Kornimate/medical-research-clean huggingface dataset:
a novel non-interfering arterial blood pressure monitoring device

Conditions: Hypertension; Hypotension; Healthy

Summary: the primary purpose of this investigation is to validate the performance and safety of the investigational device (id) against a validated and legally cleared device for measuring blood pressure (bp). the secondary purpose is to validate the performance of the id over a period of 24 hours against a validated and legally cleared device for ambulatory blood pressure monitoring (abpm).

the clinical investigation is conducted as a controlled (subject as own control), prospective, randomised, comparative investigation in a population with a representative spread of bps to ensure that the id performs as good as current marketed and approved devices. the study will be conducted in compliance with the international standard ansi/aami/iso 81060-2 - non-invasive sphygmomanometers - clinical validation of automated measurement type. this clinical investigation will enrol up to 96 male and female subjects to ensure the recording of 85/35 evaluable datasets in accordance with the ansi/aami/iso standard \[11\]. all measurements will be paired and falls into 2 categories: auscultatory measurements as gold standard reference, oscillometric measurements for clinical practise reference and further validation of ambulatory monitoring and pulse shape measurements.

Eligibility criteria:
inclusion criteria: * at least 30% of the subjects must be males (n=29) * at least 30% of the subjects must be female (n=29) * age ≥ 18 years old * limb size circumference ≥ 17 cm * blood pressure distribution: * at least 25 % of the subjects should be hypertensive * at least 5 % of the subjects should be hypotensive exclusion criteria: * breached skin * acknowledged pregnancy * pacemaker * diagnosed cardiac arrhythmia (tachycardia, bradycardia, atrial/ventricular fibrillation) * implanted metal in upper limb: * elbow prosthesis * shoulder prosthesis * metal screws * bone plates * metal chips * surgical clips * implantable cardiac defibrillator (icd) * cardiac resynchronization therapy - defibrillator (crt-d) * premature ventricular contractions (pvc) * premature arterial contractions (pac) * sensitivity or allergy towards adhesives * presence of an arterial-venous shunt * recent axillary node dissection
implementation of a qsofa score in the emergency department

Conditions: Sepsis

Summary: the quick-sofa score (qsofa), identifies septic patients with a mortality risk higher than 10%. in our study all adult patients coming to the emergency for suspected infection are screened according to the qsofa score on arrival. if qsofa ≥ 2, the patient should be referred to emergency vital room, if the score \<2, the patient will be in the box. the objectives are : 1) to evaluate the mortality at 28 days with the orientation, 2) to compare support time of medical contact and initiation of antibiotics according to the orientation in the emergency department.


Eligibility criteria:
inclusion criteria: * body temperature below 36 °c or above 38 °c * require hospitalization exclusion criteria: * hospital transfer, * patients with pre hospital care * language barrier, * refusal to participate

Keywords: screening qsofa sepsis emergency care unit
the effect of clindamycin and a live biotherapeutic on the reproductive outcomes of ivf patients with abnormal vaginal microbiota

Conditions: Bacterial Vaginoses; Infertility, Female

Summary: study question: does antibiotic alone or in combination with live biotherapeutic treatment of an abnormal vaginal microbiota improve the reproductive outcomes of ivf couples? study hypothesis: the investigator hypothesize that treatment of the reproductive tract pathogens and restoration of vaginal lactobacillus will improve the reproductive outcomes of ivf patients. what is known already? ultra-deep sequencing methods enable the refinement of reproductive tract microbiology in infertile patients. a recent meta-analysis reported that 19% of infertile patients had abnormal vaginal microbiota moreover, someone have detected the presence of a gardnerella (g.) vaginalis dominated endometrial biofilm in 50% of non-infertile patients with abnormal vaginal microbiota undergoing curettage; thus the treatment of such an endometrial biofilm might play an important role for the endometrial receptivity and subsequently the clinical pregnancy rate. pilot study: in a recent pilot study it was observed that an abnormal vaginal microbiota negatively affects the clinical pregnancy rate in ivf patients. in this study the prevalence of abnormal vaginal microbiota was 28% (36/130) and only 9% of patients with qpcr defined abnormal vaginal microbiota obtained a clinical pregnancy (p=0.004). this association remained significant in an adjusted analysis. furthermore, the invetigators have preliminary results demonstrating that vaginal bacteria such as g. vaginalis can be found in the endometrium of ivf patients, which is also supported by recent publications what is the novelty of this study? to the investigators knowledge, no previous treatment study of abnormal reproductive tract microbiota has been performed in ivf patients; this relatively small intervention holds the potential to increase the baby-take-home rate after ivf treatment.


Eligibility criteria:
inclusion criteria: * abnormal vaginal microbiota. * the screening swab should be repeated if more than 3 months old. * hiv, hepatitis b or c positivity. * first, second or third ivf stimulation cycle or embryo transfer therefrom. * bmi\<35 * written informed consent. exclusion criteria: * known or suspected hypersensitivity to clindamycin. * hpv cin 2 or higher. * former or current inflammatory bowel disease * severe concomitant disease, including diabetes. * max 2 embryos may be transferred * artificial heart valve * intrauterine malformations with operation indication as determined by treating physician (polyps, septum, fibroma)
open-label lesinurad monotherapy extension study in gout

Conditions: Gout

Summary: this study will assess the serum uric acid lowering effects and safety of lesinurad over a long-term timeframe.

this is a phase 3, open-label, uncontrolled, extension study to assess the long-term efficacy and safety of lesinurad monotherapy in subjects who completed the double-blind treatment period in study rdea594-303.

Eligibility criteria:
inclusion criteria: * subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity. * subject completed the double-blind treatment period in study rdea594-303 and was actively receiving and tolerating study medication (lesinurad or placebo) at month 6 visit. * subject is willing to adhere to the visit/protocol schedules. * subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth control during the study and for at least 14 days after the last dose of study medication. exclusion criteria: * subject has any other medical or psychological condition, which in the opinion of the investigator and/or the medical monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or to complete the study. * subject has a past medical history of urolithiasis, nephrolithiasis, or kidney stone diathesis. * subject developed kidney stones during study rdea594-303
post-marketing safety monitoring program of fluticasone propionate (fp) in chinese subjects with asthma aged 1 to <4 years

Conditions: Asthma

Summary: for the prophylactic treatment of asthma, fp inhaled aerosol (flixotide ®) administered via a pressurized metered-dose inhaler (pmdi) was approved in china in adults, adolescents older than 16 years of age and children aged 4 to 16 years. this post-marketing safety monitoring program will evaluate the safety profile of fp 50 micrograms (µg) inhaled via a pediatric spacer device with a face mask in chinese subjects aged 1 to \<4 years. the adverse drug reactions (adrs) and predictors of these adverse reactions among subjects will be reported. this single arm observational study will include subjects prescribed with fp 50 µg inhaled via a pediatric spacer device with a face mask. the maximum duration of the study will be 12 weeks with 3 visits. visit 1 (day 1) will be on-site visit and will also mark the start of the observational program. the follow-up visits will be scheduled at visit 2 (week 4), and visit 3 (week 12) conducted on site or by telephone. a total of 150 asthmatic subjects who have been prescribed fp 50 µg treatment for appropriate medical use for the first time in china will be enrolled in the study. flixotide is a registered trademark of glaxosmithkline (gsk) group of companies.


Eligibility criteria:
inclusion criteria: * an appropriately signed and dated assent must be obtained from the parent/guardian of the subject. * subjects with 1 to \<4 years of age at visit 1. * subjects who have been prescribed flixotide 50 µg for a medically appropriate use for the first time will be included in this observational program; flixotide 50 µg therapy should be in line with the approved dosing: 50 to100 µg twice daily; subjects should have the ability to inhale the doses via a pediatric spacer with a face mask appropriately; subjects who have been exposed to flixotide 50 µg, 125 µg and 250 µg treatment previously will not be included. * the parent/guardian of the subject must provide reliable contact information which includes home phone or cell phone for the follow up visits. * the parent/guardian of the subject must have the ability to comply study procedures. * specific information regarding warnings, precautions, contraindications, aes, and other pertinent information on flixotide 50 μg that may impact subject eligibility is provided in the approved product label. exclusion criteria: -

Keywords: cci18781 observational post-marketing fluticasone propionate asthma
reverse shoulder prosthesis prospective multi-center study

Conditions: Rotator Cuff Deficiency; Shoulder Arthropathy; Failed Shoulder Replacement

Summary: the purpose of this study is to evaluate the use and efficacy of the reverse® shoulder prosthesis for treatment of rotator cuff deficiency in subjects who are candidates for a total shoulder replacement (primary and revision subjects).

reverse shoulder arthroplasty for the treatment of rotator cuff deficiency and glenohumeral arthritis have shown favorable outcomes in pain and function over the short and medium term. a prospective, multi-center study on the outcomes of subjects treated with the rsp would be a valuable addition to the literature and give important information regarding an ever-increasing treatment option for subjects with rotator cuff deficiency. the study will take place at multiple sites across the united states and will be managed by the djo surgical clinical affairs department. the study will include only subjects who meet the indications for use criteria for the reverse® shoulder prosthesis and who are candidates for total shoulder replacement surgery.

Eligibility criteria:
inclusion criteria: * subject must be a candidate for a total shoulder joint replacement * subject must be diagnosed with one or more of the following conditions: irreparable rotator cuff tear with gleno-humeral arthritis; failed rotator cuff surgery with gleno-humeral instability or antero- superior escape; failed shoulder replacement surgery * subject has a functional deltoid muscle * subject's joint must be anatomically and functionally suited to receive the selected implant * subject is 60 years of age or older (≥ 60 yrs of age) at time of consent * subject is likely to be available for all study visits * subject is able and willing to sign the informed consent and follow study procedures * subject is not pregnant exclusion criteria: * subject has a non-functional deltoid muscle * subject has a mental condition(s) that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the subject's cognitive abilities, senile dementia, and alzheimer's disease) * subject is a prisoner * subject has high levels of physical activity (ex. competitive sports, heavy physical labor) * subject is pregnant * subject has an active infection or sepsis * subject has loss of ligamentous structures * subject has a history of alcoholism or other addictions (current or past) * subject has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., parkinson's disease, syringomyelia and multiple sclerosis, charcot joints) * subject has severe glenoid bone loss * subject has known materials sensitivity (to metals) * subject is younger than 60 years of age (\< 60 years of age) at consent
zonisamide in addition to e-cpt-c for veterans with ptsd and comorbid alcohol dependence

Conditions: Alcohol Dependence; Post-Traumatic Stress Disorder (PTSD)

Summary: this is a randomized, controlled trial with 50 veterans diagnosed with post-traumatic stress disorder (ptsd) and comorbid alcohol dependence. veterans will be randomized to receive either zonisamide (400 mg) or placebo for 12 weeks in a double blind fashion. randomization will be done using 3:1 ratio and will be performed by our research pharmacy using a random assignment in blocks of 4- 3 will be assigned to active medication and 1 to placebo. medication will be titrated over a 6 week titration phase followed by a 6 week treatment phase. all veterans will receive e-cpt-c therapy for the 12 weeks of treatment; e-cpt-c will be provided by trained and qualified clinicians with extensive experience providing e-cpt-c. veterans will be recruited primarily through advertisement, but also through the clinical facilities at the va and from other collaborators.


Eligibility criteria:
inclusion criteria: * current alcohol dependence, as determined by a structured clinical interview (structured clinical interview for dsm-iv axis i disorders) (scid) * current ptsd as determined by a structured clinical interview (scid) * veterans with current alcohol dependence, with at least one recent episode of heavy drinking over the past 14 days. * medically and neurologically healthy on the basis of history, physical examination, ekg, screening laboratories * for women, negative pregnancy test and use of acceptable method of contraception exclusion criteria: * females who are pregnant or lactating. * veterans with a current unstable medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology, which in the opinion of the physician would preclude the subject from fully cooperating or be of potential harm during the course of the study * veterans who meet current scid criteria for a major axis i diagnosis (bipolar disorders, schizophrenia and schizophrenia-type disorders). * history of substance dependence (other than alcohol, tobacco or cannabis) by dsm-iv criteria in the last 90 days. * veterans taking mood stabilizers and antipsychotic medications for specific psychiatric disorders. * veterans with a history of allergy to zonisamide. * veterans already receiving cpt.

Keywords: alcohol dependence post-traumatic stress disorder (ptsd) zonisamide cognitive processing therapy (cpt)
regional blocks for postoperative analgesia after video-assisted thoracoscopic surgery

Conditions: Pain, Postoperative

Summary: the aim of this study is to compare serratus anterior plane block and erector spinae plane block for postoperative analgesia after vats as measured by the duration till 1st requirement of analgesia.

video-assisted thoracoscopic surgery has become the standard surgical procedure for both minor and major oncological lung surgery, as it is considered less invasive and equally effective compared with thoracotomy . however, it is a fact that pain following vats can be severe and long-lasting. according to homma et al., 18.8% of patients who undergo vats present with persistent pain 2 months after surgery. serratus anterior plane block is a type of interfascial plane block that was defined by blanco and his colleagues in 2013 .ultrasound-guided sapb has recently gained the interest of the anesthesiologists and pain physicians due to its efficacy, relative ease, single-injection method with limited side-effect profile. the sapb targets the lateral cutaneous branches of the thoracic intercostal nerves, which arise from the anterior rami of the thoracic spinal nerves and run in a neurovascular bundle immediately inferior to each rib. at the midaxillary line, the lateral cutaneous branches of the thoracic intercostal nerve traverse through the internal intercostal, external intercostal, and serratus anterior muscles innervating the musculature of the lateral thorax.these branches of the intercostal nerves, therefore, travel through the two potential spaces described above. local anesthetic inserted into these planes will spread throughout the lateral chest wall, resulting in paresthesia of the t2 through t9 dermatomes of the anterolateral thorax. erector spinae plane block is an interfascial plane block that was defined by forero and colleagues in 2016. erector spinae plane block has a wide indication range for pain management of the thoracic, abdominal , lumbar, hip, and even shoulder areas . erector spinae plane block is a paraspinal block that targets the dorsal and ventral rami so that it can provide analgesia in the anterolateral and posterior chest wall . erector spinae plane block emerged in recent years to be effective in reducing postoperative pain at 24 h, i.e. preoperative espb plus intravenous opioid reduced pain scores and opioid consumption after vats when compared with intravenous fentanyl only .

Eligibility criteria:
inclusion criteria * patients with american society of anesthesiologists (asa) physical status 1-3 -- * scheduled for vats . exclusion criteria: 1. ≤20 or ≥80 years old. 2. refusing to participate in the study . 3. history of allergy to the medications used in the study. 4. contraindication to regional anesthesia (including coagulopathy and local infection). 5. severe hepatic impairement (serum protein \ 3mg/dl) . 6. renal dysfunction (as determined by creatinine levels greater than 2mg/dl or predicted creatinine clearance (clcr)\<50ml/min). 7. psychiatric disorder. 8. pregnancy. 9. body mass index (bmi) ≥40 or ≤18 kg/m2.
effects of ferrous sulfate on the pharmacokinetics of akb-6548

Conditions: Healthy Volunteers

Summary: the primary purpose of this study is to assess the single-dose bioavailability of akb-6548 with ferrous sulfate relative to akb-6548 in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy male subjects 18 to 55 years of age with a body mass index between 18 and 30 kg/m2 * participants and their partners must use a highly effective form of contraception during the study and for 1 month following discharge from the clinical research unit (cru) * subjects must discontinue all iron preparations for 14 days prior to study drug administration exclusion criteria: * current or past history of cardiovascular, cerebrovascular, pulmonary, renal or liver disease * positive serology results for hbsag, hcv, and hiv at screening * renal impairment (estimated glomerular filtration rate (egfr) of \<65ml/min) * known active cancer (except non-melanoma skin cancer) or history of chemotherapy use within the previous 24 months * current or past history of gastric or duodenal ulcers or other diseases of the gi tract (including gastric bypass surgeries) that could interfere with absorption of study drug * subjects with a known history of smoking and/or have used nicotine or nicotine-containing products within the past 6 months

Keywords: pharmacokinetics anemia chronic kidney disease ckd chronic renal insufficiency renal impairment ferrous sulfate iron drug-drug interaction end stage renal disease dialysis erythropoietin oral anemia treatment hypoxia-induciable factor hif hypoxia-induciable factor prolyl-hydroxylase inhibitor hif-phi
evaluation of eeg power spectrum in patients with traumatic coma

Conditions: Coma; Brain Injuries, Traumatic

Summary: development of objective, reliable, and convenient assessment methods of disorders of consciousness is crucial. we aim to conduct multicenter prospective observational study and non-invasively collect eeg from patients with traumatic coma to analyze the sequential characteristics of eeg power spectrum, and explore their prognostic value for consciousness recovery.

trauma brain injury is a leading cause of chronic disorders of consciousness (doc), posing significant socioeconomic burdens due to the extensive resources required for long-term medical care. doc patients are clinically categorized into coma, unresponsive wakefulness syndrome (uws) and minimally conscious state (mcs), with the latter further subdivided into mcs- and mcs+. the coma recovery scale-revised (crs-r) remains a cornerstone for diagnosis and assessment of doc, despite its susceptibility to fluctuations caused by various factors such as comorbidities and medication. given these challenges, the development of objective, reliable, and convenient assessment methods of doc is crucial. electroencephalography (eeg) stands out for its accessibility and is recommended by guidelines. the mesocircuit model underscores the role of central thalamic neurons and their frontostriatal connections in maintaining consciousness. based on this mechanism, eeg power spectra were categorized into 4 patterns, i.e. the abcd model, which can be used to understand the varying levels of structural or functional deafferentation that occur in patients with doc. preliminary studies have shown the potential of corticothalamic eeg classification in correlating with crs-r scores and neurological outcomes, suggesting its value in monitoring treatment effects and predicting prognosis. this multicenter prospective observational study aims to enroll patients with traumatic coma, analyze the sequential characteristics of corticothalamic eeg power spectrum, and explore their prognostic value for consciousness recovery.

Eligibility criteria:
inclusion criteria: * coma over 28 days due to closed traumatic brain injury * age above 18 years old * consented by legal representative exclusion criteria: * unstable vital signs * history of mental disorder or neurodegenerative diseases * uncontrolled epilepsy * unable to record scalp eeg * pregnancy

Keywords: coma traumatic brain injury eeg power spectrum