Kornimate/medical-research-clean huggingface dataset:
assessment of the capability of pulmovista 500 to continuously monitor changes of ventilation over time

Conditions: Mechanical Ventilation; Single-lung Ventilation; ARDS; ALI - Acute Lung Injury; Weaning From Ventilator

Summary: the results of this study will help to define the capability and reliability of pulmovista 500 to detect changes in both global and regional ventilation.


Eligibility criteria:
inclusion criteria - the population included in the clinical study will be selected from a pool of patients undergoing respiratory support who are scheduled to have their ventilation settings changed. as a subgroup, patients who are scheduled for surgeries that need one-lung-ventilation (olv) will be enrolled to the study. * male and female patients at the age of 18 years or older * on respiratory support in icu care or scheduled for such ( e.g. postoperatively) or scheduled for surgery with olv * patients of which the monitoring of ventilation distribution may be of clinical interest * patients being ventilated via an artificial airway with a mechanical ventilator that is compatible with pulmovista 500 * patients scheduled for changes in ventilation settings that may cause relevant changes in the ventilation * chest circumference between 70 and 150 cm * written informed consent to participate in the study provided by either the patient or the legal representative of the patient. exclusion criteria * currently has a permanent or temporary pacemaker, implantable cardiac device (icd) or other device emitting electrical energy * a bmi ≥ 50 * tidal volume (vt) ≤ 200 ml * current uncontrolled body movements such as tics, tremors or seizures, * current wound dressings or infections on the chest that might interfere with the pulmovista 500 electrode belt placement * women of child bearing potential whose pregnancy cannot be excluded based on a pregnancy test or other proven facts. * allergic to materials used in the electrode belt * participation of the patient in an interventional trial within the last four weeks before enrollment in this trial * evidence suggesting that the patient or his legal representative is not likely to follow the trial protocol (e.g. lacking compliance) * known infectious diseases that require isolation of patient (e.g. mrsa) * concomitant use of an air anti-decubitus medical mattress with dynamic inflation that cannot be deactivated during eit measurements

Keywords: ventilation monitoring electrical impedance tomography
recognition of heart failure with micro electro-mechanical sensors (reflecs) fi

Conditions: Heart Failure; Heart Diseases; Cardiovascular Diseases

Summary: in this study the ability of smartphone sensors (accelerometer and gyroscope) to identify patients with heart failure will be studied.

heart failure (hf) is a condition where heart is unable to maintain adequate volume of blood in circulation corresponding to prevailing physiological demand. gyrocardiography is a technique that utilizes micro electromechanical sensors (mems), accelerometer and gyroscope, to detect vibrations and rotation of thorax caused by cardiac motion. the main purpose of this study is to test the ability of an app of a smartphone with embedded motion sensors, positioned on the chest which measures the movements and function of the heart, to identify patients with different types of heart failure and their characteristics, as compared with clinical diagnosis. echocardiography will also be used to confirm changes in cardiac cardiac mechanics including strain, cardiac torsion, diastolic filling characteristics.

Eligibility criteria:
inclusion criteria: * age \>18 years * patients visiting hospital for heart failure, either outpatient clinic or cardiac ward * signed informed consent as an acceptance to participate to the trial exclusion criteria: * age \<18 years * severe cardiac valve disease * previous prosthetic cardiac valve * major adverse cardiovascular event or surgery within 6 weeks of planned study enrollment * patients with pacemaker * informed consent form not signed.
ep4-receptor antagonism and prostaglandin e2 (pge2) in a human headache model

Conditions: Headache, Migraine

Summary: the purpose of this study is to determine whether ep-4 receptor antagonist can prevent the headache expected during a prostaglandin e2 infusion.


Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * tension headache * all other primary forms of headache * cardiovascular, central nervous system (cns) and autoimmune diseases * gastrointestinal disease * previous or clinical signs of mental illness or substance abuse. * participation in a clinical study of a medicinal product without regulatory approval or marketing authorisation within 1 month prior to this trial * pregnancy/nursing * daily intake of medication (except oral contraceptives)
a open-label, randomized, crossover study to assess pk of pregabalin

Conditions: Peripheral Nueropathy Pain

Summary: the purpose of this trial to compare the pharmacokinetic characteristics of yhd1119(pregabalin 300mg) and lyrica capsule(pregabalin 150mg). yhd1119 is controlled release formulation which is made by yuhan corporation. primary endpoints are cmax,ss and auctau and secondary endpoints are auclast,ss, aucinf,ss, tmax,ss and t1/2.


Eligibility criteria:
inclusion criteria: * 19\~50 years old, healthy male volunteers * \>55kg(body weight) and 18.5\<bmi\<28 exclusion criteria: * ast or alt \> 3 \* upper normal range (lab) * total bilirubin \> 2.0 mg/dl * systolic bp \>140 or \ 100 or \<60
intramuscular injection of human chorionic gonadotropin in frozen embryo transfer cycles

Conditions: Embryo Implantation

Summary: this study is a randomized controlled clinical trial to compare the pregnancy outcomes of infertile women with frozen embryo transfer. the study population in frozen embryo transfer cycles receive three doses of human chorionic gonadotropin (hcg) to recognize the effectiveness of hcg on pregnancy outcomes in reproductive biomedicine research center, royan institute, tehran iran.

during implantation, the biochemical crosstalk between the endometrium and embryo has a very important role. the endometrium secrets cytokines and growth factors that modulate embryonic differentiation and early development. one of the important molecular messages between the embryo and endometrium is human chorionic gonadotropin (hcg). hcg is expressed by the blastocyst before the implantation, while increasingly produced after implantation by the syncytiotrophoblast. in order to study the direct effect of hcg on the endometrium at implantation, this randomized, controlled clinical trial evaluated whether hcg supplementation would be beneficial for pregnancy outcomes of cryopreserved-thawed embryo transfer with estrogen/ progesterone replacement cycles at royan institute. block randomization method is designed by epidemiologist using stata software version 13 and the number of blocks considered is 6. the random allocation list for patients is solely available to the epidemiologist. in order to hide the random allocation process, a total of 200 envelopes are prepared, and only the methodologist has been aware of table of random numbers. when the doctor declared the patient's eligibility, the methodologist provided the doctor with the envelope. the group will be selected and based on the type of group mentioned in the envelope.

Eligibility criteria:
inclusion criteria: * infertile women candidates for frozen embryo transfer * age 20-40 years * body mass index under than 30 kg/m2 * having at least three good quality embryos exclusion criteria: * women with hematologic and autoimmune disorders * couples with chromosomal and genetic abnormalities * women with uterine anomalies * women with uterine and ovaries surgical history * women with endometriosis and adenomyosis * women with hydrosalpinx * women with uterine fibroids * women with history of recurrent abortion or recurrent implantation failure * severe male factor infertility (azoospermia) * embryo donation cycle * endometrial thickness less than 8 millimeter on the day of embryo transfer

Keywords: human chorionic gonadotropin frozen embryo transfer infertility assisted reproduction technology estrogen/ progesterone replacement cycles
evaluation of the middle turbinate implant for affixing the middle turbinate to the nasal septum

Conditions: Sinusitis

Summary: the purpose of this study is to determine the functional performance of the middle turbinate implant (mti). the mti will be used in all patients requiring endoscopic sinus surgery in which the principal investigator determines clinical relevance.


Eligibility criteria:
inclusion criteria: * subject is between the ages of 18 and 65 years and will be receiving endoscopic sinus surgery. * subject is able to provide a signed informed consent form. * subject will agree to comply with all study-related procedures. * subject is not pregnant at this time by confirmation of one of the following: * subject is male * subject not of child bearing age * subject is surgically sterile * subject is not pregnant per negative hcg test * subject does not plan on becoming pregnant and is not breast feeding during the course of the study. exclusion criteria: * subject does not meet inclusion criteria. * presence of non-viable tissue at the implantation site. * history of septal perforation. * history of polyps. * presence of concha bullosa. * subject is currently using cpap (continuous positive airway pressure) for sleep apnea. * subject is participating in a clinical trial which could affect the healing of the middle turbinate. * subject has uncontrolled diabetes. * subject is a: * smoker * severe drug abuser * severe alcohol abuser * subject has an autoimmune disease deemed clinically significant by the principal investigator.

Keywords: turbinate implant sinus surgery turbinates
pain patch versus injections in the treatment of pain associated with shoulder impingement syndrome

Conditions: Shoulder Pain

Summary: objective: this purpose of this pilot study is to explore the potential usefulness of synera for the treatment of pain associated with shoulder impingement syndrome.

subjects will receive either a subacromial injection at baseline or will be issued synera patches to use daily for 2 weeks and then prn for an additional 2 weeks.

Eligibility criteria:
inclusion criteria: * be at least 18 years of age. * have pain associated with shoulder impingement syndrome in a single shoulder (minimum 2-week duration). * have tenderness at the attachment site of the rotator cuff tendons. * have positive hawkin's and neer's signs. * report an average pain intensity score of 4 (on an 11-point scale) over the past 24 hours at the screening/baseline visit. exclusion criteria: * have used any topically applied pain medication on the target treatment area within 14 days preceding study day 1, such as non-steroidal anti-inflammatory drugs (nsaids), menthol, methyl salicylate, local anesthetics (including lidoderm®), or steroids. * have used any injected medication within 60 days preceding study day 1, such as local anesthetic (lidocaine) or steroids. * have a clinically significant illness within 14 days of screening/day 1 that, in the opinion of the investigator, would preclude the subject from participating in the study. * are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.) * have a history of and/or past diagnosis of severe hepatic disease. * have participated in a clinical trial of an unapproved drug within 30 days prior to screening. * are pregnant, breastfeeding, or a female of childbearing potential and not practicing an acceptable method of birth control. * are unable or unwilling, in the opinion of the investigators, to comply with all study procedures and cooperate fully with research staff. * have filed a disability claim or are currently receiving disability payments for shoulder impingement syndrome.

Keywords: shoulder pain shoulder impingement syndrome
awake-prone positioning strategy for hypoxic patients with covid-19

Conditions: Covid19; Respiratory Failure

Summary: this study aims to determine if a strategy of recommending prone (on stomach) positioning of patients positive or suspected positive for coronavirus disease 2019 (covid-19) requiring supplemental oxygen, but not mechanically ventilated, is feasible in the inpatient setting. this study will be performed as a pragmatic pilot clinical trial to gain information relevant to the future conduct of a larger trial.

severe acute respiratory syndrome coronavirus-2, sars-cov-2, the virus causing coronavirus disease 2019 (covid-19) pandemic, has rapidly led to significant morbidity and mortality worldwide, primarily through lower respiratory tract involvement progressing from hypoxemia to acute respiratory distress syndrome. novel approaches to improving oxygenation are urgently needed to limit aerosolization concerns and resource scarcity associated with intubation and, to a lesser extent, other forms of advanced respiratory support. prone positioning in mechanically ventilated patients with hypoxemic respiratory failure has been associated with improvement in oxygenation and mortality in patients with acute respiratory distress syndrome (ards). the prone position appears to provide more uniform lung perfusion, shifting ventilation to well-perfused lung segments and recruitment of dependent atelectatic regions of lung. physiological alterations associated with the prone position would foreseeably also apply to spontaneously breathing patients and evidence from small observational studies suggests that prone positioning in non-intubated patients is feasible associated with improvement in oxygenation. however, it remains unknown if a prone ventilation strategy is truly beneficial for non-intubated hypoxic covid-19 patients, and this question has stimulated interest in the conduct of rigorous randomized controlled trials (rct). however, the awake prone strategy is a complex medical intervention with multiple implementation nuances such as adoption, feasibility, and tolerability that may affect successful conduct of a definitive rct. in order to increase the likelihood of a successful future rct, the investigators will conduct the apps pilot study. the overall aim of the apps pilot trial was to assess feasibility and important contextual factors for a large rct to compare the clinical effectiveness of an awake-prone positioning strategy (apps) for respiratory support versus usual care alone for hypoxic adults with covid-19.

Eligibility criteria:
inclusion criteria: * hospitalized patients with positive covid testing during hospitalization or 7 days prior or hospitalized with suspected covid pneumonia * room air oxygen saturation \ or equal to 3 liters per minute exclusion criteria: * unable to turn self, spinal instability, facial or pelvic fractures, open chest or open abdomen, altered mental status, anticipated difficult airway, show signs of respiratory fatigue, or receiving end-of-life care
radiologic scoring of patients with chronic sinusitis and nasal polyps

Conditions: Chronic Sinusitis

Summary: to detect the effect of hypertonic saline and fluticasone sprays on computed tomography scan of paranasal sinuses of patients having chronic sinusitis and/or nasal polyps.


Eligibility criteria:
inclusion criteria: * adult patients with chronic sinusitis and/or nasal polyps. exclusion criteria: * patients with previous nasal or sinus surgery. * patients with sinonasal malignancy. * immunocompromised patients. * patients with ciliary motility disorders. * pregnant women
the efficacy of phosphatidylserine-omega3 in elderly with age associated memory impairment

Conditions: Age Associated Memory Impairment

Summary: the primary objective of this trial is to assess the ability of an oral administration of phosphatidylserine-omega3 to improve attention and memory complaints in comparison to placebo in age associated memory impaired subjects.


Eligibility criteria:
inclusion criteria: 1. ability to give written informed consent 2. age: 90≥ years ≥50 3. gender: male and female 4. cdr ≤ 0.5 5. complaints of memory loss reflected in such everyday problems as difficulty remembering names of individuals following introduction, misplacing objects, difficulty remembering multiple items to be purchased or multiple tasks to be performed, difficulty remembering telephone numbers or zip codes, and difficulty recalling information quickly or following distraction. onset of memory loss must be described as gradual, without sudden worsening in recent months. complaints of memory loss to be assessed by the mac-q scale. 6. mini-mental state examination (mmse) ≥27 for subjects with college education (ba) and ≥ 26 for all others 7. memory test performance that is at least 1 sd below the mean established for young adults on at least one neuropsychological subtest of nexade. 8. language: subjects must be able to read, write and speak hebrew. 9. ability to perform tests and interviews exclusion criteria: 1. evidence of delirium, confusion, or other disturbances of consciousness 2. any neurological disorder that could produce cognitive deterioration. such disorders include ad, parkinson's disease, stroke, intracranial hemorrhage, local brain lesions including tumors, and normal pressure hydrocephalus 3. history of any infective or inflammatory brain disease including those of viral, fungal, or syphilitic etiologies 4. evidence of significant cerebral vascular pathology 5. head injury immediately preceding cognitive deterioration. 6. current psychiatric diagnosis according to dsm iv criteria of depression, mania, or any other major psychiatric disorder 7. current diagnosis or history of alcoholism or drug dependence. 8. evidence of depression as determined by the geriatric depression scale (short version) score of 5 or more. 9. any medical disorder that could produce cognitive deterioration including renal, respiratory, cardiac, and hepatic disease, diabetes mellitus, endocrine, metabolic or hematological disturbances unless well controlled, and malignancy not in remission for more than two years 10. use of psychotropic drug or any other drug or supplement that may significantly affect cognitive functioning during the month prior to psychometric testing. 11. use of any experimental medication within 1 month prior to screening or as concomitant medications. 12. subject has a history of hypersensitivity or allergy to fish or fish oil or soy.
paclitaxel, cisplatin,5-fu vs. radiotherapy plus paclitaxel, cisplatin as preoperative therapy for locally advanced esc

Conditions: Esophageal Cancer Stage IIB; Esophageal Cancer Stage III

Summary: this is a phase iii clinical trail which comparing paclitaxel, cisplatin plus 5-fu (tcf) versus radiotherapy with paclitaxel plus cisplatin (tc-rt) as preoperative therapy for locally advanced esophageal squamous cancer. the preoperative chemoradiotherapy with radical surgery is the standard treatment in china. but, many patients do not receive this treatment for many other reasons. most of them refused or abandon radiotherapy because of the intolerable adverse effects of radiotherapy, so we have launched a randomized controlled trial to confirm the non-inferiority of tcf over chemoradiotherapy with tc (tc-rt) as preoperative therapy for locally advanced esophageal squamous cancer in overall survival.


Eligibility criteria:
inclusion criteria: * histologically proven squamous cell carcinoma. * all lesions are located in the thoracic esophagus. * clinical stages iib and iii (excluding t4) based on the 7th uicc-tnm classification. * 20-75 years old. * ecog performance status of 0 or 1. * measurable lesions not required. * no prior therapy against esophageal cancer except for complete resection by endoscopic mucosal resection/endoscopic submucosal dissection with either pm1/m2 disease or pm3 disease without vascular infiltration. * no prior chemotherapy, radiotherapy or hormonal therapy against any cancers * adequate organ function. * written informed consent. exclusion criteria: * synchronous or metachronous double cancers, except for intramucosal tumor curatively resected by local therapy. * active infection requiring systemic therapy * positive hepatitis b surface antigen and hepatitis b core antigen or human immunodeficiency virus antibody.(only positive hepatitis b surface antigen should receive anti-virus treatment during study) * pregnant or lactating women or women of childbearing potential. * patients requiring systemic steroid medication. * iodine hypersensitivity. * psychiatric disease. * hypersensitivity for cremophorel. * poorly controlled diabetes. * severe emphysema or pulmonary fibrosis. * poorly controlled hypertension. * unstable angina within 3 weeks or with a history of myocardial infarction within 6 months.

Keywords: preoperative chemotherapy preoperative chemoradiotherapy clinical trial phase iii esophageal squamous cancer
neuropathic pain caused by radiation therapy

Conditions: Neuropathic Pain Secondary to Radiation Therapy

Summary: to investigate if topical amitriptyline 2%, ketamine 1%, and lidocaine 5% in pluronic lecitine organogel (akl in plo gel) can improve management of neuropathic pain from radiation skin reactions adjunctively or better than standard treatment.

1. topical amitriptyline and ketamine and topical lidocaine alone have been shown to improve management of neuropathic pain in nonmalignant subjects. anecdotal experience has shown improvement in use of all three topical drugs combined in radiation skin reactions. there currently is no research evidence for the use of all three compounded interventions. this study aims to target subjects with pain from radiation therapy who are not receiving adequate relief with standard interventions and may be eligible to receive this alternate intervention. 2. hypothesis:topical akl in plo gel can effectively and safely reduce neuropathic pain experienced by patients with radiotherapy induced skin reactions. 3. justification: standard treatment of painful radiation skin reactions such as moist desquamation consists of saline soaks, silver sulfadiazine and oral analgesics. however, sometimes the pain exceeds this standard intervention, patients are sulfa allergic or patients are intolerant to oral analgesics such as opioids. akl in plo gel is targeted for neuropathic pain and may be used alternatively to standard interventions. the participation rate will help to further estimate the feasibility of a larger sample size study to look at efficacy.

Eligibility criteria:
inclusion criteria: * age greater or equal to 18 years with ability to provide written informed consent. * subjects currently receiving radiation therapy or having completed radiotherapy in less than 4 weeks from study entry, who have developed skin reactions that are painful. * radiation skin reaction pain has qualities of burning as scored on uwnps of 1 or more * skin toxicity assessment tool showing dry desquamation or worse * presence of objective dynamic allodynia and/or pinprick hyperalgesia as assessed by physician * subjects show less than 1 point decrease in uwnps after 2 days of using standard intervention. * subjects are allergic or intolerant to standard intervention. * subjects must be available by telephone 2 and 6 weeks after rt treatment is completed. exclusion criteria: * allergy to amitriptyline, ketamine or lidocaine * untreated severe major depression * ongoing use of monoamine oxidase inhibitor * pain from another source as severe or greater than the pain under study * evidence of another type of neuropathic pain not included in this study. * normal cognitive and communicative ability as judged by clinical assessment and ability to complete self-report questionnaires * not pregnant or breastfeeding