Kornimate/medical-research-clean huggingface dataset:
a study of pembrolizumab (mk-3475) plus carboplatin and paclitaxel as first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma (mk-3475-b10/keynote b10)

Conditions: Squamous Cell Carcinoma of Head and Neck

Summary: the goal of this study is to evaluate the efficacy and safety of pembrolizumab combined with carboplatin and paclitaxel as first-line treatment in participants with recurrent/metastatic head and neck squamous cell carcinoma (r/m hnscc). no statistical hypothesis will be tested in this study.


Eligibility criteria:
inclusion criteria: * has histologically or cytologically-confirmed diagnosis of r/m hnscc that is considered incurable by local therapies * male participants refrain from donating sperm plus are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 95 days after carboplatin/paclitaxel * female participants are not pregnant or breastfeeding and are either not a woman of child-bearing potential (wocbp) or use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after pembrolizumab or 30 days after paclitaxel or 6 months after carboplatin whichever occurs last, and agree not to donate or freeze eggs during this period * has adequate organ function exclusion criteria: * has disease that is suitable for local therapy administered with curative intent * has a life expectancy of less than 3 months and/or has rapidly progressive disease * has a diagnosed and/or treated additional malignancy within 5 years prior to allocation with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, curatively resected in situ cervical cancer and curatively resected in situ breast cancer * has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention * has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention * has known active central nervous system (cns) metastases and/or carcinomatous meningitis * has a history of or current non-infectious pneumonitis/interstitial lung disease that requires steroids * has an active infection requiring systemic therapy * has a known history of human immunodeficiency virus (hiv) infection * has a known history of hepatitis b or hepatitis c virus infection * has had an allogenic tissue/solid organ transplant

Keywords: programmed cell death-1 (pd1, pd-1) programmed death-ligand 1 (pdl1, pd-l1)
study evaluating safety and efficacy of bazedoxifene/conjugated estrogens combinations in postmenopausal women

Conditions: Endometrial Hyperplasia; Osteoporosis

Summary: the purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in postmenopausal women.


Eligibility criteria:
inclusion criteria: * generally healthy, postmenopausal women aged 40 - 75 years inclusive * intact uterus * last natural menstrual cycle (without exogenous hormone therapy) completed at least 12 consecutive months before screening exclusion criteria: * a history or active presence of thrombophlebitis, thrombosis or thromboembolic disorders * a history or active presence of cerebrovascular accident, stroke, or transient ischemic attack * a history or active presence of malignancy, or treatment for malignancy, within the previous 10 years additional criteria applies.

Keywords: menopause
the impact of regional anaesthesia on hormone levels in thoracic surgery.

Conditions: Hormones; Anesthesia, Conduction; Thoracic Surgical Procedure

Summary: basic aspects of thoracic anaesthesia are general anesthesia often combined with regional anesthesia, intubation with double lumen tube and separation of lung ventilation. proper assessment of pain and adequate analgesia in intraoperative and postoperative period is a challenging issue for medical practitioners. intraoperative trauma may lead to many metabolic implications and disturbance of haemostasis, what can be reflected in change of blood and saliva hormone and other substance levels. the aim of this study is to assess the impact of regional anesthesia on hormone levels in patients requiring videothoracoscopic procedures.

basic aspects of thoracic anaesthesia are general anesthesia often combined with regional anesthesia, intubation with double lumen tube and separation of lung ventilation. proper assessment of pain and adequate analgesia in intraoperative and postoperative period is a challenging issue for medical practitioners. intraoperative trauma may lead to many metabolic implications and disturbance of haemostasis, what can be reflected in change of blood and saliva hormone and other substance levels, such as alpha-amylase, cortisol, testosterone, secretory iga, β-endorphin, nerve growth factor, calcitonin gene-related protein and p substance. the aim of this study is to assess the impact of regional anesthesia on hormone levels in postoperative period. saliva was collected from participants in order to perform laboratory tests, using a special disposable salivette tube (sarstedt ag \& co, germany). saliva was collected by placing a sterile tampon under the tongue or chewing for 30-45 seconds. the soaked saliva pad was then placed in a suspended insert with a perforated bottom. the insert with a tampon was placed in a centrifuge tube and closed with a stopper. next the tube was centrifuged (1000 x g for 10 min.) to obtain a ready to test saliva supernatant. approximately 0,7 ml of the supernatant from every sample collected was used for further testing. samples were frozen after centrifugation at - 85°c until performing laboratory tests. blood was collected for laboratory tests from the ulnar vein. blood for testing was collected using disposable equipment in a volume of 5ml into a tube containing ethylenediaminetetraacetic acid (edta) and aprotinin. next the tube was centrifuged (1000 x g for 5 min.). after centrifugation and separation of morphotic elements, the obtained plasma was divided into two tubes and frozen at - 85°c until performing laboratory tests.

Eligibility criteria:
inclusion criteria: -qualification to elective videothoracoscopic procedures and general anaesthesia exclusion criteria: * lack of consent to participation in the study, * significant coagulopathy, * contraindication to the thoracic paravertebral block or drugs used in protocol, * history of chronic pain, * chest wall neoplastic invasion, * previous thoracic spine surgery, * mental state preventing from effective use of pca device, * renal failure (gfr \<60 ml/min/1,73 m2).
atropine vs isoprenaline in the invasive diagnosis of arrhythmias

Conditions: Cardiac Arrhythmia; Supraventricular Arrhythmia

Summary: during electrophysiological study (eps) multiple drugs are used to reveal arrhythmias and/or conductive system disorders. two most often used agents are atropine and isoprenaline. due to their distinct pharmacological properties, they are affecting myocardium in different manner. those dissimilarities can affect the eps course and long-term prognosis. the aim of presented study is to evaluate the optimal protocol of pharmacotherapy during eps.

electrophysiological study (eps) is essential tool for heart rhythm disorders diagnostic. inducibility of arrhythmia before ablation to confirm the diagnosis and inability to do so after the procedure is crucial for long-term success. multiple drugs are used to reveal arrhythmias and/or conductive system disorders. two most often used are atropine and isoprenaline. atropine is a natural, selective antagonist of cholinergic receptors m1 and m2. it reverses the inhibitory effect of vagal nerve on myocardium. this improves sinus node automatism and conduction in atrioventricular node. isoprenaline is a preferential agonist of beta-1-adrenergic receptors. it has bathmotropic and chronotropic effect. during daily clinical practice those two drugs are often used interchangeably. however, differences in pharmacokinetics and pharmacodynamics may affect the results. there are lack of data directly comparing those two agents. there are isolated evidences that arrhythmia inducibility rate after the ablation differs between those two drugs. this may lead to the misconception of ablation as successful. the aim of presented study is to evaluate the optimal protocol of pharmacotherapy during eps.

Eligibility criteria:
inclusion criteria: * patients with indication for electrophysiological study according to present guidelines of european society of cardiology exclusion criteria: * not willing or incapable to give written informed consent. * previous diagnosed ventricle tachycardia or fibrillation * previous diagnosed atrial fibrillation or flutter * glaucoma (contraindication for atropine)

Keywords: electrophysiological study atropine isoprenaline supraventricular arrhythmia ablation
prediction of chronic renal disease after acute kidney injury in the intensive care unit

Conditions: Acute Kidney Injury; Chronic Renal Disease

Summary: the study aims to develop and validate a prediction score of chronic renal disease occurrence within 3 years after icu discharge in patients who suffered an acute kidney failure during icu stay and recovered normal renal function at 90 days following their discharge. the primary study outcome is the incidence of chronic renal disease within the first 3 years after icu discharge, defined by a lower glomerular filtration rate (gfr) under 60 ml/minute/1.73m2.

as second objectives, the study aims to: * evaluate the gfr decline in patients who had an underlying chronic kidney disease. * evaluate factors associated with a persistent decreased gfr at day-90. * characterization the clinical and biological phenotype of chronic renal disease in these patients. * evaluate treatments provided to these patients according to ckd occurence. * evaluate the rate of cardiovascular and thrombo-embolic morbidity-mortality. * assess the quality of life every year for 3 years. * evaluate the medico-economic burden of ckd.

Eligibility criteria:
inclusion criteria: * patient ⩾ 18 years; * patient suffering an acute kidney injury (defined by akin score ⩾1) during icu stay; * patient discharged alive from the icu; * patient's signed consent obtained; * patient covered by a healthcare insurance. exclusion criteria: * pregnant or breastfeeding woman; * sofa score \< 1 (except for kidney assessment) at time of icu admission; * end-stage of renal failure or dialysis treatment or renal transplantation prior to icu admission; * patient treated with dialysis at icu discharge; * immunosuppressive treatment prior to icu admission; * patient under legal incapacity (tutor or guardian protection); * being unable to follow-up of the study; * life expectancy expected shorter than 90 days; * refusal to participate in the study; * patient's main address is outside of il de france region for the centers in this region; * patient \< 18 years; * patient not affiliated to national social security scheme; * patient deprived of liberty by judicial measure.

Keywords: prediction chronic renal disease acute kidney injury
a study investigating the efficacy of various wound closure devices in reducing postoperative wound complications

Conditions: Joint Disease; Arthropathy

Summary: a single-center, phase iv, randomized, prospective study investigating the efficacy of various wound closure devices in reducing postoperative wound complications.

the zipper wound technology is a new wound closure device that is an alternative to the commonly used conventional staples and sutures. the device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin. the other treatment groups include monocryl + dermabond (conventional sutures and skin adhesive glue) and polyester mesh + dermabond. all products have been fda approved. a randomized control trial will provide the highest level of evidence without altering the potential risks to the patient as all three wound closure techniques have been found to have comparable complication rates. the three different treatment devices will be administered following the normal standard of care. all three wound closure devices are currently being used at nyulmc. no modifications to the normal standard of practice other than the randomization process will be implemented. given the nature of the application of the wound closure device, which will be visible to the surgeon at the time of application and the patient postoperatively, the study will not be blinded to either the surgeon or the patient. prior to discharge, a blinded plastic surgeon will be asked to assess the wound based on comesis and overall quality of wound healing.

Eligibility criteria:
inclusion criteria: * patients who are undergoing joint arthroplasty exclusion criteria: * treatment of total joint replacement surgery at an outside institution

Keywords: monocryl dermabond polyester mesh joint disease arthropathy joint replacement
effect of an incubator cover on term and preterm neonates' vital signs

Conditions: Neonatal Disease; Nursing Caries

Summary: the aim of this study is to evaluate the effect of an incubator cover on the vital signs of term and preterm neonates hospitalized in a neonatal intensive care unit. methods: 91 neonates presenting to a neonatal intensive care unit who met the inclusion criteria were included in the study. vital signs of neonates were measured with and without incubator cover. measurements were performed three times (0th, 15th, and 30th minute).

term and preterm are exposed to many stimuli during their stay in the neonatal intensive care unite (nicu). these stimuli; operation and alarm sounds of devices, continuous and high level ambient lighting. these stimuli can cause deviations in the physiological indicators of newborns, and hearing and vision loss. the aim of this study is to evaluate the effect of an incubator cover on the vital signs of term and preterm neonates hospitalized in a neonatal intensive care unit. methods: this study is a prospective repeated measure pretest-posttest repeated-measures design. 91 term and preterm newborns who were hospitalized in the neonatal intensive care unit and met the inclusion criteria were included in this study. neonates were admitted to the study if they satisfied all of the following criteria: (1) term and preterms, (2) admitted to nicu, (3) clinically stable, (4) verbal and written consent from the parent. term and preterm neonates were randomized into two groups (term group = 44, and preterm group = 47 neonates). vital signs of both groups were measured with and without incubator cover. measurements were performed three times (0th, 15th, and 30th minute).

Eligibility criteria:
inclusion criteria: * parents giving verbal and written consent, * hospitalized in the ii. level nicu * those born at 38-42 weeks of gestation * those born at 24-38 weeks of gestation * newborns with a body weight of 1500-2500 grams exclusion criteria: * having life-threatening health problems

Keywords: term preterm vital signs incubator cover
efficacy and safety of app13007 for treatment of inflammation and pain after cataract surgery

Conditions: Ocular Inflammation and Pain

Summary: this phase 3 study will evaluate app13007 in comparison to the matching vehicle placebo in a randomized, parallel-group, double-masked fashion. the subjects will have undergone routine cataract surgery on day 0 of the study and will be assessed the next day (post-operative day 1; pod1) after uncomplicated surgery for eligibility for randomization to study treatment.


Eligibility criteria:
inclusion criteria: * patients 18 years of age or older expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye. * have a pin-hole corrected visual acuity without other correction of ≤ 1.3 logarithm of the minimum angle of resolution (logmar) in the study eye to be operated and contralateral eye as measured using an early treatment diabetic retinopathy study (etdrs) chart at visit 1. * willing and able to comply with study requirements and visit schedule. * provide signed and dated informed consent. exclusion criteria: * have a known sensitivity or allergy to clobetasol propionate, corticosteroids, or any of the study medication's components including benzalkonium chloride and soybean lecithin or any routine medication required during cataract surgery or for the conduct of study procedures * have an acc count \> 0 or any evidence of intraocular inflammation (e.g., flare) in either eye at the screening visit * have a grade \> 0 on the ocular pain assessment in either eye at the screening visit note: other inclusion/exclusion criteria apply.
efficacy, safety, and tolerability rollover study of eteplirsen in subjects with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy (DMD)

Summary: the primary objective of this study is to assess the ongoing efficacy, safety, and tolerability of an additional 212 weeks of treatment with eteplirsen injection in duchenne muscular dystrophy (dmd) subjects who have successfully completed the 28 week eteplirsen study: study 4658-us-201. this study will also evaluate the correlation between biomarkers for dmd and the clinical status of participating dmd subjects.

this is an open label, multiple dose extension study to assess the ongoing efficacy, safety, and tolerability of weekly intravenous (iv) infusions of eteplirsen in dmd subjects who have successfully completed study 4658-us 201. subjects will have the opportunity to enroll in this study during the last visit of study 4658-us-201 (week 28). eligible subjects will receive once weekly iv infusions of eteplirsen (50 or 30 mg/kg) for an additional 212 weeks. subjects will receive the same dose of eteplirsen they received in study 4658-us-201. subjects will thereafter continue to receive once weekly iv infusions of eteplirsen for up to an additional 72 week period (through week 284). if commercial eteplirsen becomes available during this additional 72 week period, participation in the study will be discontinued as subjects transition to commercial eteplirsen. safety, efficacy, pharmacokinetic (pk), and biomarker assessments will be performed at scheduled visits; adverse events (aes) and concomitant medications and therapies will be continuously monitored. if review of data from this open label study suggests that continued treatment with eteplirsen is warranted, this study may be extended by protocol amendment or subjects who successfully complete this study may have the opportunity to participate in a separate follow on, open label eteplirsen study.

Eligibility criteria:
inclusion criteria: a subject must meet all of the following criteria to be eligible for this study. 1. the subject and/or their parent/legal guardian are willing and able to provide signed informed consent. 2. the subject has successfully completed 28 weeks of treatment in study 4658-us-201. 3. the subject has a parent(s) or legal guardian(s) who is able to understand and comply with all of the study procedure requirements. exclusion criteria: a subject who meets any of the following criteria will be excluded from this study. 1. the subject has a prior or ongoing medical condition that, in the investigator's opinion, could adversely affect the safety of the subject or make it unlikely that the course of treatment or follow-up would be completed or impair the assessment of study results.

Keywords: dmd, duchenne, eteplirsen, dystrophy, dystrophin, exon 51
object finder for a retinal prosthesis

Conditions: Retinitis Pigmentosa

Summary: the proposed project seeks to provide object recognition as a feature in a retinal implant system. participants will be able to direct an object recognition application to find a desired object in the field of view of the head-mounted camera, and to direct the participant's view towards it through the presentation of a recognizable icon. a prototype system will be developed and evaluated in human subjects in phase i. a full system implementation and a second phase of the trial will be completed in phase ii.

the investigators propose to add an object-finding feature to a retinal prosthesis system. to use this feature, the participant will enable a special mode and input the desired object from a set of pre-programmed object types. imagery from the visible light camera in the system eyeglasses will be processed using object recognition software as the participant scans their head across the room scene. when the object is identified in the scene by the processor, a flashing icon will be output to the epiretinal array in the appropriate position to guide the participant to the physical location of the object. once located, the system will track the location of the object. there will be two phases to the human subjects evaluation, each run initially through simulations in sighted human subjects, followed by tests in argus ii participants. in phase 1, system evaluation in human subjects at johns hopkins university (jhu) will explore performance in representative tasks and compare prosthetic visual performance without and with the new object finding feature. an important aspect of the evaluation will be the comparison of different icons and presentation modes to assist participants in locating and reaching objects. in phase 2, the system will be integrated into the argus ii video processing unit (vpu), and jhu will conduct human trials that include functional testing of the integrated prototype in representative environments and optimizing the ergonomics of the system, e.g. simultaneous finding and tracking of multiple objects/icons.

Eligibility criteria:
inclusion criteria: * for healthy volunteers: vision corrected to 20/25, good general health * for retinitis pigmentosa (rp) patients: end-stage retinitis pigmentosa, recipient of an argus ii retinal prosthesis system exclusion criteria: * none

Keywords: retinitis pigmentosa argus ii retinal prosthesis system