience of pleural procedure (chest tube, thoracocentesis). patients : inclusion criteria: * patients requiring a first-time thoracentesis in routine care. * older than 18 years old. * speaking and understanding french. * valid health insurance. * no opposition to participate to the study (signed consent form). exclusion criteria: * patient with previous experience of pleural procedure (thoracocentesis, chest tube...). * patient having a high-volume pleural effusion according to radiological/ultrasound criteria. * patient with low-volume pleural effusion according to radiological/ultrasound criteria. * patient with poor clinical tolerance of the pleural effusion(respiratory instability, dependence on ventilation machine with positive expiratory pressure...). * patients with higher risk of complication during the procedure (bmi \> 35 kg/m², with increased risk of bleeding...). * contraindication to the use of lidocaine. * local infection. * impossibility to provide detailed information to the patient. * subject under legal protection.

Keywords: thoracentesis augmented virtual reality simulator medical student training
absolute bioavailability of yh4808 with accelerator mass spectrometry(ams)-based microdose study

Conditions: Gastroesophageal Reflux Disease

Summary: this study aims to determine the absolute bioavailability of yh4808 using simultaneous oral therapeutic- and \[14c\]-labeled intravenous microdoses.


Eligibility criteria:
inclusion criteria: * healthy male subject aged 20 to 45 at screening * subjects who have weight over 55 kg with bmi ranged from 20.0 to 25.0 * subjects who decide to participate voluntarily and write a informed consent form exclusion criteria: * subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor * clinically significant allergic disease (except for mild allergic rhinitis) * subjects who have determined not eligible by screening test (medical history, physical examination, 12-lead ecg, laboratory test, etc) within 28 days of study start * subjects considered unsuitable for inclusion by the investigator

Keywords: absolute bioavailability, microdose, ams
to assess bioequivalence of loratadine oral solution/syrup versus claritin peach syrup

Conditions: Histamine H1 Antagonists, Non-Sedating

Summary: to assess the bioequivalence of loratadine oral solution/syrup 1mg/ml (gpla formula) versus claritin peach syrup 1mg/ml (anna formula)


Eligibility criteria:
inclusion criteria: * healthy adult (men or women), age 18 to 55 years inclusive; * body mass index 18.5 to 30.0 kg/m\*2 inclusive; * able to read and understand the written informed consent for study-related information and instruction; * able to comply with protocol requirements, including overnight stays, blood sample collections as defined in the protocol; * agree not to donate whole blood or components of blood (e.g. plasma, thrombocytes) starting from signing the informed consent form through 30 days after the last study procedure, except for the blood samples collected for this study; * female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, injectable contraceptive (e.g. depo-provera), or a double barrier and have a negative pregnancy test at screening and prior to study drug administration on day 0 of dosing periods 1 and 2. female subjects of non-childbearing potential must be amenorrheic for at least two years or had a hysterectomy and/or bilateral oophorectomy; exclusion criteria: * pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal; * known hypersensitivity to any medication (active substances or excipients of the preparations) to be used in the study; * known galactose intolerance, lactase deficiency or glucose-galactose malabsorption * known severe allergies (e.g. allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids); * use of, within 1 month before the first study drug administration, systemic or topical medicines or substances which might affect the study objectives, e.g * any drug known to induce cytochrome p3a4/5 or p glycoprotein (e.g. rifampin, carbamazepine, st. john's wort); * any drug known to inhibit cytochrome p3a4/5 or p glycoprotein (e.g. erythromycin, clarithromycin, chloramphenicol, ketoconazole); * any drug known to induce cytochrome p2d6 (e.g. rifampin, dexamethasone); * any drug known to inhibit cytochrome p2d6 (e.g. cimetidine, desipramine, fluoxetine, metoclopramide); * positive urine pregnancy, urine drug test or hepatitis b, hepatitis c or hiv tests; * clinically relevant findings in the physical examination, e.g., signs of bleeding diathesis, signs of heart failure, evidence of peripheral circulatory disturbances, and skin abnormalities;

Keywords: allergy
describing the clinical-laboratory aspects of diabetes through the creation of a registry

Conditions: Diabetes

Summary: the main objective of the study is to describe the clinical-laboratory aspects of diabetes by creating a registry in which to census all newly diagnosed or already diagnosed cases after 1/1/2000 at the o.u. of endocrinology and diabetes prevention and care.

the main objective of the study is to describe the clinical-laboratory aspects of diabetes by creating a registry in which to census all newly diagnosed or already diagnosed cases after 1/1/2000 at the o.u. of endocrinology and diabetes prevention and care. the clinical-laboratory aspects covered by this study also include family history, survival, comorbidities, psychological aspects, and in any case all those data that add relevant scientific information. this registry may be used to review the ou's case history and to confirm or obtain new scientific evidence on diabetes through cohort studies conducted using the data that will be recorded.

Eligibility criteria:
inclusion criteria: * age \>18 years * newly or previously diagnosed patients with diabetes mellitus at any stage of disease * obtaining informed consent exclusion criteria: - patients whose diagnosis of diabetes mellitus is uncertain