Kornimate/medical-research-clean huggingface dataset:
the elegant trial: elevate transvaginal mesh vs. anterior colporrhaphy

Conditions: Pelvic Organ Prolapse

Summary: this study is designed to compare the safety and efficacy of a commercially available mesh kit used for surgical repair of anterior vaginal wall prolapse with traditional suture repair surgery.

this is a multicenter, double blinded, randomized controlled trial, comparing elevate® system with interpro® lite™, anterior and apical prolapse repair system (american medical systems) and anterior colporrhaphy (anterior suture repair) in women with symptomatic pelvic organ prolapse, who have opted to have surgical repair. the goals of the study are to compare both efficacy and safety of the two procedures and to compare the surgical impact of mesh and suture repairs on vaginal function. the principal investigator is from mayo clinic in rochester, minnesota. mayo clinic will serve as the data gathering and coordination site for this multicenter trial.

Eligibility criteria:
inclusion criteria: * women with symptomatic pelvic organ prolapse who opt for a vaginal repair * require both apical and anterior compartment repairs * willing to return for follow-up visit * understand and have signed informed consent to undergo randomization * need both an apical and anterior repair * all trial participants who have a uterus will require a hysterectomy exclusion criteria: * known or suspected vulvodynia * known or suspected interstitial cystitis * history of chronic pelvic pain * current pregnancy * desire to maintain fertility * history of reconstructive pelvic surgery with synthetic mesh * history of radical pelvic surgery * history of pelvic radiation therapy * currently undergoing treatment for a malignancy * medically poor candidates for surgery

Keywords: cystocele bladder prolapse anterior prolapse vaginal prolapse uterine prolapse urinary incontinence
aevicemd for detection of wheeze in pediatric and adult populations

Conditions: Subject Presenting Wheeze; Asthma; Bronchial Disease; Respiratory Tract Diseases; Pediatric Asthma; Chronic Respiratory Disease

Summary: respiratory signs and symptoms consisting of wheeze, cough, and breathlessness are obtained in a manual fashion through history taking and physical examination by the healthcare professional. auscultation of the lung assesses airflow through the trachea-bronchial tree and is helpful in diagnosing various respiratory disorders. aevicemd is a wearable device that can acquire and process lung sounds, thus assisting in the detection of abnormal lung sounds. the primary objective of this study is to determine if aevicemd can detect wheeze of pediatrics and adults as accurately as a physician through auscultation. the secondary objective is to investigate if aevicemd can be used for remote auscultation of breath sounds.


Eligibility criteria:
inclusion criteria: * the subject is willing and/or parents/guardians are able to give informed consent for participation in the study. * male or female, aged ≥ 3 years. * diagnosed with acute asthma exacerbation by an ed provider. exclusion criteria: * any other significant disease or disorder which, in the opinion of the investigator, may either put the subjects at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study.

Keywords: wheeze auscultation wearable medical device
the relationship between morbid obesity and carotid artery stenosis

Conditions: Carotid Artery Diseases; Morbid Obesity; Metabolic Syndrome

Summary: the correlation between metabolic syndrome and carotid artery stenosis is well established. the purpose of this study is to evaluate the relationship between morbid obesity and carotid artery stenosis.

the investigators hypothesis is that there is a direct relationship between morbid obesity and carotid artery stenosis. the investigators hypothesize that metabolic/bariatric surgery improves the stenosis in the carotid artery. this is a prospective comparative study on the candidates for metabolic/bariatric surgery in the bariatric center, emek medical center, afula, israel. the investigators will compare the candidate for metabolic surgery with metabolic syndrome risk factors to the ones without metabolic syndrome risk factors. the assessment of the carotid artery will be done by ultrasound doppler before surgery and 6, 12 and 24 month post surgery.

Eligibility criteria:
inclusion criteria: • candidates for first bariatric surgery exclusion criteria: * smokers or past smokers * patients who are post carotid artery intervention

Keywords: morbid obesity carotid stenosis metabolic syndrome
magnetic stimulation as a treatment for auditory hallucinations in schizophrenia

Conditions: Schizophrenia

Summary: schizophrenia is a chronic, severe, and disabling brain disease. auditory hallucinations are the most frequent symptoms with an incident of 50% to 70% in patients. transcranial magnetic stimulation (tms) can significantly reduce symptoms of schizophrenia. tms is capable of inducing changes in the electrical activities of the brain in humans. the purpose of this trial is to study the use of tms to decrease auditory hallucinations in schizophrenia.

we hypothesize that: true treatment with rtms will have significant decrease in auditory hallucinations versus sham treatment over the temporoparietal cortex. fmri will highlight areas of activation with auditory hallucinations distinct from the area identified by hoffman's scalp based method. cortical inhibition as measured by paired pulse tms will be increased after true tms but not sham tms.

Eligibility criteria:
inclusion criteria: * schizophrenia * auditory hallucinations occuring more than 5 times per day * adequate (6 weeks) trial of antipsychotic medication * including at least 1 atypical antipsychotic medication * medication stable for 4 weeks prior to commencement of the study * competent to consent exclusion criteria: * history of seizure disorder in patient or first degree relative * recent head injury * acute suicidality * alcohol or substance abuse * implanted pacemaker or metal in head or neck * pregnancy

Keywords: transcranial magnetic stimulation paired pulse
combination of thrombopoietin mimetic and immunosuppressive therapy in aplastic anaemia

Conditions: Aplastic Anemia

Summary: to the investigator's knowledge this is the first study that will assess treatment with thrombopoietin mimetic plus immunosuppressivetherapy in egyptian patients with aplastic anaemia. aim of the work : 1. to evaluate the efficacy, tolerability and toxicity of the combination of thrombopoietin mimetic and immunosuppressive therapy in egyptian patients with aa. 2. to study the influence of this combination on patients' quality of life. 3. to access evolution to paroxysmal nocturnal hemoglobinuria (pnh), myelodysplastic syndrome , acute leukemia or development of fibrosis

aplastic anemia (aa) is a bone marrow failure syndrome that, although benign in nature, it influences patients' quality of life and carries poor prognosis.the pathophysiological basis of development of acquired aa include immune-mediated attack, inherent hematopoietic stem cell insufficiency and telomere defects. bone marrow transplantation (bmt) is the only curative treatment for aa. unfortunately it is unavailable for many patients due to lack of matched donors furthermore others are ineligible for bmt due to old age or co-morbid conditions. immunosuppressive therapy was the mainstay of treatment for aa for many years, however many patients developed resistance or refractoriness. immunosuppressive therapy was in the form of antithymocyte globulin (atg) which gave hematologic response in nearly 50% of patients , adding cyclosporin a increases this response to 70%. why some patients became resistant to immunosuppressive therapy ? the answer is not known. thrombopoietin mimetic (eltrombopag) was firstly fda approved for treatment of immune thrombocytopenic purpura. numerous clinical trials proved the efficacy of anthropometric mimetic in patients with refractory severe aa, leading to its fda approval for this group of patients. some researchers proven the efficacy of thrombopoietin mimetic in patients with moderate aplastic anemia. this study aimed to asses the combination of thrombopoietin mimetic and immunosuppressive therapy in patients with aa.

Eligibility criteria:
inclusion criteria: * eligible for treatment with thrombopoietin mimetic. * willing to participate in the study and signed informed consent. * unavailability of bmt - exclusion criteria: * patient with inherited aplastic anemia * underlying immune deficiency * contra indication to cyclosporin a * endstage hepatic or renal disease * pregnancy and lactation

Keywords: thrombopoietin mimetic egyptian aplastic
randomized controlled study for analyzing clinical benefit of pain focused sedation with combination of fentanyl and propofol during endoscopic retrograde cholangiopancreatography (ercp)

Conditions: Endoscopic Retrograde Cholangiopancreatography

Summary: the investigators study is the randomized controlled study for analyzing clinical benefit of pain focused sedation with combination of fentanyl and propofol during endoscopic retrograde cholangiopancreatography (ercp). the investigators will assess recovery time and adverse effect during ercp as the primary end point between two group. the investigators will also access satisfaction score for endoscopist and patients as the secondary end point.


Eligibility criteria:
inclusion criteria: * the patients who scheduled for ercp exclusion criteria: * the patients with asa physical classification v * the patients with history of sulfite, egg or soy bean allergy * the patients during pregnancy or latency period * the patients who informed consent could not be obtained * the patients who were under 20 years old

Keywords: ercp sedation fentanyl propofol
the efficacy of pyridostigmine therapy after transurethral resection of prostate in cases with underactive urinary bladder.

Conditions: Underactive Bladder; TURP(transurethral Resection of Prostate); BPH (Benign Prostatic Hyperplasia)

Summary: the efficacy of pyridostigmine therapy after transurethral resection of prostate in cases with underactive urinary bladder

underactive bladder is a decrease in detrusor contraction and/or shortening of the contraction time, resulting in an incomplete and/or prolongation of the bladder emptying within the normal time frame. prolonged bladder outlet obstruction due to prostatic enlargment one of the main causes of bladder hypocontractility. to make a diagnosis, it is necessary to perform a pressure-flow study. decrease in maximum urine flow rate related to bladder outlet obstruction or poor contractility can be distinguished by pressure-flow study. parasympathomimetics (cholinergic receptor stimulating agents) could be beneficial for patients with underactive bladder. however, no systematic review with meta-analysis addressing potential benefits or adverse effects exists. pyridostigmine is a medication used to treat myasthenia gravis and underactive bladder as well. patients with underactive bladder after transurethral resection of prostate may still complain of recurrent attacks of obstructive lower urinary tract symptoms.

Eligibility criteria:
inclusion criteria: * patients who are not younger than 45 or older than 75 years. * patients with benign prostatic hyperplasia who are eligible for transurethral resection of prostate. * patients who has decreased bladder contractility confirmed by urodynamic study (pressure flow study) and plotted on international continence society (ics) nomogram. exclusion criteria: * patients younger than 45 or older than 75 years. * patients who have diabetes. * patients with a history of neurological diseases. * patients with a previous history of pelvic surgery.

Keywords: bph turp underactive bladder pyridostigmine
the predictive value of coronary artery calcium score

Conditions: Coronary Artery Disease

Summary: in this analytical prospective study 498 patients over 40 years with any cardiovascular symptoms and without pre-established coronary artery disease ( cad) were enrolled. patients underwent ct scans to measure coronary artery calcium score (cacs), and total calcium scores were recorded. then, conventional coronary angiography was performed for all the participants as the gold standard for diagnosing cad (defined as at least one stenotic coronary artery with ≥ 50%). framingham risk score (frs) was also estimated for all the patients

in this prospective study 498 patient who referred to cardiology clinic with any cardiac symptoms and positive noninvasive tests without preestablished coronary artery disease ( cad), were enrolled. all the patients underwent coronary artery calcium score (cacs) testing, and total calcium scores were recorded. a calcium score of zero was considered as having very low risk for cad. a score of 1 to 99 was defined as having low risk, 101 to 299 as having intermediate risk, and 400 or more as having high risk for cad. then, invasive (conventional) coronary angiography by radial access, as the gold standard for the diagnosis of cad, was performed for all of the involved participants. coronary artery stenosis equal to or more than 50% was considered as a significant narrowing \[25\]. patients with at least one diseased coronary artery with a significant narrowing were considered to have cad. minor branches were considered only if their main supplying branch was not diseased. a group of expert interventional cardiologists performed and reported coronary angiographies. the study was single-blind; cardiologists were unaware of the results of cac scores when performing conventional coronary angiographies

Eligibility criteria:
inclusion criteria: * age over 40 years, having cardiovascular symptoms (including chest pain, dyspnea on exertion, etc.), and positive primary non-invasive tests, such as myocardial perfusion imaging (mpi) or exercise tolerance test (ett) exclusion criteria: * previously diagnosed coronary artery disease * cerebrovascular accident (cva) * peripheral artery disease * pregnancy * medical instability * hypersensitivity to contrast materials * having atrial fibrillation

Keywords: coronary artery disease coronary calcium score cardiovascular risk score
written communication in the intensive care unit

Conditions: Communication; Satisfaction, Patient; Burnout

Summary: the goal of this study is to compare the experience of intensive care unit (icu) families and care providers before and after the implementation of an approach whereby clinicians initiate written communication with families the main questions it aims to answer are 1. is icu care-provider initiated written communication feasible and acceptable to participants? 2. does icu care-provider initiated written communication affect the experience of families and care providers? participants will complete surveys and participate in interviews during a 3 month pre-implementation phase and a 3 month post-implementation phase


Eligibility criteria:
inclusion criteria (family members or surrogates) • self-identify as one of the patient's decision makers exclusion criteria (family members or surrogates) * cannot read or understand english * unwilling to participate in study procedures inclusion criteria for care providers (physicians, physician assistants, and nurses) • work during the day shift exclusion criteria for care providers (physicians, physician assistants, and nurses) • none
epidemiological observation from a smartphone self-monitoring application for suspected covid-19 patients' triage

Conditions: COVID-19

Summary: a coronavirus pandemic began on 12/31/2020 with the first chinese patient. as of 3/16/2020, the epidemic affects more than 100 countries with 169,000 official infections and 6,500 deaths. this virus causes a pathology ranging from simple flu symptoms in 80% of cases to acute respiratory distress syndromes requiring resuscitation in 5% of cases and a death rate of 1.4 to 4% of cases. the arrival in france on 02/25/2020 with an exponential development of the infection (more than 5,000 cases on 03/15/2020) was accompanied by an unprecedented number of calls to the french emergency service call number (15) of worried patients with overload and sometimes saturation of the service that can impact calls and the care of patients really recovering from an emergency. we previously developed a moovcare® web application which showed a 7 months survival benefit by early detection of relapsed lung cancer based on the reporting of patient symptoms analyzed by a validated algorithm in 300 patients and 1 trial randomized. another application for detecting and monitoring chemo-induced febrile aplasia appears to show a reduction in the number of hospitalizations for sepsis. finally, smokecheck, a self-assessment application for symptoms by smokers, has shown that it improves the detection of symptomatic operable bronchial cancers (9 to 24%, p = 0.04). the web application https://www.maladiecoronavirus.fr/ was developed with a group of physicians from the institut pasteur, hospitals group of paris, hospitals of lille and rennes and the ilc jean bernard in le mans. it makes it possible to guide symptomatic patients and patients who wishing to know what to do (call their general practitioner, teleconsultation, or call emergency service) based on symptoms and predictive factors of severity. following the availability of this new tool, we want to assess the impact of the application on the number and relevance of calls to emergency service.


Eligibility criteria:
inclusion criteria: * all users of the https://www.maladiecoronavirus.fr/ application over the age of 18 exclusion criteria: * not applicable

Keywords: m-health covid-19 self-assessment application epidemiology symptoms
study of sb-497115 in healthy subjects and subjects with mild, moderate or severe renal impairment

Conditions: Purpura, Thrombocytopaenic, Idiopathic

Summary: the main purpose of this study is to compare how one 50 mg tablet of sb-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe kidney problems. the study is also being done to 1) check on how well the study drug is tolerated by healthy subjects versus those with liver problems and 2) to check if liver impairment affects how the study drug binds to protein in the blood.


Eligibility criteria:
inclusion criteria: * healthy or have renal impairment * females (the following requirement applies only if able to have children): agree to doctor approved birth control methods, or partner has had a vasectomy * negative drug, alcohol, and hiv tests. exclusion criteria: * taking a medication or therapy not approved by the study doctor * rapidly changing kidney function * drug or alcohol abuse within past 6 months * used an investigational drug in the past 30 days * females who are pregnant or nursing * have active hepatitis b or c

Keywords: renal impairment, chronic immune thrombocytopenia purpura, thrombocytopenia, chemotherapy induced thrombocytopenia
impact of hand grip strength on length of hospital stay after cardiac surgery among elderly patients

Conditions: Sarcopenia; Frailty

Summary: hand grip strength has been shown to be a predictor of adverse cardiovascular outcomes in the elderly population. this study aims to investigate whether measurement of hand grip strength could be used as a predictor of prolonged hospital stay after cardiac surgery in elderly patients.


Eligibility criteria:
inclusion criteria: * age ≥70 years * undergoing isolated coronary artery bypass grafting or isolated valve surgery or combined coronary and valve procedures * being oriented and cooperative enough to understand and comply with the instruction of gripping the hand dynamometer exclusion criteria: * age \<70 years * emergent status * hemodynamic instability * inability to cooperate due to neurocognitive disorder * loss of upper extremity motor function of any degree (such as due to previous stroke) * history of upper extremity amputation of any level
individualized exercise combined with manual therapy in severe hemophilia patients with polyarthropathy

Conditions: Severe Hemophilia

Summary: the aim of this study is to investigate the effect of individualized physical therapy, combined manual therapy and exercise intervention, for pain perception, range of motion (rom), muscle strength, joint health, cardiopulmonary endurance and quality of life (qol) in patients with severe hemophilia a and multiple hemophilic arthropathy.

the main clinical manifestations of hemophilia are muscle and joint bleeding. recurrent bleeding leads to a degenerative process known as hemophilic arthropathy. past studies investigated the effect of manual therapy of exercise for individuals with hemophilia and found to enhance muscle strength, balance, fitness and promote quality of life. however, less study has evaluated the safety and effectiveness of manual therapy combined with exercise for individuals with multiple hemophilic arthropathy. therefore, the aim of this study is to investigate the effect of individualized physical therapy, combined manual therapy and exercise intervention, for pain perception, range of motion (rom), muscle strength, joint health, cardiopulmonary endurance and quality of life (qol) in patients with severe hemophilia a and multiple hemophilic arthropathy.

Eligibility criteria:
inclusion criteria: * over 20 years old and diagnosed with severe hemophilia * those who receive prophylaxis regularly * there are more than 2 target joints (hemophilic arthropathy) exclusion criteria: * unwilling to sign the informed consent * any neurological disease or specific musculoskeletal condition (such as fracture) one year ago * more than 3 (excluding 3) joint replacement surgeries (different joints) * unable to walk due to hemophilia joint disease or any other diseases * major bleeding events that pose risks or hinder research * unable to follow instructions due to cognitive impairment

Keywords: physiotherapy manual therapy exercise
reorganization of the healthcare system during covid-19 pandemic: impact on management of patients with exocrine pancreatic cancer

Conditions: Pancreatic Adenocarcinoma

Summary: pancreatic adenocarcinoma will be the 2nd cause of death by cancer in europe in 2030. pancreatic adenocarcinoma has poor prognosis with an all-stages combined 5-year survival rate below 8%. since december 2019, a new coronavirus (severe acute respiratory syndrome corona virus 2, sars-cov-2) is responsible of covid-19 infection with potentially severe respiratory syndrome or even multi-organ failure. an increased risk of severe covid-19 infection in cancer patients is suggested in several chinese series. cancer care structures quickly reorganized to limit high-risk situations (diagnostic procedure, major surgery, cytotoxic poly-chemotherapy) and use alternatives such as on-hold chemotherapy. these reorganizations could be associated with a loss of chance for pancreatic adenocarcinoma.

the aim of this study is to study impact of reorganization of the healthcare system during covid-19 pandemic on pancreatic adenocarcinoma patients management

Eligibility criteria:
inclusion criteria : 1. aged 18 or over, 2. with pancreatic adenocarcinoma diagnosed by anatomopathological specimen or without biopsy but with suspicion of pancreatic adenocarcinoma in presence of imaging techniques or ca19.9 level without evidence for neuroendocrine tumor, 3. assessed during multidisciplinary meeting in one participating center between 01/09/2019 and 31/10/2020, 4. accepting to participate to the study, 5. with or without sars-cov-2 infection. exclusion criteria : 1. with neuroendocrine neoplasia 2. for whom histology showed non pancreatic 3. with cystadenoma or ipmn without invasive adenocarcinoma

Keywords: pancreatic adenocarcinoma patient management healthcare system reorganization sars-cov-2